Device and method for placing within a patient an enteral tube after endotracheal intubation

• US 7,921,847 B2
• Filed: 07/25/2005
• Issued: 04/12/2011
• Est. Priority Date: 07/25/2005
• Status: Expired due to Fees

• Current Assignee: KM Technology Partners, LP
• Original Assignee: Intubix, LLC
• Inventors: Totz, Kenneth A.
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): Patel; Nihir
• Application Number:
  US11/188,821
• Publication Number:
  US 20070017527A1
• Time in Patent Office: 2,087 Days
• Field of Search: 128/207.14, 128/207.15, 128/207.16, 128/200.26, 604/94.01, 604/96.01, 604/101.01, 604/101.04, 604/264, 604/284, 604/523, 604/544, 606192-196
• US Class Current: 128/207.15
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0415 with access means to the stomach
• CPC Class Codes: A61M 16/0418 with integrated means for changing the degree of curvature, e.g. for easy intubation
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0479 above the cuff, e.g. giving access to the upper trachea
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• 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 2205/32 with radio-opaque indicia

Abstract

The present invention is directed to a novel device and method for providing a disposable endotracheal intubation device for use with an auxiliary passageway serving as a guide for the placement of an orogastic or other enterally directed device in a patient. The present invention pertains to a combination intubation device comprising an endotracheal tube and a catheter proximate the endotracheal tube to guide the path of an enteral tube. In a preferred embodiment, the endotracheal tube is capable of defining an arcuate path in a first geometric plane between its proximal end and its distal end to facilitate introduction of the tube into the trachea of a patient. In a preferred embodiment, the catheter employs a fenestration to facilitate removal of the intubation device from the patient without removal of any enteral device previously directed therethrough into the patient.

Claims

1. A combination intubation device comprising:

an endotracheal tube for ventilation of a patient'"'"'s lungs, said endotracheal tube having an outside diameter, an inside diameter defining an endotracheal ventilation lumen, a proximal end and a distal end,

said endotracheal tube capable of defining an arcuate path in a first geometric plane between its proximal end and its distal end to facilitate introduction of said endotracheal tube into the trachea of the patient,

said endotracheal tube having a wall thickness defined as the space between said outside diameter and said inside diameter,

said arcuate path, when so defined, having a concave side and a convex side substantially opposite said concave side,

said endotracheal tube, when so defined in said arcuate path, having a concave side and a convex side substantially opposite said concave side,

said outside diameter of said endotracheal tube having a first edge along the concave side of said defined arcuate path and a second edge along the convex side of said defined arcuate path,

an inflatable cuff for achieving a seal, when inflated, with said endotracheal tube outside diameter and an inner wall of the trachea of the patient when the distal end of said endotracheal tube is inserted into the patient'"'"'s trachea, said cuff being positioned generally toward the distal end of said endotracheal tube,

said inflatable cuff being in fluid communication with an inflation port positioned generally toward the proximal end of said endotracheal tube, and

a catheter capable of receiving an enteral tube therethrough and guiding the path of the enteral tube, said catheter comprising;

a length defined by a proximal end and a distal end,

a catheter first side capable of being attached to said endotracheal tube along the length of said catheter, the length of said catheter extending along only a portion of the length of said endotracheal tube,

a catheter second side substantially opposite said catheter first side,

an outside diameter,

an inside diameter suitable to facilitate the movement of the enteral tube therethrough, said inside diameter defining an internal catheter conduit space between said catheter proximal and distal ends, the enteral tube having an outside diameter of sufficient size to permit movement of the enteral tube through said internal catheter conduit space,

a catheter proximal end opening at said catheter proximal end for receiving the enteral tube into said internal catheter conduit space,

a catheter distal end opening at said distal end to permit the enteral tube to enter the esophagus of the patient, and

a catheter wall thickness defined as the space between said outside diameter and said inside diameter,

said distal end of said catheter being positioned proximate the opening of the patient'"'"'s esophagus when the distal end of said endotracheal tube is inserted into the patient'"'"'s trachea.

2. The device of claim 1 wherein said endotracheal tube is constructed of a flexible, generally transparent material.

3. The device of claim 1 wherein said first side of said catheter is attached to said endotracheal tube along substantially the entire length of said catheter.

4. The device of claim 1 wherein said catheter is constructed of a flexible, generally transparent material.

5. The device of claim 1 wherein the enteral tube is an orogastric tube.

6. The device of claim 1 wherein the distal end of said catheter is positioned to direct the path of the enteral tube posteriorly toward the esophagus of the patient after the enteral tube exits from said catheter distal end opening.

7. The device of claim 1 wherein the distal end of said catheter is positioned to direct the path of the enteral tube into the esophageal limb of the patient.

8. The device of claim 1 wherein said distal end of said catheter has a diagonal cut at said end to facilitate the introduction of the enteral tube into the esophagus of the patient after the enteral tube exits from said catheter distal end opening.

9. The device of claim 1 wherein the proximal end of said catheter is positioned generally within said first plane and the distal end of said catheter is positioned generally within said first plane.

10. The device of claim 1 wherein the proximal end of said catheter is positioned generally within said first plane and the distal end of said catheter is positioned generally outside of said first plane.

11. The device of claim 1 wherein the proximal end of said catheter is positioned generally outside of said first plane and the distal end of said catheter is positioned generally within said first plane.

12. The device of claim 1 wherein the proximal end of said catheter is positioned generally outside of said first plane and the distal end of said catheter is positioned generally outside of said first plane.

13. The device of claim 1 wherein said arcuate path concave side is generally pointing in a direction away from the patient'"'"'s vertebra when said endotracheal tube is inserted into the patient, and said arcuate path convex side is generally pointing toward the patient'"'"'s vertebra when said endotracheal tube is inserted into the patient,

said outside diameter of said endotracheal tube having a first edge along the first side of said arcuate path and a second edge along the second side of said arcuate path.

14. The device of claim 13 wherein the proximal end of said catheter is positioned generally within said first plane,

said catheter defining a substantially linear path along the second edge of the outside diameter of said endotracheal tube.

15. The device of claim 13 wherein the proximal end of said catheter is positioned generally outside said first plane,

said catheter defining a substantially partial-spiral path around the outside diameter of said endotracheal tube to position said distal end of said catheter in said first plane proximate the second edge of the outside diameter of said endotracheal tube.

16. The device of claim 15 wherein said substantially partial spiral path traverses approximately 90-degrees along the outside diameter of said endotracheal tube.

17. The device of claim 15 wherein the proximal end of said catheter is side-by-side said endotracheal tube in a second plane substantially normal to said first plane.

18. The device of claim 17 wherein the distal end of said catheter is side-by-side said endotracheal tube in a second plane substantially normal to said first plane.

19. The device of claim 13 wherein said catheter further comprises a fenestration along substantially the entire length of the catheter wall to facilitate the removal from said catheter of an enteral tube having previously been placed therethrough without the need to remove the enteral tube from the patient.

20. The device of claim 19 wherein said fenestration is located along said outer diameter of said catheter substantially medially between said catheter first side and said catheter second side.

21. The device of claim 19 wherein said fenestration is a membrane-like material capable of tearing open sufficient to permit said enteral tube to be pulled substantially laterally through said membrane until said enteral tube is without said catheter.

22. The device of claim 19 wherein said fenestration comprises a slit through the entire thickness of said catheter wall thickness along the entire length of said catheter sufficient to permit said enteral tube to be pulled substantially laterally through said slit until said enteral tube is without said catheter.

23. The device of claim 22 wherein said slit is maintained in a substantially closed position with a removable strip of tape placed over said slit on the outside diameter of said catheter.

24. The device of claim 22 wherein said slit has a width of lesser size than the outer diameter of said enteral tube.

25. The device of claim 24 wherein said slit has a width of between ¼

and ½

the size of the outer diameter of said enteral tube.

26. The device of claim 13 further comprising:

an endotracheal tube axis located in the distal portion of said endotracheal tube, said endotracheal tube axis being substantially aligned with the axis of the patient'"'"'s trachea when said distal end of said endotracheal tube is placed within the patient'"'"'s trachea,

a first catheter zone located between the proximal and distal ends of said catheter, wherein said catheter has a first catheter axis that is substantially parallel to said endotracheal tube axis, and

a second catheter zone located proximate the distal end of said catheter wherein said catheter has a second catheter axis that diverges from said first catheter axis.

27. The device of claim 26 wherein said second catheter axis diverges from said first catheter axis to direct the path of the enteral tube posteriorly toward the esophagus of the patient.

28. The device of claim 26 wherein said second catheter axis diverges from said first catheter axis to form an angle between both said axes to optimally align the distal end of said catheter for directing the path of the enteral tube posteriorly toward the esophagus of the patient.

29. The device of claim 28 wherein said angle is between about 15 degrees and 60 degrees.

30. The device of claim 1 wherein the proximal end of said catheter is positioned generally outside said first plane,

said catheter defining a substantially helical path around the outside diameter of said endotracheal tube.

31. The device of claim 1 wherein the proximal end of said catheter is positioned generally within said first plane,

said catheter defining a substantially helical path around the outside diameter of said endotracheal tube.

32. The device of claim 1 wherein said catheter further comprises an expandable sleeve connected to the outside diameter of said catheter for attaching said catheter to said endotracheal tube,

said expandable sleeve capable of snugly sliding over the outside diameter of said endotracheal tube.

33. The device of claim 32 wherein said expandable sleeve further comprises a stretchable material.

34. The device of claim 32 wherein said expandable sleeve is connected along a portion of the outside diameter of said catheter.

35. The device of claim 32 wherein said expandable sleeve is connected along substantially the entire length of the outside diameter of said catheter.

36. The device of claim 32 wherein said expandable sleeve further comprises a plurality of expandable sleeves connected along the outside diameter of said catheter.

37. The device of claim 32 wherein said expandable sleeve further comprises one or more closable and reopenable closures connected along the outside diameter of said catheter,

said one or more closures being capable of wrapping around the outside of said endotracheal tube diameter to secure said catheter to said endotracheal tube.

38. The device of claim 1 wherein said catheter is fixably attached to said endotracheal tube.

39. The device of claim 38 wherein said catheter is fixably attached to said endotracheal tube using one or more attachment methods selected from group consisting of:

extrusion molding, gluing, heat welding, chemical bonding, ring clips, tape, hook and loop fasteners, mating channels, mated compression fittings, fasteners, clamps and encapsulation with shrink wrap.

40. The device of claim 38 wherein said catheter is fixably attached to said endotracheal tube so that a seam is created between the outside diameter of said catheter and the outside diameter of said endotracheal tube, said seam having a length that is adjustable.

41. The device of claim 1 wherein said catheter is removably attached to said endotracheal tube.

42. The device of claim 41 wherein said catheter and said endotracheal tube contain mated linear tracks for slidably attaching the outer diameter of said catheter to the outer diameter of said endotracheal tube.

43. The device of claim 41 wherein said catheter is removably attached to said endotracheal tube using one or more attachment methods selected from group consisting of:

ring clips, mated compression fittings, fasteners, and clamps.

44. The device of claim 1 wherein said catheter is slidably attached to said endotracheal tube,

said catheter having one or more cylindrical tubes fixably attached to the anterior side of said catheter,

said one or more cylindrical tubes being substantially co-axially aligned with each other,

said one or more cylindrical tubes having a cross-sectional shape substantially similar to the cross-section of said endotracheal tube, an outside diameter, and an inside diameter suitable to facilitate the frictional movement of said endotracheal tube therethrough, a proximal end and a distal end.

45. The device of claim 1 further comprising:

a first section proximate the proximal end of said endotracheal tube wherein the proximal end of said catheter is maintained external to said endotracheal tube,

a second section between the proximal and distal ends of said endotracheal tube wherein said catheter is maintained within said endotracheal tube, and

a third section toward the distal end of said endotracheal tube wherein the distal end of said catheter is maintained external to said endotracheal tube.

46. The device of claim 1 further comprising:

a first section proximate the proximal end of said endotracheal tube wherein the proximal end of said catheter is maintained within the wall of said endotracheal tube, said proximal end of said catheter being flush with the outside diameter of said endotracheal tube and remaining capable of having the enteral tube pass therethrough,

a second section between the proximal and distal ends of said endotracheal tube wherein said catheter is maintained within said endotracheal tube, and

a third section toward the distal end of said endotracheal tube wherein the distal end of said catheter is maintained within the wall of said endotracheal tube, said distal end of said catheter being flush with the outside diameter of said endotracheal tube and remaining capable of having the enteral tube pass therethrough.

47. The device of claim 1 wherein said catheter is a conduit located within the wall of said endotracheal tube.

48. The device of claim 1 wherein said endotracheal tube further comprises a malleable stylet for use in shaping said endotracheal tube,

said stylet having a distal end and a proximal end.

49. The device of claim 48 wherein said stylet employs fiber optics capable of transmitting an optical image signal from said distal end of said stylet to a display device connected to said proximal end of said stylet.

50. The device of claim 48 wherein said stylet is integrated into said endotracheal tube.

51. The device of claim 48 wherein said stylet is built into said wall of said endotracheal tube.

52. The device of claim 48 wherein said stylet is insertable into and removable from said inside diameter of said endotracheal tube.

53. The device of claim 1 wherein said endotracheal tube further comprises one or more strands of a flexible, memory retaining material capable of being manipulated to facilitate the defining of said arcuate path.

54. The device of claim 1 wherein said catheter further comprises a malleable stylet for use in shaping said catheter tube.

55. The device of claim 54 wherein said stylet is integrated into said catheter.

56. The device of claim 54 wherein said stylet is built into said wall of said catheter.

57. The device of claim 54 wherein said stylet is insertable into and removable from said inside diameter of said catheter.

58. The device of claim 1 wherein said catheter further comprises one or more strands of a flexible, memory retaining material capable of being manipulated to facilitate the shaping of said catheter.

59. The device of claim 1 wherein said endotracheal tube and said catheter further comprise one or more strands of a flexible, memory retaining material capable of being manipulated to facilitate the shaping of said endotracheal tube and said catheter.

60. The device of claim 1 wherein said endotracheal tube contains markings to assist medical personnel in ascertaining placement and positioning of the device.

61. The device of claim 1 wherein said endotracheal tube has a substantially circular cross-section.

62. The device of claim 1 wherein said catheter has a substantially circular cross-section.

63. A combination medical device comprising:

an endotracheal tube for use in ventilating a patient'"'"'s lungs, said endotracheal tube having an outside diameter, an inside diameter defining an endotracheal ventilation lumen, a proximal end and a distal end,

said endotracheal tube capable of defining an arcuate path in a first geometric plane between its proximal end and its distal end to facilitate introduction of said endotracheal tube into the trachea of the patient,

an inflatable cuff for achieving a seal, when inflated, with said endotracheal tube outside diameter and an inner wall of the trachea of the patient when the distal end of said endotracheal tube is inserted into the patient'"'"'s trachea, said cuff being positioned generally toward the distal end of said endotracheal tube,

said inflatable cuff being in fluid communication with an inflation port positioned generally toward the proximal end of said endotracheal tube, and

a catheter capable of receiving an enteral tube therethrough and guiding the path of the enteral tube, said catheter comprising;

a length defined by a proximal end and a distal end,

an outside diameter,

an inside diameter suitable to facilitate the movement of the enteral tube therethrough, said inside diameter defining an internal catheter conduit space between said catheter proximal and distal ends,

a catheter proximal end opening at said catheter proximal end for receiving the enteral tube into said internal catheter conduit space,

a catheter distal end opening at said distal end to permit the enteral tube to enter the esophagus of the patient, and

said catheter being attached to said endotracheal tube along substantially the entire length of said catheter,

said proximal end of said catheter being positioned generally outside said first plane,

the length of said catheter extending along only a portion of the length of said endotracheal tube,

said catheter defining a substantially partial-spiral path around the outside diameter of said endotracheal tube to position said distal end of said catheter in said first plane,

said distal end of said catheter having a diagonal cut at said end and being positioned proximate the opening of the patient'"'"'s esophagus when the distal end of said endotracheal tube is inserted into the patient'"'"'s trachea.

64. The combination of claim 63 wherein said catheter further comprises a fenestration along substantially the entire length of the catheter wall to facilitate the removal from said catheter of an enteral tube having previously been placed therethrough without the need to remove the enteral tube from the patient.

65. The device of claim 63 wherein said endotracheal tube has a substantially circular cross-section.

66. The device of claim 63 wherein said catheter has a substantially circular cross-section.

67. A method of intubating a patient comprising:

(a) providing a combination intubation device, said intubation device comprising,

an endotracheal tube for ventilation of the patient'"'"'s lungs, said endotracheal tube having an outside diameter, an inside diameter defining an endotracheal ventilation lumen, a proximal end and a distal end,

said endotracheal tube capable of defining an arcuate path in a first geometric plane between its proximal end and its distal end to facilitate introduction of said endotracheal tube into the trachea of the patient,

said endotracheal tube having a wall thickness defined as the space between said outside diameter and said inside diameter,

said arcuate path, when so defined, having a concave side and a convex side substantially opposite said concave side,

said endotracheal tube, when so defined in said arcuate path, having a concave side and a convex side substantially opposite said concave side,

said outside diameter of said endotracheal tube having a first edge along the concave side of said defined arcuate path and a second edge along the convex side of said defined arcuate path,

an inflatable cuff for achieving a seal, when inflated, with said endotracheal tube outside diameter and an inner wall of the trachea of the patient, said cuff being positioned generally toward the distal end of said endotracheal tube,

said inflatable cuff being in fluid communication with an inflation port positioned generally toward the proximal end of said endotracheal tube, and

a catheter capable of receiving an enteral tube therethrough and guiding the path of the enteral tube, said catheter comprising;

a length defined by a proximal end and a distal end,

a catheter first side capable of being attached to said endotracheal tube along the length of said catheter, the length of said catheter extending along only a portion of the length of said endotracheal tube,

a catheter second side substantially opposite said catheter first side,

an outside diameter,

an inside diameter suitable to facilitate the movement of the enteral tube therethrough said inside diameter defining an internal catheter conduit space between said catheter proximal and distal ends, the enteral tube having an outside diameter of sufficient size to permit movement of the enteral tube through said internal catheter conduit space,

a catheter proximal end opening at said catheter proximal end for receiving the enteral tube into said internal catheter conduit space,

a catheter distal end opening at said distal end to permit the enteral tube to enter the esophagus of the patient, and

a catheter wall thickness defined as the space between said outside diameter and said inside diameter,

said distal end of said catheter being positioned proximate the opening of the patient'"'"'s esophagus when the distal end of said endotracheal tube is inserted into the patient'"'"'s trachea;

(b) inserting into the oral cavity of a patient said intubation device oriented such that the distal end of said endotracheal tube enters first;

(c) orienting said distal end of said endotracheal tube with the patient'"'"'s trachea;

(d) inserting said distal end of said endotracheal tube into the patient'"'"'s trachea;

(e) inflating said inflatable cuff by administering a source of air into said inflation port; and

(f) ventilating the patient through said endotracheal tube ventilation lumen.

68. The method of claim 67 comprising the additional step of:

(g) directing a desired enteral tube into said catheter proximal end opening, through said internal catheter conduit space, out said catheter distal end opening and into the patient'"'"'s esophagus or other desired location of the patient that is accessed via the patient'"'"'s esophagus.

69. The method of claim 68 comprising the additional step of removing the intubation device without removing said enteral tube from within the patient.

70. The method of claim 68 wherein said catheter of said intubation device further comprises a fenestration along substantially the entire length of the catheter wall to facilitate the removal of an enteral tube having previously been placed therethrough without the need to remove the enteral tube from the patient, said fenestration also facilitating the removal of said endotracheal tube and said catheter without the need to remove said enteral tube previously placed within the patient through said catheter, said method comprising the additional steps of:

deflating said inflatable cuff;

maintaining said enteral tube in its desired location while withdrawing said intubation device from the patient'"'"'s oral cavity; and

maintaining said enteral tube in its desired location while directing said enteral tube through said fenestration.

71. The method of claim 67 wherein said intubation device further comprises an integrated, malleable stylet for use in shaping said intubation device, said method comprising the additional step of:

shaping said intubation device prior to inserting said device into the oral cavity of a patient so that said shape of said intubation device facilitates the insertion of said device into the oral cavity of the patient.

72. The method of claim 67 wherein said intubation device further comprises an integrated array of fiber optics capable of transmitting an optical image signal from said distal end of said device to a display device external to the patient, said method comprising the additional step of:

Viewing the display of said fiber optics image signal on said display device while inserting said intubation device into the patient to facilitate placement of said intubation device.

73. The method of claim 67 comprising the additional steps of inserting a stylet into the inside diameter of said endotracheal tube and shaping said endotracheal tube to facilitate placement of said intubation device into the patient.

74. The method of claim 67 wherein said endotracheal tube has a substantially circular cross-section.

75. The method of claim 67 wherein said catheter has a substantially circular cross-section.