GB2164565A - Endotracheal tube assembly having inflatable cuff - Google Patents

Abstract

An endotracheal tube 1 has a cuff 4 at its patient end that is inflatable via an inflation line 11. The inflation line 11 includes a connector 14 of a compliant plastics material at its machine end. An adaptor 3 is fitted in the machine end of the tube and has a flange 33 that go extends radially on opposite sides. Two notches 34 are formed in each side of the flange 33, the notches being of circular shape and having a restricted opening 35 so that any one of the notches can receive and retain the connector 14 as a push fit. In this way, the machine end of the inflation line 11 is retained with the tube to prevent it being trapped at the edge 51 of packaging 50 and to prevent it coming into contact with the cuff 4. In use, the assembly is retained at the patient's mouth by a tape secured to the notches 34 in the adaptor flange 33. <IMAGE>

Description

SPECIFICATION Tracheal tube assemblies and packs This invention relates to tracheal tube assemblies and packs including such assemblies.

The invention is more particularly concerned with tracheal tube assemblies of the kind having an inflatable cuff around the patient end of the assembly, which is inflated to seal the tube with the trachea.

Such tracheal tube assemblies generally have a small-bore passage extending within the wall of the main tube which opens at the patient end into the cuff. The passage is connected, at some point between the ends of the main tube with an inflation line, in the form of a small-bore flexible tube. The inflation line may have an inflation indicator which is located outside the trachea and is responsive to pressure within the cuff. The inflation line is usually termined with a connector by which a syringe can be connected to the inflation line for the purpose of inflating the cuff with air.

Tracheal tube assemblies are commonly packaged in a plastics tray or envelope that is heatsealed around its edge. Packaging of the assemblies is made more difficult by the inflation line, since care has to be taken that it is not inadvertently trapped at the edge during the heat-sealing process, and that the connector does not come in contact with the cuff, causing possible damage to the cuff during long-term storage.

It is an object of the present invention to provide a tracheal tube assembly and a pack by which this packing difficulty is mitigated.

According to one aspect of the present invention there is provided a tracheal tube assembly including a tracheal tube having an inflatable cuff towards the patient end of the tube adapted for sealing with the patient's trachea, and a flexible inflation line, the patient end of which communicates with the interior of the cuff, the assembly including retaining means that is arranged to retain the machine end of the inflation line with the tube during packaging of the assembly.

The retaining means may include a notch that is arranged to receive the machine end of the inflation line as a push fit. The retaining means is preferably provided by an adaptor mounted at the machine end of the tube. The adaptor may have a radiallyextending flange, and the flange may project on opposite sides of the adaptor. The flange prefembly has two notches on each side of the flange, each notch being adapted to receive the machine end of the inflation line as a push fit, and the notches being arranged to provide a key to receive a tape by which the assembly can be secured to the patient. The or each notch may be of substantially circular shape and have an opening of restricted width.The inflation line may include an inflation tube and connector means of a compliant material at the machine end of the inflation tube, the retaining means being adapted to engage the connector means of the inflation line.

According to another aspect of the present invention there is provided a pack including packaging and a tracheal tube assembly according to the above, one aspect of the present invention.

The packaging may comprise two sheets on opposite sides of the assembly, the two sheets being sealed together about their edge.

According to a further aspect of the present invention there is provided a pack including a tracheal tube assembly and packaging containing the tracheal tube assembly, the tracheal tube assembly including a tracheal tube having an inflatable cuff towards the patient end of the tube adapted for sealing with the patient's trachea, and a flexible inflation line, the patient end of which communicates with the interior of the cuff, the assembly including retaining means that is arranged to retain the machine end of the inflation line with the tube in the packaging.

The assembly may include an adaptor mounted at the machine end of the tube, the adaptor having a radially extending flange having a notch therein, the inflation line including an inflation tube and a connector of a compliant material at the machine end of the tube, and the connector being a push fit in the notch.

A cuffed endotracheal tube assembly and a pack including such an assembly, in accordance with the present invention, will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is a plan view of the pack showing the assembly in its packaging; Figure 2 is a plan view of a part of the assembly to a larger scale; and Figure 3 is a cross-sectional view along the line Ill-Ill of Figure 2.

The pack comprises outer packaging 50 and the assembly 60 which in turn comprises a standard endotracheal tube 1 and an adaptor 3 in the machine end of the tube.

A soft, inflatable cuff 4 encircles the tube 1 close to its open, bevelled patient end 2. The cuff 4 is in communication with a small passageway (not shown) which extends rearwardly within the wall of the tube 1 and which in turn communicates with the patient end 10 of an inflation line 11. The inflation line 11 is about 220mm long and includes a flexible plastics tube 12 of about 1.5mm external diameter.

The machine end 13 of the tube 12 is joined to a connector 14 of a soft, compliant plastics material.

The connector 14 is of a conventional kind, being a generally cylindrical body with an open machine and adapted to receive the tip of a syringe (not shown); inflation of the cuff 4 is achieved by using the syringe to pump air along the inflation line 11 to the cuff. The connector 14 preferably has an integral stopper 15 connected to the main body of the connector by a flexible web 16. After inflation, the cuff 4 is sealed by means of the stopper 15.

Alternatively, the connector 14 may include a oneway valve. At the patient end of the connector 14 an inflation indicator 17 encircles the tube 12, opening to the interior of the connector. The inflation indicator 17 is in the form of a flexible envelope or balloon that is inflated by pressure in the inflation line 11, thereby indicating whether or not the cuff 4 is inflated.

The inflation line 11 is retained close to the endotracheal tube 1, whilst in its packaging 50, by retaining means at the machine end of the assembly. The retaining means is provided by the adaptor 3. The adaptor 3 has a tapered male patient end 31 that seals within the machine end of the tube 1 and that opens into a larger female tapered cylindrical section 32 that is adapted to mate with tubing (not shown) from a ventilating machine.

Midway along the adaptor 3 there is a radiallyextending flange 33 of a generally oval shape which projects from the adaptor on opposite sides. Each side of the flange 33 has two cut-away notches 34.

The notches 34 are, in shape, the major part of a circle, such that the opening 35 to the notches, at the edge of the flange, is of restricted width which opens to a larger width inwardly of the flange.

The notches 34 serve a dual purpose. One purpose is to provide a key to which a tape (not shown) may be secured for use in holding the machine end of the assembly in the correct position relative to the patient's mouth, the tape being tied around the patient's head. The other purpose is to retain the connector 14. The size of the notches 34 is selected such that the connector 14 can be pushed into one or other of the notches and retained in position. The compliant nature of the connector, and the restricted opening 35 to the notches ensure a positive location and secure retention.

In this way, the machine end of the inflation line 11 can be retained close to the machine end of the tube 1 during packing. The packaging 50 may comprise a sheet of gas-permeable paper and a sheet of flexible plastics between which the endotracheal tube assembly lies, the two sheets being sealed together around the edge 51. It will be appreciated that, by retaining the inflation line close to the tube, during packing, there is less risk that the inflation line will become inadvertently trapped between the two sheets at the edge. Also, there is no risk that the connector 14 will come into contact with the cuff 4. Because of this, packing is facilitated and timetaken to pack the assembly can be reduced.

Also, handling of the pack is eased since no special precautions have to be taken to prevent the inflation line connector interfering with the cuff. The connector 14 is easily pulled out of the notch 34 when it is removed from the packaging 50, so that the cuff 4 can be inflated, in the usual way, with the connector in the most convenient position.

It will be appreciated that the invention may be used with other cuffed tracheal tubes, such as, tracheostomy tubes. The invention can also be used with different forms of packaging and, in this respect, could be used with packaging in which the assembly is contained in a semi-rigid tray of plastics that is closed with a gas-permeable paper sheet heat-sealed to the edge of the tray. Other forms of retaining means could be used to hold the inflation line close to the main tube during packaging.

Claims (15)

1. A tracheal tube assembly including a tracheal tube having an inflatable cuff towards the patient end of the tube adapted for sealing with the patient's trachea, and a flexible inflation line, the patient end of which communicates with the interior of the cuff, wherein the assembly includes retaining means that is arranged to retain the machine end of the inflation line with the tube during packaging of the assembly.

2. Atracheal tube assembly according to Claim 1, wherein the retaining means includes a notch that is arranged to receive the machine end of the inflation line as a push fit.

3. Atracheal tube assembly according to Claim 1 or 2, wherein the retaining means is provided byan adaptor mounted at the machine end of the tube.

4. Atracheal tube assembly according to Claim 3, wherein the adaptor has a radially-extending flange.

5. Atracheal tube assembly according to Claim 4, wherein the flange projects on opposite sides of the adaptor.

6. A tracheal tube assembly according to Claim 5, wherein the flange has two notches on each side of the flange, wherein each notch is adapted to receive the machine end of the inflation line as a push fit, and wherein the notches are arranged to provide a key to receive a tape by which the assembly can be secured to the patient

7. Atracheal tube assembly according to any one of the preceding claims, wherein the or each notch is of substantially circular shape and has an opening of restricted width.

8. Atracheal tube assembly according to any one of the preceding claims, wherein the inflation line includes an inflation tube and connector means of a compliant material at the machine end of the inflation tube, and wherein the retaining means is adapted to engage the connector means of the inflation line.

9. A tracheal tube assembly substantially as hereinbefore described with reference to the accompanying drawing.

10. A pack including packaging and a tracheal tube assembly according to any one of the preceding claims.

11. A pack according to Claim 10, wherein the packaging comprises two sheets on opposite sides of the assembly, and wherein the two sheets are sealed together about their edge.

12. A pack including a tracheal tube assembly and packaging containing the tracheal tube assembly, the tracheal tube assembly including a tracheal tube having an inflatable cuff towards the patient end of the tube adapted for sealing with the patient's trachea, and a flexible inflation line, the patient end of which communicates with the interior of the cuff, wherein the assembly includes retaining means that is arranged to retain the machine end of the inflation line with the tube in the packaging.

13. A pack according to Claim 12, wherein the assembly includes an adaptor mounted at the machine end of the tube, wherein the adaptor has a radially extending flange having a notch therein, wherein the inflation line includes an inflation tube and a connector of a compliant material at the machine end of the tube, and wherein the connector is a push fit in the notch.

14. A pack substantially as hereinbefore described with reference to the accompanying drawing.

15. Any novel feature or combination of features as hereinbefore described.