EP3806941A1

EP3806941A1 - An endotracheal tube-inserting device

Info

Publication number: EP3806941A1
Application number: EP19819903.6A
Authority: EP
Inventors: Ronny BRAKHYA; Måns Collner; Robert Axelsson
Original assignee: Allytec AB
Current assignee: Turmidas AB
Priority date: 2018-06-12
Filing date: 2019-06-11
Publication date: 2021-04-21
Also published as: EP3806941A4; WO2019240655A1; SE1850711A1; SE542354C2

Abstract

An endotracheal tube-inserting device (1) comprises a stylet part (3) and a handle part (2) for operating the stylet part (3). The stylet part (3) has a proximal stylet end part (7) with a proximal stylet end (8) and an opposite curved distal stylet end part (5) with a distal stylet end (5a). The distal stylet end part (5) has an extension in form of a bendable tip part (4). A first string-operating member (14) is operatively connected to at least a first securing position (54a) at the bendable tip part (4) by means of a first string member (14), and a second string-operating member (15) is operatively connected to at least a second securing position (54b) at the bendable tip part (4) by means of a second string member (15). The bendable tip part (4) has a bendable proximal tip part (18) that extends into a bendable distal tip part (19) via a string- guiding member (46).

Description

An endotracheal tube-inserting device

The present invention relates to an endotracheal tube-inserting device comprising a stylet part and a handle part for operating the stylet part. The stylet part has a proximal stylet end part with a proximal stylet end and an opposite curved distal stylet end part with a distal stylet end. The distal stylet end has an extension in form of a bendable tip part. A first string- operating member is operatively connected to at least a first securing position at the bendable tip part by means of a first string member and a second string-operating member is operatively connected to at least a second securing position at the bendable tip part by means of a second string member.

In particular the present invention relates to endotracheal intubation, and apparatuses and methods useful in the positioning of an endotracheal tube within the airway of a patient. The term "endotracheal tube-inserting device" used in the context of the present application means a device adapted for inserting an endotracheal tube into trachea. The "endotracheal tube-inserting device" is an intubator, thus a device for controlling, directing, and placing an intubation tube within the trachea.

Unsuccessful direct laryngoscopy for orotracheal intubation occurs in particularly for patients having a "difficult airway" . Failure incidence has been reported to be as high as 0.3% to 0.43% in the studies of Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994; 41 (5) : 372-383. doi: 10.1007/BF03009858, and of Burkle CM, Walsh MT, Harrison BA, Curry TB, Rose SH. Airway management after failure to intubate by direct laryngoscopy: outcomes in a large teaching hospital. Can J Anaesth. 2005;52(6) :634-640. doi: 10.1007/BF03015776. Various kinds of blades and stylets are known in the art to improve the visuality of the airway when intubating a patient. Even though it may still be a huge challenge to help guide the endotracheal tube into and along the patient's trachea, including lifting vallecula out of the way, and trapping epiglottis to better expose the glottis and vocal cords.

Laryngoscopes are therefore often used to obtain a view of the glottis or the larynx, or to manipulate the tongue, glottis or larynx in order to facilitate insertion of such an endotracheal tube or other instruments such as endoscopes.

Even though airway-related complications associated with intubation procedures still occur. Examples of such complications include but are not limited to abrasion, hematoma, lacerations to lips, tongue, palate, pharynx, hypopharynx, larynx, and esophagus, injuries to lingual and/or hypoglossal nerve.

So despite the availability of various stylets and other implements, the insertion of endotracheal tubes can be difficult even for skilled physicians, particularly in patient's having anterior trachea and other conditions that make it challenging to guide the distal end of the endotracheal tube past the vocal cords and into the trachea.

As a tool to remedy at least some of the above side effects today widespread use is made of a video laryngoscope, such as a GlideScope® (Verathon, Inc., Bothell, WA) , for real-time viewing a patient's airway during the intubation. This procedure has improved visuality of the airway significantly. Video laryngoscopes are however today used with rigid stylets, e.g. the GlideScope® is used with the GlideRite® Rigid Stylet that has a preformed rigid curvature. Other rigid stylets can be bend to a given preformed curvature but the tip has no individual maneuverability. A typical conventional stylet contains a single flexible wire with a PVC coating and a uni-directional end cap that prevents the stylet from moving forward during the intubation process to lower the risk of unnecessary trauma to the patient. The stylet is inserted into the endotracheal tube so that the tube connector engages the uni-directional end cap.

US patent no. 6,539,942 discloses a tubular endotracheal tube- inserting device capable of being flexed into an L-shape and through which a conventional imaging device, such as a nasopharyngoscope, is inserted centrally, so as to allow for direct visualization of the vocal cords

US patent application no. 2013/255671 discloses an articulating stylet device having the ability to bend an endotracheal tube in more than one direction while the tube is being positioned in a patient's airway. This known articulating stylet device can bend the endotracheal tube in two directions, e.g. clockwise bend over a middle portion of the endotracheal tube and a counter-clockwise bend over a distal end portion of the endotracheal tube. This known articulating stylet is comprised of a plurality of beads arranged in sequential series. Each series is composed of differently configured beads having adjacent angled or beveled end surfaces. The beads have first and second longitudinal passageways for being threaded on a respective first and second metal wire, to make a stylet in form of a bendable "string of beads" . One metal wire is secured to the free bead at the free distal end of the string of beads and the other metal wire is secured a distance from the first wire six beads proximal to the free distal bead. This different securing position of the first metal wire and the second metal wire makes the string of beads a separately articulating stylet device. This known stylet is given sufficient rigidity to keep elongate but bendable shape by keeping the beads intimately together on the metal wires, and has special tensioning means for that purpose. However it is a challenge to arrange the beads correctly on the metal wires and a challenge to tension the wires correctly after all beads have been arranged as intended.

A major disadvantage of this known stylet is that the beads inevitabley become slightly dislocated if tensioning of a wire is unsuccessful, or if the wire is too slack. The angled or beveled end surfaces of two adjacent beads need to be arranged in intimate contact to prevent jamming of the beads. If tensioning is lost the string of beads gets too slack and cannot keep required dimensional shape to constitute a stylet for inserting an endotracheal tube, and if just a single bead becomes slightly offset or dislocated the string of bead cannot be bend as intended. A further huge disadvantage is that the gap between two adjacent beads may accidentally pinch and injure the endotracheal tube on the beaded stylet, and dislocation of beads may increase stylet diameter and prevent its retraction from the endotracheal tube.

US patent no. 5,327,881 relates to a fiberoptic intubating stylet, having a distal end that is able to be articulated in order to control the positioning of an endotracheal tube. The stylet is an elongate member that includes a first, semi- malleable portion at the proximal end thereof, a flexible region adjacent to the semi-malleable portion, and a distal end adjacent the flexible region. The distal end is rigid due to including or consisting of a lens device for facilitating viewing of objects. The rigid distal end with the lens extends into the flexible region, which is configured as a flexible bellow that can be manipulated by an articulation control assembly including control wires inside the stylet and extending from an attachment point at the distal end of the flexible region and terminating with control rings that are disposed outside of the stylet and the body. Thus the shape of the distal end part of the stylet cannot be altered during intubation, nor should it because then the lens cannot visualize as intended. Only the shape of the bellow can be altered to move the rigid distal end with the lens around. A further disadvantage is that once the semi-malleable portion and the flexible region has been bend to provide a curvature to the stylet, the bellow of the flexible region may hit against the interior wall of the endotracheal tube with the result that retraction of the stylet from the endotracheal tube cannot be done smoothly, and retraction is at the high risk that e.g. an expanded cuff of the inserted endotracheal tube dislocate, move to another location, and that air is supplied at an unintended location, or to a too low extent. Because the lens is situated at the distal stylet end such accidents will not be discovered before the patient gets difficulty in breathing.

The endotracheal tube-inserting devices known from the applicant's International patent application PCT/EP2017/082677 filed 13 December 2017 remedy many of the above-mentioned advantages. The present invention constitutes yet an improvement of especially the bendable tip that facilitates maneuvering the bendable tip and thus the stylet part around anatomic obstacles, e.g. when passing along pharynx, epiglottis, larynx and into trachea.

It is a main aspect of the present invention to provide an alternative endotracheal tube-inserting device of the kind mentioned in the opening paragraph that is very easy to operate .

It is yet an aspect of the present invention to provide an endotracheal tube-inserting device of the kind mentioned in the opening paragraph that has a bendable tip part with improved bendability . It is yet an aspect of the present invention to provide an endotracheal tube-inserting device of the kind mentioned in the opening paragraph for use together with a video laryngoscope.

It is yet an aspect of the present invention to provide an endotracheal tube-inserting device of the kind mentioned in the opening paragraph by means of which the risk of accidental injuring the patient's airway during intubation is reduced.

It is yet an aspect of the present invention to provide an endotracheal tube-inserting device of the kind mentioned in the opening paragraph for use in an endotracheal procedure that is fast, efficient, and safe to the patient.

The novel and unique whereby these and other aspects are achieved according to the present invention consist in that the bendable tip part has a bendable proximal tip part that extends into a bendable distal tip part via a string-guiding member that is adapted to guide the first string member and the second string member on opposite sides of the bendable tip part, whereby said string members does not entangle when the string members are operated. So said string members can curve independent of each other in response to actuation of the string-operating members.

The string-guiding member can e.g. be provided so that the bendable tip part has a bendable proximal tip part which is joined to a bendable distal tip part in extension of said bendable proximal tip part by means of a flexible joint, e.g. a hinge, which hinge simply may be a living hinge, a pivot or a similar structural modification or component that that allow the bendable proximal tip part and the bendable distal tip part to be curved independent of each other. For example, can the string-guiding member be an integral part of the bendable tip part, which integral part is included during molding of said bendable tip part so that the bendable proximal tip part extends without any additionally added or structured coupling means into the bendable distal tip part.

So the bendable proximal tip part of the bendable tip part may have a first proximal tip part end in extension of the curved distal stylet end part and an opposite second proximal tip part end in extension, e.g. hinged, to the bendable distal tip part. Said opposite second proximal tip part end may be joined to a first distal tip part end of the bendable distal tip part of the bendable tip part in extension of said bendable proximal tip part by means of the string-guiding member, e.g. a living hinge .

In the above alternative embodiment a proximal main body of the bendable proximal tip part and a distal main body of the bendable distal tip part have been made integral by being molded as a main body, such as a common elongate main body, where the transition between the proximal main body and the distal main body is configured as the string-guiding member that serves to guide the first string member and the second string member on opposite sides of the elongate main body of the bendable tip part at said transition.

In this embodiment the string-guiding member at the transition between the proximal main body and the distal main body may simply be one or more holes or openings, through the common elongate main body, for passage of the string members. As will be described later the string-guiding member and/or the transition can be provided with further means to improve and aid movement of the string members close to and alongside the bendable tip part, above and below said bendable tip part. Preferably the elongate main body is an elongate strip, e.g. of a plastic material, whereby the transition can be configured as a living hinge. An elongate plastic strip can be manufactured by injection molding and additional integral components and structures be added in same injection molding process, e.g. by IK or Multi-K injection moulding.

In the following general description, if the string-guiding member is referred to as a hinge, such references are not meant to exclude alternatives string-guiding members.

Within the context of the present application the term "proximal" is used to indicate a position nearest to the handle part and the term "distal" is used to indicate a position nearest the free tip of the bendable tip part. The term "housing" is used for a receptacle that is hollow to accommodate at least some of the mechanisms to operate the endotracheal tube-inserting device. The term "support" in context of the present application means that the stylet part "supports" the string members and that the string members runs close to the major part of the stylet part where possible to guide said string members and close along the distal part as well. Within the context of the present application the terminology that "a hinge that joins two part" refers to a means that permits motion of the two joined parts in same plane. In the present context the bendable tip part can move up and down but not to the sides and the proximal curvature of the bendable proximal tip part can be modified independent of the distal curvature of the bendable distal tip part, and vice versa, or both the proximal curvature and the distal curvature can be modified at the same time. Modifications of curvatures can be done prior to and during intubation, as well as during retraction of the stylet part from the endotracheal tube, thus after the endotracheal tube is in place.

To conduct a typical laryngoscopic, orotracheal procedure the patient is first positioned so that the axial planes of the oral, pharyngeal and tracheal axes are aligned. The operator holds the laryngoscope, preferably a video laryngoscope, in his/her left hand. A cricoid pressure may be maintained, typically by another person assisting the operator, until the end of the procedure where the endotracheal tube is in correct place and the cuff has been inflated. The tip of the video laryngoscope is inserted into the right side of the patient's mouth and the blade is advanced to the base of the tongue, which is moved to the side, and the blade is moved forward. A straight blade is moved beneath the epiglottis and a curved blade is placed into the vallecula above the epiglottis keeping attention to keep the curved blade in midline and not applying traction along the axis of the laryngoscope handle as the laryngoscope lifts the tongue upwards away from the larynx to reveal the glottie opening and visualize the vocal cords. The endotraceal tube is then inserted through the vocal cords holding the stylet with the endotracheal tube with the right hand. An angled stylet may interfere with the passage of the endotracheal tube into the trachea and may cause difficult manipulation to pass through the vocal cords. Once the tip of the endotracheal tube is past the vocal cords the stylet is removed, optionally the position of the endotracheal tube is corrected, the laryngoscope is removed, the cuff is inflated and safe insertion confirmed, e.g. by monitoring or observing end-tidal C0₂, listening using a stethoscope, observing condensation in the exterior length of the endotracheal tube, X-ray, etc. The skilled person knows these medical procedures.

Most known stylets for use in the above intubation procedures have a predetermined fixed curvature of both the stylet part and of the bendable distal tip part at the beginning of the intubation. Thus the bendablity is limited to bending into an overall final desired shape of the stylet part that cannot be altered during intubation rather than offering a bendable distal tip part that is bendable on demand during intubation.

The bendable proximal tip part and the bendable distal tip part may conveniently be individually bendable by the first string- operating member being operatively connected to at least a first securing position at the bendable proximal tip part and the bendable second string-operating member being operatively connected to at least a second securing position at the bendable distal tip part.

A bendable tip part composed of two individually, optionally independently, bendable sub-components or sub-parts, the bendable proximal tip part and the bendable distal tip part, that are lengthwise in extension of each other, e.g. joined, optionally hinged together, provides the bendable tip part with improved freedom to be bend and straightened when maneuvering the device to insert the endotracheal tube into trachea of a patient in need of ventilation. The bendable proximal tip part and the bendable distal tip part may be bendable to same or different degree, e.g. by be of same or different material, have same or different thickness, having same or different cross-sections, etc. Inherent bendability can be given to the bendable proximal tip part and the bendable distal tip part in consideration of e.g. these features. Suitable materials may be any plastic materials that possess stability of shape but still can be bend and flexed without rupturing or breaking. As an example of a suitable plastic material can be mentioned polyoxymethylene (POM) , however any plastic materials that confer sufficient stiffness, low friction, good dimensional stability and preferably also allows for inexpensive injection molding of the bendable tip parts are suited for manufacturing the bendable tip part of the present invention.

Furthermore, the string-guiding member, e.g. an integral living hinge, also creates a plain bearing that defines a bending axis that allows the bendable proximal tip part to move up and down in relation to the bendable distal tip part in a plane common to said bendable proximal tip part and said bendable distal tip part. The hinge can also be a journal bearing that allows the bendable distal tip part to tilt in response to relaxing and tensioning the string members by operating the string-operating members .

In particular the bendable distal tip part, but also the bendable proximal tip part, can also have the ability to be individually bended or straighten as the intubation situation requires thereby improving navigation options and options for changing the shape of the bendable tip part at all stages of the intubation procedure.

Furthermore, both bendable tips part may have the ability to be manually shaped, e.g. straightened, simply by e.g. grasping said part between the fingers and apply the desired shape. Optionally operating one or both of the string-operating members, optionally also keeping a certain actuated position of such a string-operating member, may assist the operator in the manual shape-giving.

A hinge may in some embodiments, at least to some extent, be composed of parts that are integral with one or both of the bendable proximal tip part and the bendable distal tip part.

For example can the bendable proximal tip part have a first proximal tip part end joined to the distal stylet end and an opposite second proximal tip part end, which is configured as a proximal hinge part of the hinge, and the bendable distal tip part have a first distal tip part end and an opposite second distal tip part end, which first distal tip part end is configured as a distal hinge part of the hinge and being hinged together with the proximal hinge part at the second proximal tip part end. So the hinge parts can be provided during the molding stage to be immediate prepared and ready for assembling into the hinge and be more or less complex. This way an inexpensive flexible joint between the bendable proximal tip part and the bendable distal tip part can be obtained. When a string member is operated independent of the other string member, via the string-operating member, that expediently can be located at of the handle part, either by a string member being tensioned or by relaxing tensioning of a string member, a respective string-securing positions can be moved in relation to the distal end of the stylet part, thus where said stylet part extends distally into the bendable tip part. Because the string members can be operated separately almost any imaginable shape of the distally arranged bendable tip part can be given to it simply by pulling the two string members more or less. One string member can be operated individually or both string members can be operated at the same time. Same or different levels of tensioning can be applied to the first string member and the second string member.

In the operating state of the endotracheal tube-inserting device the operator grasps around the handle part to operate the tip part operating member to almost arbitrarily move the first string member and/or the second string member lengthwise inside the stylet part to bend the bendable tip part at the distal stylet end.

In order to always keep the first string member close to the bendable proximal tip part, irrespective of the bending stage and current shape of the bendable proximal tip part, said bendable proximal tip part may have a first plurality of spaced apart first guide means adapted for retaining the first string member along the length of the bendable proximal tip part. For similar reasons the bendable distal tip part may have a second plurality of spaced apart second guide means adapted for retaining the second string member along the length of the bendable distal tip part. The string members then co-curve with the respective part of the bendable distal tip part, whereby the string members are kept free of contact with the interior face of the endotracheal tube, so that the endotracheal tube can be easily sheathed on and ejected from the stylet part during the intubation steps. The plurality of individual guide means serves to guide the string members to follow the curvature of the respective bendable tip parts, preferably along the entire length of the bendable tip parts. Gaps between adjacent guide means of the pluralities of guide means increase the bending quality of the bendable tip parts.

A tubular cover may encase the bendable tip part, and depending on the selected length of said tubular cover also more or less of the stylet part .

By arranging the first plurality of spaced apart first guide means along the length of the proximal main body of the bendable proximal tip part so that said first plurality of spaced apart first guide means protrudes in the opposite direction of the second plurality of spaced apart second guide means, that are arranged along the distal main body of the bendable distal tip part to protrude from said bendable distal tip part, the first string member and the second string member become able to curve and bend the bendable proximal tip part and the bendable distal tip part in opposite directions.

The second distal tip part end of the bendable distal tip part can e.g. be moved up and down in relation to the stylet part, when seen in the operative orientation of the endotracheal tube-inserting device, to curve the bendable distal tip part. The second proximal tip part end of the bendable proximal tip part can also be moved up and down and curved in relation to the stylet part, when seen in the operative orientation of the endotracheal tube-inserting device, to curve the bendable tip part, e.g. into an S-shape. When the first string member is tensioned the first proximal tip part end and the second proximal tip part end are moved towards each other while the first plurality of spaced apart first guide means keeps the first string member close to the bendable proximal tip part. When the second string member is tensioned the first distal tip part end and the second distal tip part end are moved towards each other while the second plurality of spaced apart second guide means keeps the second string member close to the bendable distal tip part. Depending on the tensioning of the first string member and of the second string member the bendable proximal tip part and the bendable distal tip part may also turn about the bending axis of the string-guiding member, e.g. the living hinge.

The first plurality of spaced apart first guide means and/or the second plurality of spaced apart second guide means may be selected from the group comprising eyes, loops and hooks and a string member run through holes in the eyes, loops and hooks so that the string member cannot escape.

Advantageously the distance between adjacent guide means of the pluralities of guide means along the length of the bendable tip part is greater than or equal to the width of a single individual guide means of the respective pluralities of guide means to provide freedom to bend, however adjusting size, such as the length of an eye, loop and hook and length of a gap between said eye, loop and hook can be used to both restrict ability to curve and to increase ability to curve, where length means the length, or thickness, along the bendable tip part.

Furthermore, the plurality of respective individual guide means of the pluralities of guide means may be equidistantly distributed, or be distributed with different distances along the length of the bendable tip part. For example the distance between adjacent second guide means of the plurality of second guide means may be different, e.g. smaller than the distance between adjacent first guide means of the plurality of first guide means. Alternatively the width of a single second guide means of the plurality of second guide means may be different, e.g. greater, than the width of a first guide means of the plurality of first guide means. Such design features add an additional structural way of influencing the bending quality of the bendable tip part. Preferably the distance between adjacent individual guide means of the pluralities of guide means is so large that adjacent individual guide means are free of contact when the bendable tip part is being bend.

The endotracheal tube-inserting device may comprise a flexible tubular cover that covers at least the bendable tip part so that the string members are kept confined and free of the endotracheal tube. The flexible tubular cover is an extra means besides the guide means to control the position of the string members and the distance between the string members and the bendable tip parts, preferably keeping the distance between the string members and the bendable tip parts substantially the same along the majority of the length of the bendable tip part irrespective of curvature. The tubular cover also sheaths the free tip part of the distal tip part that is exposed from the endotracheal tube sheathed on the endotracheal tube-inserting device .

Optionally the tubular cover also covers at least a part of the stylet part to serve as an ejector sleeve that reduces friction between the stylet part and the endotracheal tube. Optionally the tubular cover covers a combined length of the stylet part and the bendable tip part corresponding to at least the length of the endotracheal tube to be used with the endotracheal tube- inserting device.

The tubular cover may thus enclose the stylet part and the bendable tip part to safely sheath, guide, support, keep, and/or confine the first string member and the second string member so that the patient's tissue never can get in direct contact with any of said string members, and to reduce friction between the stylet part, the bendable tip part and the endotracheal tube. Should the unimaginable accident occur that a string member disconnects from its string-securing position such a detached end of a string member can never spring back to come in contact with patient's tissue and injure the patient because the tubular cover prevents it.

If the same happens for the beaded wire of the prior art stylet disclosed in US patent application no. 2013/255671 one or more beads could drop off the wire when the stylet is retracted from the endotracheal tube. Loose beads can in the best-case scenario be trapped inside the endotracheal tube in which case the procedure must be repeated, or worse, be trapped inside the airway, which could be fatal to the patient or require emergency surgery. In case an eye, hook or loop accidentally gets open such eye, hook or loop remains solid with the respective proximal and distal main bodies of the respective bendable proximal tip part or bendable distal tip part. So even a damaged eye, hook or loop stay in the same position on the respective bendable proximal or bendable distal tip part.

It is preferred that the exterior face of the tubular cover has a coefficient of friction that is lower than the coefficient of friction of an endotracheal tube to be mounted on the endotracheal tube-inserting device so that the endotracheal tube can be mounted and demounted the endotracheal tube- inserting device without sticking to said endotracheal tube- inserting device. The tubular cover can e.g. be a soft low friction plastic tube, e.g. of polyethylene or polyethylene vinyl chloride, but any material can be used provided that the tubular cover is able to yield and bend in response to bending of the bendable tip part by pulling at the string members at third positions inside the tubular cover without any noticeable increase in the overall diameter of the bendable tip part. Therefore the materials suitable for the tubular cover are any material that are flexible, bendable, does not stick to the endotracheal tube, and which has minimum friction to the endotracheal tube. Fabrics are within the scope of suitable materials. Such fabric may have a friction-reducing exterior surface, e.g. a Teflon® coating.

The bendable tip part may include at least one pulley wheel for controlling the direction of any of the first string member and the second string member.

The at least one pulley wheel may be selected from the group of pulley wheels comprising

- an intermediate pulley wheel incorporated in the string- guiding-member,

- an intermediate pulley wheel arranged at the second proximal tip part end,

- an intermediate pulley wheel arranged at the first distal tip part end,

- a proximal pulley wheel arranged at the first proximal tip part end, and

- a distal pulley wheel arranged at the second distal tip part end.

Within the context of the present invention the term "pulley wheel" covers rotating and non-rotating wheels with rotating wheels being preferred to reduce friction and reduce force needed to operate the string-operating members.

The at least one pulley wheel may have its axle fixed at a string-securing position, to the first proximal tip part end, to the second proximal tip part end, to the first distal tip part end, to the second distal tip part end, or to the distal stylet end of the stylet part. The securing position of the intermediate pulley wheel can e.g. be at the afore-mentioned transition between the bendable proximal tip part and the bendable distal tip part.

In one embodiment the intermediate pulley wheel may be inserted at an overlapping second proximal tip part end and a first distal tip part end, and the intermediate pulley wheel may have its axle journaled at opposite overlapping walls of said second proximal tip part end and said first distal tip part end to provide a string-guiding member, such as a hinge or joint, between the bendable proximal tip part and bendable distal tip part with the intermediate pulley wheel provided for guiding and smooth pulling at a string member to curve the bendable tip part on demand.

In an alternative embodiment the intermediate pulley wheel is arranged at the pivot axis of a living hinge at the transition between the proximal main body of the proximal tip part and the distal main body of the distal tip part.

The proximal pulley wheel may be arranged at the first proximal tip part end of the bendable proximal tip part to guide the first string member, and the distal pulley wheel may be arranged at the second distal tip part end to guide the second string member, and both the first string member and the second string member may pass around the intermediate pulley wheel thereby advantageously reducing the force needed to actuate the string-operating members and gaining a mechanical advantage. The term "mechanical advantage" is to be understood in its common technical understanding as a measure of force amplification, in the present context including using the string members and the pulley wheels, whereby forces applied to the string members by actuating the respective string-operating members trades off forces against movement to obtain a desired amplification in the bending force on the respective bendable proximal tip part and bendable distal tip part of the bendable tip part.

The bigger the mechanical advantage, the less force needs to be applied to the string-operating members, so by maximizing the length of a string member that extends from a string-operating member to a pulley wheel the actuation force needed to bend the bendable tip part is reduced whereby the operator much easier, faster and with less effort can provide the bendable tip part with a certain shape and change the shape on demand and "ad hoc' ' .

When a force is applied to a string member the pulley wheels are pulled towards each other thereby bending either the bendable proximal tip part if the first string member is pulled at, or the bendable distal tip part if the second string member is pulled at. The arrangement of the intermediate pulley wheel with its axle journaled at opposite overlapping walls of the second proximal tip part end and first distal tip part end or at the transition provides the string-guiding member, e.g. in form of a hinge, such as a living hinge.

In an embodiment of a bendable tip part with the above- mentioned three pulley wheels the first string-securing position and the second string-securing position may both be at the intermediate pulley wheel. In this case the first string member runs one or more times around the proximal pulley wheel and the intermediate pulley wheel. In a similar manner the second string member runs one or more times around the intermediate pulley wheel and the distal pulley wheel. This way the string members can be lengthened by e.g. 2 times or more the distance between the pulley wheels which they run around thereby contributing to the mechanical advantage to make it easy to operate the respective string-operating members.

The first string-securing position and the second string- securing position can also be different, e.g. be situated lengthwise offset. The first string-securing position can e.g. be at the distal stylet end, at the first proximal tip part end, and optionally at the proximal pulley wheel. The second string-securing position can e.g. be at the second distal tip part end, optionally at the distal pulley wheel, or at the free tip of the bendable tip part. The choice of string-securing position facilitates bending of the bendable tip part in a more or less distinct S-shape, mirror S-shape, L-shape or C-shape, or combinations of said shapes, to assume a shape that can navigate the least obstructed into a patient's airway and be made straight again if and when desired and needed, e.g. for retracting the stylet part, e.g. retracting the stylet part from an endotracheal tube that was sheathed on the stylet part prior to the introduction of the endotracheal tube-inserting device into the airway and now is left as introduced for ventilation of the patient.

At least a part of the first string member and at least a part of the second string member may run inside a common lumen of the stylet part to be protected inside said lumen, or run alongside a solid stylet part either just protected by the endotracheal tube or by being in confined alignment with at least a proximal length of the solid stylet part, e.g. running inside a respective recess in the solid stylet part, and/or being protected by a long flexible tubular cover extended to also cover said string members along the solid stylet part, e.g. a tubular cover of a fabric, e.g. an elastic fabric, optionally a fabric having an exterior friction-reducing surface .

Opposite the first distal tip part end of the bendable distal tip part, said bendable distal tip part may have a second distal tip part end provided with an enlarged tip. The enlarged tip at the end of the bendable distal tip part may have a larger cross-section than the bendable distal tip part and made an integral part of said bendable distal tip part during molding. Since the tubular cover is flexible it inherently adapts and conforms to the large volume of the enlarged tip and retracts to fit around the length of the bendable tip part without interfering with the string members. Alternatively the enlarged tip may be provided at the closed end of the tubular cover, however a closed end of the tubular cover need not be enlarged .

In order to make it easy to push the endotracheal tube onto and off an endotracheal tube-inserting device that has an enlarged tip an enlarged tip at the end of the bendable distal tip part may advantageously be soft and flexible. The enlarged tip may be so soft that it automatically forms into a large contact area when pushed against an obstacle, so that the enlarged tip cannot damage sensitive tissue at a given force acting on the tissue when the endotracheal tube-inserting device is being forced forward into the airway of a patient. Softness of the enlarged tip can be adjusted by choice of material and/or by way of design and shape, including by selecting a certain wall thickness or graduation of said wall thickness. An enlarged soft tip may be provided in lengthwise extension of the distal pulley wheel or surround the distal pulley wheel.

That the enlarged tip is soft and/or flexible is however not mandatory. In yet an alternative embodiment of a bendable tip part the free tip of the bendable distal tip part is made from the same material as the bendable distal tip part and the shape and size are determined by the provision of the distal pulley provided at the free tip of the bendable distal tip part. The shape of the free tip of the bendable tip part, whether it be enlarged or not, or rigid or flexible or not, can be round or drop-shaped .

The handle part may advantageously comprise a housing for accommodating and protecting components of the endotracheal tube-inserting device, such as at least some of a proximal stylet end part, a proximal end of the string members, a tube ejecting mechanism, and optionally at least part of the string- operating members. The housing may have various shapes depending on the configuration of said components. An ergonomic, easy graspable and maneuverable shape of the handle part may be preferred. In one embodiment the stylet part can be a curved pipe inside which at least a part of the string members are guided and accommodated.

The proximal stylet end part, the distal stylet end part and the bendable tip part may have same of different initial curvatures. The choice of appropriate same or different initial curvatures may depend on the length of said parts and be selected in view of reducing wobbling during use. Said curvatures may also depend on the design of the housing and of the position and configuration of the string-operating members on or in relation to the housing.

The centers of curvature of an endotracheal tube-inserting device may advantageously be located on opposite sides of the endotracheal tube-inserting device along its length. The stylet end part may follow a concave function and extend into the pre shaped bendable tip part that follows a convex function to provide a device with an overall S-shape, that are very easy to grasp and maneuver. When this embodiment of an endotracheal tube-inserting device is inserted via the patient's mouth the stylet part curves around the patient's face. In this alternative embodiment at least the proximal stylet end part can have a first center of curvature below the stylet part and the distal stylet end part have a second center of curvature on the opposite side, thus above the bendable tip part when the endotracheal tube is just guided in position during intubation.

In order to adapt to the curvature of the proximal stylet end part the housing may curve the same way as said proximal stylet end part of the stylet part.

The housing can e.g. be a curved tubular body having a circumferential exterior wall that encases several of the components of the endotracheal tube-inserting device needed for its operation. The tubular body offers a good grip for holding on to the endotracheal tube-inserting device close to the patient for improved control during the tube-inserting procedure .

Preferably the stylet part can have a curvature following a sector of a circle or have curved sections of different curvatures. E.g. a proximal end part of the stylet part may be defined by a first sector of a circle having a large first radius. This proximal end part may extend via an intermediate part of the stylet part defined by a second sector of a circle having a second radius smaller than the first radius, which intermediate part then again may extend into a distal end part of the stylet part, which distal end part can have a third radius smaller than the second radius. This design is just given as an example of a suitable curvature design of the stylet part and variations are indeed feasible within the scope of the present invention. Preferred curvature (s) of the stylet part may be the curvature (s) that conforms, at least to some extent, to the shape of the airway with the patient's head held in the neutral position, a curvature often referred to as the "the Magill Curve". "A Magill Curve" having a radius of curvature of 140 mm ± 20 mm is found to be about optimum for the average airway, [Tracheal intubation and sore throat: A mechanical explanation; M. Chandler; Anaesthesia, 2002, 57. pages 155-161], and suited for the present invention, although various curvatures may work better for various target patients.

The stylet part can e.g. be made of aluminium or similar lightweight material. Alternatively the stylet part is made of plastic. The stylet part may be form-stable, thus not malleable, although malleable stylet parts are not excluded within the scope of the present invention.

Bending and relaxing the bendable tip part, whether it be manually using the fingers directly on the bendable tip part and/or by using the string-operating members, can take place both during inserting the bendable tip part with or without an endotracheal tube sheathed on the stylet part as well as when the endotracheal tube-inserting device is retracted.

Emphasis is made that for some patients it may suffice that just one of the first string member and the second string member is operated for the bendable tip part to assume a shape suited for easy passing the endotracheal tube-inserting device past the glottis and between the vocal cords.

For difficult airway it is however highly beneficial that the endotracheal tube-inserting device of the present invention is provided with the ability to arbitrarily control and customize the shape and curvature of the bendable tip part to a shape specific for the airway anatomy of a certain patient, which significantly eases the insertion of both the stylet part and the accompanying endotracheal tube sheathed on the stylet part.

The above-mentioned improved and very versatile in situ and real time ability to change the shape of the bendable tip part both outside and inside the patient's body provides an endotracheal tube-inserting device that is very fast and convenient to operate, insert correct, and retract without injuring or otherwise harming the patient. The bendable tip part can be given a plurality of different positions so that its shape can be adapted for use with even the most difficult airway thereby making the endotracheal tube-inserting device of the present invention not only user-friendly but also patient- friendly .

The handle part incorporates actuator means adapted to operate the bendable tip part of the stylet part. A first actuator may serve as, or be part of, the first string-operating member and a second actuator may serve as, or be part of, the second string-operating member. Depressing the first actuator then shapes the bendable proximal tip part, and depressing the second actuator shapes the bendable distal tip part.

The first actuator and the second actuator are both accessible for the operator when holding on the housing. Preferably the first actuator and the second actuator protrude from a respective first opening and second opening in the housing. Optionally the first actuator and the second actuator can pivot in and out of its respective first opening and second opening.

In such above-mentioned embodiment the first actuator and the second actuator may be hinged to an tubular exterior wall of a curved tubular body that defines the housing to pivot between a relaxed position wherein an actuator protrudes spaced from the tubular exterior wall and an actuated position wherein the actuator are closer to the tubular exterior wall than in the relaxed position or even inside the housing. The tubular body is convenient to grasp to operate the actuators, which actuators may be arranged adjacent each other to be operated by adjacent fingers of the hand used to grasp on the tubular body that are part of the handle part.

The actuators can for example simply be pivotable flaps, such as a first actuator in form of a pivotable first flap to which a proximal first string end of the first string member is secured, and a second actuator in form of a pivotable second flap to which a proximal second string end of the second string member is secured. The respective opposite distal string ends are secured to the string securing positions at the bendable tip part.

Said flaps may preferably be curved flaps having same center of curvature as a cross-section as the exterior tubular wall, however other curvatures are within the scope of the present invention. The curved flaps can for example be provided by a cross-sectional segments of the exterior tubular wall, in which embodiment the curved flaps extends pivotably by its attachment of a single flap edge at the joining to the exterior tubular wall, the connecting flap edge constituting a living hinge, by being pivotable solid with said tubular wall. The living hinge may have optionally have a weakening, indent of similar feature that facilitates and promotes the pivoting of the associated flap. The flaps can also be hinged to the exterior tubular wall by means of another kind of hinge, such as a leaf hinge. Other kinds of flaps, curved or straight, can be secured to the exterior tubular wall as separate objects. In the relaxed condition of the string members, said string members can either pass into the interior of the tubular body via a respective string hole made for this entry purpose, or span the somewhat larger opening left when the flaps are excised form the exterior tubular wall and run outside the exterior tubular wall before it enters the lumen of the tubular body at the vicinity of the top of the proximal stylet end, e.g. passing over a common top pulley wheel having separate tracks for each string member, or passing by individual top pulley wheels, one for each string member. So the string members can be guided from securing points at the respective pivotable flaps, to the top of the handle, down along the stylet part, preferably inside the stylet part, be passed around the pulley wheels at the bendable tip part, as described above, and be secured at the respective securing positions.

Because an actuator is located remote from a string-securing position maximum force application is achieved by minimum depression of the corresponding actuator.

The tensioning of the string members may be adjusted so that the actuators automatically jump back into a relaxed position once any force applied to said actuators is relieved. Furthermore the actuators may have an inherent springiness provided, amongst others, by the way the actuators are connected to the housing combined with the length and positions of the string members, but the provision of a spring for promoting return to its relaxed condition of a string-operating member that has been subjected to a force is not excluded by the present invention, such provision of a spring may even be preferred in some embodiments.

The proximal stylet end of the stylet part is conveniently located inside the housing to provide a solid anchoring of the stylet part and reduce overall length of the endotracheal tube- inserting device.

The endotracheal tube-inserting device of the present invention may additionally expediently comprise a tube connector adapted for detachably and temporarily securing to an airway connector of an endotracheal tube mounted on the stylet part so that the endotracheal tube stay put on the device when the device is introduced into the patient's airway.

Prior to the intubation procedure the endotracheal tube is pushed over the distal tip part, that is covered by the tubular cover, and moved further towards the handle part along the stylet part, that also can be covered by the tubular cover, so that the airway connector of the endotracheal tube engages the tube connector of the endotracheal tube-inserting device. When the endotracheal tube-inserting device with the endotracheal tube mounted on it has been inserted properly into the patient's airway facilitated by the improved maneuverability of the bendable tip part and preferably under supervision using a video-laryngoscope, the endotracheal tube is gradually moved off the stylet part and off the bendable distal part by means of a tube-ejecting mechanism. When the endotracheal tube is in correct position the engagement between the tube connector and the airway connector is terminated and the endotracheal tube- inserting device is retracted from the patient and ventilation established, optionally the stylet part and corresponding bendable tip part is retracted first and then the tubular cover is retracted as a separate last component from the endotracheal tube .

The present invention also relates to an endotracheal tube- inserting device provided with and an endotracheal tube. For use in endotracheal intubation an endotracheal tube may advantageously be provided on the stylet part. The nature and curvature of the endotracheal tube, if not straight and pliable, may optionally be of the kind that conforms to or has the same curvature as the curvature of the stylet part of the stylet part, thereby also conforming to the shape of the patient's airway, as in the position wherein the patient's head is held in the neutral position, as described above.

The endotracheal tube suited for the present endotracheal tube- inserting device may e.g. have a standardized airway connector of internal diameters of e.g. 15 mm and 22 mm, thus conforming to ISO standard no. 5356-1, so that it by way of its standardization also can be connected to all other airway equipment. Situations with non-compatibility between coupling of airway equipment and endotracheal tube, and urgent need for special adaptors to establish ventilation, are thus prevented.

A conical shape or part of the tube connector allows the tube connector to fit to engage with airway connectors of different diameters. A large diameter conical part of an airway connector is just moved closer upwards towards the handle part to couple around the conical tube connector than needed for a smaller diameter tube connector.

There are different lengths of endotracheal tubes and therefore the position of the conical tube connector on the stylet part may in some embodiments be made adjustable, e.g. by allowing the tube connector to slide on the stylet part, which ability may also be utilized during ejecting the endotracheal tube. The endotracheal tube may, or may not, have a cuff which can be inflated to seal the lungs against the liquid secretions present in the upper airway, and seal distally to allow ventilation of the patient under controlled pressure and defined gas mixture. Use of an endotracheal tube with inflatable cuff is almost always used for adults whereas most pediatric tubes are uncuffed.

The endotracheal tube-inserting device of the present invention may be used with both an uncuffed endotracheal tube and a cuffed endotracheal tube. The size of the appropriate endotracheal tube depends on e.g. the patient's age and airway anatomy size. If a cuffed endotracheal tube is used the internal diameter in millimeters is typically calculated as 4 + (Age / 4) . In case of a cuffed endotracheal tube the size of its internal diameter is typically calculated as 3.5 + (Age / 4) . Such endotracheal tubes may however have standard airway connectors that allow the same endotracheal tube-inserting device to be used with several different endotracheal tubes.

Operation of the endotracheal tube-inserting device according to the present invention can be done with one and the same hand, even without the hand needs to be taken off the handle part. Thus the endotracheal tube-inserting device can easily be held steady and be operated without huge motions of the hand holding and operating it, and without the need to change the position of the hand on the handle part at any time during the endotracheal procedure, and without the operator needing to apply huge force and move his hand around on the handle part. The endotracheal tube-inserting device has a convenient size and shape of the substantially tubular curved handle part.

The string-operating members may be adapted to provide a tactile feed-back to the operator in response to applying a force on and/or relieving said force from the string-operating members . In order to get the endotracheal tube off the stylet part, the endotracheal tube-inserting device may, as already mentioned above, further have the tube ejecting mechanism.

An exemplary tube-ejecting mechanism may comprise a ratchet mechanism and a reciprocating third actuator for operating the ratchet mechanism to stepwise move a tube-displacing member wherefrom the tube connector protrudes. The endotracheal tube is sheathed on the stylet part along the stylet part and can be displaced into the patient's airway by means of the tube- displacing member that pushes the airway connector towards the distal stylet end.

The housing can expediently also accommodate at least a part of the tube ejecting mechanism and be open distally to allow the tube-displacing member to move along the length of the handle part on the proximal stylet part .

The invention will be explained in greater details below with reference to the drawing, which illustrates exemplary embodiments to disclose further advantageous and technical features and effects of the present invention.

Fig. 1 is a perspective view of an endotracheal tube-inserting device of the present invention seen oblique from the side,

Fig. 2 shows the same but with part of the housing of the handle part left out,

Fig. 3 is a partly exploded enlarged scale view of the bendable tip part seen from above, which bendable tip part is encircled in fig. 2, and in fig. 3 is shown without string members,

Fig. 4 shows the same in assembled state but without pulley wheels and from the side, Fig. 5 is an enlarged scale perspective view partly from the side and from below of the bendable tip part without string members ,

Fig. 6 is a perspective enlarged scale fragmentary view of the encircled detail in fig. 4 illustrating a few of the individual first guide means of the first plurality of guide means of the bendable tip part, as seen in fig.4,

Fig. 7 is a perspective side view of the bendable tip part provided with the first string member only,

Fig. 8 is a perspective side view of the bendable tip part provided with the second string member only,

Fig. 9 is a perspective side view of the bendable tip part provided with both the first string member and the second string member,

Fig. 10 is a cross-sectional view taken along line X-X in fig.

7,

Fig. 11 is a longitudinal sectional view taken along line XI-XI in fig . 4 ,

Fig. 12 shows the bendable tip part from the side and without string-members ,

Fig. 13 shows the paths of the string-members around the pulley wheels ,

Fig. 14 shows the paths of the string members as they extend from the bendable tip part inside the stylet part, into the housing and around the actuator pulley wheels towards the actuators , Fig. 15 is a perspective fragmentary enlarged scale view of the distal handle part illustrating the actuators,

Fig. 16 shows in perspective the endotracheal tube-inserting device slightly from behind,

Fig. 17 is a perspective exploded view of the same seen inside the first shell part of the tubular housing with the tube- displacing member arranged on the stylet part,

Fig. 18 shows the same but inside the second shell part of the tubular housing,

Figs. 19, 20 and 21 show the tube-displacing member from the slide part, from the side and from the tube connector, and

Fig. 22 shows the tubular cover on the bendable tip part and on the stylet part from the side.

An endotracheal tube-inserting device 1 of the present invention is seen from the exterior side in a perspective view and partly from the side in fig. 1. In fig. 2 a part of the tubular handle part 2 is left out to better visualize the interior components of said endotracheal tube-inserting device 1. The tubular cover is also left out to visualize the structural components of the endotracheal tube-inserting device 1.

The endotracheal tube-inserting device 1 comprises a handle part 2 and a stylet part 3. The stylet part 3 extends into a bendable tip part 4 at a distal stylet end part 5 of the stylet part 3, and inside a tubular housing 6 of the handle part 2 at an opposite proximal stylet part 7 that has a proximal stylet end 8. The housing 6 defines a receptacle that accommodates at least a tube ejecting mechanism 9 to eject from said stylet part 3 an endotracheal tube (not shown) sheathed on the stylet part 3. In the present exemplary embodiment of an endotracheal tube- inserting device 1 the stylet part 3 is shown to be a smoothly curved pipe. The configuration, structure and operation of the bendable tip part 4 will be elaborated in relation to the description of the further figures. The stylet part 3 is S- shaped with a proximal stylet subpart 3a of the proximal stylet end part 7 that is inside the tubular housing 6 having an initial backbend curvature of concave function. A distal stylet subpart 3b having a forward bend curvature of convex function extends into a bendable tip part 4, which bendable tip part 4 initially is shown curved following a convex function.

As seen best in fig. 2 the mechanism to bend the bendable tip part 4 includes a first string member 10 and a second string member 11 that run from respective string-securing positions at the bendable tip part 4 along said bendable tip part 4 and inside the lumen of the stylet part 3 over a top pulley wheel 12 located at the top end 13 of the tubular housing 6 opposite the bendable tip part 4. From the top pulley wheel 12 the first string member 10 and the second string member 11 traverse the lumen of the tubular housing 6 towards a first string-operating member in form of a first actuator 14 and a second string- operating member in form of a second actuator 15, respectively, guided in the direction towards said actuators 14,15 via respective first actuator pulley wheel 16 and second actuator pulley wheel 17, so that the first string member 10 has its proximal first string end secured to the first actuator 14 and the second string member 11 has its proximal second string end secured to the second actuator 15. This way the actuators 14,15 are put in operative contact with the bendable tip part 4. The actuators 14,15 are configured as pivoting flaps having, in the present embodiment of an endotracheal tube-inserting device 1, a radius of curvature substantial similar to the radius of curvature of the cross-section of the tubular housing 6 of the handle part 2 to allow the flaps to pass in and out of openings made in the tubular housing in order to enable even deep strokes of said flaps.

The respective opposite distal first string end and distal second string end of the string members 10,11 that exit the distal stylet subpart 3b are secured to the bendable tip part 4 at respective first string-securing position and second string- securing position.

Fig. 3, 4 and 5 show, in enlarged scale view, the bendable tip part 4, which is encircled in fig. 2, from various angles. The bendable tip part 4 is shown without string members 10,11.

The bendable tip part 4 comprises a main body 4a constituted by a proximal main body 18a of a bendable proximal tip part 18 and a distal main body 19a of a bendable distal tip part 19. In order to guide the string members (not shown) along the bendable tip part 4, the main body 4a is provided with three spaced apart pulley wheels in form of a proximal pulley wheel 20, an intermediate pulley wheel 21, and a distal pulley wheel 22.

In the present embodiment the bendable proximal tip part 18 is longer than the bendable distal tip part 19 however other ratios of lengths are within the scope of the present invention .

The bendable proximal tip part 18 has a first proximal tip part end 23 that, via a proximal tip part body 24, extends into an opposite second proximal tip part end 25. The bendable distal tip part 19 has a first distal tip part end 26 that, via a distal tip part body 27, extends into an opposite second distal tip part end 28. The proximal tip part body 24 has a plurality of spaced apart first guide means 29 in form of first hooks 30 provided on a proximal main body 18a to hold the first string member 10 close to the proximal tip part body 24. The distal tip part body 27 has a plurality of spaced apart second guide means 31 in form of second hooks 32 provided on a distal main body 19a, to hold the second string member 11 close to the distal tip part body 27.

The proximal tip part body 24 is generally a flat strip, e.g. of a flexible plastic material, on which the first guide means 29 are distributed spaced apart along an upper surface 33. The opposite lower surface 34 may have one or more means 35, such as e.g. a track, a furrow, or small third hooks 36, to lengthwise support the second string member 11, and to guide said second string member 11 to reach the bendable distal tip part 19 without entangling with the first string member 10.

The first proximal tip part end 23 is configured to connect to the distal stylet end 5a of the distal stylet end part 5. In order to make such connection the first proximal tip part end 23 can have a plug part 37 to be plugged into the distal stylet end 5a of the hollow stylet part 3. The plug part 37 may have one or more recesses 38a, 38b that, at least to a slight extent that does not make a negative impact on the string members 10,11 ability to slide in the recesses 38a, 38b, confer radial flexibility to said plug part 37. The flexibility facilitates introduction into the distal stylet end 5a in that the legs 37a, 37b of the recessed plug part 37 can be pressed together during connection of the stylet part 3 and the bendable tip part 4. Once the bifurcated plug part 37 has been placed inside the distal stylet end 5a of the stylet part 3 the applied compression on the legs 37a, 37b is relieved and the one or more recesses 38a, 38b can return to less compressed state, and the legs 37a, 37b exert pressure to the interior wall of the stylet part 3 at the distal stylet end part 5. The primary purpose of the recesses 38a, 38b is however to guide the string members 10,11 separately away from the bendable tip part 4. At the transition between the recessed plug part 37 and the strip-shaped proximal tip part body 24 the first proximal tip part end 23 has a proximal bearing 39 with a proximal axle 40 for suspending of the proximal pulley wheel 20. The second proximal tip part end 25 has a proximal hinge part 41 that combines with a distal hinge part 42 into an intermediate bearing 44 that has an intermediate axle 45 for suspending of the intermediate pulley wheel 21, which distal hinge part 42 is provided at the first distal tip part end 26 of the distal tip part body 27 of the bendable distal tip part 19. The intermediate bearing 44, the intermediate axle 45, and the intermediate pulley wheel 21 constitute in the present embodiment of an endotracheal tube-inserting device 1 the string-guiding member in form of a hinge 46, such as a living hinge .

The distal hinge part 42 of the bendable distal tip part 19 extends via the distal tip part body 27 into a distal bearing 47 that has a distal axle 48 for suspending of the distal pulley wheel 22.

The distal tip part body 27 is generally a flat strip on which the individual second guide means of the plurality of second guide means 32 are distributed spaced apart along a lower surface 49. The opposite upper surface 50 may have one or more of a means 51, such as e.g. a track 52, a furrow, or small fourth hooks, to guide the second string member 11 to reach the distal pulley wheel 22, and thus the free tip 52 of the bendable tip part 4.

Fig. 6 is a perspective enlarged scale fragmentary view of the encircled first guide means 29 of the proximal tip part 18 seen in fig. 4. The first guide means 29 are hooks 30 that have their respective hook openings 30a facing alternating towards opposite long sides along the length of the bendable tip part 4 to prevent sideways movement of the first string member 10 when said first string member is operated using the first actuator 14. The second guide means 31 are arranged in a similar manner along the distal tip part 19 with alternating hook openings 32a to prevent sideways movement of the second string member 11 when said second string member is operated using the second actuator 15.

Fig. 7 is a perspective side view of the bendable tip part 4 provided with the first string member 10 only. The first string member 10 is secured at a first securing position 54a at the hinge 46 and loops around the intermediate pulley wheel 21 and the proximal pulley wheel 20 at least one time under the control of the first hooks 30 before it exits the proximal tip part 18 via the first recess 38a of the recessed plug part 37 and extends inside the lumen of the stylet part 3 around the top pulley wheel 12 and into the lumen of the tubular housing 6, and then via the first actuator pulley wheel 16 to a first actuator securing position 55 at the first actuator 14 so that the first string member 10 is attached firmly at both ends to establish operative communication between the first actuator 15 and the proximal tip part 18.

Fig. 8 is a perspective side view of the bendable tip part 4 provided with the second string member 11 only. The second string member 11 is secured at a second securing position 54b at the hinge 46, which second securing position 54b can be the same as the first securing position 54a, wherefrom it loops around the intermediate pulley wheel 21 and the distal pulley wheel 22 at least one time under the control of the second hooks 32 before it exits the distal tip part 19 at the intermediate pulley wheel 20 and passes along the lower surface of the proximal tip part 18 along and under the control of the third hooks 36 out of the recessed plug part 37 via the second recess 38b, wherefrom it extends inside the lumen of the stylet part 3 around the top pulley wheel 12 and into the lumen of the tubular housing 6, and then via the second actuator pulley wheel 17 to a second actuator securing position 56 at the second actuator 15 so that the second string member 11 is attached firmly at both ends to establish operative communication between the second actuator 15 and the distal tip part 19.

Fig. 9 is a perspective side view of the bendable tip part 4 provided with both the first string member 10 and the second string member 11.

The first recess 38a and the second recess 38b are seen best in fig. 10, which is a cross-sectional view along line X-X in fig. 7, of the recessed plug part 37. The first recess 38a and the second recess 38b keeps the first string member 10 and the second string member 11 free of each other and from entangling.

Fig. 11 is a longitudinal sectional view taken along line XI-XI in fig. 4, and fig. 12 shows the same but with pulley wheels 20,21,22 suspended at respective axles 40,45,48. The string members are not shown.

The path and looping of the first string member around the proximal pulley wheel 20 and the intermediate pulley wheel 21 and the path and looping of the second string member 11 around the distal pulley wheel 22 and the intermediate pulley wheel 21 is more clear from fig. 13 where the main bodies of the proximal tip part 18 and the distal tip part 19 are removed. The remaining part of the paths of the string members 10,11 are seen better in fig. 14 where the tubular housing 6 and the stylet part 3 has been removed together with the tube ejecting mechanism 9. The paths of the string members 10,11 extend inside up along the stylet part (not shown) , around the top pulley wheel 12, down into the tubular housing 6 and around the actuator pulley wheels 16,17, which, as seen more clearly in fig. 15, are journaled at ridges 57,58 on the tubular housing 6 next to the openings 59, 60 made in the tubular housing 6 for providing space for pivoting actuators 14,15.

Fig. 16 shows in perspective the endotracheal tube-inserting device slightly from behind and from the side, where fig. 1 shows the same from the side slightly from the front.

The tube connector 61 of the tube-displacing member 68 of the tube ejecting mechanism 9 is mounted of the stylet part 3 and the tube-displacing member 68 is visible via a window or opening 62 in the tubular housing 6. The lengthwise window or opening 62 allows the user to confirm, optionally optimize engagement/disengagement between the airway connector (not shown) of the endotracheal tube (not shown) and the tube connector 61 of the tube-displacing member 68. The window or opening 62 also allows the user to monitor at least a part of the forward movement of the endotracheal tube (not shown) along the stylet part 3.

The curved tubular housing 6 has a first shell part 6a and an opposite second shell part 6b that, when assembled, provides a receptacle with space for e.g. some of the components of the tube ejecting mechanism 9, the proximal stylet end part 7, and some of the length of the string members 10,11. The curvature of the tubular housing 6 and the proximal stylet end part 7 avails the operator of the endotracheal tube inserting device 1 with good working posture and good working conditions to the benefit of the patient, and the intubation can be done carefully and considerate. The bendable tip part 4 is shown in its pre-shaped relaxed condition that continues to curve in extension of the proximal stylet end part 7, however the shape of the distal tip part 4 can be adjusted manually if needed prior to intubation. The backwards bending of the handle part 2 provides clearance to the patient when inserting the bendable tip part 4 via the mouth into trachea while also preserving good control of the device 1. The tubular housing 6 has a proximal housing end 63, at which the top pulley wheel 12 is journaled, and an opposite, distal housing end 60, which is open for passage of at least a length of the stylet part 3. The first string member 10 is secured at a first actuator securing position 55 at the first actuator 14 and the second string member 11 is secured at second actuator securing position 56 at the second actuator 15.

The tube ejecting mechanism 9 can e.g. be the tube ejecting and retracting mechanisms known from the applicant's international patent application no. PCT/EP2017/082677, which tube ejecting and retracting mechanisms include a ratchet mechanism with a third actuator 76 that protrudes from the tubular housing 6.

The tube ejecting mechanism 9 with or without a tube retracting mechanism may comprise the same tube-displacing member, tube ejecting mechanism and tube retracting mechanism as disclosed in PCT/EP2017 / 082677 , which tube-displacing member, tube ejecting mechanism and tube retracting mechanism are incorporated by reference in the current application. An alternative tube-displacing member 68 is presented herein.

Figs. 17 and 18 are exploded perspective views of the endotracheal tube inserting device 1 seen from opposite sided and illustrating the main components of the alternative tube ejecting mechanism 9 and a tube retracting mechanism 69.

The tube-displacing member 68 comprises, as seen best in figs. 19, 20 and 21, a slide part 70 with a tube connector 61. The tube-displacing member 68 interacts with a ratchet mechanism 71 arranged inside the housing 6. The ratchet mechanism 71 has a an elongate stationary rack part 72, which is integral with the first shell part 6a, and an elongate feeder component 73 that is moveable in relation to the stationary rack parts 72. The elongate stationary rack part 72 has first teeth 75 and the feeder component 73 has second teeth 65. The tube retracting mechanism 69 includes a moveable third rack part 77 with a fourth actuator 78. The feeder component 73, the moveable third rack part 77 and the tube-displacing member 68 are slideable arranged in elongate grooves of the housing 6.

The tube-displacing member 68 is illustrated in figs. 19 - 21 from various angles. The tube-displacing member 68 has the tube connector 61 protruding from a slide part 70. The tube connector 61 is adapted to carry an airway connector (not shown) of an endotracheal tube (not shown) . The tube connector 61 has a central bore 79 for being slidable mounted on the stylet part 3. A pawl 80 has at least one projecting third tooth 81 that engages the first teeth 75 to hold the tube- displacing member 68 and the feeder component 73 in an advanced position when a third actuator 76 of the feeder component 73 is pressed towards the distal housing end 60.

Opposite the at least one projecting third tooth 81 the pawl 80 has an enlarged male coupling part 82 configured to detachably snap together with a female coupling recess 83 arranged at the top 84 of the slide part 70 due to a resilient spring component 85 that extend between the male coupling part 82 and the top 84 of the slide part 70.

The moveable third rack part 77 is arranged to be lengthwise and stepwise displaced in an elongate groove of the housing to move the tube-displacing member 68 back towards the proximal housing end 67 if the need arises to move the endotracheal tube a bit back again. The fourth actuator 78 protrudes through an actuator slot 85 in the tubular housing 6 to be moved up and down in a restricted manner. The moveable third rack part 77 has alternating first crests 86 and first troughs 87 to engage alternating second crests 88 and second troughs 89 of the combined first shell part 6a and second shell part 6b and by pressing the fourth actuator 78 the engagement between the third teeth and the first 75 and second teeth 65 is set free, which allows the stroke of the third actuator 76 to be reversed should the need arise to reposition the endotracheal tube on the stylet part 3 while the bendable distal tip part 4 is still inside the patient. A spring member 67 that protrudes from the slide part 70 of the tube-displacing member 68 may be used to manually apply a lifting force to the moveable third rack part 77 to lift the first crests 86 and first troughs 87 free of the second crests 88 and second troughs 89.

The actuator slot 90 of the second shell part 6b allows the third actuator 76 to be accessible for the operator and the length of the actuator slot 90 defines the maximum length that the tube-displacing member 68 can be displaced during a stroke.

The tube retracting mechanism 69 includes a first resilient and/or elastic member 91 at the distal housing end 60 and the tube ejecting mechanism 9 includes a second resilient and/or elastic member 92 at the proximal housing end 63.

The first resilient and/or elastic member 91 of the tube retracting mechanism 69 enables the moveable third rack part 77 to be automatically, at least partly, retracted towards the distal housing end 60 in order for the moveable third rack part 77 to perform yet a stroke to stepwise return the tube- displacing member 68 towards its start position at the proximal housing end 63. Similarly the feeder component 73 may be automatically retracted by means of the second resilient and/or elastic member 92 at the proximal housing end 63 towards the proximal housing end 63 after the tube-displacing member 68 has been at least partly displaced to its advanced position on the stylet part 3 to repeat a stroke.

So when the fourth actuator 78 is pressed towards the proximal housing end 63 the elongate moveable third rack part 77 inside the tubular housing 6 moves lengthwise whereby a first crest 86 of the elongate moveable third rack part 77 moves on top of a second crests 88 of the combined first shell part 6a and second shell part 6b thereby applying pressure to the pawl 80. The pressure on the pawl 80 tensions the resilient spring component 85, so that the tube-displacing member 68 can be forced back one step after the other per stroke of the fourth actuator 68 to the proximal housing end 63.

Fig. 22 shows a tubular cover 43 which covers both the bendable tip part 4 and the majority of the stylet part 7. The tubular cover 43 has a distal cover end 94 that is closed and has an enlargement 95 that fits over the distal pulley wheel 21 to accommodate said distal pulley wheel 21.

The above described second embodiment of an endotracheal tube inserting device 1 can be configured with the actuators 14,15 and the third actuator 76 and the fourth actuator 78 be positioned for use by right hand or left hand. Due to the actuator 14,15 being positioned on the side of the tubular housing 6 the fingers of the operator will inherently be placed correctly on the tubular housing. The tubular housing 6 rests in the palm and optionally the hand may rest on and/or be supported by a protruding hand rest 93 provided at the distal housing end 60 at the exterior face of the tubular housing 6. The thumb can be used to operate the third actuator 76 of the tube ejecting mechanism 9.

Although the above endotracheal tube inserting device has actuators protruding from a short edge towards the center of curvature of the stylet part the third actuator is reachable by the thumb from a side of the housing and usable by right-handed or left-handed operators depending on from which side the third actuator protrude.

Within the scope of the present invention a string member can e.g. be any kind of elongate thin pulling means that can fit inside the stylet part and having a sufficient strength to pull the bendable tip part without accidentally rupturing when tensioned. Suitable string members include but are not limited to a metal wire, a nylon wire, e.g. a fish line, or similar means that can tension the tip-shaping member in response to application of a force onto a string-operating member.

The present invention has a minimum of structural components, which makes productions costs low and the risk that a structural components fails is at an absolute minimum.

Moreover since the structural components to be accommodated inside the tubular housing are small and simple, and can be combined at minimum space, the handle part of the endotracheal tube-inserting device of the present invention has a very ergonomic design.

The stylet part can advantageously be made of metal, such as malleable aluminium, which allows the stylet part to be easily adapted to any desired anatomy and use, but plastic is an alternative, and malleability is not mandatory.

The advantages of the endotracheal tube-inserting device and endotracheal procedure and methods described herein further include, without limitation, the ability to control the shape of the distal tip part of an endotracheal tube, the ability to respond to unique anatomical differences in tracheal position and shape. The entire endotracheal tube-inserting device may be disposable in its entirety, or at least some of the components be reusable. For example can the endotracheal tube-inserting device be a kit of parts, which parts e.g. may include a reusable handle part and a selection of stylet parts and endotracheal tubes to go with the stylet part. Alternative compositions of the kits of parts are within the scope of the present invention.

Claims

1. An endotracheal tube-inserting device (1) comprising a stylet part (3) and a handle part (2) for operating the stylet part (3) ,

the stylet part (3) has a proximal stylet end part (7) with a proximal stylet end (8) and an opposite curved distal stylet end part (5) with a distal stylet end (5a) ,

the distal stylet end part (5) has an extension in form of a bendable tip part (4),

a first string-operating member (14) is operatively connected to at least a first securing position (54a) at the bendable tip part (4) by means of a first string member (10), and

a second string-operating member (15) is operatively connected to at least a second securing position (54b) at the bendable tip part (4) by means of a second string member (11),

characterized in that the bendable tip part (4) has a bendable proximal tip part (18) that extends into a bendable distal tip part (19) via a string-guiding member (46), which string-guiding member (46) is adapted to guide the first string member (10) and the second string member (11) on respective opposite sides of the bendable tip part (4) .

2. An endotracheal tube-inserting device (1) according to claim 1, characterized in that the string-guiding member (46) is a joint or a hinge (46), or the string-guiding member (46) is an integral flexible part, such as a living hinge .

3. An endotracheal tube-inserting device (1) according to any of the preceding claims 1 or 2, characterized in that a proximal main body (18a) of the bendable proximal tip part (18) and a distal main body (19(a) of the bendable distal tip part (19) are molded as a common elongate main body (4a) of the bendable tip part (4), where the transition between the proximal main body (18a) and the distal main body (19b) provides the function of the string-guiding member (46), preferably the elongate main body (4a) is an elongate strip, preferably the elongate main body (4a) is an elongate plastic strip.

4. An endotracheal tube-inserting device (1) according to any of the preceding claims 1, 2 or 3, characterized in that the bendable proximal tip part (18) and the bendable distal tip part (19) are individually bendable by the first string-operating member (14) being operatively connected to at least a first securing position (54a) at the bendable proximal tip part (18) and the second string- operating member (15) being operatively connected to at least a second securing position (54b) at the bendable distal tip part, optionally the first securing position (54a) and the second securing position (54b) are the same.

5. An endotracheal tube-inserting device (1) according to any of the preceding claims 1 - 4, characterized in that the bendable proximal tip part (18) has a first proximal tip part end (23) joined to the distal stylet end (5a), and an opposite second proximal tip part end (25) , which optionally is configured as a proximal hinge part (41) of the string-guiding member (46), and the bendable distal tip part (19) has a first distal tip part end (26) and an opposite second distal tip part end (28), which first distal tip part end (26) optionally is configured as a distal hinge part (42) of the string-guiding member (46) and is hinged together with the proximal hinge part (41) .

6. An endotracheal tube-inserting device (1) according to any of the preceding claims 1 - 5 characterized in that the bendable proximal tip part (18) has a first plurality of spaced apart first guide means (30) adapted for retaining the first string member (10) along the length of the bendable proximal tip part (18) and the bendable distal tip part (19) has a second plurality of spaced apart second guide means (32) adapted for retaining the second string member (11) along the length of the bendable distal tip part (19).

7. An endotracheal tube-inserting device (1) according to claim 6 characterized in that the first plurality of spaced apart first guide means (30) are arranged along the bendable proximal tip part (18) to protrude in an opposite direction than the second plurality of spaced apart second guide means (32) that are arranged along the bendable distal tip part (19) to protrude from said bendable distal tip part (19).

8. An endotracheal tube-inserting device (1) according to any of claims 6 or 7 characterized in that the first plurality of spaced apart first guide means (30) and/or the second plurality of spaced apart second guide means (32) is/are selected from the group comprising eyes, loops and hooks.

9. An endotracheal tube-inserting device (1) according to any of the preceding claims 1 - 8 characterized in that endotracheal tube-inserting device (1) comprises a flexible tubular cover that covers at least the bendable tip part (4), optionally the tubular cover also covers at least a distal stylet part of the stylet part (3) , optionally the tubular cover covers a combined length of the stylet part (3) and the bendable tip part (4) corresponding to at least the length of the endotracheal tube to be used with the endotracheal tube-inserting device (1) .

10. An endotracheal tube-inserting device (1) according to any of the preceding claims 1 - 9 characterized in that the bendable tip part (4) includes at least one pulley wheel (20,21,22) for controlling the direction of any of the first string member (10) and the second string member (11), which at least one pulley wheel (20,21,22) is selected from the group of pulley wheels (20,21,22) comprising

- an intermediate pulley wheel (21) incorporated in or located at the string-guiding member (46),

- an intermediate pulley wheel (21) arranged at the second proximal tip part end (25),

- an intermediate pulley wheel (21) arranged at the first distal tip part end (26),

- a proximal pulley wheel (20) arranged at the first proximal tip part end (23), and

- a distal pulley wheel (22) arranged at the second distal tip part end (28) .

11. An endotracheal tube-inserting device (1) according to any of the preceding claims 1 - 10 characterized in that opposite the first distal tip part end (26) of the bendable distal tip part (4), said distal tip part (4) has a second distal tip part end (28) provided with an enlarged tip.

12. An endotracheal tube-inserting device (1) according to any of the preceding claims 1 - 11 characterized in comprising a tube connector (61) adapted for detachably and temporarily securing to an airway connector of an endotracheal tube mounted on the stylet part (3) to be displaced over the bendable tip part (4) .

13. A bendable tip part (4) as defined in any of the preceding claims 1 - 12.