WO2016178141A1 - Appareil pour ventilation pulmonaire non invasive et procédé de calcul d'au moins un signal de respiration - Google Patents
Appareil pour ventilation pulmonaire non invasive et procédé de calcul d'au moins un signal de respiration Download PDFInfo
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
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- 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
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
- A61B5/036—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
- A61B5/037—Measuring oesophageal pressure
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- A—HUMAN NECESSITIES
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
- A61B5/087—Measuring breath flow
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
- A61M16/022—Control means therefor
- A61M16/024—Control means therefor including calculation means, e.g. using a processor
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0666—Nasal cannulas or tubing
- A61M16/0672—Nasal cannula assemblies for oxygen therapy
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- 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
- A61M16/0858—Pressure sampling ports
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- 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
- A61M16/0866—Passive resistors therefor
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- A—HUMAN NECESSITIES
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A61M16/0683—Holding devices therefor
- A61M16/0688—Holding devices therefor by means of an adhesive
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/20—Valves specially adapted to medical respiratory devices
- A61M16/201—Controlled valves
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- 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
- A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
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- A—HUMAN NECESSITIES
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- 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
- A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
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- A61M2205/00—General characteristics of the apparatus
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- 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
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61M2210/00—Anatomical parts of the body
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- A—HUMAN NECESSITIES
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- A61M2210/00—Anatomical parts of the body
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- A61M2230/00—Measuring parameters of the user
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- A61M2230/00—Measuring parameters of the user
- A61M2230/40—Respiratory characteristics
- A61M2230/46—Resistance or compliance of the lungs
Definitions
- the present illustration relates in general to the field of the pulmonary noninvasive ventilation, hereinafter called for convenience in abbreviated form NIV.
- the NIV modes or techniques are all those whereby the interaction between the respiratory apparatus of the patient and the ventilation circuit fed by the ventilation system does not provide the in sito insertion of the endotracheal tube.
- the respiratory assistance takes place, mostly, by means of using different interfaces, such as the helmet, the facial mask (FM), and the nasal cannulae or nasocannulae (NC).
- different interfaces such as the helmet, the facial mask (FM), and the nasal cannulae or nasocannulae (NC).
- the NIV respiratory assistance in the various modes thereof: “High Flow Nasal Cannula” (HFNC), “Nasal Continuous Positive Airways Pressure” (NCPAP), “Nasal Bilevel PAP” (NBiPAP), “Nasal Intermittent Positive Pressure Ventilation” (NIPPV), “Nasal Synchronized Intermittent Positive Pressure Ventilation” (NSIPPV) e “Nasal Synchronized Intermittent Mandatory Ventilation” (NSIMV), nowadays allows assisting most patients with acute or chronic respiratory insufficiency and then avoiding the invasive mechanical ventilation.
- NC circuit (CNC).
- the GRF is capable of supplying to the CV, thereto it is connected in series, the selected value of the air oxygen-enriched, heated and humidified according to the clinical requirements.
- the flow supplied by the GRF is designated as ventilation flow (Fven).
- the CV constituted by a corrugated cylindrical tube (branch), connects the GRF output to the CNC input, the output thereof is ending with the NC.
- the CNC can assume the 2 following different types:
- CNC constituted by a single corrugated tube with medium-big size for large flows, to be used in case of adult patient (CNC_line);
- CNC constituted by a small corrugated tube shaped like a ring with small size for reduced flows, to be used in case of paediatric patient (CNC_ring).
- the conventional ACFs are used in the mode or technique for NIV respiratory assistance designated HFNC ("High Flow Nasal Cannula") wherein, apart from the oxygen percentage included in the air mixture supplied to the patient (%02), the only parameter which is set manually by varying an inner resistance to the GRF, is Fven.
- Fven the only parameter which is set manually by varying an inner resistance to the GRF.
- the above-mentioned uncertainty does not allow to detect and monitor the oscillations subjected by Fven around the equilibrium value thereof set due to the spontaneous respiratory activity of the patient (disadvantage ⁇ ).
- any NIV respiratory assistance apparatus or system is not capable of providing on itself such information and then the clinician has not the possibility of modifying the parameters to be set of the NIV respiratory assistance system based upon the patient's requirements but only based upon clinical or hemogasanalytical data, which often are late.
- the optimization of the ventilator parameters to be set has important involvements in managing the patient with respiratory insufficiency such as improving the patient conditions and avoiding that NIV fails and one has to have recourse to the mechanical ventilation.
- any conventional SMMRP combined with the conventional ACFs in the HFNC mode is not capable of measuring the Fres signal due to the flow losses occurring between the CNC and the distal airways of the patient, mainly through the mouth and the nasal cavities. Due to such losses, the Fres signal does not coincides with the Fven signal (the only one which can be measured and monitored by the conventional SMMRP systems), but it results to be equal to the difference between the Fven signal and the total flow signal associated to the losses themselves (Floss), according to the following expression:
- the Fres signal is obtained by deriving the VC signal itself with respect to time.
- Both RIP and the other above-mentioned techniques do not provide sufficiently reliable performances, in the sense that the error associated to the measurement is not acceptable. Besides, they are quite expensive, particularly those associated to the remote sensing.
- a third drawback is linked to the impossibility of verifying "online", that is contemporarily to the ventilation, if the set Fven value allows obtaining the primary purpose of the HFNC mode.
- Such impossibility is the consequence of disadvantage_2 and in particular, in absence of a specific application innovation, of the absence of the Floss signal, by analysing the information included inside thereof it is possible to verify "online” if the conditions associated to the primary purpose of the HFNC mode have been reached.
- NC circuit (CNC).
- the CV is constituted by 2 corrugated cylindrical tubes (branches) having a terminal in common (intersection) and the other one differentiated.
- the first branch of CV (CV_1) connects the GRF output tot the CNC input (intersection), the output thereof is terminated with NC.
- CNC can assume the following 2 different types:
- CNC constituted by a single corrugated tube with medium-big size for large flows, to be used in case of adult patient (CNC_line);
- CNC constituted by a small corrugated tube shaped like a ring with small size for reduced flows, to be used in case of paediatric patient (CNC_ring).
- the second branch of CV (CV_2) connects the intersection to the input of the first one of the following 2 devices in series therebetween:
- the Ron/off output is connected to the Rext input, the output thereof is connected to the outer environment.
- an ACP is capable of applying the selected pressure at the level of the intersection by adjusting the Rext value depending upon the flow crossing CV_2 designated outer flow (Fext).
- the pressure at the level of the intersection (Pcv) is equal to the product between Fext and Rext.
- the flow supplied by GRF to CNC designated flow to the nasocannulae (Fnc) results to be equal to the difference between Fven and Fext, according to the following expression:
- the conventional ACP are used in the following modes or techniques for NIV respiratory assistance:
- NCPAP Nasal Continuous Positive Airways Pressure
- NBiPAP Nasal Bilevel Positive Airways Pressure
- NSIPPV Neuronal Synchronized Intermittent Positive Pressure Ventilation
- NSIMV Neuronal Synchronized Intermittent Mandatory Ventilation
- the Ron/off remains always open in the NCPAP and NBiPAP, whereas it is cyclically opened and closed with frequency set in the NIPPV or in synchrony with the spontaneous respiratory activity of the patient in the NSIPPV and NSIMV.
- CPAP the only parameter which is set by varying both the resistance inside GRF (Rg) and Rext, is the Pcv equilibrium value designated CPAP.
- CPAP the only parameter which is set by varying both the resistance inside GRF (Rg) and Rext, is the Pcv equilibrium value designated CPAP.
- NBiPAP differentiates from NCPAP only for the fact that the Pcv equilibrium value varies cyclically between 2 different set values.
- NIPPV is a mode or technique during which ACPs apply positive pressure waves to the CV level with set (controlled breaths) features and periodicity (frequency) alternating with the spontaneous breaths performed by the patient. These latter are assisted as in NCPAP.
- NSIPPV and NSIMV are modes or techniques during which ACPs, by detecting a triggering signal apply positive pressure waves at the level of CV (controlled breaths) in synchrony with the attempts of spontaneous breaths performed by the patient.
- a triggering signal applies positive pressure waves at the level of CV (controlled breaths) in synchrony with the attempts of spontaneous breaths performed by the patient.
- CV controlled breaths
- a triggering signal is represented by a variation experienced by a ventilatory quantity.
- Fnc increases consequently to the Pes decrease which occurs at the beginning of the spontaneous inspiration whereas Pcv decreases as, by increasing Fnc, Fven and Rext being equal, Fext decreases.
- the most widespread triggering signal is the flow trigger which, in the conventional ACPs, is detected by inserting in series to CNC a PNT with the purpose of monitoring the Fnc signal.
- the first drawback consists in that the detection of the beginning of attempt of spontaneous inspiration is not carried out on the signal most effective to the purpose (Fres), on the contrary on the Fnc signal. From what said previously about the HFNC mode, in fact, and by observing Figure 6, it results evident that Fnc does not coincide with Fres, the latter resulting to be equal to the difference between Fnc and Floss, according to the following expression:
- the second drawback consists in that the insertion of a PNT involves inevitably both an increase in the fluidodynamical resistance which the patient has to contrast to inspire, with associated increase in the effort and the respiratory work and a more cumbersome and heavy CNC (disadvantage_5).
- any NIV apparatus or respiratory assistance system is not capable of providing such information on itself and then the clinical has not the possibility of modifying the parameters to be set of the NIV respiratory assistance system based upon the patient's requirements, but only based upon clinical or hemogasanalytical data, which often are late.
- the Fres signal does not coincide with the Fven signal nor with the Fnc one (the only ones which can be measured and monitored by the conventional SMMRP systems), but, as it derives from (6) and (7) it results to be equal to the difference between the Fnc signal (in turn equal to the difference between the Fven signal and the Fext signal) and the total flow signal associated to the losses themselves (Floss), according to the following expression:
- tidal volume tidal volume
- RIP respiratory Impedance or Inductance Plethysmography
- Other techniques are under study, currently used exclusively in experimental field, which through the use of remote electromagnetic sensors (remote sensing) are potentially capable of monitoring the VC signal.
- the Fres signal is obtained by deriving the VC signal itself with respect to time.
- Both RIP and the other above-mentioned techniques do not provide sufficiently reliable performances, in the sense that the error associated to the measurement is not acceptable. Besides, they are quite expensive, particularly those associated to the remote sensing.
- a technical problem underlying the present illustration is in the fact of making available an apparatus which could allow overcoming the 3 above-mentioned disadvantages of a ACF system by using a new apparatus according to the present illustration which can be integrated with all conventional apparatuses used in the NIV respiratory assistance by means of NC and in particular, with the conventional ACFs used in the HFNC mode.
- the apparatus according to the present illustration allows measuring and monitoring "online" the respiratory mechanics in the patient with respiratory insufficiency subjected to NIV respiratory assistance in the HFNC mode.
- the apparatus according to the present illustration is capable of performing the detections contemporarily to the NIV assistance in the HFNC mode, by allowing not to lose the advantages of the same during measurements and to verify instantaneously if the set Fven value determines the physiopathological conditions required for the HFNC mode (see Procedure for the optimum control of the HFNC mode by means of the apparatus according to the present illustration ).
- the apparatus allows measuring, monitoring and storing the Fres signal and in synchronous mode with respect thereto, the signals related to the pressures at airways (Paw), pharyngeal (Pfa), oesophageal (Pes), gastric (Pga), internal to the respiratory orofacial mask (Pma) or sometimes even called facial mask integrated with CNC sealingly on the face (MORI).
- Paw pressures at airways
- Pfa pharyngeal
- Pga gastric
- Pma internal to the respiratory orofacial mask
- MORI facial mask integrated with CNC sealingly on the face
- the apparatus according to the present illustration is compatible to the production of a portable apparatus which can be used directly at the sick person's bed, thus by offering the guarantee of optimizing the respiratory assistance parameters instantaneously without having to wait for the offline data processing (see Procedure for the "online" monitoring of the respiratory mechanics in the patient in the HFNC mode and Procedure for the optimum control of the HFNC mode by means of the apparatus according to the present illustration).
- the monitoring of the signals related to the pressure is performed by connecting, by means of a small tube, a sensible element of a differential pressure transducer (TPD) with the customized involved section.
- the monitoring of the signals related to the flow is performed by connecting, by means of 2 small pneumatic tubes, the 2 terminals of a pneumotachograph (PNT), connected in series to the duct inside thereof the flow to be measured flows, with the 2 sensible elements of a TPD.
- PNT in fact, is a device capable of generating between the 2 terminals thereof a difference in pressure proportional to the flow crossing it.
- the apparatus according to the present illustration includes a respiratory orofacial mask integrated with CNC and configured to be sealingly placed onto a user's face. The mask is provided with TPD and PNT.
- the mask is apt to be connected to a measurement and acquisition apparatus (AMA) interfaced with CV, CNC and with MORI (see Element H);
- AMA measurement and acquisition apparatus
- the apparatus is configured to process data according to a dedicated software principle (SW), developed in MATLAB environment, residing in a portable computer (LAP) interfaced with AMA (see Element I).
- SW dedicated software principle
- LAP portable computer
- the above-mentioned technical problem, and in particular the above-mentioned three disadvantages of a known ACP system are solved and overcome by using a new apparatus according to the present illustration which can be integrated with all conventional apparatuses used in the NIV respiratory assistance by means of NC and in particular, with the conventional ACPs used in the NCPAP, NBiPAP, NIPPV, NSIPPV and NSIMV modes.
- the apparatus according to the present illustration allows measuring and "online" monitoring the respiratory mechanics in the patient with respiratory insufficiency subjected to NIV respiratory assistance in the NCPAP, NBiPAP, NIPPV, NSIPPV and NSIMV modes.
- the apparatus according to the present illustration is capable of performing the detections contemporarily to the NIV assistance in the NCPAP, NBiPAP, NIPPV, NSIPPV and NSIMV modes, by allowing not to lose the advantages of the same during the measurements.
- the apparatus allows measuring, monitoring and storing the Fres signal and in asynchronous mode with respect thereto, the signals related to the pressures at the airways (Paw), pharyngeal (Pfa), oesophageal (Pes), gastric (Pga), internal to the respiratory orofacial mask integrated with CNC sealingly on the face (MORI) (Pma).
- Paw airways
- Pfa pharyngeal
- Pga gastric
- MORI internal to the respiratory orofacial mask integrated with CNC sealingly on the face
- the apparatus can be compatible with the production of a portable apparatus which can be used directly at the sick person's bed, thus by offering the guarantee to optimize the respiratory assistance parameters instantaneously without having to wait for the offline data processing (see procedure for the "online" monitoring of the respiratory mechanics in the patient in the NCPAP, NBiPAP, NIPPV, NSIPPV and NSIMV modes).
- the monitoring of the signals related to the pressure can be performed by connecting, by means of a small tube, a sensible element of a differential pressure transducer (TPD) with the customized involved section.
- the monitoring of the signals related to the flow is performed by connecting, by means of 2 small pneumatic tubes, the 2 terminals of a pneumotachograph (PNT), connected in series with the duct inside thereof the flow to be measured flows, with the 2 sensible elements of a TPD.
- PNT pneumotachograph
- a PNT in fact, is a device capable of generating between the 2 terminals thereof a difference in pressure proportional to the flow crossing it.
- the apparatus according to an embodiment according to the present illustration is constituted by the following functional components:
- SW dedicated software
- LAP portable computer
- each embodiment of the subject of the present illustration can have one or more advantages enlisted above; in any case it is not however requested that each embodiment has simultaneously all enlisted advantages.
- FIG. 1 shows a scheme of a conventional ACF
- FIG. 2 shows an apparatus including a mask according to an embodiment of the present illustration
- - figure 3 shows an additional apparatus including a mask according to an embodiment of the present illustration
- - figure 4 shows schematically an operating principle of an apparatus according to an embodiment of the present illustration
- FIG. 5 shows a scheme of a conventional ACP
- FIG. 6 further shows schematically an operating principle of an apparatus according to an embodiment of the present illustration
- FIG. 7 shows a side view di a mask according to an embodiment of the present illustration under worn condition
- figure 8 shows a front view of the mask of figure 7
- FIG. 9 shows a view of a mask according to an additional embodiment of the present illustration under worn condition
- figure 10 shows a view of a detail in enlarged form of the detail X of figure 9;
- figure 1 1 shows a view from the top in schematic form of a mask according to the embodiment of figure 9;
- FIG. 12 shows further views of a stop body for the mask of figure 9.
- FIG. 3 an apparatus 10 according to an embodiment of the present illustration is shown.
- an apparatus 10 provided with an orofacial mask is made available, suitable to be sealingly placed onto a user's face even in presence of NC.
- an apparatus 10 is made available equipped with an orofacial mask apt to be sealingly placed on the face of a user even in presence of NC.
- the apparatus includes a ventilation circuit (CV), a nasal cannula circuit and a flow generator (GRF),
- CV ventilation circuit
- GRF flow generator
- an orofacial mask equipped with one or more passages for receiving one or more conduits of the nasal cannula circuit CNC and configured to create a sealed chamber when associated to the face of a user
- a first measurement device PNT_1 connected in series to the ventilation circuit (CV) between the ventilation circuit itself (CV) and the flow generator (GRF) for measuring and monitoring a first signal or ventilation value (Fven);
- a second measurement device associated to the orofacial mask (MORI); wherein the second measurement device is apt to measure a second signal or value representative a total flow loss which occurs inside the chamber of the orofacial mask(Floss);
- a calculator apt to calculate and/or quantify an actual ventilation value corresponding to, or based upon, the difference between the signal or ventilation value (Fven) and the signal or flow loss (Floss) value.
- the apparatus 10 provides the insertion (integration) of a first measurement device (PNT_1) between GRF and CV which allows the precise and accurate measurement and the monitoring of the Fven signal.
- PNT_1 is connected to the corresponding TPD (TPD_1) thereof belonging to AMA.
- TPD_1 TPD
- PNT_3 allows measuring and monitoring the Floss signal.
- PNT_3 is connected to the corresponding TPD (TPD_3) thereof belonging to AMA.
- the apparatus provides the use both of a facial mask (allowing to implement a sealing chamber for measuring Floss) and a nasal-cannula circuit.
- the apparatus according to the present illustration is characterized by the following structure:
- Element A PNT_1 connected in series to CV between CV itself and GRF for measuring and monitoring the Fven signal.
- PNT_1 is connected to TPD_1 belonging to AMA;
- Element B (not present in case of ACF for the HFNC mode);
- Element C small connection tube between MORI and TPD_4, belonging to AMA, for measuring Pma;
- Element D oesophageal/gastric catheter with balloon, for measuring Pes and Pga, connected through two small connection tubes to corresponding TPD_6 and TPD_5;
- Element E pharyngeal catheter with multiple terminal holes, for measuring Pfa, connected through a small connection tube to TPD_ 7;
- Element F MORI on the main opening thereof PNT_3 (Element G) is inserted. It is equipped with several outputs with pneumatic sealing for the oesophageal/gastric (Element _D) and pharyngeal (Element _E) catheters, for the connector thereon the small tube for measuring Pma (Element C) is inserted and for CNCJine and CNC_ring. MORI is further equipped with systems for fastening to the patient's head which guarantee a complete adhesion of the same to the patient face and prevent the flow loss from the edges of the mask;
- Element G PNT_3 inserted directly in the main opening of MORI, for measuring and monitoring the flow directed from the MORI itself towards outside or loss flow (Floss).
- PNT_3 is connected to TPD_3 belonging to AMA;
- Element H AMA constituted by 7 TPD and by an apparatus for monitoring, filtering, sampling, converting and storing in synchronous way (AMS) 7 signals outgoing from TDP.
- the conversion is necessary so that the measuring unit associated to the values of the respective quantity is transformed by a potential difference (volt) to the one congruous for the pressure (cmH 2 0) or for the flow (litres/minute or millilitres/second).
- Each one of the 7 TPD is connected, by means of a double or single small pneumatic tube, to the following devices or critical points already described previously:
- PNT_1 for measuring Fven
- PNT_2, for measuring Fext (TPD_2) (deactivated in case of ACF for the HFNC mode); 3) PNT_3, for measuring Floss (TPD_3);
- Element I control and processing unit (LAP) connected to a display (MONITOR).
- LAP control and processing unit
- AMS monitor
- SW control and processing unit
- AMS interfaced with AMS
- SW for managing acquisition by means of AMS
- software for the analysis and "on-line” and "off-line” processing of the signals available from AMS developed in MATLAB environment.
- Element F MORI
- MORI can be constituted by a facial mask with pneumatic seal, shown in section thereon 3 openings at as many outputs are performed.
- the main opening (AP_1) the PNT_3 dedicated to the Floss monitoring is inserted.
- a second opening (AP_2) is necessary to make that the small tube connecting the oesophageal/gastric small probe to AMA could cross the MORI, by allowing to measure Pfa.
- AP_3 is necessary to make that the 2 small tubes connecting the pharyngeal small probe to AMA could cross the MORI, by allowing to measure Pes and Pga.
- Both AP_2 and AP_3 are equipped with a mechanism allowing to activate the perfect pneumatic sealing at the same and to deactivate the same, with the purpose of making to flow depending upon the patient's needs and the procedure described hereinafter.
- Such mechanism consists in a hollow conical stiff connector surrounding the small tubes connected to the respective small probes and which can be inserted by interlocking into the AP_2 and AP_3 themselves. In order to deactivate such mechanism it is sufficient extracting the above-mentioned connector from AP_2 and AP_3.
- the correct procedure for applying the MORI provides the following sequential procedures:
- the MORI application according to the 8 just described procedures being necessary for carrying out the Procedure for the "online” monitoring of the respiratory mechanics in the patient in the HFNC mode and for the Procedure for the optimum Control of the HFNC mode, both described hereinafter, is finalized to optimize the diagnostic and functional performances of the apparatus according to the present illustration.
- the MORI application is reserved only to such time intervals. In this case, outside such "diagnostic” and “functional” time intervals, it will be sufficient to perform the first 5 procedures only of the just-described procedure.
- MORI represents the specific applicative innovation required to solve the problem of measuring and monitoring the Floss signal.
- MORI represents the specific applicative innovation required to solve the problem of measuring and monitoring the Floss signal.
- MORI and that is, a sealing orofacial mask on the patient face surrounding nose and mouth, it is possible detecting, measuring and monitoring the flow losses and that is, the Floss signal both during inspiration and expiration.
- the Fres signal results to be equal to the difference between the Fven signal coming from GRF and the total loss flow (Floss), in perfect agreement with (1).
- MORI can include a soft plastic body shaped like a hollow or shell or cap, and provided on an edge 100 intended to be placed on the face of a patient by means of an adhesive tape of known type and adequate to fasten MORI sealingly.
- MORI plastic material is made so as to allow a maximum adaptability and adherence of the edge 100 onto the user face.
- MORI in order to allow the passage of the conduits feeding the nasal cannulae (NC), MORI is equipped with an opening in the lower area wherein the conduits of the nasal-cannula circuit (CNC) insert sealingly.
- a stopper 102 or cover can be provided wherein the conduits are inserted by sliding until maximum adhesion.
- a similar stopper 102 can be provided for the small tubes for monitoring the gastric, oesophageal and pharyngeal pressure.
- the stopper 102 is a rubber disc equipped with holes, in case with conical section, with decreasing diameter as one goes towards the inside of the facial mask.
- the conduits of the nasal cannula circuit and/or the small tubes are inserted into the holes as far as obtaining maximum adhesion.
- the stopper is then inserted by pressure, with respective maximum adhesion in the hole obtained in the mask.
- a stop body 1 10 is provided shaped like a block or parallelepiped or any other adequate form, which is placed adjacent to the mask at respective recesses intended to accommodate the conduits of the nasal cannula circuit (CNC).
- CNC nasal cannula circuit
- the stop body is a body with a central hole interposed between two half-portions connected by the central hinge (see figures 9-13).
- the stop body 1 10 is opened to allow positioning the conduits of the nasal cannula circuit CNC, and then re-closed and fastened, for example by means of adhesive tape or similar adhesive application.
- Glue can be provided on one side of the stop body 1 10 intended to be adhered to the edge of the MORI mask and on one side destined to be placed in contact with the skin of a user.
- the opening side of the stop body 1 10 is opposite with respect to the side directed towards the patient, to avoid a surface continuity with the recesses for the conduits of the nasal cannula circuit (CNC).
- stop body 1 10 as the one described is of practical use for a user who has to wear the MORI, in fact it is sufficient for the operator to open the stop body and make to slide therein the conduits of the nasal cannula circuit (CNC) as far as the stop body adheres against the user face and the mask.
- CNC nasal cannula circuit
- the perfect pneumatic sealing of MORI can be controlled by verifying that the value of the inspiratory tidal volume (VCi), which can be calculated as the integral of the Fres signal with respect to the time during inspiration is identical to the value of the expiratory tidal volume (VCe), which can be calculated as the integral of the Fres signal with respect to time during expiration.
- An additional verification of the perfect pneumatic sealing of MORI can be performed by monitoring and checking the Pma signal.
- Tstart_drop_Pes Start-lnspiratory effort time
- Tdelay Time interval between Tstart_ins and Tstart_drop_Pes
- PTP_res Resistive component of inspiratory effort (Pressure Time Product)
- PTP_elas_pulm Elastic component (pulmonary expansion) of inspiratory PTP
- WOBJot per litre WOBJotJit
- the above-mentioned disadvantage 4, disadvantage 5 and disadvantage 6 can be overcome by using MORI and 3 PNT.
- the first PNT (PNT_1) is inserted between GRF and CV_1 and it allows the Fven measurement.
- the second PNT (PNT_2) is inserted between the output of CV_2 and outside and it allows the Fext measurement.
- the third PNT (PNT_3) is inserted directly in the main opening of MORI and it allows the Floss measurement.
- PNT_1 , PNT_2 and PNT_3 are connected to their respective TPD (TPD_1 , TPD_2 and TPD_3) belonging to AMA.
- the apparatus offers, intrinsically, optimum performances in terms of effectiveness, response time and auto-trigger associated to the trigger signal. Furthermore, the absence of a PNT inserted between the intersection and NCs, as used in the NIV synchronized conventional modes or techniques, allows obtaining 2 considerable advantage.
- the first advantage consists in the drastic reduction in the resistance (and then even in the associated effort and respiratory work) which the patient has to contrast for generating an upper inspiratory flow than the threshold fixed for the "trigger”.
- the second advantage consists in the use of circuits connecting the NCs and the clearly less cumbersome and lighter intersection.
- the apparatus according to an embodiment of the present illustration can be characterized by the following structure:
- Element A PNT_1 connected in series to CV between CV_1 and GRF for measuring and monitoring the Fven signal.
- PNT_1 is connected to TPD_1 belonging to AMA;
- Element B PNT_2 connected in series to CV between CV_2 and outside for measuring and monitoring the Fext signal.
- PNT_2 is connected to TPD_2 belonging to AMA;
- Element C small connection tube between MORI and TPD_4, belonging to AMA, for measuring Pma;
- Element D oesophageal/gastric catheter with balloon, for measuring Pes and Pga, connected through two small connection tubes to corresponding TPD_6 and TPD_5;
- Element E pharyngeal catheter with multiple terminal holes, for measuring Pfa, connected through a small connection tube to TPD_ 7;
- Element F MORI on the main opening thereof the PNT_3 (Element G) is inserted. It is equipped with several outputs with pneumatic sealing for the oesophageal/gastric (Element_D) and pharyngeal (Element_E) catheters for the connector thereon the small tube is inserted for measuring Pma (Element C) and for CNCJine and CNC_ring. MORI is further equipped with systems for fastening to the patient head which guarantee a complete adhesion of the same to the patient face and prevent the flow loss from the mask edges;
- Element G PNT_3 inserted directly in the main opening of MORI, for measuring and monitoring the flow directed from the MORI itself towards outside or loss flow (Floss).
- PNT_3 is connected to TPD_3 belonging to AMA;
- Element H AMA constituted by 7 TPD and by an apparatus for monitoring, filtering, sampling, converting and storing in synchronous way (AMS) the 7 signals outgoing from TDP.
- the conversion is necessary so that the measuring unit associated to the values of the respective quantity is transformed by a potential difference (volt) to the one congruous for the pressure (cmH 2 0) or for the flow (litres/minute or millilitres/second).
- Each one of the 7 TPD is connected, by means of a double or single small pneumatic tube, to the following devices or critical points already described previously:
- PNT_1 for measuring Fven
- oesophageal/gastric small probe for measuring Pes (TPD_6); 7) pharyngeal small probe, for measuring Pfa (TPD_7).
- Element I control and processing unit (LAP) connected to a display (MONITOR).
- LAP control and processing unit
- AMS interfaced with AMS, there are both SW for managing the acquisition by means of AMS, and the software for the analysis and "on-line” and “off-line” processing of the signals available from AMS developed in MATLAB environment.
- MORI is constituted by a facial mask with pneumatic sealing, shown in section, whereon 3 openings at corresponding as many outputs are performed.
- AP_1 PNT_3 dedicated to the Floss monitoring is inserted.
- a second opening (AP_2) is necessary to make that the small tube connecting the oesophageal/gastric small probe to AMA could cross the MORI, by allowing to measure Pfa.
- AP_3 is necessary to make that the 2 small tubes connecting the pharyngeal small probe to AMA could cross the MORI, by allowing to measure Pes and Pga.
- Both AP_2 and AP_3 are equipped with a mechanism allowing to activate the perfect pneumatic sealing at the same and to deactivate it, with the purpose of making to flow depending upon the patient's needs and the procedure described hereinafter.
- Such mechanism consists in a hollow conical stiff connector surrounding the small tubes connected to the respective small probes and which can be inserted by interlocking into the AP_2 and AP_3 themselves. In order to deactivate such mechanism it is sufficient extracting the above-mentioned connector from AP_2 and AP_3.
- the MORI application according to the 8 just described procedures being necessary for carrying out the Procedure for the "online" monitoring of the respiratory mechanics in the patient in the NCPAP, NBiPAP, NIPPV, NSIPPV and NSIMV modes, described hereinafter, is finalized to optimize the diagnostic and functional performances of the apparatus according to the present illustration.
- the MORI application is reserved only to such time intervals. In this case, outside such "diagnostic” and “functional” time intervals, it will be sufficient to perform the first 5 procedures of the just-described procedure.
- MORI represents the specific applicative innovation required to solve the problem of measuring and monitoring the Floss signal.
- the perfect pneumatic sealing of MORI can be controlled by verifying that the value of the inspiratory tidal volume (VCi), which can be calculated as the integral of the Fres signal with respect to time during inspiration is identical to the value of the expiratory tidal volume (VCe), which can be calculated as the integral of the Fres signal with respect to time during expiration.
- An additional verification of the perfect pneumatic sealing of MORI can be performed by monitoring and checking the Pma signal.
- the monitoring of the respiratory mechanics is implemented by the apparatus according to the present illustration by means of detecting and measuring in synchronous way the Paw, Pfa, Pes, Pga and Fres signals, and by processing them in suitable way it is possible calculating the main parameters linked to the respiratory mechanics in the patient and the various components of the effort and the respiratory work performed by the patient himself/herself.
- the Fres signal whose values are expressed in millilitres (ml) per second (s)
- the VC signal in ml is obtained.
- PTP_res Resistive component of inspiratory effort
- PTP_tot per minute PTP_tot_min
- the purpose of the HFNC mode is to supply to the patient, through NCs, a continuous flow of oxygen-enriched air so as to create inside the oro-pharyngeal cavity a chamber with positive continuous pressure.
- the "dead space" is drastically reduced and that is, the volume inside the CV terminated with NCs which does not contribute in effective way to the gaseous exchange at pulmonary level.
- This is very important, as at the beginning of each inspiration the portion of the immediately available oxygen enriched air is considerably higher.
- the outgoing of air enriched with carbon dioxide through the mouth is favoured by the high pressure gradient existing between the oropharyngeal cavity and outside.
- An air flow can cross any conduit by following 2 different directions which are discriminated by the different (positive or negative) algebraic sign associated to the flow itself.
- the scheme thereof is shown in Figure 4, by considering MORI as point ("node") wherein 3 different flows (Fven, Floss, Fres) intersect, it is possible deducing as follows.
- Fven is a unidirectional flow, that is, always flowing (both during apnea, and during inspiration and during expiration) in the same direction from the ventilation circuit to MORI.
- Such direction by definition, is associated to the positive algebraic sign.
- Floss is a bidirectional flow, that is, which can flow, in different time instants, in the direction from inside to outside of MORI (positive algebraic sign) or viceversa (negative algebraic sign).
- Fres which assumes null values during apnea, is a bidirectional flow, flowing from NCs to the lungs during inspiration (inspiratory flow: positive algebraic sign) or from the lungs to MORI during expiration (expiratory flow: negative algebraic sign).
- Figure 4 outside the relative conduits, arrows are shown designating the directions of the 3 flows associated to the respective algebraic signs.
- the primary purpose of the HFNC mode is to make that, during inspiration, only the oxygen-enriched flow coming from CNC (Fven) contributes to the VCi formation, by avoiding then the contribution of the not oxygen enriched flow directed from outside towards inside of MORI (negative Floss). From what said previously, it results clear that, in order to guarantee the above-mentioned primary purpose, it is necessary to make that the value set for Fven is higher than the Fres maximum or peak value required by the patient during inspiration. If this occurs, according to (3), the difference between Fven and Fres is always positive in any instant of inspiration. Differently, the patient would be obliged to take a flow portion from the outer environment which results to be not oxygen-enriched.
- condition (4) is associated to the following condition:
- Fven can and has to be adjusted at the end of each breath ("breath to breath” check) by making that the average difference between the above-mentioned peaks of Floss and Pma and the zero line is sufficient to guarantee an appropriate safety margin for satisfying the primary purpose.
- how much one can go beyond the value determined by the above-mentioned safety margin is to be verified by checking both VCi and the critical levels of Pes and Pfa, and the values of the features of the mechanic, the effort and the respiratory work.
- the subject of the present illustration has been sofar described with reference to preferred embodiments thereof. It is to be meant that other embodiments belonging to the same inventive core may exist, all within the protection scope of the here-below reported claims.
Abstract
La présente invention concerne un appareil (10) pour une ventilation pulmonaire non invasive, l'appareil (10) comprenant un circuit de ventilation (CV), un circuit de canule nasale (CNC) et un générateur de débit (GRF). L'appareil (10) comprend en outre un masque oro-facial (MORI) doté d'un ou de plusieurs passages ou évidements pour recevoir un ou plusieurs conduits du circuit de canule nasale (CNC) et configuré pour créer une chambre étanche lorsqu'il est associé au visage d'un utilisateur ; un premier dispositif de mesure (PNT_1) relié en série au circuit de ventilation (CV) entre le circuit de ventilation (CV) lui-même et le générateur de débit (GRF) pour mesurer et surveiller un premier signal ou une première valeur de ventilation (Fven) ; un second dispositif de mesure (PNT_3) associé au masque oro-facial (MORI), le second dispositif de mesure étant capable de mesurer un second signal ou une seconde valeur représentant d'une perte de débit (Floss) qui se produit dans la chambre étanche du masque oro-facial ; un calculateur capable de calculer et/ou de quantifier au moins une valeur de ventilation réelle correspondant à, ou basée sur, une différence entre le signal ou la valeur de ventilation (Fven) et le signal ou la valeur de perte de débit (Floss).
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US11317828B2 (en) | 2016-02-19 | 2022-05-03 | Covidien Lp | System and methods for video-based monitoring of vital signs |
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US11484208B2 (en) | 2020-01-31 | 2022-11-01 | Covidien Lp | Attached sensor activation of additionally-streamed physiological parameters from non-contact monitoring systems and associated devices, systems, and methods |
IT202200001706A1 (it) * | 2022-02-01 | 2023-08-01 | Dimar S R L | Manometro per interfaccia respiratoria non invasiva e relativa interfaccia respiratoria. |
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