GB2606702A - Intubation aid - Google Patents

Abstract

An intubation aid 1 for facilitating endotracheal intubation, the intubation aid comprising a handle 20 comprising a lever 31, an elongate rod 20 extending from the handle and comprising a flexible portion 23 disposed between a distal portion 22 and a proximal portion 21, and a control wire (40, Fig 4) affixed at the distal portion and extending to the lever. A sheath 24 encloses the rod and the control wire from the distal portion to the handle. The lever 31 is preferably pivotable so as to move the distal portion 22 of the rod between flexed and unflexed positions via the control wire. Preferably, a proximal end of the control wire (40, Fig 4) is affixed to the lever and aligned with a longitudinal axis of the proximal portion of the rod when in a first position. An intubation system is also provided comprising the intubation aid and an endotracheal tube 10 mountable over the rod of the intubation aid.

Description

IAITUBATION AID

Field of the Invention

The present invention relates to an intubation aid and particularly, although not exclusively, to an intubation aid for assisting with the insertion of an endotracheal tube into the trachea of a patient.

Background

Endotracheal intubation is performed on a patient when they cannot maintain their airway or cannot breathe unassisted. These situations may arise when a patient is anaesthetised or unconscious. An endotracheal tube (ETT) is inserted into the trachea which supports the airway and can be connected to a ventilator to deliver oxygen to the lungs.

Intubation aids facilitate endotracheal intubation, in particular they facilitate passing an endotracheal tube (ETT) through the glottis. During endotracheal intubation, the ETT is most commonly inserted through the mouth and into the trachea. This is usually done by direct laryngoscopy using a Macintosh intubation blade. Endotracheal intubation by direct laryngoscopy may be difficult or unsuccessful as a result of unusual anatomy or pathologies affecting the airway. Under these circumstances, intubation aids may be used. The most common of these is a bougie (or introducer) device. This is a device with greater flexibility and a smaller diameter than an endotracheal tube. The distal end of a bougie is typically angled at about 30 degrees. In use, the bougie is held with the angled distal end pointing anteriorly for insertion into the trachea under direct laryngoscopy. Once the boogie is placed in the trachea, an ETT can be railroaded onto it and inserted into the trachea under direct vision (i.e. there is a direct line of sight) with the laryngoscope still in place. Once the ETT is in place, the bougie can be removed and then disposed of (i.e. it is a single patient use item).

Other intubation aids are known that comprise a deflective tip to assist navigation of the ETT into the trachea. The ETT may need to be pre-mounted onto this type of intubation aid before its insertion into the trachea. After insertion, the intubation aid can then be removed leaving the endotracheal tube in place to maintain the patient's airway.

Some of these intubation aids comprise a handle and a control wire for actuating deflection of the tip In one arrangement, the proximal end of the intubation aid may be pulled during use to actuate the deflective tip. Such intubation aids require two operators: one to perform the intubation and the other actuate the deflective tip by pulling the proximal end. In another arrangement, the intubation aid comprises a lever handle to allow both positioning of the intubation aid and actuation of the deflective tip (i.e. by a single operator). However, there can be problems with these lever-operated intubation aids, the control wire may be exposed or damaged during use and the actuation of the deflective tip can be difficult to control.

The present invention aims to provide an improved intubation aid which can facilitate endotracheal intubation.

Summary of e invention

According to a first aspect, there is provided an intubation aid comprising: a handle comprising a lever; an elongate rod extending from he handle and comprising a distal portion, a proximal portion and a flexible portion interposed between the distal portion and the proximal portion; a control wire having a distal end coupled with the distal portion and a proximal end coupled with the lever; and a sheath enclosing the rod and the control wire from the distal portion to the handle.

By enclosing the control wire and elongate rod within a sheath, the elongate rod and the control wire can be protected from contact with a patient (or fluid within the patient). This prevents contamination of the control wire and the rod, and may allow re-use of the intubation aid (e.g. by replacement of the sheath).

Additionally, the sheath retains the control wire against the elongate rod (i.e. so as to guide the control wire along the elongate rod). This means that the size of the intubation aid in cross--section, does not change as it flexes and therefore the endotracheal tube can be railroaded over it as easily in the flexed position as in the neutral unflexed position.

In some embodiments, the lever is oivotable between a first position and a second position to move the distal portion between respective neutral unflexed and activated flexed positions via the control wire. The unflexed position may represent a neutral (i.e. relaxed) position of the distal portion. In the flexed position, the distal portion may be pivoted towards the proximal portion (i.e. such that a distal end of the distal portion is closer to the proximal portion than in the unflexed position). In other words, an angle defined between a longitudinal axis of the distal portion and a longitudinal axis of the proximal portion may be greater in the unfiexed position than the flexed position.

For the avoidance of doubt, references to "longitudinal axis" herein are references to the axis extending in the direction of the long dimension of the relevant component. Thus, for example, the longitudinal axis of the proximal portion is the axis that extends along the length of the proximal portion between the handle and the flexible portion.

In some embodiments; the proximal portion of the rod comprises a curved section. The curved section may be proximate a distal end of the proximal portion. The curved section may be a smooth continuous curve formed in the proximal portion (but could otherwise be formed of a series of linear sub-sections arranged to approximate a curve). The curved section may be formed using known information about the anatomy of the airway or in line with a laryngoscope blade (which may be designed for direct or indirect laryngoscopy) as a guide. In this respect, the proximal portion may be deformable, such that the profile of the curved section (i.e. the shape of the curve of the curved section) is adjustable, The proximal portion may be longer than the distal portion. The proximal portion may be longer than the flexible portion. The flexible portion may be longer than the distal portion. In some embodiments, the proximal portion is between 250 mm and 850 mm long, for example, the proximal portion may be about 550 mm long. In some embodiments, the distal portion is between 5 mm and 50 mm long, for example the distal portion may be about 15 mm long. In some embodiments, the flexible portion is between 10 mm and 60 mm long, for example the flexible portion may be about 35 mm long, It should be appreciated that anatomical features of patients vary (for example; with age). Accordingly; the lengths of the various portions (proximal, distal; and flexible) may be selected so as to be suited to a particular anatomical structure.

The proximal portion may be hollow The proximal portion may be tubular. The proximal portion may be formed of metal, such as e.g. stainless steel. The proximal portion may, for example, have a diameter of 2 mm to 5 mm.

In some embodiments, the control wire extends through the proximal portion (e.g. extends through the hollow interior of the proximal portion). The proximal portion may comprise an aperture that opens to the hollow interior (i.e. through a wall of the proximal portion). The control wire may enter/exit Me hollow interior of the proximal portion via the aperture.

The aperture may be proximate the distal end of the proximal portion. In some embodiments, the aperture is spaced from the distal end of the proximal portion by between 1 rnm and 20 mm, for example, the aperture may be spaced from the distal end of the proximal portion by about 10 mm.

The aperture may be in the form of a slot. An elongate axis of the slot may be parallel to the longitudinal axis of the proximal portion. The slot may be between 1 mm and 15 mm long, for example, the slot may be about 6 mm long. The slot may be between 1 mm and 3 mm wide, for example, the slot may be about 1.5 mm wide.

The distal portion may be hollow. The distal portion may be tubular. The distal portion may be formed of metal, such as e.g. stainless steel. The distal portion may, for example; have a diameter of 2 mm to 5 mm.

The aperture formed in the proximal portion (as discussed above) may be referred to as a first aperture, and the distal portion may comprise a second aperture that opens to the hollow interior of the distal portion (i.e. through a wall of the distal portion). The second aperture may be proximate a distal end of the distal portion. The second aperture may be spaced from the distal end of the distal portion by between 1 mm and 7 mrn, for example, the second aperture may be spaced from the distal end of the distal portion by about 1 mm to 5 mm. The second aperture may be circular. The second aperture may have a diameter of between 1 mm arid 3 mm, for example, the second aperture may have a diameter of about 1.5 mm.

In some embodiments the distal portion comprises an open distal end (i.e the end of the distal portion may be open to the hollow interior of the distal portion rather than e.g. being capped).

The control wire may be coupled with the distal portion in such a way that the distal end ot the control wire is freely rotatable with respect to the distal portion. In other embodiments, the control wire may be directly fixed (e.g. welded) to the distal portion.

In some embodiments, the control wire comprises a looped portion, which may be at a distal end of the control wire. For example, the end of the control wire may be looped back and secured to itself (e.g. by welding) to form the looped portion. In this way the distal end of the control wire may be secured (e.g. welded) to a portion of the control wire that is located between the first and second apertures.

The looped portion may be looped around or through at least part of the distal portion to couple the control wire with the distal portion. This may allow actuation of the distal portion by the control wire. The looped portion may loop through the second aperture and the open distal end of the distal portion.

In some embodiments, the control wire is a wire rope e.g. a 7x7 wire rope. The control wire may be a metal control wire e.g. a stainless steel control wire. The control wire may have a diameter of between 0.5 mm and 2.5 mm, for example, the control wire may have a diameter of about 1 mm.

In some embodiments the flexible portion is a wire rope. In some embodiments, the flexible portion is formed of metal e.g. stainless steel. In some embodiments the flexible portion comprises a coating e.g. a nylon coating. In some embodiments, the flexible portion has a nominal diameter of e.g. about 1.6 mm. At least part of the flexible portion may have a diameter equal to the nominal diameter.

In some embodiments, a proximal end of the flexible portion is received in the proximal portion via an open distal end of the proximal portion (i.e. defining an opening to the hollow interior of the proximal portion). The proximal end of the flexible portion may be attached (e.g. welded or adhered) to the proximal portion. In some embodiments, the proximal end of the flexible portion has a diameter that less than the nominal diameter e.g. about 1.2 mm.

In some embodiments, the flexible portion is received in the distal portion via an open proximal end of the distal portion (i.e. open to the hollow interior of the distal portion). The distal end of the flexible portion may be attached (e.g. welded or adhered) to the distal portion. The distal end of the flexible portion may have a diameter less than the nominal diameter e.g. about 1.2 mm.

Forming the flexible portion with wire rope, and forming the proximal/distal portions with tubing, can provide a rod that is simple and cost effective to manufacture using standard components (e.g. metal tubes and wire rope), whilst maintaining a robust assembly.

Turning now to the handle, the handle may be rotatable relative to the rod (i.e. rotatable about an axis that extends along the length of the rod). In this way, the orientation of the handle with respect to the distal portion can be adjusted.

In some embodiments, the handle may be oriented such that the lever of the handle and the distal portion are on the same side of the proximal portion (at least when the distal portion is in the flexed position). In other words, if a reference axis is defined along a linear part (i.e. a non-curved part) of the proximal portion, then both the lever and the distal portion may lie on the same side of that reference axis (i.e. may be spaced from the reference axis in the same direction).

In normal use of the intubation aid, a patient will be in the supine position and an operator will be positioned at the head of the patient, facing the patient's feet. The intubation aid is inserted into the mouth of the patient and is then manoeuvred into the trachea, such that distal portion of the intubation aid is generally directed anteriorly (and somewhat inferiorly). When the lever of the handle is positioned on the same side of the proximal portion as the distal portion (i.e anteriorly); as described above; then the operator is able to grip the lever with their fingers in order to actuate the lever. Such an arrangement may be desirable from an ergonomic perspective and may facilitate accurate control of the movement of the distal portion.

The handle may comprise a grip and a lever pivotably mounted to the grip. In use, the grip can be received in the palm of an operator's hand, and the operator's fingers may then extend around the lever to actuate the lever. The grip may comprise an outwardly (laterally or radially) projecting fulcrum portion to which the lever may be pivotably mounted. For example, the lever may be pivotably mounted to the fulcrum portion by a pin. The pin may be a bolt e.g. an M2 bolt. The pin may be held in place by a nut e.g. an M2 nut.

The lever may pivot about an axis, referred to herein as the pivot axis. The pivot axis may be generally orthogonal to the rod (e.g. orthogonal to a longitudinal axis of the proximal portion).

In some embodiments; the fulcrum portion comprises first and second spaced apart arms. The lever may be mounted between the first and second spaced apart arms. The first and second arms may be substantially parallel to one another. The first and second arms may be spaced from one another in the direction of the pivot axis (defined above) so as to define a recess therebetween. The first and second arms may be connected by a crossbar. The crossbar may extend transversely from the first arm to the second arm at a distal (free) end of the fulcrum portion. In this way, the first arm; second arm, and crossbar may define a substantially rectangular shaped recess (or "gate").

In some embodiments, the lever comprises a first lever portion, and a second lever portion projecting from the first lever portion. The first and second lever portions may be substantially perpendicular to one another. In that respect, the lever may be generally L-shaped. The first lever portion may be disposed between the first and second arms of the fulcrum portion (i.e. within the recess defined between the arms). Each of the arms of the fulcrum portion and the first lever portions may comprise through-holes, through which the pin is received for pivotable mounting.

In some embodiments, the first lever portion at least partly extends over a proximal end of the grip ot the handle. Actuation of the lever may move the first lever portion away from the proximal end of the grip. In the first position, the first lever portion (e.g. a lower surface thereof) may abut the proximal end of the grip of the handle. In the second position, the first lever portion may be spaced from the proximal end of the grip. In this second position (La in which a user has squeezed the lever), the second lever portion may be pivoted towards the grip.

As discussed above, a proximal end of the control wire is coupled with the lever. The control wire may be coupled with the first portion of the lever. In some embodiments, the lever comprises an attachment portion with which the control wire is coupled.

The attachment portion of the lever may be in the form of a through-hole, through which the control wire passes (referred to herein as a wire-receiving hole). The wire-receiving hole may be oriented so as to extend along an axis that is substantially aligned with (i.e. coaxial with) the longitudinal axis of the proximal portion. This may reduce or avoid any bending of the wire as it passes from the proximal portion to the lever.

In some embodiments, the proximal end of the control wire may comprise a stopper to prevent retraction of the control wire back through the wire-receiving hole formed in the first lever portion. The proximal end of the control wire may pass through the wire-receiving hole and the stopper may be disposed at a part of the control wire extending beyond the wire-receiving hole. In this way, the stopper may prevent the proximal end of the control wire from passing back through the wire-receiving hole and in doing so secures the control wire to the lever. As a result, the stopper engages with the upper surface of the lever such that when the lever is actuated (i.e. moves from the first position to the second position), the stopper is moved by the lever. Consequently, the control wire is pulled with the stopper when the lever is moved from the first position to the second position causing the distal portion (of the rod) to move from the neutral unitexed position to the activated flexed position.

In some embodiments the stopper is a nut e.g. a stainless steel M2 hex nut. The stopper may be welded e.g. spot welded to the control wire. The proximal end of the control wire may be bent back on itself (i.e. doubled-up and e.g. welded), which may improve the retaining strength of the stopper (i.e. doubling the cross-sectional area of the proximal end of the control wire may make it more difficult for the proximal end to pass back through the wire-receiving hole formed in the lever).

In some embodiments the lever end portion of the control wire is aligned (i.e. substantially coaxial) wwith the longitudinal axis of the proximal portion of the rod when the lever is in the first position.

The alignment of the lever end portion of the control wire with the longitudinal axis of the proximal portion of the rod may result in less bending of the wire as it is pulled. This may reduce wear of the control wire on the interior of the proximal portion of the rod or the handle (reducing frictional forces, and preserving the control wire for lonaer) and may reduce the level of force required from the operator to actuate the lever. The result is an int:Mahon aid which may have improved user control and ease of use.

The handle may comprise a plastic e.g. a thermoplastic e.g. polylactic acidipolylactide (PLA). The handle may comprise a bioplastic e.g. polylactic acidipolylactide (PLA). The handle may be formed of a biodegradable material. The handle may be manufactured using additive manufacturing i.e. 3D printing.

In some embodiments, the sheath (enclosing the control wire and the rod) is a plastic sheath. The sheath may comprise a low friction outer surface. The sheath may be a PROACTO standard ET tube introducer or similar. The sheath may be formed of a biodegradable material.

The sheath may be removably mounted to the handle such that it may be removable andlor replaceable. A proximal end of the sheath may be removably mounted to a distal end of the grip of the handle. The distal end of the grip may comprise a protrusion received inside the proximal end of the sheath (i.e. such that the proximal end of the sheath fits snugly around the protrusion). The protrusion of the grip of the handle (upon which the sheath is mounted) may also provide for attachment of an endotracheal tube (i.e. in the same manner as the sheath). At least a portion of the protrusion may taper inwardly to facilitate mounting of the endotracheal tube thereto. For example, at least a portion of the protrusion may be frustoconical.

In a second aspect there is provided an intubation system comprising: an intubation aid according to the first aspect; and an endotracheal tube mountable over the rod of the intubation aid.

The rod of the intubabon aid may be substantially longer than the endotracheal tube. For example, the length of the rod may be greater than 1.5 times, or greater than 2 times the length of the endotracheal tube.

In this way, the endotracheal tube may be positioned over the rod (i.e. such that the rod is received through the endotracheal tube) adjacent the handle, and the distal end of the rod may extend beyond the endotracheal tube. Thus, the (exposed) distal end of the rod can be inserted into the patient's trachea with the endotracheal tube remaining completely outside of the patient. Subsequently, once the rod is in place, the endotracheal tube can be moved along the rod and into position within the patient's trachea.

The intubation aid can then be removed completely, leaving the endotracheal tube in place within the trachea.

Summary of the Figures

Embodiments illustrating the principles of the invention will now be discussed with reference to the accompanying figures in which: Figure la is a perspective view of an intubation aid assembled with an endotracheal tube, with the distal portion in the neutral urrilexed position; Figure lb is a perspective view of the intubation aid of figure is shown without the endotracheal tube and with the distal portion is in the activated flexed position.

Figure 2a shows the interior of the rod of the intubation aid shown in figure 1 in the neutral unflexed position. The control wire is not shown and the proximal portion of the rod does not yet comprise a deflection.

Figure 2b is a detail view of the distal portion; flexible portion and distal end of the proximal portion of the interior of the rod shown in figure 2a with the tip in a neutral unflexed position.

Figure 3 is an illustration of the looped portion of the control wire.

Figure 4 shows the intubation aid shown in figure 1 with the sheath removed in theneutral unflexed position. The rod does not yet comprise a deflection.

Figure 5 shows the handle of intubation aid shown in figure 1 with the lever in the first position. The control wire and the rod are not attached.

Figure 6 shows another view of the handle of the intubation aid shown in figure 1 showing the lever in the first position and the attachment of the control wire to the handle.

Detailed Description of the Invention

Aspects and embodiments of the present invention will now be discussed with reference to the accompanying figures. Further aspects and embodiments will be apparent to those skilled in the art. All documents mentioned in this text are incorporated herein by reference.

Figure is shows an exemplary embodiment of an intubation aid 1. An endotracheal tube 10 is shown mounted to the intubation aid 1. The intubation aid 1 comprises a rod 20, a handle 30, and a sheath 24 enclosing substantially the entire the rod 20. In this figure, the intubation aid 1 is in a neutral unflexed position. As will be described further below, the intubation aid 1 is moveable from the unflexed position to a flexed position. The intubation aid 1 is shown in this flexed position in Figure lb On which the endotracheal tube has been removed).

The rod 20 is shown in more detail in figures 2a and 2b. The rod 20 comprises a distal portion 22; a proximal portion 21 and a flexible portion 23 interposed between the distal portion 22 and the proximal portion 21. Although not apparent from these figures, a control wire el 0 (see figure 4) is affixed to the distal portion 22 of the rod 20 and extends from the distal portion 22 to the handle 30.

In figures 2a and 2b, the proximal portion 21 is shown in a pre-formed condition and; for that reason, is illustrated as being linear. It should, however, be appreciated that at some point prior to use of the intubation aid 1, the proximal portion 21 of the rod 20 is deformed so as to have a curvature (as shown in figure 1) which follows a smooth continuous curve. This curved section may be formed using a laryngoscope blade as a guide.

The proximal portion 21 is longer than the distal portion 22 and longer than the flexible portion 23. The flexible portion 23s longer than the distal portion 22. The proximal portion 21 is 550 mm long, the flexible portion 23 is 35 mm long and the distal portion 22 is 15 mm long.

The proximal portion 21 is a hollow stainless steel tube and comprises an aperture (referred to herein as a first aperture 25) formed in a wall thereof. The control,vvire 40 passes along the hollow interior of the proximal portion 21 (from the handle 30) and exits the hollow interior of the proximal portion 21 via the first aperture 25. As is evident from Figure 2b, the first aperture 25 is in the form of an elongate slot which has a distal end that is spaced approximately 10 mm from the distal end of the proximal portion 21. The elongate slot is 6 mm long and 1.5 mm wide.

The distal portion 22 is also a hollow stainless steel tube and also comprises an aperture (referred to herein as the second aperture 28). Additionally, the distal end 27 of the distal portion 22 is open (i.e. defining an opening to interior of the distal portion 22). The second aperture 26 is a hole which is spaced a distance of 5 ruin from the distal end 27 of the distal portion 22 and has a diameter of 1.5 mm. This second aperture 26 allows for the control wire 40 to be secured to the distal portion 22 via a looped portion 41 of the control wire 40.

This looped portion 41 is apparent in Figures 3 and 4, which depicts the control wire 40. The control wire is formed of a 7x7 stainless steel wire rope and has a diameter of 1 mm. The looped portion 41 is formed by looping a free end of the control wire 40 back on itself and forming a join with the free end via a weld 42 (in the form of a plurality of spot welds).

As is apparent from Figure 3, in particular, the control wire 40 is secured to the distal portion 22 by looping the looped portion 41 through the second aperture 28 and the open distal end 27 of the distal portion 22. In other words; the distal end of the control wire 40 extends (from the proximal portion 21) into the distal portion 22 through the second aperture 26 and out of the open distal end 27, before looping back on itself. In this way the distal end of the control wire 40 is secured (welded) to a portion of the control wire 40 that is located between the first 25 and second 28 apertures.

As noted above, the distal portion 22 and proximal portion 21 are joined by a flexible portion 23 (shown in figures 2a and 2b). The flexible portion 23 is in the form of a stainless steel wire rope and has a nylon coating. The flexible portion 23 has a nominal diameter of 1.6 mm.

The flexible portion 23 is secured to the proximal portion 21 via an open distal end 28 of the proximal portion (defining an opening to the hollow interior of the proximal portion 21). In particular, a proximal end 23a of the flexible portion 23 is received in the open distal end 28 of the proximal portion 21, and then welded (spot welded) to the proximal portion 21. The proximal end 23a of the flexible portion 23 has a diameter of approximately 1.2 mm and is approximately 5 mm long.

The flexible portion 23 is secured to the distal portion 22 in a similar manner. A distal end 23b of the flexible portion 23 is received in an open proximal end of the distal portion 22. The distal end 23b of the flexible portion 23 is welded (spot welded) to the distal portion 22. The distal end 23b of the flexible portion 23 has a diameter of approximately 1.2 mm and is approximately 5 mm long.

The handle is Illustrated in more detail in Figures 5 and 6. The handle 30 comprises a grip 32 and a lever 31 pivotably mounted to the grip 32. The grip 32 of the handle has a substantially oval cross-sectional area and is hollow (for receipt of the control wire 40 therethrouoh). Although not apparent from the figures, the handle 39 is rotatably mounted to the rod 29 (i.e. so as to be rotatable about a longitudinal axis of the rod 20). Of course, the handle 30 may alternatively be fixed with respect to the rod 20. A preferred position is shown in figures la and lb in which both the lever 31 and the distal portion 22 are arranged on the same side of the proximal portion 21. In particular, the handle 30 and the distal portion 22 (and flexible portion 23 and curved section of the proximal portion 21) lie in the same plane.

A fulcrum portion 33 extends outwardly (i.e. laterally) from a proximal end of the grip 32. The extension of the fulcrum portion 33 is such that it forms an obtuse angle with a longitudinal axis of the rod 20. The lever 31 is pivotably mounted to the fulcrum portion such that the lever pivots about a pivot axis that is perpendicular to the longitudinal axis of the rod 20.

The fulcrum portion 33 comprises first 33a and second 33b spaced apart parallel arms. The arms 33a, 33b are spaced from one another along the pivot axis and the lever 31 is received therebetween. To facilitate mounting of the lever therebetween, a first through-hole passes through the first arm 33a and a second through-hole passes through the second arm 33b. The first through-hole and the second through-hole each have a diameter of about 2 mm.

The first arm 33a and the second arm 33b are connected by a crossbar 35 at a distal end of the fulcrum portion 33 (i.e. distal from the portion of the grip 32 from which the fulcrum portion 33 extends). The crossbar 35 extends transversely from the first arm 33a to the second arm 33b such that the first arm 33a, the second arm 33b and the crossbar 35 define a substantially rectangular recess (or gate).

The lever 31 has a substantially rectangular transverse cross-sectional shape and comprises a first lever portion 31a and a second lever portion 31b projecting from the first lever portion. The first lever portion 31 a and the second lever portion 31b are substantially perpendicular such that the lever 31 is generally L-shaped. The first lever portion 31a comprises a third through-hole (not shown) which is substantially coaxial with the first and second through-holes (formed in the arms 33a, 33b of the fulcrum portion 33). The third through-hole has a diameter of about 2 mm.

The lever 31 is pivotably mounted to the fulcrum portion 33 by a pin 36 which passes through the first, second and third through-holes and is aligned with the pivot axis. The pin 36 is an P,A2 bolt and is held in place by an IM2 nut. This assembly allows the lever 31 to pivot from the first position to the second position (and vice versa) relative to the grip 32 of the handle 30.

The first lever portion 31a of the lever 31 extends over the proximal end of the grip 32. In the first position, the first lever portion 31a of the lever 31 has a lower surface which abuts the proximal end of the grip 32. In the second position, the first lever portion 31a of the lever 31 is spaced from the proximal end of the grip 32.

The lever 31 comprises a wire-receiving hole 34 which extends from an upper surface of the lever 31. The wire-receiving hole 34 extends along an axis that is substantially aligned with the longitudinal axis of the proximal portion 21 of the rod 20 when the lever 31 is the first position. The wire-receiving hole 34 has a diameter of 1.5 mm.

The wire-receiving hole 34 allows a proximal end 43 of the control wire 40 to be affixed to the lever 31. The proximal end 43 of the control wire 40 is passed through the wire-receiving hole 34, so as to extend above an upper surface of the lever 31, and a stopper 44 is provided on proximal end 43 of the control wire 40 that extends beyond the wire-receiving hole 34. The stopper 44 prevents the proximal end 43 of the control wire 40 from passing back through the wire-receiving hole 34. In this way, when the lever 31 is moved from the first position to the second position, the stopper 44 engages the upper surface of the lever 31 so as to pull the control wire 40 (seen in figure 1).

The stopper 44 is a stainless steel M2 hex nut and is welded (spot weld) to the proximal end 43 of the control wire 40. The proximal end 43 of the control wire 40 is bent back on itself and welded (with a plurality of spot welds) to improve the retaining strength of the stopper 44 by increasing the cross-sectional area of the proximal end 43. This reduces the possibility of the proximal end 43 of the control wire 40 passing back through the wire-receiving hole 34.

As noted above, the wire-receiving hole 34 is aligned with the longitudinal axis of the proximal portion 21. As a result, the proximal end 43 of the control wire 40 also aligns with the longitudinal axis of the proximal portion 21 when the lever 31 is in the first position. This reduces stresses on the control wire 40 that may otherwise be caused by bending of the wire 40.

The handle 30 is a made from polylacfic acidipolylactide (FLA, a thermoplastic and bioplastic) and is manufactured by way of additive manufacturing i.e. 3D printing.

The sheath 24 (shown best in Figures la and 1 b) is a plastic sheath 24 with a low friction outer surface.

More specifically the sheath is a PROACT® standard ET tube introducer. The sheath 24 may be removably mounted to the handle 30 so as to be replaceable. In this way, the sheath 24 represents a single-use component of the intubation aid 1, but allows the remaining components of the intubation aid 1 to be re--used.

A distal end of the grip 32 of the handle 30 is open (to the hollow interior of the rod 20). The proximal portion 21 is received in the grip 32 via this open distal end. The sheath 24, which encloses the proximal portion 21. is attached to the grip 32 via a protrusion 45 at the distal end of the grip 32. The protrusion 45 is received inside the open proximal open end of the sheath 24 such that the proximal end of the sheath 24 fits snugly about the protrusion (Le. providing an interference fit). The protrusion 45 (i.e. at the distal end of the grip 32) comprises a tapered portion that facilitates attachment of an endotracheal tube in a similar manner to the sheath 24.

As is discussed briefly above, the intubation aid 1 is movable between a neutral unflexed position and a flexed activated position. As should now be apparent, the lever 31 is pivotable between the first position and the second position to move the distal portion 22 between the respective neutral unflexed and activated flexed positions via the control wire 40. Figure la shows the lever 31 in the first position and the distal portion 22 in the unfiexed position and figure lb shows the lever 31 in the second position and the distal portion 22 in the activated flexed position.

The features disclosed in the foregoing description, or in the following claims, or in the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for obtaining the disclosed results, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse forms thereof.

While the invention has been described in conjunction with the exemplary embodiments described above, many equivalent modifications and variations will be apparent to those skilled in the art when given this disclosure. Accordingly, the exemplary embodiments of the invention set forth above are considered to be illustrative and not limiting. Various changes to the described embodiments may be made without departing from the scope of the invention.

For the avoidance of any doubt, any theoretical explanations provided herein are provided for the purposes of improving the understanding of a reader. The inventors do not wish to be bound by any of these theoretical explanations.

Any section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

Throughout this specification, including the claims which follow, unless the context requires otherwise, the woM "comprise" and "include", and variations such as "comprises", "comprising", and "including" will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

It must be noted that, as used n the specification and the appended claims, the singular forms "a," "a and "the" include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by the use of the antecedent "about," it will be understood that the particular value forms another embod ment. The term "about" in relation to a numerical value is optional and means for example +1--10%.

Claims (1)

1. Claims 1 An intubation aid comprising: a handle comprising a lever; an elongate rod extending from the handle and comprising a distal portion, a proximal portion and a flexible portion interposed between the distal portion and the proximal portion; a control wire having a distal end coupled with the distal portion and a proximal end coupled with the lever; and a sheath enclosing the rod and the control wire from the distal portion to th 2. An intubation aid according to claim 1 wherein the handle is rotatable relative to the proximal portion.3. An intubation aid according to claim 1 or 2 wherein the handle comprises a grip and a lever pivotal:11y mounted to the grip.4. An intubation aid according to claim 3 wherein the lever is pivotable between a first position and a second position to move the distal portion between respective unflexed and flexed positions via the control wire.5. An intubation aid according to claim 3 or 4 wherein the handle is oriented such that the lever of the handle on the same side of the proximal portion as the distal portion.6. An intubation aid according to claim 4, or claim 5 when dependent on claim 4, wherein a proximal end of the control wire is affixed to the lever and wherein the proximal end of the control wire is aligned with a longitudinal axis of the proximal portion of the rod when the lever is in the first position.7 An intubation aid according to claimS wherein the lever comprises a wire-receiving hole and wherein the proximal end of the control wire passes through the wire-receiving hole, the control wire comprising a stopper configured to prevent the proximal end of the control wire from passing back through the wire-receiving hole.8. An intubation aid according to any one of the preceding claims wherein the control wire extends through the proximal portion.9. An intubation aid according to claim 8 wherein the proximal portion is tubular.10. An intubation aid according to claim 8 or 9 wherein the proximal portion comprises a first aperture in a wall of the proximal portion and wherein the control wire passes through the first aperture from an interior of the proximal portion.11. An intuhation aid according to any one of the preceding claims wherein the control wire comprises a looped portion and wherein the looped portion is looped around or through at least part of the distal portion.12. An intubation aid according to claim 11 wherein the looped portion is looped through a second aperture, formed in a wail of the distal portion, and an open distal end of the distal portion.13. An intubation aid according to any one of the preceding claims wherein the sheath is removably mounted to the handle.14. An intubation aid according to claim 13, when dependent on claim 3, wherein the grip of the handle comprises a protrusion received inside a proximal end of the sheath.15. An intubation aid according to claim 14 wherein at least a portion of the protrusion is tapered.16. An intubation aid according to any one of the preceding claims wherein the flexible portion a wire rope.17. An intubation aid according to any one of the preceding claims wherein the sheath is formed of a biodegradeable material, 18. An intubation aid according to any one of the preceding claims wherein the handle is formed of a biodegradeable material.19. An intubation system comprising: an intubation aid according to any one of the preceding claims; and an endotracheal tube mountable over the rod of the intubation aid.20. An intubation system according to claim 19 wherein the rod of the intubation aid is substantially longer than the endotracheal tube.21. An intubation system according to claim 20 wherein the length of the rod is greater than 1.5 times the length of the endotracheal tube.