Myoelectrically activated respiratory leak sealing

• US 7,963,283 B2
• Filed: 01/16/2002
• Issued: 06/21/2011
• Est. Priority Date: 01/16/2001
• Status: Expired due to Fees

• Current Assignee: The University of Montreal
• Original Assignee: Universite De Montreal, L'
• Inventors: Sinderby, Christer
• Primary Examiner(s): Douglas; Steven O
• Assistant Examiner(s): OSTRUP, CLINTON T
• Application Number:
  US10/466,699
• Publication Number:
  US 20050011519A1
• Time in Patent Office: 3,443 Days
• Field of Search: 128/204.23, 128/200.24, 128/204.18, 128/204.21, 128/204.26, 128/205.14, 128/205.16, 128/205.25, 128/206.21, 600/546, 600/593, 600/587, 600/547
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0409 with mean for closing the oesophagus
• CPC Class Codes: A61M 16/0415 with access means to the stomach
• CPC Class Codes: A61M 16/044 External cuff pressure control or supply, e.g. synchronisation with respiration
• CPC Class Codes: A61M 16/0461 Nasoendotracheal tubes
• CPC Class Codes: A61M 2230/08 Other bio-electrical signals
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user

Abstract

The method and system are for sealing/unsealing (regulating) airway leaks occurring between the ventilator circuit and respiratory airways during lung ventilatory support in response to myoelectrical activity of diaphragm. Myolectrical activity of a patient'"'"'s respiratory-related muscle is sensed to detect respiratory effort, and to produce a myoelectrical signal representative of the sensed muscle myoelectrical activity. Respiratory flow and pressure can also be measured to produce respective respiratory pressure and respiratory flow signals. A logic trigger sealing/unsealing of airway leaks in relation to the myoelectrical signal, respiratory flow signal and/or respiratory pressure signal to assist respiration of the patient. The amplitude of the myoelectrical signal is compared to a given threshold, and airway leaks are sealed when the amplitude of the myoelectrical signal is higher than this threshold. Increment of myoelectrical signal amplitude can be also detected to trigger the airway leak regulating device to seal the airway leaks, while decrement of the myoelectrical signal amplitude can be detected to unseal the airway leaks and thus permit air evacuation from the patient'"'"'s lungs.

Claims

1. A method for controlling an air seal between a ventilator air circuit and a patient'"'"'s respiratory airways, comprising:

mounting an air seal modifier between the ventilator air circuit and the patient'"'"'s respiratory airways;

sensing myoelectrical activity of a respiratory-related muscle of the patient to produce a myoelectrical signal representative of respiratory effort of the patient;

analyzing the myoelectrical signal to produce an air seal controlling signal; and

controlling the air seal modifier in response to the air seal controlling signal to (a) seal the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways during respiratory effort of the patient, and (b) unseal the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways to allow gas leaks during relaxation of respiratory effort of the patient.

2. A method for controlling an air seal as recited in claim 1, wherein the respiratory-related muscle is selected from the group consisting of diaphragm, parasternal intercostal muscles, sternocleidomatoids, scalenes, and alas nasi.

3. A method for controlling an air seal as recited in claim 2, wherein the respiratory-related muscle is the diaphragm.

4. A method for controlling an air seal as recited in claim 3, wherein the myoelectrical activity is sensed in an electrically active region of the diaphragm (DDR).

5. A method for controlling an air seal as recited in claim 4, wherein the myoelectrical activity is sensed near a centre of the DDR.

6. A method for controlling an air seal as recited in claim 5, wherein sensing the myoelectrical activity of the respiratory-related muscle comprises sensing at least one signal above said DDR and at least one signal below said DDR, and subtracting these two signals to yield at least one myoelectrical signal representative of the respiratory effort of the patient.

7. A method for controlling an air seal as recited in claim 1, wherein:

the sensing the myoelectrical activity of the respiratory-related muscle of the patient step comprises producing at least one myoelectrical signal representative of respiratory effort of the patient;

the analyzing the myoelectrical signal step comprises comparing the myoelectrical signal to a predetermined value so as to determine a highest value between a value of the myoelectrical signal and the predetermined value, wherein the highest value forms the air seal controlling signal; and

the controlling the air seal modifier step comprises controlling the air seal modifier in response to the highest value.

8. A method for controlling an air seal as recited in claim 7, further comprising filtering from said at least one myoelectrical signal at least one of the following disturbances:

motion artifacts, electrocardiogram (EGG), electrical interference, and high frequency noise.

9. A method for controlling an air seal as recited in claim 7, wherein the predetermined value is a predetermined threshold, and wherein controlling the air seal modifier comprises (a) sealing the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways when said at least one myoelectrical signal is the highest value, thereby avoiding gas leaks during respiratory effort of the patient, and (b) unsealing the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways when the predetermined threshold is the highest value, thereby allowing gas leaks during relaxation of the respiratory effort of the patient.

10. A method for controlling an air seal as recited in claim 9, wherein two different thresholds are used in (a) and in (b).

11. A method for controlling an air seal as recited in claim 9, wherein the predetermined threshold is predetermined by manual adjustment using visual feedback.

12. A method for controlling an air seal as recited in claim 9, wherein the predetermined threshold is predetermined automatically by letting the level be relative to a predetermined noise level.

13. A method for controlling an air seal as recited in claim 7, wherein the analyzing the myoelectrical signal step further comprises multiplying a current sample of said at least one myoelectrical signal by a predetermined constant to produce a multiplied sample;

wherein the predetermined value corresponds to a prior sample of said at least one myoelectrical signal; and

wherein the controlling the air seal modifier step comprises (a) sealing the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways when a value of the multiplied sample is the highest value, thereby avoiding gas leaks during the respiratory effort of the patient, and (b) unsealing the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways when a value of the prior sample of said at least one myoelectrical signal is the highest value, thereby allowing gas leaks during relaxation of the respiratory effort of the patient.

14. A method for controlling an air seal as recited in claim 7, further comprising detecting a level of noise in said at least one myoelectrical signal;

and determining whether the respiratory-related muscle of the patient is active in relation to the detected level of noise.

15. A system for controlling an air seal between a ventilator air circuit and a patient'"'"'s respiratory airways, comprising:

a modifier of the air seal;

a sensor of a myoelectrical activity of a respiratory-related muscle of the patient to produce a myoelectrical signal representative of respiratory effort of the patient;

an analyzer of the myoelectrical signal to produce an air seal controlling signal; and

an air seal controller responsive to the air seal controlling signal to activate the air seal modifier for (a) sealing the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways during respiratory effort of the patient, and (b) unsealing the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways to allow gas leaks during relaxation of the respiratory effort of the patient.

16. A system for controlling an air seal as recited in claim 15, wherein the air seal modifier comprises a sealing balloon.

17. A system for controlling an air seal as recited in claim 16, wherein:

the sealing balloon is mounted on a ventilatory assist tube of the ventilator air circuit; and

the ventilatory assist tube includes a first lumen defining an air passage of the ventilator air circuit, and a second lumen defining a fluid passage for fluid communication between the sealing balloon and a balloon inflation device and pressure control of the sealing balloon both forming part of the air seal controller.

18. A system for controlling an air seal as recited in claim 15, wherein the air seal modifier comprises a face mask including a seal pressure lumen.

19. A system for controlling an air seal as recited in claim 15, wherein the sensor comprises an array of electrodes.

20. A system for controlling an air seal as recited in claim 19, wherein the array of electrodes is provided with a constant inter-electrode distance.

21. A system for controlling an air seal as recited in claim 19, wherein the array of electrodes includes nine electrodes.

22. A system for controlling an air seal as recited in claim 19, further comprising at least one differential amplifier connected to both the electrodes and the analyzer.

23. A system for controlling an air seal as recited in claim 22, wherein said at least one differential amplifier includes single-ended amplifiers, allowing monopolar readings.

24. A system for controlling an air seal as recited in claim 22, wherein said at least one differential amplifier is connected to the electrodes via electric wires.

25. A system for controlling an air seal as recited in claim 24, further comprising means for filtering from the myoelectrical signal at least one of the following disturbances:

motion artifacts;

EGG, electrical interference, and high frequency noise.

26. A system for controlling an air seal as recited in claim 22, wherein the array of electrodes comprises pairs of electrodes and wherein said at least one differential amplifier comprises a differential amplifier for each pair of electrodes.

27. A system for controlling an air seal as recited in claim 22, wherein said at least one differential amplifier is configured for sampling the myoelectrical signal to form signal segments.

28. A system for controlling an air seal as recited in claim 15, wherein the sensor is mounted on a free end of a catheter.

29. A system for controlling an air seal as recited in claim 28, wherein the sensor includes a steel wire wound around the catheter.

30. A system for controlling an air seal as recited in claim 29, wherein the steel wire wound around the catheter is smoothed out by solder.

31. A system for controlling an air seal as recited in claim 28, wherein the catheter is an oesophageal catheter.

32. A system for controlling an air seal as recited in claim 15, wherein the sensor is mounted on a free end of a nasogastric tube.

33. A system for controlling an air seal as recited in claim 15, wherein the analyzer comprises a personal computer.

34. A system for controlling an air seal as recited in claim 15, wherein the analyzer comprises a comparator of the myoelectrical signal with a predetermined value to produce the air seal controlling signal.

35. A system for controlling an air seal between a ventilator air circuit and a patient'"'"'s respiratory airways, comprising:

means for modifying the air seal;

means for sensing myoelectrical activity of a respiratory related muscle of the patient to produce a myoelectrical signal representative of respiratory effort of the patient;

means for analyzing the myoelectrical signal to produce an air seal controlling signal; and

air seal control means responsive to the air seal controlling signal to activate the air seal modifying means for (a) sealing the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways during respiratory effort of the patient, and (b) unsealing the air seal between the ventilator air circuit and the patient'"'"'s respiratory airways to allow gas leaks during relaxation of respiratory effort of the patient.