AN AIRWAY MANAGEMENT DEVICE AND METHODS OF MANUFACTURING AN OBJECT

Abstract

An airway management device has a body (6) including an external shell moulded from a polypropylene copolymer (PP) blended with a thermoplastic elastomer (TPE) of styrene-ethylene/butylene-styrene (SEBS), the external shell extending from a proximal opening to a distal tip of the body (6), the external shell having a curved portion (35) and a linear portion (37). Methods of manufacturing are also disclosed.

Claims

1. An airway management device, comprising: a body (6) including an external shell moulded from a polypropylene copolymer (PP) blended with a thermoplastic elastomer (TPE) of styrene-ethylene/butylene-styrene (SEBS), the external shell extending from a proximal opening to a distal tip of the body (6), the external shell having a curved portion (35) and a linear portion (37).

2. The airway management device of claim 1, further including an intermediate strip (38) moulded from a polypropylene copolymer (PP) attached to said external shell intermediate to the curved portion (35) and the linear portion (37).

3. The airway management device of claim 1, further including a first over-mould of SEBS comprising a posterior contour (35) and a distal contour (34) on the external shell.

4. The airway management device of claim 3, wherein the first over-mould comprises a distal perimeter (26) defining a first opposed edge of an over-moulded cuff membrane (25) continuing tangentially from said perimeter (26) as a toroidal curve whose end point is in spaced relation and normal to the first opposed edge, the end points defining an open posterior (27) perimeter or second opposed edge and a linear portion (37) over-moulding a proximal end such that said curved portion (35) and the linear portion (37) are joined as a single moulding by planar sealing voids (36) to first and second sides of an intermediate strip (38).

5. The airway management device of claim 4, further including a second over-mould of SEBS closing said open length of membrane (27), forming an inflatable cuff.

6. The airway management device of claim 5, wherein the posterior contour (35) of the body (6) is adapted to be located within a hypopharynx and a distal end (2) is adapted to be located within an upper oesophageal sphincter creating an oesophageal seal, wherein immediately superior to a distal opening (20), and the anterior compound curvature (33) of the external shell is an internal posterior surface of a passage or gastric drain tube (24) reducing the bulk of the distal tip (2).

7. The airway management device of claim 6, further including a surrounding contour (34) over-moulding said anterior compound curvature (33) of the external shell and which is adapted for locating and pressing against the hypopharynx, the distal to proximal full length configuration of the external shell providing resistance against displacement of the distal opening (20) superiorly from increasing oesophageal pressure (70).

8. The airway management device of claim 6, wherein the drain tube (24) and a drain tube distal opening (20) are integral with a distal posterior contour (34) and where the said drain tube (24) is not surrounded by an annular volume of said inflatable cuff.

9. The airway management device of claim 6, further including a closed tubular section (30) forming a chamber (32) providing a space for a distal portion of the inflatable cuff with a posterior displacement when inflated.

10. The airway management device of claim 6, wherein through any horizontal cross section of said inflatable cuff, first and second edges (27), for at least the length of the distal portion of the gastric drain tube (31), are maintained parallel to a median plane (10) of the curved portion (35) such that the width between the first and second edges (27) after second over-moulding is equal to an outer diameter of the distal drain tube (31).

11. The airway management device of claim 10, wherein a curvature of the inflatable cuff membrane (25) between said first (26) and second (27) opposed edges is a single contiguous curve of uniform durometer hardness, sealing posteriorly against a hypopharynx and anteriorly against a laryngeal inlet without adhesive joint.

12. A method of forming the airway management device according to claim 1, comprising: providing a removable connector/adaptor (39) on the linear portion to reduce a length from a proximal opening (42) of the body (6) through to a trachea (68), thereby providing additional depth of insertion of a distal tip (63) of an endotracheal tube.

13. A method of forming the airway management device according to claim 1, comprising: providing a finger stopper (60) creating a fixed position to rest a thumb during insertion, to grip a proximal end (37) when removing the device after intubation and to act as a depth indicator, with reference to teeth, when the device is in situ.

14. A method of forming an airway management device, comprising: providing a body (6) comprising polypropylene copolymer (PP) and thermoplastic elastomer (TPE) of styrene-ethylene/butylene-styrene (SEBS), including an external shell moulded from a majority PP copolymer blended with SEBS extending from a proximal opening to a distal tip of the body (6).

15. The method of claim 14, further including the step of: attaching an intermediate strip (38) moulded from polypropylene copolymer to said external shell intermediate to a curved portion (35) and a linear portion (37) of the body (6).

16. The method of claim 15, further including the step of: providing a first over-mould of SEBS comprising an initial posterior contour (35) and distal contour (34) over-moulded onto the external shell, whose distal perimeter (26) defines a first opposed edge of an over-moulded cuff membrane (25) that continues tangentially from said distal perimeter (26) as a toroidal curve whose end point is in spaced relation and normal to the first opposed edge, the end points collectively defining an open posterior (27) perimeter or second opposed edge and a linear portion over-moulding the proximal end (37) such that said curved portion (35) and the linear portion (37) are joined as a single moulding by planar sealing voids (36) to lateral sides of said intermediate strip (38).

17. The method of claim 16, further including the step of: providing a second over-mould of SEBS closing said membrane (25), forming an inflatable cuff and completing the said body (6).

18. A method of forming an object, comprising: injection moulding a first portion of the object over a first core associated with a fixture; after the injection moulding of the first portion, moving a second core associated with the fixture to a deployed position; and injection moulding a second portion of the object over the second core and the first portion.

19. The method of claim 18, wherein the step of moving the second core associated with the fixture to the deployed position comprises rotating the second core relative to the fixture.

20. The method of claim 18, further including the steps of: attaching a pre-formed part to the object; placing one or more removable cores into the object; and placing one or more removable cores inside the injection mould prior to moulding a second portion of the object; and over-moulding a membrane as part of the second portion of the object.

21-52. (canceled)

Description

BRIEF DESCRIPTION OF DRAWINGS

[0049] FIG. 1 is an isometric view of a body of an airway management device according to one embodiment;

[0050] FIG. 2 is an isometric view of an insert for the body of FIG. 1;

[0051] FIG. 3 is an isometric view of the body of FIG. 1;

[0052] FIG. 4 is an isometric view of the insert of FIG. 2;

[0053] FIG. 5 is an isometric view of an oxygen supply adaptor of an airway management device according to another embodiment;

[0054] FIG. 6 is a cross sectional view of the body of FIG. 7;

[0055] FIG. 6a is a detail cross sectional view of the body of FIG. 7;

[0056] FIG. 7 is an isometric view of the body of FIG. 1;

[0057] FIG. 8 is an isometric view of the body of FIG. 1;

[0058] FIG. 9 is an elevation view of the body of FIG. 1;

[0059] FIG. 10 is a plan view of the body of FIG. 1;

[0060] FIG. 11 is a front view of a body of an airway management device according to a further embodiment;

[0061] FIG. 12 is a back view of the body of FIG. 11;

[0062] FIG. 13 is a detail cross sectional view of the body of FIG. 12;

[0063] FIG. 14 is a detail cross sectional view of the body of FIG. 12;

[0064] FIG. 15 is an isometric and cross-sectional view of the body of FIG. 12;

[0065] FIG. 16 is an isometric view of the body of FIG. 12;

[0066] FIG. 17 is an isometric of a receiving tube of an airway management device;

[0067] FIG. 18 is a back of a body of an airway management device;

[0068] FIG. 19 is a back of a body of an airway management device;

[0069] FIG. 20 is a side elevation view of the body of FIG. 18;

[0070] FIG. 21 is a side elevation view of the body of FIG. 19;

[0071] FIG. 22 is a back-elevation view of the body of FIG. 18;

[0072] FIG. 23 is a back-elevation view of the body of FIG. 19;

[0073] FIG. 24 is an isometric view of a body of an airway management device;

[0074] FIG. 25 is an isometric view of the body of FIG. 24;

[0075] FIG. 26 is a front view of a body of an airway management device according to a further embodiment;

[0076] FIG. 27 is a partially cut-away front view of the embodiment of FIG. 26;

[0077] FIG. 28 is a partially cross-sectional, enlarged end view of the embodiment of FIG. 26;

[0078] FIG. 29 is a cross-sectional side-view of the embodiment of FIG. 26;

[0079] FIG. 30 is presents cross-sectional views of the embodiment of FIG. 26 under different operating conditions;

[0080] FIG. 31 is a side view of a further embodiment;

[0081] FIG. 32 is an isometric view of the FIG. 31 embodiment; and

[0082] FIGS. 33 and 34 are views of an airway management device in situ.

[0083] FIG. 35-45 relate to a method of forming an object, such as the airway management device(s) of FIGS. 1-34, as one example, using an injection moulding technique.

DETAILED DESCRIPTION

[0084] With reference now to FIGS. 1-34, various embodiments of an airway management device are disclosed. The airway management device includes a body 6, such as the airway tube (FIGS. 1 and 3) extending from the proximal end 1 of the device through to the distal tip 2. The horizontal cross section A-A (FIG. 6) through the straight portion of the proximal airway tube, shows the primary 3 and secondary passage 4 configured either side of the median plane. This configuration forms a shell providing a first moment of area greater than a similarly dimensioned circular or elliptical cross section. This provides the device with sufficient flexural strength and so acting as an exoskeleton as compared with prior art devices where much of the flexural strength is derived from components within the device, and so demonstrating an endo-skeleton structure.

[0085] Inserted into the airway tube proximal opening is an adaptor (FIGS. 5 and 17), which facilitates connection to an oxygen supply as well as combining into a more rigid structure able to cope with and to facilitate the forces of circumduction during insertion. The parallel and sagittal planar relationship of these two passages defines an additional partial posterior channel 5 that, together with an intermediate strip (FIGS. 2 and 4), creates a laterally offset third passage to facilitate gastric drainage.

[0086] Cross section A-A of FIG. 6 progresses inferiorly through an anatomically approximated curvature of approximately 101 degrees (FIG. 9), parallel to the median plane, whereupon it transitions from a closed cross section to an open cross section (FIGS. 8 and 9) coinciding with the ventral opening of the device 7, where the primary and secondary passages terminate openly. Within this opening, the primary passage provides gaseous communication. When the adaptor is removed, this primary passage 3 allows for blind intubation (FIG. 10). The secondary passage 4 provides for endoscopic access during blind intubation as well as a secondary passage for spontaneous breathing during blind intubation.

[0087] Continuing inferiorly from this transition, the airway tube cross section maintains the semi-circular contour of the partial posterior channel 5 until reaching the proximal end 8 of the medial slot 9, a feature congruent with the anterior or ventral opening. When viewed anteriorly toward the frontal plane (FIGS. 6 and 10), the medial slot provides a route of progressive curvature for gastric drainage, from the partial posterior channel 5 through the medial slot to the anterior side of the distal airway tube; aligning the route for gastric drainage to the median plane of the distal tip 10; allowing the passing of a gastric drainage or suction tube with minimal frictional resistance.

[0088] Attached to the posterior of the airway tube is the intermediate strip (FIGS. 2 and 4) which exhibits curvature in the sagittal plane matching the airway tube and horizontal cross section 11 providing geometric conformance and attachment to the airway tube (FIGS. 6 and 6a). The proximal intermediate strip (FIGS. 9 and 10) is defined by a tubular feature 12 that serves as the entry point for gastric drainage or suction tube; and whose median axis when viewed laterally, adopts an angle of approximately 23.5 degrees with the horizontal plane coincident with the median axis 13 through the proximal end of the airway tube (FIGS. 9 and 21). When positioned on the airway tube, the intermediate strip covers the partial posterior channel 5 which is essentially an elongate recess which together defines a third passage as a route for gastric drainage. The intermediate strip, once positioned, is flush with an external surface of the body of the device. The distal end of the intermediate strip terminates at the proximal end of the medial slot 8. Continuing inferiorly to the distal extremity 2, the airway tube cross section progressively reduces in width and first moment of area. Horizontal cross sections throughout this transition exhibit ventrally concave curvature i.e. maintaining the posterior contour 34 were the intermediate strip (FIGS. 2, 4 and 9) to continue until the distal extremity of the airway tube.

[0089] When combined with the elastic properties of the polyolefin material, the ventrally concave curvature parallel to the medial slot 33a and horizontally through 33b the medial slot creates a compound curvature (FIG. 15) or partial conical spring (Belleville washer) that encourages an immediate elastic response from the polyolefin material during flexure; thus maintaining contact between posterior airway tube and the posterior hypo-pharynx during insertion, without excessive force contributing to co-morbidity and soft tissue damage.

[0090] In pure mechanical terms, the distal end of the airway tube can be considered as the fixed support, whilst the airway tube by itself can be considered to act as a cantilever beam. Force exerted through the straight proximal portion of the airway tube during insertion concentrates flexion and extension through a horizontal axis coincident with two laterally opposed slots 23. The primary passage being larger in diameter than the secondary passage allows a degree of rotation around the medial axis of the proximal airway tube that can be transferred as torsion through to the distal tip. SAD's using semi-rigid PVC materials for the airway tube behave in a viscous manner i.e. when force is applied, they resist shear and exhibit linear strain (relationship change in length to original length) for the duration of the applied force. However, these forces are dissipated into the PVC material such that when force is released, PVC will not immediately respond and return to its original state. This lost energy, or hysteresis, is a significant disadvantage of prior art based on PVC materials. Polyolefin materials such as polypropylene exhibit a superior viscoelastic response, characterised by elastic rather than viscous response.

[0091] During insertion, the forces transferred through the airway tube are manifested by circumduction. Consequently, hysteresis in the materials used by existing prior may prevent the distal tip being correctly in situ with the upper oesophageal sphincter. Prior art describes the possibility of the distal tip entering the larynx or, the distal tip of the LMA or SAD may fold under, a phenomenon described as down-folding. Unlike other LMA or SAD, this invention uses an airway tube that extends from the proximal end to the distal tip and whose form and function utilise the more immediate viscoelastic response of a rigid polyolefin material. Where other SAD's describe a ventral displacement of the distal tip in relation to a dorsal or posterior reference point on the airway tube to better conform to the anatomy, this invention provides for a wide range of flexional response that obviates the ventral displacement described by prior art.

[0092] Protruding from the external surface of the gastric drain tube opening in closest proximity to the adaptor (FIG. 16), a raised step 14 is defined that has a corresponding cut out (FIG. 17) or notch 43 in the outer surface of the adaptor. This raised step retains and prevents the adaptor from separating away from the airway tube (FIG. 20).

[0093] When viewed superiorly toward the distal tip (FIG. 7), the proximal end 12 of the gastric drain tube is aligned with the median plane of the airway tube i.e. both passages share common a mid-plane (FIG. 7). It must be noted that the mid-plane of the airway tube is with reference to the lateral extremities of the airway tube rather than an alignment with the primary or secondary passage. To provide a primary passage of sufficient internal diameter to accommodate the insertion of an ETT and blind intubation, the third passage is laterally offset and divided by an impermeable barrier (posterior surface of airway tube) to ensure simultaneous blind intubation and gastric access.

[0094] As the median axis of the proximal opening (FIG. 9) approaches an intersection with the median axis of the adaptor and airway tube 13a, the tubular cross section transitions increasingly elliptical and no longer exhibits an enclosed perimeter, having opened up 15 to straddle the proximal airway tube (FIG. 2). When a gastric drainage suction tube is inserted through the tubular feature 12, the distal tip of the suction tube will make tangential contact 16 with posterior surface of the primary passage (FIG. 3). Further insertion deflects the suction tube laterally, seeking alignment with the supporting structure of supports, such as ribs 17 adjacent to the posterior channel or third passage in this region. The suction tube can then be guided inferiorly to exit at the distal tip of the device 20.

[0095] Proximally, the intermediate strip is attached by 4 latches, 2 per side positioned laterally 18 where the intermediate strip straddles the airway tube. Coinciding at the tangent where the straddling straight section of the airway tube terminates and the curvature 6 begins, the intermediate strip narrows abruptly 19. The supporting structure of ribs 17 follow the curvature of the airway tube 6; opposing ribs 11a integral with the intermediate strip (FIG. 6a) provide alignment and minimal interference, sufficient to provide for aforementioned attachment. Ribs 11a and 17 progressively diminish and terminate at the proximal end of the medial slot 8.

[0096] Having described the airway tube, intermediate strip and adaptor, any or all of which may be manufactured from polyolefin material in one possible embodiment, the description now focuses on the inflatable cuff manufactured from a thermoplastic elastomer (TPE) compounded from the same base polyolefin material. This in itself provides the means of assembly for the device described herein. The self-adhering property of TPE, adheres the intermediate strip to the airway tube and create an open thin walled cuff membrane by virtue of an initial injection moulding processes; a subsequent injection moulding process entraps the open membrane and creates an airtight and inflatable cuff, integral to the form and function of the device.

[0097] Viewed anteriorly toward the frontal plane (FIG. 11), the initial injection moulding process surrounds the perimeter of the distal airway tube with an elliptical shape cuff membrane of TPE, in a generally toroidal shape about the airway tube. In a specific embodiment, the cuff membrane may be characterised by; a distal tip whose curvature and width facilitate the tubular distal opening of the third passage 20 or gastric drain tube; lateral extremities 21 defined by curvature extending superiorly and tangential to the distal tip; an increasing rate of change of curvature that closes the elliptical shape at the median plane 22, just superior to the horizontal axis through two laterally opposed slots 23 and; an enclosed third passage or gastric drain tube 24, totally covering the medial slot 9 and whose contour and curvature 31 reconcile with that of the partial posterior channel 5. It will be appreciated that in alternative embodiments, the membrane may be a variety of open shapes, which may allow closure through a second moulding process to seal the open membrane and thus permit inflation of the cuff.

[0098] Horizontal cross sections B-B and C-C (FIGS. 13 and 14) illustrate the ventral or anterior opening 7 through which the primary and secondary passages exit. With respect to FIG. 14, the perimeter of the ventral opening is defined by a thin walled inflatable cuff membrane exhibiting an elliptical section 25. Adhered in the first instance to the perimeter of distal airway tube 26 and continuing tangentially from the immediate anterior of the airway tube toward its lateral extremity and normal to the edge of the airway tube. The method of manufacturing requires the cuff membrane to be open along the posterior opening 27 of the perimeter (FIGS. 12 and 14), except for a region surrounding the distal opening (FIG. 13) of the gastric drain tube that is moulded into a closed section 28 defining the configuration of the inflatable cuff surrounding the distal drain tube. To this end, as a result of the first injection moulding step, the inflatable portion or cuff is in the form of an open toroidal shape having the membrane open along a periphery of the toroid and adjacent to the periphery of the airway tube.

[0099] With reference to FIG. 8, the thickness of airway tube along the perimeter 26 varies from 1.00 at location 26a to 0.5 mm at location 26b combines with the compound curvature 33 at the distal airway tube to provide flexural articulation rather than flexure of the distal tip around a fixed horizontal axis. The thickness of the inflatable cuff membrane varies between 0.25 mm (leading edge of posterior opening 27) and 1.50 mm along the perimeter of the distal airway tube 26. All other cuff membrane wall thicknesses are optimised to provide for the ideal inflated shape and mechanical strength e.g. that portion of the inflatable cuff membrane (FIGS. 11, 20 and 21) surrounding a small tubular port 29 for attaching an inflation tube 29a extruded from thermoplastic elastomer (FIGS. 24 and 25) and equipped at its proximal end with an inflation balloon 29b and check valve allowing gaseous communication with the inflatable cuff.

[0100] In some embodiments, the distal portion of the gastric drainage tube may not intersect the inflated volume of the cuff (FIGS. 13 and 14). In this embodiment the outside diameter may not be directly exposed to the inflation pressure within the inflatable cuff; wall thickness of the gastric drainage requires no reinforcement structure to prevent occlusion; thereby avoiding a bulbous distal cuff configuration. Instead, and consistent with the closed section 28, the inflatable cuff membrane 25 is moulded into a closed tubular section 30 concentric with the third passage or gastric drain tube 24 creating a free space, or chamber, 32 adjacent to the tip of the device, and between the inflatable membrane and the distal third passage particularly about the aperture through which the gastric drainage tube projects. When in situ and inflated, the closed section of cuff membrane 30 will not expand to an extent that all free space or chamber 32 is eliminated and the gastric drain tube 24 compressed and occluded. The free space or chamber 32 therefore provides an expansion buffer, the size of which may be determined through design to accommodate sufficient inflation of the cuff. The cuff will therefore expand to within proximity, providing support to the third passage, or gastric drain tube 24, and the distal opening 20 against the upper oesophageal sphincter.

[0101] Furthermore, immediately superior to the distal opening, the anterior of distal airway tube compound curvature 33 defines the internal posterior surface of the third passage or gastric drain tube; the narrow width and curvature of the airway tube; the reducing thickness 26b and; the surrounding contour 34 of self-adhered TPE elastomer, minimise the deflated thickness of the distal tip. The elastic response of the polyolefin airway tube is manifest at the distal tip, now assisted by the softer TPE. This configuration keeps combined thickness of materials to a minimum, a characteristic evident when the cuff is deflated prior to deployment, negating the potentially bulbous nature of the distal cuff and gastric drainage supporting structure.

[0102] The contour of TPE adhering to the distal anterior airway tube (FIG. 13), having defined the closed section 28, progresses superiorly along the progressive curvature 31 of the medial slot 9, blending the resultant posterior contour 35 smoothly onto the intermediate strip, where it locates against the proximal end 8 of the medial slot. At this juncture the TPE diverts either side of the intermediate strip (FIGS. 7 and 12) filling the sagittal planar voids 36 defined by the intermediate strip locating against the posterior curvature of the airway tube 6. Proximally, at the juncture of the abruptly narrowing intermediate strip 19, the TPE 37 converges to surround the latches 18 and the intermediate strip in its entirety where it straddles the airway tube; the union of the intermediate strip and the airway tube is completed. Surrounded by TPE, the sealed union creates an enclosed third passage or gastric drain tube with proximal and distal opening.

[0103] The angle of the tubular feature relative to the adaptor (FIGS. 16 and 17) combined with the elastic nature of the TPE allows the user to; apply leverage to the tubular feature 12; in a direction 40 such that the angle of incidence through the retaining step 14 relative to the frontal plane (FIG. 9) is reduced and; remove the adaptor for insertion of an endotracheal tube or endoscope.

[0104] The adaptor can be returned to its original position by inserting the distal end into the proximal airway tube opening 42 and pushing it posteriorly. Once the notch 43 in the adaptor encounters the raised step 14 on the tubular feature 12; a moderate increase in pressure will enable the adaptor to snap back into the home position; the mating face 44 of the adaptor (FIG. 5) is pressed into and creates an airtight seal against the TPE 45 covering the proximal end 1 airway tube and intermediate strip and; a cylindrical cut-out 46 in the adaptor provides a minimal clearance against the tubular feature 12.

[0105] The subsequent injection moulding process provides a core and cavity that locates the leading edge of the open cuff membrane firmly against an airway portion such as the posterior distal airway tube perimeter 26. TPE interacts with the leading peripheral edges, entrapping them and blending with the already complete distal closed section 28 and conforming to the finished inflatable cuff contour defined by the injection mould core and cavity to close the toroidal cuff. A further embodiment (FIG. 12) of this interaction encourages the TPE to further entrap the leading edge via small cut-outs 47 and adhere it directly to the posterior of the distal airway tube.

[0106] The finished contour of the distal portion (FIGS. 18, 20 and 22) adds additional TPE to the initial posterior contour 35 of the airway tube, wrapping around and completing a sealed circumference of the airway tube 48; creating an airtight inflatable cuff. A further embodiment of this circumferential blend (FIGS. 19, 21 and 23) shows the step 49 tapering away to a smooth blend 50 around the circumference of the airway tube.

[0107] The inflatable cuff membrane completes the manufacturing of the device described by this invention, without the need for adhesives or solvents. Using entirely polyolefin-based materials achieves a more ecological sustainable alternative to PVC and vinyl elastomers that may contain DEHP plasticisers or, LSR that cannot be recycled and similarly re-processed because it is a thermoset material whose cross-linking during moulding cannot be reversed.

[0108] According to a further aspect of the disclosure, and with reference to FIGS. 26-34, in some embodiments, the body 6 may comprise a thin wall moulding of a majority of polypropylene random co-polymer, blended with a lesser amount of SEBS, the latter creating a dispersed elastomeric phase within the polypropylene (Abreu FOMS, Forte MMC, Liberman SA. SBS and SEBS block copolymers as impact modifiers for polypropylene compounds. Journal of Applied Polymer Science, Vol. 95,254-263 (2005)). This thin walled moulding is henceforth interchangeably referred to as an external shell when discussing the mechanics of the body as a lever, and an airway tube when referencing the function of the body 6 as a breathing conduit or passage.

[0109] Specifically, according to one embodiment, the initial posterior contour 35 may comprise SEBS over-moulded onto the external shell that flows into the cuff membrane 25 forming the inflatable cuff. Being mutually soluble, the SEBS diffuses into the polypropylene and likewise, the polypropylene diffusing into the SEBS creating an interphase of entangled polypropylene and SEBS along the perimeter of the distal airway tube 26 creating a first opposed edge. Simultaneously, a linear portion is over-moulded to the proximal end 37 such that the curved or initial posterior contour 35 and the linear portion 37 are joined as a single moulding by virtue of the sealing voids 36 to the left and right sides of the intermediate strip 38. Completing a first over-moulding without adhesive bonding or welding of discrete components, immediately followed by a second over-moulding of SEBS that seals the posterior open perimeter 27 or second opposed edge of the cuff membrane 25. The second over-mould covers the initial posterior contour 35 with additional SEBS closing and sealing the cuff membrane with the sealed circumference 48. The body 6, as described, has effectively been “assembled in the mould” using three separate injection moulding processes and is now complete with all required fluid communication passages and inflatable cuff.

[0110] The inflatable cuff is used to seal the upper oesophageal sphincter 70, as shown by FIG. 33 but the distal portion of the inflatable cuff must include a mechanism that reduces compression of the glottic inlet along the anteroposterior axis when the distal end 2 of the body 6 is wedged into the upper oesophageal sphincter 70. A cross section through the distal end 2 is shown in FIG. 29. The distal posterior contour 34 of the distal end 2 over-moulds the compound curvature 33 of the external shell. The distal contour 34 of over-moulded TPE extends superiorly, blending into the initial posterior contour 35 and the distal perimeter of the external shell or first opposed edge 26. This extension or closed section 28 (FIG. 26 Section C-C) completes the over-moulded distal portion of the third passage or gastric drainage tube 24. The anterior of this compound curvature 33 defines the internal diameter and the route of the gastric drain tube 24; terminating at the distal opening 20. With the distal posterior contour 34 and closed section 28 located and pressed against the hypopharynx 74, displacement of this distal portion superiorly by increasing oesophageal pressure 71 (FIG. 34), is resisted by the distal to proximal full-length configuration and anatomical curvature of the body 6 within the pharynx. The softer distal posterior contour 34 and distal opening 20 wedged into the upper oesophageal sphincter, maintaining an effective oesophageal seal.

[0111] When the cuff is inflated, the gastric drain tube 24 and the drain tube distal opening 20 are not displaced anteriorly as they are integral with the distal posterior contour 34 pressed against the hypopharynx 74 i.e. the third passage or gastric drain tube 24 is not surrounded by an annular volume within the inflated cuff (FIG. 29) and in consideration thereof, does not require stiffening against occlusion by an expanding inflatable cuff. Only the distal portion of the cuff membrane moulded into a closed section 30 concentric to the gastric drain tube 24 is displaced anteriorly. The chamber 32 formed by the closed section 30 provides a space for said distal portion 30 to adapt to the anatomy with a posterior displacement when inflated, rather than pushing the glottis 66 anteriorly.

[0112] In this embodiment, the non-inflatable bulk of the body 6 within the pharynx is reduced because the required resilience and flexural response is provided by the thin walled external shell rather than an assembly of multiple components of differing hardness and thickness. The close proximity of (or gap between) all points describing the perimeter of the distal airway tube 26, normal to those describing the leading edge of the open cuff membrane 27, or first and second opposed edges respectively, is closed by the second over-mould creating the inflatable cuff. The cuff seals posteriorly against the hypopharynx 74 and anteriorly against the laryngeal inlet 65 by a single inflatable membrane 25 without adhesive joint (FIG. 30). Effectively maximising the surface area of inflatable cuff and minimising contact of non-inflatable surfaces (surfaces with no elastic recoil) to the anatomy and therefore, minimising direct compression of nervous structures by non-inflatable surfaces.

[0113] Neurological injury is multifactorial with the inflatable cuff being the significant contributing factor, either too rigid during insertion or direct compression of nervous structures whilst in situ. The cuff membrane 25 over-moulded and integral with the body 6 exhibits resilience and a measured elasticity during insertion. The cuff membrane can be deflated to present a flat wedge shape facilitating insertion between the teeth, past the tongue and through the palatoglossal arch. The ability of SEBS to stretch or elongate more than its original length for a given tensile force can be limited by the relative amounts of hard and soft domains within individual polymer strands; soft domains offering elasticity and conformance to the anatomy when inflated, the harder domains ensuring resilience and conformance to the as moulded shape. LSR or PVC elastomer, being single domain, tend to expand anterolateral when anteroposterior resistance is encountered, abandoning the as moulded shape and compressing nervous structures such as the lingual and hypoglossal nerve.

[0114] Cross section B-B (FIG. 30) through the lateral cuff reveals an under-square relationship of the height 51 to width 52, i.e., the height is always greater than the width. At low inflation pressure or when pressure inside and outside of the cuff membrane 25 is equal, this under-square relationship combined with the cuff membrane 25 maintaining the as moulded shape, creates an initial anatomical seal. When inflated 25a, the same under-square relationship is conserved ensuring reduced anterolateral expansion of the cuff.

[0115] With reference to FIG. 26, curvature of each lateral extremity or curved perimeter 21 meets tangentially at their intersection with the median plane 22. Both lateral portions of the cuff 53 blend into the proximal portion 54, the ventral opening 7 adopting a rectangular configuration where each blend 55 is an arc whose radii are equal in magnitude; being a continuation of the internal radius of first passage 56 and the radius of second passage 57 respectively illustrated by FIG. 28. A line 58 passing through the centre of each radius blend 55 at 70 degrees either side of Section A-A creates a vertical angle of 140 degrees. Section F-F of FIGS. 26 and 27 is a planar section through one of the lines 58. The enclosed 2D sectional area of the cuff membrane 25 is the least of all other under-square sections through the cuff membrane. When inflated (FIG. 27), both lateral portions 53 and the proximal portion 54 expand, compressing against each other at this Section F-F such that each blend 55 becomes a fold 59 and maintaining the ventral opening 7 into the first bore and in so doing, limiting over-inflation of the proximal portion of the inflatable cuff 25 against the base of the tongue 75; the proximal portion of the inflatable cuff 25 maintaining alignment with and pressing against the tip of the epiglottis 76 (FIGS. 33 and 34).

[0116] With the patient in the supine position (FIG. 34), intubation with an endotracheal tube (ETT) 61 requires the distal end 62 to exit the ventral opening 7 through the laryngeal inlet 65 and aligned with the glottis 66. As the ETT 61 continues inferiorly through the glottis, the distal end 62 of the ETT 61 must be correctly aligned with the trachea 68 (FIGS. 33 and 34). Overall, the length of the airway tube from the proximal opening 42 to ventral opening 7 should be kept to a minimum so that the distal end 62 of the ETT can be positioned sufficiently inferior to the glottis 66. To facilitate this minimum requirement, pressure is applied superiorly to the tubular port 12 to release the raised step 14 that retains the connector 39 (FIG. 31-33).

[0117] The most effective path or conduit for intubation and gastric drainage occupy the same anatomical space intermediate to the ventral opening 7 and the proximal opening for the combined primary and secondary passage 42. Their relative relationship contributes to the overall bulk of the device. With limited space available in the oropharynx 73 and to avoid pressure neuropraxia from the body 6, an anatomically approximating curvature is used with precedence given to the first or primary passage 3 occupying the space closest to the median plane 22 of the body 6, albeit slightly offset from said median plane (FIG. 28).

[0118] The third passage for gastric drainage is symmetrically opposite and parallel to the first passage 3, with the planar voids 36 on either side of the intermediate strip 38 defining this offset. Rather than just occupying interior space of the airway tube, the third passage for gastric drainage is a structural component, i.e., it contributes to the overall flexural strength of the external shell of the body 6, allowing the wall thickness of the primary passage 3 to be minimised in favour of maximum interior space for intubation. SEBS filling the planar voids 36 creates an interphase of entangled polypropylene and SEBS along the entire length of the anatomical curvature described by the supporting ribs 17 and intermediate strip 38. During insertion, flexion and extension applied to the proximal end of the body 6 are dissipated as shear, absorbed by the aforementioned interphase bonded to the intermediate strip 38 of the body 6.

[0119] The combined width of the body 6 may be symmetrical about the median plane 22. A nominal (e.g. 1.00 mm) wall thickness of the external shell reduces overall bulk and maximises the inside diameter for the first passage 3 allowing for an adult ETT 61 of a typical 8.5 mm inside diameter for a size 4 device. The removable connector/adaptor 39 reduces the length from the proximal opening 42 of the body 6 through to the trachea 68, providing additional depth of insertion of the ETT 61.

[0120] If an ETT 61 comprising a semi-rigid curved PVC tube is inserted into the proximal opening of the body 42 with the curvature of the tube orientated as if using a laryngoscope (ETT curvature follows the anatomical curvature) then the exit of the ETT distal tip 63 as it enters the laryngeal inlet 65 will be directed toward the thyroid cartilage 69 rather than the glottis 66. However, the exit trajectory of the ETT distal tip 63 from the first passage 3 through the ventral opening 7 and into the laryngeal inlet 65 can be optimised by lifting the proximal opening 42 of the body 6 anteriorly by gripping the receiving tube 12. The distal tip 61 of the ETT 62 can exit the ventral opening 7 and enter the laryngeal inlet 65 with closer alignment to the trachea 68 as shown in FIG. 34. As ETT's are predominantly manufactured from PVC and PVC being characterised as a viscous polymer, the force of bending the ETT shaft 61 through the primary or first passage 3 encourages a curvature whose equivalent radius is smaller than the pre-set curvature of the ETT shaft 61. The energy required to bend the ETT shaft 61 is dissipated into and through the length of the shaft. When the ETT distal tip 63 exits the ventral opening 7, the protruding distal tip 63 including the balloon 62, tries to return to its original curvature. However, recovery is not immediate.

[0121] This lost energy or delayed recovery can be advantageous toward alignment of the distal tip 63 with the glottis 66. As the ETT distal tip 63 enters further into the laryngeal opening, the lost energy is recovered allowing the shaft of the ETT 61 to partially straighten. During recovery, the body 6 can be raised anteriorly by gripping the receiving tube 12 to align the ETT distal tip 63 to the glottis 66. Thereafter, the ETT 61 is further inserted; the distal tip 63 passing through the vocal cords 67 and into the trachea 68. The connector/adaptor 64 is then removed from the tubular shaft of the ETT 61. The inflatable cuff 25 is deflated and the body 6 is removed, leaving the ETT in situ. Thereafter, the ETT connector/adaptor 64 is returned to its previous position. The viscous nature of the ETT tube body will allow a progressive and atraumatic recovery of curvature.

[0122] According to a further aspect of the disclosure, a method of manufacturing is also disclosed. As background, a conventional injection mould comprises a core that generally defines the concave or inside of the moulded component and a cavity that defines the convex or outside of the moulded component. Molten polymer is injected into the mould via a single screw/plunger mechanism. Allowed to cool and solidify, the polymer shrinks onto the core from whence it is removed. A second screw mechanism can be added so that polymer of two different colours or two different polymers can be injected into the mould, in most instances sequentially.

[0123] The requisite mould characterised by the complexity of moulding the initial component with the first polymer; then rotating the core by some inclusive mechanism to over-mould with the second polymer. Typically, the two cores are identical, but the corresponding cavities are different; the first cavity describes the substrate or base component geometry, the second cavity the final over-mould. Referred to as multiple component moulding, components separate to the process can also be introduced and over-moulded thus broadening the definition to in mould assembly. Technically, the scope of application using this method is limited to relatively small prismatic components and sub-assemblies because the application is confined within the physical constraint of a single injection moulding machine. Such complexity of moulds interacting in sequence can be described as a rigid body system, each mould requiring kinematic constraint i.e. the interaction between core and cavity for each mould set being a prismatic pair with a single degree of freedom (mould open and close) and the interaction between subsequent processes within the moulding machine frame being revolute pairs (core rotates to the next cavity when the mould opens). Both constraints characterised by a single degree of freedom.

[0124] From the aforementioned embodiment, the synthesis of design features that reduce the characteristic bulk of the distal tip, reduce compression of the glottic inlet along the anteroposterior axis, reduce the risk of neurological injury and define the under square relationship of the inflatable cuff membrane 25, are realised by moulding cores, each core a rigid body and collectively a rigid body system. With reference to FIGS. 35 to 45, the fixture frame 90 is a constrained rigid body. Each mould core is joined, aligned or linked to the fixture frame 90 via a kinematic pair, or mechanism. Each kinematic pair refers to the kinematic constraints between each pair of rigid bodies that limits the motion of one rigid body with respect to the other. Constraints are planar or spatial degrees of freedom (DOF) i.e. linear or rotational displacement. An unrestrained rigid body has linear displacement in 3 axes and rotational displacement about each of these axes; a total of 6 DOF. The collective magnitudes of displacement for the kinematic pairs being sufficient to enable the completed body 6 to be removed from the rigid body system, henceforth referred to as the system.

[0125] The body 6 is not conceived of simple solid primitives displaying symmetry; the freeform geometric complexity of the passages or fluid paths within the body 6 requires moulding cores capable of linear and rotational displacement and combinations thereof, varying from one to six DOF. It is this complexity that sets it apart from multiple component moulding or in mould assembly. Rather than in mould assembly using a single injection moulding machine, body 6 is manufactured by transferring the system through a sequence of injection moulding machines. In this embodiment, three injection moulding machines (processes) are required. The external shell is the initial base or substrate component (first injection moulding process), the initial posterior contour 35, sagittal planar voids 36 together with the intermediate strip 38, and the linear portion 37 are the first over-mould (second injection moulding process). Subsequently, the initial posterior contour 35 and the planar voids 36 become the substrate and the sealed circumference 48 the second over-mould (third injection moulding process).

[0126] In mould assembly restricts the degrees of freedom related to mould configuration and therefore complexity of the moulded article, whilst creating an injection moulding process of significant complexity. To realise the design synthesis as described, the fixture frame 90 must be removable, transferable between injection moulding machines and in and of itself facilitate accurate interlock within each injection moulding process. Sequentially, within the space between moulding machines, additional components can be introduced, moulding cores added, removed or displaced by linear or rotational displacement or combinations thereof without the kinematic constraints inherent within the physical dimensions of a single moulding machine. The fixture frame 90 serves a datum reference for all processes until the completed device is removed from the fixture frame 90 using a demoulding mechanism. Essentially, the body 6 is assembled via the transfer of the system between injection moulding and non-injection moulding processes, each step of the assembly being an injection moulding process or assembly in the mould(s). The non-injection moulding processes allowing manipulation of the system mechanism and the introduction of external components using greater DOF than that possible by in mould assembly.

[0127] Beginning with FIGS. 35 and 36, a first rotating core 91 is a revolute pair constrained by a first pivot shaft 97. The revolute pair obeying a single DOF that permits the first rotating core 91 to rotate about an axis defined by the first pivot shaft 97. Similarly, a second rotating core 92 is a revolute pair constrained by a second pivot shaft 98. Proximal core 94 is a prismatic pair allowing linear displacement in one direction, and a single DOF is provided via slide mechanism shared with the fixture frame 90.

[0128] At the commencement of the manufacturing process and as illustrated by FIGS. 35 and 36, the rigid body system is placed into the first injection mould to mould the external shell. At this juncture, the rigid body system is in static equilibrium. The first rotating core 91 is constrained by the pivot shaft 97 and its rotation delimited by proximal core 94 and the second rotating core 92, whose position is fixed by a retainer, which may comprise an angular facet on the pivot shaft 98 bearing against the flat spring 103. When manually lifted by the handle 104, the mass of the system is supported by the proximal core 94 which bears against the first rotating core 91, which in turn bears against the second rotating core 92, fixed by the angular facet on a second pivot shaft 98 bearing against the flat spring 103.

[0129] FIG. 37 shows the external shell moulded onto the first rotating core 91 and proximal core 94. After removal of the system from the first mould and prior to the placement in the second injection mould (second injection moulding process is the first over-mould), the second rotating core 92 is rotated to the position illustrated by FIG. 38 by releasing the flat spring 103. A distal core pin 93 is also introduced as an unrestrained rigid body in relation the fixture frame 90. This distal core pin 93 fits into an inclined channel 105 in the fixture frame 90 and locks into position. Note the supporting ribs 17 that will locate the intermediate strip 38.

[0130] FIG. 39 illustrates the intermediate strip 38 orientated for attachment to the external shell. Latches 18 help to secure the intermediate strip 38 to the external shell. As the effective path for intubation and gastric drainage occupy the same space, precedence has been given to intubation and the partial third channel 5 (the intermediate portion of the third passage or gastric drainage tube 24) has been offset through the intermediate portion of the body. At the proximal and distal extremities of the third passage, the tubular port 12 and the distal tip 26a/b of the external shell are realigned with the central axis. This realignment and the angular configuration of the tubular port 12 relative to the partial posterior channel 5 prevent the use of a moulding core as there is no means of removing it. Hence, the unique feature of the intermediate strip 38 is that it is over-moulded without any means of resisting deformation from the heat and pressure of injection moulding other than the supporting ribs 17.

[0131] The system is placed into a second injection mould for the first over-mould. Unrestrained rigid bodies, such as a first removable core 95 and a second removable core 96, are also placed into the second injection mould. Closure of the mould locates the removable cores 95 and 96 in close proximity to the first rotating core 91 and second rotating core 92 as illustrated by FIG. 41. Subsequent over-moulding of the external shell becomes the body 6 complete with intermediate strip 38, the inflatable cuff membrane 25, the planar voids 36 and the linear portion 37 is shown by FIG. 42. Note the posterior opening 27 of cuff membrane 25. The system is then removed from the second injection mould.

[0132] First removable core 95 and second removable core 96, when over-moulded with a material such as SEBS (forming the cuff membrane 25), are initially constrained by this membrane. In relation to the fixture frame 90, these removable cores 95 and 96 are unrestricted rigid bodies that are removed through the open cuff membrane by an external mechanism able to exploit the six degrees of freedom shown in FIG. 43.

[0133] Thereafter, the system is transferred to a third injection mould where the open cuff membrane 25 is closed up against the initial posterior contour 35 and subsequently over-moulded to create the sealed circumference 48 and 49 shown in FIG. 44. Additional embodiments of this sealed circumference are illustrated by FIGS. 18 to 22. This sealed circumference is the second over-mould. Future embodiments are not limited by the number of additional over-moulding processes because assembly in the mould is assembly via a sequence of moulding processes in separate injection moulding machines rather than in mould assembly, which implies numerous moulds within single injection moulding machine. The system is transferable availing itself to secondary processes without kinematic constraint.

[0134] As described above, the unique feature of the intermediate strip 38 is that it is over-moulded without any means of resisting deformation from the heat and pressure of injection moulding. To elucidate, the intermediate arc 106 shown in FIG. 44 represents the intermediate arc section of the body 6. The intermediate arc section 2X is common for any plane perpendicular to points along the intermediate arc and the centre point of the equivalent radius of the intermediate arc 106. The inside concave curvature or diameter of the intermediate strip 38 is identical to the cross-sectional diameter of the partial posterior channel 5 in the body 6; each intermediate arc section through the intermediate strip 38 being representative of a simply supported beam. During over-moulding, the sagittal planar voids 36 are filled with a material such as SEBS. The outer edges of the intermediate strip 38 being parallel to the sagittal planar voids 36 taper to a fine edge 38a. As illustrated by the partial enlarged section 6X of FIG. 44, these fine edges 38a act as a shield to protect the support ribs 17. Being sacrificial, the heat from first over-moulding process will melt the fine edges 38a of the polypropylene intermediate strip 38 diffusing it into the SEBS filling the sagittal planar voids 36. In addition, the pressure against the fine edge 38a presses it against the support rib 17, further sealing the third passage. The fine edges 38a also increase the over-mould surface area to better secure the intermediate strip 38.

[0135] Finally, to remove the completed body 6 from the fixture frame 90, the individual cores defining each passage or fluid path, are functionally displaced following a finite path with respect to the fixture frame 90 which remains stationary. In FIG. 45, the first rotating core 91 rotates 90 degrees and proximal core 94 is displaced linearly to release the proximal end of the body 6. Distal core pin 93 is initially constrained by the over-moulded material exhibiting a planar pair. Surface treatment of the distal core pin 93 to reduce friction, enables transition to an unrestrained rigid body as it is removed from the body 6. Lastly, the body 6 remains attached to the second rotating core 92, the kinetic constraint being a cylindrical pair. Rotation around that portion of the second rotating core 92 that defines the closed tubular section 30 and a linear displacement along the axis of this tubular section 30 allows removal of the completed body. The constrained rigid body is returned to the configuration described by FIG. 35 and the process repeats.

[0136] In this embodiment, assembly in the mould is a kinematic synthesis of passages or fluid paths where passages are by design, functionally independent of each other and in combination, structurally dependent as one body. This synthesis is combination of material compatibility, design features and the unique manufacturing method as described.

TABLE-US-00001 Numbered Feature Index 1 Proximal end of Body/ External Shell 2 Distal end of Body/ External Shell 3 Primary Passage 4 Secondary Passage 5 Partial Posterior Channel 6 Body exhibits an angle of curvature intermediate to proximal and distal ends 7 Ventral opening 8 Proximal end of Medial Slot 9 Medial Slot 10 Median Plane, Distal Tip 11 Cross Section through curvature intermediate to distal and proximal ends of Body 11a Ribs on Intermediate Strip that straddle the supporting ribs 17 12 Tubular feature or port for gastric drain tube 13 Median axis of proximal Body 13a Median axis of Adaptor 14 Raised Step to retain Adaptor 15 Intermediate Strip transitions from tubular feature (port) elliptically straddling Body 16 Tubular contour opposite the elliptical transition 15 17 Supporting Ribs that follow curvature of External Shell of the Body 6 locating Intermediate Strip 38 18 Latches for attaching the Intermediate Strip 19 Immediate narrowing of the Intermediate Strip 20 Distal opening of the Body 21 Lateral extremities of curvature of Cuff/ Body 22 Median plane representing tangential closure of lateral curvatures 21 23 Laterally opposed slots to capture stress concentration for flexion and extension 24 Third passage or Gastric Drain Tube enclosing the Medial Slot 9 25 Cuff membrane 26 Perimeter of lateral portion of patient or distal end of External Shell 26a, Perimeter of distal portion of patient or distal end of External 26b Shell 27 Posterior opening of Cuff perimeter 28 Closed section of Cuff forming distal Gastric Drain Tube 29 Port for Inflation Tube 29a Inflation Tube 29b Inflation Balloon/ Check Valve Assembly 30 Closed tubular section concentric with third passage or Gastric Drain Tube 24 31 Curvature defining the route of the Gastric Drain Tube 24 32 Free space chamber between tubular section 30 and Drain Tube 24 33 Compound curvature of distal airway tube 33a Anterior of distal airway tube compound curvature, parallel to the Medial Slot. 33b Anterior of distal airway tube compound curvature, perpendicular to the Medial Slot. 34 Distal posterior contour of TPE adjacent to the Distal Opening 20 35 Initial posterior contour of TPE integral with Cuff membrane 25 36 Sagittal planar voids joining over-moulding intermediate strip 38 to body 6. 37 Proximal end of Body, TPE covering Intermediate Strip straddling the External Shell 38 Intermediate Strip 38a Fine edge of Intermediate Strip 39 Connector/ Adaptor 40 Direction of leverage to release the Raised Step 14 from the Adaptor Notch 40 41 Distal end of Adaptor mates with the proximal opening for the Adaptor in the Body 42 Proximal opening, the combined Primary and Secondary Passage 43 Notch in Adaptor to accept Raised Step 14 44 Mating face of the Adaptor to the over-moulded proximal end of the Body 45 45 TPE over-moulded proximal end of Body against which the Adaptor creates a seal 46 Cylindrical cut-out to clear Tubular Feature 12 47 Additional embodiment for over-moulding Sealed Circumference 48 48 Sealed circumference of TPE over-moulding the initial posterior contour 35 49 Moulded edge defining sealed circumference around external shell 50 Additional embodiment, sealed circumference 48 blends smoothly into intermediate portion of body 6 without moulded edge 49 51 Height of cuff through Cross Section B-B 52 Width of cuff through Cross Section B-B 53 Lateral portion of the cuff 54 Proximal portion of the cuff 55 Blend between lateral and proximal cuff creating an arc 56 Internal radius of first passage 57 Internal radius of second passage 58 Line either side of Section A-A creating a vertical pair. 59 Fold created by inflated lateral and proximal cuff compressing against each other 60 Finger stop 61 Endotracheal tube (ETT) 62 ETT balloon 63 ETT distal tip 64 ETT Connector/ Adaptor 65 Laryngeal Inlet 66 Glottis 67 Vocal Cords 68 Trachea 69 Thyroid Cartilage 70 Upper Oesophageal Sphincter 71 Increasing oesophageal pressure 72 Nasopharynx 73 Oropharynx 74 Hypopharynx 75 Tongue 76 Epiglottis 90 Fixture Frame 91 First Rotating Core 92 Second Rotating Core 93 Distal Core Pin 94 Proximal Core 95 First Removable Core 96 Second Removable Core 97 First Pivot Shaft 98 Second Pivot Shaft 99 Handle Shaft 100 Spring Pin 101 Ball Plunger 102 Dowel Pin 103 Flat Spring 104 Stationary Handle 105 Inclined channel 106 Intermediate arc

[0137] This disclosure may be considered to be related to any or all of the foregoing items in any combination:

1. An airway management device, comprising:

[0138] a body (6) including an external shell moulded from a polypropylene copolymer (PP) blended with a thermoplastic elastomer (TPE) of styrene-ethylene/butylene-styrene (SEBS), the external shell extending from a proximal opening to a distal tip of the body (6), the external shell having a curved portion (35) and a linear portion (37).

2. The airway management device of item 1, further including an intermediate strip (38) moulded from a polypropylene copolymer (PP) attached to said external shell intermediate to the curved portion (35) and the linear portion (37).
3. The airway management device of item 1 or item 2, further including a first over-mould of SEBS comprising a posterior contour (35) and a distal contour (34) on the external shell.
4. The airway management device of any of items 1-3, wherein a or the first over-mould comprises a distal perimeter (26) defining a first opposed edge of an over-moulded cuff membrane (25) continuing tangentially from said perimeter (26) as a toroidal curve whose end point is in spaced relation and normal to the first opposed edge, the end points defining an open posterior (27) perimeter or second opposed edge and a linear portion (37) over-moulding a proximal end such that said curved portion (35) and the linear portion (37) are joined as a single moulding by planar sealing voids (36) to first and second sides of an intermediate strip (38).
5. The airway management device of any of items 1-4, further including a second over-mould of SEBS closing said open length of membrane (27), forming an inflatable cuff.
6. The airway management device according to any of items 1-5, wherein a or the posterior contour (35) of the body (6) is adapted to be located within a hypopharynx and a distal end (2) is adapted to be located within an upper oesophageal sphincter creating an oesophageal seal, wherein immediately superior to a distal opening (20), and the anterior compound curvature (33) of the external shell is an internal posterior surface of a passage or gastric drain tube (24) reducing the bulk of the distal tip (2).
7. The airway management device according to any of items 1-6, further including a surrounding contour (34) over-moulding said anterior compound curvature (33) of the external shell and which is adapted for locating and pressing against the hypopharynx, the distal to proximal full length configuration of the external shell providing resistance against displacement of the distal opening (20) superiorly from increasing oesophageal pressure (70).
8. The airway management device of any of items 1-7, wherein a or the drain tube (24) and a drain tube distal opening (20) are integral with a distal posterior contour (34) and where the said drain tube (24) is not surrounded by an annular volume of said inflatable cuff.
9. The airway management device of any of items 1-8, further including a closed tubular section (30) forming a chamber (32) providing a space for a distal portion of the inflatable cuff with a posterior displacement when inflated.
10. The airway management device of any of items 1-9, wherein through any horizontal cross section of said inflatable cuff, first and second edges (27), for at least the length of the distal portion of the gastric drain tube (31), are maintained parallel to a median plane (10) of the curved portion (35) such that the width between the first and second edges (27) after second over-moulding is equal to an outer diameter of the distal drain tube (31).
11. The airway management device of any of items 1-10, wherein a curvature of the inflatable cuff membrane (25) between said first (26) and second (27) opposed edges is a single contiguous curve of uniform durometer hardness, sealing posteriorly against a hypopharynx and anteriorly against a laryngeal inlet without adhesive joint.
12. A method of using the airway management device according to any of items 1-11, comprising:

[0139] providing a removable connector/adaptor (39) on the linear portion to reduce a length from a proximal opening (42) of the body (6) through to a trachea (68), thereby providing additional depth of insertion of a distal tip (63) of an endotracheal tube.

13. A method of using the airway management device according to any of items 1-11, comprising:

[0140] providing a finger stopper (60) creating a fixed position to rest a thumb during insertion, to grip a proximal end (37) when removing the device after intubation and to act as a depth indicator, with reference to teeth, when the device is in situ.

14. A method of forming an airway management device, comprising:

[0141] providing a body (6) comprising polypropylene copolymer (PP) and thermoplastic elastomer (TPE) of styrene-ethylene/butylene-styrene (SEBS), including an external shell moulded from a majority PP copolymer blended with SEBS extending from a proximal opening to a distal tip of the body (6).

15. The method of item 14, further including the step of:

[0142] attaching an intermediate strip (38) moulded from PP copolymer to said external shell intermediate to a curved portion (35) and a linear portion (37) of the body (6).

16. The method of item 14 or item 15, further including the step of:

[0143] providing a first over-mould of SEBS comprising an initial posterior contour (35) and distal contour (34) over-moulded onto the external shell, whose distal perimeter (26) defines a first opposed edge of an over-moulded cuff membrane (25) that continues tangentially from said distal perimeter (26) as a toroidal curve whose end point is in spaced relation and normal to the first opposed edge, the end points collectively defining an open posterior (27) perimeter or second opposed edge and a linear portion over-moulding the proximal end (37) such that said curved portion (35) and the linear portion (37) are joined as a single moulding by planar sealing voids (36) to lateral sides of said intermediate strip (38).

17. The method of item 16, further including the step of providing a second over-mould of SEBS closing said membrane (25), forming an inflatable cuff and completing the said body (6).
18. A method of forming an object, comprising:

[0144] injection moulding a first portion of the object over a first core associated with a fixture;

[0145] after the injection moulding of the first portion, moving a second core associated with the fixture to a deployed position; and

[0146] injection moulding a second portion of the object over the second core and the first portion.

19. The method of item 18, wherein the step of moving the second core associated with the fixture to the deployed position comprises rotating the second core relative to the fixture.
20. The method of item 18 or item 19, further including the steps of:

[0147] attaching a pre-formed part to the object;

[0148] placing one or more removable cores into the object; and

[0149] placing one or more removable cores inside the injection mould prior to moulding a second portion of the object; and

[0150] over-moulding a membrane as part of the second portion of the object.

21. The method of any of items 18-20, further including the step of injection moulding a third portion closing and sealing the membrane to form an inflatable portion of the object.
22. The method of any of items 18-21, further including the step of removing the removable cores from the membrane of the object prior to injection moulding the third portion.
23. The method of any of items 18-21, wherein:

[0151] the step of injection moulding the first portion is completed in a first mould including the fixture; and

[0152] the step of injection moulding the second portion is completed in a second mould including the fixture; and

[0153] the step of injection moulding the third portion to close and seal the membrane in a third mould including the fixture.

24. The method of any of items 18-23, further including the step of transferring the fixture from a first mould to a second mould between the steps of injection moulding the first portion and second portion of the object.
25. The method of any of items 18-24, wherein the step of injection moulding the first portion of the object over the first core associated with the fixture comprises forming the external shell of the object.
26. The method of any of items 18-25, further including the steps of:

[0154] moving the first core to release a proximal end of the object; and

[0155] removing the object from the second core of the fixture.

27. The method of any of items 18-26, further including the step of:

[0156] providing a body comprising polypropylene copolymer (PP) and thermoplastic elastomer (TPE) of styrene-ethylene/butylene-styrene (SEBS), and wherein the first portion comprises an external shell moulded during the first injection moulding step from a majority PP copolymer blended with SEBS extending from a proximal opening to a distal tip of the body.

28. The method of any of items 18-27, wherein the object comprises an airway management device.
29. An apparatus for forming an injection moulded object, comprising:

[0157] a reconfigurable fixture including a first movable core over which a first portion of the injection moulded object is formed and a second movable core over which a second portion of the injection moulded object is formed.

30. The apparatus of item 29, wherein the first movable core is adapted for rotating relative to the fixture.
31. The apparatus of item 29 or item 30, wherein the second movable core is adapted for rotating relative to the fixture.
32. The apparatus of any of items 29-31, further including a first removable core adapted for being removably attached to the fixture.
33. The apparatus of item 32, wherein the first removable core comprises a connector for connecting to the fixture.
34. The apparatus of item 32, wherein the first removable core comprises a handle.
35. The apparatus of any of items 29-34, wherein the fixture comprises a spring for maintaining the second movable core in a deployed position.
36. A method of manufacturing an airway management device, comprising:

[0158] providing a tubular body having a linear portion and a curved portion, the tubular body including a plurality of supports adjacent to a posterior channel;

[0159] providing an intermediate strip in engagement with the plurality of supports and overlying the posterior channel; and

[0160] over-moulding material onto the intermediate strip.

37. The method of item 36, further comprising the steps of:

[0161] injection moulding a first portion of the body of the airway management device over a first core associated with a fixture;

[0162] after the injection moulding of the first portion, moving a second core associated with the fixture to a deployed position; and

[0163] injection moulding a second portion of the body over the second core and the first portion of the body.

38. The method of item 37, wherein the step of moving the second core associated with the fixture to the deployed position comprises rotating the second core relative to the fixture.
39. The method of any of items 36-38, further including the steps of:

[0164] placing one or more removable cores in the tubular body; and

[0165] placing one or more removable cores inside the second injection mould; and

[0166] over-moulding the removable cores with a membrane as part of the second portion of the body.

40. The method of item 39, further including the steps of:

[0167] removing said removable cores from close proximity to the first core and second core leaving an open membrane; and

[0168] over-moulding the second portion with a third portion closing and sealing the membrane to form an inflatable cuff on the tubular body.

41. The method of claim 39 or item 40, further including the step of moving the first core and removing the removable cores to release the tubular body.
42. The method of any of items 36-41, further including the steps of:

[0169] placing a first material in one or more voids adjacent the intermediate strip with a first material; and

[0170] melting a portion of the intermediate strip comprising a second material so as to diffuse the first material into the second material.

43. A method of forming an object, comprising:

[0171] in a first injection mould, injection moulding a first portion of the object over a first core associated with a fixture;

[0172] placing the fixture in a second injection mould; and

[0173] injection moulding a second portion of the object.

44. The method of item 43, wherein the first core is movable relative to the fixture, and further including the step of moving the first core following the injection moulding of the first portion or the second portion of the object.
45. The method of item 43 or item 44, wherein the step of injection moulding the second portion of the object comprises injection moulding over a second core associated with the fixture.
46. The method of any of items 43-45, wherein the second core is movable relative to the fixture, and further including the step of moving the second core to a deployed position after the step of injection moulding the first portion of the object and prior to the injection moulding of the second portion of the object.
47. The method of any of items 43-46, further including the step of placing one or more removable cores inside the second injection mould prior to the step of injection moulding the second portion of the object.
48. The method of any of items 43-47, wherein the step of injection moulding the second portion of the object comprises over-moulding a membrane onto the one or more removable cores.
49. The method of any of items 43-48, wherein the one or more removable cores are removed from the second injection mould together with the fixture.
50. The method of any of items 43-49, wherein the one or more removable cores are removed from the membrane after injection moulding the second portion and prior to injection moulding the third portion of the object.
51. The method of item 50, further including the step of closing and sealing the membrane to form an inflatable portion of the object.
52. An airway management device formed by the method of any of items 36-51.

[0174] Each of the following terms written in singular grammatical form: “a”, “an”, and the”, as used herein, means “at least one”, or “one or more”. Use of the phrase “One or more” herein does not alter this intended meaning of “a”, “an”, or “the”. Accordingly, the terms “a”, “an”, and “the”, as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or the context clearly dictates otherwise. For example, the phrases: “a unit”, “a device”, “an assembly”, “a mechanism”, “a component, “an element”, and “a step or procedure”, as used herein, may also refer to, and encompass, a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and, a plurality of steps or procedures, respectively.

[0175] Each of the following terms: “includes”, “including”, “has”, “having”, “comprises”, and “comprising”, and, their linguistic/grammatical variants, derivatives, or/and conjugates, as used herein, means “including, but not limited to”, and is to be taken as specifying the stated components), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof. Each of these terms is considered equivalent in meaning to the phrase “consisting essentially of.” Each of the phrases “consisting of” and “consists of”, as used herein, means “including and limited to”. The phrase “consisting essentially of” means that the stated entity or item (system, system unit, system sub-unit device, assembly, sub-assembly, mechanism, structure, component element or, peripheral equipment utility, accessory, or material, method or process, step or procedure, sub-step or sub-procedure), which is an entirety or part of an exemplary embodiment of the disclosed invention, or/and which is used for implementing an exemplary embodiment of the disclosed invention, may include at least one additional feature or characteristic” being a system unit system sub-unit device, assembly, sub-assembly, mechanism, structure, component or element or, peripheral equipment utility, accessory, or material, step or procedure, sub-step or sub-procedure), but only if each such additional feature or characteristic” does not materially alter the basic novel and inventive characteristics or special technical features, of the claimed item.

[0176] The term “method”, as used herein, refers to steps, procedures, manners, means, or/and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or/and techniques, either known to, or readily developed from known steps, procedures, manners, means, or/and techniques, by practitioners in the relevant field(s) of the disclosed invention.

[0177] Terms of approximation, such as the terms about, substantially, approximately, generally, etc., as used herein, refer to ±10% of the stated numerical value or as close as possible to a stated condition.

[0178] It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or sub-combination in the context or format of a single embodiment may also be illustratively described and presented in the context or format of a plurality of separate embodiments.

[0179] Although the invention has been illustratively described and presented by way of specific exemplary embodiments, and examples thereof, it is evident that many alternatives, modifications, or/and variations, thereof, will be apparent to those skilled in the art. Accordingly, it is intended that all such alternatives, modifications, or/and variations, fall within the spirit of, and are encompassed by, the broad scope of the appended claims.