Granted Patent B2

US 12,741,111 · App. 17/910,102 · Granted Sep 22, 2026

Inventors: Christer Sinderby (Ontario, CA); Jennifer Beck (Toronto, CA); Norman Comtois (Scarborough, CA)

Assignee: UNITY HEALTH TORONTO

A61M16/024A61B5/087A61M2016/0027A61M2016/0039

Abstract

Claims (475)

1 . A method for controlling a level of ventilatory assist applied to a patient by a mechanical ventilator, comprising:

determining a first respiratory volume of the patient during at least a part of an under-assisted breath of the patient;

determining a second respiratory volume of the patient during at least a part of the assisted breath of the patient for a duration matching the at least a part of the under-assisted breath of the patient;

calculating a volume assistance correction based on the first and second respiratory volumes;

measuring a pressure at the mechanical ventilator or at an airway of the patient;

calculating a load of a respiratory system of the patient based on the volume assistance correction and on the pressure at the mechanical ventilator or at the airway of the patient; and

controlling the mechanical ventilator according to the load of the respiratory system of the patient:

wherein the first and second respiratory volumes are measured for a same value of a neural respiratory drive of the patient; and

using respiratory volume measurements of the patient obtained over a plurality of under-assisted breaths of the patient and over a plurality of assisted breaths of the patient to predict a value of the neural respiratory drive of the patient based on a statistical probability of a similar mean neural drive between the under-assisted and assisted breaths of the patient.

2 . The method of claim 1 , wherein the value of the neural respiratory drive of the patient is obtained by measuring an electrical activity of a respiratory muscle of the patient during an under-assisted breath of the patient and during an assisted breath of the patient.

3 . The method of claim 2 , wherein the mechanical ventilator is controlled according to the load of the respiratory system of the patient so that at least one of the following conditions is met:

a target respiratory volume is delivered to the patient,

the electrical activity of the respiratory muscle during an assisted breath of the patient meets or exceeds a target threshold, and

a total respiratory pressure of the patient is equal to a target respiratory pressure plus or minus a safety margin.

4 . The method of claim 3 , further comprising:

determining a time of an earliest peak of electrical activity between the electrical activity of the respiratory muscle of the patient measured during the under-assisted breath and the electrical activity of the respiratory muscle of the patient measured during the assisted breath of the patient;

wherein:

the first respiratory volume of the patient is determined from a start of the under-assisted breath of the patient until the time of the earliest peak of electrical activity;

the second respiratory volume of the patient is determined from a start of the assisted breath of the patient until the time of the earliest peak of electrical activity; and

the pressure is measured at the mechanical ventilator or at the airway of the patient at the time of the earliest peak of electrical activity.

5 . The method of claim 4 , wherein determining the time of the earliest peak of electrical activity between the electrical activity of the respiratory muscle of the patient measured during the under-assisted breath and the electrical activity of the respiratory muscle of the patient measured during the assisted breath of the patient comprises determining a shortest duration until a peak of electrical activity between (a) the start of the under-assisted breath of the patient and a peak of electrical activity in the under-assisted breath, and (b) the start of the assisted breath of the patient and a peak of electrical activity in the assisted breath.

6 . The method of claim 4 , wherein the volume assistance correction is calculated based on a ratio of the first and second respiratory volumes.

7 . The method of claim 6 , wherein the volume assistance correction is calculated as follows:

V

AssistCorr

=

V

Assist

@

EAdiPeak

⁢

1

-

V

Assist

@

EAdiPeak

⁢

1

·

(

V

NOAssist

@

EAdiPeak

⁢

1

V

Assist

@

EAdiPeak

⁢

1

)

n

;

wherein:

V AssistCorr is the volume assistance correction,

V NoAssist@EAdiPeak1 is the first respiratory volume of the patient measured from the start of the under-assisted breath of the patient until the time of the earliest peak of electrical activity,

V Assist@EAdiPeak1 is the second respiratory volume of the patient measured from the start of the assisted breath of the patient until the time of the earliest peak of electrical activity, and

n is a power factor selected from 2 and 3.

8 . The method of claim 4 , wherein the volume assistance correction is calculated as follows:

V

AssistCorr

=

V

Assist

@

EAdiPeak

⁢

1

-

V

Assist

@

EAdiPeak

⁢

1

·

(

F

NOAssist

@

EAdiPeak

⁢

1

F

Assist

@

EAdiPeak

⁢

1

)

n

;

wherein:

V AssistCorr is the volume assistance correction,

V Assist@EAdiPeak1 is the second respiratory volume of the patient measured from the start of the assisted breath of the patient until the time of the earliest peak of electrical activity,

F NoAssist@EAdiPeak1 is a first respiratory flow of the patient measured between the start of the under-assisted breath of the patient and the time of the earliest peak of electrical activity,

F Assist@EAdiPeak1 is a second respiratory flow of the patient measured between the start of the assisted breath of the patient and the time of the earliest peak of electrical activity, and

n is a power factor selected from 2 and 3.

9 . The method of claim 7 , wherein the load of the respiratory system of the patient is calculated as follows:

L

KRS

=

P

Vent

@

EAdiPeak

⁢

1

V

AssistCorr

@

EAdiPeak

⁢

1

;

wherein:

L KRS is the load of the respiratory system of the patient, and

P vent@EAdiPeak1 is the pressure at the mechanical ventilator or at the airway of the patient at the time of the earliest peak of electrical activity.

10 . The method of claim 9 , further comprising:

determining a third respiratory volume of the patient in a totality of the under-assisted breath of the patient;

determining a fourth respiratory volume of the patient in a totality of the assisted breath of the patient;

calculating a pressure generated by the patient as follows:

Ppat

RS

=

L

KRS

·

V

NoAssist

·

(

V

NOAssist

V

Assist

)

n

;

wherein:

Ppat RS is the pressure generated by the patient,

V NoAssist is the third respiratory volume of the patient in the totality of the under-assisted breath of the patient, and

n is equal to 1; and

calculating the total respiratory pressure of the patient as follows;

Ptot

RS

=

L

KRS

·

V

Assist

;

wherein:

Ptot RS is the total respiratory pressure of the patient, and

V Assist is the fourth respiratory volume of the patient in the totality of the assisted breath of the patient.

11 . The method of claim 10 , wherein:

determining the third respiratory volume of the patient in the totality of the under-assisted breath of the patient comprises:

measuring a respiratory flow of the patient during the under-assisted breath, and

integrating the respiratory flow of the patient in the totality of the under-assisted breath of the patient; and

determining the fourth respiratory volume of the patient in a totality of the assisted breath of the patient comprises:

measuring a respiratory flow of the patient during the assisted breath, and

integrating the respiratory flow of the patient in the totality of the assisted breath of the patient.

12 . The method of claim 11 , wherein:

determining the first respiratory volume of the patient from the start of the under-assisted breath of the patient until the time of the earliest peak of electrical activity comprises truncating the integration of the respiratory flow of the patient at the time of the earliest peak of electrical activity; and

determining the second respiratory volume of the patient from the start of the assisted breath of the patient until the time of the earliest peak of electrical activity comprises truncating the integration of the respiratory flow of the patient at the time of the earliest peak of electrical activity.

13 . The method of claim 11 , further comprising:

calculating a pressure generated by the patient at the time of the earliest peak of electrical activity according to:

Ppat

RS

@

EAdiPeak

⁢

1

=

L

KRS

·

V

NoAssist

@

EAdiPeak

⁢

1

*

(

V

NOAssist

@

EAdiPeak

⁢

1

V

Assist

@

EAdiPeak

⁢

1

)

n

;

wherein:

Ppat RS@EAdiPeak1 is the pressure generated by the patient at the time of the earliest peak of electrical activity,

V NoAssist@EAdiPeak1 is the first respiratory volume of the patient measured from the start of the under-assisted breath of the patient until the time of the earliest peak of electrical activity,

V Assist@EAdiPeak1 is the second respiratory volume of the patient measured from the start of the assisted breath of the patient until the time of the earliest peak of electrical activity, and

n is equal to 1; and

calculating a neuromechanical efficiency of the patient according to:

NME

pat

=

Ppat

RS

@

EAdiPeak

⁢

1

EAdi

@

EAdiPeak

⁢

1

;

wherein:

NME pat is the neuromechanical efficiency of the patient, and

EAdi @EAdiPeak1 i s the electrical activity of the respiratory muscle of the patient at the time of the earliest peak of electrical activity.

14 . The method of claim 13 , further comprising:

calculating a neuroventilatory efficiency of the patient according to:

NVE

pat

=

V

NoAssist

@

EAdiPeak

⁢

1

EAdi

@

EAdiPeak

⁢

1

;

wherein:

NVE pat is the neuroventilatory efficiency of the patient.

15 . The method of claim 13 , further comprising:

calculating a total respiratory pressure of the patient at the time of the earliest peak of electrical activity according to:

Ptot

RS

@

EAdiPeak

⁢

1

=

L

KRS

·

V

Assist

@

EAdiPeak

⁢

1

;

wherein:

Ptot RS@EAdiPeak1 is the total respiratory pressure of the patient at the time of the earliest peak of electrical activity; and

calculating a total neuromechanical efficiency according to:

NME

tot

=

Ptot

RS

@

EAdiPeak

⁢

1

EAdi

@

EAdiPeak

⁢

1

;

wherein:

NME tot is the total neuromechanical efficiency.

16 . The method of claim 13 , further comprising:

calculating a total neuroventilatory efficiency according to:

NVE

tot

=

V

Assist

@

EAdiPeak

⁢

1

EAdi

@

EAdiPeak

⁢

1

;

wherein:

NVE tot is the total neuroventilatory efficiency.

17 . The method of claim 9 , further comprising:

measuring a pressure P Vent@EAdi≤70% at the mechanical ventilator or at the airway of the patient when the electrical activity of the respiratory muscle of the patient has reduced to 70% of its peak or less;

comparing the total respiratory pressure of the patient with a sum of (i) the pressure P Vent@EAd≤70% and (ii) a correction factor RLcorr representing a pressure adapted to overcome a residual load of the patient; and

in response to the sum of the pressure P Vent@EAdi≤70% and of the correction factor RLcorr being greater than the total respiratory pressure of the patient:

calculating a total corrected pressure Ptot RSCorr according to:

Ptot

RSCorr

=

P

Vent

@

EAdi

≤

70

⁢

%

+

RLcorr

,

calculating a ratio Ptot RsCorrRatio to correct for unaccounted elastic load compensation according to:

Ptot

RSCorrRatio

=

Ptot

RSCorr

/

Ptot

RS

,

and

using the ratio Ptot RSCorrRatio as a multiplication factor to adjust the calculation of the load of the respiratory system of the patient.

18 . The method of claim 1 , wherein the mechanical ventilator is controlled according to the load of the respiratory system of the patient so that at least one of the following conditions is met:

a target respiratory volume is delivered to the patient, and

a total respiratory pressure of the patient is equal to a target respiratory pressure plus or minus a safety margin.

19 . The method of claim 1 , wherein the volume assistance correction is calculated based on a ratio of the first and second respiratory volumes.

20 . The method of claim 19 , wherein the volume assistance correction is calculated as follows:

V

AssistCorr

=

V

Assist

-

V

Assist

·

(

V

NOAssist

V

Assist

)

n

;

wherein:

V AssistCorr is the volume assistance correction,

V NoAssist is the first respiratory volume of the patient measured during the at least a part of the under-assisted breath of the patient,

V Assist is the second respiratory volume of the patient measured during the at least a part of the assisted breath of the patient, and

n is a power factor selected from 2 and 3.

21 . The method of claim 19 , wherein the volume assistance correction is calculated as follows:

V

AssistCorr

=

V

Assist

-

V

Assist

·

(

F

NOAssist

V

Assist

)

n

;

wherein:

V AssistCorr is the volume assistance correction,

V Assist is the second respiratory volume of the patient measured during the at least a part of the assisted breath of the patient,

F NoAssist is a first respiratory flow of the patient measured during the at least a part of the under-assisted breath of the patient,

F Assist is a second respiratory flow of the patient during the at least a part of the assisted breath of the patient, and

n is a power factor selected from 2 and 3.

22 . The method of claim 20 , wherein the load of the respiratory system of the patient is calculated as follows:

L

KRS

=

P

Vent

V

AssistCorr

;

wherein:

L KRS is the load of the respiratory system of the patient, and

P Vent is the pressure at the mechanical ventilator or at the airway of the patient.

23 . The method of claim 22 , further comprising:

determining a third respiratory volume of the patient in a totality of the under-assisted breath of the patient;

determining a fourth respiratory volume of the patient in a totality of the assisted breath of the patient;

calculating a pressure generated by the patient as follows:

Ppat

RS

=

L

KRS

·

V

NoAssist

·

(

V

NOAssist

V

Assist

)

n

;

wherein:

Ppat RS is the pressure generated by the patient,

V NOAssist is the third respiratory volume of the patient in the totality of the under-assisted breath of the patient,

V Assist is the fourth respiratory volume of the patient in the totality of the assisted breath of the patient,

n is equal to 1; and

calculating the total respiratory pressure of the patient as follows;

Ptot

RS

=

L

KRS

·

V

Assist

;

wherein:

Ptot RS is the total respiratory pressure of the patient.

24 . The method of claim 23 , wherein:

determining the third respiratory volume of the patient in the totality of the under-assisted breath of the patient comprises:

measuring a respiratory flow of the patient during the under-assisted breath, and

integrating the respiratory flow of the patient in the totality of the under-assisted breath of the patient; and

determining the fourth respiratory volume of the patient in a totality of the assisted breath of the patient comprises:

measuring a respiratory flow of the patient during the assisted breath, and

integrating the respiratory flow of the patient in the totality of the assisted breath of the patient.

25 . The method of claim 1 , wherein the under-assisted breath is a non-assisted breath.

26 . The method of claim 1 , wherein the under-assisted breath is a breath during which the mechanical ventilator provides less assist than in the assisted breath.

27 . A system for controlling a level of ventilatory assist applied to a patient by a mechanical ventilator, comprising:

a determiner of a respiratory volume delivered to the patient;

a pressure sensor adapted for measuring a pressure at the mechanical ventilator or at an airway of the patient; and

a controller operatively connected to the determiner of the respiratory volume, and to the pressure sensor, the controller comprising:

a processor, and

a non-transitory computer-readable medium having stored thereon machine executable instructions for performing, when executed by the processor, the method according to claim 1 .

28 . The system of claim 27 , wherein the determiner of the respiratory volume delivered to the patient comprises:

a flow meter adapted for detecting a respiratory flow of the patient; and

an integrator adapted for determining the respiratory volume delivered to the patient by integrating the respiratory flow of the patient.

29 . The system of claim 27 , comprising the mechanical ventilator.

30 . The system of claim 27 , further comprising an operator interface operatively connected to the controller and adapted for providing to the controller at least one configuration parameter for controlling the mechanical ventilator.

31 . The system of claim 30 , wherein the controller further comprises a memory adapted to store the at least one configuration parameter.

32 . The system of claim 31 , wherein the at least one configuration parameter defines a range for the level of ventilatory assist applied to the patient by the mechanical ventilator, a low end of the range causing the mechanical ventilator to provide no assist to the patient, a high end of the range causing the mechanical ventilator to fulfill a totality of a ventilatory need of the patient.

33 . The system of claim 31 , further comprising an electrical sensor operatively connected to the controller, the electrical sensor being adapted for detecting an electrical activity of a respiratory muscle of the patient, wherein the controller is adapted to:

control an initial operation of the mechanical ventilator using the range for a level of ventilatory assist applied to the patient by the mechanical ventilator defined by the at least one configuration parameter;

implement a recurring sequence, each instance of the sequence comprising controlling the mechanical ventilator for at least one under-assisted breath and for a plurality of assisted breaths; and

following each instance of the sequence:

recalculate the load of the respiratory system of the patient using electrical activity measurements of the respiratory muscle of the patient, respiratory volume determinations and pressure measurements obtained in the course of the sequence, and

modify control of the mechanical ventilator according to the recalculated load of the respiratory system of the patient.

34 . The system of claim 33 , wherein:

the at least one configuration parameter further comprises:

an inclusion criterion for the electrical activity measurements,

an inclusion criterion for respiratory volume determinations, and

an inclusion criterion for pressure measurements; and

the controller is further adapted for ignoring measurements obtained during a given assisted or under-assisted breath when recalculating the load of the respiratory system of the patient when at least one of the inclusion criterion is not met.

35 . The system of claim 31 , wherein the processor is further adapted to:

calculate a spontaneous breathing prediction for the patient based on the calculated load of the respiratory system of the patient;

store the spontaneous breathing prediction for the patient in the memory; and

use the stored spontaneous breathing prediction for the patient for back-up control of the level of ventilatory assist to the patient when the patient is not spontaneous breathing.

Assignments (1)

Continuity (2)

References Cited (21)