Patent Application
20100154800
The present invention relates to medical devices generally. More specifically, the invention relates to an improved endotracheal tube connector, as well as a packaging, and sizing system.
Endotracheal intubation is a necessary skill for a variety of medical professionals. Anesthesiologists, Emergency Physicians, Paramedics, and other professional personnel secure a patient's airway by placement of an endotracheal tube (also known as an ET tube) within the trachea of a patient. Placement may occur in a controlled way, such as an operating room environment, or may be undertaken more emergently at bedside, in the Emergency Department, or by trained ambulance personnel in a field or battlefield setting. Proper placement of an endotracheal tube is of paramount importance; potentially catastrophic implications may be expected where a patient is not ventilated or is inadequately ventilated.
Endotracheal tube placement may be difficult and challenging, even for seasoned professionals, and may be complicated by the patient's physiological status, as well as other factors, including traumatic deformation of the oropharynx, blood, dentition, vomitus, or other foreign material in the patient's oral cavity. Additionally, infants and pediatric patients may present special challenges in securing adequate tube placement.
Following successful tube placement, professionals are cautious to avoid disconnecting the connector from proximal portion of the endotracheal tube; unrecognized disconnections may be life threatening. The probability that a connector will become unintentionally disconnected is increased where ventilation occurs in a setting outside the operating room, such as a complicated field setting (e.g. the extrication of a trapped patient), or where the patient must be moved. Accordingly, it is important to maintain proper tube placement—particular in circumstances where initial placement was difficult.
Selecting the proper size ET tube size is also critically important. Where the chosen tube is too small, the relatively smaller cross-sectional luminal diameter will be smaller compared to the required tidal volume—making ventilation more difficult. Further, an improperly small tube may be more subject to dislodgement, may inadequately seal the airway, and may make any necessary subsequent required instrumentation occurring through the tube (e.g. bronchoscopy) more difficult. In contrast, an improperly large tube may be unnecessarily difficult to pass and cause trauma to the airway. Improper tube selection is more common under rushed or emergent circumstances, where the professional performing the skill has relatively limited recent experience, and in settings where intubation is infrequently performed.
The need to verify proper tube placement and size is common, particularly where a patient is transferred from one professional or service to another. As a placed tube is often secured by tape, confirmation of the tube size may be difficult where tube sizing indicia itself is obscured by the tape. Lastly, patient management may become problematic where the free end of the pilot balloon line becomes entangled in other equipment or where the pilot balloon cannot be quickly located where intubation is performed in unfavorable field settings.
There have been devices utilizing color coding to assist with identification of tube size. For example, U.S. Pat. No. 4,483,337 to Clair, discloses, in part, a color-coding system for identifying endotracheal tube size, including a color-coded strip along the longitudinal length of the tube from the connector to approximately the area of the exit of the pilot line. U.S. Pat. No. 6,050,263 to Choksi, et al. discloses, in part, an endotracheal tube holder having, inter alia, a support bar and platform and tube that may have coloration to indicate size. U.S. Pat. No. 4,926,885 to Hinkle discloses, in part, a method of identifying and selecting medical equipment, medication doses and/or medical supplies, and to the equipment used to carry out the method; the method is largely based upon anatomical dimensions. However, the prior art solutions are not without problems. For example, use of a color coded strip may interfere with patient care efforts and become soiled in any traumatic resuscitative events. Apparatus designed to serve as an endotracheal tube holder may be cumbersome in certain clinical circumstances and require specific clinician familiarity before use. Further, methodologies derived largely from anatomical dimensions may be more time consuming to apply, particularly in emergency situations.
The present invention discloses a color-coding system which matches the color of an endotracheal tube and connector to a specific cross-sectional luminal diameter. Further embodiments provide for corresponding packaging permitting at least a portion of a colored connector, tube, or both to be visible through the packaging thereby aiding in rapid selection of an appropriate tube size. The invention further discloses a series of non-uniform improved endotracheal tube connectors to provide a more secure attachment between an endotracheal tube and connector and may permit the connector to be secured to a tube more tightly than a conventional connector. Further, the connector may be tightened more easily as the user applies a twisting action to insert the connector into the tube. Further, in specific embodiments, the connector has threading which may provide a more secure connection by disrupting a fluid layer that may accumulate between the connector and tube's interior. Further, as at least a portion the tube must stretch or deform to accommodate certain embodiment connectors, the tube must likewise change shape before it can slip—making inadvertent disconnection less likely. The inventive connector will allow purposeful separation when needed. In a further embodiment, the connector bears one or more notches where the pilot balloon of an endotracheal tube may be secured.
In one embodiment of the present invention,
One aspect of the present invention is to provide an endotracheal tube connector that more securely attaches to the proximal end 14 of tube 12. Generally, endotracheal tube connectors are straight and smooth and may slightly narrowingly taper. One aspect of the present invention is to provide a series of improved connectors that permit greater resistance to dislodging from tube 12 and, in some embodiments, may prevent leakage and may decrease contamination passing around second end 26 into tube 12 or from within tube 12 around second end 26 to contaminate the outside of tube 12.
For illustrative purposes, when referring to connector 20, it will be helpful to consider the first end 22 as the proximal end and second end 26 as the distal end. In one embodiment illustrated by
It should be clear from the foregoing disclosure and expressly noted that the above example embodiments are for illustrative purposes only. It is specifically recognized that various disclosed variables may be interchanged and utilized together or independently, including: taper or non-tapering, the degree or rapidity of taper, the location for the beginning or termination of tapering (e.g. entire distance of second end 26, distal third, etc.), the presence or absence of a flaring portion (and the degree of flare), and the presence or absence of a barb. Also, multiple threading types are illustratively disclosed in non-limiting examples, such as a positive threading ridge and a negative threading groove. Threading size (including height from the surface and width across the surface of second end 26) and shape and number of windings comprising the spiral is variable as is the utilization of diminishing or non-diminishing threading. Additionally, any portion of the second end 26 may be smooth and utilized in conjunction with various thread forms. Also, as second end 26 may have a helical or spiral shape, the density, pitch, height, and width of threading on second end 26 is variable. In a specific alternative embodiment, second end 26 has a plurality of helices independent of each other.
Turning now to coloration, in one example embodiment, the endotracheal tube is color coded to correspond to a particular endotracheal tube size. Several coloration schemes can be adopted and utilized. One particular useful scheme uses solid colors for each integer size, and a color with stripes for each next non-integer half-size. An exemplar scheme, illustrated by
To facilitate easy recognition prior to use, the endotracheal tube 10 is packaged in packaging 32 which, in one embodiment comprises a first side 36 having printable paper surface that provides printed indicia 40, such as tube size information. In an alternative embodiment, printed indicia 40 may be omitted. The second side 34 has a clear transparent packaging surface allowing direct visualization of the colored tube 10 and connector 20 within packaging 32. In an alternative embodiment, the second side may have any surface that permits at least a portion of tube 10 or connector 20 to be visualized sufficient to identify the coloration of either or both. As examples, such surfaces may include a translucent surface or fenestrated surface sufficient to permit color identification.
In one specific embodiment, the coloration of the packaging is correlated to the tube size and matches the coloration of connector 20, tube 10, or both. In this embodiment, packaging 32 may be opaque.
It should be clearly understood that aspects of the present invention may be practiced independently of one another. For example, tube 10 may be colorized and connector 20 may or may not be colorized, and if connector 20 is colorized, the coloration may correspond to the coloration of tube 10 or may be distinct. Further, connector 20 may be colorized and tube 10 may or may not be colorized, and if tube 10 is colorized, the coloration may correspond to the coloration of connector 20 or may be distinct. Moreover, it should be noted that the varied embodiments of connector 20 may be utilized with or without notches 24. It should be apparent that connector 20 may be utilized with or without regard to connector or tube 10 coloration.
While exemplar tube sizes are disclosed, it is recognized that a veterinary application may result in utilization of tubes with different cross-sectional luminal diameters. Accordingly, tube size discussed herein is for illustrative purposes only, and aspects of the present invention may be utilized with larger or smaller tubes.
Although the present invention has been described with reference to the preferred embodiments, it should be understood that various modifications and variations can be easily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing disclosure should be interpreted as illustrative only and is not to be interpreted in a limiting sense. It is further intended that any other embodiments of the present invention that result from any changes in application or method of use or operation, method of manufacture, shape, size, or material which are not specified within the detailed written description or illustrations contained herein yet are considered apparent or obvious to one skilled in the art are within the scope of the present invention.
This application claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Application U.S. 61/073,165 entitled “Endotracheal tube with color-coded secure connector and packaging” filed Jun. 17, 2008, which is herein incorporated by reference as if more fully set forth.
| Number | Date | Country | |
|---|---|---|---|
| 61073165 | Jun 2008 | US |
