US20230172484A1 - Device and method for non-invasive analysis of particles during medical ventilation - Google Patents
Device and method for non-invasive analysis of particles during medical ventilation Download PDFInfo
- Publication number
- US20230172484A1 US20230172484A1 US18/056,179 US202218056179A US2023172484A1 US 20230172484 A1 US20230172484 A1 US 20230172484A1 US 202218056179 A US202218056179 A US 202218056179A US 2023172484 A1 US2023172484 A1 US 2023172484A1
- Authority
- US
- United States
- Prior art keywords
- particles
- particle
- patient
- ventilator
- airways
- 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.)
- Pending
Links
- 239000002245 particle Substances 0.000 title claims abstract description 225
- 238000000034 method Methods 0.000 title claims description 34
- 238000004458 analytical method Methods 0.000 title claims description 18
- 238000009423 ventilation Methods 0.000 title description 9
- 239000012530 fluid Substances 0.000 claims abstract description 15
- 238000012512 characterization method Methods 0.000 claims abstract description 8
- 238000012544 monitoring process Methods 0.000 claims description 22
- 238000003745 diagnosis Methods 0.000 claims description 12
- 239000000443 aerosol Substances 0.000 claims description 11
- 238000005399 mechanical ventilation Methods 0.000 claims description 8
- 239000000126 substance Substances 0.000 claims description 7
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 5
- 238000001095 inductively coupled plasma mass spectrometry Methods 0.000 claims description 4
- 230000003287 optical effect Effects 0.000 claims description 4
- 206010002091 Anaesthesia Diseases 0.000 claims description 3
- 230000037005 anaesthesia Effects 0.000 claims description 3
- 238000002290 gas chromatography-mass spectrometry Methods 0.000 claims description 3
- 238000004895 liquid chromatography mass spectrometry Methods 0.000 claims description 3
- 238000005011 time of flight secondary ion mass spectroscopy Methods 0.000 claims description 3
- 238000010256 biochemical assay Methods 0.000 claims description 2
- 238000000921 elemental analysis Methods 0.000 claims description 2
- 238000001506 fluorescence spectroscopy Methods 0.000 claims description 2
- 238000004949 mass spectrometry Methods 0.000 claims description 2
- 238000000816 matrix-assisted laser desorption--ionisation Methods 0.000 claims description 2
- 238000003753 real-time PCR Methods 0.000 claims description 2
- 238000004626 scanning electron microscopy Methods 0.000 claims description 2
- 238000002042 time-of-flight secondary ion mass spectrometry Methods 0.000 claims description 2
- 238000002965 ELISA Methods 0.000 claims 1
- 210000004072 lung Anatomy 0.000 abstract description 29
- 239000007789 gas Substances 0.000 description 28
- 238000001514 detection method Methods 0.000 description 26
- 238000005259 measurement Methods 0.000 description 13
- 238000009826 distribution Methods 0.000 description 12
- 230000029058 respiratory gaseous exchange Effects 0.000 description 10
- 239000000523 sample Substances 0.000 description 8
- 238000005070 sampling Methods 0.000 description 7
- 206010069351 acute lung injury Diseases 0.000 description 6
- 238000009833 condensation Methods 0.000 description 6
- 230000005494 condensation Effects 0.000 description 6
- 210000002345 respiratory system Anatomy 0.000 description 6
- 230000006378 damage Effects 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 150000001875 compounds Chemical class 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 238000002414 normal-phase solid-phase extraction Methods 0.000 description 4
- 239000007787 solid Substances 0.000 description 4
- 238000010897 surface acoustic wave method Methods 0.000 description 4
- 206010001052 Acute respiratory distress syndrome Diseases 0.000 description 3
- 208000028399 Critical Illness Diseases 0.000 description 3
- 102000004127 Cytokines Human genes 0.000 description 3
- 108090000695 Cytokines Proteins 0.000 description 3
- 230000000721 bacterilogical effect Effects 0.000 description 3
- 238000004891 communication Methods 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 239000004094 surface-active agent Substances 0.000 description 3
- 230000003612 virological effect Effects 0.000 description 3
- 108091032973 (ribonucleotides)n+m Proteins 0.000 description 2
- 206010040047 Sepsis Diseases 0.000 description 2
- 230000000274 adsorptive effect Effects 0.000 description 2
- 238000001949 anaesthesia Methods 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000004590 computer program Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 230000002757 inflammatory effect Effects 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 230000003434 inspiratory effect Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 108020004999 messenger RNA Proteins 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 201000003144 pneumothorax Diseases 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 238000011002 quantification Methods 0.000 description 2
- 238000003380 quartz crystal microbalance Methods 0.000 description 2
- 230000000241 respiratory effect Effects 0.000 description 2
- 239000002594 sorbent Substances 0.000 description 2
- 238000004611 spectroscopical analysis Methods 0.000 description 2
- 238000006557 surface reaction Methods 0.000 description 2
- 230000004083 survival effect Effects 0.000 description 2
- 230000008733 trauma Effects 0.000 description 2
- 208000004852 Lung Injury Diseases 0.000 description 1
- 208000034486 Multi-organ failure Diseases 0.000 description 1
- 238000001069 Raman spectroscopy Methods 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 208000013616 Respiratory Distress Syndrome Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 238000005299 abrasion Methods 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 208000011341 adult acute respiratory distress syndrome Diseases 0.000 description 1
- 201000000028 adult respiratory distress syndrome Diseases 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 239000000090 biomarker Substances 0.000 description 1
- 210000000748 cardiovascular system Anatomy 0.000 description 1
- 230000005574 cross-species transmission Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 238000009795 derivation Methods 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 238000007306 functionalization reaction Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 231100000516 lung damage Toxicity 0.000 description 1
- 231100000515 lung injury Toxicity 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 210000003097 mucus Anatomy 0.000 description 1
- 208000029744 multiple organ dysfunction syndrome Diseases 0.000 description 1
- 239000002070 nanowire Substances 0.000 description 1
- 230000004768 organ dysfunction Effects 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 238000006213 oxygenation reaction Methods 0.000 description 1
- 238000005192 partition Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 230000007115 recruitment Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 238000004416 surface enhanced Raman spectroscopy Methods 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
- A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
- A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0066—Blowers or centrifugal pumps
- A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0816—Joints or connectors
- A61M16/0833—T- or Y-type connectors, e.g. Y-piece
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0816—Joints or connectors
- A61M16/0841—Joints or connectors for sampling
- A61M16/085—Gas sampling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0875—Connecting tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/10—Preparation of respiratory gases or vapours
- A61M16/104—Preparation of respiratory gases or vapours specially adapted for anaesthetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/10—Preparation of respiratory gases or vapours
- A61M16/105—Filters
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N15/10—Investigating individual particles
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/497—Physical analysis of biological material of gaseous biological material, e.g. breath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/02—Gases
- A61M2202/0241—Anaesthetics; Analgesics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/22—Devices for withdrawing samples in the gaseous state
- G01N2001/2244—Exhaled gas, e.g. alcohol detecting
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N2015/0023—Investigating dispersion of liquids
- G01N2015/0026—Investigating dispersion of liquids in gas, e.g. fog
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0255—Investigating particle size or size distribution with mechanical, e.g. inertial, classification, and investigation of sorted collections
- G01N2015/0261—Investigating particle size or size distribution with mechanical, e.g. inertial, classification, and investigation of sorted collections using impactors
Definitions
- This invention pertains in general to the field of breathing apparatuses, such as medical ventilators or anaesthesia machines. More particularly the invention relates to continuously diagnosing and monitoring of patients during ventilation or respiration.
- Inflammatory markers may be established through bronchoalveolar lavage (BAL) where e.g. 50-100 ml isotonic saline is instilled into the lung, recollected and analysed for bio-markers and surfactants.
- BAL bronchoalveolar lavage
- BAL is an invasive method that worsens the oxygenation and is restrictively used, for example, for infection diagnostic at stable patients.
- US 2007/0157931 relates to a disclosure of systems, methods, and devices for controlling delivery of aerosolized formulations to patients in need of treatment, which optimizes aerosol deposition to the respiratory tract of the patient and can be adapted for use in spontaneously breathing patients or in those requiring mechanical ventilation.
- the disclosure in this document does not teach that particles origin from the airways may be used for diagnosis or monitoring of a condition of the airways, such as parts of the lungs, of a patient. Neither does it disclose that these characterizations of these particles may be used for optimisation of, for example, PEEP.
- the only disclosure is related to determining a delivered dose of aerosolized formulation to a patient by monitoring exhaled waste and having knowledge of respiratory parameters, for example, the tidal volume.
- the method, device and/or system could be used to control and optimise the mechanical ventilator’s parameters, such as providing feedback to the ventilator based on information provided from diagnosis and/or monitoring of a ventilated patient’s airways. Further advantageous would be improved cost-effectiveness compared to the invasive methods used today.
- examples of the present disclosure preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a device, a system, and a method for diagnosing or monitoring a patient ventilated using a mechanical ventilator, according to the appended patent claims.
- Examples of the disclosure relate to continuously diagnosing and/or monitoring ventilation or respiration by quantifying, such as by means of counting or weighting, particles in exhaled breath from a patient ventilated by a mechanical ventilator, wherein said particles are formed in the patient’s airways, such as originating from the respiratory tract lining fluid (e.g. in the lungs). More particularly the provided information may be used to control the ventilator. In particular breathing patterns or mechanical breathing control modes of the ventilator may be controlled or adjusted based on the provided information.
- a diagnostic device for characterisation of particles from a patient’s airways, such as a lung, when ventilated by a ventilator.
- the device may also be used for controlling of the medical ventilator using the obtained information from the characterisation of the particles.
- the device comprising a particle detecting unit configured to be connected to a conduit for passing expiration fluid from the patient. Further, the particle detecting unit is configured for obtaining data related particles exhaled from the patent’s airways.
- the device may have a control unit configured for analysing the particle data to diagnose and/or monitor a condition of the patients.
- the main particles are aerosols being released from a patient’s airways, e.g. part of the respiratory systems, such as a lung.
- a particle in this context means solid, liquid and/or liquid-coated solid objects, which are often suspended in a gas, normally but not necessarily air. Some of the particles of interest may be endogenous particles.
- Object sizes normally but not necessarily being larger than 0.005 micrometre and normally, but not necessarily, being smaller than 15 micrometre, such as between 0.1 to 15 micrometre, such as between 0.3 to 10 micrometer, such as between 0.3 to 5 micrometre..
- size is meant either aerodynamic diameter or electrical mobility diameter.
- control unit may be configured to adjust the apparatus to provide a mechanical ventilation mode based on the particle data related to particles exhaled from the patent’s airways
- a diagnostic system for characterisation of particles from a patient’s airways, such as a lung, when ventilated by a ventilator.
- the device may also be used for controlling of the medical ventilator using the obtained information from the characterisation of the particles.
- the system comprising, a particle detecting unit configured to be connected to conduit for passing expiration fluid from the patient.
- the particle detecting unit is configured for obtaining particle data related to particles exhaled from the patent’s airways.
- the system may further comprise a particle collection unit, such as an impactor, configured to be connected to the conduit downstream said ventilator.
- the particle collection unit comprises collection plates for collecting the exhaled particles.
- the collection plates are positioned so that the particles may be sorted according to their size or mass. Hence a particle profile may be obtained.
- the obtained information may be used for diagnosis, monitoring and/or treatment of a patient
- the particle collection unit may also be a particle trap (adsorptive, cryogenic, chemical), or at least one filter, or a collection chamber, or electrostatic collection components, or sampling bags, or canisters, or Solid-phase extraction (SPE) membrane, or sorbent tubes, or condensation components (such as surface condensation collectors), or utilising surface functionalization or derivation, or any other type of collectors suitable for collecting or capturing particles from exhaled fluids.
- a particle trap asdsorptive, cryogenic, chemical
- at least one filter or a collection chamber, or electrostatic collection components, or sampling bags, or canisters, or Solid-phase extraction (SPE) membrane, or sorbent tubes, or condensation components (such as surface condensation collectors), or utilising surface functionalization or derivation, or any other type of collectors suitable for collecting or capturing particles from exhaled fluids.
- SPE Solid-phase extraction
- a method for diagnosing or monitoring a condition of a patient connected to a ventilator comprising, providing a particle detecting unit configured to be connected to a conduit for passing expiration fluid from the patient’s obtaining airways, and data related particles being exhaled from the patent’s airways.
- Yet use another embodiment of the disclosure provides of a particle counter, wherein data from said particle counter is used for controlling said mechanical ventilator or respirator, such as controlling Positive end Expiratory Pressure (PEEP), or airway pressure, or tidal volume, or continues positive airway pressure (CPAP).
- PEEP Positive end Expiratory Pressure
- CPAP continues positive airway pressure
- Some examples of the disclosure provide for continuous non-invasive monitoring and/or diagnosis of a patient being ventilated by a mechanical ventilator.
- a mechanical ventilator For example, over-dimension, over-destination, and abrasive damages of the lungs may be avoided.
- Some examples of the disclosure also provide for controlling a mechanical ventilator by optimizing the control parameters by using the information provided by the monitoring and/or diagnostic device.
- Some examples of the disclosure also provide for a safer and more careful treatment of ventilated critically ill patients, thus increased chance of survival. Further, even patients not suitable to invasive methods, such as BAL, may be diagnosed or monitored without the related drawbacks.
- Some examples of the disclosure also provide for a more cost-effective way of monitoring and/or diagnosing patients than normally used methods.
- Some examples of the disclosure also provide for a warning of acute respiratory distress syndrome (ARDS), or acute lung injury (ALI), for instance due to trauma; or sepsis; or collapse of lung; or acute lung injury.
- ARDS acute respiratory distress syndrome
- ALI acute lung injury
- the warning may be due to detection of a rapid increase in particles in the exhaled breath.
- FIGS. 1 A to 1 E are showing schematic illustrations of different examples of a particle detecting unit connected to a medical ventilator according to the disclosure
- FIG. 2 is showing a schematic illustration of an exemplary system using both a particle detecting unit for continues particle quantification and a collection unit, such as an impactor, according to the disclosure;
- FIG. 3 is schematically illustrating an exemplary embodiment of a method according to the disclosure
- FIG. 4 A is showing an decrease in different size fractions after an increase in PEEP.
- FIG. 4 B is showing an increase in different size fractions after a decrease in PEEP.
- the following description focuses on an embodiment of the present disclosure applicable to a device, system and method for diagnosing and/or monitoring ventilated patients and in particular to quantifying particles in exhaled air from ventiled patients. Additionally, the particles may be sampled or collected for further analyses. Further, the device, system and/or method may be used to control or optimise the parameters of the mechanical ventilator.
- the present inventors have during their research found out that particles originating from the airways and especially particles generated in the airways of the respiratory system, such as in the lungs, may be used as a marker for the condition of the airways.
- the condition of a ventilated patient’s airways e.g. lung
- the amount of quantified particles may indicate the state of the lung.
- information related to an increase or a decrease of detected particles may also be used to provide an indication of the state of a patient’s airways.
- distributions of particles may also be used for monitoring and/or diagnosis purposes. This applies in particular to particles in the expiratory fluid. In some examples, this may also be applicable to particles in the inspiratory gas.
- PEEP positive end expiratory-pressure
- CPAP continuous positive pressure
- ventilator can be a mechanical controlled using feedback from the obtained measurement data and/or signals provided by the particle detecting unit used for quantifying the particles.
- the amount of particles in expiratory airflow will decrease with increased PEEP until leveling out, for example, when reaching a plateau.
- the optimal PEEP may be applied to the airways of the vventilated patient.
- a PEEP adjustment may be initiated, at least temporarily, based on the particle measurement data. If an at least partly closed lung is detected, a PEEP increase may be initiated, e.g. by a control unit of a ventilator, or software executed in a processing unit thereof, such as the aforementioned control unit. Detection of increasing particle levels is an indication of alveoli recruitment, i.e. opening up the lung.
- detection of the aforementioned plateau level over a predefined time may be taken for aborting a period of increased PEEP.
- the inventors have, for example, found out there is a correlation between the proteins in the BAL-liquid and the particles identified in exhaled breath. For instance a PExA-system (such as disclosed in PCT/SE08/51110, incorporated by reference herein in its entirety) may be used for this identification in certain examples. Until now it has been impossible to study this mucus layer and/or respiratory tracked lining fluid non-invasively. Previous studies have mostly used invasive methods, such as BAL.
- the particle quantification may be combined with collection of particles for chemical, biological, DNA/RNA/mRNA, virological and bacteriological, or any other analysis of the particles.
- the main particles are aerosols, released from a patient’s airways, e.g. part of the respiratory systems, such as a lung.
- a particle in this context means solid, liquid and/or liquid-coated solid objects, which are often suspended in a gas, normally but not necessarily air. Some of the particles of interest may be endogenous particles. Object sizes normally but not necessarily being larger than 0.005 micrometre and normally but not necessarily being smaller than 15 micrometre. By size is meant either aerodynamic diameter or electrical mobility diameter, suitably aerodynamic diameter.
- Expired gases may further be directed to a collection site, e.g. for contaminated fluids, e.g. via filter systems or to an evacuation system of a central hospital gas evacuation system.
- FIG. 1 A a configuration 1 is illustrated where the particle detecting unit 10 is connected to the expiratory airflow conduit 11 from a patient, here illustrated as connected downstream a Y-piece of the tubing of a mechanical ventilator connectable to a patient (not shown).
- the inspiratory airflow is connected to the patient through conduit 12 .
- the particle detection unit 10 may be connected to a user interface such as a display or a sound source to provide medical staff, such as doctors or nurses, with patient airway related information. This information may be used to optimise the parameters of the mechanical ventilator 14 .
- the particle detection unit 10 may be connected to expiratory airflow conduit 11 either inside the ventilator 14 or after the ventilator.
- the particle detection unit 10 and the interface 13 may be connectable to a control unit 15 to automatically control some of the parameters of the mechanical ventilator 14 . This may be performed using a feedback loop. Alternatively, or in addition, the obtained related information may be transferred to the ventilator 14 from the detection unit for display on a display unit of the ventilator 14 .
- the particle detection unit 10 may in some examples be connected directly to the expiratory airflow conduit in a mainstream configuration since it has a low pressure drop impact on the expiratory flow. This is important as expiration is often passive even during mechanical ventilation (maximum gas flow without externally increased obstruction/pressure drop is desired) and/or work of breathing is desired to be kept at a minimum.
- the particle detecting unit may quantify the particles, on-line, in the mainstream of the exhaled gas. Additionally the particle detecting unit 10 may in some examples sort the particles according to their mass. Alternatively, and/or additionally, the particles’ sizes may also provide a particle distribution profile of the particles. The particle distribution profile is a measure of how many particles of a particular mass or size (or mass or size range) are present in the exhaled air, and can also be used to determine a medical condition of a subject.
- the particle detection unit may be, for example, a particle counter such as a Grimm 1.108 optical particle counter (Grimm Aerosoltechnik, Ainring, Germany), capable of counting, and sizing particles in 15 size intervals from 0.3 to 20 micrometre. But other optical particle counters such as a Grimm 1.107 and 1.109 may be used. Other manufacturers such as TSI have particle sizers but also time of flight equipment that may be used as particle detection units 10 . Other options may be, Non-optical, electrostatically, conductance, condensation particle counters, Quartz Crystal Microbalance (QCM), Surface Plasmon Resonance (SPR) or surface acoustic-wave (SAW) etc.
- QCM Quartz Crystal Microbalance
- SPR Surface Plasmon Resonance
- SAW surface acoustic-wave
- the particle detecting unit 10 may provide a number size distribution of the measured aerosol or a mass distribution, calculated from the measured number size distribution.
- particle-laden gas is passed through a small, well defined, intensely illuminated volume in a manner so that only one particle at a time is illuminated.
- the illuminated particle gives rise to a pulse of scattered light, the intensity of which is measured. Since the intensity of scattered light depends on the particle size, it is possible to count and size the particles in the air stream.
- the conduit 11 may comprise a sub-volume where the exhaled gas flow supplies the small well defined volume with a suitably measurable gas flow. By calibration the number of particles passing through the well defined volume is made proportional to the total amount of particles passing through the conduit 11 .
- Time of flight may also be used as a measurement principle for a particle detecting unit 10 .
- the time of particle propagation from one laser beam to another is measured.
- the time it takes for the particle to move from one beam to the other depends on the particle’s mass or size which may therefore be measured and characterised.
- the particle detecting unit is continuously measuring the number of particles online in the exhaled gas.
- the sample time to detect a sufficient number of particles before updating the interface 13 of the particle detection unit 10 may be in real time, such as 1 second. It may also be over a time interval such as 2 seconds, such as 4 seconds, such as 10 second. Alternatively the sampling time may be minutes, such as 1 minute, such as 5 minutes, such as 10 minutes such as 30 minutes, such as 60 minutes.
- the sampling period may also be defined in exhalations, one exhalation may provide a sufficient number of particles, but particles may also be quantified over repeated exhalations.
- FIG. 1 B A further configuration 2 of the disclosure is illustrated in FIG. 1 B .
- This example is similar to the configuration illustrated in FIG. 1 A .
- the particle detecting unit 10 is directly connected to the expiratory conduit 11 it is side-streamed through the conduit 16 .
- This may have the advantage to be easier to connect to the hoses of the ventilator.
- a potential pressure drop in the main lumen 11 is avoided.
- the side stream conduit 16 may have a much smaller diameter making it easier to calibrate than measuring on the larger expiration conduit 11 .
- a predefined ratio of the air flow in the conduit 11 is directed and then connected back at a different point. This may be facilitated by a side-stream sampling pump ensuring a constant sampling gas flow. Thus loss of pressure is avoided which may disturb the ventilator 14 .
- FIG. 1 C an example of an alternative side stream configuration 7 is illustrated.
- the expired gases is directed into a side stream conduit 1.6 to be measure using a particle detection unit 10 .
- the expired gases may then be directed to a collection site, e.g. for contaminated fluids, e.g. via filter systems or to an evacuation system of a central hospital gas evacuation system.
- FIG. 1 D a further configuration 3 is illustrated, the particle detection unit is connected before (upstream) the Y-piece, making it possible to measure or detect particles in both expiration and inspiration gases. This may alternatively be made in a side stream configuration as in FIG. 1 B .
- one particle detection unit 10 is connected to the expiration conduit 11 and one particle detection unit 18 is connected to the inspiration conduit 12 .
- the particle entering the airways may be characterised and used in the analysis. For example detection of particles in inspiration gases may provide a warning to increase safety since particles in the inspiration gases may indicate failure of, for example, a filter.
- detection of particles in the inspiration gases may also provide a warning, such as during delivery of anaesthesia to a patient, that a delivered medicament is not fully evaporated.
- detection of an amount of particles in the inspiration gases may also provide a possibility of estimate the amount of medicament delivered. For example, those instances when the medicament is delivered as aerosols in the inspiration conduit.
- the information related to a detected increase in exhaled particles may also be used to automatically adjust, for example the PEEP to avoid opening and closing and thereby avoid decrease in surfactants that may lead to multi organ failure or death, using the control unit 15 connected to the ventilator 14 .
- some examples of the disclosure also provide for a warning of acute respiratory distress syndrome (ARDS) or acute lung injury (ALI) for instance due to trauma; or sepsis; or collapse of lung; or acute lung injury.
- ARDS acute respiratory distress syndrome
- ALI acute lung injury
- the warning may be provided upon to detection of a rapid increase in particles in the exhaled breath.
- FIG. 2 an embodiment of a system 5 comprising a further particle collection unit 19 is illustrated.
- This collection unit is used to collect or sample volatile, semi-volatile and/or non-volatile compounds or materials in the exhaled breath.
- the collection unit 19 may be used to collect or sample particles being vehicles for transporting such compounds or materials, for example non-volatile compounds transported by aerosol particles.
- the collection unit 19 may be a cascade impactor, such as a commercially available PM10 Impactor, Dekati Ltd, Tampers, Finland. It should be noted that the PM10 Impactor is only known for other purposes and uses than the herein described.
- the collection unit may also be a particle trap (adsorptive, cryogenic, chemical), or at least one filter, or a collection chamber, or electrostatic collection components, or sampling bags or canisters, Solid-phase extraction SPE membrane, sorbent tubes, condensation components (such as surface condensation collectors), or utilising surface functionalization, or any other type of collectors suitable for collecting particles from exhaled fluids.
- the particle collection unit 19 is here illustrated to be connectable downstream the ventilator 14 .
- the ventilator may not be affected by a pressure drop, such an impactor may cause on the system.
- the exhaust gas from the ventilator 14 is flowing through the particle collection unit 19 either driven by a pump (not shown) or by the under pressure provided by an evacuation system (not shown).
- the particle collection unit 19 may be connected at other locations on the conduit 11 or by utilizing a side stream, but then a compensation for any pressure drops may be needed, for example by using a pump.
- the detection unit 10 is here illustrated to be positioned at the exhalation conduit 11 but may in some examples be positioned at any position hereinabove described in conjunction with FIG. 1 A to FIG. 1 E .
- the detection unit 10 may be positioned apposition to the collection unit, such as in or after the ventilator 14 .
- the particle collectiong unit 19 e.g. a suitable impactor, has an inlet and an outlet, and comprising a plurality of stages arranged such that a gas stream comprising particles enters the impactor via the inlet and passes through each stage in turn before exiting the impactor via said outlet.
- Each stage of the impactor is separated from adjacent stages by a partition having an orifice which directs the gas stream towards collection plates, the major face of each collection plate being arranged substantially perpendicular to the direction of flow of the gas stream.
- Exhaled particles are passed through the inertial impactor in a gas stream, such that the primary gas stream is directed towards each collection plates in each stage in turn.
- the at least first collection plate located in a first stage collects particles of a first mass and at least a second collection plate located in a second stage collects particles of a second mass. In this way a particle profile is obtained. After being sorted according to their size or mass, particles are analysed.
- TOP-SIMS time-of-flight secondary ion mass spectrometry
- MALDI-MS matrix assisted laser desorption ionization mass spectrometry
- GCMS gas-chromatography mass spectrometry
- LCMS liquid chromatography mass spectrometry
- biochemical assays or protocols based on labelled antibodies such as multiplex Elisa plates, quantitative PCR analysis, scanning electron microscopy (SEM), surface plasmon resonance (SPR), fluorescence spectroscopy, Raman spectroscopy, Surface enhanced Raman spectroscopy (SERS), TOC (total organic content) analysis, elemental analysis and inductively coupled plasma mass spectrometry (ICP-MS), surface acoustic-wave (SAW) and nano-wires for detection of particular proteins with or without being first washed off the collection plates.
- TOP-SIMS time-of-flight secondary ion mass spectrometry
- MALDI-MS matrix assisted laser desorption ionization mass spectrometry
- the particle collection unit 19 may be used to collect or sample particles or compounds in exhaled breath for chemical, biological DNA, virological and bacteriological analysis of the particles.
- analyses may be carried out off-line. Alternatively, using some of the analysis techniques mentioned above, it may in some examples be preferable to carry out these analyses on-line.
- a possible implementation of an embodiment for on -line analysis may be use of SERS-technique in combination with the impactor, such as use of specific surface coatings i.e. SERS-substrates, metal-doped sol-gel, derivatizationable coatings or other types of functionalization (i.e. SERS-labeled gene-probes or antibodies).
- Diagnosis of ongoing ventilation and adaptation of ventilation strategies may in some examples be made based on both the particles measurements and additionally based on the chemical, biological, DNA/RNA/mRNA, virological and/or bacteriological analysis of the particles themselves.
- the analysis conducted using the particle collection unit 19 may provide possibilities of detecting diseases or damages to the airways, such as lungs.
- the obtain information may be used for diagnosis, monitoring and/or treatment of a patient.
- the information provided by the particle collection unit 19 may also in some examples be used to optimize the ventilation of the patient.
- the collection time of the collection unit 19 may be similar to the aforementioned times for the particle detection unit 10 .
- a collector unit such as an impactor, may be used to quantifying the number of particles by weight. By collecting specific size and/or mass ranges of particles on the collection plates, the number of particles exhaled during a particular collection time may be estimated.
- the ventilator may be used to control the patient’s breathing to optimise the collection of particles.
- the ventilator may for example be controlled so that the patient is simulated to hold his breath for a period of time before performing a deep exhalation.
- the performing measurements it may be advantageous if the particle collection unit is kept at a temperature such that the size distribution of the exhaled aerosol is not changed either by evaporation or condensation of water vapor.
- the same may also apply for the measurements using the particle detection unit.
- the size distribution of the exhaled aerosol is not changed when obtaining a particle distribution profile of the particles.
- the exhaled air passes an opening into the particle collection unit which is located in a thermostated compartment, also here with the purpose of maintaining the aerosol size distribution.
- a particle detection unit in the compartment is located a reservoir for the exhaled air.
- an inertial impactor for the collection of particles is connected to the reservoir first opening.
- a sample is taken in the following way by the particle collection unit when being an impactor. It is assumed that the impactor is loaded with clean collection plates, and that the system, especially the impactor, has attained the desired temperature. First, the flow meter is zeroed to allow a proper measurement of flows, and then the moist clean air flow is set at a value so that a positive flow will be maintained from the system during measurement. Then the impactor flow is set at a value lower than the clean air flow. During this procedure, no deposit will be collected on the plates, since the system is fed by clean particle free air. Then the optical particle counter is started and it is checked that no spurious particles are present, e.g. indicating a leak into the system.
- the particle counter continuously draws a sample and produces a size distribution every six seconds while the impactor collects samples for later analysis.
- the collection is terminated, the time of sampling and exhaled volume recorded.
- the flow through the impactor is turned off, the impactor removed from the measurement system and the loaded plates are recovered.
- a further aspect of the disclosure provides for a method 6 illustrated schematically in FIG. 3 .
- the method 6 provides diagnosis and/or monitoring of a condition of a patient connected to a ventilator.
- the method 6 is carried out by providing 100 a particle detecting unit connected to a conduit for passing expiration fluid from said patient. Further, the method comprises a step of obtaining data 110 related particles exhaled from said patient’s airways.
- the related data may be analysed to provide further information concerning the state of the ventilated patient’s airways, for example the amount and/or size and/or mass profile of the detected particles.
- the obtained data or information may be used by medical staff to improve the treatment of the ventilated patient, such as optimising the mechanical ventilator.
- the information may optionally be used for automatically adjusting 120 the mechanical ventilator using a control unit similar to what has previously been described.
- a particle collection unit may be provided 130 to obtain further information which may be used in diagnosing and/or monitoring the patient.
- the disclosure also relates to use of a particle counter to measure a number of particles in exhaled breath from a patient ventilated by a mechanical ventilator or respirator, for diagnosis or monitoring of the patient’s airways.
- the data from the particle counter is used for controlling the mechanical ventilator or respirator, such as controlling PEEP, tidal volume, CPAP etc.
- FIG. 4 A and FIG. 4 B illustrates clinical observations at patients having Adult respiratory distress syndrome and treated using mechanical ventilation.
- the graph 200 in FIG. 4 A is showing particles in exhaled air when increasing the PEEP. The particles are measured using a particle detection unit. The graphs show a clear decrease in particles in the exhaled air for all size fractions.
- the curves in the graph 200 illustrate different ranges of particle sizes.
- the top curve 201 shows particles with a diameter larger than 2 microns and the lowest curve 202 shows particle with a diameter between 0.3 and 0.4 microns.
- the decrease happened about 10 to 20 seconds after the increase of PEEP.
- the decrease may happen earlier or immediately after an increase of PEEP.
- the decrease may happen later than 20 seconds.
- the graph 210 in FIG. 4 B is showing particles in exhaled air measured in conjunction with a decrease in PEEP.
- the graphs show a clear increase in particles in the exhaled air for all size fractions.
- the curves in the graph 210 illustrate different ranges of particle sizes the top curve 201 in the graph 210 is showing particles with a diameter larger than 2 microns and the lowest curve 202 shows particles with a diameter between 0.3 and 0.4 microns.
- the increase happened about 10 to 20 seconds after the decrease of PEEP. In other examples the increase may happen earlier or immediately after a decrease of PEEP. In some other examples, the increase may happen later than 20 seconds.
Abstract
A diagnostic device is disclosed for characterisation of particles from a patient’s airways, such as a lung, when ventilated by a ventilator, and/or for control thereof, comprising a particle detecting unit configured to be connected to a conduit for passing expiration fluid from said patient, for obtaining data related to particles being exhaled from said patent’s airways.
Description
- This invention pertains in general to the field of breathing apparatuses, such as medical ventilators or anaesthesia machines. More particularly the invention relates to continuously diagnosing and monitoring of patients during ventilation or respiration.
- It is known that mechanical ventilation provided by ventilators may induce lung injuries. This is in particular related to application of non physiological excess pressures when mechanically ventilating the lungs. For example structural damages such as over-distension of the lungs, such as alveoli rupture, as well as abrasion damages to the lungs due to phasic opening or closing may occur.
- Mechanical ventilation lowers the levels of surfactant in the lungs with a higher risk of collapsing of the distal airways and alveolar. This will cause increased levels of released inflammatory markers, i.e. cytokines. Inflammatory markers may be established through bronchoalveolar lavage (BAL) where e.g. 50-100 ml isotonic saline is instilled into the lung, recollected and analysed for bio-markers and surfactants.
- It has been shown that “protective” strategies with lower tidal volumes and higher end expiratory-pressure may be advantageous to lower pulmonary cytokines and systematic release of cytokines, measured using BAL. There are evidences suggesting that a spill-over of mediators to the cardiovascular system may help to cause organ dysfunction or failure, such as renal insufficiency.
- For critically ill patients with a high demand of oxygen, BAL is an invasive method that worsens the oxygenation and is restrictively used, for example, for infection diagnostic at stable patients.
- US 2007/0157931 relates to a disclosure of systems, methods, and devices for controlling delivery of aerosolized formulations to patients in need of treatment, which optimizes aerosol deposition to the respiratory tract of the patient and can be adapted for use in spontaneously breathing patients or in those requiring mechanical ventilation.
- The disclosure in this document does not teach that particles origin from the airways may be used for diagnosis or monitoring of a condition of the airways, such as parts of the lungs, of a patient. Neither does it disclose that these characterizations of these particles may be used for optimisation of, for example, PEEP. The only disclosure is related to determining a delivered dose of aerosolized formulation to a patient by monitoring exhaled waste and having knowledge of respiratory parameters, for example, the tidal volume.
- Thus, there is a need for an improved method, device and/or system for non-invasive, online diagnosis and/or monitoring of a ventilated patient’s airway (e.g. lung) condition. Such a method, device and system can provide information to facilitate adjustments of the ventilator by a medical doctor. Thereby, the possibilities of a more careful ventilation treatment may increase and in the end a higher likelihood of survival of critically ill patients.
- Further, it would be advantageous if the method, device and/or system could be used to control and optimise the mechanical ventilator’s parameters, such as providing feedback to the ventilator based on information provided from diagnosis and/or monitoring of a ventilated patient’s airways. Further advantageous would be improved cost-effectiveness compared to the invasive methods used today.
- Accordingly, examples of the present disclosure preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a device, a system, and a method for diagnosing or monitoring a patient ventilated using a mechanical ventilator, according to the appended patent claims.
- Examples of the disclosure relate to continuously diagnosing and/or monitoring ventilation or respiration by quantifying, such as by means of counting or weighting, particles in exhaled breath from a patient ventilated by a mechanical ventilator, wherein said particles are formed in the patient’s airways, such as originating from the respiratory tract lining fluid (e.g. in the lungs). More particularly the provided information may be used to control the ventilator. In particular breathing patterns or mechanical breathing control modes of the ventilator may be controlled or adjusted based on the provided information.
- According to aspects of the disclosure, a diagnostic device is provided for characterisation of particles from a patient’s airways, such as a lung, when ventilated by a ventilator. In some examples, the device may also be used for controlling of the medical ventilator using the obtained information from the characterisation of the particles. The device comprising a particle detecting unit configured to be connected to a conduit for passing expiration fluid from the patient. Further, the particle detecting unit is configured for obtaining data related particles exhaled from the patent’s airways.
- Additionally, the device may have a control unit configured for analysing the particle data to diagnose and/or monitor a condition of the patients.
- The main particles are aerosols being released from a patient’s airways, e.g. part of the respiratory systems, such as a lung. A particle in this context means solid, liquid and/or liquid-coated solid objects, which are often suspended in a gas, normally but not necessarily air. Some of the particles of interest may be endogenous particles. Object sizes normally but not necessarily being larger than 0.005 micrometre and normally, but not necessarily, being smaller than 15 micrometre, such as between 0.1 to 15 micrometre, such as between 0.3 to 10 micrometer, such as between 0.3 to 5 micrometre.. By size is meant either aerodynamic diameter or electrical mobility diameter.
- In some examples of the disclosure, the control unit may be configured to adjust the apparatus to provide a mechanical ventilation mode based on the particle data related to particles exhaled from the patent’s airways
- According to aspects of the disclosure, a diagnostic system is provided for characterisation of particles from a patient’s airways, such as a lung, when ventilated by a ventilator. In some examples, the device may also be used for controlling of the medical ventilator using the obtained information from the characterisation of the particles. The system comprising, a particle detecting unit configured to be connected to conduit for passing expiration fluid from the patient. The particle detecting unit is configured for obtaining particle data related to particles exhaled from the patent’s airways. The system may further comprise a particle collection unit, such as an impactor, configured to be connected to the conduit downstream said ventilator.
- In some examples of the disclosure, the particle collection unit comprises collection plates for collecting the exhaled particles. The collection plates are positioned so that the particles may be sorted according to their size or mass. Hence a particle profile may be obtained.
- By analysing the chemical content of the particles possibilities of detecting diseases or damages to the airways, such as lungs may be provided. The obtained information may be used for diagnosis, monitoring and/or treatment of a patient
- Alternatively, the particle collection unit may also be a particle trap (adsorptive, cryogenic, chemical), or at least one filter, or a collection chamber, or electrostatic collection components, or sampling bags, or canisters, or Solid-phase extraction (SPE) membrane, or sorbent tubes, or condensation components (such as surface condensation collectors), or utilising surface functionalization or derivation, or any other type of collectors suitable for collecting or capturing particles from exhaled fluids.
- According to another aspect of the disclosure, a method for diagnosing or monitoring a condition of a patient connected to a ventilator is provided. The method comprising, providing a particle detecting unit configured to be connected to a conduit for passing expiration fluid from the patient’s obtaining airways, and data related particles being exhaled from the patent’s airways.
- Further examples of the disclosure provides use of a particle counter to measure a number of particles in exhaled breath from a patient ventilated by a mechanical ventilator or respirator, for diagnosis and/or monitoring of the patent’s airways.
- Yet use another embodiment of the disclosure provides of a particle counter, wherein data from said particle counter is used for controlling said mechanical ventilator or respirator, such as controlling Positive end Expiratory Pressure (PEEP), or airway pressure, or tidal volume, or continues positive airway pressure (CPAP).
- Further examples of the disclosure are defined in the dependent claims, wherein features for the second and subsequent aspects of the disclosure are as for the first aspect mutatis mutandis.
- Some examples of the disclosure provide for continuous non-invasive monitoring and/or diagnosis of a patient being ventilated by a mechanical ventilator. Thus, for example, over-dimension, over-destination, and abrasive damages of the lungs may be avoided.
- Some examples of the disclosure also provide for controlling a mechanical ventilator by optimizing the control parameters by using the information provided by the monitoring and/or diagnostic device.
- Some examples of the disclosure also provide for a safer and more careful treatment of ventilated critically ill patients, thus increased chance of survival. Further, even patients not suitable to invasive methods, such as BAL, may be diagnosed or monitored without the related drawbacks.
- Some examples of the disclosure also provide for a more cost-effective way of monitoring and/or diagnosing patients than normally used methods.
- Some examples of the disclosure also provide for a warning of acute respiratory distress syndrome (ARDS), or acute lung injury (ALI), for instance due to trauma; or sepsis; or collapse of lung; or acute lung injury. The warning may be due to detection of a rapid increase in particles in the exhaled breath.
- It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
- These and other aspects, features and advantages of which examples of the disclosure are capable of will be apparent and elucidated from the following description of examples of the present disclosure, reference being made to the accompanying drawings, in which
-
FIGS. 1A to 1E are showing schematic illustrations of different examples of a particle detecting unit connected to a medical ventilator according to the disclosure; -
FIG. 2 is showing a schematic illustration of an exemplary system using both a particle detecting unit for continues particle quantification and a collection unit, such as an impactor, according to the disclosure; -
FIG. 3 is schematically illustrating an exemplary embodiment of a method according to the disclosure; -
FIG. 4A is showing an decrease in different size fractions after an increase in PEEP; and -
FIG. 4B is showing an increase in different size fractions after a decrease in PEEP. - Specific examples of the disclosure will now be described with reference to the accompanying drawings. This disclosure may, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein; rather, these examples are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. The terminology used in the detailed description of the examples illustrated in the accompanying drawings is not intended to be limiting of the disclosure. In the drawings, like numbers refer to like elements.
- The following description focuses on an embodiment of the present disclosure applicable to a device, system and method for diagnosing and/or monitoring ventilated patients and in particular to quantifying particles in exhaled air from ventiled patients. Additionally, the particles may be sampled or collected for further analyses. Further, the device, system and/or method may be used to control or optimise the parameters of the mechanical ventilator.
- When parts of a patient’s airways, e.g. the respiratory system, such as the lungs, fail to function correctly, such as a partly collapse of the airways, parts of the airways become narrow and/or alveolar may come into contact. These contacts and/or collapses may result in an increase in particle production during breathing, particularly when these at least partially collapsed parts completely or to some extent phasic open and close.
- The present inventors have during their research found out that particles originating from the airways and especially particles generated in the airways of the respiratory system, such as in the lungs, may be used as a marker for the condition of the airways. By continuously quantifying, i.e. counting and/or weighting and/or determining the size of these particle, the condition of a ventilated patient’s airways, e.g. lung, may be diagnosed and/or monitored. The amount of quantified particles may indicate the state of the lung. Alternatively and/or additionally information related to an increase or a decrease of detected particles may also be used to provide an indication of the state of a patient’s airways.
- Further, distributions of particles, such as size distribution characteristics of the particles may also be used for monitoring and/or diagnosis purposes. This applies in particular to particles in the expiratory fluid. In some examples, this may also be applicable to particles in the inspiratory gas. By quantifying the particles in the expiratory airflow, parameters related to the breathing as positive end expiratory-pressure (PEEP), pattern, such or continuous positive pressure (CPAP), may be optimized.
- Alternatively and/or additionally, in some examples, ventilator can be a mechanical controlled using feedback from the obtained measurement data and/or signals provided by the particle detecting unit used for quantifying the particles.
- Thus collapse of airways or repeated airway closure opening may be avoided. Further, the information and from detecting or quantifying the particles in expiratory gas flow from a patient’s airways may give information of the degree of collapse and reopening of portions of a lung.
- When applying at least temporary increased PEEP levels to open up part of a patient’s airways, such as a lung, the amount of particles in expiratory airflow will decrease with increased PEEP until leveling out, for example, when reaching a plateau. When the plateau has been reached the optimal PEEP may be applied to the airways of the vventilated patient.
- When the lung is opened up, the PEEP level or ventilation pressures in general may be lowered again. This is advantageous as lung damage, for example over-dimension, over-destination, from a too high pressure during mechanical ventilation is effectively prevented. A description of examples of suitable ventilation manoeuvres controllable by means of the herein described particle measurement principle is described in an article entitled “Open up the lung and keep the lung open” by B. Lachmann in Intensive Care Med (1992) 18:319-321.
- Hence, a PEEP adjustment may be initiated, at least temporarily, based on the particle measurement data. If an at least partly closed lung is detected, a PEEP increase may be initiated, e.g. by a control unit of a ventilator, or software executed in a processing unit thereof, such as the aforementioned control unit. Detection of increasing particle levels is an indication of alveoli recruitment, i.e. opening up the lung.
- Additionally and/or alternatively, in some examples, detection of the aforementioned plateau level over a predefined time may be taken for aborting a period of increased PEEP.
- The inventors have, for example, found out there is a correlation between the proteins in the BAL-liquid and the particles identified in exhaled breath. For instance a PExA-system (such as disclosed in PCT/SE08/51110, incorporated by reference herein in its entirety) may be used for this identification in certain examples. Until now it has been impossible to study this mucus layer and/or respiratory tracked lining fluid non-invasively. Previous studies have mostly used invasive methods, such as BAL.
- The particle quantification may be combined with collection of particles for chemical, biological, DNA/RNA/mRNA, virological and bacteriological, or any other analysis of the particles.
- The main particles are aerosols, released from a patient’s airways, e.g. part of the respiratory systems, such as a lung. A particle in this context means solid, liquid and/or liquid-coated solid objects, which are often suspended in a gas, normally but not necessarily air. Some of the particles of interest may be endogenous particles. Object sizes normally but not necessarily being larger than 0.005 micrometre and normally but not necessarily being smaller than 15 micrometre. By size is meant either aerodynamic diameter or electrical mobility diameter, suitably aerodynamic diameter.
- Various examples will now be elucidated in more detail with reference to the appended
FIG. 1A toFIG. 1E . In all illustrations the expiratory airflow is coupled to the mechanical ventilator via suitable patient tubing. Expired gases may further be directed to a collection site, e.g. for contaminated fluids, e.g. via filter systems or to an evacuation system of a central hospital gas evacuation system. - In
FIG. 1A , aconfiguration 1 is illustrated where theparticle detecting unit 10 is connected to theexpiratory airflow conduit 11 from a patient, here illustrated as connected downstream a Y-piece of the tubing of a mechanical ventilator connectable to a patient (not shown). The inspiratory airflow is connected to the patient throughconduit 12. Theparticle detection unit 10 may be connected to a user interface such as a display or a sound source to provide medical staff, such as doctors or nurses, with patient airway related information. This information may be used to optimise the parameters of themechanical ventilator 14. - Alternatively, in some examples of the disclosure, the
particle detection unit 10 may be connected toexpiratory airflow conduit 11 either inside theventilator 14 or after the ventilator. - In some examples the
particle detection unit 10 and theinterface 13 may be connectable to acontrol unit 15 to automatically control some of the parameters of themechanical ventilator 14. This may be performed using a feedback loop. Alternatively, or in addition, the obtained related information may be transferred to theventilator 14 from the detection unit for display on a display unit of theventilator 14. - The
particle detection unit 10 may in some examples be connected directly to the expiratory airflow conduit in a mainstream configuration since it has a low pressure drop impact on the expiratory flow. This is important as expiration is often passive even during mechanical ventilation (maximum gas flow without externally increased obstruction/pressure drop is desired) and/or work of breathing is desired to be kept at a minimum. - The particle detecting unit may quantify the particles, on-line, in the mainstream of the exhaled gas. Additionally the
particle detecting unit 10 may in some examples sort the particles according to their mass. Alternatively, and/or additionally, the particles’ sizes may also provide a particle distribution profile of the particles. The particle distribution profile is a measure of how many particles of a particular mass or size (or mass or size range) are present in the exhaled air, and can also be used to determine a medical condition of a subject. - The particle detection unit may be, for example, a particle counter such as a Grimm 1.108 optical particle counter (Grimm Aerosol Technik, Ainring, Germany), capable of counting, and sizing particles in 15 size intervals from 0.3 to 20 micrometre. But other optical particle counters such as a Grimm 1.107 and 1.109 may be used. Other manufacturers such as TSI have particle sizers but also time of flight equipment that may be used as
particle detection units 10. Other options may be, Non-optical, electrostatically, conductance, condensation particle counters, Quartz Crystal Microbalance (QCM), Surface Plasmon Resonance (SPR) or surface acoustic-wave (SAW) etc. - The
particle detecting unit 10 may provide a number size distribution of the measured aerosol or a mass distribution, calculated from the measured number size distribution. In some examples of theparticle detecting unit 10, particle-laden gas is passed through a small, well defined, intensely illuminated volume in a manner so that only one particle at a time is illuminated. The illuminated particle gives rise to a pulse of scattered light, the intensity of which is measured. Since the intensity of scattered light depends on the particle size, it is possible to count and size the particles in the air stream. Theconduit 11 may comprise a sub-volume where the exhaled gas flow supplies the small well defined volume with a suitably measurable gas flow. By calibration the number of particles passing through the well defined volume is made proportional to the total amount of particles passing through theconduit 11. - Time of flight may also be used as a measurement principle for a
particle detecting unit 10. Here, the time of particle propagation from one laser beam to another is measured. The time it takes for the particle to move from one beam to the other depends on the particle’s mass or size which may therefore be measured and characterised. - The particle detecting unit is continuously measuring the number of particles online in the exhaled gas. The sample time to detect a sufficient number of particles before updating the
interface 13 of theparticle detection unit 10 may be in real time, such as 1 second. It may also be over a time interval such as 2 seconds, such as 4 seconds, such as 10 second. Alternatively the sampling time may be minutes, such as 1 minute, such as 5 minutes, such as 10 minutes such as 30 minutes, such as 60 minutes. - The sampling period may also be defined in exhalations, one exhalation may provide a sufficient number of particles, but particles may also be quantified over repeated exhalations.
- A
further configuration 2 of the disclosure is illustrated inFIG. 1B . This example is similar to the configuration illustrated inFIG. 1A . But instead of theparticle detecting unit 10 being directly connected to theexpiratory conduit 11 it is side-streamed through theconduit 16. This may have the advantage to be easier to connect to the hoses of the ventilator. Moreover, a potential pressure drop in themain lumen 11 is avoided. Further theside stream conduit 16 may have a much smaller diameter making it easier to calibrate than measuring on thelarger expiration conduit 11. In the side stream a predefined ratio of the air flow in theconduit 11 is directed and then connected back at a different point. This may be facilitated by a side-stream sampling pump ensuring a constant sampling gas flow. Thus loss of pressure is avoided which may disturb theventilator 14. - In
FIG. 1C an example of an alternative side stream configuration 7 is illustrated. In this example the expired gases is directed into a side stream conduit 1.6 to be measure using aparticle detection unit 10. The expired gases may then be directed to a collection site, e.g. for contaminated fluids, e.g. via filter systems or to an evacuation system of a central hospital gas evacuation system. - In
FIG. 1D afurther configuration 3 is illustrated, the particle detection unit is connected before (upstream) the Y-piece, making it possible to measure or detect particles in both expiration and inspiration gases. This may alternatively be made in a side stream configuration as inFIG. 1B . - Alternatively as in the configuration 4 depicted in
FIG. 1E , oneparticle detection unit 10 is connected to theexpiration conduit 11 and oneparticle detection unit 18 is connected to theinspiration conduit 12. - By measuring on both the expiration and inspiration gases the particle entering the airways may be characterised and used in the analysis. For example detection of particles in inspiration gases may provide a warning to increase safety since particles in the inspiration gases may indicate failure of, for example, a filter.
- Alternatively and/or additionally, detection of particles in the inspiration gases may also provide a warning, such as during delivery of anaesthesia to a patient, that a delivered medicament is not fully evaporated.
- Alternatively and/or additionally, detection of an amount of particles in the inspiration gases may also provide a possibility of estimate the amount of medicament delivered. For example, those instances when the medicament is delivered as aerosols in the inspiration conduit.
- When continuously monitoring the exhaled air an increase in particles may indicate collapses of a patient’s airways, such as lung. Thus a warning may be sent to medical staff from the
interface 13. - Alternatively and/or additionally, in some examples, the information related to a detected increase in exhaled particles may also be used to automatically adjust, for example the PEEP to avoid opening and closing and thereby avoid decrease in surfactants that may lead to multi organ failure or death, using the
control unit 15 connected to theventilator 14. - Further, some examples of the disclosure also provide for a warning of acute respiratory distress syndrome (ARDS) or acute lung injury (ALI) for instance due to trauma; or sepsis; or collapse of lung; or acute lung injury. The warning may be provided upon to detection of a rapid increase in particles in the exhaled breath.
- In
FIG. 2 , an embodiment of a system 5 comprising a furtherparticle collection unit 19 is illustrated. This collection unit is used to collect or sample volatile, semi-volatile and/or non-volatile compounds or materials in the exhaled breath. Alternatively and/or additionally, thecollection unit 19 may be used to collect or sample particles being vehicles for transporting such compounds or materials, for example non-volatile compounds transported by aerosol particles. - The
collection unit 19 may be a cascade impactor, such as a commercially available PM10 Impactor, Dekati Ltd, Tampers, Finland. It should be noted that the PM10 Impactor is only known for other purposes and uses than the herein described. Alternatively the collection unit may also be a particle trap (adsorptive, cryogenic, chemical), or at least one filter, or a collection chamber, or electrostatic collection components, or sampling bags or canisters, Solid-phase extraction SPE membrane, sorbent tubes, condensation components (such as surface condensation collectors), or utilising surface functionalization, or any other type of collectors suitable for collecting particles from exhaled fluids. - The
particle collection unit 19 is here illustrated to be connectable downstream theventilator 14. Thus the ventilator may not be affected by a pressure drop, such an impactor may cause on the system. The exhaust gas from theventilator 14 is flowing through theparticle collection unit 19 either driven by a pump (not shown) or by the under pressure provided by an evacuation system (not shown). - Alternatively the
particle collection unit 19 may be connected at other locations on theconduit 11 or by utilizing a side stream, but then a compensation for any pressure drops may be needed, for example by using a pump. - The
detection unit 10 is here illustrated to be positioned at theexhalation conduit 11 but may in some examples be positioned at any position hereinabove described in conjunction withFIG. 1A toFIG. 1E . - Alternatively the
detection unit 10 may be positioned apposition to the collection unit, such as in or after theventilator 14. - The
particle collectiong unit 19, e.g. a suitable impactor, has an inlet and an outlet, and comprising a plurality of stages arranged such that a gas stream comprising particles enters the impactor via the inlet and passes through each stage in turn before exiting the impactor via said outlet. Each stage of the impactor is separated from adjacent stages by a partition having an orifice which directs the gas stream towards collection plates, the major face of each collection plate being arranged substantially perpendicular to the direction of flow of the gas stream. Exhaled particles are passed through the inertial impactor in a gas stream, such that the primary gas stream is directed towards each collection plates in each stage in turn. The at least first collection plate located in a first stage collects particles of a first mass and at least a second collection plate located in a second stage collects particles of a second mass. In this way a particle profile is obtained. After being sorted according to their size or mass, particles are analysed. They may be analysed by at least one analysis technique selected from the group consisting of: time-of-flight secondary ion mass spectrometry (TOP-SIMS), matrix assisted laser desorption ionization mass spectrometry (MALDI-MS), gas-chromatography mass spectrometry (GCMS), liquid chromatography mass spectrometry (LCMS), or other mass spectrometric techniques, biochemical assays or protocols based on labelled antibodies, such as multiplex Elisa plates, quantitative PCR analysis, scanning electron microscopy (SEM), surface plasmon resonance (SPR), fluorescence spectroscopy, Raman spectroscopy, Surface enhanced Raman spectroscopy (SERS), TOC (total organic content) analysis, elemental analysis and inductively coupled plasma mass spectrometry (ICP-MS), surface acoustic-wave (SAW) and nano-wires for detection of particular proteins with or without being first washed off the collection plates. - The
particle collection unit 19 may be used to collect or sample particles or compounds in exhaled breath for chemical, biological DNA, virological and bacteriological analysis of the particles. - These analyses may be carried out off-line. Alternatively, using some of the analysis techniques mentioned above, it may in some examples be preferable to carry out these analyses on-line. A possible implementation of an embodiment for on -line analysis may be use of SERS-technique in combination with the impactor, such as use of specific surface coatings i.e. SERS-substrates, metal-doped sol-gel, derivatizationable coatings or other types of functionalization (i.e. SERS-labeled gene-probes or antibodies).
- Diagnosis of ongoing ventilation and adaptation of ventilation strategies may in some examples be made based on both the particles measurements and additionally based on the chemical, biological, DNA/RNA/mRNA, virological and/or bacteriological analysis of the particles themselves.
- The analysis conducted using the
particle collection unit 19 may provide possibilities of detecting diseases or damages to the airways, such as lungs. The obtain information may be used for diagnosis, monitoring and/or treatment of a patient. - Further, the information provided by the
particle collection unit 19 may also in some examples be used to optimize the ventilation of the patient. - The collection time of the
collection unit 19 may be similar to the aforementioned times for theparticle detection unit 10. - Additionally and/or alternatively, in some further examples, a collector unit, such as an impactor, may be used to quantifying the number of particles by weight. By collecting specific size and/or mass ranges of particles on the collection plates, the number of particles exhaled during a particular collection time may be estimated.
- Additionally and/or alternatively, in some examples of a system having a
particle collection units 19 connected to the expiration air, the ventilator may be used to control the patient’s breathing to optimise the collection of particles. The ventilator may for example be controlled so that the patient is simulated to hold his breath for a period of time before performing a deep exhalation. - Additionally and/or alternatively, the performing measurements it may be advantageous if the particle collection unit is kept at a temperature such that the size distribution of the exhaled aerosol is not changed either by evaporation or condensation of water vapor.
- The same may also apply for the measurements using the particle detection unit.
- By keeping the temperature substantially stable, the size distribution of the exhaled aerosol is not changed when obtaining a particle distribution profile of the particles.
- The exhaled air passes an opening into the particle collection unit which is located in a thermostated compartment, also here with the purpose of maintaining the aerosol size distribution. In some examples of a particle detection unit, in the compartment is located a reservoir for the exhaled air. In these examples, an inertial impactor for the collection of particles is connected to the reservoir first opening.
- A sample is taken in the following way by the particle collection unit when being an impactor. It is assumed that the impactor is loaded with clean collection plates, and that the system, especially the impactor, has attained the desired temperature. First, the flow meter is zeroed to allow a proper measurement of flows, and then the moist clean air flow is set at a value so that a positive flow will be maintained from the system during measurement. Then the impactor flow is set at a value lower than the clean air flow. During this procedure, no deposit will be collected on the plates, since the system is fed by clean particle free air. Then the optical particle counter is started and it is checked that no spurious particles are present, e.g. indicating a leak into the system. Exhalation into the system then begins; the particle counter continuously draws a sample and produces a size distribution every six seconds while the impactor collects samples for later analysis. When a required amount of sample has been obtained, the collection is terminated, the time of sampling and exhaled volume recorded. The flow through the impactor is turned off, the impactor removed from the measurement system and the loaded plates are recovered.
- A further aspect of the disclosure provides for a
method 6 illustrated schematically inFIG. 3 . - The
method 6 provides diagnosis and/or monitoring of a condition of a patient connected to a ventilator. Themethod 6 is carried out by providing 100 a particle detecting unit connected to a conduit for passing expiration fluid from said patient. Further, the method comprises a step of obtainingdata 110 related particles exhaled from said patient’s airways. Optiononally, in some examples, the related data may be analysed to provide further information concerning the state of the ventilated patient’s airways, for example the amount and/or size and/or mass profile of the detected particles. - The obtained data or information may be used by medical staff to improve the treatment of the ventilated patient, such as optimising the mechanical ventilator.
- Additionally and or alternatively, the information may optionally be used for automatically adjusting 120 the mechanical ventilator using a control unit similar to what has previously been described.
- Additionally, a particle collection unit may be provided 130 to obtain further information which may be used in diagnosing and/or monitoring the patient.
- The disclosure also relates to use of a particle counter to measure a number of particles in exhaled breath from a patient ventilated by a mechanical ventilator or respirator, for diagnosis or monitoring of the patient’s airways.
- Additionally and/or alternatively to some examples of the disclosure, the data from the particle counter is used for controlling the mechanical ventilator or respirator, such as controlling PEEP, tidal volume, CPAP etc.
-
FIG. 4A andFIG. 4B illustrates clinical observations at patients having Adult respiratory distress syndrome and treated using mechanical ventilation. Thegraph 200 inFIG. 4A is showing particles in exhaled air when increasing the PEEP. The particles are measured using a particle detection unit. The graphs show a clear decrease in particles in the exhaled air for all size fractions. The curves in thegraph 200 illustrate different ranges of particle sizes. Thetop curve 201 shows particles with a diameter larger than 2 microns and thelowest curve 202 shows particle with a diameter between 0.3 and 0.4 microns. In this exemplary measurement the decrease happened about 10 to 20 seconds after the increase of PEEP. In other examples the decrease may happen earlier or immediately after an increase of PEEP. In some other examples, the decrease may happen later than 20 seconds. - The
graph 210 inFIG. 4B is showing particles in exhaled air measured in conjunction with a decrease in PEEP. The graphs show a clear increase in particles in the exhaled air for all size fractions. The curves in thegraph 210 illustrate different ranges of particle sizes thetop curve 201 in thegraph 210 is showing particles with a diameter larger than 2 microns and thelowest curve 202 shows particles with a diameter between 0.3 and 0.4 microns. In this exemplary measurement, the increase happened about 10 to 20 seconds after the decrease of PEEP. In other examples the increase may happen earlier or immediately after a decrease of PEEP. In some other examples, the increase may happen later than 20 seconds. - Studies on healthy patients have shown a correlation between opening of the airways, after a closure, and an increase of particles in the exhaled air. This means that these measurements may be an indication of how well collapsed parts of a lung have been kept open using optimal PEEP during treatment by a mechanical ventilator.
- Examples of the present disclosure are described herein with reference to flowchart and/or block diagrams. It will be understood that some or all of the illustrated blocks may be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
- It is to be understood that the functions/acts noted in the diagrams may occur out of the order noted in the operational illustrations. For example, two blocks shown in succession may in fact be executed substantially concurrently or the blocks may sometimes be executed in the reverse order, depending upon the functionality/acts involved. Although some of the diagrams include arrows on communication paths to show a primary direction of communication, it is to be understood that communication may occur in the opposite direction to the depicted arrows.
- The present disclosure has been described above with reference to specific examples. However, other examples than the above described are equally possible within the scope of the disclosure. Different method steps than those described above, performing the method by hardware or software, may be provided within the scope of the disclosure. The different features and steps of the disclosure may be combined in other combinations than those described. The scope of the disclosure is only limited by the appended patent claims the steps or acts of the method are recited.
Claims (21)
1. A diagnostic device for characterization of particles from a patient’s airways, when ventilated by a ventilator, and/or for controlling said ventilator, comprising:
a particle detecting unit configured to be connected to a conduit for passing expiration fluid from said patient, said particle detecting unit is configured for obtaining particle data related to particles exhaled from said patent’s airways; and
a control unit configured for analyzing said particle data to diagnose and/or monitor a condition of said patients airways.
2. The diagnostic device of claim 1 , wherein said particle detecting unit is a particle counter or sizer.
3. The diagnostic device of claim 1 , wherein said particles are aerosols derived from said patient’s airways.
4. The diagnostic device of claim 1 , wherein said conduit is an expiration conduit downstream a Y-connector connectable to said patient.
5. The diagnostic device of claim 1 , wherein said conduit is a side-stream conduit connected to an expiration conduit downstream a Yconnector connectable to said patient.
6. The diagnostic device of claim 1 , wherein said particle detecting unit is configured to be connected to both an expiration conduit and an inspiration conduit.
7. The diagnostic device of claim 1 , wherein said control unit is configured to adjust said ventilator to provide a mechanical ventilation mode based on said data related to particles being exhaled from said patent’s airways.
8. The diagnostic device of claim 1 , wherein said control unit is configured to control said ventilator, due to a characteristic of said particles.
9. A diagnostic system for characterization of particles from a patient’s airways, when ventilated by a ventilator, and/or for controlling said ventilator, comprising:
a particle detecting unit configured to be connected to a conduit for passing expiration fluid from said patient, said particle detecting unit is configured for obtaining particle data related to particles being exhaled from said patent’s airways; and
a particle collection unit configured to be connected to said conduit downstream said ventilator.
10. (canceled)
11. A diagnostic system of claim 9 , wherein said particles are collected by collection plates in said particle collection unit and sorted according to their size or mass.
12. The diagnostic system of claim 9 , wherein chemical content of said particles are analyzed by at least one analysis technique selected from the group consisting of: time-of flight secondary ion mass spectrometry (TOF - SIMS), matrix assisted laser desorption ionization mass spectrometry (MALDI-MS), biochemical assays or protocols based on labelled antibodies, quantitative PCR analysis, scanning electron microscopy (SEM), gas-chromatography mass spectrometry (GC-MS), liquid chromatography mass spectrometry (LC-MS), surface plasmon resonance (SPR), fluorescence spectroscopy, TOC (total organic content) analysis, elemental analysis, and inductively coupled plasma mass spectrometry (ICPMS) and ELISA, with or without being first washed off said collection plates.
13. A method for diagnosing or monitoring a condition of a patient’s airways when connected to a ventilator, comprising:
providing a particle detecting unit connected to a conduit for passing expiration fluid from said patient,
obtaining particle data, by said particle detecting unit, related to particles exhaled from said patent’s airways; and
analyzing said particle data to diagnose and/or monitor said condition of said patient’s airways.
14. The method of claim 13 , comprising:
Use of using a particle counter to measure a number of particles in exhaled breath from a patient ventilated by a mechanical ventilator or respirator, for diagnosis and/or monitoring of said patent’s airways.
15. The method of claim 14 , wherein data from said particle counter is used for controlling said mechanical ventilator or respirator, such as controlling PEEP, tidal volumes and/or CPAP.
16. The method of claim 13 , comprising Use of using a particle counter to measure a number of particles in inhaled air to a patient being ventilated by a mechanical ventilator or respirator, for warning of filter failure.
17. The method of claim 13 , comprising using a particle counter to measure a number of particles in inhaled air to a patient being ventilated by a mechanical ventilator during delivery of anesthesia, for warning of delivered medicament not fully evaporated or estimating an amount of medicament delivered to the patient.
18. The diagnostic device of claim 1 , wherein said particle detecting unit is an optical based particle counter or sizer.
19. The diagnostic device of claim 1 , wherein said control unit is configured to control a positive end expiratory pressure (PEEP), tidal volumes and/or CPAP, due to a characteristic of said particles.
20. The diagnostic device of claim 1 , further comprising a particle collection unit configured to be connected to said conduit downstream said ventilator.
21. A diagnostic system of claim 9 , wherein the particle collection unit is an impactor.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US18/056,179 US20230172484A1 (en) | 2012-02-08 | 2022-11-16 | Device and method for non-invasive analysis of particles during medical ventilation |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261596444P | 2012-02-08 | 2012-02-08 | |
SE1250093 | 2012-02-08 | ||
SE1250093-0 | 2012-02-08 | ||
PCT/EP2013/052620 WO2013117747A1 (en) | 2012-02-08 | 2013-02-08 | A device and method for non-invasive analysis of particles during medical ventilation |
US201414377588A | 2014-08-08 | 2014-08-08 | |
US18/056,179 US20230172484A1 (en) | 2012-02-08 | 2022-11-16 | Device and method for non-invasive analysis of particles during medical ventilation |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/377,588 Continuation US11547322B2 (en) | 2012-02-08 | 2013-02-08 | Device and method for non-invasive analysis of particles during medical ventilation |
PCT/EP2013/052620 Continuation WO2013117747A1 (en) | 2012-02-08 | 2013-02-08 | A device and method for non-invasive analysis of particles during medical ventilation |
Publications (1)
Publication Number | Publication Date |
---|---|
US20230172484A1 true US20230172484A1 (en) | 2023-06-08 |
Family
ID=48946928
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/377,588 Active 2035-07-12 US11547322B2 (en) | 2012-02-08 | 2013-02-08 | Device and method for non-invasive analysis of particles during medical ventilation |
US18/056,179 Pending US20230172484A1 (en) | 2012-02-08 | 2022-11-16 | Device and method for non-invasive analysis of particles during medical ventilation |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/377,588 Active 2035-07-12 US11547322B2 (en) | 2012-02-08 | 2013-02-08 | Device and method for non-invasive analysis of particles during medical ventilation |
Country Status (3)
Country | Link |
---|---|
US (2) | US11547322B2 (en) |
EP (1) | EP2811902A1 (en) |
WO (1) | WO2013117747A1 (en) |
Families Citing this family (26)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10983040B2 (en) | 2013-03-15 | 2021-04-20 | Particles Plus, Inc. | Particle counter with integrated bootloader |
US10352844B2 (en) | 2013-03-15 | 2019-07-16 | Particles Plus, Inc. | Multiple particle sensors in a particle counter |
US9677990B2 (en) | 2014-04-30 | 2017-06-13 | Particles Plus, Inc. | Particle counter with advanced features |
US11579072B2 (en) | 2013-03-15 | 2023-02-14 | Particles Plus, Inc. | Personal air quality monitoring system |
US20160067531A1 (en) * | 2014-09-04 | 2016-03-10 | Particles Plus, Inc. | System and method for respirators with particle counter detector unit |
US9726684B1 (en) | 2015-01-18 | 2017-08-08 | Hound Labs, Inc. | Compositions for target substance detection and measurement |
SE538864C2 (en) * | 2015-05-25 | 2017-01-10 | The Lung Barometry Sweden AB | Method System and Software for Protective Ventilation |
FR3050031B1 (en) * | 2016-04-06 | 2018-04-13 | Eco Logic Sense Sas | SENSOR FOR MEASURING THE ATMOSPHERIC CONCENTRATION OF PARTICLES |
EP3448256B1 (en) * | 2016-04-25 | 2023-09-20 | Owlstone Medical Limited | Systems and device for capturing breath samples |
US9933445B1 (en) | 2016-05-16 | 2018-04-03 | Hound Labs, Inc. | System and method for target substance identification |
US11813050B2 (en) | 2016-11-22 | 2023-11-14 | The Regents Of The University Of California | Selectively sorting aerosol droplets in exhaled human breath based on a mass-size parameter |
US11026596B1 (en) | 2017-05-19 | 2021-06-08 | Hound Labs, Inc. | Detection and measurement of target substance in exhaled breath |
SE541748C2 (en) | 2017-07-10 | 2019-12-10 | Pexa Ab | System for collecting exhaled particles |
US11187711B1 (en) | 2017-09-11 | 2021-11-30 | Hound Labs, Inc. | Analyte detection from breath samples |
DE102017218116A1 (en) * | 2017-10-11 | 2019-04-11 | Robert Bosch Gmbh | System and method for collecting respiratory aerosols and respiratory condensates |
EP3818354B1 (en) | 2018-07-04 | 2024-05-01 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Device and method for determining an aerosol delivery |
US11890414B2 (en) | 2018-10-17 | 2024-02-06 | Maquet Critical Care Ab | Lung recruitment in mechanical ventilation |
US11426097B1 (en) | 2018-10-17 | 2022-08-30 | Hound Labs, Inc. | Rotary valve assemblies and methods of use for breath sample cartridge systems |
US20200245899A1 (en) | 2019-01-31 | 2020-08-06 | Hound Labs, Inc. | Mechanical Breath Collection Device |
US11977086B2 (en) | 2019-03-21 | 2024-05-07 | Hound Labs, Inc. | Biomarker detection from breath samples |
CN114041048A (en) * | 2019-04-11 | 2022-02-11 | 皇家飞利浦有限公司 | Particle sensing system, for example for an anti-fouling mask |
CN110179467B (en) * | 2019-05-29 | 2023-11-14 | 中国医学科学院生物医学工程研究所 | Respiratory sampling device for lung cancer diagnosis |
US11933731B1 (en) | 2020-05-13 | 2024-03-19 | Hound Labs, Inc. | Systems and methods using Surface-Enhanced Raman Spectroscopy for detecting tetrahydrocannabinol |
KR102268711B1 (en) * | 2020-09-25 | 2021-06-24 | 국방과학연구소 | Examination system and examination apparatus for exhalation |
US11806711B1 (en) | 2021-01-12 | 2023-11-07 | Hound Labs, Inc. | Systems, devices, and methods for fluidic processing of biological or chemical samples using flexible fluidic circuits |
WO2023078961A1 (en) | 2021-11-02 | 2023-05-11 | Pexa Ab | A device and method for determining a respiratory system infection from exhaled breath |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8820325B2 (en) * | 2002-10-11 | 2014-09-02 | The Regents Of The University Of California | Bymixer apparatus and method for fast-response, adjustable measurement of mixed gas fractions in ventilation circuits |
WO2006076265A2 (en) * | 2005-01-10 | 2006-07-20 | Pulmatrix, Inc. | Method and device for decreasing contamination |
WO2007008825A2 (en) | 2005-07-11 | 2007-01-18 | Emory University | System and method for optimized delivery of an aerosol to the respiratory tract |
US8449473B2 (en) * | 2006-10-18 | 2013-05-28 | Anaxsys Technology Limited | Gas sensor |
US20080202523A1 (en) * | 2007-02-23 | 2008-08-28 | General Electric Company | Setting mandatory mechanical ventilation parameters based on patient physiology |
US20080243007A1 (en) * | 2007-03-28 | 2008-10-02 | Cardiac Pacemakers, Inc. | Pulmonary Artery Pressure Signals And Methods of Using |
CA2701352A1 (en) * | 2007-10-02 | 2009-04-09 | Ann-Charlotte Almstrand | Collection and measurement of exhaled particles |
TW201034710A (en) * | 2009-03-31 | 2010-10-01 | Top Vision Medical Equipment Consultant Co Ltd | Gas supply device capable of sensing and displaying concentration of suspended particles |
-
2013
- 2013-02-08 WO PCT/EP2013/052620 patent/WO2013117747A1/en active Application Filing
- 2013-02-08 US US14/377,588 patent/US11547322B2/en active Active
- 2013-02-08 EP EP13703805.5A patent/EP2811902A1/en active Pending
-
2022
- 2022-11-16 US US18/056,179 patent/US20230172484A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
US20160000358A1 (en) | 2016-01-07 |
WO2013117747A1 (en) | 2013-08-15 |
EP2811902A1 (en) | 2014-12-17 |
US11547322B2 (en) | 2023-01-10 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20230172484A1 (en) | Device and method for non-invasive analysis of particles during medical ventilation | |
JP7067811B2 (en) | A new system for collecting exhaled particles | |
US10359417B2 (en) | Portable sampling device and method for detection of biomarkers in exhaled breath | |
JP5258892B2 (en) | Collection and measurement of exhaled particles | |
RU2446389C2 (en) | Gas side fraction sampler and method of measuring gas main flow sample components concentration (versions) | |
US7779840B2 (en) | Ventilator breath condensate sampler and method of collecting a breath condensate sample | |
JP2018105874A (en) | Portable sampling device and method for sampling drug substances from exhaled breath | |
JP2019516113A (en) | System and device for capturing exhaled sample | |
US20100292601A1 (en) | Apparatus for and method of condensing exhaled breath | |
JP2010540959A5 (en) | ||
CN104287735A (en) | Respiratory monitoring and breath analysis system | |
CN205263092U (en) | Measurement device for expiration nitric oxide and carbon monoxide concentration | |
US20160338616A1 (en) | Medical device for determining components of the expiration volume | |
EP2919649A1 (en) | Device and method for pulmonary function measurement | |
US9931054B2 (en) | Low dead space liquid trap | |
JP2004077467A (en) | Sampling method and device of end expiration | |
JP7389063B2 (en) | Devices and methods for determining aerosol delivery | |
Wang et al. | A concise review of exhaled breath testing for respiratory clinicians and researchers | |
Figueras‐Aloy et al. | Attempt to normalize simulated exhaled nitric oxide according to ventilatory settings | |
EP2248464A1 (en) | Use of endogenous generated particles in the expired air of people to diagnose lung sicknesses |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: FINAL REJECTION MAILED |