Method and apparatus for providing ventilatory support to a patient

• US 6,457,472 B1
• Filed: 12/11/1997
• Issued: 10/01/2002
• Est. Priority Date: 12/12/1996
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Smith, Philip L., Schwartz, Alan R.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): WEISS JR, JOSEPH
• Application Number:
  US08/989,106
• Time in Patent Office: 1,755 Days
• Field of Search: 128/204.21, 128/204.23, 128/204.26, 128/207.14, 128/207.16
• US Class Current: 128/204.23
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user

Abstract

A ventilatory support system which controls the flow of breathing gas to a patient based on the physiological requirements of the patient is disclosed. Gas pressure in the trachea of the patient is measured, and the delivery of breathing gas to the patient is controlled based on the sensed gas pressure. Depending on the physiological needs of the patient, a tracheal gas pressure limit and a breathing gas flow rate value are established. When the tracheal gas pressure limit is reached, the flow of breathing gas is reduced or terminated. The flow of breathing gas is resumed, for example, after a delay period, or after the tracheal gas pressure falls to a predetermined level.

Claims

1. A method of providing interactive ventilatory support to a patient based on the physiological requirements of the patient, the method comprising:

initially determining a degree of obstruction in an upper airway of the patient; and

subsequently delivering a controlled rate of flow of breathing gas directly to the trachea of the patient below the location of potential obstruction based on the gas pressure measured directly in the trachea of the patient and the determined degree of obstruction in the upper airway of the patient in order to facilitate exhalation through the upper airway of the patient.

2. The method of claim 1, further comprising delivering the controlled flow of breathing gas transtracheally to the patient.

3. The method of claim 1, further comprising:

establishing a tracheal gas pressure limit for the patient;

establishing a breathing gas flow rate value for the patient;

delivering the breathing gas to the patient at the breathing gas flow rate value when the gas pressure in the trachea of the patient is below the tracheal gas pressure limit; and

reducing the flow of breathing gas to the patient when the gas pressure in the trachea of the patient reaches the tracheal gas pressure limit.

4. The method of claim 3, further comprising:

establishing a critical tracheal gas pressure level of the patient; and

establishing the tracheal gas pressure limit above the critical tracheal gas pressure level.

5. The method of claim 3, further comprising resuming the flow of breathing gas after a delay period subsequent to the reduction of the flow of breathing gas.

6. The method of claim 3, further comprising

establishing an expiratory target tracheal gas pressure level below the tracheal gas pressure limit;

and

resuming the flow of breathing gas when the gas pressure in the trachea of the patient reaches the expiratory target tracheal gas pressure.

7. The method of claim 1, further comprising substantially continuously monitoring the gas pressure in the trachea.

8. The method of claim 1, wherein the determination of whether the upper airway of the patient is obstructed comprises measuring gas pressure in the trachea of the patient while providing gas to the trachea at a controlled flow rate.

9. The method of claim 1, wherein the controlled rate of breathing gas is delivered to the patient below a potential obstruction in the upper airway of the patient.

10. A method of providing breathing gas to a patient comprising:

inserting a catheter into the trachea of a patient;

initially determining a critical tracheal gas pressure level of the patient below which the upper airway of the patient occludes;

initially establishing a tracheal gas pressure limit for the patient;

measuring gas pressure directly in the trachea; and

subsequently controlling rate of flow of the breathing gas delivered directly to the trachea below a potential obstruction in the upper airway of the patient through the catheter based on the critical tracheal gas pressure level of the patient and the measured gas pressure in the trachea in order to provide an adequate supply of breathing gas to the patient and to facilitate exhalation through the upper airway of the patient.

11. The method of claim 10, further comprising inserting the catheter transtracheally into the trachea of the patient.

12. The method of claim 10, further comprising establishing a breathing gas flow rate value for the patient.

13. The method of claim 12, further comprising:

substantially continuously monitoring the gas pressure in the trachea.

14. The method of claim 12, further comprising:

storing information corresponding to the measured gas pressure in the trachea.

15. The method of claim 12, wherein the breathing gas comprises from about 21 to 100 percent oxygen.

16. The method of claim 12, further comprising humidifying the breathing gas.

17. The method of claim 12, further comprising heating the breathing gas to approximately the same temperature as the body temperature of the patient.

18. The method of claim 12, further comprising employing the method on a patient suffering from obstructive sleep apnea.

19. The method of claim 12, further comprising establishing the tracheal gal pressure limit and the breathing gas flow rate value by:

initializing the tracheal gas pressure limit at an initial value;

increasing the breathing gas flow rate until swings in the measured gas pressure in the trachea are less than a predetermined value;

adjusting the initial tracheal gas pressure limit to a predetermined pressure value above the critical tracheal gas pressure level of the patient;

increasing the breathing gas flow rate if swings in the measured gas pressure in the trachea are greater than a predetermined value;

maintaining the tracheal gas pressure limit and breathing gas flow rate value if the patient experiences substantially no glottic apneas; and

decreasing the tracheal gas pressure limit by a predetermined amount if the patient experiences substantial glottic apneas.

20. The method of claim 19, further comprising:

initializing the tracheal gas pressure limit at an initial value of from about 10 to about 30 cmH₂O;

increasing the breathing gas flow rate until the swings in the measured gas pressure in the trachea are less than a predetermined value of from about 5 to about 20 cmH₂O;

adjusting the initial tracheal gas pressure limit to a predetermined pressure value of from 0 to about 20 cmH₂O above the critical tracheal gas pressure level of the patient;

increasing the breathing gas flow rate from about 0.5 to about 10 liters/minute if the swings in the measured gas pressure in the trachea are greater than a predetermined value of from about 2 to about 10 cmH₂O; and

decreasing the tracheal gas pressure limit by a predetermined amount of from about 2 to about 10 cmH₂O if the patient experiences substantial glottic apneas.

21. The method of claim 12, wherein the breathing gas flow rate value is substantially constant.

22. The method of claim 12, wherein the breathing gas flow rate value is from about 4 to about 60 liters per minute.

23. The method of claim 12, further comprising reducing the flow of breathing gas when the measured gas pressure in the trachea reaches the tracheal gas pressure limit.

24. The method of claim 12, further comprising terminating the flow of breathing gas when the measured gas pressure in the trachea reaches the tracheal gas pressure limit.

25. The method of claim 12, further comprising:

establishing a maximum tracheal gas pressure value for the patient; and

terminating the flow of breathing gas when the measured gas pressure in the trachea reaches the maximum tracheal gas pressure value.

26. The method of claim 12, further comprising:

establishing the tracheal gas pressure limit above the critical tracheal gas pressure level.

27. The method of claim 26, wherein the critical tracheal gas pressure level is not less than 5 cmH₂O below atmospheric pressure.

28. The method of claim 26, wherein this critical tracheal gas pressure level is below atmospheric pressure.

29. The method of claim 28, further comprising at least partially blocking flow of gas through the upper airway of the patient.

30. The method of claim 26, wherein the tracheal gas pressure limit is from 0 to abut 30 cmH₂O above the critical tracheal gas pressure level.

31. The method of claim 26, wherein the tracheal gas pressure limit is from about 5 to about 20 cmH₂O above the critical tracheal gas pressure level.

32. The method of claim 10, wherein the critical tracheal gas pressure level is above atmospheric pressure.

33. The method of claim 12, further comprising:

reducing the flow of breathing gas when the measured gas pressure in the trachea reaches the tracheal gas pressure limit; and

subsequently increasing the flow of breathing gas after a delay period.

34. The method of claim 33, wherein the delay period is from about 0.5 to 10 seconds.

35. The method of claim 33, further comprising:

terminating the flow of breathing gas when the measured gas pressure in the trachea reaches the tracheal gas pressure limit; and

resuming the flow of breathing gas at a substantially constant flow rate after the delay period.

36. The method of claim 12, further comprising:

establishing an expiratory target tracheal gas pressure level below the tracheal gas pressure limit;

reducing the flow of breathing gas when the measured gas pressure in the trachea reaches the tracheal gas pressure limit; and

subsequently increasing the flow of breathing gas when the measured gas pressure in the trachea reaches the expiratory target tracheal gas pressure level.

37. The method of claim 36, wherein the expiratory target tracheal gas pressure is from about 2 to about 40 cmH₂O below the tracheal gas pressure limit.

38. The method of claim 36, further comprising:

terminating the flow of breathing gas when the measured gas pressure in the trachea reaches the tracheal gas pressure limit; and

resuming the flow of breathing gas at a substantially constant flow rate when the measured gas pressure in the trachea reaches the expiratory target tracheal gas pressure level.

39. The method of claim 36, further comprising:

establishing a critical tracheal gas pressure level of the patient; and

establishing the differential tracheal gas pressure level above the critical tracheal gas pressure level.

40. Apparatus for providing breathing gas to a patient comprising:

means for determining a critical tracheal gas pressure level of the patient below which the upper airway of the patient occludes;

means for delivering breathing gas directly into the trachea of the patient below a potential obstruction in the upper airway of the patient;

means for measuring gas pressure directly in the trachea; and

means for subsequently controlling rate of flow of the breathing gas through the breathing gas delivery means directly into the trachea based on the critical tracheal gas pressure level of the patient and the measured gas pressure in the trachea in order to provide an adequate supply of breathing gas to the patient and to facilitate exhalation through the upper airway of the patient.

41. The apparatus of claim 40, wherein the breathing gas delivery means comprises a transtracheal catheter.

42. The apparatus of claim 41, wherein transtracheal catheter comprises a proximal end connected to a source of the breathing gas and a distal end for insertion through the trachea of the patient, and the gas pressure measuring means comprises a pressure sensor mounted on the distal end of the catheter.

43. The apparatus of claim 40, wherein the flow controlling means comprises means for intermittently delivering the breathing gas through the breathing gas delivery means into the trachea at a prescribed gas flow rate value.

44. The apparatus of claim 43, wherein the gas flow rate value is substantially constant.

45. The apparatus of claim 40, wherein the flow controlling means comprises means for reducing the flow of the breathing gas when the measured gas pressure reaches a prescribed tracheal gas pressure limit.

46. The apparatus of claim 45, wherein the flow controlling means comprises means for subsequently increasing the flow of the breathing gas after a prescribed delay period.

47. The apparatus of claim 45, wherein the flow controlling means comprises means for subsequently increasing the flow of the breathing gas after the measured gas pressure falls to a prescribed expiratory target tracheal pressure level below the tracheal gas pressure limit.

48. The apparatus of claim 40, further comprising means for at least partially blocking flow of gas through the upper airway of the patient.

49. The apparatus of claim 40, further comprising means for substantially continuously monitoring the gas pressure in the trachea.

50. The apparatus of claim 40, further comprising means for storing information corresponding to the measured gas pressure in the trachea.

51. The apparatus of claim 40, further comprising means for humidifying the breathing gas prior to delivery of the breathing gas into the trachea.

52. The apparatus of claim 40, further comprising means for heating the breathing gas to approximately the same temperature as the body temperature of the patient prior to delivery of the breathing gas into the trachea.

53. Apparatus for providing breathing gas to a patient comprising:

a source of breathing gas;

a catheter in flow communication with the source of the breathing gas having a distal end structured and configured for placement below a potential obstruction in the upper airway of the patient;

an upper airway flow sensor structured and configured for placement above the potential obstruction for measuring an initial gas flow rate through the upper airway of the patient;

a tracheal pressure sensor structured and configured for placement in the trachea of the patient for measuring gas pressure directly in the trachea of the patient; and

a breathing gas flow controller operatively coupled to the source of breathing gas and the tracheal pressure sensor for controlling the rate of flow of the breathing gas delivered directly to the trachea below the potential obstruction from the source of breathing gas through the catheter based on the initial gas flow rate through the upper airway and the measured gas pressure in the trachea in order to provide an adequate supply of breathing gas to the patient and to facilitate exhalation through the upper airway of the patient.

54. The apparatus of claim 53, further comprising a valve in flow communication with the source of breathing gas and the catheter, and operatively coupled to the flow controller for reducing and increasing the flow of the breathing gas through the catheter.

55. The apparatus of claim 53, wherein the catheter is a transtracheal catheter.

56. The apparatus of claim 53, further comprising a monitor operatively coupled to the tracheal pressure sensor for substantially continuously monitoring the gas pressure in the trachea.