Method and device for non-invasive ventilation with nasal interface

• US 20050066976A1
• Filed: 08/18/2004
• Published: 03/31/2005
• Est. Priority Date: 08/18/2003
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Menlo Lifesciences LLC
• Inventors: Wondka, Anthony D.
• Granted Patent: US 7,406,966 B2
• Time in Patent Office: Days
• US Class Current: 128/207.180
• CPC Class Codes: A61M 16/0009 with sub-atmospheric pressure, e.g. during expiration
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/021 operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• 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 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment

Abstract

A nasal ventilation interface including a pair of tubes configured to deliver a ventilation gas. The tubes are attachable at a first end to a ventilation gas supply hose and engageable at a second end with a person'"'"'s nostril. A coupler is configured to align the pair of tubes with the person'"'"'s nostrils, wherein each tube has an absence of pneumatic interconnection with the other tube.

Claims

1. A nasal ventilation interface comprising:

a pair of tubes configured to deliver a ventilation gas, the tubes attachable at a first end to a ventilation gas supply hose and engageable at a second end with a person'"'"'s nostril; and

a coupler configured to align the pair of tubes with the person'"'"'s nostrils, wherein each tube has an absence of pneumatic interconnection with the other tube.

2. The interface of claim 1, wherein an absence of abrupt angles within the tubes provides for laminar flow of the ventilation gas.

3. The interface of claim 1, wherein the pair of tubes has an arcuate non-angulated shape.

4. The interface of claim 1, wherein the pair of tubes further comprises a pair of supply hoses and a pair of delivery tubes configured to engage the person'"'"'s nares, wherein the supply hoses are attachable to the ventilation gas supply hose via a Y-connector at one end and to the pair of delivery tubes at the other end.

5. The interface of claim 4, wherein the Y-connector further comprises at least one swivel.

6. The interface of claim 1, further comprising a sealing cushion configured to be attachable to the second end of each of the tubes and configured to impinge the nostril.

7. The interface of claim 6, wherein the second end of each tube further comprise a swivel adjustment adapted to align the sealing cushions with a rim of the nostril.

8. The interface of claim 6, wherein the sealing cushion further comprises a step, wherein the step prevents the sealing cushion from extending beyond a desired depth into the nostril.

9. The interface of claim 1, wherein the coupler further comprises a facial pad, the facial pad configured to allow for adjustment of the second end of the pair of tubes with the nostrils.

10. The interface of claim 9, further comprising a first strap, wherein the first strap is attachable to the coupler beneath the nose.

11. The interface of claim 10, wherein the first strap extends laterally over the ears providing upward lift directly beneath the nose.

12. The interface of claim 1, wherein the coupler is adjustable such that a spacing of the tubes can be adjusted to align the second end of the tubes with the nostrils.

13. The interface of claim 10, further comprising a second strap, wherein the second strap is attachable to the pair of tubes in a vicinity of a person'"'"'s neck.

14. A kit comprising:

a pair of tubes configured to deliver a ventilation gas, the pair of tubes attachable at a first end to a ventilation gas supply hose and engageable at a second end with a person'"'"'s nostril;

a coupler configured to align the pair of tubes with the person'"'"'s nostrils, wherein each tube has an absence of pneumatic interconnection with the other tube; and

at least one pair of sealing cushions configured to be attachable to the second end of each ventilation interface tube and configured to impinge the nostril.

15. The kit of claim 14, wherein the pair of ventilation interface tubes further comprises a pair of supply hoses and a pair of delivery tubes configured to engage the rim of the nostril, wherein the supply hose is attachable to the ventilation gas supply hose via a Y-connector at one end and to the pair of delivery tubes at the other end.

16. The kit of claim 14, further comprising a facial pad configured to allow for adjustment of the second end of the ventilation tubes with the nostrils by contacting the skin beneath the nose.

17. The kit of claim 14, further comprising a first strap, wherein the first strap is attachable to the coupler beneath the nose.

18. A method of receiving a pressurized gas comprising:

positioning a ventilation interface device on a patient, the ventilation interface device comprising;

a pair of tubes configured to deliver a ventilation gas, the pair of tubes attachable at a first end to a ventilation gas supply hose and engageable at a second end with a person'"'"'s nostril;

a coupler configured to align the pair of tubes with the person'"'"'s nostrils, wherein each tube has an absence of pneumatic interconnection with the other tube; and

securing the ventilation interface with a first strap extending laterally over the ears from underneath the nose such that the first strap provides upward lift.

19. The method of claim 18, further comprising a second strap configured to secure the ventilation interface device to the person'"'"'s body.

20. The method of claim 18, wherein the pair of tubes further comprises at least one pair of sealing cushions configured to be attachable to the second end of each of the tubes and configured to impinge each of the nostrils.

21. The method of claim 18, wherein the pair of tubes further comprises a pair of supply hoses and a pair of delivery tubes configured to engage the rim of the nostril, wherein the supply hose is attachable to the ventilation gas supply hose via a Y-connector at one end and to the pair of delivery tubes at the other end.

22. An apparatus for supplying ventilation gas comprising:

a connector configured to be attachable to a ventilation gas supply;

a pair of tubes extending from the connector and configured to impinge a rim of a user'"'"'s nostril such that a pressurized gas from the ventilation gas supply can be supplied to the user'"'"'s respiratory system; and

a coupler configured to align the pair of tubes with the user'"'"'s nostrils, wherein each tube has an absence of pneumatic interconnection with the other tube.

23. The apparatus of claim 22, wherein connector is a Y-connector configured to deliver the ventilation gas supply to the pair of tubes.

24. The apparatus of claim 22, wherein the pair of tubes has an arcuate non-angulated shape.

25. The apparatus of claim 22, wherein the pair of tubes further comprises a pair of supply hoses and a pair of delivery tubes configured to engage the rim of the nostril, wherein the supply hose is attachable to the ventilation gas supply hose via the Y-connector at one end and to the pair of delivery tubes at the other end.

26. The apparatus of claim 25, wherein the Y-connector further comprises at least one swivel.

27. The apparatus of claim 22, further comprising a sealing cushion configured to be attachable to the second end of each of the tubes and configured to impinge the rim of the nostril.

28. The apparatus of claim 27, wherein the second ends of the tubes further comprise a swivel adjustment adapted to align the sealing cushions with the rim of the nostril.

29. The apparatus of claim 27, wherein the sealing cushion further comprises a step, wherein the step prevents the sealing cushion from extending beyond a desired depth into the nostril.

30. The apparatus of claim 22, wherein the coupler further comprises a facial pad configured to allow for adjustment of the second end of the ventilation tubes with the nostrils by contacting the skin beneath the nose.

31. The apparatus of claim 30, further comprising a first strap, wherein the first strap is attachable to the coupler beneath the nose.

32. The apparatus of claim 31, wherein the first strap extends laterally over the ears providing upward lift directly under the nose.

33. The apparatus of claim 22, wherein the coupler is adjustable such that a spacing of the tubes can be adjusted to align the second end of the tubes with the nostrils.

34. The apparatus of claim 31, further comprising a second strap, wherein the second strap is attachable to the pair of tubes in a vicinity of the user'"'"'s neck.

35. A nasal ventilation interface comprising:

a distal end configured to engage a user'"'"'s nostrils;

a proximal end configured to attach to a ventilation gas supply; and

a mid-section between the proximal and distal ends, wherein the distal end and the mid-section comprises a pair of tubes having an arcuate non-angulated shape and having an absence of pneumatic interconnections between each of the tubes of the pair.

36. The interface of claim 35, further comprising a coupler, wherein the coupler is configured to align the distal end with the user'"'"'s nostrils, and each tube has an absence of pneumatic interconnection with the other tube.

37. The interface of claim 35, wherein the pair of tubes extend from the distal end downward posteriorly and laterally from the user'"'"'s nostrils toward the mandible between an anterior and an posterior aspects of the mandible, and further extending from the mandible to the anterior aspect of the neck and joining at a location below the chin.

38. The interface of claim 35, wherein the mid-section extends from the distal end unidirectionally away from the nostrils to the same side of the face.

39. The interface of claim 35, wherein the mid-section is routed around the back of the user'"'"'s neck.

40. The interface of claim 35, wherein the distal end is pre-formed into a curved tubular shape, wherein the shape comprises three sections, a first generally straight distal portion, a second generally curved portion which extends downward, outward, and backward, and a third proximal portion which is curved downward, wherein the curves place the proximal end of the distal end tubing section generally lateral to the corners of the user'"'"'s mouth.

41. The interface of claim 35, wherein the distal end is preferably comprised of a thermoset or a thermoplastic material.

42. The interface of claim 35, wherein a portion of the tube has a non-circular, flat cross-sectional profile, and wherein a wider section of the profile is placed against the user'"'"'s skin.

43. The interface of claim 35, wherein the pair of tubes are joined together below the chin to facilitate positioning of the tubes against the face.

44. The interface of claim 35, further comprising a mouth shield, wherein the mouth shield is attachable to the pair of tubes and configured to be placed at least partially in the mouth to control air flow exiting the mouth.

45. The interface of claim 44, wherein the mouth shield further comprises a compliant flat section for insertion into the mouth of the user.

46. The interface of claim 35, wherein the pair of tubes are treated with a hypo-allergenic material.

47. The interface of claim 35, further comprising at least one lumen in a wall of the pair of tubes, wherein the lumen is attached to a source of supplemental oxygen.

48. The interface of claim 47, further comprising exhaust vent ports, wherein the ports are comprised of fennestrations in the wall of the pair of tubes, and wherein the fenestrations are angulated diagonally outward or laterally from the nose.

49. The interface of claim 35, further comprising a receptacle for receiving a source of aroma therapy solution, wherein the source of aroma is released into the tubing for carrying the aroma to the user'"'"'s nose with the ventilation gas.

50. A nasal ventilation interface comprising:

a pair of tubes, the tubes configured to engage a user'"'"'s nostrils at a distal end and configured to attach to a ventilation gas supply hose at a proximal end; and

a coupler configured to connect the pair of tubes having a movable joint between the pair of tubes, wherein the movable joint comprises a swivel to permit rotational movement of the tubes in at least one plane, and align each tube with a nostril foramen.

51. The interface of claim 50, wherein the coupler further comprises a length adjustment means so as to align the tubes with the nostril foramen.

52. The interface of claim 50, wherein the coupler is removably attachable and available in a plurality of sizes or lengths so as to allow the user to adjust the spacing between the distal end tubes.

53. The interface of claim 50, further comprising a sealing member, wherein the sealing member comprises an enlarged diameter at a distance proximal to the distal end wherein the enlarged diameter creates the general configuration of a step, and wherein the enlarged diameter is a dimension larger than the nostril rim inner diameter, and wherein when used the step engages the nostril rim to effect a seal and to prevent over penetration of the tubes into the nostril.

54. The interface of claim 53, wherein the sealing members comprise a double seal, wherein the step comprises a first seal on the rim of the nostril and wherein a second seal occurs inside the nostril and wherein the second seal further comprises a at least on ring on or near the distal end of the sealing member.

55. The interface of claim 54, wherein the sealing member further comprises an attachment member, wherein the attachment members attaches the sealing member to the tube distal end and comprises a locking means, wherein the locking means prevents inadvertent dislodgment of the sealing member from the interface tubes.

56. The interface of claim 53, wherein the sealing members further comprise a leash configured to be grasped with fingers for attachment and removal of the cushion.

57. The interface of claim 53, wherein the sealing members are air filled.

58. The interface of claim 53, wherein the sealing members are comprised of a material having a durometer of about 40 to about 70 Shore OO durometer.

59. A nasal ventilation interface for the purpose of supplying ventilation gas to a person'"'"'s airway, the interface comprising;

a generally tubular construction with a distal end configured with a first and a second tube for engagement with a person'"'"'s nostrils, a proximal end configured for attachment to a ventilation gas supply hose;

a coupler connecting the first and second distal ends of the tubes; and

a lifting means applied substantially directly under the nose to the distal end of the first and second tubes, wherein the lift creates and maintains an engagement force between the tubes'"'"' distal tip and the nostrils.

60. The interface of claim 59, wherein the lifting means is a first strap attachable to the distal end of the tubes via the coupler.

61. The interface of claim 60, wherein the first strap comprises two ends, wherein the two ends extend bilaterally away from the nose and join at the back or side of the head.

62. The interface of claim 60, wherein the first strap further comprises a malleable member.

63. The interface of claim 60, wherein the first strap further comprises a shape memory member.

64. The interface of claim 60, wherein the tension and location of the first strap are adjustable.

65. The interface of claim 60, further comprising a facial pad, wherein the facial pad is attachable to the first strap and positions the distal end of the interface beneath the nose.

66. A nasal ventilation interface apparatus for the purpose of supplying ventilation gas to a person'"'"'s airway, the apparatus comprising a generally tubular construction with a distal end comprising a first and second tube configured to engage a person'"'"'s nostrils, a proximal end configured to attach to a ventilation gas supply hose, wherein the distal end comprises a facial pad positioned between the tubes and skin between the user'"'"'s nose and upper lip, wherein the facial pad cushions the user'"'"'s skin and tilts the distal end of the tubes aligns the distal end tubes with the rim of the user'"'"'s nostril.

67. The apparatus of claim 66, wherein the facial pad is comprised of a viscoelastic material and the pair of tubes are comprised of a plastic material.

68. The apparatus of claim 66, wherein the facial pad is comprised of an energy absorption material.

69. A nasal ventilation interface apparatus for the purpose of supplying ventilation gas to a person'"'"'s airway comprising a generally tubular construction with a distal end comprising a first and a second tube configured to engage a person'"'"'s nostrils, a proximal end configured to attach to a ventilation gas supply hose, further comprising a band member substantially circumventing the head from the chin to the top of the head, wherein the band member applies upward compression on the chin so as to bias the mouth in a close state, and wherein the band attaches the apparatus to the band member.

70. The apparatus of claim 69, wherein the band member provides an upward force on the distal end first and second tubes, wherein the force maintains compression between the nostrils and the distal ends of the first and second tubes wherein the compression substantially seals the first and second tubes to the nostrils.

71. The apparatus of claim 69, wherein the distal end of the tubes is generally circular and comprises an inner diameter generally approximately equal to or less than the diameter of the nostril opening of the user.

72. The apparatus of claim 71, wherein the distal end of the tubes has an inner diameter of about 6 mm to about 22 mm.