Method and device for non-invasive ventilation with nasal interface

• US 7,406,966 B2
• Filed: 08/18/2004
• Issued: 08/05/2008
• 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.
• Primary Examiner(s): Yu; Justine R.
• Assistant Examiner(s): DIXON, ANNETTE FREDRICKA
• Application Number:
  US10/922,054
• Publication Number:
  US 20050066976A1
• Time in Patent Office: 1,448 Days
• Field of Search: 128/200.24, 128/204.18, 128/204.21, 128/206.11, 128/207.13, 128/207.17, 128/207.18
• US Class Current: 128/207.18
• 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 for providing ventilation including,

a distal section of the pair of tubes configured to be engagable with a person'"'"'s nostrils,

a proximal section attachable to a ventilation gas supply, and

a midsection of the pair of tubes configured for connecting the distal and proximal sections;

wherein the distal section pair of tubes comprise;

(a) compound arcuate curves which are configured such that the distal section of the pair of tubes are adapted to extend from the nostril downward around the corners of the mouth to the chin and which are substantially stabilized in a performed configuration to stabilize and position the compound arcuate curves around the corners of the mouth and chin,

(b) the compound arcuate curves are configured such that the pair of tubes are adapted to curve such that the distal section of the pair of tubes is adapted to be in substantial contact with the skin and are substantially stabilized in a performed configuration to stabilize and position the compound arcuate curves substantially in contact with the skin and resist malformation of the configuration of the curves,

(c) and a coupling element interconnecting the pair of tubes that is adapted to be positioned between the nostrils and upper lip wherein the coupling element comprises a length adjuster.

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, further comprising a sealing cushion configured to be attachable to said distal section pair of tubes and configured to impinge the rim of the nostril.

4. The interface of claim 3, wherein the sealing cushion further comprises a step, wherein the step provides a seal on the rim of the nostril and prevents the sealing cushion from extending beyond a desired depth into the nostril.

5. The interface of claim 1, wherein said coupling element and said distal end section tubes are joined together by a swivel means, said swivel means configured to adjust and align the angle of the distal end of the distal end section with the angle of the nostrils.

6. The interface of claim 1, wherein the skin side of the coupler further comprises a facial pad, the facial pad configured to allow for angular adjustment of the distal end of the distal section pair of tubes to angularly align with the angle of the nostrils in the sagital plane.

7. The interface of claim 6, further comprising a first strap, wherein the first strap is attachable to the bottom side of the coupler beneath the nose and in the center of the face.

8. The interface of claim 7, wherein the first strap extends laterally over the ears providing upward lift directly beneath the nose.

9. 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,

the tubes comprising

a first curved section at the distal end adapted to curve downward and laterally from the user'"'"'s nostrils toward the corner of the mouth,

a second curved section adapted to curve laterally, posteriorly and downward around the corner of the mouth toward a mandible between an anterior and a posterior aspect of the mandible, and

a third curved section adapted to curve downward and medially to the anterior aspect of the neck and further wherein the tubing in at least one of the curved sections is positioned against the user'"'"'s skin and wherein the first, second and third curved sections are substantially stabilized in a preformed configuration adapted to secure the first, second and third curved sections in substantial contact with the skin and resist malformation of the first, second and third curved sections away from the skin.

10. The interface of claim 9, further comprising a coupler connecting said distal end pair of tubes together, said coupler comprising:

(a) a swivel joint at the attachments to said distal tubes, and (b) a length adjustment.

11. The interface of claim 9, wherein the mid-section is routed around the back of the user'"'"'s neck.

12. The interface of claim 9, 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.

13. The interface of claim 9, wherein a portion of the distal section of tubing has a non-circular, flat cross-sectional profile, and wherein a wider section of the profile is against placed the user'"'"'s skin.

14. The interface of claim 9, 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.

15. The interface of claim 14, wherein the mouth shield further comprises a compliant flat section for insertion into the mouth of the user.

16. The interface of claim 9, 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.

17. The interface of claim 9, further comprising exhaust vent ports, wherein the ports are comprised of fenestrations in the wall of the pair of tubes, and wherein the fenestrations are angulated diagonally outward or laterally from the nose.

18. The interface of claim 9, further comprising a receptacle for receiving a therapeutic compound, wherein the ventilation gas picks up and conducts molecules of the compound to the user'"'"'s nose with the ventilation gas.

19. A nasal ventilation interface comprising:

a pair of tubes having at a distal end configured to engage a user'"'"'s nostrils and a proximal end configured to attach to a manifold;

a single tube including a proximal end configured to attach to a ventilation gas supply, and a distal end configured to attach to the manifold, wherein the single tube is configured to extend unidirectionally away from the nostrils to one side of the face and a distal section of the single tube comprises;

(a) compound arcuate curves which are configured to extend from the manifold downward around the corner of the mouth to the chin and is substantially stabilized in a performed configuration to stabilize and position the curves around the corner of the mouth and chin,

(b) the compound arcuate curves are configured such that the single tube is adapted to curve such that the distal section is adapted to be in substantial contact with the skin and is substantially stabilized in a performed configuration adapted to stabilize and position the curves substantially in contact with the skin and resist malformation of the curves.

20. The interface of claim 19, further comprising a sealing cushion configured to be attachable to the distal section and configured to impinge a rim of the nostril.

21. The interface of claim 20, wherein the sealing cushion further comprises a step, wherein the step is adapted to provide a seal on the rim of the nostril and prevents the sealing cushion from extending beyond a desired depth into the nostril.

22. The interface of claim 19, wherein a skin side of the manifold further comprises a facial pad, the facial pad configured to allow for angular adjustment of the distal end of the distal section of the tube to angularly align with the angle of the nostrils in the sagital plane.