Ventilatory stabilization technology

• US 7,073,501 B2
• Filed: 01/23/2004
• Issued: 07/11/2006
• Est. Priority Date: 02/04/1999
• Status: Expired due to Fees

• Current Assignee: UTI Limited Partnership
• Original Assignee: University Technologies International, Inc.
• Inventors: Hajduk, Eric A., Remmers, John E., Platt, Ronald S.
• Primary Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US10/762,979
• Publication Number:
  US 20040216740A1
• Time in Patent Office: 900 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/204.26, 128/205.23, 128/201.26, 128/201.28, 128/202.22, 128/205.24, 128/205.25, 128/206.11, 128/206.12, 128/206.18, 128/206.21, 128/206.28, 128/206.29, 128/207.12, 128/207.13, 128/848, 128859-861
• US Class Current: 128/204.18
• CPC Class Codes: A61M 16/0045 Means for re-breathing exhaled gases, e.g. for hyperventilation treatment
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• 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 16/085 Gas sampling
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0042 in the expiratory circuit
• CPC Class Codes: A61M 2016/103 the CO2 concentration
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 Mouth
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)
• CPC Class Codes: A62B 18/006 with pumps for forced ventilation A62B18/045 takes precedence

Abstract

A system for reducing central sleep apnea (CSA) is described in which certain methods of increasing a patient'"'"'s rebreathing during periods of the sleep cycle are used. By increasing rebreathing during periods of overbreathing, the over-oxygenation which typically results from the overbreathing period can be reduced, thus reducing the compensating underbreathing period and effectively reducing the loop gain associated with the central sleep apnea. Nasal occlusion and a leak resistant oral interface provide control for gas leaks from a patent interface.

Claims

1. An apparatus for treating a breathing disorder comprising:

a gas supplying means; and

a leak resistant patient interface operably connected using a tube to the gas supplying means, the leak resistant patient interface having an exit, wherein the apparatus is arranged such that during periods of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube towards the gas supplying means and away from the exit;

wherein the apparatus is adapted such that during an initial exhale portion of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube towards the gas supplying means and away from the exit and wash flow out of the tube such that during a next inhale portion a sufficient amount of rebreathing occurs to control the breathing disorder.

2. The apparatus of claim 1, wherein the leak resistant patient interface comprises an oral interface and nasal occlusion device.

3. The apparatus of claim 2, wherein the apparatus is adapted such that during normal breathing periods little rebreathing occurs.

4. The apparatus of claim 3, wherein the apparatus is adapted such that during normal breathing periods some retrograde flow occurs but wash flow is sufficient to remove exhaled air before a next inhale portion.

5. The apparatus of claim 4, wherein the retrograde flow into the tube is influenced by gas pressure from the gas supplying means and by an exit hole size.

6. The apparatus of claim 1, wherein gas pressure from the gas supplying means is set below four cm H₂O pressure.

7. An apparatus for treating a breathing disorder comprising:

a gas supplying means; and

a leak resistant patient interface operably connected using a tube to the gas supplying means, the leak resistant patient interface having an exit, wherein the apparatus is arranged such that during periods of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube towards the gas supplying means and away from the exit, wherein gas pressure from the gas supplying means is set at a controlled level below four cm H₂O pressure independently of the respiratory cycle of the patient.

8. The apparatus of claim 7, wherein the leak resistant patient interface comprises an oral interface and nasal occlusion device.

9. The apparatus of claim 8, wherein a size of the exit size is adjustable.

10. The apparatus of claim 9, wherein pressure in the leak resistant patient interface is set high enough to treat obstructive sleep apnea.

11. The apparatus of claim 10, wherein the gas-supplying means comprises a blower which blows air to the leak resistant patient interface.

12. The apparatus of claim 7, wherein the leak resistant patient interface is adapted to fit about a patient'"'"'s nose.

13. The apparatus of claim 7, wherein the gas-supplying means is adjustable.

14. A method of treating a patient suffering from a breathing disorder, the method comprising:

providing an apparatus comprising a gas supplying means and a leak resistant patient interface adapted to be fit on the patient'"'"'s airway, the leak resistant patient interface operably connected using a tube to the gas supplying means, the leak resistant patient interface having an exit;

fitting the leak resistant patient interface to the patient; and

adjusting the apparatus such that during periods of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube, wherein the adjusting step is done such that during an initial exhale portion of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube and wash flow out of the tube such that during a next inhale portion some rebreathing occurs sufficient to treat the breathing disorder.

15. The method of claim 14, wherein the leak resistant patient interface comprises a dental appliance and a nasal occlusion device, and fitting the leak resistant patient interface to the patient comprises:

fitting the dental appliance to the mouth of the patient; and

blocking the patient'"'"'s nose with the nasal occlusion device.

16. The method of claim 15, wherein the adjusting step is done such that during normal breathing periods little rebreathing occurs.

17. The method of claim 16, wherein the adjusting step is done such that during normal breathing periods some retrograde flow occurs but wash flow is sufficient to remove exhaled air before a next inhale portion.

18. The method of claim 15, wherein the retrograde flow into the tube is influenced by gas pressure from the gas supplying means and by an exit hole size.

19. The method of claim 14, wherein the adjusting step is such that gas pressure from the gas supplying means is set below four cm H₂O pressure.

20. A method of treating a patient suffering from a breathing disorder, the method comprising:

providing an apparatus comprising a gas supplying means and a leak resistant patient interface adapted to be fit on the patient'"'"'s airway, the leak resistant patient interface operably connected using a tube to the gas supplying means, the leak resistant patient interface having an exit;

fitting the leak resistant patient interface to the patient; and

adjusting the apparatus such that during periods of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube wherein the adjusting step is such that gas pressure from the gas supplying means is set at a level below four cm H₂O pressure independently of the respiratory cycle of the patient.

21. The method of claim 20, wherein the leak resistant patient interface comprises a dental appliance and a nasal occlusion device, and fitting the leak resistant patient interface to the patient comprises:

fitting the dental appliance to the mouth of the patient; and

blocking the patient'"'"'s nose with the nasal occlusion device.

22. The method of claim 21, wherein the adjusting step includes adjusting an exit hole size.

23. The method of claim 21, wherein pressure in the leak resistant patient interface is set high enough to treat obstructive sleep apnea.

24. The method of claim 21, wherein the gas supplying means comprises a blower.

25. An apparatus for treating a breathing disorder comprising:

a gas supplying means;

a leak resistant patient interface adapted to be fit on a patient'"'"'s airway, the leak resistant patient interface operably connected using an input tube to the gas supplying means, the leak resistant patient interface having an exit;

a variable air resistance means operably connected to the exit of the leak resistant patient interface; and

a controller operably connected to the variable air resistance means to adjust a level of rebreathing that occurs and maintain a temporally variable flow of air in the input tube without producing significant deviations in leak resistant patient interface pressure.

26. The apparatus of claim 25, wherein the leak resistant patient interface comprises an oral interface and nasal occlusion device.

27. The apparatus of claim 26, wherein the variable air resistance means comprises an adjustable valve.

28. The apparatus of claim 27, further comprising an exit tube between the leak resistant patient interface and the adjustable valve.

29. The apparatus of claim 26, wherein the controller adjusts the variable air resistance means to provide a dead space during certain portions of a sleep cycle.

30. The apparatus of claim 26, wherein the controller adjusts the variable air resistance means to modify exit flow out of the leak resistant patient interface at different times during a night'"'"'s sleep.

31. The apparatus of claim 26, further comprising a flow meter adapted to provide signals to the controller.

32. The apparatus of claim 26, wherein the controller detects periodicities in sleep cycle to determine how to adjust the level of rebreathing.

33. An apparatus for treating a breathing disorder comprising:

a blower;

a leak resistant patient interface adapted to be fit on a patient'"'"'s airway, the leak resistant patient interface incorporating a dental appliance to reduce mouth leaks and a nasal occlusion device to eliminate nose leaks, the leak resistant patient interface operably connected using a tube to the blower; and

a processor adapted to adjust a level of rebreathing to control the breathing disorder in the patient by adjusting an active control element of the apparatus.

34. The apparatus of claim 33, wherein the active control element is a variable air resistance means operably connected to a exit of the leak resistant patient interface.

35. The apparatus of claim 33, wherein the active control element is a unit to adjust a blower output.

36. The apparatus of claim 35, wherein the active control element is a unit to adjust a blower output revolutions per minute.

37. The apparatus of claim 35, further comprising an exit tube connected to the leak resistant patient interface.

38. The apparatus of claim 33, wherein the active control element is a recirculator.

39. The apparatus of claim 33, wherein the active control element is a valve to a dead space volume.

40. The apparatus of claim 33, wherein the active control element is adjusted during a periodic sleep cycle of the patient.

41. The apparatus of claim 33, wherein the active control element is adjusted over an entire sleeping period.

42. The apparatus of claim 33, wherein the processor receives data from a flow meter or a carbon dioxide sensor.

43. An apparatus for treating a breathing disorder comprising:

a blower; and

a leak resistant patient interface adapted to be fit on a patient'"'"'s airway, the leak resistant patient interface operably connected using a tube to the blower, the leak resistant patient interface having an exit, the resistance of the exit being set such that during treatment of the breathing disorder in the patient, expiratory air from the patient flows through the tube towards the blower and away from the exit, wherein the apparatus is arranged such that a gas flow from the blower is less than that used to treat obstructive sleep apnea.

44. The apparatus of claim 43, wherein the leak resistant patient interface comprises an oral interface and nasal occlusion device.

45. The apparatus of claim 44, wherein gas pressure from blower is set at four cm H₂O pressure or below.

46. The apparatus of claim 44, wherein the apparatus is arranged such that during periods of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube.

47. The apparatus of claim 46, wherein the apparatus is adapted such that during an initial exhale portion of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube and wash flow out of the tube such that during a next inhale portion some rebreathing occurs.

48. The apparatus of claim 46, wherein the apparatus is adapted such that during normal breathing periods little rebreathing occurs.

49. The apparatus of claim 46, wherein the apparatus is adapted such that during normal breathing periods some retrograde flow occurs but wash flow is sufficient to remove exhaled air before a next inhale portion.

50. The apparatus of claim 44 wherein the blower is adjustable.

51. A method of treating a patient suffering from a breathing disorder, the method comprising:

providing an apparatus comprising a blower and a leak resistant patient interface adapted to be fit on the patient'"'"'s airway, the leak resistant patient interface operably connected using a tube to the blower, the leak resistant patient interface having an exit;

fitting the leak resistant patient interface to the patient'"'"'s airway; and

adjusting the apparatus such that gas flow from the blower is controlled at a variable flow rate and essentially constant pressure, the pressure being less than that used to treat obstructive sleep apnea, in order to treat the breathing disorder in the patient.

52. The method of claim 51, wherein the leak resistant patient interface comprises a dental appliance and a nasal occlusion device, and fitting the leak resistant patient interface to the patient comprises:

fitting the dental appliance to the mouth of the patient; and

blocking the patient'"'"'s nose with the nasal occlusion device.

53. The method of claim 52, wherein the adjusting step is such that gas pressure from the blower is set below four cm H₂O pressure.

54. The method of claim 52, wherein the adjusting step is such that during periods of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube.

55. The method of claim 54, wherein the adjusting step is done such that during an initial exhale portion of increased breathing associated with the breathing disorder, some of the patient'"'"'s exhaled gasses flow retrograde into the tube and wash flow out of the tube such that during a next inhale portion some rebreathing occurs.

56. The method of claim 54, wherein the adjusting step is done such that during normal breathing periods little rebreathing occurs.

57. The method of claim 56, wherein the adjusting step is done such that during normal breathing periods some retrograde flow occurs but wash flow is sufficient to remove the exhaled air before a next inhale portion.

58. The method of claim 54, wherein the retrograde flow into the tube is influenced by gas pressure from the blower and by a size of the exit.

59. A method comprising:

providing an apparatus comprising a blower and a leak resistant patient interface adapted to be fit on a patient'"'"'s airway, the leak resistant patient interface operably connected using a tube to the blower, the leak resistant patient interface having an exit, the resistance of the exit being set that during treatment of a breathing disorder in the patient, expiratory air from the patient flows through the tube towards the blower and away from the exit;

fitting the leak resistant patient interface to the patient'"'"'s airway;

treating an obstructive sleep apnea with the apparatus;

adjusting the apparatus to treat the breathing disorder; and

treating obstructive sleep apnea with the apparatus.

60. The method of claim 59 in which the leak resistant patient interface comprises a dental appliance and a nasal occlusion device, and fitting the leak resistant patient interface to the patient comprises:

fitting the dental appliance to the mouth of the patient; and

blocking the patient'"'"'s nose with the nasal occlusion device.

61. The method of claim 60, wherein the adjusting step comprises adjusting the apparatus such that gas flow from the blower is less than that used to treat obstructive sleep apnea to treat the breathing disorder in the patient.

62. The method of claim 60, wherein the adjusting step is such that gas pressure from the blower is set below four cm H₂O pressure.

63. The method of claim 60 wherein the adjusting step is such that during periods of increased breathing associated with the breathing disorder, some of the patient'"'"'s exhaled gasses flow retrograde into the tube.

64. The method of claim 63, wherein the adjusting step is done such that during an initial exhale portion of increased breathing associated with the breathing disorder, some exhaled gasses from the patient flow retrograde into the tube and wash flow out of the tube such that during a next inhale portion some rebreathing occurs.

65. The method of claim 63, wherein the adjusting step is done such that during normal breathing periods little rebreathing occurs.

66. The method of claim 65, wherein the adjusting step is done such that during normal breathing periods some retrograde flow occurs but wash flow is sufficient to remove exhaled air before a next inhale portion.

67. The method of claim 60, wherein the retrograde flow into the tube is influenced by gas pressure from the blower and by a size of the exit hole.

68. The method of claim 60, wherein the obstructive sleep apnea treating step comprises supplying blower pressure greater than eight cm H₂O.

69. The method of claim 60, wherein the obstructive sleep apnea treating step occurs before the adjusting step.