Tracheostomy tubes and their manufacture
The neck flange 3 of a tracheostomy tube is of a soft plastics such as silicone and has neck tie or suture openings 35 at opposite ends reinforced to prevent damage to the flange. The openings are reinforced by tubular inserts 38 of a harder plastics. The patient end of each insert has an enlarged, radially extending head 41 sitting flush in an enlarged recess 43 around the patient end of each opening. The opposite end of each insert also has an enlarged head 42 overlapping the flange but formed after the insert has been inserted in the flange. The opposite end head 42 may be heat formed from the end of the insert or may be a separate component clipped onto the end of the insert.
1 . A tracheostomy tube comprising:
a shaft with a patient end adapted to locate in a trachea and an elongate flange of a first plastics material with two opposite ends at a machine end of the shaft for securing the tube with a neck of a patient, the flange extending outwardly of the shaft and having respective openings towards each of the opposite ends, wherein each of the openings has a radially-enlarged recess around it on each of a patient-facing side of the flange adapted to face the patient and an opposite machine-facing side of the flange adapted to face away from the patient;
respective hollow inserts of a second plastics material harder than the first plastics material of the flange, the respective inserts each having a tubular body forming a passage extending axially along the tubular body between a patient end and a machine end;
wherein each insert is received in a corresponding one of the respective openings of the flange;
wherein each insert has a disc-shaped head on the patient end having a thickness equal to a depth of the corresponding radially-enlarged recess on the patient-facing side of the flange and adapted to closely fit with the corresponding radially-enlarged recess on the patient-facing side of the flange so as to form a smooth patient-facing surface of the flange,
wherein the machine end of each insert is retained with the flange by an upper radially-enlarged domed head heat-formed to overlap the flange around the corresponding opening on the machine-facing side of the flange, wherein the domed head extends beyond the radially-enlarged recess on the machine-facing side of the flange so as to form a non-smooth machine-facing surface of the flange, and
wherein the passage of each insert is configured to allow a neck tie or suture to extend therethrough to secure the tracheostomy tube with the neck of the patient.
2 . The tracheostomy tube according to claim 1 , wherein the hollow inserts are of circular cross section.
3 . The tracheostomy tube according to claim 1 , wherein the first plastics material of the flange is silicone.
4 . A method of reinforcing neck tie or suture openings in a flange of a tracheostomy tube wherein the openings each have a radially-enlarged recess on each of a patient side of the flange and an opposite machine side of the flange, wherein for each of the openings the method comprises:
providing an insert having a patient end and a machine end and a tubular body forming a passage extending axially between the patient end and the machine end, one radially-enlarged head at the patient end of the insert,
inserting the insert into the opening from the patient side of the flange so that the one radially-enlarged head of the insert closely fits in the radially-enlarged recess on the patient side of the flange and a patient end surface of the one radially-enlarged head lies flush with a patient end surface of the flange, and
subsequently heat forming a radially-enlarged domed head at the machine end of the insert to overlie a first machine end surface of the flange around the opening and thereby retain the insert securely with the flange, wherein the domed head extends beyond the radially-enlarged recess on the machine side of the flange such that it does not lie flush with a second machine end surface of the flange,
wherein the passage of the insert is configured to allow a neck tie or suture to extend therethrough to secure the tracheostomy tube with a neck of a patient.
5 . A tracheostomy tube having a flange with neck tie or suture openings, wherein each of the openings is reinforced by a method comprising:
providing an insert for the opening having a patient end and a machine end and a tubular body forming a passage extending axially along the tubular body between the machine end and the patient end, one radially-enlarged head at the patient end of the insert,
inserting the insert into the opening from a patient side of the flange so that the one radially-enlarged head of the insert closely fits in a radially-enlarged recess on a patient side of the flange and a patient end surface of the radially-enlarged head of the insert lies flush with a patient end surface of the flange, and
subsequently heat forming a radially-enlarged domed head at the machine end of the insert to overlie a first machine end surface of the flange around the opening within a radially-enlarged recess on an opposite machine side of the flange and thereby retain the insert securely with the flange, wherein the domed head extends beyond the radially-enlarged recess on the machine side of the flange such that it does not lie flush with a second machine end surface of the flange,
wherein the passage of the insert is configured to allow a neck tie or suture to extend therethrough to secure the tracheostomy tube with a neck of a patient.