GB2538860A

GB2538860A - Tracheostomy tube assemblies

Info

Publication number: GB2538860A
Application number: GB1606927.0A
Authority: GB
Inventors: Thomas Jeffrey Andrew; John Woosnam Christopher
Original assignee: Smiths Medical International Ltd
Current assignee: Smiths Medical International Ltd
Priority date: 2015-05-08
Filing date: 2016-04-21
Publication date: 2016-11-30
Also published as: GB201508038D0

Abstract

A tracheostomy tube has a neck flange 20 formed by two wings 21 and 22 each of which has a ball 28 at the end of an arm 29 extending inwardly towards the hub 14 of the tube. On each side of the hub 14 a pair of rings 43 and 44 project outwardly and trap respective ones of the balls 28 between them. The ball and ring arrangement enables the flange wings 21 and 22 to be pivoted forwardly to enable access to the skin around the stoma and also allow the shaft 10 to rotate about an axis H1-H2 extending longitudinally of the flange so that it can conform to the patient anatomy.

Description

TRACHEOSTOMY TUBE ASSEMBLIES

This invention relates to tracheostomy tube assemblies of the kind including a shaft having a patient end adapted for location within the trachea and a machine end adapted for location outside the patient, the assembly including a flange assembly by which the tube assembly can be secured with the neck of the patient.

Tracheostomy tubes are used to enable ventilation or respiration of a patient. The tube is inserted into the trachea via a surgically-formed opening in the neck so that one end locates in the trachea and the other end locates outside the patient adjacent the neck surface. Various types of different tracheostomy tubes are presently available to suit different needs. Tracheostomy tubes are also available with an inner cannula, which can be removed and replaced periodically to prevent the build-up of secretions and avoid the need to replace the tube itself. Tracheostomy tubes can be inserted by different techniques, such as the surgical cut down procedure carried out in an operating theatre or a percutaneous dilatation procedure, which may be carried out in emergency situations.

Tracheostomy tubes are generally used for more long-term ventilation or where it is not possible to insert an airway through the mouth or nose. The patient is often conscious while breathing through a tracheostomy tube, which may be open to atmosphere or connected by tubing to some form of ventilator. The tube is secured in position by means of a flange fixed with the machine end of the tube and positioned to extend outwardly on opposite sides of the tube. The flange has apertures on either side to which a neck strap can be fastened. There can be considerable differences in the anatomy between different patients, which may cause a problem by making it difficult to secure the flange with the neck surface without putting excessive force on the tube, even though the flange and its attachment with the tube may be flexible. Force applied to the tube in this way can lead to incorrect positioning of the tube in the trachea, can cause trauma to patient tissue in or around the stoma and can cause discomfort to the patient. Discomfort can also be caused to the patient when he moves because of the relatively inflexible connection between the flange and shaft of conventional tubes. Another problem with conventional tracheostomy tubes is that the flange can obscure the region around the stoma, making it difficult to inspect and clean this region. PCT/GB2016/000031 describes a tracheostomy tube with a ball formation on the hub of the shaft and a single flange with two projecting rings in which the ball is received. This arrangement allows for a limited relative displacement between the tube and the flange but does not enable the flange to be hinged away from the skin surface sufficiently for inspection and cleaning around the stoma. W02006/087513 describes a tracheostomy tube with a flange assembly that can be moved to different positions along the length of the tube and where the flange has two hinged wings that lock against the outside of the tube when folded forwardly.

It is an object of the present invention to provide an alternative tracheostomy tube assembly.

According to the present invention there is provided a tracheostomy tube assembly of the above-specified kind, characterised in that the flange assembly includes two laterally-extending wings hinged with the tube by means of a ball formation and a ball capture formation for each wing arranged to enable each wing to be displaced separately about an axis extending generally parallel to the plane of the tube and to enable the tube to be displaced relative to the wings about an axis extending laterally of the tube and generally longitudinally of the respective wing.

Each ball capture formation preferably includes a pair of ring members. Each ball formation is preferably mounted with a respective wing and each ball capture formation is preferably mounted with the tube.

A tracheostomy tube assembly according to the present invention will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is a perspective view of the tracheostomy tube assembly; Figure lA is an enlarged cross-sectional view along an inner part of one of the wings of the flange assembly; Figure 2 is a plan view the tracheostomy tube assembly illustrating displacement of the wings of the flange assembly; and Figure 3 is a side elevation view of the tracheostomy tube assembly illustrating displacement of the tube relative to the flange assembly.

With reference first to Figures 1 and 1A, the tracheostomy assembly comprises a curved shaft 10 of circular section with a patient end 12 adapted to be located within the trachea of the patient. The shaft 10 may have a conventional sealing cuff towards its patient end although the tube shown does not have any such sealing cuff. The shaft 10 is moulded or extruded and is bendable but relatively stiff, being made of a plastics material such as PVC or silicone. The machine end 13 of the shaft 10 is adapted, during use, to be located externally and adjacent the tracheostomy opening formed in the patient's neck. The machine end 13 of the shaft 10 supports a hub 14 and a 15mm male tapered connector 15 fixed with or forming a part of the hub and having a tapered external surface 16. The connector 15 is adapted to make a removable push fit in a conventional 15mm female connector (not shown) at one end of a breathing tube extending to a ventilator or anaesthetic machine.

The tracheostomy tube assembly also includes a flange assembly 20 with a forward surface that is adapted to lie against the skin surface of the neck on either side of the tracheostomy stoma. The flange assembly 20 has two separate, laterally-extending wings 21 and 22, each having a tapering plate 23 with an opening 24 at its outer end for attachment to a neck strap (not shown) used to support the tube with the patient's neck. The opposite, inner end of each plate 23 is cut away to form a square recess 52 midway across its width between an upper and lower finger 26 and 27. Each wing 21 and 22 also includes part of a ball joint provided by a spherical formation or ball 28 at one end of a support arm 29. The major part of the length of each support arm 29 extends longitudinally of its respective wing 21 or 22. The support arm 29 is set rearwardly of the rear face of the plate 23 by a short stem portion 30 extending at right angles to the arm and projecting orthogonally from the rear face of the plate adjacent the edge of the recess 52. In this way, the ball 28 on each wing 21 and 22 is mounted centrally across the width of the recess 52, lying just above the rear surface of the plate 23, as shown most clearly in Figure 1A.

The tracheostomy assembly further includes a support on the tube 10 by which the flange assembly 20 is retained. The support includes a collar 40 extending around and secured fixedly with the forward end of the hub 14, the collar having two ball capture formations 41 and 42 integrally formed with it on opposite lateral sides of the collar and the hub 14. The support on the tube 10 could be formed integrally as a part of the hub 14. Each ball capture formation 41 and 42 includes two annular rings 43 and 44 extending horizontally and parallel to one another with a central opening 45 and 46. The common axes VI and V2 of the rings 43 and 44 extend parallel to the plane of curvature of the tube 10 and at right angles to the axis of the hub 14. The diameter of the openings 45 and 46 and the spacing between the two rings 43 and 44 is selected such that the balls 28 are retained securely between the two rings but can be rotated to a limited extent relative to the rings. More particularly, this configuration enables the two wings 21 and 22 to be rearwardly and forwardly displaced about the two parallel vertical axes VI and V2 as shown by the arrows in Figure 2. In use, therefore, with the tube shaft 10 extending within the trachea, the wings 21 and 22 of the flange assembly 20 can be folded rearwardly, away from the skin surface around the neck, so that the skin around the stoma can be inspected and cleaned.

The two wings 21 and 22 can also be rotated relative to the tube 10 about respective horizontal axes Hi and H2 aligned with the support arms 29, as shown in Figure 3. The freedom of the wings 21 and 22 to be able to move angularly about the horizontal axes Hi and 1-b relative to the tube shaft 10 enables the tube shaft to adopt the angular orientation relative to the flange assembly 20 best adapted to the patient's anatomy without applying stress to any part of the tube assembly or to patient tissue. This enables the flange assembly 20 to be positioned flat against the surface of the neck regardless of small anatomical variations between patients, with the shaft 10 applying the least force to patient tissue in and around the stoma and trachea. The assembly also overcomes the problem of the discomfort or damage that patients with a tracheostomy tube can suffer when changing position, such as turning their head or moving in bed. Although the neck flange assembly 20 is secured firmly in position, the tube shaft 10 can articulate to accommodate changes in angle to position itself and fit more naturally in the trachea. The assembly can also accommodate patients with an unusual anatomy and an abnormal trachea.

Instead of the ball formations being mounted on the wings and the ball capture rings extending from the tube it would be possible for the ball formations to project laterally from the tube and for the ball capture rings to project from the wings.

Claims

CLAIMS1. A tracheostomy tube assembly including a shaft having a patient end adapted for location within the trachea and a machine end adapted for location outside the patient, the assembly including a flange assembly by which the tube assembly can be secured with the neck of the patient, characterised in that the flange assembly (20) includes two laterally-extending wings (21 and 22) hinged with the tube (10) by means of a ball formation (28) and a ball capture formation (41 and 42) for each wing arranged to enable each wing to be displaced separately about an axis (Vi and V2) extending generally parallel to the plane of the tube (10) and to enable the tube to be displaced relative to the wings (21 and 22) about an axis (HI -H2) extending laterally of the tube and generally longitudinally of the respective wing.
2. A tracheostomy tube assembly according to Claim 1, characterised in that each ball capture formation (41 and 42) includes a pair of ring members (43 and 44).
3. A tracheostomy tube assembly according to Claim 1 or 2, characterised in that each ball formation (28) is mounted with a respective wing (21 and 22) and that each ball capture formation (41 and 42) is mounted with the tube (10).