EP4580716A1 - Method and system for expiratory high frequency percussive ventilation - Google Patents
Method and system for expiratory high frequency percussive ventilationInfo
- Publication number
- EP4580716A1 EP4580716A1 EP23762532.2A EP23762532A EP4580716A1 EP 4580716 A1 EP4580716 A1 EP 4580716A1 EP 23762532 A EP23762532 A EP 23762532A EP 4580716 A1 EP4580716 A1 EP 4580716A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- patient
- ventilation
- pressure
- high frequency
- flow
- 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
Classifications
-
- 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. ventilators; Tracheal tubes
- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
- A61M16/022—Control means therefor
- A61M16/024—Control means therefor including calculation means, e.g. using a processor
-
- 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. ventilators; Tracheal tubes
- A61M16/0096—High frequency jet ventilation
-
- 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. ventilators; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0066—Blowers or centrifugal pumps
-
- 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. ventilators; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0072—Tidal volume piston pumps
-
- 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. ventilators; Tracheal tubes
- A61M16/20—Valves specially adapted to medical respiratory devices
- A61M16/201—Controlled valves
- A61M16/202—Controlled valves electrically actuated
-
- 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. ventilators; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
- A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
-
- 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. ventilators; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
-
- 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. ventilators; 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
- A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1014—Diaphragm
-
- 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/60—Muscle strain, i.e. measured on the user
-
- 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/63—Motion, e.g. physical activity
Definitions
- the present invention relates to the field of devices and systems for mechanical ventilation, more particularly for delivering lung protective ventilation for patients needing respiratory support.
- IPPV Intermittent Positive Pressure Ventilaton
- PIP Peak Inspiratory Pressure
- PEEP Positive End Expiratory Pressure
- a system for mechanical ventilation of a human patient including: pressure generator means for generating a pressure or flow of breathing gasses to produce ventilation waveforms; interface means for delivering the ventilation to a patient, including a patient interface and a breathing circuit, the breathing circuit connecting the pressure generator means to the patient interface; detecting means adapted to detect the inspiration/expiration phases of the patient’s breathing cycle and to determine a first value indicative of the airflow entering the breathing circuit and a second value indicative of the airflow at the patient’s airway opening; a microprocessor adapted to receive information from the detecting means and to control the generator means; characterized in that the microprocessor is configured to control the pressure generator means to provide a high frequency ventilation to the patient only during the expiration phase and to maintain, during expiration phase, the rate of flow entering the breathing circuit equal or greater than the peak flow exiting the patient’s airway opening for allowing purging of exhaled breath at
- the microprocessor is further configured to control the pressure generator means to produce a conventional ventilation pattern to ventilate the patient during the inspiratory phase and to superimpose a high frequency ventilation patter on the conventional ventilation pattern to ventilate the patient during the expiratory phase, together with the purging flow.
- the pressure generator means include: a flow generator configured to produce a ventilation waveform; and a high frequency oscillatory pressure generator configured to generate high frequency oscillatory pressure; the microprocessor being configured to control the flow generator and a high frequency oscillatory pressure generator to provide a combined ventilation pattern where a high frequency ventilation pattern is superimposed on the conventional ventilation pattern to ventilate the patient during the expiratory phase.
- the generation of high frequency oscillatory pressure can be done with one or more of the following technique: piston/voice coil actuator system, high speed proportional gas valves, high dynamic radial compressor, pneumatic or jet systems.
- the detecting means can include one or more of the following: airway opening of patient’s circuit pressure sensor, patient’s flow sensor, Graseby capsule to detect movements of the patient’s thoraco-abdominal wall, sensor to detect electrical signals of patient’s diaphragmatic activity, breathing circuit input flow sensors, breathing circuit outlet flow sensors, devices for measuring the pressure generator operating conditions that allows determining the gas flow entering the breathing circuit (such as differential pressure and rotational speed for blowers, shaft position and differential pressure for proportional valves).
- the conventional ventilation includes one or more of the following technique: controlled mechanical ventilation; assisted mechanical ventilation; assisted mechanical ventilation with trigger systems for detecting the patient spontaneous activity and synchronize the delivery of the inspiratory or expiratory pressure to the patient’s spontaneous breaths.
- the breathing circuit can optionally include an inspiratory line and a separated exhalation line.
- the breathing circuit can include a single tube and an intentional leak allowing gas purging at the patient’s airway opening during expiratory phase.
- a method for operating the system of any preceding claim comprising the step of: detecting by means of the at least one sensor the alternation of inspiration and expiration phases in a patient; controlling the high frequency oscillatory pressure generator to provide a High Frequency Ventilation overimposed to the conventional ventilation pattern to the patient only during the expiration phase.
- the method and system according to preferred embodiments of the present invention applies high-frequency component during the expiration phase only, thus maintaining the benefit of increased diffusion gas exchange as for percussive ventilation without increasing the peak inspiratory pressure applied to the patients, thereby providing protection against excessive stress and strain to lung and airway tissue.
- Producing a ventilation mode according to the present invention combines the advantages of conventional mechanical ventilation and high-frequency mechanical ventilation without the drawbacks of percussive ventilation.
- the system produces a conventional ventilation pattern during the inspiratory phase delivering a PIP to the patients, e.g. with the modes currently used in mechanical ventilators (fast pressure rise, ramp pressure increase, etc) for the duration of the inspiration.
- the system superimposes a high-frequency oscillatory ventilation pattern.
- the system and method (including the therapeutic method) of the present invention can be very useful for several kind of patients, including patients with healthy lungs, with respiratory disorders, such as adverse hypoxia/hypercapnia encountered in chronic respiratory conditions (COPD, chest wall or lung tissue restrictive disorders, neuromuscular diseases), obesity, bariatric surgery, or surgeries requiring capnoperitoneum.
- respiratory disorders such as adverse hypoxia/hypercapnia encountered in chronic respiratory conditions (COPD, chest wall or lung tissue restrictive disorders, neuromuscular diseases), obesity, bariatric surgery, or surgeries requiring capnoperitoneum.
- COPD chronic respiratory conditions
- COPD chronic respiratory conditions
- ALI Acute Lung Injury
- ARDS Acute Respiratory Distress Syndrome
- VILI Ventilator-Induced Lung Injury
- Figure 1 shows a comparison between traditional mechanical ventilation and the expiration Percussive High Frequency Percussive Ventilation (eHFPV) according to a preferred embodiment of the present invention: the graph shows tracheal pressure signals during application of conventional pressure-controlled ventilation (PCV) and expiratory High Frequency Percussive Ventilation (e-HFPV) in a rabbit by adding 5 Hz pressure fluctuations with 2 cmH20 peak-to-peak pressure.;
- PCV pressure-controlled ventilation
- e-HFPV expiratory High Frequency Percussive Ventilation
- Figure 2 is a schematic diagram of the system implementing a preferred embodiment of the present invention
- Figures 3a and 3b show possible embodiment of the breathing circuit according to the present invention
- Figure 4 schematically shows an alternative embodiment, using a chest cuirass for delivering the pressure oscillations to the patient.
- HFPV High-frequency Percussive Ventilation
- CMV mechanical ventilation
- HAV High Frequency Ventilation
- the pressure and/or flow will be measured at the airway opening of the patient, and data processing algorithm will detect the beginning and the end of the expiratory phase, whenever determined by the patient (assisted ventilation modes) of by the ventilator (controlled ventilation modes).
- This signal will be used to enable the high-frequency pressure generator that will be activated only during expiration.
- the resulting ventilation waveform is the combination of a conventional ventilation and the superimposed high-frequency component during expiration.
- the high-frequency component will be preferable delivered between 5 and 15 Hz with peak-to-peak pressure greater than 2 cmH20, with maximum airway opening pressure during expiration preferably not exceeding patient’s specific PIP.
- the high frequency oscillatory pressure and the conventional ventilation pressure may be generated by proper controlling a single high speed actuator or, alternatively, by two different devices, controlled by a microprocessor, each one generating a different kind of ventilation.
- a combination of conventional and high pressure ventilation is provided with the high frequency wave form being superimposed on the conventional wave form.
- the purged flow can be estimated from the pressure of the gas in the breathing circuit after a proper characterisation of the pressure-flow relationship of the intentional leak.
- the design of the intentional leak should be done considering the expected range of MOEF and the minimum circuit pressure during expiration, known as Positive End Expiratory Pressure (PEEP).
- PEEP Positive End Expiratory Pressure
- FIG. 1 Represented in Figure 1 are two graphs showing the comparison of e-HFPV method according to a preferred embodiment of the present invention with a whole cycle HFPV and conventional mechanical ventilation (CMV).
- CMV mechanical ventilation
- One of the advantages of implementing eHFPV is to enhance CO2 clearance and to increase oxygenation by facilitating dynamic diffusion without overdistending the lungs. Indeed, our results confirmed the improvements in gas exchange when a high-frequency signal with an amplitude of 2 cmhhO and frequency of 5 Hz was applied in the expiratory phase only. The improved CO2 clearance was also confirmed by the capnography results demonstrating enhancements in Vco2 at all amplitudes and frequencies during eHFPV (p ⁇ 0.001 ), and improvements in ventilation dead space (VDF/VT) and phase 2 slope (S2V) at higher oscillatory amplitudes.
- VDF/VT ventilation dead space
- S2V phase 2 slope
- a method according to the present invention avoids the application of high-frequency oscillation in the inspiratory phase, limiting the maximum pressure applied to the lungs. This is confirmed by the lack of an increase in peak airway pressure during e-HFPV while delivering the same tidal volume VT as the HFPV or the conventional CMV. Due to this benefit of e-HFPV, this modality is expected to protect lung tissue injury since the lung compliance is minimal at end-inspiration, causing the lung tissues to be more prone to injure in this phase of the breathing cycle.
- FIG. 2 represents a block diagram of a device to implement the e-HFPV ventilation according to a preferred embodiment of the present invention.
- the system (device) 200 for mechanical ventilation of a human patient 201 includes a flow or pressure generator 203, configured to produce a ventilation pattern and a high frequency oscillatory pressure generator 205 configured to generate a High Frequency oscillatory pressure signal to improve gas diffusion processes within the patients’ lung.
- a controller e.g. a microprocessor
- the controller 207 receives input from detecting means 209 (e.g.
- the microprocessor controls the high frequency oscillatory pressure generator to provide a High Frequency Percussive Ventilation to the patient only during the expiration phase.
- the system according a preferred embodiment of the present invention provides the patient with a conventional ventilation delivering a PIP to the patients with the modes currently used in mechanical ventilators (fast pressure rise, ramp pressure increase, etc) for the duration of the inspiration.
Landscapes
- Health & Medical Sciences (AREA)
- Emergency Medicine (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102022000018081A IT202200018081A1 (en) | 2022-09-02 | 2022-09-02 | Method and system for mechanical ventilation High Frequency Percussive Ventilation in the expiratory phase |
| PCT/EP2023/074077 WO2024047245A1 (en) | 2022-09-02 | 2023-09-01 | Method and system for expiratory high frequency percussive ventilation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4580716A1 true EP4580716A1 (en) | 2025-07-09 |
Family
ID=83996535
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP23762532.2A Pending EP4580716A1 (en) | 2022-09-02 | 2023-09-01 | Method and system for expiratory high frequency percussive ventilation |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4580716A1 (en) |
| IT (1) | IT202200018081A1 (en) |
| WO (1) | WO2024047245A1 (en) |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130220324A1 (en) * | 2012-02-29 | 2013-08-29 | Nellcor Puritan Bennett Llc | Systems and methods for providing oscillatory pressure control ventilation |
| US9833584B2 (en) * | 2013-03-22 | 2017-12-05 | Breathe Technologies, Inc. | Portable ventilator secretion management system |
| US20220152338A1 (en) * | 2020-11-17 | 2022-05-19 | Koninklijke Philips N.V. | Airway therapy system |
-
2022
- 2022-09-02 IT IT102022000018081A patent/IT202200018081A1/en unknown
-
2023
- 2023-09-01 WO PCT/EP2023/074077 patent/WO2024047245A1/en not_active Ceased
- 2023-09-01 EP EP23762532.2A patent/EP4580716A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| IT202200018081A1 (en) | 2024-03-02 |
| WO2024047245A1 (en) | 2024-03-07 |
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