WO2019140313A1

WO2019140313A1 - Devices and methods for introducing and exchanging an endotracheal tube

Info

Publication number: WO2019140313A1
Application number: PCT/US2019/013364
Authority: WO
Inventors: Sean RUNNELS; Will ROBERGE; David Van Ness
Original assignee: Runnels Sean; Roberge Will; David Van Ness
Priority date: 2018-01-12
Filing date: 2019-01-11
Publication date: 2019-07-18

Abstract

An introducer usable with a tracheal intubation system is disclosed. Methods for using the introducer and systems that incorporate the introducer are also disclosed. In some examples, an introducer adapted for mounting an endotracheal tube comprises a shaft with a bulge or in combination with a dilator. The shaft comprises a distal shaft portion and a proximal shaft portion that have a continuous exterior surface. The proximal shaft portion has a body portion and a tip portion.

Description

DEVICES AND METHODS FOR INTRODUCING AND EXCHANGING AN

ENDOTRACHEAL TUBE

BACKGROUND

[0001] Many surgical procedures are typically performed while the patient is under general anesthesia. During these procedures, the patient is given a combination of medications to cause a loss of consciousness and muscle paralysis. The medications that cause loss of consciousness and muscle paralysis also interfere with the patient’s ability to breath. Accordingly, patients often undergo tracheal intubation during these procedures so that the patient may be connected to an external ventilator or breathing circuit. Patients may also be intubated for nonsurgical conditions in which enhanced oxygen delivery is required. Tracheal intubation may also be used in other circumstances.

[0002] During tracheal intubation, an endotracheal tube is placed in the patient’s airway. Generally, the endotracheal tube is advanced through the patient’s nose or mouth into the patient’s trachea. The endotracheal tube is then connected to an external ventilator or breathing circuit. The ventilator is then able to breath for the patient, delivering oxygen into the patient’s lungs.

[0003] The patient’s vocal cords and the space between them form the entrance to the trachea, these structures are also known as the glottis. The glottis is visible from and may be accessed through the pharynx. The pharynx is the portion of the upper airway that is located behind the patient’s mouth and below the patient’s nasal cavity. The mouth and the nasal cavity meet in the pharynx. Additionally, the esophagus and the glottis may be accessed through the pharynx.

During the intubation process, the endotracheal tube must be carefully advanced through the patient’s pharynx and placed through the vocal cords into the trachea. In addition, it is critical that the endotracheal tube be placed at the proper depth once in the trachea. If it is placed too shallow in the trachea, it can fall out. If it is placed too deep, only one lung may be ventilated resulting in poor oxygen delivery to the blood or hyperventilation on the ventilated lung, and hypoventilation to the non-ventilated lung. All of this can result in patient injury or death.

[0004] The intubation process interferes with the patient’s ability to breathe and thus deliver oxygen to the body independently. If the patient is without oxygen for more than two or three minutes, tissue injury may occur, which can lead to death or permanent brain damage. Accordingly, the intubation process must be performed quickly and accurately.

SUMMARY

[0005] In general terms, this disclosure is directed to an introducer for use with a tracheal intubation system. In one possible configuration and by non-limiting example, the tracheal intubation system allows a medical professional to properly position an endotracheal tube in a normal or difficult airway quickly, accurately, and safely. In another configuration and by non limiting example, the tracheal intubation system allows a medical professional to properly perform an endotracheal tube exchange procedure quickly, accurately, and safely.

[0006] One aspect is an introducer for mounting an endotracheal tube, the introducer comprising: a shaft comprising: a proximal shaft portion, wherein the shaft portion is malleable; a distal tip portion extending from the shaft portion, the tip portion being malleable, having plurality of depth assessment band, each depth assessment band having a visually distinct color or pattern from an adjacent depth assessment band, and having a round shape and a closed end.

[0007] Another aspect is a method for inserting an endotracheal tube in a patient comprising: inserting a blade of a laryngoscope in a mouth of the patient; viewing a trachea of the patient with the laryngoscope; providing the introducer; inserting the introducer into the patient;

inserting the endotracheal tube along the introducer and into the trachea of the patient; removing the introducer from the new endotracheal tube, while the endotracheal tube remains in the patient.

[0008] A further aspect is a method for inserting an endotracheal tube in a patient comprising: inserting a blade of a laryngoscope in a mouth of the patient; viewing a trachea of the patient with the laryngoscope; providing the introducer; mounting the endotracheal tube on the introducer; inserting the endotracheal tube and dilator combination into the trachea of the patient; removing the introducer from the new endotracheal tube, while the endotracheal tube remains in the patient.

[0009] Yet another aspect is a kit for inserting an endotracheal tube into a patient, the kit comprising: an introducer comprising a shaft comprising: a proximal shaft portion; a distal tip portion extending from the shaft portion, wherein the tip portion includes a tip having a round shape and a closed end; a dilator comprising a shaft having a first diameter at a first end and a second diameter at an opposing end; and an endotracheal tube.

[0010] Another aspect is a method for inserting an endotracheal tube in a patient comprising: inserting a blade of a laryngoscope in a mouth of the patient; viewing a trachea of the patient with the laryngoscope; providing a kit; mounting the dilator on the introducer; inserting the introducer and dilator combination into the patient; inserting the endotracheal tube along the introducer and into the trachea of the patient; and removing the introducer from the new endotracheal tube, while the endotracheal tube remains in the patient.

[0011] A further aspect is an introducer for mounting an endotracheal tube, the introducer comprising: a shaft comprising: a proximal shaft portion having a first diameter; a distal tip portion extending from the shaft portion having the first diameter; and a bulge extending between the proximal shaft portion and distal tip portion having a second diameter, wherein the second diameter is larger than the first diameter.

[0012] Yet another aspect is a method for inserting an endotracheal tube in a patient comprising: inserting a blade of a laryngoscope in a mouth of the patient; viewing a trachea of the patient with the laryngoscope; providing an introducer; inserting the introducer into the patient; inserting the endotracheal tube along the introducer and into the trachea of the patient; and removing the introducer from the new endotracheal tube, while the endotracheal tube remains in the patient.

[0013] Another aspect is an introducer for mounting an endotracheal tube, the introducer comprising: a shaft comprising: a proximal shaft portion having a first diameter; and a distal tip portion extending from the shaft portion having a second diameter, wherein the second diameter is smaller than the first diameter, and wherein the second diameter tapers to the first diameter.

[0014] A further aspect is a method for inserting an endotracheal tube in a patient comprising: inserting a blade of a laryngoscope in a mouth of the patient; viewing a trachea of the patient with the laryngoscope; providing an introducer; inserting the introducer into the patient; inserting the endotracheal tube along the introducer and into the trachea of the patient; and removing the introducer from the new endotracheal tube, while the endotracheal tube remains in the patient.

[0015] Yet another aspect is a method for exchanging an endotracheal tube in a patient comprising: inserting a blade of a laryngoscope in a mouth of the patient; viewing a trachea of the patient with the laryngoscope; inserting a malleable introducer into an existing endotracheal tube; removing the existing endotracheal tube from the patient, while the malleable introducer remains in place in the trachea; inserting the new endotracheal tube and along the malleable introducer and into the trachea of the patient; and removing the malleable introducer from the new endotracheal tube, while the new endotracheal tube remains in the patient.

[0016] Another aspect is an introducer for mounting an endotracheal tube, the introducer comprising: a shaft comprising: a proximal shaft portion; a distal shaft portion comprising a distal tip portion, and includes a tip having a round shape and a closed end; and a hinge connecting the proximal shaft portion and distal shaft portion; wherein the introducer has an open position wherein the proximal shaft portion and distal shaft portion are linear and a closed position wherein the proximal shaft portion and distal shaft portion are folded adjacent to each other at hinge.

DESCRIPTION OF THE DRAWINGS

[0017] FIG. l is a diagram of an example tracheal intubation system including a

laryngoscope being used to intubate a patient.

[0018] FIG. 2 is a perspective view of an example laryngoscope.

[0019] FIG. 3 is a perspective view of an example introducer.

[0020] FIG. 4 is a perspective view of an example endotracheal tube.

[0021] FIG. 5 is a flowchart of an example process of placing an endotracheal tube in a patient using an example tracheal intubation system including a laryngoscope.

[0022] FIG. 6 is a flowchart of an example process of placing an endotracheal tube in a patient using an example tracheal intubation system including a laryngoscope.

[0023] FIG. 7 is a cross-sectional view of a patient after a laryngoscope is positioned to view the glottis during an intubation procedure using an example tracheal intubation system including a laryngoscope.

[0024] FIG. 8 is a cross-sectional view of a patient after the tip of the introducer is advanced into the field of view of a laryngoscope during an intubation procedure using an example tracheal intubation system including a laryngoscope.

[0025] FIG. 9 is a cross-sectional view of a patient after the tip of an introducer is advanced into the trachea to a second depth-assessment band during an intubation procedure using an example tracheal intubation system including a laryngoscope. [0026] FIG. 10 is a cross-sectional view of a patient after an endotracheal tube is advanced over the introducer into the field of view of the laryngoscope during an intubation procedure using an example tracheal intubation system including a laryngoscope.

[0027] FIG. 11 is a cross-sectional view of a patient after an endotracheal tube is advanced over the introducer into a final position in the trachea during an intubation procedure using an example tracheal intubation system including a laryngoscope.

[0028] FIG. 12 is a perspective view of an example introducer.

[0029] FIG. 13 is a cross-section view of the example introducer of FIG. 12.

[0030] FIG. 14 is a cross-section view of the example introducer of FIG. 13 along line A— A.

[0031] FIG. 15 is a perspective view of an example malleable introducer.

[0032] FIG. 16 is a perspective view of an example endotracheal tube disposed on an introducer.

[0033] FIG. 17 is a perspective view of an example embodiment of an introducer with a bulge.

[0034] FIG. 18 is a perspective view of an example introducer with a bulge.

[0035] FIG. 19 is a cross-section view of the example introducer of FIG. 18.

[0036] FIG. 20A is a cross-section view of the example introducer of FIG. 19 along line B—

B.

[0037] FIG. 20B is a cross-section view of the example introducer of FIG. 19 along line C—

C.

[0038] FIG. 21 is a perspective view of an example embodiment of an introducer with a bulge.

[0039] FIG. 22 is a cross-section view of the example introducer of FIG. 21.

[0040] FIG. 23 A is a cross-section view of the example introducer of FIG. 20 along line D—

D.

[0041] FIG. 23B is a cross-section view of the example introducer of FIG. 20 along line E—

E.

[0042] FIG. 24 is a cross-sectional view of an introducer with a taper.

[0043] FIG. 25 is a cross-sectional view of an introducer with a dilator and an endotracheal tube.

[0044] FIG. 26 is a perspective view of an introducer with a dilator and an endotracheal tube.

[0045] FIG. 27 is cross-sectional view of an introducer with a dilator and an endotracheal tube.

[0046] FIG. 28 is a cross-section view of the example introducer of FIG. 27 along line F— F.

[0047] FIG. 29 is a perspective view of an introducer with a bulge and an endotracheal tube.

[0048] FIG. 30 is a cross-sectional view of an introducer of FIG. 29.

[0049] FIG. 31 is a cross-section view of the example introducer of FIG. 30 along line G— G.

[0050] FIG. 32 is a perspective view of a foldable introducer.

[0051] FIGS. 33A and 33B are a perspective view of another example of a foldable introducer.

[0052] FIG. 34 is a perspective view of an introducer with a first and second balloon.

DETAILED DESCRIPTION

[0053] Various embodiments will be described in detail with reference to the drawings, wherein like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the claims attached hereto. Additionally, any examples set forth in this specification are not intended to be limiting and merely set forth some of the many possible embodiments for the appended claims.

[0054] The present disclosure relates generally to an introducer that is usable with a tracheal intubation system. An introducer is a slender probe that is used to guide placement of an endotracheal tube. Introducer are also sometimes referred to a stylet or catheter. This disclosure also relates to methods of performing tracheal intubation and endotracheal tube exchange procedures.

[0055] Introducers are used to help guide an endotracheal tube into place in a patient. It can be difficult to place an endotracheal tube in patients who have abnormal airways, are overweight, have undergone trauma, have arthritis, have had cervical fusions, or are combative. An introducer helps place an endotracheal tube in a patient when placing the endotracheal tube independently it otherwise not possible.

[0056] In some cases, the endotracheal tube of an intubated patient needs to be exchanged for a new endotracheal tube. One method for this exchange process involves placing an introducer through the existing endotracheal tube until the tip of the introducer enters the trachea. The existing endotracheal tube is then removed over the introducer, while the introducer is left in place. A new endotracheal tube is then placed over the introducer. The new endotracheal tube is then advanced over the introducer until the tip of the new endotracheal tube is properly placed in the trachea. The introducer is then removed from the patient. The new endotracheal tube is then connected to an external ventilator or breathing circuit. The ventilator is then able to breath for the patient, delivering oxygen into the patient’s lungs.

[0057] Many potential complications may arise during endotracheal tube exchange procedures. For example, the tip of the introducer can cause tracheal and lung trauma, which can cause harm or death to the patient. In another example, patients with endotracheal tubes may require a chest x-ray to determine the tip depth of the endotracheal tube. This process may be time consuming, costly and may require patient movement in order to obtain the chest x-ray. Patient movement during performance of a chest x-ray is a leading cause of accidental extubation. It may be therefore advantageous to design equipment to confirm the depth of endotracheal tubes, introducers or other devices in the patent’s trachea that does not require chest x-rays. Poor depth control of the tip of the introducer in the trachea during the endotracheal tube exchange procedure is a contributing factor in this trauma to the trachea or lungs. An additional potential complication is the accidental removal of the tip of the introducer from the trachea during the endotracheal tube exchange procedure. This can lead to the new endotracheal tube not entering the trachea, resulting in a failed endotracheal intubation and harm or death to the patient.

[0058] FIG. 1 is a diagram of an example tracheal intubation system 100 including a laryngoscope being used to intubate a patient P. The example intubation system 100 includes a laryngoscope 102, an introducer 104, and an endotracheal tube 106. Also illustrated are the mouth M and the nose N of the patient P. In this example, the laryngoscope 102 is inserted into the mouth M of the patient P, the introducer 104 is inserted into the nose N of the patient P, and the endotracheal tube 106 is mounted on the introducer 104. Alternatively, the introducer 104 is inserted into the mouth M of the patient P.

[0059] The patient P is a person or animal who is being intubated. Although the intubation system 100 is particularly useful to intubate a patient with a difficult airway, the intubation system 100 may also be used on a patient with a normal airway. Examples of patient P include adults, children, infants, elderly people, obese people, people with tumors affecting the head or neck, and people with unstable cervical spines. In some embodiments, the intubation system 100 may be used to intubate animals with normal or difficult airways. The intubation system 100 may be used to intubate other people or animals as well.

[0060] The laryngoscope 102 is a medical instrument configured to permit a medical professional to directly or indirectly view, among other things, the glottis of the patient P. In some embodiments, the laryngoscope 102 includes a blade with an integrated optical capture device and light source. In some embodiments, the blade is configured to be inserted through the mouth M of the patient P and positioned so that the glottis is in the field of view of the optical capture device. The image captured by the laryngoscope 102 is viewed from a position that is external to the patient P. In some embodiments, the image captured by the laryngoscope 102 is viewed on an external display device, such as a screen. The laryngoscope 102 is illustrated and described in more detail with reference to FIG. 2.

[0061] The introducer 104 is a device that is inserted into the patent P’s airway. In this example, the introducer 104 is used to guide the placement of the endotracheal tube 106. The introducer 104 includes a thin, flexible tube that may be directed and advanced into the airway of the patient P. The introducer 104 may be configured to be viewed with the laryngoscope 102 during the intubation procedure. The introducer 104 is illustrated and described in more detail throughout the application, including with reference to FIGS. 12-33.

[0062] In some embodiments, the endotracheal tube 106 is a hollow tube that is configured to be placed in the airway of the patient P. When the patient P is intubated, one end of the endotracheal tube 106 is disposed inside the trachea of the patient P and the other end is connected to an external ventilator or breathing circuit. The endotracheal tube 106 is configured to occlude the airway of the patient P. Thus, gases (e.g., room air, oxygenated gases, anesthetic gases, expired breath, etc.) may flow into and out of the trachea of the patient P through the endotracheal tube 106. In some embodiments, the endotracheal tube 106 may be connected to a breathing circuit, including for example a machine-powered ventilator or a hand-operated ventilator. In other embodiments, the patient P may breathe through the endotracheal tube 106 spontaneously. The endotracheal tube 106 is illustrated and described in more detail with reference to FIG. 4.

[0063] The endotracheal tube 106 is configured to be mounted on the introducer 104 by sliding over the tip and along the shaft of the introducer 104. After a medical professional has positioned the tip of the introducer 104 in the trachea of the patient P, the endotracheal tube 106 is advanced over the shaft of the introducer 104 and into the trachea of the patient P. In this manner, the introducer 104 guides the endotracheal tube 106 into the proper location in the trachea of the patient P. The process of positioning the endotracheal tube 106 is illustrated and described in more detail with reference to FIGS. 5-11.

[0064] FIG. 2 is a perspective view of an example of the laryngoscope 102. In some embodiments, the laryngoscope 102 includes a blade 110, handle 112, and display device 114.

[0065] In some embodiments, the blade 110 is curved and has a first end 116 and a second end 118. The first end 116 is coupled to the handle 112. The second end 118 is configured to be inserted through the mouth of the patient and into the pharynx of the patient as illustrated and described with reference to FIG. 7. In some embodiments, the blade 110 is straight. In some embodiments, the cross section of the blade 110 is trough-like, while in other embodiments the cross section of the blade 110 is tubular. Yet other embodiments of the blade 110 are possible.

[0066] In some embodiments, the blade 110 includes an optical capture device 120 and light source 122. In some embodiments, the optical capture device 120 and the light source 122 are disposed near the second end 118 of the blade 110. Accordingly, when the blade 110 is inserted into the pharynx of the patient, the light source 122 illuminates the glottis of the patient and the optical capture device 120 captures an optical representation of the glottis of the patient, such as an image, a video, or light waves. In some embodiments, the blade 110 includes multiple optical capture devices 120 and light sources 122.

[0067] The optical capture device 120 is a device for capturing images. In some

embodiments, the optical capture device 120 is a camera or image capture sensor, such as a charge-coupled device or complementary metal-oxide-semiconductor. In some embodiments, the optical capture device 120 is a digital video camera. In other embodiments, the optical capture device 120 is an optical fiber. In yet other embodiments, the optical capture device 120 is a mirror. Yet other embodiments of the optical capture device 120 are possible as well.

[0068] The light source 122 is a device that is configured to transmit or direct light towards the glottis. In some embodiments, the light source 122 is configured to generate light. In other embodiments, the light source 122 is configured to reflect light. Examples of the light source 122 include light emitting diodes, incandescent bulbs, optical fibers, and mirrors. Other embodiments include other light sources. [0069] The handle 112 is coupled to the first end 116 of the blade 110 and is configured to be held in a hand of a user. The user may be an autonomous robot, a semi-autonomous robot, a robot remotely controlled by a medical professional, or a medical professional. Throughout the specification, any user is referred to as a medical profession, which is not intended to be limiting. The handle 112 operates to receive inputs from a medical professional and to adjust the position and orientation of the blade 110, and accordingly to aim the optical capture device 120 contained at the second end 118 thereof.

[0070] In some embodiments, the handle 112 has a cylindrical shape. In some embodiments, the cross section of the handle 112 is rectangular. In other embodiments, the cross section of the handle 112 is rectangular with rounded comers. In some embodiments, the handle 112 includes one or more molded finger grips. Other embodiments have other configurations of handle 112.

[0071] The display device 114 is configured to display, among other things, videos, images, or light waves that are captured by the optical capture device 120. In some embodiments, the display device 114 includes a screen 126. In some embodiments, the display device 114 is coupled to the handle 112 with a cable 124. In other embodiments, the display device 114 is formed integrally with the handle 112. In some embodiments, the display device 114 is a mirror. In some embodiments, a single mirror operates as both the display device 114 and the optical capture device 120. Yet other embodiments of display device 114 are possible.

[0072] In some embodiments, a cable 124 is disposed inside part or all of the handle 112, the blade 110, or both. In some embodiments, the cable 124 is configured to carry power to the optical capture device 120 and light source 122 and to carry electrical signals representing the video or images generated by the optical capture device 120 to the display device 114. In other embodiments, cable 124 is a fiber cable and operates to optically transmit light waves captured by the optical capture device 120 to the display device 114. Other embodiments do not include cable 124. For example, in some embodiments, video or images captured by the optical capture device 120 are transmitted wirelessly to the display device 114. In yet other embodiments, images captured by the optical capture device 120 are transmitted with one or more mirrors.

[0073] In some embodiments, the screen 126 is a liquid crystal display. In other

embodiments, the screen 126 is a light-emitting diode display or cathode ray tube. In some embodiments, screen 126 is the surface of a mirror. Still other embodiments of the screen 126 are possible as well. The screen 126 operates to receive a signal representing an image and display that image.

[0074] Examples of the laryngoscope 102 include the GLIDESCOPE® video laryngoscope, manufactured by Verathon Inc. of Bothell, WA, the VIVIDTRAC VT-A100® video intubation device, manufactured by Vivid Medical Inc. of Palo Alto, CA, and the C-MAC® video laryngoscope, manufactured by Karl Storz GmbH & Co. KG of Tuttlingen, Germany. Other examples of laryngoscope 102 include other video laryngoscopes, fiberoptic bronchoscopes, fiberoptic stylets, mirror laryngoscopes, and prism laryngoscopes. There are many other examples of the laryngoscope 102 as well.

[0075] FIG. 3 is a perspective view of an example introducer 104 configured to guide an endotracheal tube into the trachea of a patient. The introducer 104 includes a handle (not shown), shaft 134, and tip 138. The shaft 134 includes an exterior surface 136 and a tip 138. The shaft 134 is configured to be inserted into the nose or mouth of a patient and directed through the glottis of the patient and into the trachea of the patient.

[0076] At an end opposite the tip 138, the shaft 134 may be coupled to the handle (not shown). In some embodiments, the shaft 134 is between two to three feet in length and has a diameter of 3/16 of an inch. In other embodiments, especially those directed towards pediatric patients, the shaft 134 has a smaller diameter. Other embodiments, with smaller or greater lengths or smaller or greater diameters are possible as well.

[0077] In some embodiments, the shaft 134 has a tubular shape and is formed from a flexible material that is configured to adapt to the shape of the airway of the patient. In some embodiments, the cross-section of the shaft 134 has an oblong shape. Other embodiments of shaft 134 with other shapes are possible.

[0078] In some embodiments, the exterior surface 136 comprises a single, continuous, uniform material. In some embodiments, the exterior surface 136 has non-stick properties. For example, in some embodiments the exterior surface 136 is formed from polytetrafluoroethylene. In other embodiments, the exterior surface 136 is configured to receive a lubricant. Other embodiments of the exterior surface 136 are possible as well. Because the exterior surface 136 is formed from a continuous material, the exterior surface 136 does not have any seams.

Accordingly, the exterior surface 136 can be quickly and inexpensively cleaned. For example, the exterior surface 136 may be sterilized without the use of expensive and time-consuming sterilization equipment (e.g., an autoclave). [0079] In some embodiments, the tip 138 is configured to minimize trauma as it moves through the nose or mouth into the upper airway and advances into the trachea of the patient. In some embodiments, the tip 138 is contained within the exterior surface 136. In some

embodiments, the tip 138 has a blunt rounded shape. In some embodiments, the tip 138 does not have edges, corners, or crevices that may potentially injure the patient. Still other embodiments of the tip 138 are possible.

[0080] In some embodiments the shaft 134 and tip 138 do not contain, and are free of, a camera, light source, or other mechanism to illuminate or capture images of the patient.

Accordingly, in some embodiments the design of the exterior surface 136 of the shaft 134 and tip 138 is designed to reduce trauma and simplify sterilization. The design of the exterior surface 136 of the shaft 134 and tip 138 is not constrained by the requirements of a camera, light source, or optical fibers, such as lenses, heating elements for defogging, and lumens for directing water or suctioning to clear the field of view.

[0081] The orientation mark 140 is an indicator that is on or visible through the exterior surface 136 and is configured to be visible when the introducer 104 is viewed with the laryngoscope 102. The orientation mark 140 is configured to convey qualitative information about the radial orientation of the introducer 104. In some embodiments, quantitative information may be conveyed as well. In some embodiments, the orientation mark 140 is a straight line that starts at or near the end of tip 138 and continues longitudinally along the length of shaft 134. In some embodiments, the orientation mark 140 is present throughout the entire length of the shaft 134. In other embodiments, the orientation mark 140 is only present along a portion of the shaft 134. In some embodiments, the orientation mark 140 is radially aligned with the direction Dl, in which the tip 138 is configured to move. In this manner, a medical professional is able to view the orientation mark 140 on the display device of the laryngoscope 102 to determine the direction the tip 138 will move if it is pivoted. Thus, a medical professional is able to quickly direct the introducer 104 into the trachea of the patient without erroneously pivoting the tip 138, which may result in delay or trauma to the patient. In other embodiments, the orientation mark 140 is absent.

[0082] In some embodiments, the orientation mark 140 is a dashed line or a series of dots. In some embodiments, the orientation mark 140 is not radially aligned with the direction Dl but still conveys the orientation information necessary for a medical professional to direct the introducer 104. In some embodiments, multiple orientation marks are included. Yet other embodiments are possible as well.

[0083] In some embodiments, the introducer 104 includes one or more depth-assessment bands 142. In the embodiment shown in FIG. 3, the introducer 104 includes a first depth- assessment band l42a, second depth-assessment band l42b, and a third depth-assessment band l42c. The depth-assessment bands 142 are visual indicators that are on or visible through the exterior surface 136 and are configured to be visible when the introducer 104 is viewed with the laryngoscope 102. The depth-assessment bands 142 are configured to convey qualitative information about the placement of the introducer 104 relative to the anatomical landmarks of the patient, such as the vocal cords, that are also visible through the laryngoscope 102. In some embodiments, quantitative information may be conveyed as well. The depth-assessment bands 142 are also configured to convey both qualitative and/or quantitative information about the longitudinal distance to the end of the tip 138.

[0084] Adjacent depth-assessment bands 142 are visually distinct from each other so that a medical professional who views a part of one of the depth-assessment bands 142 from the laryngoscope is able to identify specifically which of the depth-assessment bands 142 is in the field of view. Because the depth-assessment bands 142 are continuous regions, it is not necessary for a medical professional to advance or retract the introducer 104 to bring one of the depth- assessment bands 142 into the field of view of the laryngoscope 102, which would create a risk of trauma to the patient or inadvertent removal of the introducer 104 from the trachea of the patient. Nor does a medical professional need to remember or count the depth-assessment bands 142 as they pass through the field of view. In this manner, the depth-assessment bands 142 minimize trauma to the patient and allow a medical professional to focus on using the introducer 104 rather than counting depth-assessment bands 142. Further, using the depth-assessment bands 142 in this manner may reduce the time necessary to complete a tracheal intubation procedure.

[0085] In some embodiments, the depth-assessment bands 142 are continuous regions of color that extend along a portion of the length of the shaft 134. For example, the first depth- assessment band l42a is a first color, the second depth-assessment band l42b is a second color, and the third depth-assessment band l42c is a third color. In other embodiments, the depth- assessment bands 142 are continuous regions of visually distinct patterns rather than colors. In some embodiments, the depth-assessment bands 142 include both visually distinct patterns and colors. Yet other embodiments are possible as well.

[0086] In some embodiments, the lengths of the depth-assessment bands 142 are selected based on the clinical precision required for the intubation procedure in which the introducer 104 is intended and the distance into the trachea of the patient, a medical professional wishes to insert the tip 138. For example, a medical professional may wish to insert the tip 138 two to four centimeters into the trachea of an adult patient. In some embodiments for adult patients, the length of each of the depth-assessment bands 142 is two centimeters. In this manner, the medical professional will know that the tip 138 is properly inserted into the trachea of the patient when any part of the second depth-assessment band l42b is aligned with the entrance of the trachea of an adult patient (i.e., the patient’s vocal cords). In another example, the medical professional may not know or be able to recall the safe distance of insertion into the trachea for an adult patient in numeric or quantitative form. In some embodiments, this safe depth is embedded in the design of the visually distinct colors or patterns of the depth-assessment band. This allows the medical professional to achieve safe depth of placement using a qualitative methodology by aligning a one or more distinctly visible depth assessment bands up with an anatomic marker (i.e., the patient’s vocal cords).

[0087] Similarly, in some embodiments for pediatric patients, the lengths of the depth- assessment bands 142 are adapted to the shorter tracheas of those pediatric patients. For example, a medical professional may wish to insert the tip 138 one to two centimeters into the trachea of the pediatric patient. In some embodiments for pediatric patients, the length of each depth- assessment band 142 is one centimeter. In this manner, the medical professional will know that the tip 138 is properly inserted into the trachea of the patient when any part of the second depth- assessment band l42b is aligned with the entrance of the trachea of a pediatric patient (i.e., the patient’s vocal cords). In another example, the medical professional may not know or be able to recall the safe distance of insertion into the trachea for a pediatric patient in numeric or quantitative form. In some embodiments, this safe depth is embedded in the design of the visually distinct colors or patterns of the depth-assessment band. This allows the medical professional to achieve safe depth of placement using a qualitative methodology by aligning a one or more distinctly visible depth assessment bands up with an anatomic marker (i.e., the patient’s vocal cords).

[0088] In some embodiments, the colors of the depth-assessment bands 142 convey information about whether the tip 138 is properly positioned. In some example embodiments, the first depth-assessment band l42a is yellow, the second depth-assessment band l42b is green, and the third depth-assessment band l42c is red. The yellow color of the first depth-assessment band l42a may convey to a medical professional to use caution in advancing the tip 138 because it is not yet properly positioned. The green color of the second depth-assessment band l42b may convey success to a medical professional because the tip 138 appears to be properly positioned. The red color of the third depth-assessment band l42c may convey warning to a medical professional because the tip 138 may be positioned too deeply in the trachea of the patient, potentially causing trauma.

[0089] Although the embodiment shown in FIG. 3 includes three depth-assessment bands 142, other embodiments that include fewer or more depth-assessment bands 142 are possible as well. In some embodiments, the depth-assessment bands 142 are uniform in length. In other embodiments, one or more of the depth-assessment bands 142 has a different length than the other depth-assessment bands 142. For example, in applications requiring great precision, one of the depth-assessment bands 142 is shorter in length than the other depth-assessment bands 142. Accordingly, when that one of the depth-assessment bands 142 is aligned with the entrance to the trachea of a patient (i.e., the vocal cords), a medical professional is able to determine the depth of the tip 138 with greater precision.

[0090] Although the embodiment of the depth-assessment bands 142 shown in FIG. 3 relates to an introducer 104, the depth-assessment bands 142 can also be used with other introducers, stylets, exchange catheters, and/or endotracheal tubes. For example, in some embodiments, the depth-assessment bands 142 are used with an introducer that is not malleable. In these embodiments, the introducer is similar to the introducer 104 described herein, except that the tip articulates and components that control the tip are included. In these embodiments, the introducer still includes the depth-assessment bands 142, which can be viewed with the laryngoscope 102 to determine the position of the non-articulating tip of the introducer relative to various anatomical landmarks. While it may be advantageous to move the tip in various directions about a single point on the shaft of the device, this single point of tip/shaft articulation does not always allow easy tube delivery as multiple angles varying in degree and orientation may be needed at various points along the shaft and tip to allow easy navigation into an airway with a tortuous pathway through the upper airway, to the entrance of the trachea. It may be also advantageous to be able to dynamically change the shape of the shaft and tip at multiple points along the shaft and tip allowing navigation of the airway into the trachea, allowing it to wind its way through a tortuous pathway.

[0091] Although the embodiments described herein relate to placement of an endotracheal tube, the depth-assessment bands, which convey quantitative and/or qualitative depth

information, are not limited to use in airway devices. In some embodiments, the depth- assessment bands 142 are included on other medical devices to guide the proper placement of those medical devices as well. For example, in some embodiments, the depth-assessment bands 142 are included in central venous catheters, endoscopic devices, devices placed in the gastrointestinal tract, devices placed inside the cardiovascular system, devices placed inside the urinary system, devices placed inside of the ears, devices placed inside of the eyes, devices placed in the central nervous system, devices placed inside of the abdomen, devices placed inside the chest, or devices placed inside the musculoskeletal system. In these embodiments, the depth- assessment bands 142 are configured to be compared to various tissue structures. In these embodiments, the depth-assessment bands 142 are configured to convey quantitative and/or qualitative information about the placement of the device relative to various anatomical landmarks compared to other organ systems inside the body or even outside of the body.

Additionally, in some embodiments, the depth-assessment bands 142 are included on non medical devices in which depth control is desired. For example, the depth-assessment bands 142 can be included in industrial devices, such as devices for the inspection of machinery or physical structures, and devices for the proper placement of fasteners or other industrial or physical parts.

[0092] FIG. 4 is a perspective view of an example endotracheal tube 106. The endotracheal tube 106 includes a pipe 170, a cuff 172, and an inflation lumen 174. In some embodiments, the endotracheal tube 106 does not include the cuff 172 or the inflation lumen 174.

[0093] In some embodiments, the pipe 170 is hollow and includes a first end 178, a second end 180, and an exterior surface 182. In some embodiments, the pipe 170 is formed from a flexible material and operates to adapt to the anatomy of the patient. For example, in some embodiments, the pipe 170 is formed from polyvinyl chloride. In other embodiments, the pipe 170 is formed from silicone rubber or latex rubber. In some embodiments, the pipe 170 is formed from a rigid or semi-rigid material, such as stainless steel.

[0094] The pipe 170 operates as a passage for gases to enter and exit the trachea of the patient. The pipe 170 also operates to protect the lungs of the patient from stomach contents. Further, in some embodiments, the pipe 170 operates as a passage to suction the trachea and lungs of the patient. The first end 178 is configured to be advanced into the trachea of the patient. The second end 180 is configured to be connected to a ventilator or breathing circuit.

[0095] In some embodiments, the cuff 172 is disposed on the exterior surface 182 of the pipe 170 near the first end 178. The cuff 172 is configured to form a seal between the exterior surface 182 of the pipe 170 and the trachea of the patient. In this manner, the cuff 172 prevents gases and liquids from entering or exiting the trachea of the patient without passing through the pipe 170. In addition, the cuff 172 secures the position of the endotracheal tube 106 in the trachea of the patient. In some embodiments, the cuff 172 is an inflatable chamber. For example, in some embodiments, the cuff 172 is a balloon. Yet other embodiments of the cuff 172 are possible as well.

[0096] The inflation lumen 174 includes an inflation port 176. The inflation lumen 174 is connected to the cuff 172 and operates as a channel for the entry of fluid into the cuff 172. The inflation port 176 is configured to receive a fluid. In some embodiments, the inflation port 176 is configured to receive a syringe that operates to expel fluid through the inflation lumen 174 and into the cuff 172. In this manner, the cuff 172 can be inflated to seal the trachea of the patient.

[0097] In some embodiments, the endotracheal tube 106 is formed from a transparent or translucent material that allows the introducer 104 to be seen there through. In some

embodiments, the endotracheal tube 106 includes one or more depth-assessment bands l84a-c (collectively depth-assessment bands 184). In the embodiment shown in FIG. 6, the example endotracheal tube 106 includes a first depth-assessment band l84a, second depth-assessment band l84b, and a third depth-assessment band l84c. The depth-assessment bands 184 are indicators that are on or visible through the exterior surface 182 and are configured to be visible when the introducer 104 is viewed with the laryngoscope 102. The depth-assessment bands 184 are configured to convey information about the placement of the endotracheal tube 106 relative to the anatomical landmarks of the patient, such as the vocal cords, that are also visible through the laryngoscope 102. The depth-assessment bands 184 are also configured to convey

information about the longitudinal distance to the end of the first end 178.

[0098] Adjacent depth-assessment bands 184 are visually distinct from each other so that a medical professional who views a part of one of the depth-assessment bands 184 from the laryngoscope 102 is able to identify which specific one of the depth-assessment bands 184 is in the field of view. Because the depth-assessment bands 184 are continuous regions, it is not necessary for a medical professional to advance or retract the endotracheal tube 106 to bring the depth-assessment bands 184 into the field of view of the laryngoscope 102, which would create a risk of trauma to the patient or inadvertent removal of the endotracheal tube 106 from the trachea of the patient. Nor does a medical professional need to remember or count the depth-assessment bands 184 as they pass through the field of view. In this manner, the depth-assessment bands 184, minimize trauma to the patient and allow a medical professional to focus on advancing the endotracheal tube 106 rather than counting depth-assessment bands 184. Further, using the depth-assessment bands 184, in this manner may reduce the time necessary to complete a tracheal intubation procedure.

[0099] In some embodiments, the depth-assessment bands 184 are continuous regions of color that extend along a portion of the length of the pipe 170. For example, the first depth- assessment band l84a is a first color, the second depth-assessment band l84b is a second color, and the third depth-assessment band l84c is a third color. In other embodiments, the depth- assessment bands 184 are continuous regions of visually distinct patterns rather than colors. In some embodiments, the depth-assessment bands 184 include both visually distinct patterns and colors. In addition, in some embodiments, one or more of the depth-assessment bands 184 may include part or all of cuff 172. Yet other embodiments of the depth-assessment bands 184 are possible as well.

[0100] In some embodiments, the lengths of the depth-assessment bands 184 are selected based on the clinical precision required for the intubation procedure in which the endotracheal tube 106 is intended and the distance into the trachea of the patient, a medical professional wishes to insert the first end 178. For example, a medical professional may wish to insert the first end 178 two to four centimeters into the trachea of an adult patient. In some embodiments for adult patients, the length of each of the depth-assessment bands 184 is two centimeters. In this manner, the medical professional will know that the first end 178 is properly inserted into the trachea of the patient when any part of the second depth-assessment band l84b is aligned with the entrance of the trachea of an adult patient (i.e., the patient’s vocal cords). In another example, the medical professional may not know or be able to recall the safe distance of insertion into the trachea for an adult patient in numeric or quantitative form. In some embodiments, this safe depth is embedded in the design of the visually distinct colors or patterns of the depth- assessment band. This allows the medical professional to achieve safe depth of placement using a qualitative methodology by aligning a one or more distinctly visible depth assessment bands up with an anatomic marker (i.e., the patients vocal cords)

[0101] Similarly, in some embodiments for pediatric patients, the lengths of the depth- assessment bands 184 are adapted to the shorter tracheas of those pediatric patients. For example, a medical professional may wish to insert the first end 178 one to two centimeters into the trachea of the pediatric patient. In some embodiments for pediatric patients, the length of each of the depth-assessment bands 184 is one centimeter. In this manner, the medical professional will know that the first end 178 is properly inserted into the trachea of the patient when any part of the second depth-assessment band l84b is aligned with the entrance of the trachea of a pediatric patient (i.e., the patient’s vocal cords). In another example, the medical professional may not know or be able to recall the safe distance of insertion into the trachea for a pediatric patient in numeric or quantitative form. In some embodiments, this safe depth is embedded in the design of the visually distinct colors or patterns of the depth-assessment band. This allows the medical professional to achieve safe depth of placement using a qualitative methodology by aligning a one or more distinctly visible depth assessment bands up with an anatomic marker (i.e., the patient’s vocal cords).

[0102] In some embodiments, the colors of the depth-assessment bands 184 convey information about whether the first end 178 is properly positioned. In some example

embodiments, the first depth-assessment band l84a is yellow, the second depth-assessment band l84b is green, and the third depth-assessment band l84c is red. The yellow color of the first depth-assessment band l84a may convey to a medical professional to use caution in advancing the first end 178 because it is not yet properly positioned. The green color of the second depth- assessment band l84b may convey success to a medical professional because the first end 178 appears to be properly positioned. The red color of the third depth-assessment band l84c may convey warning to a medical professional because the first end 178 may be positioned too deeply in the trachea of the patient, potentially causing trauma.

[0103] Although the embodiment shown in FIG. 6 includes three depth-assessment bands 184, other embodiments that include fewer or more depth-assessment bands 184 are possible as well. In some embodiments, the depth-assessment bands 184 are uniform in length. In other embodiments, one or more of the depth-assessment bands 184 has a different length than the other depth-assessment bands 184. For example, in applications requiring great precision, one of the depth-assessment bands 184 is shorter in length than the other depth-assessment bands 184. Accordingly, when that one of the depth-assessment bands 184 is aligned with the entrance to the trachea of a patient (i.e., the vocal cords), a medical professional is able to determine the depth of the first end 178 with greater precision.

[0104] FIG. 5 is a flowchart of an example method 500 of generally positioning an endotracheal tube in a patient using an example tracheal intubation system including a laryngoscope and an introducer.

[0105] Initially, at step 502, the laryngoscope is positioned to view the glottis of the patient. In some embodiments, the laryngoscope is inserted through the mouth of the patient. In other embodiments, the laryngoscope is inserted through the nose of the patient. An medical professional, usually a physician or a person assisting a physician, grips the handle of the laryngoscope and maneuvers the handle to position the blade so that the optical capture device of the laryngoscope has a clear view of the glottis of the patient. In some embodiments, the medical professional verifies that the laryngoscope is properly positioned by checking the screen of the display device of the laryngoscope.

[0106] At operation 504, the introducer is advanced into the pharynx of the patient until it is visible with the laryngoscope. The introducer is advanced until it is positioned in the trachea. In an example embodiment, the introducer is advanced individually into the patient. In an alternative embodiment, the endotracheal tube is mounted on the introducer before being advanced into the patient. The endotracheal tube is mounted by placing the second end of the endotracheal tube over the tip of the introducer and sliding the tube up the shaft of the introducer. This operation may be performed by the physician, someone assisting the physician, or someone preparing the equipment in advance. An example of an introducer with an endotracheal tube mounted is shown in FIG. 16. Alternatively, the endotracheal tube may be mounted after the introducer is placed in the trachea.

[0107] The tip of the introducer is positioned in the pharynx of the patient and is advanced until the tip is visible on the screen of the laryngoscope. In some embodiments, the tip of the introducer is inserted through the nose of the patient. In other embodiments, depending on the anatomy of the patient, the tip of the introducer is inserted through the mouth of the patient. [0108] The tip of the introducer may be angled towards the entrance to the trachea of the patient. That is, the tip is angled so that when the introducer is advanced, the tip will pass between the vocal cords of the patient and into the trachea of the patient. In some embodiments, a medical professional, usually a physician or person assisting a physician, angles the tip of the introducer before being advanced into the patient. The medical professional angles the tip of the introducer while viewing the tip on the screen of the laryngoscope. An example embodiment of the introducer with the tip angled towards the entrance of the trachea of the patient is shown in FIG. 8.

[0109] In some embodiments, the introducer includes one or more depth-assessment bands. The medical professional views the shaft of the introducer on the screen of the laryngoscope to determine which depth-assessment band is adjacent to the vocal cords of the patient. Depending on which depth-assessment band is adjacent to the vocal cords, the medical professional may continue to advance the introducer or stop advancing the introducer.

[0110] For example, in an embodiment in which the introducer includes three depth- assessment bands and the second depth-assessment band represents the target insertion depth, a medical professional will continue to advance the introducer until the second depth-assessment band is adjacent to the vocal cords of the patient. Accordingly, if the screen of the laryngoscope shows that the first depth-assessment band is adjacent to the vocal cords, the medical professional may continue to advance the introducer. Similarly, if the screen of the laryngoscope shows that the second depth-assessment band is adjacent to the vocal cords of the patient, the medical professional may determine that the tip of the introducer is properly positioned and, accordingly, will stop advancing the introducer. Finally, if the screen of the laryngoscope shows that the third depth-assessment band is adjacent to the vocal cords of the patient, the medical professional may determine that the tip of the introducer has been advanced too far and will stop advancing the introducer or, in some cases, will retract the introducer. An example embodiment of the introducer with three depth-assessment bands being advanced into the trachea of the patient is shown in FIGS. 8-11.

[0111] At operation 506, the endotracheal tube is advanced over the shaft of the introducer. In some embodiments, a medical professional, usually a physician or person assisting a physician grabs the endotracheal tube and slides it along the introducer until the first end of the

endotracheal tube enters the trachea of the patient. An example embodiment of the endotracheal tube being advanced over the shaft of the introducer is shown in FIGS. 10 and 11.

[0112] At operation 508, the cuff of the endotracheal tube is inflated. In some embodiments, a medical professional, usually a physician or person assisting a physician inserts a fluid into the inflation port of the endotracheal tube. This causes the inflation cuff to expand and secures the endotracheal tube in the trachea of the patient. In addition, the inflation cuff seals the trachea of the patient so that gases will not flow around the endotracheal tube. Further, the inflation cuff seals the trachea of the patient so that liquids, such as the contents of the stomach of the patient, will not enter the trachea and the lungs of the patient. An example embodiment of an

endotracheal tube with an inflated cuff is shown in FIG. 11. In embodiments where the endotracheal tube does not include a cuff, this operation 508 is not performed.

[0113] At operation 510, the introducer and laryngoscope are removed. The shaft of the introducer is pulled out of the endotracheal tube, leaving the endotracheal tube in place. In addition, the laryngoscope is also removed from the patient. The laryngoscope is removed by grabbing the handle and pulling the blade out of the pharynx of the patient.

[0114] At operation 512, the endotracheal tube is connected to a ventilator or breathing circuit to provide ventilation for the patient. In some embodiments, the endotracheal tube is connected to the ventilator or breathing circuit before the laryngoscope is removed.

[0115] FIG. 6 is a flowchart of an example method 600 for removing an existing first endotracheal tube and replacing it with a new second endotracheal tube using an example tracheal intubation system including a laryngoscope and introducer.

[0116] Initially, at step 602, the laryngoscope is positioned to view the glottis of the patient. When the laryngoscope is properly positioned, both the glottis and the existing first endotracheal tube will be visible in the field of view of the laryngoscope. An medical professional, usually a physician or a person assisting a physician, grips the handle of the laryngoscope and maneuvers the handle to position the blade so that the optical capture device of the laryngoscope has a clear view of the glottis of the patient. In some embodiments, the medical professional verifies that the laryngoscope is properly positioned by checking the screen of the display device of the laryngoscope.

[0117] At operation 604, the introducer is advanced into the pharynx of the patient through an existing endotracheal tube until it is visible with the laryngoscope. The introducer is advanced until it reaches or goes beyond the tip of the existing first endotracheal tube. This ensures that the tip of the articulating stylet is in the trachea.

[0118] In an embodiment, the shaft of the introducer includes markers that indicate the distance from the marker to the tip of the articulating stylet. By monitoring these markers on the shaft of the introducer, a medical professional can determine when the introducer is fully inserted through the endotracheal tube. In some embodiments, the endotracheal tube is transparent or translucent, and the medical professional monitors markers (e.g., the depth-assessment bands) on or near the tip of the introducer to determine the position of the tip of the introducer. In other embodiments, the medical professionals monitors a series of numbers on the shaft of the articulating stylet that correspond to the distance from the number to the tip of the introducer to determine the position of the tip of the introducer. These numbers on the shaft of the introducer can be compared to the proximal end of the endotracheal tube. Because the length of the endotracheal tube is known, the position of the tip of the introducer can be determined relative to it.

[0119] The tip of the introducer may be angled towards the entrance to the trachea of the patient. That is, the tip is angled so that when the introducer is advanced, the tip will pass between the vocal cords of the patient and into the trachea of the patient. In some embodiments, a medical professional, usually a physician or person assisting a physician, angles the tip of the introducer before being advanced into the patient. The medical professional angles the tip of the introducer while viewing the tip on the screen of the laryngoscope. An example embodiment of the introducer with the tip angled towards the entrance of the trachea of the patient is shown in FIG. 8.

[0120] In some embodiments, the introducer includes one or more depth-assessment bands. The medical professional views the shaft of the introducer on the screen of the laryngoscope to determine which depth-assessment band is adjacent to the vocal cords of the patient. Depending on which depth-assessment band is adjacent to the vocal cords, the medical professional may continue to advance the introducer or stop advancing the introducer.

[0121] At operation 606, the cuff of the existing endotracheal tube is deflated. While the cuff of the existing endotracheal tube is deflated, the introducer remains in place at a desired depth. In embodiments where the endotracheal tube does not include a cuff, this operation 606 is not performed.

[0122] At operation 608, the existing endotracheal tube is removed from the patient. The existing endotracheal tube slides along the introducer, while the introducer remains in place. In this manner, the existing first endotracheal tube is removed from the patient. A medical professional continues to advance the existing first endotracheal tube until it is completely pulled over the lever of the introducer and off the introducer. Throughout this operation, the medical professional monitors the depth-assessment bands on the tip of introducer using the laryngoscope to ensure that the introducer does not move into or out of the patient’s trachea. The position of the tip of the introducer can be determined by monitoring the depth-assessment bands on the tip of the introducer through a transparent or translucent endotracheal tube or by monitoring depth markers on the shaft of the introducer.

[0123] At operation 610, a new second endotracheal tube is loaded over the lever of the introducer and advanced over the shaft of the introducer. In some embodiments, a medical professional, usually a physician or person assisting a physician grabs the endotracheal tube and slides it along the introducer until the first end of the endotracheal tube enters the trachea of the patient. Throughout this operation, the medical professional also monitors the depth-assessment bands on the tip of introducer using the laryngoscope to ensure that the tip of the introducer does not move into or out of the patient’s trachea. The position of the tip of the introducer can be determined by monitoring the depth-assessment bands on the tip of the introducer through a transparent or translucent endotracheal tube or by monitoring depth markers or numbers on the shaft of the introducer.

[0124] At operation 612, the cuff of the endotracheal tube is inflated. In some embodiments, a medical professional, usually a physician or person assisting a physician inserts a fluid into the inflation port of the endotracheal tube. This causes the inflation cuff to expand and secures the endotracheal tube in the trachea of the patient. In addition, the inflation cuff seals the trachea of the patient so that gases will not flow around the endotracheal tube. Further, the inflation cuff seals the trachea of the patient so that liquids, such as the contents of the stomach of the patient, will not enter the trachea and the lungs of the patient. An example embodiment of an

endotracheal tube with an inflated cuff is shown in FIG. 11. In embodiments where the endotracheal tube does not include a cuff, this operation 612 is not performed.

[0125] At operation 614, the introducer and laryngoscope are removed. The shaft of the introducer is pulled out of the endotracheal tube, leaving the endotracheal tube in place. In addition, the laryngoscope is also removed from the patient. The laryngoscope is removed by grabbing the handle and pulling the blade out of the pharynx of the patient.

[0126] At operation 616, the endotracheal tube is connected to a ventilator or breathing circuit to provide ventilation for the patient. In some embodiments, the endotracheal tube is connected to the ventilator or breathing circuit before the laryngoscope is removed.

[0127] If the articulating stylet is removed from the trachea of the patient at any point during the endotracheal tube exchange process 600, the medical professional can notice this with the laryngoscope.

[0128] FIG. 7 is a cross-sectional view of a patient P during an intubation procedure using an example tracheal intubation system including a laryngoscope.

[0129] The mouth M and nose N of the patient P are shown. The blade 110 of the laryngoscope 102 is disposed in the pharynx of the patient P. The blade 110 is oriented so that the field of view 50 of the optical capture device on blade 110 includes the vocal cords V and trachea T of the patient P. Screen 126 shows the contents of the field of view 50 of the optical capture device in the laryngoscope 102.

[0130] The screen 126 displays an image of the trachea T. The entrance to the trachea T is defined by the vocal cords VI and V2 (collectively vocal cords V). The vocal cords V meet at the arytenoids A. The esophagus E is below the trachea T and parallel to the trachea T. It is important that the blade 110 of the laryngoscope 102 is oriented so that screen 126 shows a clear image of the entrance of the trachea T because the articulating stylet will be directed into the trachea T.

[0131] FIG. 8 is a cross-sectional view of a patient P during an intubation procedure using an example tracheal intubation system including a laryngoscope. The tip 138 of the introducer 104 is angled up. The screen 126 shows that the tip 138 is now directed towards the entrance of the trachea T.

[0132] FIG. 9 is a cross-sectional view of a patient P during an intubation procedure using an example tracheal intubation system including a laryngoscope. The tip 138 of the introducer 104 is advanced further into the trachea T of the patient P as compared to FIG. 8. The screen 126 shows that the second depth-assessment band l42b is now adjacent to the vocal cords V.

Accordingly, a medical professional may determine that the tip 138 is properly positioned and does not need to be advanced further into the trachea T.

[0133] FIG. 10 is a cross-sectional view of a patient P during an intubation procedure using an example tracheal intubation system including a laryngoscope. The tip 138 of the introducer 104 is properly positioned in the trachea T of the patient P. The endotracheal tube 106 has been advanced over the shaft 134 of the introducer 104. The endotracheal tube 106 is guided by the introducer 104 through the nose N of the patient P and into the pharynx of the patient P. The first end 178 and the first depth-assessment band l84a of endotracheal tube 106 are visible on the screen 126.

[0134] The tip 138 of the introducer 104 is properly positioned in the trachea T of the patient P when the second depth-assessment band l84b is adjacent to the vocal cords V. The

endotracheal tube 106 is guided into the trachea T of the patient P by the introducer 104. The screen 126 displays that the first end 178 of endotracheal tube 106 has not yet reached the vocal cords V. Both the first depth-assessment band l84a and the second depth-assessment band l84b are visible on screen 125. However, neither the first depth-assessment band l84a nor the second depth-assessment band l84b are adjacent to the vocal cords V yet. Accordingly, the medical professional may determine that the first end 178 of the endotracheal tube 106 needs to be advanced further to enter the trachea T of the patient P.

[0135] FIG. 11 is cross-sectional view of a patient P during an intubation procedure using an example tracheal intubation system including a laryngoscope. The endotracheal tube 106 has been advanced further along shaft 134 of the introducer 104 as compared to FIG. 10. The screen 126 displays that the endotracheal tube 106 has entered the trachea T. Additionally, screen 126 displays that the second depth-assessment band l84b is adjacent to the vocal cords V.

Accordingly, a caretaker may determine that the endotracheal tube 106 has been guided into the trachea T of the patient P and has been properly positioned therein. If instead the first depth- assessment band l84a were adjacent to the vocal cords V, a medical professional may determine that the endotracheal tube 106 needs to be advanced further into the trachea T of the patient P. Conversely, if instead the third depth-assessment band l84c were adjacent to the vocal cords V, the medical professional might determine that the endotracheal tube 106 was advanced too far into the trachea T of the patient P. Once the endotracheal tube 106 is properly positioned, the cuff 172 is inflated to seal the trachea T and secure the endotracheal tube 106 in position.

[0136] FIG. 12 is a perspective view of an example embodiment of an introducer 104 configured to guide an endotracheal tube into the trachea of a patient. The introducer 104 includes a shaft 134 having an exterior surface 136, and a tip 138. The shaft 134 is configured to be inserted into the nose or mouth of a patient and directed through the glottis of the patient and into the trachea of the patient.

[0137] At an end opposite the tip 138, the shaft 134 may be coupled to a handle (not shown). In some embodiments, the shaft 134 is between two to three feet in length and has a diameter of 3/16” of an inch. In other embodiments, especially those directed towards pediatric patients, the shaft 134 has a smaller diameter. Other embodiments, with smaller or greater lengths or smaller or greater diameters are possible as well.

[0138] In some embodiments, the shaft 134 has a tubular shape and is formed from a flexible material that is configured to adapt to the shape of the airway of the patient. In some

embodiments, the cross-section of the shaft 134 has an oblong shape. Other embodiments of shaft 134 with other shapes are possible.

[0139] In an embodiment, the exterior surface 136 comprises a single, continuous, uniform material. In some embodiments, the exterior surface 136 has non-stick properties. For example, in some embodiments the exterior surface 136 is formed from polytetrafluoroethylene. In other embodiments, the exterior surface 136 is configured to receive a lubricant. Other embodiments of the exterior surface 136 are possible as well. Because the exterior surface 136 is formed from a continuous material, the exterior surface 136 does not have any seams. Accordingly, the exterior surface 136 can be quickly and inexpensively cleaned. For example, the exterior surface 136 may be sterilized without the use of expensive and time-consuming sterilization equipment (e.g., an autoclave).

[0140] In some embodiments, the tip 138 is configured to minimize trauma as it moves through the nose or mouth into the upper airway and advances into the trachea of the patient. In some embodiments, the tip 138 is contained within the exterior surface 136. In some

[0141] In some embodiments the shaft 134 and tip 138 do not contain, and are free of, a camera, light source, or other mechanism to illuminate or capture images of the patient.

[0142] The introducer 104 includes a first depth-assessment band l42a, second depth- assessment band l42b, and a third depth-assessment band l42c. The depth-assessment bands 142 are visual indicators that are on or visible through the exterior surface 136 and are configured to be visible when the introducer 104 is viewed with the laryngoscope 102. The depth-assessment bands 142 are configured to convey information about the placement of the introducer 104 relative to the anatomical landmarks of the patient, such as the vocal cords, that are also visible through the laryngoscope 102. The depth-assessment bands 142 are also configured to convey qualitative and/or quantitative information about the longitudinal distance to the end of the tip 138.

[0143] Adjacent depth-assessment bands 142 are visually distinct from each other so that a medical professional who views a part of one of the depth-assessment bands 142 from the laryngoscope is able to identify specifically which of the depth-assessment bands 142 is in the field of view. Because the depth-assessment bands 142 are continuous regions, it is not necessary for a medical professional to advance or retract the introducer 104 to bring one of the depth- assessment bands 142 into the field of view of the laryngoscope 102, which would create a risk of trauma to the patient or inadvertent removal of the introducer 104 from the trachea of the patient. Nor does a medical professional need to remember or count the depth-assessment bands 142 as they pass through the field of view. In this manner, the depth-assessment bands 142 minimize trauma to the patient and allow a medical professional to focus on using the introducer 104 rather than counting depth-assessment bands 142. Further, using the depth-assessment bands 142 in this manner may reduce the time necessary to complete a tracheal intubation procedure.

[0144] In some embodiments, the depth-assessment bands 142 are continuous regions of color that extend along a portion of the length of the shaft 134. For example, the first depth- assessment band l42a is a first color, the second depth-assessment band l42b is a second color, and the third depth-assessment band l42c is a third color. In other embodiments, the depth- assessment bands 142 are continuous regions of visually distinct patterns rather than colors. In some embodiments, the depth-assessment bands 142 include both visually distinct patterns and colors. Yet other embodiments are possible as well.

[0145] In some embodiments, the lengths of the depth-assessment bands 142 are selected based on the clinical precision required for the intubation procedure in which the introducer 104 is intended and the distance into the trachea of the patient, a medical professional wishes to insert the tip 138. For example, a medical professional may wish to insert the tip 138 two to four centimeters into the trachea of an adult patient. In some embodiments for adult patients, the length of each of the depth-assessment bands 142 is two centimeters. In this manner, the medical professional will know that the tip 138 is properly inserted into the trachea of the patient when any part of the second depth-assessment band l42b is aligned with the entrance of the trachea of an adult patient (i.e., the patient’s vocal cords). In another example, the medical professional may not know or be able to recall the safe distance of insertion into the trachea for an adult patient in numeric or quantitative form. In some embodiments, this safe depth is embedded in the design of the visually distinct colors or patterns of the depth-assessment band. This allows the medical professional to achieve safe depth of placement using a qualitative methodology by aligning a one or more distinctly visible depth assessment bands up with an anatomic marker (i.e., the patient’s vocal cords).

[0146] Similarly, in some embodiments for pediatric patients, the lengths of the depth- assessment bands 142 are adapted to the shorter tracheas of those pediatric patients. For example, a medical professional may wish to insert the tip 138 one to two centimeters into the trachea of the pediatric patient. In some embodiments for pediatric patients, the length of each depth- assessment band 142 is one centimeter. In this manner, the medical professional will know that the tip 138 is properly inserted into the trachea of the patient when any part of the second depth- assessment band l42b is aligned with the entrance of the trachea of a pediatric patient (i.e., the patient’s vocal cords). In another example, the medical professional may not know or be able to recall the safe distance of insertion into the trachea for a pediatric patient in numeric or quantitative form. In some embodiments, this safe depth is embedded in the design of the visually distinct colors or patterns of the depth-assessment band. This allows the medical professional to achieve safe depth of placement using a qualitative methodology by aligning a one or more distinctly visible depth assessment bands up with an anatomic marker (i.e., the patient’s vocal cords).

[0147] In some embodiments, the colors of the depth-assessment bands 142 convey information about whether the tip 138 is properly positioned. In some example embodiments, the first depth-assessment band l42a is yellow, the second depth-assessment band l42b is green, and the third depth-assessment band l42c is red. The yellow color of the first depth-assessment band l42a may convey to a medical professional to use caution in advancing the tip 138 because it is not yet properly positioned. The green color of the second depth-assessment band l42b may convey success to a medical professional because the tip 138 appears to be properly positioned. The red color of the third depth-assessment band l42c may convey warning to a medical professional because the tip 138 may be positioned too deeply in the trachea of the patient, potentially causing trauma.

[0148] Although the embodiment shown in FIG. 12 includes three depth-assessment bands 142, other embodiments that include fewer or more depth-assessment bands 142 are possible as well. In some embodiments, the depth-assessment bands 142 are uniform in length. In other embodiments, one or more of the depth-assessment bands 142 has a different length than the other depth-assessment bands 142. For example, in applications requiring great precision, one of the depth-assessment bands 142 is shorter in length than the other depth-assessment bands 142. Accordingly, when that one of the depth-assessment bands 142 is aligned with the entrance to the trachea of a patient (i.e., the vocal cords), a medical professional is able to determine the depth of the tip 138 with greater precision.

[0149] FIG. 13 shows a longitudinal cross-sectional schematic view of an embodiment of the introducer of FIG. 12.

[0150] FIG. 14 shows a cross-sectional schematic view of an embodiment of the introducer of FIG. 13, along line A— A. The proximal shaft body portion 1402 includes a lumen 1404. The lumen 1404 may be formed as a generally round recess in an extruded plastic structure. In other embodiments, more than one lumen 1404 may be present in the shaft body portion 1402.

[0151] FIG. 15 is a perspective view of an example alternative embodiment of a malleable introducer 1500. The malleable introducer 1500 is configured to guide an endotracheal tube into the trachea of a patient. In some embodiments, the malleable introducer 1500 is configured to be used during an endotracheal tube exchange procedure in which an existing endotracheal tube is replaced with a new endotracheal tube. In some cases, the malleable introducer 1500 may form a segmented curve. In other cases, the malleable introducer 1500 may form a more continuous curve that does not include as many discontinuities or section breaks as shown in FIG. 15.

[0152] The malleable introducer 1500 includes a shaft 1502. The shaft 1502 includes an exterior surface 1504 and a tip 1506. In some embodiments, the shaft 1502, the exterior surface 1504, and the tip 1506 are similar to the shaft 134, the exterior surface 136, and the tip 138 respectively, which are all shown and described in greater detail with respect to FIG. 3.

[0153] In an embodiment, the shaft 1502 is malleable. The whole shaft 1502 may be malleable, part of the shaft 1502 may be malleable, or alternatively, only the tip 1506 may be malleable. In an example embodiment, the shaft 1502 is malleable only in one direction.

Alternatively, shaft 1502 is malleable in two opposing direction. Still further, shaft 1502 may be malleable 360 degrees. In embodiments, where only the tip 1506 is malleable, the tip 1506 is malleable in only one direction. Alternatively, tip 1506 is malleable in two opposing directions. Still further, tip 1506 is malleable in 360 degrees.

[0154] Introducer 1500 may be made from materials that are malleable, such as plastic or metal. In embodiments where only the tip 1506 is malleable, tip 1506 may be made from a material that is malleable, while shaft 1502 is made from a stiffer material. In other

embodiments, malleability comes from a stiffening wire that extends through a core of the shaft 1502 (e.g., an aluminum wire or other metallic core). A stiffening wire may be made from carbon fiber, metal, plastic, or from materials that are malleable.

[0155] A patient may be intubated with the aid of a malleable introducer 1500. First, the malleable introducer 1500 is shaped as desired by the medical professional. For example, the body of the malleable introducer may be kept straight, while the tip may be shaped to form a“J” shape or a hook shape, such as the shape of a hockey stick.

[0156] Next, a laryngoscope is placed into the mouth of the patient and advanced until a view of the glottis is obtained. The malleable introducer is placed into the patient’s mouth and is guided through the vocal cords. The malleable introducer is advanced until the green zone of the color depth zones lies adjacent to the glottis. Once the introducer is at the appropriate location, it is held in place.

[0157] An endotracheal tube is placed over the malleable introducer and is advanced down the shaft of the malleable introducer into the trachea. The green zone of the malleable introducer should remain adjacent to the glottis while the endotracheal tube is advanced. If the yellow zone of the malleable introducer is adjacent to the glottis, the medical professional advances the malleable introducer further into the patient’s trachea until the green zone is adjacent the glottis again. If the red zone of the malleable introducer is adjacent to the glottis, the medical professional retracts the malleable introducer from the patient’s trachea until the green zone is adjacent the glottis again.

[0158] Once the distal tip of the new endotracheal tube reaches the glottis, the medical professional can observe the tip of the endotracheal tube to pass smoothly through the glottis over the malleable introducer. Throughout advancing the endotracheal tube, the medical professional continually keeps the green zone of the malleable introducer at the glottis.

[0159] Once the distal tip of the endotracheal tube reaches the glottis, the medical professional can observe that the tip of the endotracheal tube passes smoothly through the glottis over the malleable introducer. Throughout advancing the endotracheal tube, the medical professional continually keeps the green zone of the malleable introducer at the glottis.

[0160] Once the distal tip of the endotracheal tube is properly placed in the trachea, the malleable introducer is removed from the new endotracheal tube, while the endotracheal tube remains properly positioned in the trachea. The endotracheal tube can then be inflated and connected to the ventilator. Finally, the laryngoscope can be removed from the patient.

[0161] If an existing endotracheal tube 106 is already positioned in the trachea T of the patient P, the malleable introducer 1500 may be advanced into the trachea T of the patient P through that endotracheal tube 106. Then the endotracheal tube 106 may be removed by advancing the endotracheal tube 106 along the malleable introducer 1500. Further, after the malleable introducer 1500 is positioned in the trachea T of the patient P, a new endotracheal tube 106 may be placed over the end and advanced along the malleable introducer 1500. In this manner, the malleable introducer 1500 can be used to perform an endotracheal tube exchange procedure in which an existing first endotracheal tube is removed and a new second endotracheal tube is inserted. The method is disclosed in further detail below.

[0162] First, the malleable introducer 1500 is shaped as desired by the medical professional. For example, the body of the malleable introducer may be kept straight, while the tip may be shaped to form a“J” shape or a hook shape, such as the shape of a hockey stick.

[0163] Next, a laryngoscope is placed into the mouth of the patient and advanced until a view of the glottis and existing endotracheal tube passing through the glottis is obtained. The malleable introducer is placed into the patient’s mouth and is guided through the vocal cords.

The malleable introducer is advanced until the green zone of the color depth zones lies adjacent to the glottis. Once the introducer is at the appropriate location, it is held in place.

[0164] The inflation cuff of the existing endotracheal tube is then deflated. Once it is deflated, it can be removed from the patient. After the existing endotracheal tube is removed, a new endotracheal tube is placed over the malleable introducer and is advanced through the trachea. The green zone of the malleable introducer should remain adjacent to the glottis while the endotracheal tube is advanced. If the yellow zone of the malleable introducer is adjacent to the glottis, the medical professional advances the malleable introducer further into the patient’s trachea until the green zone is adjacent the glottis again. If the red zone of the malleable introducer is adjacent to the glottis, the medical professional retracts the malleable introducer from the patient’s trachea until the green zone is adjacent the glottis again.

[0165] Once the distal tip of the new endotracheal tube reaches the glottis, the medical professional can observe that the tip of the endotracheal tube passes smoothly through the glottis over the malleable introducer. Throughout advancing the endotracheal tube, the medical professional continually keeps the green zone of the malleable introducer at the glottis.

[0166] Once the distal tip of the new endotracheal tube is properly placed in the trachea, the malleable introducer is removed from the new endotracheal tube, while the endotracheal tube remains properly positioned in the trachea. The new endotracheal tube can then be inflated and connected to the ventilator. Finally, the laryngoscope can be removed from the patient.

[0167] In another method, the malleable introducer is loaded into a central lumen on the endotracheal tube until the tip of the malleable introducer is in the correct position relative to the endotracheal tube tip. The medical professional is able to view the malleable introducer through the transparent wall of the endotracheal tube. In an embodiment, the correct position is determined by the medical professional. In an alternative embodiment, the correct position can be determined by a stopper located at a proximal end of the malleable introducer.

[0168] Next, the malleable introducer and endotracheal tube combination can be bent into a desired shaped by the medical professional. For example, the body of the malleable introducer may be kept straight, while the tip may be shaped to form a“ J” shape or a hook shape, such as the shape of a hockey stick.

[0169] Next, a laryngoscope is placed into the mouth of the patient and advanced until the vocal cords are in view. The malleable introducer and endotracheal tube are placed into the patient’s mouth and are guided through the vocal cords. As the malleable introducer and endotracheal tube combination is inserted through the trachea, the relationship to the vocal cords is continually monitored. [0170] If the yellow zone of the malleable introducer is adjacent to the vocal cords, the medical professional advances the malleable introducer further into the patient’s trachea until the green zone is adjacent the vocal cords again. If the red zone of the malleable introducer is adjacent to the vocal cords, the medical professional retracts the malleable introducer from the patient’s trachea until the green zone is adjacent the vocal cords again.

[0171] If the green zone of the malleable introducer is adjacent to the vocal cords, the endotracheal tube is at a proper depth, and advancement of the malleable introducer and endotracheal tube can stop. Once the endotracheal tube reaches a safe depth in the trachea, the malleable introducer is removed from the trachea, while the endotracheal tube remains in place.

[0172] The endotracheal tube can then be inflated and connected to the ventilator. Finally, the laryngoscope can be removed from the patient. If needed, the placement of the endotracheal tube can be confirmed via techniques known in the art, such as ET, C02, breath sounds, or CXR.

[0173] Yet another method includes loading the malleable introducer into a central lumen of the endotracheal tube until the tip of the malleable introducer is in a correct position relative to the endotracheal tube tip. The medical professional is able to view the malleable introducer through the transparent wall of the endotracheal tube. In an embodiment, the correct position of the introducer in the endotracheal tube is determined by the medical professional. In an alternative embodiment, the correct position can be determined by a stopper located at a proximal end of the malleable introducer.

[0174] Next, the malleable introducer and endotracheal tube combination can be bent into a desired shaped by the medical professional. For example, the body of the malleable introducer may be kept straight, while the tip may be shaped to form a“ J” shape or a hook shape, such as the shape of a hockey stick.

[0175] Next, a laryngoscope is placed into the mouth of the patient and advanced until the vocal cords are in view. The malleable introducer and endotracheal tube are placed into the patient’s mouth and are guided through the vocal cords. As the malleable introducer and endotracheal tube combination is inserted through the trachea, the relationship to the vocal cords is continually monitored.

[0176] If the yellow zone of the malleable introducer is adjacent to the vocal cords, the medical professional advances the malleable introducer further into the patient’s trachea until the green zone is adjacent the vocal cords again. If the red zone of the malleable introducer is adjacent to the vocal cords, the medical professional retracts the malleable introducer from the patient’s trachea until the green zone is adjacent the vocal cords again.

[0177] If the green zone of the malleable introducer is adjacent to the vocal cords, the endotracheal tube is at a proper depth, and advancement of the malleable introducer and endotracheal tube can stop. Once the endotracheal tube reaches a safe depth in the trachea, the malleable introducer is removed from the trachea, while the endotracheal tube remains in place.

[0178] The endotracheal tube can then be inflated and connected to the ventilator. Finally, the laryngoscope can be removed from the patient. If needed, the placement of the endotracheal tube can be confirmed via techniques known in the art, such as ET, C02, breath sounds, or CXR.

[0179] FIG. 16 is a view of an example of an endotracheal tube 106 mounted on an introducer 1500. As described in FIG. 4, the endotracheal tube 106 includes a pipe with a first end 178 and a second end 180. The shaft 1502 of the introducer 1500 passes through the endotracheal tube 106. The endotracheal tube 106 is oriented so that the first end 178 is nearer to the tip 138 of the introducer 1500 and the second end 180 is nearer an opposing end of the introducer 1500.

[0180] FIG. 17 is another example embodiment of an endotracheal tube 106 mounted on an introducer 104. The introducer 104 may or may not be malleable. The endotracheal tube 106 includes a pipe with a first end 178 and a second end 180. The shaft 134 of the introducer 104 passes through the endotracheal tube 106. The endotracheal tube 106 is oriented so that the first end 178 is nearer to the tip 138 of the introducer 104 and the second end 180 is nearer an opposing end of the introducer 104. Introducer 104 include a bulge 1702. Bulge 1702 extends outward from shaft wall in a diameter to be slightly smaller than a diameter of the endotracheal tube 106. When the introducer 104 is inserted into the patient, the bulge 1702 is positioned at the vocal cords when the introducer 104 is properly placed.

[0181] FIG. 18 is a perspective view of an introducer 104 with a bulge 1702. Bulge 1702 may be located adjacent to the tip 138. In some embodiments, the introducer 104 may have a central channel or lumen, open at both ends running from end to end.

[0182] In some embodiments, the exterior surface 136 comprises a single, continuous, uniform material. In some embodiments, the exterior surface 136 has non-stick properties. For example, in some embodiments the exterior surface 136 is formed from polytetrafluoroethylene. In other embodiments, the exterior surface 136 is configured to receive a lubricant. Other embodiments of the exterior surface 136 are possible as well. Because the exterior surface 136 is formed from a continuous material, the exterior surface 136 does not have any seams.

Accordingly, the exterior surface 136 can be quickly and inexpensively cleaned. For example, the exterior surface 136 may be sterilized without the use of expensive and time-consuming sterilization equipment (e.g., an autoclave).

[0183] FIG. 19 shows a longitudinal cross-sectional schematic view of an embodiment of the introducer of FIG. 18. Introducer 104 includes a bulge 1702 located adjacent to tip 138. Alternatively, bulge 1702 may be located at tip 138, or further away from the tip 138 of the shaft 134.

[0184] FIGS. 20 A and 20B show a cross-sectional schematic view of an embodiment of the introducer of FIG. 19, along lines B— B and C— C, respectively. The distal shaft body portion 2002 includes a lumen 2004. The lumen 2004 may be formed as a generally round recess in an extruded plastic structure. In other embodiments, more than one lumen 2004 may be present in the shaft body portion 2002. The proximal shaft body portion 2006 includes a lumen 2008. The lumen 2008 may be formed as a generally round recess in an extruded plastic structure. In other embodiments, more than one lumen 2008 may be present in the shaft body portion 2006. As shown, the distal shaft body portion 2002 has a larger diameter than proximal shaft body portion 2006. The bulge 1702 is located at distal shaft body portion 2002.

[0185] FIG. 21 is a perspective view of an introducer 104 having an oblong shape with a bulge 1702. Introducer 104 includes a bulge 1702 located adjacent to tip 138. Alternatively, bulge 1702 may be located at tip 138, or further down shaft 134.

[0186] In some embodiments, the exterior surface 136 comprises a single, continuous, uniform material. In some embodiments, the exterior surface 136 has non-stick properties. For example, in some embodiments the exterior surface 136 is formed from polytetrafluoroethylene. In other embodiments, the exterior surface 136 is configured to receive a lubricant. Other embodiments of the exterior surface 136 are possible as well. Because the exterior surface 136 is formed from a continuous material, the exterior surface 136 does not have any seams.

[0187] FIG. 22 shows a longitudinal cross-sectional schematic view of an embodiment of the introducer of FIG. 21.

[0188] FIGS. 23A and 23B show a cross-sectional schematic view of an embodiment of the introducer of FIG. 22, along lines D— D and E— E, respectively. The distal shaft body portion 2002 includes a lumen 2004. The lumen 2004 may be formed as a generally round recess in an extruded plastic structure. In other embodiments, more than one lumen 2004 may be present in the shaft body portion 2002. The proximal shaft body portion 2006 includes a lumen 2008. The lumen 2008 may be formed as a generally round recess in an extruded plastic structure. In other embodiments, more than one lumen 2008 may be present in the shaft body portion 2006. As shown, the distal shaft body portion 2002 has a larger diameter than proximal shaft body portion 2006. The bulge 1702 is located at distal shaft body portion 2002.

[0189] An example method of using an introducer with a bulge to replace an existing endotracheal tube is described. First, a laryngoscope (with or without video) is placed into the mouth of a patient and is advanced until a view of the glottis and existing endotracheal tube passing through the glottis is obtained.

[0190] The existing endotracheal tube is disconnected from the ventilator. Then the bulge introducer is inserted into the existing endotracheal tube and advanced until the bulge of the bulge introducer is at the glottis.

[0191] Then the cuff of the existing endotracheal tube is deflated and the existing endotracheal tube can be withdrawn from the trachea over the bulge introducer, while the bulge introducer remains in place. If the bulge moves from below the opening of the glottis, the medical professional should withdraw the bulge introducer from the patient’s trachea until the bulge is present again at the opening of the glottis. Alternatively, if the bulge appears entirely above the opening of the glottis, the medical professional should advance the bulge introducer further into the trachea until the bulge is present again at the opening of the glottis.

[0192] In an embodiment, the bulge introducer as has color zones. The green zone of the bulge introducer should remain adjacent to the glottis while the endotracheal tube is advanced. If the yellow zone of the bulge introducer is adjacent to the glottis, the medical professional advances the bulge introducer further into the patient’s trachea until the green zone is adjacent the glottis again. If the red zone of the bulge introducer is adjacent to the glottis, the medical professional retracts the bulge introducer from the patient’s trachea until the green zone is adjacent the glottis again. [0193] Once the distal tip of the new endotracheal tube reaches the glottis, the medical professional can observe the tip of the endotracheal tube to pass smoothly through the glottis over the bulge introducer. Throughout advancing the endotracheal tube, the medical professional continually keeps the green zone of the bulge introducer at the glottis.

[0194] Once the distal tip of the new endotracheal tube is properly placed in the trachea, the bulge introducer is removed from the new endotracheal tube, while the endotracheal tube remains properly positioned in the trachea. The new endotracheal tube can then be inflated and connected to the ventilator. Finally, the laryngoscope can be removed from the patient.

[0195] FIG. 24 is an example embodiment of an introducer 104 with a tapered end 2402. When introducer 104 is inserted in patient, tapered end 2402 is positioned at the vocal cords when the introducer 104 is properly placed. The introducer 104 is configured to guide an endotracheal tube into the trachea of a patient. The introducer 104 includes a shaft 134 that includes an exterior surface 136 and a tip 138. In some embodiments, the shaft 134 has a tubular shape and is formed from a flexible material that is configured to adapt to the shape of the airway of the patient. In some embodiments, the cross-section of the shaft 134 has an oblong shape. Other embodiments of shaft 134 with other shapes are possible.

[0196] In some embodiments, the exterior surface 136 comprises a single, continuous, uniform material. In some embodiments, the exterior surface 136 has non-stick properties. For example, in some embodiments the exterior surface 136 is formed from polytetrafluoroethylene. In other embodiments, the exterior surface 136 is configured to receive a lubricant. Other embodiments of the exterior surface 136 are possible as well. Because the exterior surface 136 is formed from a continuous material, the exterior surface 136 does not have any seams.

[0197] In some embodiments, the tip 138 is configured to minimize trauma as it moves through the nose or mouth into the upper airway and advances into the trachea of the patient. In some embodiments, the tip 138 is contained within the exterior surface 136. In some

embodiments, the tip 138 has a blunt rounded shape. In some embodiments, the tip 138 does not have edges, corners, or crevices that may potentially injure the patient. Still other embodiments of the tip 138 are possible. [0198] An example method of using an introducer with a bulge to replace an existing endotracheal tube is described. First, a laryngoscope (with or without video) is placed into the mouth of a patient and is advanced until a view of the glottis and existing endotracheal tube passing through the glottis is obtained.

[0199] The existing endotracheal tube is disconnected from the ventilator. Then the tapered introducer is inserted into the existing endotracheal tube and advanced until the proximal end of the taper of the introducer is at the glottis.

[0200] Then the cuff of the existing endotracheal tube is deflated and the existing

endotracheal tube can be withdrawn from the trachea over the tapered introducer, while the tapered introducer remains in place. If the proximal end of the tapered introducer moves from below the opening of the glottis, the medical professional should withdraw the tapered introducer from the patient’s trachea until the proximal end of the tapered introducer is present again at the opening of the glottis. Alternatively, if the proximal end of the tapered introducer appears entirely above the opening of the glottis, the medical professional advances the tapered introducer further into the trachea until the proximal end of the tapered introducer is present again at the opening of the glottis.

[0201] In an embodiment, the tapered introducer as has color zones. The green zone of the tapered introducer should remain adjacent to the glottis while the endotracheal tube is advanced. If the yellow zone of the tapered introducer is adjacent to the glottis, the medical professional advances the tapered introducer further into the patient’s trachea until the green zone is adjacent the glottis again. If the red zone of the tapered introducer is adjacent to the glottis, the medical professional retracts the tapered introducer from the patient’s trachea until the green zone is adjacent the glottis again.

[0202] Once the distal tip of the new endotracheal tube reaches the glottis, the medical professional can observe the tip of the endotracheal tube to pass smoothly through the glottis over the tapered introducer. Throughout advancing the endotracheal tube, the medical professional continually keeps the green zone of the bulge introducer at the glottis.

[0203] Once the distal tip of the new endotracheal tube is properly placed in the trachea, the tapered introducer is removed from the new endotracheal tube, while the endotracheal tube remains properly positioned in the trachea. The new endotracheal tube can then be inflated and connected to the ventilator. Finally, the laryngoscope can be removed from the patient. [0204] FIG. 25 is an example embodiment of an endotracheal tube 106 mounted on an introducer 104 with a dilator 2408. As described in FIG. 4, the endotracheal tube 106 includes a pipe with a first end 178 and a second end 180. The shaft 134 of the introducer 104 passes through the endotracheal tube 106. The endotracheal tube 106 is oriented so that the first end 178 is nearer to the tip 138 of the introducer 104 and the second end 180 is nearer an opposing end of the introducer 104.

[0205] The dilator 2408 is flexible enough to follow the contour of the introducer 104. The dilator 2404 bridges a gap between an endotracheal tube 106 and introducer 104, so that the gap is not present to catch on the patient’s vocal cords when the endotracheal tube passes over the introducer.

[0206] When passing an endotracheal tube through the glottis, the beveled tip of the endotracheal tube may catch on the glottic structures. This may be problematic for many reasons. Catching may interfere with the smooth advancement of the endotracheal tube into the trachea. Resolving the catching problem can distract the operator’s attention, add mental task load to the operator, delay proper placement of the endotracheal tube into the trachea causing a delay in delivery of oxygen to the patient, and can even cause a failed intubation. Catching of the tip on the glottis may irritate or injure the glottic structures. This catching problem is especially likely when an endotracheal tube is placed into the trachea using a technique in which an introducer is first placed into the trachea and an endotracheal tube is slid over the introducer into the trachea as a gap may form between the introducer and the beveled tip of the endotracheal tube, which may increase the likelihood of catching a glottic structure in that gap. In some cases, a catheter may be used in place of an introducer.

[0207] It may be advantageous to the patient and operator to decrease the likelihood and minimize the severity of the catch problem when intubation of the trachea with any medical device.

[0208] It may be advantageous to design equipment that allows an operator to view the glottic opening and its relationship to the devices being placed into the trachea throughout the procedure.

[0209] Closing the gap between the external surface of the endotracheal tube and the tip of the endotracheal tube or other devices sliding over the introducer as it passes through the glottis can decrease the chances that the glottic structures might catch on the tip of the endotracheal tube tip as it passes through the glottis.

[0210] It may be advantageous that the endotracheal tube slides as smoothly and easily as possible over the introducer guiding the endotracheal tube into the trachea during placement into the trachea. It may be advantageous to minimize or reduce surface friction between the introducer and the endotracheal tube as the endotracheal tube is passed over the introducer and into the trachea.

[0211] It may be advantageous to close the gap between the inside of the endotracheal tube tip and the outside of the introducer in the area of the glottic opening to reduce the chances of glottic catch problem while at the same time allow a gap between the inside of the endotracheal tube and the outside of the introducer along the introducer that is not interacting with the glottic opening to allow the endotracheal tube to slide as smoothly and easily over the introducer and into the trachea.

[0212] In some cases, closing the gap between the endotracheal tube tip and the introducer has been solved by either uniformly increasing the cross-sectional diameter of the entire introducer so that it fills the lumen of the endotracheal tube or bending the endotracheal tube tip inward so that it rides along the surface of the introducer acting to close the gap as it rides down the introducer.

[0213] Both of these solutions present other clinical problems that would be advantageous to solve. Uniformly increasing the cross-sectional diameter of the introducer to fill endotracheal tube lumen increases surface contact between the introducer and endotracheal tube making it more difficult to slide over the introducer into the trachea. Specialized endotracheal tubes with inwardly bending tips must be immediately available for use, which may not be the case in all care settings.

[0214] An introducer with variable cross-sectional diameters may solve this problem. Where the introducer is not interacting with the glottis, the cross-sectional diameter of the introducer may be smaller to minimize surface friction between the introducer and the endotracheal tube as the endotracheal tube is passed over the introducer and into the trachea. Where the introducer is interacting with the glottis, the cross-sectional diameter of the introducer may be larger to close the gap between the inside of the endotracheal tube tip and the outside of the introducer in the area of the glottic opening to reduce the chances of glottic catch problem. An introducer with variable cross-sectional diameters can minimize the glottic catch problem while at the same time maximize the overall surface contact between the introducer and endotracheal tube.

[0215] It may be advantageous for the tip of an airway introducer to be small, as it is easier to place a small tip into a glottic opening than a large tip into the same size glottic opening. It may be advantageous to have an airway introducer taper from a small diameter at the tip to a larger diameter so that it is easy to place the introducer into the glottic opening. Once the tip is passed into the trachea to a certain proper depth, it may be advantageous to have the portion of the shaft in the glottic opening be a larger diameter, or taper to be a larger diameter. That larger diameter could be the proper diameter to fill the inside of the endotracheal tube, thereby closing the gap between the endotracheal tube tip and the shaft of the introducer lying at the glottis in order to decrease the risk of the tip of the tube catching on the glottis.

[0216] FIG. 26 illustrates an embodiment of introducer 104 and dilator 2408 being as it fits together with an endotracheal tube 106. Introducer 104 and dilator 2408 are assembled together, and are capable of having an endotracheal tube 106 placed over the combination.

[0217] FIG. 27 shows a longitudinal cross-sectional schematic view of an embodiment of the complex formed when the endotracheal tube 106 is properly mounted on the dilator 2408 without the introducer 104 depicted in figure FIG. 26.

[0218] FIG. 28 shows a cross-sectional schematic view of an embodiment of the introducer of FIG. 27, along line G— G. The dilator includes a lumen 2802. The lumen 2802 may be formed as a generally round recess in an extruded plastic structure. The endotracheal tube also includes a lumen with a shaft body portion 2806. In other embodiments, more than one lumen 2802 may be present in the shaft body portion 2804 of the dilator 2802 or the shaft body portion 2806 of the endotracheal tube 106. In some embodiments, no lumen is present in the dilator. As shown, the shafts 2804, 2806 have a tubular shape and may be formed from a flexible material that is configured to adapt to the shape of the airway of the patient. In some embodiments, the cross- section of the shafts 2804, 2806 have an oblong shape. Other embodiments of shafts 2804, 2806 with other shapes are possible.

[0219] FIG. 29 illustrates a separated embodiment of an endotracheal tube 106 mounted on an introducer 104 with a dilator 2408. The endotracheal tube 106 includes a pipe with a first end 178 and a second end 180. The first end 178 is configured to be inserted through dilator 2408 and over introducer 104. Endotracheal tube 106 is inserted until first end 178 is over tip 138. Introducer 104 and dilator 2408 can be removed from endotracheal tube 106, while endotracheal tube 160 remains in patient.

[0220] FIG. 30 shows a longitudinal cross-sectional schematic view of an embodiment of the introducer of FIG. 26, with endotracheal tube 106 mounted on introducer 104 through dilator 2404. Endotracheal tube 106 is inserted until first end 178 is over tip 138. Tip 138 remains extends beyond endotracheal tube 106.

[0221] FIG. 31 shows a cross-sectional schematic view of an embodiment of the introducer 104, endotracheal tube 106, and dilator 2408 of FIG. 27, along line F— F. The introducer includes a lumen 2802. The lumen 2802 may be formed as a generally round recess in an extruded plastic structure. In other embodiments, more than one lumen 2802 may be present in the shaft body portion 2808 of the introducer 104. In some embodiments, no lumen is present in the introducer. Surrounding introducer shaft body portion 2808 is shaft body 2804 of a dilator 2408.

Surrounding shaft body 2804 of dilator 2408 is a shaft body 2806 of an endotracheal tube 106.

As shown, the shafts 2804, 2806, 2808 have a tubular shape and may be formed from a flexible material that is configured to adapt to the shape of the airway of the patient. In some

embodiments, the cross-section of the shafts 2804, 2806, 2808 have an oblong shape. Other embodiments of shafts 2804, 2806, 2808 with other shapes are possible.

[0222] FIG. 32 shows an example embodiment of a foldable introducer 3200. Airway introducers, such as introducer 3200, may be long devices that can make them difficult to store in work areas with limited space or when airway equipment needs to be transported, such as in portable medical kits. In these cases it may be advantageous to make an airway introducer that could be stored in shorter sections that might then be quickly and easily reassembled prior to use. Foldable introducer include a proximal shaft portion 3202 and a distal shaft portion 3204.

Proximal shaft portion 3202 and distal shaft portion 3204 pivot at hinge 3206. Hinge 3206 is located at a middle portion of shaft 3210. In other embodiments, hinge 2306 may be located nearer tip 3212, or alternatively, hinge 2306 may be located nearer opposing end 3214. Other types of hinges 3206 include standard hinges, ball-and-socket hinges, living hinges, and other similar types of hinges.

[0223] As shown in FIGS. 33A and 33B, foldable introducer 3200 may alternatively be assembled similar to a tent-pole using three shaft portions 3202, 3204, 3206 and stretchable strings 3302. In alternative embodiment, two shaft portions may be used, or more than three shaft portions may be used, where each shaft portion is connected to the next shaft portion with a stretchable string or other stretchable connection mechanism. In some cases, the foldable introducer 3200 may include a locking mechanism, which may allow at least one configuration of foldable introducer 3200 to be locked into place. For example, foldable introducer 3200 is configured to be inserted into the patient, a locking mechanism may be engaged to ensure that the foldable introducer 3200 does not transform to another configuration (e.g., the storage configuration). The locking mechanism may be any type of structure configured to prevent or mitigate the likelihood that the configuration of the foldable introducer 3200 changes.

[0224] Foldable introducer 3200 may include a first depth-assessment band, second depth- assessment band, and a third depth-assessment band. The depth-assessment bands 184 are indicators that are on or visible through the exterior surface and are configured to be visible when the foldable introducer 3200 is viewed with the laryngoscope 102. The depth-assessment bands are configured to convey information about the placement of the endotracheal tube 106 relative to the anatomical landmarks of the patient, such as the vocal cords, that are also visible through the laryngoscope 102. The depth-assessment bands are also configured to convey information about the longitudinal distance to the end of the first end.

[0225] Adjacent depth-assessment bands are visually distinct from each other so that a medical professional who views a part of one of the depth-assessment bands from the

laryngoscope 102 is able to identify which specific one of the depth-assessment bands is in the field of view. Depth-assessment bands are similar to those described above with regard to FIG. 3.

[0226] In some embodiments, the depth-assessment bands are continuous regions of color that extend along a portion of the length of the pipe. For example, the first depth-assessment band is a first color, the second depth-assessment band is a second color, and the third depth- assessment band is a third color. In other embodiments, the depth-assessment bands are continuous regions of visually distinct patterns rather than colors. In some embodiments, the depth-assessment bands include both visually distinct patterns and colors. Yet other

embodiments of the depth-assessment bands 184 are possible as well.

[0227] In some embodiments, the lengths of the depth-assessment bands are selected based on the clinical precision required for the intubation procedure in which the endotracheal tube 106 is intended and the distance into the trachea of the patient, a medical professional wishes to insert the first end. For example, a medical professional may wish to insert the first end two to four centimeters into the trachea of an adult patient. In some embodiments for adult patients, the length of each of the depth-assessment bands is two centimeters. In this manner, the medical professional will know that the first end is properly inserted into the trachea of the patient when any part of the second depth-assessment band is aligned with the entrance of the trachea of an adult patient (i.e., the patient’s vocal cords).

[0228] Similarly, in some embodiments for pediatric patients, the lengths of the depth- assessment bands are adapted to the shorter tracheas of those pediatric patients. For example, a medical professional may wish to insert the first end one to two centimeters into the trachea of the pediatric patient. In some embodiments for pediatric patients, the length of each of the depth- assessment bands is one centimeter. In this manner, the medical professional will know that the first end is properly inserted into the trachea of the patient when any part of the second depth- assessment band is aligned with the entrance of the trachea of a pediatric patient (i.e., the patient’s vocal cords).

[0229] A foldable introducer 3200 may include one hinge 2306, but more than one hinge 2306 may be present. For example, if foldable introducer 3200 includes two hinges 2306, three shaft portions (not shown) are present.

[0230] A method of using a foldable introducer 3200 is as follows. The foldable introducer 3200 is unfolded to a straight configuration and assembled by the medical professional. A laryngoscope is placed into the mouth and carefully advanced until a view of the glottis is obtained. The foldable introducer in a straight configuration is then placed into the patient's mouth and guided through the vocal cords.

[0231] Then, the assembled introducer is advanced in the patient, but is halted when the green zone of the color depth zones on the distal tip of the lies adjacent to the glottis.

[0232] An endotracheal tube is placed over the foldable introducer and is advanced through the trachea. The green zone of the foldable introducer should remain adjacent to the glottis while the endotracheal tube is advanced. If the yellow zone of the foldable introducer is adjacent to the glottis, the medical professional advances the foldable introducer further into the patient’s trachea until the green zone is adjacent the glottis again. If the red zone of the foldable introducer is adjacent to the glottis, the medical professional retracts the foldable introducer from the patient’s trachea until the green zone is adjacent the glottis again.

[0233] Once the distal tip of the endotracheal tube reaches the glottis, the medical professional can observe the tip of the endotracheal tube to pass smoothly through the glottis over the foldable introducer. Throughout advancing the endotracheal tube, the medical professional continually keeps the green zone of the foldable introducer at the glottis.

[0234] Once the distal tip of the endotracheal tube is properly placed in the trachea, the foldable introducer is removed from the endotracheal tube, while the endotracheal tube remains properly positioned in the trachea. The endotracheal tube can then be inflated and connected to the ventilator. Finally, the laryngoscope can be removed from the patient.

[0235] FIG. 33 illustrates and an example embodiment of an introducer 104 with a first and second balloon 3302, 3304. First and second balloon 3302, 3304 are located at a distal end of the shaft 134. When introducer 104 is inserted into the patient, first balloon 3302 is located superior to vocal cords, and second balloon 3304 is located inferior to vocal cord, when introducer 104 is properly placed. The introducer 104 is configured to guide an endotracheal tube into the trachea of a patient. The introducer 104 includes a shaft 134 that includes an exterior surface 136 and a tip 138. In some embodiments, the shaft 134 has a tubular shape and is formed from a flexible material that is configured to adapt to the shape of the airway of the patient.

[0236] Balloons 3302, 3304 are configured to be flexible enough to be placed in patient without causing damage. Alternative, balloons 3302, 3304 may be inflated after introducer 104 is properly placed. In some embodiments, the exterior surface 136 has non-stick properties. For example, in some embodiments the exterior surface 136 is formed from polytetrafluoroethylene.

[0237] The various embodiments described above are provided by way of illustration only and should not be construed to limit the claims attached hereto. Those skilled in the art will readily recognize various modifications and changes that may be made without following the example embodiments and applications illustrated and described herein, and without departing from the true spirit and scope of the following claims.

Claims

What is claimed is:

1. An introducer for mounting an endotracheal tube, the introducer comprising:

a shaft comprising:

a proximal shaft portion, wherein the shaft portion is malleable; and

a distal tip portion extending from the shaft portion, the distal tip portion being malleable; wherein the distal tip portion has a qualitative depth assessment system to allow qualitative assessment of distal tip portion placement.

2. The introducer of claim 1, wherein the qualitative depth assessment system includes a plurality of depth assessment bands, each depth assessment band being visually distinct from an other depth assessment band.

3. The introducer of claim 2, wherein each depth assessment band has a visually distinct color or pattern from an other depth assessment band.

4. The introducer of claim 1, wherein the qualitative depth assessment system allows a user to evaluate tip placement based on an observation of the qualitative depth assessment system relative to an anatomical structure of a patient.

5. The introducer of claim 4, wherein the distal tip portion has a round shape and a closed end.

6. The introducer of claim 4, wherein the anatomical structure of the patient is a glottis of the patient.

7. The introducer of claim 4, wherein the anatomical structure of the patient is a lip of the patient.

8. The introducer of claim 4, wherein the anatomical structure of the patient is a tooth of the patient.

9. The introducer of claim 1, in combination with an endotracheal tube, wherein the introducer is loaded within the endotracheal tube.

10. The introducer of claim 9, wherein the tip of the introducer extends from a distal end of the endotracheal tube.

11. The introducer of claim 1, further comprising a bulge between the proximal shaft portion and distal tip portion.

12. The introducer of claim 11, wherein the proximal shaft portion has a first diameter and the bulge has a second diameter, wherein the second diameter is larger than the first diameter.

13. The introducer of claim 1, wherein either or both of the proximal shaft portion and the distal tip portion of the introducer is malleable.

14. A method for inserting an endotracheal tube into a patient comprising:

inserting a blade of a laryngoscope into a mouth of the patient;

viewing a trachea of the patient with the laryngoscope;

providing an introducer;

inserting the introducer into the trachea of the patient;

inserting the endotracheal tube into the trachea of the patient along the introducer; and removing the introducer from the endotracheal tube, while the endotracheal tube remains in the patient.

15. A method for inserting an endotracheal tube and dilator into a patient comprising:

inserting a blade of a laryngoscope into a mouth of the patient;

viewing a trachea of the patient with the laryngoscope;

providing an introducer;

mounting the endotracheal tube and dilator on the introducer;

inserting the endotracheal tube and dilator into the trachea of the patient along the introducer; and

removing the introducer from the endotracheal tube, while the endotracheal tube remains in the patient.

16. A kit for inserting an endotracheal tube into a patient, the kit comprising:

an introducer comprising a shaft, the shaft further comprising:

a proximal shaft portion;

a distal tip portion extending from the shaft portion, wherein the tip portion includes a tip having a round shape and a closed end; and

a dilator comprising a shaft having a first diameter at a first end and a second diameter at an opposing end; and

an endotracheal tube.

17. The kit of claim 16, wherein the distal tip portion comprises a qualitative depth assessment system.

18. The kit of claim 17, wherein the qualitative depth assessment system includes a plurality of depth assessment bands, each depth assessment band having a visually distinct color or pattern from an adjacent depth assessment band.

19. The kit of claim 16, wherein the introducer is loaded within the endotracheal tube.

20. The kit of claim 16, wherein the tip portion of the introducer extends from a distal end of the endotracheal tube.

21. The kit of claim 16, wherein either or both of the proximal shaft portion and the distal tip portion of the introducer are malleable.

22. A method for inserting an endotracheal tube into a patient comprising:

inserting a blade of a laryngoscope into a mouth of the patient;

viewing a trachea of the patient with the laryngoscope; providing a kit;

mounting the dilator on the introducer;

inserting the introducer and dilator into the patient;

inserting the endotracheal tube along the introducer and into the trachea of the patient; and

23. The method of claim 22, wherein the introducer comprises a qualitative depth assessment system.

24. The method of claim 23, wherein the qualitative depth assessment system includes at least one qualitative depth assessment band, the at least one depth assessment band having a visually distinct color or pattern, and wherein when the introducer is inserted to an appropriate depth, the at least one depth assessment band indicates the appropriate depth of the introducer.

25. The method of claim 24, wherein the appropriate depth is adjacent to a glottis of the patient.

26. An introducer for mounting an endotracheal tube, the introducer comprising: a shaft comprising:

a proximal shaft portion; and

a distal tip portion extending from the shaft portion, wherein the distal tip portion may be articulated at more than one point along its length.

27. The introducer of claim 26, wherein the distal tip portion may be articulated to form a substantially j-shaped curve.

28. The introducer of claim 26, wherein the distal tip portion may be articulated to form a substantially s-shaped curve.

29. The introducer of claim 26, further comprising a qualitative depth assessment system to allow qualitative assessment of tip placement.

30. The introducer of claim 29, wherein the qualitative depth assessment system includes a plurality of depth assessment bands, each depth assessment band being visually distinct from an other depth assessment band.

31. The introducer of claim 30, wherein each depth assessment band has a visually distinct color or pattern from an other depth assessment band.

32. The introducer of claim 29, wherein the qualitative depth assessment system allows a user to evaluate tip placement based on an observation of the qualitative depth assessment system relative to an anatomical structure of a patient.

33. The introducer of claim 32, wherein the anatomical structure of the patient is a glottis of the patient.

34. The introducer of claim 32, wherein the anatomical structure of the patient is a lip of the patient.

35. The introducer of claim 32, wherein the anatomical structure of the patient is a tooth of the patient.

36. The introducer of claim 26, in combination with an endotracheal tube, wherein the introducer is loaded within the endotracheal tube.

37. The introducer of claim 36, wherein the tip of the introducer extends from a distal end of the endotracheal tube.

38. The introducer of claim 26, further comprising a bulge between the proximal shaft portion and distal tip portion.

39. The introducer of claim 38, wherein the proximal shaft portion has a first diameter and the bulge has a second diameter, wherein the second diameter is larger than the first diameter.

40. The introducer of claim 26, wherein either or both of the proximal shaft portion and the distal tip portion of the introducer are malleable.

41. The introducer of claim 26, wherein the tip portion has a round shape and a closed end.

42. An introducer for mounting an endotracheal tube, the introducer comprising:

a shaft comprising:

a proximal shaft portion having a first diameter; and

a distal tip portion extending from the shaft portion having a third diameter, wherein the third diameter is smaller than the first diameter, and wherein the third diameter tapers to the first diameter.

43. The introducer of claim 42, wherein the distal tip portion comprises a plurality of depth assessment bands, each depth assessment band having a visually distinct color or pattern from an other depth assessment band.

44. The introducer of claim 42, wherein either or both of the proximal shaft portion and distal tip portion of the introducer are malleable.

45. A method for inserting an endotracheal tube in a patient comprising:

inserting a blade of a laryngoscope in a mouth of the patient;

viewing a glottis of the patient with the laryngoscope;

providing an introducer;

inserting the introducer into the patient;

46. The method of claim 45, wherein the introducer comprises at least one qualitative depth assessment band, the at least one depth assessment band having a visually distinct color or pattern, and wherein the introducer is inserted to an appropriate depth, the at least one depth assessment band indicates the appropriate depth of the introducer.

47. The method of claim 46, wherein the appropriate depth is adjacent to a glottis of the patient.

48. A method for exchanging an endotracheal tube in a patient comprising:

inserting a blade of a laryngoscope in a mouth of the patient;

viewing a glottis of the patient with the laryngoscope;

inserting a malleable introducer into an existing endotracheal tube;

removing the existing endotracheal tube from the patient, while the malleable introducer remains in place in the trachea;

inserting the endotracheal tube and along the malleable introducer and into the trachea of the patient; and

removing the malleable introducer from the endotracheal tube, while the endotracheal tube remains in the patient.

49. The method of claim 48, wherein the introducer comprises at least one depth assessment band, the at least one depth assessment band having a visually distinct color or pattern, and wherein the introducer is inserted to an appropriate depth, the at least one depth assessment band indicates the appropriate depth of the introducer.

50. The method of claim 49, wherein the appropriate depth is adjacent to a glottis of the patient.

51. An introducer for mounting an endotracheal tube, the introducer comprising:

a shaft comprising:

a proximal shaft portion; a distal shaft portion comprising a distal tip portion, and includes a tip; and a hinge connecting the proximal shaft portion and distal shaft portion;

wherein the introducer has an open position wherein the proximal shaft portion and distal shaft portion are linear and a closed position wherein the proximal shaft portion and distal shaft portion are folded adjacent to each other at the hinge.

52. The introducer of claim 51, wherein the shaft comprises a plurality of depth assessment bands, each depth assessment band having a visually distinct color or pattern from an other depth assessment band.

53. The introducer of claim 51, in combination with an endotracheal tube, wherein the introducer is loaded within the endotracheal tube.

54. The introducer of claim 53, wherein the tip of the introducer extends from a distal end of the endotracheal tube.

55. The introducer of claim 51, in combination with a dilator, wherein the introducer is capable of being inserted into the dilator.

56. The introducer of claim 51, wherein the tip has a round shape and a closed end.