WO2019145669A1

WO2019145669A1 - Medico-surgical tube assemblies and mounts

Info

Publication number: WO2019145669A1
Application number: PCT/GB2019/000004
Authority: WO
Inventors: Timothy Bateman; Andrew Thomas Jeffrey; Christopher John WOOSNAM
Original assignee: Smiths Medical International Limited
Priority date: 2018-01-24
Filing date: 2019-01-07
Publication date: 2019-08-01
Also published as: GB201801136D0

Abstract

An adjustable flange (2) for a tracheostomy tube (1) includes a clamp (25) with two hinged arms (26) and (27) and a clamping lever (50) with a threaded stem (51) and a handle (55). The threaded stem (51) extends between the two arms (26) and (27) so that they can be brought together to clamp about the tube by rotating the handle (55). The mount (2) also includes a locking slider (70) movable along its length from an unlocked position to a locked position where it extends across the free end of the handle (55) of the clamping lever (50) when this is in its clamped position, thereby preventing the lever being released. The locking slider (70) and the body (125) of the clamp include engaging teeth (130) and (131) that allow the slider to be moved to the locking position but prevent movement in the opposite direction.

Description

MEDICO-SURGICAL TUBE ASSEMBLIES AND MOUNTS

This invention relates to medico-surgical tube assemblies of the kind including a tube and a mount that can be moved along a part at least of the length of the tube and fixed in position, the mount including a body that can be clamped with the tube, and a first, manually-displaceable clamping member mounted with the body and movable between a first position in which the mount is free to move along the part at least of the tube and a second position in which the mount is clamped against movement along the tube.

Medico-surgical tubes, such as tracheostomy tubes, are commonly provided with a flange or other mount to secure the tube to the patient’s body. In the case of a tracheostomy tube, the flange is positioned close to the surface of the neck where the tube enters the tracheostomy, a tape is threaded through openings in the flange and fastened around the neck. For most patients, a comfortable fit can be achieved using one of a range of several different size tubes, each having a flange mounted at a fixed location along the tube suitable for patients having an average anatomy. There are, however, some situations where a fixed flange is not suitable, such as, for example, in obese patients where tissue between the neck surface and the trachea is very thick. In these situations, it is preferable for the flange to be movable along the tube to the ideal position and to be lockable in that position. The position of the flange may need to be adjusted during use if swelling of tissue around the tracheostomy should increase or decrease. Tubes with adjustable flanges are described in, for example, US5026352, US4249529, US4449527, US4498903, US4530354, US4530354, US4649913, US4683882, US4774944, W080/02645, WO84/03217, US4278081, US8104476, W016/116721, W016/174378 and W006/087513. Tubes with adjustable flanges, however, are not usually recommended for use outside hospitals and clinical establishments because of the risk that the flange may inadvertently be unlocked. This could make it possible for the tube to move relative to the flange into or out of the trachea. This could result in a compromised airway and respiratory distress. It is an object of the present invention to provide an alternative medico- surgical tube assembly and a mount for such a tube assembly.

According to one aspect of the present invention there is provided a medico- surgical tube assembly of the above-specified kind, characterised in that the mount includes a second, locking member movable between a first position in which movement of the first member between the first and second positions is substantially unimpeded and a second position in which movement of the first member from the second position to the first position is prevented, and that the locking member is movable from its first to its second position but is not movable from its second position to its first position without damaging the mount, such that, once the clamping member has been moved to its second position and the locking member has been moved to its second position the first member cannot subsequently be moved back to its first position.

The clamping member may be a lever arranged to clamp two parts of the body together against opposite sides of the tube when the clamping member is in the second position. The locking member may be a slider a part of which extends into the path of movement of a part of the clamping member. The locking member and or

alternatively the body may have cooperating teeth that allow movement of the locking member from its first position to its second position but prevent movement from the second to the first position. The tube may be a tracheostomy tube.

According to another aspect of the present invention there is provided a mount including a body that can be clamped with a medico-surgical tube, a first, manually- displaceable clamping member mounted with the body and movable between a first position in which the mount is free to move along a part at least of the tube and a second position in which the mount is clamped against movement along the tube, characterised in that the mount includes a second, locking member movable between a first position in which movement of the first member between the first and second positions is substantially unimpeded and a second position in which movement of the first member from the second position to the first position is prevented, and that the locking member is movable from its first to its second position but is not movable from its second position to its first position without damaging the mount, such that, once the clamping member has been moved to its second position and the locking member has been moved to its second position the clamping member cannot subsequently be moved back to its first position.

According to a further aspect of the present invention there is provided a medico-surgical tube assembly including a tube and a mount that can be moved along a part at least of the length of the tube and fixed in position, the mount including a body that can be clamped with the tube, a first, manually-displaceable clamping member mounted with the body and movable from a first position in which the mount is free to move along the part at least of the tube to a second position in which the mount is clamped against movement along the tube, characterised in that the mount includes a locking arrangement operable to prevent movement of the clamping member from the second position to the first position without damaging the mount.

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 perspective view of the assembly, showing the tube in phantom;

Figure 2 is a side elevation view of the locking assembly showing the locked and unlocked positions of the lever,

Figure 3 is a perspective view of the clamping lever; Figure 4 is a simplified perspective view of a part of the assembly in an unlocked state;

Figure 5 is a simplified perspective view of a part of the assembly in a locked state;

Figure 6 is a partly-sectional plan view of a part of the assembly in an unlocked state; and

Figure 7 is a partly-sectional plan view of a part of the assembly in a locked state.

The tube assembly comprises a tube 1 (shown in phantom) and a mount or flange 2 with a body or clamp 25. The flange 2 can be moved along the tube 1 and can be fixed or clamped at different locations along its length.

The tube 1 is made of a conventional, bendable plastics material, such as PVC, polyurethane or silicone, is hollow with a circular section and has a smooth inner surface. Alternatively, the tube could be of a metal such as stainless steel or silver.

The shaft of the tube 1 could be reinforced with a helical wire or similar member. An inflation lumen 10 extends along the length of the tube 1 in a small rib on its outside surface. At one end, the lumen 10 connects with the interior of a sealing cuff 11. Towards its other, rear end, die inflation lumen 10 connects with one end of an inflation line 13 the other end of which is connected with a pilot balloon and connector 14. The tube 1 has a machine end 15 adapted to be located outside the body and may be connected to patient breathing apparatus or left open to air. The shaft of the tube 1 comprises a straight machine end region 16, a curved intermediate region 17 and a straight patient end region 18 extending at substantially right angles to the patient end region. Alternative shape shafts are possible, such as shafts that are curved continuously along their length or shafts that have a natural straight shape but are highly flexible so that they can conform readily to the shape of the anatomy. The flange 2 has a rectangular central plate 20 with a central circular aperture the diameter of which is such that the tube 1 is a close sliding fit within it. Two wings

22 and 23 extend from the central plate 20 on opposite sides. The two wings 22 and

23 are generally rectangular, being curved slightly along their length and are each formed with a lateral slot 24 towards their free end by which a tape, strap or the like can be secured to the wing. The two wings 22 and 23 are attached with the central plate 20 by respective flexure sections or webs 42 and 43 formed integrally with the plate and the wings. The webs 42 and 43 have a reduced width compared with the plate 20 and wings 22 and 23 to allow them to flex when the wings are pulled forwardly. This allows the wings to hinge when they are pulled forwardly after positioning, for access, observation or cleaning of the region under the flange. The reduced width of the webs 42 and 43 also allows some rotational movement between the wings and the central plate, and hence the tube. This helps reduce the torque applied to the patient. The flange is also arranged such that the rear, patient side of the wings 22 and 23 is set forwardly relative to the rear side of the central plate 20 by 1- 2mm so as to reduce pressure on the stoma site. The wings 22 and 23 are designed to be relative large in area so as to help reduce pressure on any one part of the neck anatomy, which may help reduce pressure sores. The large size of the wings reduces the risk of the flange becoming lost in the skin folds present in a larger neck mass.

The clamp 25 is mounted centrally on the rear or machine face of the central plate 20. The clamp 25 has an integral moulded plastics body 125 comprising arms 26 and 27 linked together towards the lower edge. The left-hand arm 26 has a C shape with a central semicircular recess 127 aligned with a circular aperture in die plate 20. The arm 26 also has a threaded aperture (not shown) in its upper mating end face. The other, right-hand arm 27 is similarly formed with a semicircular recess 36. The free end 38 of the right-hand arm 27 has a mating face and a circular aperture aligned with the aperture in the other arm 26. When the free arm 27 of the clamp 25 is folded up, as shown in Figure 1 , it has a generally rectangular shape extending in a plane at right angles to the axis of the tube 1. The clamp 25 is completed by a clamping member in the form of a lever 50, as shown in Figure 3, of a rigid plastics material such as nylon. The lever 50 has a stem 51 of circular section and formed with a partial screw thread 52 towards its free end 53. The inner end 54 of the stem 51 is smooth. The stem 51 is attached and moulded integrally with one end of a handle 55, which extends at right angles to the stem. The shape of the handle 55 is chosen to match that of the clamp arms 26 and 27. The inner edge 56 of the handle 55 follows closely the outer edge of the right-hand arm 27. The outer edge 57 of the handle matches the outer edge 58 of the left-hand clamp arm 26. The front surface 60 of the handle 55 aligns with the front surface of the clamp arm 27 but its rear surface 61 tapers to a reduced thickness away from the stem so as to leave a gap for finger access between the handle and the central plate 20 when locked. The stem 51 of the lever 50 projects through the aperture in the right-hand arm 27, with the threaded portion 52 of the stem engaged as a screw-fit in the threaded aperture in the left-hand arm 26.

The clamping lever 50 is displaceable about the axis of the stem 51 between a free position and a clamped position. In the free position the handle 55 of the lever 50 projects rearwardly at an angle of between 90° and 180° to the plane of the clamp 25, as shown by the broken outline in Figure 2 where it extends at 90°, that is, parallel to the tube 1. In this position, the free end 38 of the right-hand arm 27 is held slightly separate from the left-hand arm 26 so that the clamp 25 does not exert any significant gripping force on the tube 1, and the flange 2 is free to slide along the length of the tube. In the clamped position, the handle 55 extends downwardly parallel with the plane of the clamp 25 and the thread 52 on the stem 51 acts to pull the upper ends of the two arms 26 and 27 tightly towards one another, so that they securely grip the outside of the tube 1. It can be seen, with the handle 55 folded down to the clamped position, that the shape of the handle forms a continuation of the shape of the clamp arms 26 and 27. It is, therefore, readily apparent to the user that the clamp 25 is unlocked if the handle 55 is angled up out of the plane of the clamp.

As so far described the locking assembly is similar to that described in W02008/003929 and as used in a product sold by Smiths Medical under the trade mark UniPerc® (UniPerc® is a registered trade mark of Smiths Medical). The assembly of the present invention differs from conventional adjustable flanges by the provision of a locking arrangement operable to prevent movement of the clamping lever 50 from the clamped position back to the free position once the locking arrangement has been moved to a locked position. The locking arrangement is arranged such that, once it has been moved to the locked position it cannot be moved back to an unlocked position without damaging it. In this way, once the locking arrangement has been engaged with the clamping lever in the clamped position it prevents the lever being moved to the unclamped position. More particularly, the locking arrangement of the present invention includes a locking member in the form of a slider 70 with a channel or U-shape section mounted on lower edge of the body 125, that is, the edge in alignment with the free end of the clamping lever 50. The slider 70 is mounted such that it can be slid along its length from a left-hand, unlocked position shown in Figures 4 and 6 to a right-hand, locking position shown in Figures 5 and 7. In this locking position the right-hand end of the slider 70 projects over the free end of the clamping lever 50 so that a part of the slider is located in the path of travel of the end of the lever to prevent it being moved out of the clamped position. The locking arrangement also includes means to prevent the slider 70 being moved back from its locking position to its unlocked position without damaging the locking arrangement. This can be provided in several different ways but preferably includes ratchet teeth 130 on the front face of the body 125 and a tooth or catch 131 on the slider 70 that can slide over the teeth in one way but cannot move in the opposite direction. It will be appreciated that the teeth could instead be on the slider and the catch on the body.

In use, the slider 70 is initially in the unlocked position and the handle 55 of the lever 50 is rotated to the unlocked position so that the flange 2 can be slid freely along the tube 1. The user positions the flange 2 at the desired position along the tube 1, such as against graduation marks. He then rotates the handle 55 of the locking lever 50 down so that it lies parallel with the clamping arms 26 and 27 and so that the flange 2 is clamped firmly in position. The flange 2 can then be secured with the neck of the patient by means of a tape or the like in the usual way. Where the patient is in hospital the locking arrangement 25 of tube assembly would normally be left with the slider 70 in the unlocked position so that the clinician can reposition the flange 2 along the tube when necessary simply by releasing the lever 50 to enable the flange 2 to be slid along the tube. It is often necessary to adjust the position of the flange as swelling of tissue around the tracheostomy increases or reduces. If, however, the patient is discharged from hospital to home or to a non-intensive care residence with the tracheostomy tube 1 in place the locking slider 70 would be simply slid to the right-hand locking position so that the clamping lever 50 cannot be released. This gives the patient and clinician all the advantages of a tube with an adjustable flange but avoids any risk that the flange could become inadvertently unlocked when outside an intensive care environment where there is not close monitoring.

The assembly could include alternative locking means apart from sliders, such as a rotatable member or a separate member that can be engaged with the clamping member to prevent movement and that cannot be subsequently removed.

The invention is not confined to tracheostomy tubes but could be used with other medico-surgical tubes having a flange for supporting the tube where it emerges from the body.

Claims

1. A medico-surgical tube assembly including a tube (1) and a mount (2) that can be moved along a part at least of the length of the tube and fixed in position, the mount (2) including a body (125) that can be clamped with the tube, and a first, manually-displaceable clamping member (50) mounted with the body (125) and movable between a first position in which the mount (2) is free to move along the part at least of the tube (1) and a second position in which the mount is clamped against movement along the tube, characterised in that the mount (2) includes a second, locking member (70) movable between a first position in which movement of the first member (50) between the first and second positions is substantially unimpeded and a second position in which movement of the first member (50) from the second position to the first position is prevented, and that the locking member (70) is movable from its first to its second position but is not movable from its second position to its first position without damaging the mount (2), such that, once the clamping member (50) has been moved to its second position and the locking member (70) has been moved to its second position the first member (50) cannot subsequently be moved back to its first position.

2. An assembly according to Claim 1 , characterised in that the clamping member is a lever (50) arranged to clamp two parts (26 and 27) of the body (125) together against opposite sides of the tube (1) when the clamping member (50) is in die second position.

3. An assembly according to Claim 1 or 2, characterised in that the locking

member is a slider (70) a part of which extends into the path of movement of a part of the clamping member (50).

4. An assembly according to any one of the preceding claims, characterised in that the locking member (70) and or alternatively the body (125) has cooperating teeth (130 and 131) that allow movement of the locking member (70) from its first position to its second position but prevent movement from the second to the first position.

5. An assembly according to any one of the preceding claims, characterised in that the tube is a tracheostomy tube (1).

6. A mount (2) including a body (125) that can be clamped with a medico- surgical tube (1), a first, manually-displaceable clamping member (50) mounted with the body (125) and movable between a first position in which the mount (2) is free to move along a part at least of the tube and a second position in which the mount (2) is clamped against movement along the tube, characterised in that the mount (2) includes a second, locking member (70) movable between a first position in which movement of the first member (50) between the first and second positions is substantially unimpeded and a second position in which movement of the first member (50) from the second position to the first position is prevented, and that the locking member (70) is movable from its first to its second position but is not movable from its second position to its first position without damaging the mount (2), such that, once the clamping member (50) has been moved to its second position and the locking member (70) has been moved to its second position the clamping member (50) cannot subsequently be moved back to its first position.

7. A medico-surgical tube assembly including a tube (1) and a mount (2) that can be moved along a part at least of the length of the tube and fixed in position, the mount (2) including a body (125) that can be clamped with the tube, a first, manually-displaceable clamping member (50) mounted with the body (125) and movable from a first position in which the mount (2) is free to move along the part at least of the tube to a second position in which file mount (2) is clamped against movement along the tube, characterised in that the mount (2) includes a locking arrangement (70) operable to prevent movement of the clamping member (50) from the second position to the first position without damaging the mount (2).