TUBE INTRODUCER INTUBATION DEVICE

An endotracheal tube introducer that includes a controller, a flexible tip, and a tube guide. The controller has an actuator and a rotatable bearing. The actuator operably coupled to move the rotatable bearing. The tube guide is operably coupled between the controller and the flexible tip. The flexible tip is operably coupled to the rotatable bearing to move in at least two degrees of freedom responsive to movement of the actuator.

FIELD OF THE INVENTION

The present invention is directed to methods and apparatus for performing oral intubation.

BACKGROUND

Various medical treatments require assisted respiration, for example, from a ventilator. By way of non-limiting surgical anesthesia, illness affecting respiratory function, and trauma can all require assisted respiration. Assisted respiration is carried out through a tube inserted through the mouth of the patient and directed to the larynx. The process of inserting the tube into position for respiration is known as oral intubation.

In some patients, the process of intubation is complicated by anatomical conditions, known in the art as difficult airways. To intubate a patient with a difficult airway, it is necessary for the medical professional to be able to navigate through any obstructions in the mouth and at the rear of the throat to successfully place a tube to establish an airway.

A difficult airway can present risk of intubation failure, which can be life threatening, or can result in injury due to the urgency to complete the intubation. Many intubations involve the use of video laryngoscopy, which involves a specialized imaging device designed to provide video images of the patient's airway to assist the physician in the intubation procedure. Other methods and devices have been used in conjunction with the video laryngoscope, and some that use other imaging and guiding techniques, to improve the intubation procedure.

In many prior art devices, the airway tube is guided into the airway using an introducer or stylet. In one prior art device, an introducer mechanism has an actuating tip. This device, a version of which is shown in U.S Patent Publication no. 2017/0203075, bends in a single direction, providing one degree of freedom movement of the actuating tip of the introducer.

An alternative to the inexpensive, disposable options is using a bronchoscope to hold and transport the tracheal tube and a video scope to view the tissue on the way through the patient's throat. Unfortunately, cleaning the bronchoscope after each use or replacing a broken device is prohibitively expensive.

SUMMARY

At least one embodiment described herein resolve the issues of prior art solutions to intubating difficult airways using a multi-dimensionally articulable introducer. The introducer eases placement of the tracheal tube when performing oral intubation in difficult airways.

A first embodiment is an endotracheal tube introducer that includes a controller, a flexible tip, and a tube guide. The controller has an actuator and a rotatable bearing. The actuator is operably coupled to move the rotatable bearing. The tube guide is operably coupled between the controller and the flexible tip. The flexible tip is operably coupled to the rotatable bearing to move in at least two degrees of freedom responsive to movement of the actuator.

Another aspect of the invention is a novel intubation method using the multi-dimensional articulable introducer or stylet. Once the introducer unit has been steered into place beyond the vocal cords with the assistance of the actuator and flexible tip, the tracheal tube can be slid off of the guide tube and into place in the airway. The device simplifies locating the tube with enhanced range of motion maneuverability through the airway. The steering intubation device decreases the likelihood of injuries and mortalities associated with intubation of difficult airways.

DETAILED DESCRIPTION

FIG. 1shows a perspective view of a first embodiment of an articulable stylet or introducer10.FIG. 2shows a side plan view of the introducer10. As will be discussed further below, the introducer10is used in an intubation procedure to place an endotracheal tube through the mouth and into the glottic opening of a patient. By way of example,FIG. 8shows an endotracheal tube200disposed over the introducer10, ready for oral insertion into the patient. In general, the introducer10and tube200are advanced through the mouth into the glottic opening, and then the introducer10is pulled out, leaving the endotracheal tube200in place. Ventilation equipment, not shown, can then be attached to the endotracheal tube200to assist the patient in ventilation.

With reference toFIGS. 1 and 2, a first embodiment is an articulable introducer10that includes a controller12, a tube guide14and a flexible tip16. In general, the controller12includes, a digitally manipulatable actuator18, a rotatable bearing20and a handle38. The actuator18is fixedly coupled to move the rotatable bearing20. As will be discussed in further detail below, the handle38supports the bearing20such that the bearing can move in at least two degrees of freedom or at least two dimensions with respect to the handle38responsive to corresponding movement of the actuator18.

The bearing20is operably coupled to the flexible tip16such that the flexible tip16moves in a way that corresponds to the rotatable movement of the bearing20. Because the actuator18is fixedly coupled to the bearing20, a user may manipulate the position of the flexible tip via movement of the actuator18. In this manner, the actuator acts like a joystick. The unactuated position of the flexible tip16is in the axially outward direction from the end of the tube14. This position is referred to as the rest position or center position30.

In this embodiment, the relative movement of the flexible tip16with respect to the tube guide14(or the center/rest position30) is substantially spherical in nature. In a spherical coordinate system (r, θ, φ), flexible tip16is movable in the θ (longitude) dimension and in the φ (latitude) dimension. With reference toFIG. 1, the flexible tip16is controllably movable or articulable (relative to the tube guide14or center/rest position30) in a 360 degree range in the φ dimension, thus allowing the user to move the tip16in the forward direction22, the backward direction24, the right direction26and the left direction28, as well as all angular directions in between.

FIG. 3shows the movement of the flexible tip16in the θ dimension, which has a range32of approximately 90 degrees. In particular,FIG. 3shows a fragmentary perspective view of the tube guide14and flexible tip16illustrating the movement in the θ dimension of the flexible tip16from center position30. In particular,FIG. 3shows four exemplary positions30,34a,34b,34cof the flexible tip16, including the center position30, and three positions34a,34b,34chaving different non-zero angled in the θ direction.

As a consequence, the user may use the actuator18to bend (movement in the θ direction) in the forward direction22, the backward direction24, the right direction26and the left direction28, as well as angular directions therebetween (φ angle).

It will be appreciated that the at least some advantages described herein can be achieved if the range of latitudinal position is less than 360 degrees, and/or of the range of longitudinal movement is less than 90 degrees. Indeed, at least some embodiments will have a range of longitudinal movement (i.e. bend angle) closer to 45 degrees. Having the ability to manipulate the tip to any set of multiple latitudinal (i.e. φ) positions and longitudinal positions (i.e. θ) provides at least some of the advantages discussed below. Again, from the user's perspective, this allows the tip16to bend (θ movement) in more than one left-right-forward-back (φ) direction. It will further be appreciated that the bending motion need not be spherical, but may take other shapes. As long as the tip16articulates in multiple left-right-forward-back (φ) directions, the user gains advantages.

Referring again to the general structure of the introducer10,FIGS. 4, 5 and 6shows the controller12in further detail, with a fragmentary portion of the tube guide14.FIG. 4shows a side plan view of the controller12with one of the covers removed,FIG. 5shows a perspective view of the controller12with one of the side covers removed, andFIG. 6shows an exploded perspective view of the controller12.

Referring toFIGS. 1, 4, 5 and 6, the handle38includes a first cover38aand a second cover38bjoined a peripheral central seam38c. The first cover38aand second cover38bhave designs that a largely symmetrical to each other along the same38c. The handle38has a back side40, a left side41, a front side42, a right side43, a top side44and a bottom46. Each of the first cover38aand the second cover38bforms about half of each of the sides40,42,44and the bottom44. The first cover38aincludes the left side41and the second cover38bincludes the right side43.

The back side40, the left side41, the front side42, and the right side43form a handle structure that extends from the top side44to the bottom46, and which is configured to receive an adult human grip. The front side42preferably has finger grooves48formed therein, to facilitate a stable grip with a free thumb for manipulating the actuator18, which extends from the top side44. In this embodiment, the back side40, the front side42, the top side44and the bottom46are largely symmetrical about the intersection seam38cof the two covers38a,38b, which allows for use by in either the right hand or the left hand. The handle38defines a vertical axis α that is intermediate back side40, the left side41, the front side42, and the right side43.

As shown inFIG. 6, the cover38aand cover38bare coupled by a plurality of fasteners38d. InFIGS. 4 and 5, the cover38ahas been removed to reveal the interior structure of the cover38b. It will be appreciated that the cover38ahas a mirror image of the interior structure of the cover38b. With reference toFIGS. 5, 6 and 7, the cover38includes a bearing seat50, a funnel section56, and a tube seat60.

The bearing seat50is configured to receive and retain the bearing20such that the bearing20may rotatable move in multiple degrees of freedom. To this end the bearing seat50in this embodiment has an interior surface50athat defines a portion of a sphere and includes vertical channels50b. In general, the bearing seat50retains the bearing20and allows partial spherical movement of the bearing20. The bearing seat50has an open top52and an open bottom54, and is centered about the common axis α. The open top52in this embodiment also forms an opening in the top side44, and is concentric with the common axis α. The open bottom54opens into the funnel section56.

The funnel section56extends from the top section open bottom54of the bearing seat50to the top end of the tube seat60. The funnel section56defines a frustoconical void68having an axis on the common axis α. The frustoconical void68has a first diameter adjacent the open bottom54and converges to its narrow diameter at the top of the tube seat60. It will be appreciated that, as with other structures in the interior of the handle38, the cone section56and the corresponding section of the second cover38bcollectively form the entire funnel section56that defines the frustoconical void68.

As shown inFIGS. 5 and 6, the controller12further includes a concentrator plate58having four slots58a-58d. The concentrator plate58is in the form of a disk in this embodiment. The four slots58a-58dextend inward from an outer periphery and terminate at locations equidistant from each other, and equidistant from the common axis α. The slots58a-58dare configured to receive and guide the wire segments as discussed below. The concentrator plate58is received in and secured by features of the second cover38b(and first cover38a) within the funnel section56, perpendicular to the common axis α. The inward extents of the four slots58a-58dare within the frustoconical section68. It will be appreciated that the slots58a-58dmay be replaced by corresponding throughholes which would also guide the wire segments.

As shown inFIGS. 4, 5 and 6, the tube seat60extends approximately from the bottom46to about halfway to the top side44terminating at the bottom of the funnel section56. The tube seat60generally defines a cylindrical interior surface60athat is configured to receive the tube guide14, and is concentric with the common axis α. Thus, the center of the bearing seat50, the axis of the frustoconical void68and the central axis of the cylindrical interior surface60aare axially aligned along the common axis α.

The bearing20in this embodiment includes a fore-aft yoke70and a lateral yoke72. The fore-aft yoke70includes an outer ring102and interior guides74,80. The outer ring102is partially received and retained with in the channel50bof the bearing50. As a consequence, the fore-aft yoke72can only rotate fore and aft, constrained by the channel50b. The outer ring102further comprises hub bores108and a plurality of wire holes110. The hub bores108extend radially through opposite sides of the outer ring102at about the vertical midpoint of the outer ring102. As will be discussed further below, the hub bores108receive the axle120of the lateral yoke72. The plurality of wire holes110are disposed below the hub bores, and are configured to receive the ends of wires therethrough. The outer ring102has a discontinuity at its top, forming a void102afor receiving the actuator18and allowing movement of the actuator18, as will discussed below. The bottom of the outer ring102includes a transverse inner groove102b.

The guides74,80cooperate to form a guide channel112for receiving a portion of the lateral yoke72, as will be discussed below. The guides74,80further cooperate to form a shroud to inhibit visual or physical access to the interior of the handle38via the open top52. The guide74includes an arcuate vertical plate76and an arcuate lateral plate78that are joined at a common edge75. The guide80similarly includes an arcuate vertical plate82and an arcuate lateral plate84.

The arcuate vertical plates76,82are oriented perpendicular to the circumference of the outer ring102, and extend in a parallel and arcuate manner from opposite sides of the void102ato locations approximately even with the vertical midlevel of the outer ring102. Thus, the arcuate vertical plates76,82and the void102aform the guide channel112. The arcuate lateral plates78,84are likewise oriented perpendicular to the circumference of the outer ring102, and are also oriented perpendicular to the vertical plates76,82.

Each of the arcuate lateral plates78,84extends arcuately from approximately the vertical midpoint of the outer ring102to the bottom of the respective one of the vertical plates76,82at the bottom of the guide channel112. It will be appreciated that the radial extent of each of the plates76,78,82,84is short of the radial extent of the outer ring102, so as to allow the outermost portion of the outer ring102to seat within the channel50bwithin the bearing seat50without interference from the plates76,78,82,84.

The lateral yoke72includes a half wheel118, an axle120. In this embodiment, the lateral yoke72is integrally formed with the actuator18, forming the rigid connection between the bearing20and the actuator18. The actuator18includes an engagement plate88and a connection post90. The engagement plate88has a top surface88a(seeFIG. 1) that is configured to receive an adult human thumb, and may include a convex shape and surface features for friction. The connection post90extends from the bottom surface of the plate88to the outer surface of the top of the half wheel118.

The half wheel118has a rim118a, radial spokes118b, and a hub118c. The half wheel118has the general design of a spoked wheel that has had its bottom half removed. Thus, the rim118aextends about 180 degrees about an axis on which the hub118cis centered. Two of the radial spokes118bform the bottom, with the hub118cdisposed therebetween. The rim118ahas an outer diameter configured to fit and rotate within the bearing seat50and guide channel112. The half wheel118has an axial width sized to fit (and rotate) within the guide channel112, and the transverse inner groove102b. The axle120extends axially through the hub118cand is rotatably received by the hub bores108in the fore-aft yoke70.

In the rest or default position, shown inFIGS. 1, 4, and 5, the connection post90extends slight askew (least 10 to 30 degrees) of the common axis α. The engagement plate88is disposed perpendicular to the connection post90, and thus tilts slightly backward toward the back side40. This rest position corresponds to the neutral or center position30of the flexible tip16. The slight backward tilt of the top surface88aof engagement plate88and post90in the rest position provides improved ergonomics as compared to being strictly aligned along the common axis α.

The yokes70and72allow for movement of the actuator18any of the 360 degrees of position. To this end, the fore-aft yoke70allows rotation along the forward and backward dimension, and the yoke72allows rotation along lateral dimension, such that combinations of rotations can result in any angle in between. More specifically, the fore-aft yoke70is constrained to forward and backward travel by the vertical channels50b, and the lateral yolk72is constrained to bidirectional lateral travel by the guide channel112, and the transverse inner groove102b. However, as the yoke70rotates, the axle120and constraints on the yoke72change, such full two-dimensional displacement of the actuator18is possible.

The two dimensional displacement of the actuator18and hence the bearing20is translated to the flexible tip16via four wire segments150,152,154and156. The four wire segments150,152,154and156are operably coupled to the bearing20and to the flexible tip16to translate the movement of the actuator18and bearing20to the flexible tip16. To this end, two of the wire segments150,152are coupled to opposite sides of the outer ring102of the fore-aft yoke70, and two of the wire segments154,156are operably coupled to the opposite sides of the rim118a. More specifically, the wire segments150,152are coupled to respective locations adjacent to and just below the hub bore108on the outer ring102(via openings110). The wire segments154,156are coupled adjacent to respective radial spokes118bof the half wheel118. It will be appreciated that the wire segments150,152,154and156could be replaced by any other suitable flexible cord.

The wire segments150,152,154and156extend through corresponding slots58a-58din the concentrator plate58, and then extend into the hollow interior of the tube guide104. The wire segments150,152,154and156are then operably coupled to the flexible tip16. In particular, as shown inFIGS. 1 to 3, the flexible tip16includes a coupler180, a catheter182, and a bulbous nub184. The wire segments150,152in this embodiment form a single continuous wire having ends connected to the fore-aft yoke70as described above, and wire body that wraps around the face184aof the nub184. Similarly, the wire segments154,156in this embodiment form a single continuous wire having ends connected to the lateral yoke72as described above, and wire body that also wraps around the face184aof the nub184.

FIG. 7shows an exploded view of an exemplary embodiment of the flexible tip16in further detail. The catheter182forms the flexible tubular member that moves in two degrees of freedom responsive to the movement of the actuator. The catheter182in this embodiment is quad-lumen catheter, having separate passages182a-182dfor each of the wire segments150,152,154,156, not shown inFIG. 7. The coupler180is a polymer device that couples the larger diameter tube guide14to the catheter180, allowing the wire segments to pass therebetween. The bulbous nub184is affixed to the distal end of the catheter182, and includes a body186having a hollow interior, and end face184ahaving four openings188a-188d. The openings188a-188dpreferably align with passages182-182dof the catheter.

Although the wire segments150,152,154and156are omitted fromFIG. 7for clarity of exposition,FIG. 7Ashows a fragmentary perspective view of the nub184with the wire segments150,152,154and156assembled thereto. The positions of the wire segments150,152,154and156is described with contemporaneous reference toFIGS. 7 and 7A.

The wire segment150, not shown inFIG. 7, extends through the tube guide16, the coupler180, the passage182aof the catheter182, and through the bulbous nub184. As shown inFIG. 7A, the wire segment150exits out of the opening188a, and ends on the end face184a. On the end face184a, the wire is essentially both wire segments150and152. As also shown inFIG. 7A, the wire segment152extends into the opening188b. The wire segment152further extends through the bulbous nub184, through the passage182bof the catheter182, through the coupler180, and through tube guide16.

In the same fashion, the wire segment154, not shown inFIG. 7, extends through the tube guide16, the coupler180, the passage182cof the catheter182, and through the bulbous nub184. As shown inFIG. 7A, the wire segment154exits out of the opening188c, and ends on the end face184a. On the end face184a, the wire is essentially both wire segments154and156. The wire segment156extends into the opening188d, through the bulbous nub184, through the passage182dof the catheter182, through the coupler180, and through tube guide16. It will be appreciated that in other embodiments, the wire segments150,152,154,156may be formed of separate wires, each having ends connected to the actuator20and to the bulbous nub184.

In any event, the wire segments the wire segments150,152,154,156are relatively taut between the tip16and the rotatable bearing20when the actuator18is in the neutral (e.g. center) position. The ends of the wire segments150,152,154,156should be sufficiently engaged at the tip16to prevent full sliding movement between the opposing segments of the same wire.

In operation, movement of actuator18causes rotation of the rotatable bearing20. As discussed above, the yokes70,72are operably coupled to allow two dimensional rotation of the rotatable bearing. Rotation of the rotatable member20pulls on one or two of the wire segments150,152,154,156located opposite the direction of the actuator pull. The one or two pulled segments150,152,154,156pull at the flexible tip from one direction corresponding to the direction of the pull, thereby causing the flexible tip16to flex toward the tension created by the pull. In this manner, movement of the actuator18in any combination of front, back, left or right movements creates a corresponding movement in the flexible tip16such as those described above in connection withFIGS. 1, 2 and 3.

Referring again toFIGS. 4, 5, 6 and 7, the handle38further includes a retainer62extending along the common axis externally away from the bottom46. The retainer62facilitates retention of the endotracheal tube on the introducer10during the intubation procedure. The retainer62includes a cylindrical portion64that aligns with, connects to, and essentially forms a continuation of the tube seat60. The retainer62also includes a frustoconical portion66that extends from the cylindrical portion64. In general, the retainer62is sized and configured to receive an endotracheal tube, not shown inFIGS. 4 to 7, in a friction fit. The tube seat60, the cylindrical portion64, and the frustoconical portion66are aligned to provide a passage for the operative end of the guide tube14. As discussed above, the distal end of the guide tube14connects to the flexible tip16. In this embodiment, the tube guide14is hollow, and has a degree of flexibility.

In general, the tube guide member14and the flexible tip16are sized to slidingly receive an endotracheal tube which is commonly used for breathing assistance during anesthesia. To this end,FIG. 8shows an endotracheal tube200disposed over tube guide14, and engaged with the retainer62. In this position, the user may insert flexible tip16, followed by the tube guide14and tube200, into the mouth of the patient. The user then can use the actuator18to manipulate the position of the tip16to help direct the tube guide14and tube200to the glottic opening of the patient not shown. After the tube200is in the proper position, the user may pull the tube200off of the connector tip62and slide the tube guide14and tip16out through the tube200while the tube remains in place. Once the tube guide14and tip16are removed from the tube200, the operative end of the tube200may be connected to assisted respiration equipment.

A more specific intubation procedure300is described herebelow in connection withFIG. 9. In step305, a video laryngoscope, not shown, but which is known in the art, is placed in the mouth of the patient. In step310, the physician uses the video laryngoscope to find a view of the vocal cords of the patient. In step315, an assistant may then hold the video laryngoscope in place while the physician advances the introducer (i.e. stylet)10with a preloaded endotracheal tube200, as shown inFIG. 8, into the mouth and to the posterior pharynx.

Thereafter in step320, the physician then uses the actuator18, which in this embodiment is thumb-controlled, to direct the tip16of stylet10in any direction22,24,26,28or directions intermediate thereof to facilitate movement of the tip16towards the glottic opening (vocal cords). Once flexible tip16is at the glottic opening, the physician in step325advances the introducer10through opening into the trachea of the patient.

The physician then, step330, pulls the endotracheal tube200off of the retainer62.FIGS. 10 and 11show fragmentary views of the endotracheal tube200and introducer10.FIG. 10shows the endotracheal tube200affixed to the introducer10, andFIG. 11shows the operative end of the endotracheal tube200taken off the retainer62in the process of separation of step330. The endotracheal tube200may then be advanced along the guide14and over the tip16through the glottic opening into the trachea.

Thereafter, in step335, the introducer10may then be removed. To this end, the user slides the introducer10back up through the operative end of the endotracheal tube200. In step340, the endotracheal tube200is connected to standard respiratory assistance equipment, which is known on the art.

FIG. 12shows a plan view of an alternative embodiment of the controller12′. Specifically, the controller includes the handle38ofFIGS. 4 to 6, an alternative actuator, and an alternative bearing420.FIG. 12shows the controller12′ with the cover38aremoved, similar to the view of the controller12inFIG. 4. The controller12′ may suitably be used with the tube14and flexible tip16in place of the controller12.

In this embodiment, the dual yoke configuration of the bearing20has been replaced by a ball configuration. The bearing420is substantially a ball shape having the upper part422of its outer surface forming a sphere section that sized and configured to be retained by, and rotate within, the bearing seat50. The bottom part424of the ball may be slightly smaller to better accommodate attachment of the wire sections150,152,154and156thereto. The actuator418in this embodiment has a ribbed, dome-shaped upper surface426, but may otherwise have a similar structure as the actuator18.

The simplicity of design of the ball shaped bearing420is an advantage, but the lack of rotational constraint (other than the wire tension) may be a disadvantage compared to the bearing20. The choice of embodiment will depend on factors of the user's specific implementation.

The above-described embodiments of the introducer10are portable, and can be used in an operating room, ambulance, or a battlefield hospital. The tube introducer10can be provided as a disposable kit that includes the introducer10with a preloaded endotracheal tube200. The handle38may suitably be constructed from injection molded polymer, and the tube guide14formed of a partly flexible polymer tube.

It will be appreciated that the above-described embodiments are merely exemplary, and that those of ordinary skill in the art may readily devise their own implementations and modifications that incorporate the principles of the present invention and fall within the spirit and scope thereof.