IMPROVED TRACHEOSTOMY DEVICE

Abstract

A tracheostomy airway device is provided comprising an outer cannula (110) having open proximal and distal ends, an inner actuation member insertable into the proximal end of the outer cannula, and one or more retention members (130). The one or more retention members are movable relative to the outer cannula between a retracted configuration in which the tracheostomy device is insertable into, and removable from, the trachea of a patient, and an extended configuration in which the one or more retention members impede removal of the tracheostomy airway device from the trachea. The retention members are operably linked to the inner actuation member or the outer cannula, such that movement of the inner actuation member relative to the outer cannula actuates movement of the one or more retention members between the retracted configuration and the extended configuration.

Claims

1. A tracheostomy airway device comprising an outer cannula having open proximal and distal ends, an inner actuation member insertable into the proximal end of the outer cannula, and one or more retention members, which are movable relative to the outer cannula between a retracted configuration in which the tracheostomy device is insertable into, and removable from, the trachea of a patient, and an extended configuration in which the one or more retention members impede removal of the tracheostomy airway device from the trachea, wherein the retention members are operably linked to the inner actuation member or the outer cannula, such that movement of the inner actuation member relative to the outer cannula actuates movement of the one or more retention members between the retracted configuration and the extended configuration.

2. A tracheostomy airway device as claimed in claim 1, wherein the inner actuation member has the form of an inner cannula.

3. A tracheostomy airway device as claimed in claim 1, wherein the inner actuation member may comprise a removable liner for facilitating cleaning of secretions that may accumulate, during use.

4-7. (canceled)

8. A tracheostomy airway device as claimed in claim 1, wherein the exterior shape of the inner actuation member substantially matches the interior shape of the outer cannula, at least those portions that are brought alongside each other on insertion of the inner actuation member into the outer cannula, such that the inner actuation member is received within the outer cannula with a close fit.

9.-10. (canceled)

11. A tracheostomy airway device as claimed in claim 1, wherein the inner actuation member comprises an engagement portion that is either adapted to come into engagement with the one or more retention members, or where the inner actuation member is fixed to the one or more retention members, the engagement portion is adapted to come into engagement with the outer cannula or other engagement member fixed to the outer cannula.

12. A tracheostomy airway device as claimed in claim 1, wherein the inner actuation member is fixable relative to the outer cannula, following insertion and movement to the extended configuration, in order to provide a configuration suitable for long-term use of the device by the patient.

13. (canceled)

14. A tracheostomy airway device as claimed in claim 1, wherein the one or more retention members comprise an engagement portion that is engaged by a corresponding engagement portion of the inner actuation member, during insertion of the inner actuation member into the outer cannula, in use.

15. (canceled)

16. A tracheostomy airway device as claimed in claim 14, wherein the one or more retention members are arranged for movement relative to the outer cannula as the inner actuation member is inserted into the outer cannula, and the engagement portion of the inner actuation member moves the engagement portion of the one or more retention members.

17. A tracheostomy airway device as claimed in claim 1, wherein the one or more retention members are mounted relative to the inner actuation member.

18. A tracheostomy airway device as claimed in claim 17, wherein the one or more retention members comprise an engagement portion that is engaged by a corresponding engagement portion of the outer cannula, during insertion of the inner actuation member into the outer cannula, in use.

19. A tracheostomy airway device as claimed in claim 18, wherein the one or more retention members are arranged for movement relative to the outer cannula as the inner actuation member is inserted into the outer cannula, and the engagement portion of the outer cannula moves the engagement portion of the one or more retention members.

20-22. (canceled)

23. A tracheostomy airway device as claimed in claim 1, wherein the one or more retention members comprise a retaining portion, which projects outwardly relative to the exterior surface of the outer cannula in the extended configuration and is arranged to impinge on the interior surface of the trachea of a patient, in the extended configuration of the device, in the event that a removal or dislodgement force and movement is applied to the device.

24.-25. (canceled)

26. A tracheostomy airway device as claimed in claim 1, wherein the one or more retention members are mounted to the outer cannula or the inner actuation member by means of a fixed portion of the one or more retention members, which does not move relative to the component to which it is fixed, and the one or more retention members being deformable.

27. A tracheostomy airway device as claimed in claim 26, wherein the portion of the one or more retention members that is deformable relative to the fixed portion may comprise a retaining portion and/or an engagement portion of the one or more retention members.

28.-29. (canceled)

30. A tracheostomy airway device as claimed in claim 1, wherein the one or more retention members are subject to a biasing force, which acts to urge the one or more retention members to a rest position which corresponds to the position of the one or more retention members in a retracted configuration, when the inner actuation member is withdrawn, e.g. at least partially or fully, from the outer cannula.

31-35. (canceled)

36. A tracheostomy airway device as claimed in claim 23, wherein a retaining portion of the one or more retention members comprises an abutment surface arranged to impinge on an interior surface of the trachea of a patient, in the event of a withdrawal or dislodgement force or movement.

37. A tracheostomy airway device as claimed in claim 36, wherein the abutment surface is orientated obliquely relative to the axis along which the corresponding portion of the outer cannula extends, and relative to the interior surface of the trachea.

38. (canceled)

39. A tracheostomy airway device as claimed in claim 36, wherein a retaining portion of the one or more retention members is movable between a position in the retracted configuration where the abutment surface is substantially aligned with the exterior surface of the outer cannula, and a position in the extended configuration in which the retaining portion and/or the abutment surface projects outwardly relative to the exterior surface of the outer cannula.

40.-41. (canceled)

42. A method of inserting a tracheostomy airway device, such as the tracheostomy device defined in claim 1, comprising: (a) providing the tracheostomy device in a retracted configuration in which the tracheostomy device is insertable into the trachea of a patient; (b) inserting an outer cannula of the tracheostomy device into the trachea of a patient; (c) inserting an inner actuation member of the tracheostomy device into a proximal end of the outer cannula; and (d) moving the inner actuation member relative to the outer cannula, thereby actuating movement of one or more retention members of the tracheostomy device into an extended configuration in which the one or more retention members impede removal of the tracheostomy airway device from the trachea.

43. A method as claimed in-claim 42, wherein the method includes a further step, for decannulation, of moving the inner actuation member relative to the outer cannula, thereby actuating movement of one or more retention members of the tracheostomy device into the retracted configuration in which the tracheostomy device is removable from the trachea of a patient.

Description

[0052] A preferred embodiment of the invention will now be described, by way of illustration only, with reference to the accompanying drawings, in which:

[0053] FIG. 1 is a first perspective view of a tracheostomy airway device according to the invention, in a retracted configuration;

[0054] FIG. 2 is a second perspective view of the tracheostomy airway device of FIG. 1, in the retracted configuration;

[0055] FIGS. 3a, 3b and 3c are side views of an outer cannula component, an inner cannula component and a retention member component, respectively, which each form part of the tracheostomy airway device of FIGS. 1 and 2;

[0056] FIG. 4 is a third perspective view of the tracheostomy airway device of the previous figures, in an extended configuration;

[0057] FIG. 5 is a fourth perspective view of the tracheostomy airway device of the previous figures, in an extended configuration;

[0058] FIG. 6 is a cross-sectional view of the tracheostomy airway device of the previous figures, in an extended configuration, along line VI-VI in shown in FIG. 4; and

[0059] FIG. 7 is a schematic view of a conventional tracheostomy airway device inserted into the trachea of a patient.

[0060] A tracheostomy airway device according to the invention is shown in FIGS. 1 and 2, in a retracted configuration, and is generally designated 100. The tracheostomy airway device 100 comprises an outer cannula component 110, an inner cannula component 120 and three retention member components 130.

[0061] The outer cannula component 110, which is shown in isolation in FIG. 3a, is tubular, with a generally circular tubular wall 112. The tubular wall 112 has a short proximal portion that is generally cylindrical in shape, and a main portion that extends along an arcuate central axis, with the central axis having a substantially constant radius. The inner and outer diameters of the tubular wall 112 are uniform along the length of the outer cannula component 110, save for an abutment flange 114, which projects radially outwardly from the tubular wall 112 near to, but separately slightly from, a proximal end of the tubular wall 112. The abutment flange separates the generally cylindrical proximal portion of the tubular wall 112 and the main portion of the tubular wall 112 that extends along an arcuate central axis. The abutment flange 114 is annular in shape, with flat annular abutment surfaces, and a cylindrical side surface. The inner and outer surfaces of the tubular wall 112, save for the abutment flange 114, are smooth, and terminate at proximal and distal ends, which comprise flat annular end surfaces, orientated perpendicularly to the adjacent central axis of the tubular wall 12.

[0062] The outer cannula component 110 also comprises three rectangular openings 118 in the tubular wall 112, which are positioned approximately one-quarter of the length of the tubular wall 112 away from the proximal end. A first rectangular opening 118 has a central, longitudinal or major axis that is aligned with the plane of curvature of the arcuate central axis of the tubular wall 112, and is disposed on the radially-inner side of the arcuate central axis of the tubular wall 112. The second and third rectangular openings 118 are arranged at 90° to the first rectangular opening, and hence are disposed diametrically opposite each other.

[0063] As shown in FIG. 2, the outer cannula component 110 also comprises a group of seven circular openings in the tubular wall, this group being positioned approximately equidistant from the proximal and distal ends of the outer cannula component 110, and on the radially-outer side of the arcuate central axis of the tubular wall 112.

[0064] The inner cannula component 120, which is shown in isolation in FIG. 3b, is tubular, with a generally circular tubular wall 122. The tubular wall 122 has a proximal portion with an enlarged external diameter, and hence an increased wall thickness, which defines a head 124 of the inner cannula 120. The external diameter of the inner cannula head 124 is approximately equal to the external diameter of the tubular wall 112 of the outer cannula component 110. The tubular wall 122 also comprises a cylindrical intermediate portion, extending along a linear central axis, and a distal portion that extends along an arcuate central axis, with the central axis of the distal portion having a substantially constant radius. The inner and outer diameters of the tubular wall 122 are uniform along the length of the inner cannula component 120, save for inner cannula head 124, which projects radially outwardly from the tubular wall 122 at the proximal end of the tubular wall 122. The outer diameter of the intermediate and distal portions of the inner cannula component 120 is approximately equal to the internal diameter of the tubular wall 112 of the outer cannula component 110. The inner cannula head 124 is annular in shape, with flat annular abutment surfaces, and a cylindrical side surface. The inner and outer surfaces of the tubular wall 122, save for the inner cannula head 124, are smooth, and the tubular wall 122 terminates at proximal and distal ends, which comprise flat annular end surfaces, orientated perpendicularly to the adjacent central axis of the tubular wall 122.

[0065] The inner cannula component 120 is slidably received within the proximal end of the outer cannula component 110, and is insertable into the proximal end of the outer cannula component 110. In a retracted configuration of the tracheostomy airway device 100, as shown in FIGS. 1 and 2, the inner cannula component 120 is inserted into the proximal end of the outer cannula component 110, with the entire arcuate distal portion and approximately half of the linear intermediate portion of the tubular wall 122 of the inner cannula component 120 being accommodated within the tubular wall 112 of the outer cannula component 110. The remaining half of the linear intermediate portion of the tubular wall 122 of the inner cannula component 120, and the inner cannula head 124, thereby projecting from the proximal end of the outer cannula component 110, as shown in FIGS. 1 and 2.

[0066] The inner cannula component 120 is slidably engageable with the outer cannula component 110 along a continuum of positions until a fully engaged position, in the extended configuration of the tracheostomy airway device 100, in which the inner cannula head 124 of the inner cannula component 120 abuts the proximal end surface of the outer cannula component 110. This engagement and the extended configuration of the tracheostomy airway device 100 is discussed in more detail below, with reference to FIGS. 4 to 6.

[0067] The three retention member components 130, one of which is shown in isolation in FIG. 3c, are all identical in form. Each retention member component 130 comprises a rectangular, planar body 132, and a tapered projection 134 extending from a distal region of one of the two major surfaces of the rectangular, planar body 132. The tapered projection 134 is generally pyramidal in shape, with four generally triangular surfaces separated by linear edges, first and second surfaces being aligned along a central longitudinal axis of the rectangular, planar body 132, and third and fourth surfaces to each side of this central longitudinal axis.

[0068] Each retention member component 130 is bonded to a region of the exterior surface of the tubular wall 112 of the outer cannula component 110 on the proximal side of a corresponding rectangular opening 118, such that the rectangular, planar body 132 of the retention member component 130 overlies the corresponding rectangular opening 118, in the retracted configuration of the tracheostomy airway device 100. In this configuration, the tapered projection 134 of each retention member component 130 extends through the corresponding rectangular opening 118, such that the tapered projection 134 of each retention member component 130 projects into the interior of the outer cannula component 110, and in particular projects radially inwardly relative to the inner surface of the tubular wall 112 of the outer cannula component 110.

[0069] The retention member component 130 may be bonded to the exterior surface of the tubular wall 112 of the outer cannula component 110 with any suitably robust form of attachment, such as by welding, by adhesive or by co-moulding, for example.

[0070] Turning now to FIGS. 4 to 6, as discussed above, the inner cannula component 120 is slidably engageable with the outer cannula component 110 along a continuum of positions until a fully engaged position, in the extended configuration of the tracheostomy airway device 100, in which the inner cannula head 124 of the inner cannula component 120 abuts the proximal end surface of the outer cannula component 110. This extended configuration is shown in FIGS. 4 to 6.

[0071] As the inner cannula component 120 is slidably moved along the interior surface of the outer cannula component 110, along a continuum of positions, towards the fully engaged position, the distal end surface of the inner cannula component 120 comes into contact with, and abuts, the first surfaces of the tapered projections 134 of the three retention member components 130. Since the first surfaces of the tapered projections 134 of the three retention member components 130 are obliquely angled relative to the direction of movement of the inner cannula component 120, further movement of the inner cannula component 120 relative to the outer cannula component 110 causes the distal end of the inner cannula component 120 to urge the tapered projections 134 of the three retention member components 130, and the corresponding underling portions of the rectangular, planar bodies 132, outwardly relative to the outer cannula component 110. Each retention member component 130 deforms about a linear hinge, aligned along the proximal edge of the rectangular opening 118 of the outer cannula component 110, as the tapered projections 134 of the three retention member components 130, and the corresponding underling portions of the rectangular, planar bodies 132, are urged outwardly relative to the outer cannula component 110.

[0072] In the extended configuration of the tracheostomy airway device 100, in which the inner cannula head 124 of the inner cannula component 120 abuts the proximal end surface of the outer cannula component 110, the tubular wall 110 of the inner cannula component 120 lies alongside, and on the radially-inner side of, the first surfaces of the tapered projections 134 of the three retention member components 130. In this configuration, the three retention member components 130 at least partially project relative to the exterior surface of the outer cannula component 110, presenting an obliquely angled, planar surface towards the proximal end of the tracheostomy airway device 100.

[0073] Although not shown in the figures, the tracheostomy airway device 100 will typically also include a fastener component or so-called ‘neck flange’, bonded to the abutment flange 114 of the outer cannula component 120, which includes two generally planar wings that extend outwardly from the outer cannula component 110, and from which ribbon ties extend for securing the tracheostomy airway device 100 around the neck of a patient.

[0074] In use, an incision is made in the anterior aspect of the neck of a patient and in the trachea, thereby opening a direct airway into the trachea. The distal end of the tracheostomy airway device 100, in the retracted configuration (as shown in FIGS. 1-3), is then inserted through resulting stoma, or tracheostomy, until the abutment flange 114 is located externally adjacent to the exterior surface of the patient's neck, and the distal end of the outer cannula component 110 is located within the trachea of the patient, in the same manner as for a conventional tracheostomy airway device, as shown in FIG. 7. The inner cannula component 120 may, or may not, be present during insertion, and may be omitted where an obturator is used. Where a fastener component is provided, the ribbon ties are then passed around the neck of a patient, and tied, to secure the tracheostomy airway device 100 to the neck of the patient.

[0075] Once the tracheostomy airway device 100 has been inserted into the neck of a patient, as illustrated for a conventional tracheostomy airway device in FIG. 7, the three retention member components 130 are located within the trachea of the patient. The inner cannula component 120 is then slidably engaged with the outer cannula component 110 along a continuum of positions until a fully engaged position, in the extended configuration of the tracheostomy airway device 100, in which the inner cannula head 124 of the inner cannula component 120 abuts the proximal end surface of the outer cannula component 110, as shown in FIGS. 4-6. In this configuration, the three retention member components 130 at least partially project relative to the exterior surface of the outer cannula component 110, presenting an obliquely angled, planar surface towards the proximal end of the tracheostomy airway device 100 and the adjacent wall of the trachea. The three retention member components 130 would therefore impinge on the interior surface of the trachea of the patient in the event that the tracheostomy airway device 100 was subject to a removal force, such that the retention member components 130 would reduce the risk of the tracheostomy airway device 100 becoming dislodged or at least would reduce the risk of the tracheostomy airway device 100 becoming sufficiently dislodged to cause complications for the patient.

[0076] In order to remove the tracheostomy airway device 100, the inner cannula component 120 is slidably withdrawn, at least partially, from the outer cannula component 110 along a continuum of positions until the distal end of the inner cannula component 120 disengages from the tapered projections 134 of the three retention member components 130, such that the three retention member components 130 reform and withdraw into the rectangular openings 118 of the outer cannula component 110, until the three retention member components 130 no longer project outwardly relative to the outer cannula component 110, in the retracted configuration of the tracheostomy airway device 100, as shown in FIGS. 4-6. The tracheostomy airway device 100 is then withdrawn fully from the neck of the patient.