Devices and methods for preventing tracheal aspiration

• US 9,526,856 B2
• Filed: 12/13/2012
• Issued: 12/27/2016
• Est. Priority Date: 12/15/2011
• Status: Expired due to Fees

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Azagury, Dan E., Garrett, Mary K., Gal, David, Bonneau, Raymond
• Primary Examiner(s): Anderson, Lynne
• Assistant Examiner(s): DITMER, KATHRYN ELIZABETH
• Application Number:
  US13/714,124
• Publication Number:
  US 20140000622A1
• Time in Patent Office: 1,475 Days
• Field of Search: 128/200.24, 128/200.26, 128/207.14, 128/207.15
• US Class Current: 1/1
• CPC Class Codes: A61B 1/267 for the respiratory tract, e.g. laryngoscopes, bronchoscopes
• CPC Class Codes: A61M 16/0402 Special features for tracheal tubes not otherwise provided for
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/044 External cuff pressure control or supply, e.g. synchronisation with respiration
• CPC Class Codes: A61M 16/0443 Special cuff-wall materials A61M16/0481, A61M16/0422 take precedence
• CPC Class Codes: A61M 16/0445 Special cuff forms, e.g. undulated
• CPC Class Codes: A61M 16/0447 Bell, canopy or umbrella shaped
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

Devices and methods for preventing tracheal aspiration as described where a cuff assembly having an inflatable member with an inflation tube fluidly coupled may be placed over a proximal end of an endotracheal tube or laryngeal mask and inserted into the patient trachea with the endotracheal tube or separately after the endotracheal tube has already been positioned. In either case, the inflatable member may be positioned distal (or inferior) to the vocal cords and proximal to the endotracheal balloon via a delivery instrument which automatically positions the balloon in proximity to the vocal cords.

Claims

1. A positioning handle assembly, comprising:

an elongate shaft which presents a profile for per-oral insertion into a trachea of a subject;

a distal stop attached to a distal end of the shaft, where the distal stop extends at least partially from a surface of the shaft and presents a stopping surface which is sized to prevent passage of the distal stop through vocal cords or laryngeal inlet of the subject; and

,

a cuff engagement member which extends distally from the distal stop at a distance and forms an edge for engagement with a cuff assembly, where the distal stop is partially circumferential extending from the surface of the shaft and wherein the cuff engagement member forms a partial tubular member such that the distal stop and cuff engagement member define an opening sized to receive an endotracheal tube therealong such that disengagement of the distal stop from the endotracheal tube allows for disengagement of the elongate shaft from the endotracheal tube via the opening, and

where the distance is sized such that the cuff engagement member extends past the vocal cords when the distal stop contacts the vocal cords or laryngeal inlet.

2. The positioning handle assembly of claim 1 wherein the elongate shaft comprises an arcuate shaft which defines a preformed curvature which presents an atraumatic profile.

3. The positioning handle assembly of claim 1 wherein the shaft has a preformed radius of curvature ranging from 12 in. to 300 in.

4. The positioning handle assembly of claim 1 wherein the shaft has a length ranging from 5 in. to 20 in.

5. The positioning handle assembly of claim 1 wherein the distal stop has a width of about 20 mm in a transverse direction relative to a length of the shaft.

6. The positioning handle assembly of claim 1 wherein the distal stop is configured to have a shape approximating a laryngeal inlet.

7. The positioning handle assembly of claim 1 wherein the stopping surface is transversely oriented relative to the shaft.

8. The positioning handle assembly of claim 1 wherein the cuff engagement member has a length of about 2 mm to 1 cm.

9. The positioning handle assembly of claim 1 further comprising the cuff assembly, wherein the cuff assembly comprises an inflation ring having an inflatable member disposed along an exterior surface of the inflation ring.

10. The positioning handle assembly of claim 9 further comprising an inflation tube fluidly coupled to the inflation ring and extending along a channel defined along the shaft.

11. The positioning handle assembly of claim 9 wherein the cuff assembly further comprises a sealing sleeve attached to the inflation ring.

12. The positioning handle assembly of claim 9 wherein the cuff assembly defines a narrowed distal end and a tapered proximal end.

13. The positioning handle assembly of claim 9 wherein the cuff assembly defines a narrowed distal end and a narrowed proximal end.

14. The positioning handle assembly of claim 1 wherein the cuff assembly is impregnated or coated with an agent.

15. The positioning handle assembly of claim 1 further comprising a sealing sleeve attached to the cuff assembly for sealing about the endotracheal tube.

16. The positioning handle assembly of claim 1 further comprising a handle coupled to a proximal end of the shaft, the handle defining a channel for receiving an inflation port.

17. The positioning handle assembly of claim 16 wherein the handle is further configured to receive a fluid reservoir.

18. The positioning handle assembly of claim 1 further comprising an endotracheal tube upon which the cuff engagement member is slidable therealong.

19. A positioning handle assembly, comprising:

an elongate arcuate shaft which defines a preformed curvature which presents an atraumatic profile for per-oral insertion into a trachea of a subject;

a distal stop attached to a distal end of the shaft, where the distal stop extends circumferentially and presents a stopping surface which is transversely oriented relative to the shaft and where the distal stop is sized to prevent passage of the distal stop through vocal cords of the subject; and

,

a cuff engagement member which extends distally from the distal stop at a distance and forms an edge for engagement with a cuff assembly, where the distal stop is partially circumferential extending from a surface of the shaft and wherein the cuff engagement member forms a partial tubular member such that the distal stop and cuff engagement member define an opening sized to receive an endotracheal tube therealong such that disengagement of the distal stop from the endotracheal tube allows for disengagement of the elongate shaft from the endotracheal tube, and where the distance is sized such that the cuff engagement member extends past the vocal cords when the distal stop contacts the vocal cords.

20. The positioning handle assembly of claim 19 wherein the shaft has a preformed radius of curvature ranging from 12 in. to 300 in.

21. The positioning handle assembly of claim 19 wherein the shaft has a length ranging from 5 in. to 20 in.

22. The positioning handle assembly of claim 19 wherein the distal stop has a width of about 20 mm in a transverse direction relative to a length of the shaft.

23. The positioning handle assembly of claim 19 wherein the distal stop is configured to have a shape approximating a laryngeal inlet.

24. The positioning handle assembly of claim 19 wherein the cuff engagement member has a length of about 2 mm to 1 cm.

25. The positioning handle assembly of claim 19 further comprising the cuff assembly, wherein the cuff assembly comprises an inflation ring having an inflatable member disposed along an exterior surface of the inflation ring.

26. The positioning handle assembly of claim 25 wherein the cuff assembly further comprises a sealing sleeve attached to the inflation ring.

27. The positioning handle assembly of claim 25 further comprising an inflation tube fluidly coupled to the inflation ring and extending along a channel defined along the shaft.

28. The positioning handle assembly of claim 19 further comprising the cuff assembly, wherein the cuff assembly defines a narrowed distal end and a tapered proximal end.

29. The positioning handle assembly of claim 19 further comprising the cuff assembly, wherein the cuff assembly defines a narrowed distal end and a narrowed proximal end.

30. The positioning handle assembly of claim 19 further comprising the cuff assembly, wherein the cuff assembly is impregnated or coated with an agent.

31. The positioning handle assembly of claim 19 further comprising a handle coupled to a proximal end of the shaft, the handle defining a channel for receiving an inflation port.

32. The positioning handle assembly of claim 31 wherein the handle is further configured to receive a fluid reservoir.

33. The positioning handle assembly of claim 19 further comprising an endotracheal tube upon which the cuff engagement member is slidable therealong.

34. A positioning handle assembly, comprising:

an elongate shaft which presents a profile for per-oral insertion into a trachea of a subject;

a distal stop attached to a distal end of the shaft, where the distal stop extends at least partially from a surface of the shaft and presents a stopping surface which is shaped for placement against a laryngeal inlet of the subject to prevent passage of the distal stop therethrough; and

,

a cull engagement member which extends distally from the distal stop at a distance and forms an edge for engagement with a cuff assembly, where the distal stop is partially circumferential extending from the surface of the shaft and wherein the cuff engagement member forms a partial tubular member such that the distal stop and cuff engagement member define an opening sized to receive an endotracheal tube therealong such that disengagement of the distal stop from the endotracheal tube allows for disengagement of the elongate shaft from the endotracheal tube, and where the distance is sized such that the cuff engagement member extends past the vocal cords when the distal stop contacts the laryngeal inlet.

35. The positioning handle assembly of claim 34 wherein the distal stop further defines an upper surface apposed to the stopping surface, where the stopping surface and upper surface are radially extending from the surface of the shaft.

36. The positioning handle assembly of claim 34 wherein the stopping surface of the distal stop presents a curved surface.

37. The positioning handle assembly of claim 34 wherein the stopping surface is transversely oriented relative to the shaft.

38. The positioning handle assembly of claim 34 wherein the cuff engagement member has a length of about 2 mm to 1 cm.