AUTO-FEEDBACK VALVE FOR A SLEEP APNEA DEVICE

• US 20140246024A1
• Filed: 05/15/2014
• Published: 09/04/2014
• Est. Priority Date: 04/13/2012
• Status: Active Grant

• Current Assignee: Fresca Medical, Inc.
• Original Assignee: Fresca Medical, Inc.
• Inventors: Cragg, Andrew H., Logan, John, Nissimov, Haim, Ewers, Richard, Adler, Mark, Chen, Eugene G., Trusheim, John Edwin, Nolting, John, Anderson, Steve, Chen, Kevin
• Granted Patent: US 10,272,226 B2
• Time in Patent Office: Days
• US Class Current: 128/204.19
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0688 by means of an adhesive
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/0866 Passive resistors therefor
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 16/209 Relief valves
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/0661 with customised shape
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/42 : Reducing noise
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8237 : Charging means
• CPC Class Codes: A61M 2205/8281 : spring operated
• CPC Class Codes: A61M 2209/06 : Packaging for specific medical equipment
• CPC Class Codes: A61M 2209/088 : on the body
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/18 : Rapid eye-movements [REM]
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

A device for treating a patient suffering from obstructive sleep apnea or snoring can include an expiratory valve connected to a manifold. The expiratory valve can include a body portion including a feedback port configured to be connected to an air flow generator. The expiratory valve can include a plunger at least partially disposed in the body portion. The expiratory valve can include a pressurizing chamber positioned between an end of the plunger and an end of the expiratory valve. The pressurizing chamber can be configured to receive air from the air flow generator through the feedback port.

Claims

1. A device for treating a patient suffering from obstructive sleep apnea or snoring, the device comprising:

a manifold;

an expiratory valve connected to the manifold, the expiratory valve comprising a first end and a second end, the first end being closer to the patient when the patient is using the device, the expiratory valve further comprising;

a body portion comprising a feedback port configured to be connected to an air flow generator;

a plunger at least partially disposed in the body portion, the plunger comprising a first end and a second end, the first end being closer to the patient when the patient is using the device; and

a pressurizing chamber positioned between the second end of the plunger and the second end of the expiratory valve, the pressurizing chamber configured to receive air from the air flow generator through the feedback port,

wherein the plunger is configured to move between a first position and a second position.

2. The device of claim 1, wherein the body portion further comprises at least one vent hole, the at least one vent hole positioned between the pressurizing chamber and the first end of the expiratory valve.

3. The device of claim 2, wherein when the plunger is in the first position, the plunger prevents air from escaping through the at least one vent hole, and wherein when the plunger is in the second position, the plunger permits air to escape through the at least one vent hole.

4. The device of any one of the preceding claims, wherein the plunger is configured to move along a longitudinal axis of the expiratory valve.

5. The device of any one of the preceding claims, wherein expiratory valve further comprises a diaphragm positioned between the plunger and the second end of the expiratory valve.

6. The device of any one of the preceding claims, wherein the expiratory valve further comprises a magnet positioned between the first end of the plunger and the first end of the expiratory valve.

7. The device of claim 6, wherein the plunger is spaced apart from the magnet when the plunger is in the first position, and wherein the plunger is not magnetically connected to the magnet when the plunger is in the second position.

8. The device of any one of the preceding claims, wherein the manifold comprises a manifold port configured to connect to the air flow generator.

9. The device of any one of the preceding claims, wherein the expiratory valve has a height of less than or equal to about 1.5 inches.

10. The device of claim 9, wherein the expiratory valve has a height of less than or equal to about 0.5 inches.

11. The device of any one of the preceding claims, further comprising at least one inspiratory valve connected to the manifold.

12. The device of claim 11, wherein the at least one inspiratory valve comprises a first inspiratory valve and a second inspiratory valve.

13. The device of claim 11, wherein the at least one inspiratory valve comprises a flap valve.

14. The device of any one of the preceding claims, wherein the second end of the plunger is a closed end and the first end of the plunger is an open end.

15. The device of any one of claims 1-13, wherein the second end of the plunger is an open end and the first end of the plunger is a closed end.

16. The device of any one of claims 1-13, wherein the plunger is disc-shaped.

17. A system for treating a patient suffering from obstructive sleep apnea or snoring, the system comprising:

the device of any one of the preceding claims;

an air flow generator connected to the device.

18. The system of claim 17, further comprising a feedback hose connecting the air flow generator to the feedback port, the hose having a diameter of less than or equal to about 1.75 mm.

19. The system of claim 17 or 18, further comprising a manifold hose connecting the air flow generator to a manifold port.

20. A method of manufacturing the device of any one of claims 1 to 16, the method comprising:

forming the expiratory valve, wherein forming the expiratory valve comprises;

positioning a plunger at least partially in the body portion to form the pressurizing chamber between the second end of the plunger and the second end of the plunger; and

connecting the expiratory valve to the manifold.

21. A device for treating a patient suffering from obstructive sleep apnea or snoring, the device comprising:

a manifold comprising a manifold port configured to be connected to an air flow generator;

an expiratory valve connected to the manifold, the expiratory valve comprising a first end and a second end, the first end being closer to the patient when the patient is using the device, the expiratory valve further comprising;

a body portion comprising a feedback port configured to be connected to an air flow generator;

a plunger at least partially disposed in the body portion;

a first chamber configured to receive air delivered through the feedback port; and

a second chamber configured to receive air delivered through the manifold port.

22. The device of claim 21, further comprising at least one vent configured to permit air to escape from the second chamber.

23. The device of claim 21 or 22, wherein the plunger is configured to move along a longitudinal axis of the expiratory valve.

24. The device of any one of claims 21 to 23, wherein the first chamber is positioned between the plunger and the second end of the expiratory valve.

25. The device of any one of claims 21 to 24, wherein the expiratory valve further comprises a diaphragm.

26. The device of any one of claims 21 to 25, wherein the expiratory valve further comprises a magnet positioned between the first end of the plunger and the first end of the expiratory valve.

27. The device of claim 26, wherein the plunger is magnetically connected to the magnet when the plunger is in a first position, and wherein the plunger is not magnetically connected to the magnet when the plunger is in a second position.

28. The device of any one of claims 21 to 27, wherein the expiratory valve has a height of less than or equal to about 1.75 inches.

29. The device of claim 28, wherein the expiratory valve has a height of less than or equal to about 0.5 inches.

30. The device of any one of claims 21 to 29, further comprising at least one inspiratory valve connected to the manifold.

31. The device of claim 30, wherein the at least one inspiratory valve comprises a first inspiratory valve and a second inspiratory valve.

32. The device of claim 30, wherein the at least one inspiratory valve comprises a flap valve.

33. The device of any one of claims 21-32, wherein an inner surface area of the first chamber is less than an inner surface area of the second chamber.

34. A system for treating a patient suffering from obstructive sleep apnea or snoring, the system comprising:

the device of any one of claims 21 to 33;

an air flow generator connected to the device.

35. The system of claim 34, further comprising a feedback hose connecting the air flow generator to the feedback port, the hose having a diameter of less than or equal to about 1.5 mm.

36. The system of claim 34 or 35, further comprising a manifold hose connecting the air flow generator to a manifold port.

37. A method of manufacturing the device of any one of claims 21 to 33, the method comprising:

forming the expiratory valve, wherein forming the expiratory valve comprises;

positioning a plunger at least partially in the body portion to form the

first chamber and the second chamber; and

connecting the expiratory valve to the manifold.

38. A device for treating a patient suffering from obstructive sleep apnea or snoring, the device comprising:

a manifold;

an expiratory valve connected to the manifold, the expiratory valve comprising a first end and a second end, the first end being closer to the patient when the patient is using the device, the expiratory valve further comprising;

a body portion;

a diaphragm connected to the body portion;

a plunger at least partially disposed in the body portion, the plunger comprising a ferro-magnetic member; and

a magnet positioned between the plunger and the first end of the expiratory valve.

39. The device of claim 38, wherein the body portion further comprises at least one vent hole, positioned between the magnet and the diaphragm.

40. The device of claim 39, wherein when the plunger is in a first position, the plunger prevents air from escaping through the at least one vent hole, and wherein when the plunger is in the second position, the plunger permits air to escape through the at least one vent hole.

41. The device of any one of claims 38 to 40, wherein the plunger is configured to move along a longitudinal axis of the expiratory valve.

42. The device of any one of claims 38 to 41, wherein the manifold comprises a manifold port configured to connect to the air flow generator.

43. The device of any one of claims 38 to 42, wherein the expiratory valve has a height of less than or equal to about 1.5 inches

44. The device of claim 43, wherein the expiratory valve has a height of less than or equal to about 0.5 inches.

45. The device of any one of claims 38 to 44, further comprising at least one inspiratory valve connected to the manifold.

46. The device of claim 45, wherein the at least one inspiratory valve comprises a first inspiratory valve and a second inspiratory valve.

47. The device of claim 45, wherein the at least one inspiratory valve comprises a flap valve.

48. A system for treating a patient suffering from obstructive sleep apnea or snoring, the system comprising:

the device of any one of claims 38 to 47;

an air flow generator connected to the device.

49. The system of claim 48, further comprising a hose connecting the air flow generator to the device, the hose having a diameter of less than or equal to about 15 mm.

50. A method of using a system for treating a patient suffering from obstructive sleep apnea or snoring, the method comprising:

flowing air into an expiratory valve through a feedback port, the expiratory valve connected to a manifold, the expiratory valve comprising a first end and a second end, the first end being closer to the patient when the patient is using the device, the expiratory valve further comprising;

a body portion;

a plunger at least partially disposed in the body portion, the plunger comprising a first end and a second end, the first end being closer to the patient when the patient is using the device;

a pressurizing chamber positioned between the second end of the plunger and the second end of the expiratory valve, the pressurizing chamber configured to receive air through the feedback port; and

at least one vent hole, the at least one vent hole positioned between the pressurizing chamber and the first end of the expiratory valve;

moving the plunger between a first position in which the plunger prevents air from escaping through the at least one vent hole and a second position in which the plunger permits air to escape through the at least one vent hole.

51. The method of claim 50, wherein flowing air to the expiratory valve comprises delivering air from an air flow generator.

52. The method of claim 50 or 51, further comprising delivering air from an air flow generator to the manifold through a manifold port.

53. The method of any one of claim 50 or 52, further comprising adjusting a pressure of the air being delivered to the pressurizing chamber, wherein adjusting the pressure of the air adjusts a resistance to the plunger moving between the first position and the second position.

54. The method of any one of claims 50 to 53, wherein moving the plunger comprises moving the plunger along a longitudinal axis of the expiratory valve.

55. The method of claim 51, further comprising flowing ambient air into the manifold for a first amount for a first amount of time, wherein during the first amount of time, the air flow generator is in an on condition.

56. A method of using a system for treating a patient suffering from obstructive sleep apnea or snoring, the method comprising:

delivering air from an air flow generator to a manifold through a manifold port;

delivering air from the air flow generator to an expiratory valve through a feedback port, the expiratory valve connected to the manifold, the expiratory valve comprising a first end and a second end, the first end being closer to the patient when the patient is using the device, the expiratory valve further comprising;

a body portion;

a plunger at least partially disposed in the body portion;

a first chamber configured to receive air delivered through the feedback port; and

a second chamber configured to receive air delivered through the manifold port.

at least one vent hole configured to permit air to escape from the second chamber;

moving the plunger between a first position in which the plunger prevents air from escaping through the at least one vent hole and a second position in which the plunger permits air to escape through the at least one vent hole.

57. The method of claim 56, further comprising adjusting a pressure of the air being delivered to the first chamber, wherein adjusting the pressure of the air adjusts a resistance to the plunger moving between the first position and the second position.

58. The method of claim 56 or 57, wherein moving the plunger comprises moving the plunger along a longitudinal axis of the expiratory valve.

59. The method of any one of claims 56 to 58, further comprising flowing ambient air into the manifold through at least one inspiratory valve.

60. The method of claim 59, wherein when flowing ambient air into the manifold, the air flow generator is in an on condition.

61. A system for treating a patient suffering from obstructive sleep apnea or snoring, the device comprising:

a manifold;

an expiratory valve connected to the manifold;

at least one inspiratory valve connected to the manifold a braided hose comprising a plurality of strands, the braided hose connecting an air flow generator to the manifold, the braided hose having a diameter of less than or equal to about 15 mm, the braided hose configured to deliver air to the manifold at a rate between about 5 L/min and about 25 L/min.

62. The system of claim 61, wherein the hose is configured to deliver air having a pressure between about 4 cmH20 and about 20 cmH20.

63. The system of claim 61 or 62, wherein the braided hose comprises a plurality of strands, each strand having a diameter of less than or equal to about 0.006 inches.

64. The system of any one of claims 61 to 63, wherein the plurality of strands comprise PET.

65. The system of any one of claims 61 to 64, wherein the braided hose can expand from a first diameter to a second diameter, the second diameter being between about 2.0 times and about 2.5 times the first diameter.

66. The system of any one of claims 61 to 65, wherein each of the plurality of strands crosses over at least one strand and under at least one strand.

67. The system of claim 66, wherein each of the plurality of strands crosses over at least two consecutive strands and under at least two consecutive strands.

68. The system of any one of claims 61 to 67, wherein the hose weighs less than or equal to about 20 grams.

69. The system of any one of claims 61 to 68, wherein the braided hose is configured to bend around a rod between about 0.5 inches and about 0.75 inches without kinking.

70. A system for treating a patient suffering from obstructive sleep apnea or snoring, the device comprising:

a manifold;

an air flow generator connected to the manifold, the air flow generator configured to transition between an off condition and an on condition;

an expiratory valve connected to the manifold, the expiratory valve comprising an effective orifice size of less than or equal to about 1.5 square inches; and

at least one inspiratory valve connected to the manifold.

71. A method of using the system of claim 70, comprising:

going to sleep when the air flow generator is in the off condition;

transitioning the air flow generator from the off condition to the on condition after a period of time.

72. The method of claim 71, wherein the user sets the period of time.

73. The method of claim 71, further comprising sensing when the patient is asleep.

74. The method of claim 73, wherein the airflow generator transitions to the on condition after the system detects that the patient is asleep.

75. The method of claim 73 or 74, wherein sensing when the patient is asleep comprises detecting movement using an accelerometer.