DEVICE FOR DIAGNOSING THE EFFICACY OF VENTILATION OF A PATIENT AND METHOD FOR DETERMINING THE VENTILATORY EFFICACY OF A PATIENT

• US 20180160970A1
• Filed: 05/30/2016
• Published: 06/14/2018
• Est. Priority Date: 06/08/2015
• Status: Abandoned Application

• Current Assignee: Archeon Co, Centre Hospitalier Regional Universitaire De Besancon, Universite De Franche-Comte
• Original Assignee: Centre Hospitalier Regional Universitaire De Besancon, Polycaptil, Universite De Franche-Comte
• Inventors: KHOURY, Abdo, DE LUCA, Alban, SALL, Fatimata Seydou, PAZART, Lionel, CAPELLIER, Gilles, SAILLARD, Pierre-Edouard, NITA, Florin Dan, VINCHANT, Jean-Francois
• Application Number:
  US15/580,526
• Publication Number:
  US 20180160970A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 5/0878 using temperature sensing means
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0078 Breathing bags
• CPC Class Codes: A61M 16/0084 self-reinflatable by elasticity, e.g. resuscitation squeeze bags
• CPC Class Codes: A61M 16/021 operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)

Abstract

A device for diagnosing the ventilatory efficacy of a patient under respiratory assistance, said device being intended to cooperate with a system for ventilating the patient, the device having: a bidirectional thermal mass sensor for measuring, in real time, the air flows during insufflation and during exhalation, an electronic casing connected to said sensor and configured to receive and process data relating to the air flows measured by the sensor, the electronic casing having: i. a user interface comprising a display device and data input means, ii. a data-processing center, the data-processing center functioning according to programmed algorithms for acquiring, processing and displaying the data, for analyzing the efficacy of the ventilation in real time, and for managing alarms, and iii. means for supplying electricity.

Claims

1. :

A device for diagnosing the ventilatory effectiveness of a patient under respiratory assistance, intended to interact with a system for ventilating the patient, the device including;

a two-way thermal mass sensor able to measure in real-time air flow rates on insufflation and on expiration;

an electronic unit connected to said sensor, configured to receive and process data relating to the air flow rates measured by the sensor, the electronic unit including;

a user interface comprising a display device and means for inputting data;

a data-processing center, the data-processing center operating according to algorithms programmed to acquire, to process and to display data, to analyze the effectiveness of the ventilation in real-time and to manage alarms; and

means for supplying electrical power.

2. :

The device as claimed in claim 1, further comprising a disconnectable connection between the sensor and the electronic unit.

3. :

The device as claimed in claim 1, wherein the display device is a screen and the means for supplying electrical power being a battery.

4. :

The device as claimed in claim 1, wherein the sensor is single-use.

5. :

The device as claimed in claim 1, further comprising at least one other sensor, chosen from the following sensors;

a pressure sensor, and

a sensor of CO₂ concentration in the air.

6. :

The device as claimed in claim 1, wherein the means for inputting data is configured to allow physical and/or physiological characteristics of the patient to be input into the electronic unit, and/or characteristics relating to the ventilation, including the type of ventilation, to the type of ventilation device and/or the type of ventilation interface to be input.

7. :

The device as claimed in claim 6, wherein the physical and/or physiological characteristics of the patient or physiological parameters of the patient measured by the sensor comprises at least two from the following characteristics or parameters;

the size of the patient, his lung capacity, his pulmonary compliance, his pulmonary resistance, his expiratory time constant, his positive end-expiratory pressure, his concentration of CO₂ in the expired air.

8. :

The device as claimed in claim 7, wherein the data-processing center is configured to, throughout the duration of the ventilatory assistance provided to the patient, in particular in each ventilation cycle, analyze said characteristics and the physiological parameters measured, in particular in each ventilation cycle, by the sensor, in order to deduce therefrom ideal ventilatory parameters for an optimal ventilation of said patient, and for each ventilatory parameter, a minimum and/or maximum threshold.

9. :

The device as claimed in claim 8, wherein the ventilatory parameters include at least two from the following parameters;

the insufflated volume, the expired volume, the tidal volume, the leak volume, the ventilatory frequency and the insufflation pressure.

10. :

The device as claimed in claim 8, wherein the data-processing center is configured to receive ventilatory parameters measured by the sensor and to compare them to said thresholds, throughout the duration of the ventilatory assistance provided to the patient, in each ventilation cycle.

11. :

The device as claimed in claim 10, wherein the data-processing center is configured to, throughout the duration of the ventilatory assistance provided to the patient, in each ventilation cycle, and for each ventilatory parameter, in case of value of a measured ventilatory parameter higher than a corresponding maximum threshold and/or lower than a corresponding minimum threshold, generate an alarm and/or a piece of information on the one or more ventilatory parameters to be modified or corrections to be carried out to achieve an optimal ventilation.

12. :

The device as claimed in the claim 11, wherein the electronic unit is configured to transmit to the user via the display device the parameters to be modified or corrections and/or the electronic unit includes a visual and/or audio and/or tactile indicator and is configured to transmit to the user via said indicator the parameters to be modified or corrections.

13. :

A ventilation system for providing respiratory assistance to a patient, including a device for diagnosing the effectiveness of the ventilation of the patient as claimed in claim 1, and a ventilation device chosen from the group consisting of;

a flexible bag, a self-inflating bag and a mechanical ventilator.

14. :

The ventilation system as claimed in claim 13, including a ventilation interface chosen from the group consisting of;

an invasive ventilation via tracheotomy or tracheal tube, and a non-invasive ventilation via a mask, the two-way thermal mass sensor being located between the ventilation device and the ventilation interface.

15. :

A method for determining the ventilatory effectiveness of a patient using a ventilation system for providing respiratory assistance to a patient, including a device for diagnosing the effectiveness of the ventilation of the patient under respiratory assistance, intended to interact with a system for ventilating the patient, the device including a two-way thermal mass sensor able to measure in real-time air flow rates on insufflation and on expiration, an electronic unit connected to said sensor, configured to receive and process data relating to the air flow rates measured by the sensor, the electronic unit including a user interface comprising a display device and means for inputting data, a data-processing center, the data-processing center operating according to algorithms programmed to acquire, to process and to display data, to analyze the effectiveness of the ventilation in real-time and to manage alarms, and means for supplying electrical power, and a ventilation device chosen from the group consisting of;

a flexible bag, a self-inflating bag and a mechanical ventilator, comprising;

a) allowing physical and/or physiological characteristics of the patient to be input into the electronic unit, and/or characteristics relating to the ventilation, in particular relating to the type of ventilation, to the type of ventilation device and/or to the type of ventilation interface to be input;

b) measuring the physiological parameters of the patient using the sensor;

c) analyzing the characteristics input in step a) and the parameters measured in step b);

d) deducing therefrom, in real-time, ideal ventilatory parameters for an optimal ventilation of said patient, and for each ventilatory parameter, a minimum and/or maximum threshold;

e) measuring in real-time the ventilatory parameters of the patient;

f) comparing the measured ventilatory parameters to said thresholds, respectively;

g) for each ventilatory parameter, in case of value of a measured ventilatory parameter higher than a corresponding maximum threshold and/or lower than a corresponding minimum threshold, generating an alarm and/or a piece of information on the one or more parameters to be modified or corrections to be carried out to achieve an optimal ventilation;

h) repeating steps b) to g) throughout the duration of the ventilatory assistance provided to the patient, in each ventilation cycle.

16. :

The method as claimed in claim 15, wherein the physical and/or physiological characteristics of the patient comprise at least two from the following characteristics or parameters;

the size of the patient, his lung capacity, his pulmonary compliance, his pulmonary resistance, his expiratory time constant, his positive end-expiratory pressure, his concentration of CO₂ in the expired air.

17. :

The method as claimed in claim 15, wherein the ventilatory parameters include at least two from the following parameters;

the insufflated volume, the expired volume, the tidal volume, the leak volume, the ventilatory frequency and the insufflation pressure.

18. :

The method as claimed in claim 15, wherein the parameters to be modified or corrections are transmitted to the user by way of a display device including a screen and/or a visual and/or audio and/or tactile indicator.