Tracheostomy tubes and their manufacture
A tracheostomy tube has a machine end coupling ( 2 ) of a relatively hard plastics and formed with a retaining ring structure formation ( 23 ) at its patient end. This is joined with a tubular shaft ( 1 ) of a softer plastics, such as silicone, to form a subassembly ( 7 ) by a moulded interconnection of the machine end of the shaft about the retaining formation ( 23 ). An enlarged boss ( 12 ) at the rear end of the shaft ( 1 ) forms a forwardly facing wall ( 15 ). The tube also includes a moulded neck flange ( 5 ) of a relatively soft plastics with a central collar ( 50 ) having an internal, rearwardly facing wall ( 59 ). The boss ( 12 ) on the subassembly ( 7 ) is bonded into the collar ( 5 ) with the wall ( 15 ) on the boss abutting the wall ( 59 ) on the flange ( 5 ).
1 . A tracheostomy tube comprising a shaft for providing a gas passage to the trachea, a coupling for enabling gas connection with the shaft, and a flange adapted to secure the tracheostomy tube with a patient's neck, characterised in that the coupling is of a harder material than the shaft, that the rear, machine end of the shaft is attached with the coupling by material of the shaft flowed around a retaining formation at the patient end of the coupling such that the coupling and the shaft are mechanically interlocked to each other to form a subassembly when the material of the shaft is cured, that an external surface at the rear end of the subassembly is formed with an abutment surface facing towards the forward, patient end of the tracheostomy tube, and that the flange has an attachment portion with an abutment surface facing rearwardly, the abutment surface on the flange abutting the abutment surface on the subassembly so as to prevent forward movement of the subassembly relative to the flange, wherein the retaining formation comprises a ring structure that includes two discs spaced from one another along and around the forward end of the coupling, and wherein the material of the shaft is flowed in and around the two discs.
2 . A tracheostomy tube according to claim 1 , characterised in that the two discs are spaced from one another by an annular cavity, and that the forward disc is formed with a plurality of apertures opening through the disc into the cavity.
3 . A tracheostomy tube according to claim 1 , characterised in that flange is bonded with the abutment surface on the subassembly.
4 . A tracheostomy tube according to claim 1 , characterised in that the abutment surface at the rear end of the subassembly is provided by an externally-enlarged boss formed with a locating lug arranged to locate in a notch formed in the flange.
5 . A tracheostomy tube according to claim 1 , characterised in that shaft is of a silicone material.
6 . A tracheostomy tube according to claim 1 , characterised in that the flange is of a silicone material.
7 . A tracheostomy tube according to claim 1 , characterised in that the coupling is of polysulphone.
8 . A method of manufacturing a tracheostomy tube comprising:
moulding a coupling of a relatively hard material to include a retaining formation comprising a ring structure having two discs spaced from one another around a forward, patient end of the coupling;
moulding a shaft of a softer material onto the coupling so that the softer material at the rear, machine end of the shaft flows in and around the two discs of the retaining formation to form a subassembly by mechanical interlocking of the shaft with the coupling, the external surface of the rear end of the subassembly being formed with an abutment surface facing forwardly;
providing a flange having an attachment portion with an opening and an abutment surface around the opening facing rearwardly;
threading the opening on the flange along the shaft from its patient end to its machine end until the abutment surface on the flange abuts the abutment surface on the subassembly; and
bonding the flange to the shaft with the engagement of the abutment surfaces and preventing forward movement of the subassembly relative to the flange.
9 . A tracheostomy tube manufactured by the process of:
moulding a coupling of relatively hard material to include a retaining formation comprising a ring structure having two discs spaced from one another around a forward, patient end of the coupling;
moulding a shaft of a softer material onto the coupling so that the softer material at the rear, machine end of the shaft flows in and around the two discs of the retaining formation to form a subassembly by mechanical interlocking of the shaft with the coupling, the external surface of the rear end of the subassembly being formed with an abutment surface facing forwardly;
providing a flange having an attachment portion with an opening and an abutment surface around the opening facing rearwardly;
threading the opening on the flange along the shaft from its patient end to its machine end until the abutment surface on the flange abuts the abutment surface on the subassembly; and
bonding the flange to the shaft with the engagement of the abutment surfaces and preventing forward movement of the subassembly relative to the flange.