Tracheostomy tubes and the manufacture of such tubes and their components
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.
1 . A tracheostomy tube including a shaft and a mounting flange towards a machine end of the shaft, the mounting flange extending radially outwardly of the tube and being provided with an opening towards each end, the opening configured to receive a securing means to retain the tube with a 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.
2 . A tracheostomy tube according to claim 1 , characterised in that the silicone material of the flange and of the inserts have a similar hardness.
3 . A tracheostomy tube according to claim 1 , characterised in that the hardness of both silicone materials is approximately 70 shore A.
4 . A tracheostomy tube according to claim 1 , characterised in that the first silicone material is a liquid silicone rubber.
5 . A tracheostomy tube according to claim 1 , 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.
6 . A tracheostomy tube according to claim 5 , characterised in that the projection is an annular ledge extending around the body.
7 . A tracheostomy tube according to claim 5 , 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.
8 . 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, the opening configured to receive a securing means.
9 . A method according to claim 8 , characterised in that the silicone material of the inserts has substantially the same hardness as the silicone material overmoulded about the inserts.
10 . A method according to claim 8 , 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.
11 . A tube having a mounting flange manufactured by 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, the opening configured to receive a securing means.