GB2542002A

GB2542002A - Tracheostomy tube assemblies

Info

Publication number: GB2542002A
Application number: GB1614646.6A
Authority: GB
Inventors: Stratton Turnbull Christopher; John Woosnam Christopher
Original assignee: Smiths Medical International Ltd
Current assignee: Smiths Medical International Ltd
Priority date: 2015-09-07
Filing date: 2016-08-26
Publication date: 2017-03-08
Also published as: GB201515803D0; GB201614646D0

Abstract

A tracheostomy tube 10 with a patent end in the trachea T and a machine end portion 13 extending outside of the neck surface 17 has an expandable sealing member 30 around the tube extending along the portion of the tube that extends through neck tissue 31 of the stoma S. The cuff expands and fills space between the outside of the tube 10 and the stoma S without obstructing passage along the trachea T. The expandable sealing member 30 may be an inflatable cuff and may be made of an elastic material such as silicone. Preferably, the cuff lies close to the surface of the tube when deflated. Cuff may be inflated with a syringe connected by connector device 38 via inflation tube 37. Flange 14 lies on the skin surface 17. Female connector 19 can receive speaking valve, HME, or filter.

Description

TRACHEOSTOMY TUBE ASSEMBLIES

This invention relates to tracheostomy tube assemblies.

Tracheostomy tubes are used to enable ventilation, respiration or spontaneous breathing of a patient. The tube is inserted into the trachea via a surgically-formed opening in the neck so that one end locates in the trachea and the other end locates outside the patient adjacent the neck surface. Tracheostomy tubes can be inserted by different techniques, such as the surgical cut down procedure carried out in an operating theatre or a cricothyroidotomy procedure, which may be carried out in emergency situations.

Tracheostomy tubes are generally used for longer-term ventilation or where it is not possible to insert an airway through the mouth or nose. The patient is often conscious while breathing through a tracheostomy tube, which may be open to atmosphere or connected by tubing to some form of ventilator. The tube is secured in position by means of a flange fixed with the machine end of the tube and positioned to extend outwardly on opposite sides of the tube. The anatomy of patients varies considerably according to age and build.

Tracheostomy tubes may be arranged to allow the patient to speak. If the tracheostomy tube has a sealing cuff towards its patient end the patient this could be deflated so that exhaled air can flow around the outside of the tube and up to the vocal folds, thereby enabling the patient to speak. Alternatively, the tube could be formed with fenestrations or openings above the sealing cuff that can be sealed by an inner cannula and that can be opened by removing the inner cannula to enable exhaled air to flow in through the patient end of the tube and along the upper part of the trachea via the fenestrations. Tracheostomy tubes without a sealing cuff also enable the patient to speak.

There can be a very large variation in the shape and dimensions of the anatomy of different patients in the region where the tracheostomy is formed. Although this problem is addressed to a certain extent by having a range of tracheostomy tubes of different sizes, shapes and materials, and by having tubes where the flange can be locked in different positions along the tube there are still a number of patient where conventional tracheostomy tubes do not form a good fit with the anatomy. Use of an ill-fitting tracheostomy tube causes problems because it can be uncomfortable to the patient, it can cause tissue damage and necrosis and it may only form a poor seal with the tracheostomy stoma, allowing air to pass between the outside of the tracheostomy tube and the surrounding, poorly fitting tissue around the stoma. This can dry out the tissue and can also make it difficult for the patient to speak because the leakage through the stoma reduces the pressure that can be built up at the vocal folds. Tubes that fit poorly within the tracheostomy stoma can also allow tracheal secretions to leak out.

It is an object of the present invention to provide an alternative tracheostomy tube assembly.

According to one aspect of the present invention there is provided a tracheostomy tube assembly comprising a tracheostomy tube adapted to extend through a tracheostomy stoma and having a patient end adapted to locate within the trachea and a machine end adapted to locate externally of the neck surface, the assembly including an expansible sealing member on the tube where this extends through the stoma, the sealing member being arranged to be expanded away from the tube around at least a part of the tube within the stoma so as to fill at least some of any space between the stoma and the outside of the tube where it extends through the stoma without obstructing passage along the trachea.

The sealing member is preferably an inflatable cuff. The cuff may be of an elastic material so that it lies close to the surface of the tube when deflated but can be inflated to fill any gaps with neck tissue around the tube. The cuff is preferably of a silicone material. A tracheostomy tube assembly according to the present invention will now be described, by way of example, with reference to the accompanying drawings, in which:

Figure 1 is a side elevation view of the assembly with the cuff deflated;

Figure 2 is a perspective view of the assembly with the cuff inflated; and

Figure 3 is a side elevation view of the assembly in place in a patient with the cuff inflated.

The tracheostomy assembly comprises a main body 1 moulded from a bendable plastics material, such as silicone, with a wall thickness sufficient to maintain its shape when inserted in the patient. The body 1 includes a tube or shaft 10 of circular section that is straight along a major part 11 of its length towards the patient end 12 of the assembly. The shaft 10 includes an optional radio-opaque line 2 extending along its length. The patient end 12 of the assembly is arranged, during use, to lie within the trachea T of the patient. The opposite, machine end portion 13 of the tube 10 is curved so that the machine end portion and patient end portion 11 lie at an angle of about 120°. The body 1 also includes a neck flange 14 at the machine end of the tube 10, the flange being circular and projecting radially around the tube with two laterally extending short lugs 15 and 16 located on opposite sides. The two lugs 15 and 16 each have slots (not visible) extending through them which can receive ends of a neck strap (not shown) used to secure the assembly in position about the patient’s neck. The flange 14 is adapted so that, in use, its forward facing surface 17 lies on the skin surface of the patient’s neck or is closely spaced from it to allow for a dressing to be placed under the flange. At its rear, machine end 18 the body 1 is formed with an enlarged, circular 22mm female connector 19 with an open machine end 20. The interior of the connector 19 opens into the bore extending along the tube 10. The connector 19 is adapted to receive within it a conventional speaking valve, HME, filter or the like inserted within it.

The assembly also includes an inflatable cuff 30 mounted on the outer surface of the tube 10 along the curved machine end portion 13 of the tube where this extends, during use, through the stoma S, that is, through the thickness of neck tissue 31. The cuff 30 takes the form of a sleeve of silicone material the opposite ends of which form collars 32 and 33 attached to the outside of the shaft 10. The diameter of the cuff 30 in its natural, uninflated state is equal to the external diameter of the tube 10 so that it lies as a close, tight fit against the surface of the tube. The length of the cuff 30 and its position on the tube is selected so that the cuff is attached to that length of the tube 10 that, in use, extends through the stoma S. The length and position of the cuff 30 on the tube 10 ensures that, when inflated, it does not occlude or constrict the trachea T on the upper airway side of the tube. Although the cuff 30 is preferably of an elastic material it could be of a non-elastic material with a natural high volume that is inflated by a relatively low pressure. The cuff could be made of different materials such as PVC or polyurethane or of multiple layers of different materials.

An inflation lumen 35 extending along the machine end of the tube 10 opens on the external surface of the tube via an opening 36 located between the two collars 32 and 33, within the cuff 30. The opposite end of the inflation lumen 35 connects with a small bore inflation tube 37, which is terminated at its machine end by a combined inflation indicator, valve and connector 38. In this way, the cuff 30 can be inflated by connecting a syringe (not shown) or similar device to the connector 38 and supplying fluid along the inflation tube 37, inflation lumen 35 and through the opening 36 into the potential space between the outside of the tube 10 and the inside of the cuff. Where the cuff 30 is of silicone it is preferable to inflate the cuff with a liquid, such as saline rather than air because silicone is relatively permeable to air. If, however, the user only needs the cuff to be inflated temporarily, air could be used for inflation.

The tube 10 illustrated is shown as not having a sealing cuff at its patient end 12 for forming a seal with the inside of the trachea T. It would, however, be possible for the tube to have such a sealing cuff. This would then need to be deflated to enable the patient to talk. Alternatively, the tube could have fenestrations above the tracheal sealing cuff that are normally covered by an inner cannula, which is removed to uncover the fenestrations when the patient wishes to talk.

In use, the assembly is inserted through the tracheostomy stoma S in the usual way, which may involve using ait introducer or obturator inserted along the tube 10 in order to stiffen and straighten it slightly during insertion. During insertion, the cuff 30 is in its natural, deflated state where it closely embraces the tube 10. Once the assembly has been correctly inserted, with the flange 14 located against or closely adjacent the skin of the neck, a syringe or the like is connected to the connector 38 and its plunger is depressed slowly to supply saline to the cuff 30. This causes the cuff 30 to expand around the tube 10, expanding preferentially where there is a greater gap between the outside of the tube and the surrounding neck tissue 31 of the stoma S. In this way, the cuff 30 fills any irregular shape gaps around the tube 10 without exerting excessive pressure on tissue in regions with a smaller gap. This effectively seals the outside of the tube 10 with the neck tissue 31, thereby blocking fluid passage between the outside of the tube and the neck tissue through the stoma S. The assembly, therefore, helps reduce or prevent exhaled air leaking through the stoma around the outside of the tube 10 when the machine end of the assembly is blocked such as by a speaking valve. This makes it easier for the patient to talk since it is easier to generate sufficient exhalation pressure and flow out of the trachea past the tube 10 to the vocal folds to talk. The assembly also helps reduce or prevent tracheal secretions leaking out along the outside of the tube T.

Claims

1. A tracheostomy tube assembly comprising a tracheostomy tube (10) adapted to extend through a tracheostomy stoma (S) and having a patient end (12) adapted to locate within the trachea (T) and a machine end (18) adapted to locate externally of the neck surface, wherein the assembly includes an expansible sealing member (30) on the tube (10) where this extends through the tissue of the stoma (S), and wherein the sealing member (30) is arranged to be expanded away from the tube (10) around at least a part of the tube within the stoma (S) so as to fill at least some of any space between the stoma and the outside of the tube where it extends through the stoma without obstructing passage along the trachea (T).

2. A tracheostomy tube assembly according to Claim 1, wherein the sealing member is an inflatable cuff (30).

3. A tracheostomy tube assembly according to Claim 2, wherein the cuff (30) is of an elastic material that lies close to the surface of the tube (10) when deflated but can be inflated to fill gaps with stoma tissue around the tube.

4. A tracheostomy tube assembly according to Claim 3, wherein the cuff (30) is of a silicone material.

5. A tracheostomy tube assembly substantially as hereinbefore described with reference to the accompanying drawings.

6. Any novel and inventive feature or combination of features as hereinbefore described.