TRACHEOSTOMY TUBES AND THE MANUFACTURE OF SUCH TUBES AND THEIR COMPONENTS

Abstract

A tracheostomy tube flange (13) of a liquid silicone material has openings (14) towards opposite ends for receiving ends of a neck strap. The openings (14) are reinforced with overmoulded inserts (137, 138) of a heat cured silicone material having a similar hardness to that of the flange material. The inserts (137, 138) have an outwardly-projecting ledge (144) between their ends.

Claims

1-11. (canceled)

12. A tracheostomy tube including a shaft and a mounting flange towards the machine end of the shaft, the mounting flange extending radially outwardly of the tube and being provided with an opening towards each end to which means can be secured to retain the tube with the patient's neck, characterised in that the flange is of a first silicone material overmoulded on two reinforcement inserts at respective ones of the openings, and that the reinforcement inserts are of a heat-cured silicone rubber material different from the first silicone material.

13. A tracheostomy tube according to claim 12, characterised in that the silicone material of the flange and of the inserts have a similar hardness.

14. A tracheostomy tube according to claim 12, characterised in that the hardness of both silicone materials is approximately 70 shore A.

15. A tracheostomy tube according to claim 12, characterised in that the first silicone material is a liquid silicone rubber.

16. A tracheostomy tube according to claim 12, characterised in that the inserts include a hollow tubular body with a passage extending therethrough and a projection extending outwardly of the body between opposite ends.

17. A tracheostomy tube according to claim 16, characterised in that the projection is an annular ledge extending around the body.

18. A tracheostomy tube according to claim 16, characterised in that opposite sides of the flange lie level with opposite ends of the body of the inserts, with the passage through each body extending through the thickness of the flange, and with both sides of the projection being covered by material of the flange.

19. A method of manufacture of a mounting flange of a tracheostomy tube including the steps of moulding two inserts of a heat-cured silicone rubber material, both inserts having a passage therethrough and an outer projection, and overmoulding the two inserts about their outer projection with a silicone material different from that of the inserts to form a mounting flange of the tube where the passage through each insert provides an opening towards opposite ends of the flange to which securing means can be secured.

20. A method according to claim 19, characterised in that the silicone material of the inserts has substantially the same hardness as the silicone material overmoulded about the inserts.

21. A method according to claim 19, characterised in that the tracheostomy tube has a shaft with a patient end and a machine end, and that the method includes attaching the mounting flange with the shaft towards the machine end of the shaft.

22. A tube having a mounting flange manufactured by a method including the steps of moulding two inserts of a heat-cured silicone rubber material, both inserts having a passage therethrough and an outer projection, and overmoulding the two inserts about their outer projection with a silicone material different from that of the inserts to form a mounting flange of the tube where the passage through each insert provides an opening towards opposite ends of the flange to which securing means can be secured.

Description

[0013] A tracheostomy tube with a mounting flange and a method of manufacture of the mounting flange and tube according to the present invention will now be described, by way of example, with reference to the accompanying drawings in which:

[0014] FIG. 1 is a perspective view of the machine end of the tube from its patient side;

[0015] FIG. 2 is an enlarged perspective view of a part of the mounting flange of the tube cut away across one of the flange openings and without the shaft; and

[0016] FIG. 3 is an enlarged perspective view of a mounting flange insert.

[0017] With reference first to FIG. 1, the tracheostomy tube 1 has a curved shaft 10 of circular section moulded from a flexible plastics such as silicone. The patient, distal or forward end 11 of the tube 1 is adapted to locate in the trachea. The machine, proximal or rearward end 12 of the tube 1 extends through the tracheostomy and opens externally of the patient. The machine end 12 of the tube supports a laterally extending mounting flange 13 adapted to lie against the skin of the neck and having openings 14 at opposite ends that receive securing means such as the ends of a neck tie (not shown) extending around the neck. Alternatively, the securing means could take the form of sutures threaded through skin adjacent the flange 13. The machine end 12 of the tube 1 also includes an externally tapered 15 mm male connector 15 arranged to receive a cooperating female connector (not shown) at one end of ventilation tubing. The connector 15 illustrated is a separate component from the shaft 10 and is moulded from a harder plastics than that of the shaft. Alternatively, the connector could be an integral component, one piece with the shaft. Where the patient is breathing spontaneously a connector might not be needed so the shaft could be terminated by a low-profile end fitting. The tube 1 is shown without any sealing cuff but it could be provided with such a conventional sealing cuff and other conventional features such as vocalisation fenestrations or suction lumens.

[0018] With reference now also to FIG. 2, the rear end of the shaft 10 is terminated by an enlarged external circular boss 16 and extends through a central opening 30 in the mounting flange 13. The flange 13 has a circular collar 31 formed around the opening 30 and projecting from the rear face of the flange. The collar 31 forms a circular cavity 32 within which the boss 16 on the shaft 10 is received and to which it is bonded.

[0019] The mounting flange 13 is moulded from a relatively soft, conformable silicone material, preferably a liquid silicone rubber with a hardness of approximately 70 shore A. This is preferably the same material as forms the shaft 10. The flange 13 has two radial arms 131 and 132 projecting outwardly of the central collar 31 along an axis orthogonal to the plane of curvature of the shaft 10. The inner part of each arm 131 and 132 has a width approximately half the diameter of the collar 31. At its outer end each arm 131 and 132 flares outwardly over a tapered region 133 and 134 to an enlarged region 135 and 136 the width of which is about twice that of the inner part of the arm. The openings 14 for receiving the ends of the neck tie or the like are provided in these enlarged regions 135 and 136 and are reinforced by means of respective inserts 137 and 138 shown more clearly in FIG. 3. The inserts 137 and 138 are retained with the flange 13 by overmoulding the flange material about the outside of the inserts.

[0020] The inserts 137 and 138 are also moulded from a silicone material but of a more abrasion-resistant grade of silicone than that forming the main part of the flange 13, namely a heat-cured silicone rubber, such as MED-4070 from Avantor, Inc, having a similar hardness to the material of the flange. It has been found that by making both the inserts and the flange of silicone materials it is possible to achieve a very good bond that is free from cracks and separation even after prolonged use and flexing. The similar hardness of the two materials also has the advantage of ensuring that the inserts do not lead to localised regions of the flange that are stiffer. The inserts 137 and 138 have a generally rectangular shape with a radially extending flat plate 140, which is rectangular with rounded corners and has a thickness about one quarter that of the arms of the flange. From the centre of opposite sides of the plate 140 projects a hollow tubular body formed by identical walls 141 and 142 of a racetrack oval shape with rounded ends 143. The external lateral dimensions of the walls 141 and 142 are less than the external dimensions of the central plate 140 so that the plate forms an annular outer projection, ledge or ring 144 with an upper, rearwardly-facing surface 145 and a lower, forwardly-facing surface 146. The upper and lower surfaces 147 of the walls 141 and 142 have a flat outer region 148 that continues as an inner rounded region 149. This provides a smooth entry to a central, elongate passage 150 through the inserts 137 and 138 forming the openings 14. The inserts 137 and 138 are embedded in the arms 131 and 132 of the mounting flange 13 with the passage 150 through each insert extending at right angles to the length of the arms. The height of the inserts 137 and 138 are equal to the thickness of the arms 131 and 132 so that the opposite surfaces of the arms lie level with the outer flat end regions 148 of the inserts. The ledge 144 of each insert 137 and 138 projects outwardly into the flange material midway across the thickness of the arms 131 and 132. The compatible nature of the silicone materials used in the main part of the flange 13 and in the inserts 137 and 138 means that the flange material forms a secure bond with the outside of the inserts, around the outer surface of the upper and lower walls 141 and 142, along the upper and lower surfaces of the ledge 144 and around its outer edge. The bond between the flange material and the inserts does not require any primer or other pre-treatment. The bond formed with the inserts 137 and 138 is resistant bending and flexing of the flange 13 without causing any separation or peeling and without creating fissures or crevices that could allow bacteria to collect. Because the inserts 137 and 138 have a similar hardness to the material of the rest of the flange 13 it avoids any difference in stiffness across the flange. In use, opposite the ends of the neck tie or sutures are threaded through or otherwise secured with the passages 150 in the inserts 137 and 138. The abrasion-resistant nature of the material of the inserts 137 and 138 ensures that force exerted by the neck tie or sutures during use and any rubbing caused by movement does not damage the flange 13, whilst the soft and conformable nature of the flange is not compromised.

[0021] The mounting flange 13 is manufactured by first moulding the inserts 137 and 138 from the heat-cured silicone rubber material and subsequently overmoulding the liquid silicone rubber material about the inserts to form the remainder of the flange. To manufacture the complete tracheostomy tube 1, the shaft 10 is moulded separately, preferably from the same silicone material as the flange, or from a similar silicone material that is compatible with the flange material for bonding purposes. The main part of the shaft is overmoulded about or otherwise attached to the patient end of a previously formed connector 15 made of a harder plastics material. The shaft 10 is threaded through the central opening 30 of the flange 13 and a suitable bonding solution is applied to outside of the enlarged boss 16 towards the machine end of the shaft and to the inside 32 of the central collar 31 of the flange.