METHODS AND DEVICES FOR TREATING SLEEP APNEA

• US 20090151719A1
• Filed: 09/26/2008
• Published: 06/18/2009
• Est. Priority Date: 02/04/2004
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Wondka, Anthony, Kapust, Gregory
• Granted Patent: US 8,925,545 B2
• Time in Patent Office: Days
• US Class Current: 128/203.120
• CPC Class Codes: A61M 16/0096 High frequency jet ventilation
• 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 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• 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 2016/0413 with detectors of CO2 in exhaled gases
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/03 Gases in liquid phase, e.g. cryogenic liquids
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user

Abstract

A ventilation apparatus for treating sleep apnea is provided. A ventilator controlled by a control system may deliver ventilation gas through a ventilation gas delivery circuit to a ventilation catheter and a distal tip on the ventilation catheter. One or more sensors may detect a breathing cycle and the control system may operate the ventilator in synchrony with the breathing cycle. The distal tip may deliver the ventilation gas superiorly from the transtracheal ventilation catheter towards an upper airway, inferiorly from the transtracheal ventilation catheter towards a lung, or a combination of both. The ventilation catheter may be a transtracheal catheter, a trans-oral catheter or a trans-nasal catheter.

Claims

1. A ventilation apparatus for treating sleep apnea, the apparatus comprising:

a ventilator for delivering ventilation gas;

a control system for the ventilator;

a transtracheal ventilation catheter for insertion into a trachea;

a distal tip on the transtracheal ventilation catheter;

one or more sensors for detecting a breathing cycle;

a ventilation gas delivery circuit connecting the ventilator to the transtracheal ventilation catheter;

wherein the control system operates the ventilator such that ventilation gas is delivered in synchrony with the breathing cycle; and

wherein the distal tip delivers the ventilation gas in a direction selected from the group consisting of superiorly from the transtracheal ventilation catheter towards an upper airway, inferiorly from the transtracheal ventilation catheter towards a lung, and combinations thereof.

2. The apparatus of claim 1, wherein the control system operates the ventilator such that ventilation gas is delivered in a manner selected from the group consisting of during an inspiration phase of the breathing cycle, during an expiration phase of the breathing cycle, during both an inspiration phase and an expiration phase of the breathing cycle, continuously during the breathing cycle, cyclically during the breathing cycle, with a flow amplitude that increases over time, with flow rates adjusted by the control system in response to measurements from the one or more sensors, and combinations thereof.

3. The apparatus of claim 1, wherein the ventilation gas is delivered at a low flow rate and a high pressure.

4. The apparatus of claim 1, wherein the ventilation gas is delivered at a high frequency.

5. The apparatus of claim 1, wherein the ventilation gas is delivered as a jet.

6. The apparatus of claim 1, wherein the ventilation gas is delivered in a manner selected from the group consisting of preemptively to prevent or minimize an obstruction or apneic event, while an obstruction or apneic event is developing, in reaction to an obstruction or apneic event, and combinations thereof.

7. The apparatus of claim 1, wherein the one or more sensors are coupled to the transtracheal ventilation catheter.

8. The apparatus of claim 1, wherein one or more sensors are external to the trachea.

9. The apparatus of claim 1, wherein the one or more sensors are one or more airflow sensors in the trachea and one or more pressure sensors in the trachea.

10. The apparatus of claim 15, wherein signals from the one or more airflow sensors and signals from the one or more pressure sensors are combined by the control system to activate the ventilator.

11. The apparatus of claim 1, wherein the one or more sensors are a first sensor for measuring actual respiration air movement and a second sensor for measuring direct or indirect respiratory muscle effort, and wherein the control system processes signals from the first sensor and the second sensor to distinguish conditions selected from the group consisting of light breathing, an obstruction, a reduced respiratory drive, and combinations thereof.

12. The apparatus of claim 11, wherein the control system activates the ventilator to deliver ventilation gas if the first sensor measures a signal that is abnormally low in amplitude and the second sensor simultaneously measures a signal that is abnormally high in amplitude.

13. The apparatus of claim 1, further comprising a humidifier.

14. The apparatus of claim 1, wherein the ventilation catheter is inserted through a stoma guide.

15. The apparatus of claim 1, wherein distal tip curves superiorly towards the upper airway within the trachea.

16. The apparatus of claim 1, wherein the transtracheal ventilation catheter comprises multiple lumens with a function selected from the group consisting of delivering gas toward the lung, delivering gas toward the upper airway and away from the lung, monitoring pressure of the trachea, containing breath sensor wiring, or combinations thereof.

17. The apparatus of claim 1, wherein the distal tip comprises two ventilation gas exit ports, wherein a first gas exit port directs ventilation gas toward the lung and a second gas exit port directs gas superiorly away from the lung toward the upper airway.

18. The apparatus of claim 1, wherein the distal tip comprises a bifurcation, wherein a first part of the bifurcation is curved or angled inferiorly toward the lung and a second part of the bifurcation is curved or angled superiorly away from the lung toward the upper airway.

19. The apparatus of claim 1, wherein the ventilation apparatus operates in a first mode during daytime use for respiratory insufficiency using a first set of parameters and in a second mode during nocturnal used during sleep using a second set of parameters.

20. A method of treating sleep apnea, the method comprising:

inserting a transtracheal ventilation catheter with a distal tip into a trachea;

measuring a breathing cycle with one or more sensors;

controlling a ventilator with a control system based upon signals from the one or more sensors;

delivering ventilation gas from the ventilator to the transtracheal ventilation catheter through a ventilation gas delivery circuit in synchrony with the breathing cycle; and

wherein the distal tip of the transtracheal ventilation catheter directs the ventilation gas in a direction selected from the group consisting of superiorly from the transtracheal ventilation catheter towards an upper airway, inferiorly from the transtracheal ventilation catheter towards a lung, and combinations thereof.

21. The method of claim 20, wherein the control system operates the ventilator such that ventilation gas is delivered in a manner selected from the group consisting of during an inspiration phase of the breathing cycle, during an expiration phase of the breathing cycle, during both an inspiration phase and an expiration phase of the breathing cycle, continuously during the breathing cycle, cyclically during the breathing cycle, with a flow amplitude that increases over time, with flow rates adjusted by the control system in response to measurements from the one or more sensors, and combinations thereof.

22. The method of claim 20, wherein the ventilation gas is delivered at a low flow rate and a high pressure.

23. The method of claim 20, wherein the ventilation gas is delivered at a high frequency.

24. The method of claim 20, wherein the ventilation gas is delivered as a jet.

25. The method of claim 20, wherein the ventilation gas is delivered in a manner selected from the group consisting of preemptively to prevent or minimize an obstruction or apneic event, while an obstruction or apneic event is developing, in reaction to an obstruction or apneic event, and combinations thereof.

26. The method of claim 20, wherein the one or more sensors are coupled to the transtracheal ventilation catheter.

27. The method of claim 20, wherein one or more sensors are external to the trachea.

28. The method of claim 20, wherein the one or more sensors are one or more airflow sensors in the trachea and one or more pressure sensors in the trachea.

29. The method of claim 28, wherein signals from the one or more airflow sensors and signals from the one or more pressure sensors are combined by the control system to activate the ventilator.

30. The method of claim 20, wherein the one or more sensors are a first sensor for measuring actual respiration air movement and a second sensor for measuring direct or indirect respiratory muscle effort, and wherein the control system processes signals from the first sensor and the second sensor to distinguish conditions selected from the group consisting of light breathing, an obstruction, a reduced respiratory drive, and combinations thereof.

31. The method of claim 30, wherein the control system activates the ventilator to deliver ventilation gas if the first sensor measures a signal that is abnormally low in amplitude and the second sensor simultaneously measures a signal that is abnormally high in amplitude.

32. The method of claim 20, further comprising a humidifier.

33. The method of claim 20, wherein the ventilation catheter is inserted through a stoma guide.

34. The method of claim 20, wherein distal tip curves superiorly towards the upper airway within the trachea.

35. The method of claim 20, wherein the transtracheal ventilation catheter comprises multiple lumens with a function selected from the group consisting of delivering gas toward the lung, delivering gas toward the upper airway and away from the lung, monitoring pressure of the trachea, containing breath sensor wiring, or combinations thereof.

36. The method of claim 20, wherein the distal tip comprises two ventilation gas exit ports, wherein a first gas exit port directs ventilation gas toward the lung and a second gas exit port directs gas superiorly away from the lung toward the upper airway.

37. The method of claim 20, wherein the distal tip comprises a bifurcation, wherein a first part of the bifurcation is curved or angled inferiorly toward the lung and a second part of the bifurcation is curved or angled superiorly away from the lung toward the upper airway.

38. The method of claim 20, wherein the ventilation apparatus operates in a first mode during daytime use for respiratory insufficiency using a first set of parameters and in a second mode during nocturnal used during sleep using a second set of parameters.

39. A ventilation apparatus for treating sleep apnea, the apparatus comprising:

a ventilator for delivering ventilation gas;

a control system for the ventilator;

a trans-oral ventilation catheter for insertion into an oral cavity;

a distal tip on the trans-oral ventilation catheter;

one or more first sensors;

one or more second sensors;

wherein signals from the one or more first sensors and the one or more second sensors are combined to determine a breathing cycle;

a ventilation gas delivery circuit connecting the ventilator to the trans-oral ventilation catheter;

wherein the control system operates the ventilator such that ventilation gas is delivered in synchrony with the breathing cycle; and

wherein the distal tip delivers the ventilation gas in a direction inferiorly from the trans-oral ventilation catheter towards a lung.

40. The apparatus of claim 39, wherein the control system operates the ventilator such that ventilation gas is delivered in a manner selected from during an inspiration phase of the breathing cycle, during an expiration phase of the breathing cycle, during both an inspiration phase and an expiration phase of the breathing cycle, and combinations thereof.

41. The apparatus of claim 39, wherein the one or more first sensors measure actual respiration air movement, and the one or more second sensors directly or indirectly measure respiratory muscle effort, and wherein the control system processes the signals from the one or more first sensors and the one or more second sensors to distinguish conditions selected from the group consisting of light breathing, an obstruction, a reduced respiratory drive, and combinations thereof.

42. The apparatus of claim 41, wherein the control system activates the ventilator to delivery ventilation gas if the one or more first sensors measure a signal that is abnormally low in amplitude, and the one or more second sensors simultaneously measure a signal that is not abnormally low in amplitude.

43. A method of treating sleep apnea, the method comprising;

inserting a trans-oral ventilation catheter with a distal tip into an oral cavity;

measuring a breathing cycle with one or more first sensors and one or more second sensors;

controlling a ventilator with a control system based upon signals from the one or more first sensors and the one or more second sensors;

delivering ventilation gas from the ventilator to the trans-oral ventilation catheter through a ventilation gas delivery circuit in synchrony with the breathing cycle; and

wherein the distal tip of the trans-oral ventilation catheter directs the ventilation gas in a direction inferiorly from the trans-oral ventilation catheter towards a lung.

44. The method of claim 43, wherein the control system operates the ventilator such that ventilation gas is delivered in a manner selected from during an inspiration phase of the breathing cycle, during an expiration phase of the breathing cycle, during both an inspiration phase and an expiration phase of the breathing cycle, and combinations thereof.

45. The method of claim 43, wherein the one or more first sensors measure actual respiration air movement, and the one or more second sensors directly or indirectly measure respiratory muscle effort, and wherein the control system processes the signals from the one or more first sensors and the one or more second sensors to distinguish conditions selected from the group consisting of light breathing, an obstruction, a reduced respiratory drive, and combinations thereof.

46. The method of claim 45, wherein the control system activates the ventilator to delivery ventilation gas if the one or more first sensors measure a signal that is abnormally low in amplitude, and the one or more second sensors simultaneously measure a signal that is not abnormally low in amplitude.

47. A ventilation apparatus for treating sleep apnea, the apparatus comprising:

a ventilator for delivering ventilation gas;

a control system for the ventilator;

a trans-nasal ventilation catheter for insertion into an nasal cavity;

a distal tip on the nasal-oral ventilation catheter;

one or more first sensors;

one or more second sensors;

wherein signals from the one or more first sensors and the one or more second sensors are combined to determine a breathing cycle;

a ventilation gas delivery circuit connecting the ventilator to the trans-nasal ventilation catheter;

wherein the control system operates the ventilator such that ventilation gas is delivered in synchrony with the breathing cycle; and

wherein the distal tip delivers the ventilation gas in a direction inferiorly from the trans-nasal ventilation catheter towards a lung.

48. The apparatus of claim 47, wherein the control system operates the ventilator such that ventilation gas is delivered in a manner selected from during an inspiration phase of the breathing cycle, during an expiration phase of the breathing cycle, during both an inspiration phase and an expiration phase of the breathing cycle, and combinations thereof.

49. The apparatus of claim 47, wherein the one or more first sensors measure actual respiration air movement, and the one or more second sensors directly or indirectly measure respiratory muscle effort, and wherein the control system processes the signals from the one or more first sensors and the one or more second sensors to distinguish conditions selected from the group consisting of light breathing, an obstruction, a reduced respiratory drive, and combinations thereof.

50. The apparatus of claim 49, wherein the control system activates the ventilator to delivery ventilation gas if the one or more first sensors measure a signal that is abnormally low in amplitude, and the one or more second sensors simultaneously measure a signal that is not abnormally low in amplitude.

51. A method of treating sleep apnea, the method comprising;

inserting a trans-nasal ventilation catheter with a distal tip into an nasal cavity;

measuring a breathing cycle with one or more first sensors and one or more second sensors;

controlling a ventilator with a control system based upon signals from the one or more first sensors and the one or more second sensors;

delivering ventilation gas from the ventilator to the trans-nasal ventilation catheter through a ventilation gas delivery circuit in synchrony with the breathing cycle; and

wherein the distal tip of the trans-nasal ventilation catheter directs the ventilation gas in a direction inferiorly from the trans-oral ventilation catheter towards a lung.

52. The method of claim 51, wherein the control system operates the ventilator such that ventilation gas is delivered in a manner selected from during an inspiration phase of the breathing cycle, during an expiration phase of the breathing cycle, during both an inspiration phase and an expiration phase of the breathing cycle, and combinations thereof.

53. The method of claim 51, wherein the one or more first sensors measure actual respiration air movement, and the one or more second sensors directly or indirectly measure respiratory muscle effort, and wherein the control system processes the signals from the one or more first sensors and the one or more second sensors to distinguish conditions selected from the group consisting of light breathing, an obstruction, a reduced respiratory drive, and combinations thereof.

54. The method of claim 53, wherein the control system activates the ventilator to delivery ventilation gas if the one or more first sensors measure a signal that is abnormally low in amplitude, and the one or more second sensors simultaneously measure a signal that is not abnormally low in amplitude.