Methods and devices for sensing respiration and controlling ventilator functions

• US 8,776,793 B2
• Filed: 04/17/2009
• Issued: 07/15/2014
• Est. Priority Date: 04/18/2008
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Wondka, Anthony D., Bryan, Robert F., McCall, Mark, Tran, Cuong Q.
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US12/988,477
• Publication Number:
  US 20110197885A1
• Time in Patent Office: 1,915 Days
• Field of Search: 12820418-20423, 128/207.14
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/0427 with removable and re-insertable liner tubes, e.g. for cleaning
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 16/0475 having openings in the tube
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/106 in a path
• CPC Class Codes: A61M 2016/0015 inhalation detectors
• CPC Class Codes: A61M 2016/0413 with detectors of CO2 in exhaled gases
• CPC Class Codes: A61M 2205/17 with redundant control systems

Abstract

Improved methods and devices are described for sensing the respiration pattern of a patient and controlling ventilator functions, particularly for use in an open ventilation system. A ventilation and breath sensing apparatus may include a ventilation gas delivery circuit and a ventilation tube coupled to the ventilation gas delivery circuit. A plurality of pressure sensing elements may be separated by a distance and may produce independent signals. The signals may be used to detect pressure differentials between the plurality of pressure sensing elements. Sensing ports may be located in an airway, and connected to transducers that are valved to optimize sensitivity and overpressure protection. Airway pressure and flow can both be obtained and used to optimize ventilator synchronization and therapy.

Claims

1. A ventilation and breath sensing apparatus comprising:

a ventilation gas delivery circuit;

a ventilation tube coupled to the ventilation gas delivery circuit and further defined by a patient airway end;

a plurality of pressure sensing elements disposed on the patient airway end of the ventilation tube and

separated by a distance, each producing independent signals, airflow through a patient airway being derived from direct measurements of pressure differentials between the plurality of pressure sensing elements;

wherein control over at least one of ventilation gas delivery timing, amplitude, speed, waveform shape, frequency, and composition is based upon a correlated combination of the signals from the pressure sensing elements and the derived airflow to adapt to a true breathing activity by a patient.

2. The ventilation and breath sensing apparatus of claim 1, wherein the plurality of pressure sensing elements are pressure sensing conduits.

3. The ventilation and breath sensing apparatus of claim 1, wherein the plurality of pressure sensing elements are pressure sensing transducers.

4. The ventilation and breath sensing apparatus of claim 1, wherein the plurality of pressure sensing elements are a combination of pressure sensing conduits and pressure sensing transducers.

5. The ventilation and breath sensing apparatus of claim 1, wherein at least one of the plurality of pressure sensing elements is associated with the ventilation tube.

6. The ventilation and breath sensing apparatus of claim 1, wherein at least one of the plurality of pressure sensing elements is associated with the ventilation gas delivery circuit.

7. The ventilation and breath sensing apparatus of claim 1, wherein at least one of the plurality of pressure sensing elements is associated with a ventilator.

8. The ventilation and breath sensing apparatus of claim 1, wherein at least one of the plurality of pressure sensing elements is a pressure sensing conduit, and the pressure sensing conduit has at least one port.

9. The ventilation and breath sensing apparatus of claim 1, wherein at least one of the plurality of pressure sensing elements is a transtracheal sensing conduit, and wherein at least one of the plurality of pressure sensing elements is coupled to the ventilation gas delivery circuit.

10. The ventilation and breath sensing apparatus of claim 1, wherein two or more of the plurality of pressure sensing elements are at a distal end of the ventilation tube for positioning in at least one of a tracheal, nasal and oral airway.

11. The ventilation and breath sensing apparatus of claim 1, wherein the ventilation tube is removably coupled to the ventilation gas delivery circuit.

12. The ventilation and breath sensing apparatus of claim 1, wherein the ventilation gas delivery circuit includes a first pressure sensing element and the ventilation tube includes a second pressure sensing element, and wherein in a coupled arrangement, the first pressure sensing element and the second pressure sensing element are in fluid communication.

13. The ventilation and breath sensing apparatus of claim 1, further comprising a tracheal, nasal or oral airflow conduit coupled to a distal end of the ventilation tube that is for positioning within a tracheal, nasal or oral airway, wherein the plurality of pressure sensing elements are disposed within the tracheal, nasal or oral airflow conduit.

14. The ventilation and breath sensing apparatus of claim 1, further comprising a spontaneous breathing conduit separate from the ventilator gas delivery circuit for extending into at least one of a tracheal, nasal and oral airway, wherein the spontaneous breathing conduit comprises a plurality of pressure taps for measuring pressure drop across the plurality of pressure taps.

15. The ventilation and breath sensing apparatus of claim 1, further comprising an outer sleeve, wherein the ventilation tube is disposed in the outer sleeve.

16. The ventilation and breath sensing apparatus of claim 1, wherein the ventilation tube includes a patient interface.

17. The ventilation and breath sensing apparatus of claim 16, wherein at least one of the plurality of breath sensing elements is located in the patient interface.

18. The ventilation and breath sensing apparatus of claim 1, further comprising a physical barrier between at least two of the plurality of pressure sensing elements.

19. The ventilation and breath sensing apparatus of claim 18, wherein the physical barrier creates a pressure drop and biases the response time of each of the at least two of the plurality of pressure sensing elements depending on direction of airflow.

20. The ventilation and breath sensing apparatus of claim 1, further comprising at least one thermal sensor disposed near or in an entrance of an airway, wherein the at least one thermal sensor is used to determine spontaneous breathing airflow, and at least one of the plurality of pressure sensing elements is used to determine breathing pressure, and wherein a combination of the spontaneous breathing airflow and the breathing pressure is used to optimize ventilator synchronization and titration of therapy.

21. A ventilation and breath sensing method comprising:

directly measuring airway pressure from a first pressure sensing element;

directly measuring airway pressure from a second pressure sensing element, wherein the second pressure sensing element is separated by a distance from the first pressure sensing element, and the first pressure sensing element produces a first signal independent from a second signal from the second pressure sensing element;

determining a pressure differential between the first signal and the second signal;

determining at least one of a tracheal, nasal and oral pressure based upon the pressure differential between the first signal and the second signal;

determining at least one of a tracheal, nasal and oral airflow representative of a true breathing activity of the patient using the corresponding one of the tracheal, nasal and oral pressure;

initiating ventilation from a ventilator based upon a combination of at least one of the determined tracheal, nasal and oral airflow and at least one of the tracheal, nasal, and oral pressure.

22. The ventilation and breath sensing method of claim 21, wherein the plurality of pressure sensing elements are pressure sensing conduits.

23. The ventilation and breath sensing method of claim 21, wherein the plurality of pressure sensing elements are located within at least one of a tracheal, nasal and oral airway.

24. The ventilation and breath sensing method of claim 21, wherein the plurality of pressure sensing elements are located within an interface between the ventilation tube and the ventilation gas delivery circuit.

25. The ventilation and breath sensing method of claim 21, further comprising determining spontaneous breathing airflow from at least one thermal sensor disposed near or in an entrance of an airway, and wherein a combination of the spontaneous breathing airflow and the tracheal, nasal or oral pressure is used to optimize ventilator synchronization and titration of therapy.

26. A ventilation and breath sensing apparatus comprising:

a ventilation gas delivery circuit;

a ventilation tube coupled to the ventilation gas delivery circuit and further defined by a patient airway end;

a plurality of breath sensing elements disposed on the patient airway end of the ventilation tube

including at least one pressure sensing port to directly measure airway breathing pressure to determine true breathing activity of a patient, and at least one thermal sensor, airflow through a patient airway being derived from measurements of the at least one thermal sensor;

wherein control over at least one of ventilation gas delivery timing, amplitude, speed, waveform shape, frequency, and composition is based upon a correlated combination of the signals from the breath sensing elements and the derived airflow to adapt to the true breathing activity of the patient.

27. The ventilation and breath sensing apparatus of claim 26, further comprising at least two thermal sensors coupled in an array.

28. A ventilation and breath sensing apparatus comprising:

a ventilation interface tube with a gas delivery conduit,

at least one breath sensing channel not connected to and parallel to the gas delivery channel and having an opening in communication within an airway of the patient to directly measure airway pressures, and

a first sensor and a second sensor in the at least one breath sensing conduit;

wherein the first sensor produces a first signal;

wherein the second sensor produces a second signal;

wherein the second sensor is at a distance from the first sensor and producing a signal independent from the first signal;

a processor for calculating (1) a pressure differential between the first signal and the second signal, (2) at least one of a tracheal, nasal and oral pressure derived from the pressure differential between the first signal and the second signal, and (3) at least one of a tracheal, nasal and oral air flow derived from the respective tracheal, nasal, and oral pressure representative of a true breathing activity of the patient; and

wherein the processor initiates ventilation based upon a combination of at least one of the tracheal, nasal and oral air flow and at least one of the tracheal, nasal, and oral pressure.

29. The ventilation and breath sensing apparatus of claim 28, wherein at least one of the first sensor and the second sensor are pressure sensors.

30. The ventilation and breath sensing apparatus of claim 28, further comprising at least one thermal sensor disposed near or in an entrance of an airway, wherein the at least one thermal sensor is used to determine spontaneous breathing airflow, and wherein a combination of the spontaneous breathing airflow and the tracheal, nasal or oral pressure is used to optimize ventilator synchronization and titration of therapy.