Introducer for tracheal tube intubation

An introducer for tracheal tube intubation has a proximal section connected to a distal section having an angled bougie tip. The introducer is configurable (i) for use as a bougie in which a tracheal tube is railroaded over the introducer's back end and into a trachea and (ii) for use as a stylet in which a tracheal tube is pre-loaded onto the introducer for insertion into a trachea. In certain embodiments, the introducer has one or more flexible or malleable sections that enable the introducer to bend into different configurations. The flexible/malleable sections have directional bending such that the sections bend in roughly the same plane as the angled bougie tip. This enables an operator always to know the orientation of the bougie tip even after it has been inserted into the trachea. The flexible/malleable sections enable the introducer to be configured with a handle or other type of grip.

BACKGROUND

Field of the Invention

The present invention relates to medical devices and techniques for using medical devices and, more specifically but not exclusively, to introducers for tracheal tube insertion (intubation) using direct laryngoscopes and video laryngoscopes.

Description of the Related Art

Emergency intubation is accomplished through direct or video imaging of the larynx, followed by tracheal tube insertion under vision, i.e., the tube is manipulated by the operator and seen entering the larynx. Since the distal end of a tracheal tube may block direct visualization of the larynx during the insertion process, a variety of techniques have been devised to overcome this visualization challenge. In 1949, Macintosh suggested the use of a gum-elastic catheter, now commonly called a bougie, to aid in tube insertion. The bougie is a rounded tube introducer, approximately 15 Fr (i.e., 5 mm) diameter and about 70 centimeters in length, with a Coude tip that is angled slightly upward (approximately 38 degrees in the original Portex device manufactured by Smiths Medical International Ltd of Kent, United Kingdom). Throughout much of Europe and the United Kingdom, this device is considered an essential piece of equipment when inserting tubes using direct laryngoscopy.

Patient outcomes in emergency airway management show a strong correlation between adverse events and number of intubation attempts. Many operators and emergency systems advocate the use of a bougie on all initial attempts should intubation be required.

In the U.S., malleable stylets were developed for controlling the insertion of tracheal tubes. Levitan et al. has described the optimal technique for shaping a stylet as “straight-to-cuff,” to denote where the bend point of a styletted tube should be. See Levitan R M, Pisaturo J T, Kinkle W C, Butler K, Everett W W, “Stylet bend angles and tracheal tube passage using a straight-to-cuff shape,”Acad Emerg Med2006, 13:1255-8. Levitan et al. advocate a 35-degree bend. In their opinion, this maximizes visualization, facilitates insertion, and minimizes the impaction of the tracheal tube tip on the tracheal rings.

The anterior two thirds of the trachea has cartilaginous rings that help preserve the patency of the airway. When inserting the bougie, which is flexible, and has an upturned tip, the tip will interact with the rings, creating a palpable click that is felt in 65-95% of insertions into the trachea. If the tip of the bougie is inserted into the esophagus, then these rings are not felt. The tactile feedback of being in the trachea is not perfect, however, because of several variables. If the tip rotates so that it is not directed anteriorly, then it will slide along the membranous trachea, which has no rings.

In situations of difficult laryngoscopy, the bougie may be blindly placed under the epiglottis, and, through tactile feedback, verification of tracheal insertion is provided, even when direct visualization of the glottis opening is limited. The bougie is very long (˜60-70 cm), and unfortunately it may be difficult to effectively control the distal tip, making sure that the distal tip stays upright, hugging the undersurface of the epiglottis on insertion. It is very susceptible to unrecognized rotation because of its uniformly round shape. It has no inherent directionality, apart from the distal tip, which becomes invisible after insertion. Finally, using the bougie is a two-person task. The operator places the device (while continuing to hold a laryngoscope), while an assistant helps railroad the tube. The tube cannot be preloaded on a bougie and held initially by the operator, because the tube will slide over the bougie, i.e., the two devices do not move as a unit.

Stylets have the advantage of being faster because they are inserted along with the tracheal tube. If shaped improperly, however, they can make intubation more difficult, either by blocking the line of sight, or through catching on the anterior tracheal rings. Stylet bend angles above 35 degrees, for instance, commonly cause tracheal ring impaction when using standard tubes with asymmetric left-facing bevels. See Levitan et al.

Styletted tubes do not provide tracheal-ring tactile feel, and, if the stylet is inadvertently allowed to project beyond the tube, then it can cause tracheal perforation. Even if the end of the stylet stops within the tracheal tube tip, if the stylet is too close to the tube tip, then it will stiffen the tip too much causing it to impact on the trachea. The trachea has a dimension of about 14-16 mm in female adults and about 16-20 mm in male adults. An excessive bend easily causes the tip to engage the tracheal rings. This may prevent tube insertion mechanically or result in tracheal trauma that could result in tears and other injuries. When tracheal tube advancement problems occur, the operator may need to rotate the tube (changing the bevel orientation) or stabilize the tube and remove the stylet before attempting re-insertion. In emergency situations, such delays may be consequential, and, if the intubation attempts are repeated multiple times, then there are high rates of adverse events.

Recently, hyper-angulated rigid stylets have been developed to use with hyper-angulated video laryngoscopes. Video laryngoscopes, like the Glidescope video laryngoscope from Verathon, Inc., of Bothell, Wash., use a curved tongue retractor and a video camera to image the larynx. These devices are hyper-angulated relative to the shape of a standard Macintosh curved laryngoscope blade. In order to deliver a tube to the larynx, however, a tube must follow the hyper-angulated blade around the tongue and be inserted into the trachea. Once the tip is in the trachea, the tube has to take a more-posterior angle to enter the trachea. The trachea follows the thoracic spine, i.e., it dives posteriorly. This creates a fundamental tube-delivery challenge with any hyper-angulated video laryngoscope. A stiff hyper-angulated tube—needed for rotation around the tongue—is too stiff for insertion into the trachea. It also has a side-to-side, long-axis dimension that exceeds the diameter of the trachea. See Levitan R M, Heitz J W, Sweeney M, Cooper R M, “The Complexities of Tracheal Intubation With Direct Laryngoscopy and Alternative Intubation Devices,”Ann Emerg Med2011; 57:240-7. Numerous case reports have documented the hazards of hyper-angulated rigid stylets using video laryngoscopes.

DETAILED DESCRIPTION

In certain embodiments of this disclosure, an improved introducer for tracheal tube intubation works with both direct laryngoscopes and video laryngoscopes. It improves on the design of a stylet by having a rounded distal tip, eliminating the risk of trachea injury. Nonetheless, it still has enough rigidity to allow for shaping of an overlying tube for either direct or video laryngoscopy. Like stylets, it has a proximal end with a mechanism for fast removal of the stylet from the tracheal tube (after the tube has been placed in the trachea).

The improved introducer also functions effectively as a bougie, permitting tactile feel of the trachea, and allowing railroading of a tracheal tube over the back end of the device and into the trachea. Unlike conventional rounded bougies, it also has inherent directionality, thereby enabling the operator always to know the direction of the upturned distal tip (even when not visible—as often occurs with conventional bougies as the tip is passed under the epiglottis).

Inserting tubes into the trachea using stylets (in order to create a straight-to-cuff shape and a narrow long axis) can be problematic if the stylets' rigidity prevents their insertion. Although a low bend angle (<35 degrees) reduces this risk, it does not eliminate it. As already mentioned, the shape of the tracheal tube tip, especially when a rigid stylet is placed to the end of the tube, can impact on the tracheal rings. If the stylet projects beyond the tube tip, it is especially dangerous due to its rigidity and small diameter. Although bougies have a lower risk of catching on the trachea rings, the commonly used, single-use plastic varieties of bougies can be quite rigid down their long axis and can also cause tracheal injury (perforation), or the tip can catch on the tracheal rings.

Like a stylet, the improved introducer permits shaping with the tube loaded on for visualization during placement (either (i) a low-axis, ˜35-degree bend for direct laryngoscopy or (ii) a more-exaggerated, ˜70-degree bend for hyperangulated blades used with a Glidescope video laryngoscope), but, at the same time, allows “un-bending” on insertion after the tube tip has passed into the trachea. Like a bougie, the improved introducer is rigid enough to maintain its narrow, long axis on insertion to the larynx, but is also not too rigid (in order to “un-bend”) as it passes the vocal cords and moves down the trachea.

The improved introducer permits one-handed placement of bougie and tube. The improved introducer has the short storage length and easy handling of a stylet, but the functional length and performance of a bougie when needed. Since the improved introducer functions equally well as a bougie or a stylet, it allows a reduction from two devices to only one needed device. Saving space and reducing complexity (stocking requirements) are important in many settings where emergency airways are needed, i.e., emergency services, tactical situations, ambulances, helicopters, etc. The improved introducer also allows one-handed conversion from use of the device as a stylet to use as a bougie, which is advantageous when unexpected tube insertion difficulty is encountered.

FIGS. 1A-1Kshow an improved introducer100according to certain embodiments of the disclosure.FIG. 1Ashows a side view of introducer100in its fully open, straight configuration (e.g., for use as a bougie), whileFIG. 1Bshows a top, plan view of portions of different sections of introducer100. As shown inFIGS. 1A and 1B, introducer100has a hinge102connecting a proximal “stylet” section104to a distal “bougie” section106. In one embodiment, the proximal stylet section104is made from a malleable metal rod, hinge102is made from a malleable plastic, and the distal bougie section106has the mechanical properties, tip108, and bend shape of a standard plastic bougie. The tip108is rounded similar to the shape of a bougie tip for interacting with the tracheal rings. The hinge section allows the introducer to bend over on itself. As described below, the proximal stylet section104is relatively thin and can fit within a recess110in the top half of the wider, distal bougie section106.

FIGS. 1C-1Fshow lateral cross-sectional views of different sections of introducer100, where the proximal stylet section104and hinge102each have a generally rectangular lateral cross section, with the hinge defined by a larger of the two rectangles. The distal bougie section106and the tip108have generally circular lateral cross sections of substantially equal diameter, except that the distal bougie section106has a longitudinal recess110that is sized and shaped to receive the proximal stylet section104, for example, with a friction fit, when the introducer100is folded upon itself at hinge102(as shown, for example, inFIGS. 1I-1K). In alternative designs, the longitudinal recess110is omitted and/or the proximal stylet section is cylindrical, similar to the rounded wire used in a standard steel stylet. The wire used for the proximal section104should be stiff enough to hold the shape of an overlying tube, and small enough to fit alongside the distal bougie section106without exceeding an outer diameter of ˜5 mm (so that it will slide easily within adult tracheal tubes having 6.5-8.5 mm inner diameters).

There are numerous manners in which the hinge section102could be constructed. In the embodiment shown inFIGS. 1A, 1B, and 1D, the hinge's rectangular cross section allows the hinge to bend up and down, but has inherent relative side-to-side strength. The hinge section could be modified with ridges, or other modifications to facilitate the bending needed, but also allow creation of a loop for removal of the introducer when it is used a stylet. The hinge102should be strong enough to keep proximal stylet section104and the distal bougie section106moving in the same plane (bending up and down, but not side-to-side). It should also permit straightening, so that, when the introducer is used as a bougie, a tube can be slid down the proximal end, over the hinge, and into the trachea.

FIG. 1Gshows introducer100configured for use as a bougie with hinge102bent to form an angle of about 100 degrees between the proximal stylet section104and the distal bougie section106. Because of the flattened shape of the hinge section102, the proximal stylet section104can be configured to be roughly perpendicular to and approximately co-planar with the upturned tip108of the distal bougie section106. When introducer100is used as a bougie for intubation, the operator knows the direction of the distal tip108because of the directionality provided to the introducer by the geometric relationship established between the bougie tip and the proximal section by the hinge102. Just like a bougie, after placement of the introducer within the trachea, a tracheal tube can be advanced over the back end of the introducer and railroaded into the trachea.

FIG. 1Hshows introducer100preloaded with a tracheal tube112with the proximal stylet section104folded over the proximal end of the tube to prevent the tube from sliding off the proximal end of the introducer and to form a handle114that provides directionality to introducer100. Unlike a standard bougie, in this configuration, introducer100can be preloaded with a tracheal tube and used with a one-hand technique. When the introducer and tube are held together, the devices do not slide on one another.

FIG. 1Ishows introducer100configured for efficient storage or for stylet use with the proximal stylet section104folded onto the distal bougie section106where the bent hinge102forms a handle116that provides directionality to introducer100. With the introducer folded on itself, it has the rigidity to shape a tracheal tube, and can be bent into a shape needed for direct laryngoscopy or video laryngoscopy. Note that, when introducer100is folded into this stylet-use configuration, the bougie tip108extends beyond the proximal stylet section104. This prevents the rigid stylet section from injuring the trachea if the tip of the introducer extends beyond the length of the tube. Although not depicted inFIG. 1I, introducer100can be configured such that the proximal stylet section104fits at least partially if not completely within recess110of the distal bougie section106to provide the introducer with a very low profile.

FIGS. 1J and 1Kshow introducer100configured as inFIG. 1Iand pre-loaded with tracheal tube112for use as a stylet for direct and video laryngoscopy, respectively, where the distal end118of the folded-over sections104and106is bent approximately 35 degrees for direct laryngoscopy (FIG. 1J) and approximately 70 degrees for video laryngoscopy (FIG. 1K). In these configurations, the handle116formed by the hinge102functions as a grab loop for removal of the introducer after the tube tip has been placed into the trachea.

Introducer100may have a lubricious coating to permit removal of the introducer through a tracheal tube either when used as a bougie or when doubled over on itself and used as a stylet.

FIGS. 2A-2Bshows an improved introducer200according to certain other embodiments of the disclosure.FIG. 2Ashows a side view of introducer200configured for use as a stylet or as a bougie, depending on whether or not a tracheal tube (not shown) is pre-loaded onto the introducer. Introducer200has a malleable proximal section202connected to a distal main body204by an attachment mechanism206. In the configuration shown inFIG. 2A, the proximal section202has been bent by about 90 degrees at three different locations to form a handle208, where the back end210of proximal section202engages with the attachment mechanism206to secure the proximal section in place and retain its handle-forming shape.

FIG. 2Bshows a close-up, side view of the handle208ofFIG. 2Aformed by the bent proximal section202and attachment mechanism206.

In this embodiment, introducer200is a rod of a length between 50 and 65 cm. When the proximal section202does not engage the attachment mechanism206, this length enables introducer200to be used as a bougie, where the introducer tip212is inserted into the trachea (it is approximately 16 centimeters from the teeth to the laryngeal entrance), and a tracheal tube (not shown) of approximately 30-34 cm is subsequently inserted over (i.e., railroaded down) the back end210of the introducer and into the trachea. Note that attachment mechanism206is designed such that, after the bougie tip212of the introducer configured as shown inFIG. 2Ahas been inserted into the trachea, the operator can disengage the attachment mechanism (e.g., with the same hand that is holding the introducer) to allow the proximal section202to unfold and a tracheal tube to be railroaded down the introducer's back end210and into the trachea (e.g., using the operator's free hand).

The distal tip212of introducer200is upturned at an angle of approximately 35 degrees (between 30 and 40 degrees) to be similar in shape and mechanical flexibility as the tips of conventional bougies. The upturned tip212preferably does not exceed 30 millimeters in length, and the total length of the upturned tip212and the main body204does not exceed about 25 millimeters. The average trachea has an anterior-posterior dimension of 14-16 mm in women and 15-20 millimeters in men. If the total length of the upturned tip and the main body is too large, then introducer200might not be able to be inserted into the trachea without catching on the anterior tracheal rings.

In some implementations, the bending of introducer200has directionality resulting from the presence of a flat malleable wire (not shown) embedded in the rod, beginning at a point behind the upturned distal tip212and extending proximally approximately 30 centimeters towards the back end210. The flat malleable wire (a metal or a plastic that can retain its shape) provides the rigidity for holding a tracheal tube in a predetermined shape. Tracheal tubes have an inherent arcuate shape, and a standard bougie cannot keep such tubes in a straightened position. Conversely, this is exactly what a stylet does—allowing straightening of the main body of the tube (and upturning the distal tip). The flatness of the malleable wire means that the introducer will tend to bend such that the introducer retains its anterior-posterior orientation, i.e., bending will be preferentially up/down as opposed to what would occur with a round wire embedded within a round rod. One implementation employs an elliptical rod (wider in its side-to-side dimension than its top-to-bottom dimension) along its entire length. This shape would cause preferential bending along the entire rod as well as along the embedded wire section.

There is an added advantage to an elliptical rod shape. When sliding a tracheal tube down such an elliptical rod, there will be less of a gap on the sides of the rod (between the outer diameter of the rod and the inner diameter of an overlying tracheal tube) than there will be between the top and bottom of the rod and overlying tube. This lateral gap is significant because, if too great a disparity exists, then the tube can catch on the laryngeal inlet as it is railroaded over the introducer. Almost all tracheal tubes use a left-facing bevel design in which the tip is not symmetric, where the main bevel faces −90 degrees from vertical when viewing a tube down its long axis, and a Murphy eye (an elliptical hole in the body of the tube within an inch of the distal tip) is located on the opposite right (+90 degree) position. The leading edge of left-facing beveled tubes is therefore located at +90 degrees. Standard tubes have a left-facing bevel, either with a straight cut, or a slight rounded tip. A Parker tube has a symmetric ski-tip shaped tip. Turning tracheal tubes to the right when they contact the tracheal rings causes the bevel to face upwards, and the inclination to turn down, facilitating insertion. When a gap exists between a bougie (typically sized at 5 millimeters outer diameter) and an overlying tube (anywhere from 7.0-9.0 millimeters internal diameter in adults), the gap hits the right arytenoid and aryepiglottic fold. The elliptical rod for introducer200could be slightly larger than a standard bougie in its side-to-side dimension, and conversely smaller in its top-to-bottom dimension, which would minimize the lateral gap, but still have a similar amount or less surface contact between devices (which would inhibit the tube from sliding over the bougie).

Located between about 30 cm and about 50 cm from the distal tip212, the attachment mechanism206allows the bent proximal section202to be locked into a fixed position approximately perpendicular to the main body204, as shown inFIG. 2A. This bending of the proximal section202over the main body204creates a T-shape (i.e., between the main body204and the straight back end210of the proximal section202), with the back end210extending a distance (below the axis of the main body204) preferably not to exceed 50 millimeters. The resulting handle208is in alignment (i.e., roughly co-planar) with the orientation of the distal upturned tip212of the introducer. This relative orientation results from the flat wire, the way the attachment mechanism206engages the back end210, and/or the elliptical shape of the rod.

FIG. 2Bshows attachment mechanism206corresponding to one possible design for engaging with the back end210of the bent proximal section202. A variety of other designs are possible. These include, without limitation, a pin or hook connection, a locking-snap mechanism, or small magnetic clips. Some possible designs enable attachment (e.g., crossing of the sections) at any several points along the proximal section202from the back end210of the malleable wire to approximately 5 centimeters from the attachment mechanism206. This would allow bending (and locking) the introducer on itself with either a large handle or a short handle, allowing the operator to vary the functional length of the introducer.

Introducer200can be configured for use as a standard bougie, e.g., fully extended (straight), such that a tube can be railroaded over its length and into the trachea.

By bending the proximal section202and securing it using the attachment mechanism206), the introducer's effective length is shortened which makes it easier to handle and insert into the trachea. The resulting handle208provides an ergonomically effective way to control the introducer and also gives the operator an indication of the orientation of the upturned tip212. Once the tip212has been inserted into the trachea, the attachment mechanism206can be easily released, e.g., by the operator's single hand holding the introducer at the T-shaped intersection. This allows subsequent railroading of a tracheal tube over the device (with the released introducer now having no impediments to sliding of a tracheal tube down its length) and into the trachea. Accordingly, the attachment mechanism206(or other attachment points (not shown) on the main body204) should be sufficiently low profile and/or shape not to restrict sliding of a tracheal tube down the introducer.

Alternatively, introducer200can be used as a stylet (shaped for either direct or video laryngoscopy), where a tracheal tube is pre-loaded onto the distal end of the introducer200pre-configured with a handle, as shown inFIG. 2A, with the distal tip212projecting beyond the pre-loaded tube and where the engagement of the bent proximal section202with the attachment mechanism206form a stop that prevents the tracheal tube from sliding any further towards the proximal end of the introducer.

FIGS. 3A-3Fshow an improved introducer300according to certain other embodiments of the disclosure. Introducer300is similar to introducer200ofFIG. 2, except that the attachment mechanism306for introducer300is different from the attachment mechanism206of introducer200. In particular, attachment mechanism306is a metal clip that wraps around the intersecting sections of the introducer300to hold them in place. Note that the attachment mechanism206ofFIG. 2is located at a fixed position along introducer200, while attachment mechanism306ofFIG. 3is movable such that it can be re-located to different positions along introducer300.

FIG. 3Ashows a side view of introducer300configured for use as a bougie with a relatively small handle308, whileFIG. 3Bshows a side view of introducer300configured for use as a bougie with a relatively large handle308. Note that the two different handle sizes are achieved by locating attachment mechanism306at two different positions along introducer300.

FIG. 3Cshows a side view of introducer300configured for use as a stylet for direct laryngoscopy (i.e., about 35-degree bend at its distal end) with a pre-loaded tracheal tube304, whileFIG. 3Dshows a side view of introducer300configured for use as a stylet for video laryngoscopy (i.e., about 70-degree bend at its distal end) with pre-loaded tracheal tube304. Note that the location of attachment mechanism306in these two configurations results in the distal end of the tracheal tube extending beyond the distal tip312of introducer300in bothFIGS. 3C and 3D.

FIGS. 3E and 3Frespectively show side views of introducer300configured for use as a stylet for direct and video laryngoscopy with pre-loaded tracheal tube304. Note that the location of attachment mechanism306in these two configurations results in the distal tip312of the introducer extending beyond the distal end of the tracheal tube and also in handle308inFIGS. 3E and 3Fbeing smaller than handle308inFIGS. 3C and 3D. In all four configurations ofFIGS. 3C-3F, the position of the attachment mechanism306determines the location of a stop that prevents further insertion of the tracheal tube304onto introducer300.

FIGS. 4A-4Eshows an improved introducer400according to certain other embodiments of the disclosure. Introducer400is similar to introducer100ofFIG. 1, except that the attachment mechanism406for introducer400is different from the attachment mechanism206of introducer200. In particular, attachment mechanism406consists of a fixed male component402and two fixed female components404(1)-404(2) located at two different positions along introducer400. In general, introducers may have one or more male components and one or more female components.

FIG. 4Ashows a side view of introducer400, whileFIG. 4Bshows a top plan view of introducer400. Note that, since the male and female components are on opposite sides of the introducer, male component402is not visible inFIG. 4A.

FIGS. 4C and 4Drespectively show close-up top views of male component402and female component404(i). Male component402includes a cylindrical or rectilinear center post408capped by a cylindrical or rectilinear cap410, whose width is larger than the width of the center post408. Female component404(i) includes two cylindrical or rectilinear posts412separated by a distance that is greater than the width of center post408, but smaller than the width of cap410. To engage the attachment mechanism406, the proximal section414of introducer400is bent a total of about 270 degrees such that the center post408of male component402is located between the two posts412of female component404(i) with the cap410of male component402preventing the attachment mechanism406from dis-engaging and introducer400from unfolding.

FIG. 4Eshows introducer400configured with male component402engaging female components404(i) to form handle416. Note that the positions of the two female components404(1) and404(2) along introducer400may be selected such that (i) configuring introducer400with male component402engaging female component404(1) would result in a relatively large handle416for a stylet for which the distal end of a pre-loaded tracheal tube (not shown) would extend beyond the distal tip of the introducer, whereas (ii) alternatively configuring introducer400with male component402engaging female component404(2) would result in a relatively small handle416for a stylet for which the distal tip of the introducer would extend beyond the distal end of the same-sized pre-loaded tracheal tube (not shown). Here, too, after insertion of the bougie tip418into the trachea, an operator can dis-engage the attachment mechanism406(for example, with one hand) to enable a tracheal tube to be railroaded over the introducer's back end and into the trachea (for example, using the operator's free hand).

FIGS. 5A-5Ishows an improved introducer500according to certain other embodiments of the disclosure.FIG. 5Ashows a side view of introducer500. As shown inFIG. 5A, introducer500has a relatively flexible proximal section502connected to a first (proximal) malleable section504connected to a relatively flexible distal section506connected to a second (distal) malleable section508. As shown inFIG. 5B, the proximal end of proximal section502has a flattened (or otherwise reduced-size) tip510, while the distal end of the second malleable section508has a conventional bougie tip512as shown inFIG. 5C.

As used herein, the term “flexible” means that the section can be relatively easily bent, but does not necessarily retain its bent shape on its own and may require application of some external retaining force to keep the section in its bent shape. On the other hand, the term “malleable” means that the section can be bent and will retain its bent shape on its own without having to apply any external retaining force.

In one embodiment, introducer500has a total length between about 50 cm and about 70 cm. This length is for use as a bougie when the introducer tip512has been inserted into the trachea and a tracheal tube of approximately 30-34 cm is subsequently inserted (i.e., railroaded down) over the back end of the introducer and into the trachea.

Introducer500has directionality created by the presence of the two malleable sections504and508. The second malleable section508begins at a point behind the upturned distal tip512and extends proximally approximately 15 centimeters. The first malleable section504is located between about 25 and about 45 centimeters from the distal tip512. The malleable sections may be created by a tubular metallic material (including a hollow thin metallic rod, slid over the bougie, metallic foil tape wound over the bougie, or a metallic material embedded in the rod, i.e., a wire or flattened wire).

Tracheal tubes have an inherent arcuate shape, and a standard bougie cannot keep it in a straightened position. Conversely, this is exactly what a stylet does—allowing straightening of the main body of the tube (and upturning the distal tip). The two malleable sections504and508enable introducer500to retain a bendable shape at two points. This permits a variety of shaping options, either with or without an overlying tracheal tube.

By having two malleable sections504and508with greater rigidity than the intervening distal section506, there is a preferential movement and flexibility between the malleable sections. For example, when a tracheal tube is slid over introducer500configured for use as a stylet, the malleable sections504and508can be shaped with the shape being maintained for tube insertion, but, upon insertion further into the trachea, the distal section506between the two malleable sections allows introducer500to unbend.

FIG. 5Dshows introducer500configured for use as a bougie with the first malleable section504bent by about 90 degrees to form a grip region514for an operator, where proximal section502is roughly co-planar with bougie tip512. After insertion of the bougie tip512into the trachea, the operator can straighten the bent malleable section504(for example, with one hand) and railroad a tracheal tube over the introducer's back end and into the trachea (for example, using the operator's free hand).

FIG. 5Eshows introducer500having the configuration ofFIG. 5Dbut pre-loaded with a tracheal tube516. With the tracheal tube516inserted up to the 90-degree bend, an operator can grip with one hand both the proximal end of the tube and the introducer at the bend for efficient insertion of the styletted tube into the trachea.

FIG. 5Fshows a side view of introducer500configured for use as a stylet for direct laryngoscopy (i.e., with an about 35-degree bend at its second malleable section508) with a pre-loaded tracheal tube516, whileFIG. 5Gshows a side view of introducer500configured for use as a stylet for video laryngoscopy (i.e., with an about 70-degree bend at its second malleable section508) with pre-loaded tracheal tube516. In these configurations, a handle518is formed by bending the flexible proximal section502by a total of about 180 degrees and forcing the flattened proximal tip510into the proximal end of the overriding tracheal tube516to secure everything in place. Note that the length at which introducer500is inserted within tube516determines (i) whether the distal end of tube516extends beyond the distal tip512of introducer500, or vice versa, and (ii) the size of handle518.FIG. 5Hshows a side view of introducer500configured for use as a stylet in which (i) the distal tip512of introducer500extends beyond the distal end of tube516and (ii) handle518is smaller than the handles ofFIGS. 5F and 5G.

The flattened proximal tip510gives introducer500an inherent directionality (i.e., the operator knows the orientation of the distal introducer tip512by the orientation of the flattened proximal tip510). By curling the proximal section502over itself (and securing it through the tracheal tube connector), the introducer's length is shortened which makes it easier to handle and insert into the trachea. The proximal curl provides an ergonomically effective way to control the introducer and also gives the operator an indication of the orientation of the upturned bougie tip512.

FIG. 5Ishows a side view of introducer500configured for efficient packaging or storage with the flexible proximal section502and the first malleable section504providing a total bend angle of about 180 degrees. Note that tape520or other fixture522may be employed to secure introducer500in this configuration.

The standard approach to dealing with a hyperangulated stylet is to withdraw the stylet after the tube tip is through the cords, and then try pushing the tube down into the trachea. But the tube comes off the stylet pointing upward, following the upward arc of the stylet, not the downward inclination of the trachea. This can cause mechanical impaction. In another approach, the stylet and tube are both turned rightward 90 degrees. The tube can then be advanced off the stylet with one hand (i.e., can be done without assistance). In another approach, the tube alone is rotated rightward 90 degrees (e.g., with assistance from another person). Both approach solve the problems of corrugation (bevel up) and inclination (tube down).

The introducer500is a tube introducer with a narrow, long axis and an upturned distal tip512. The introducer500has an outer diameter small enough (e.g., 5 mm) to receive any tracheal tube. The upturned tip facilitates visualization and bounces off the trachea rings, providing a tactile confirmation of tracheal placement. It is useful to know the direction of the upturned tip on placement, especially in poor views. The grips shown inFIGS. 5E-5Hlabelled above allow this (unlike a standard pencil grip on device).

It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain embodiments of this invention may be made by those skilled in the art without departing from embodiments of the invention encompassed by the following claims.