TRACHEOSTOMY TUBE ASSEMBLIES AND PROTECTORS

Abstract

A paediatric tracheostomy tube (1) has a protector (50) covering the cuff inflation indicator (37) to prevent damage to the inflation indicator caused by the patient chewing or biting it. The protector is in two parts: a base (52) extending around the open machine end (40) of the indicator and through which the inflation valve can be accessed, and a transparent sleeve (60) extending around the inflation balloon (38) and through which the balloon is visible. The sleeve has a small opening (65) at its patient end opening to a longitudinal slot (66) along one side so that the sleeve can be assembled on the inflation line (31) by threading the inflation line sideway through the slot.

Claims

1-14. (canceled)

15. A tracheostomy tube assembly including a tracheostomy tube having a shaft with an inflatable sealing cuff towards its patient end and an inflation line communicating with the sealing cuff and having an inflation indicator towards its machine end, characterised in that the assembly also includes a protective enclosure extending around and enclosing the inflation indicator to protect it from damage by chewing, and that the protective enclosure is transparent, at least in part, to enable the inflation indicator to be viewed through the enclosure.

16. The tracheostomy tube assembly according to claim 15, characterised in that the protective enclosure has a first part arranged to receive a machine end of the inflation indicator and a second part having a transparent sleeve adapted to extend around the inflation indicator and fit with the first part

17. The tracheostomy tube assembly according to claim 16, characterised in that the second part is open at its machine end that fits with the first part, and that the second part has an opening at its patient end through which the inflation line extends and has a slot extending along its length between the open machine end and the opening at the patient end so that the inflation line can be threaded through the slot.

18. The tracheostomy tube assembly according to claim 16, characterised in that the second part has a projecting rim at one end adapted to engage a groove around the first part.

19. The tracheostomy tube assembly according to claim 15, characterised in that the inflation indicator has a substantially flat inflatable balloon, and that the protective enclosure includes two opposite slots aligned with opposite edges of the balloon.

20. The tracheostomy tube assembly according to claim 15, characterised in that the protective enclosure includes at least one projecting feature adapted to be chewed by the patient.

21. The tracheostomy tube assembly according to claim 20, characterised in that the at least one projecting feature is provided by two flanges oriented with the planes of the flanges substantially orthogonal to one another.

22. A protector for an inflation indicator of a tracheostomy tube, characterised in that the protector is adapted to extend around and enclose the inflation indicator to protect it from damage by chewing, and that the protector is transparent, at least in part, to enable the inflation indicator to be viewed through it.

23. The protector according to claim 22, characterised in that the protector has a first part arranged to receive the machine end of the inflation indicator and a second part having a transparent sleeve adapted to extend around the inflation indicator and fit with the first part.

24. The protector according to claim 23, characterised in that the sleeve is open at its machine end that fits with the first part, and that the sleeve has an opening at its patient end through which the inflation line extends and has a slot extending along its length between the open machine end and the opening at the patient end so that the inflation line can be threaded through the slot.

25. The protector of claim 22, characterised in that the protector is included in a tracheostomy tube assembly including a tracheostomy tube having an inflatable sealing cuff towards its patient end and an inflation line terminated by the inflation indicator at its machine end.

26. A method of forming a paediatric tracheostomy tube assembly including the steps of providing a paediatric tracheostomy tube with a sealing cuff and an inflation indicator, providing a protective enclosure in two parts comprising a base part and a transparent sleeve, fitting the sleeve over an inflatable part of the inflation indicator, and joining one end of the sleeve to the base part such that the machine end of the inflation indicator is received in the base part.

27. The method according to claim 26, characterised in that the transparent sleeve has a slot extending longitudinally of the sleeve between openings at opposite ends of the sleeve such that the inflation line can be threaded sideways through the slot and then the sleeve can be slid along the inflation line to enclose the inflation indicator.

28. A paediatric tracheostomy tube assembly formed by the method according to claim 26.

Description

[0016] FIG. 1 is a perspective view of the tracheostomy tube assembly;

[0017] FIG. 2 is an enlarged perspective view of the inflation indicator from one end;

[0018] FIG. 3 is an enlarged perspective view of the inflation indicator from the opposite end;

[0019] FIG. 4 shows the parts of the inflation indicator before assembly;

[0020] FIG. 5 is a perspective view of a modified embodiment of the protector from its patient end; and

[0021] FIG. 6 is a perspective view of the modified embodiment of the protector from its machine end.

[0022] With reference first to FIGS. 1 to 4, the assembly includes a tracheostomy tube 1 of a paediatric size having a curved shaft 10 of circular section and with an inner diameter of around 6mm. The shaft 10 has a patient end 12 adapted to be located within the trachea of the patient and has a conventional sealing cuff 13 towards its patient end. The cuff 13 shown is of a high pressure kind made of an elastic material that lies close to the shaft 10 when deflated and is stretched outwardly when inflated. The shaft 10 and cuff 13 are both moulded of a silicone material. It will be appreciated that the tube could be of a different sizes, shapes and materials according to the application.

[0023] The machine end 14 of the shaft 10 is adapted, during use, to be located externally of the tracheostomy opening formed in the patient's neck. The machine end 14 of the shaft 10 is bonded into a hub or connector 15 having a conventional 15 mm male tapered outer surface 16. The connector 15 is adapted to make a removable push fit in a conventional 15 mm female connector (not shown) at one end of a breathing tube extending to a ventilator or anaesthetic machine. Alternatively, the machine end of the tube 1 could be left open to atmosphere when the patient is breathing spontaneously. The tracheostomy tube 1 also includes a radially-extending support flange 20 adapted to lie against the skin surface of the neck on either side of the tracheostomy stoma. The flange 20 is moulded integrally as one part with the shaft 10 at its machine end 14 or may be formed separately. The flange 20 has openings 21 at opposite ends for attachment to a neck strap (not shown) used to support the tube with the patient's neck.

[0024] The shaft 10 also includes an inflation line 31 in the form of a small-bore tube secured in a channel 32 extending along the outside of one side of the shaft. The inflation line 31 has an opening 33 towards its patient end located approximately midway along the length of the sealing cuff 13. The machine end of the inflation line 31 extends through the flange 20 and continues unattached with the shaft 10 being joined with and extending into one end 36 a conventional inflation indicator 37. The inflation indicator 37 includes a flat, flexible envelope or balloon 38 into which the inflation line 31 opens so that the balloon is inflated or deflated according to the inflation state of the sealing cuff 13. The opposite end of the inflation indicator balloon 38 is bonded to one end of the outside of a rigid connector sleeve 39 containing a valve (not visible in the drawing) and being open at its machine end 40 to receive a male coupling such as the nose of an inflation syringe.

[0025] As so far described the tracheostomy tube assembly is conventional. The assembly differs from conventional tracheostomy tubes by the addition of a protector enclosure 50 adapted to extend around and enclose the inflation indicator 37 to protect it from damage by chewing.

[0026] FIGS. 2 to 4 show the inflation indicator 37 before and after assembly of the protector enclosure 50 onto the inflation indicator 37. The enclosure 50 consists of two main parts. The first, machine-end part or base 51 is a moulding of a semi-rigid, opaque plastics material, such as having a Shore D hardness of about 50. The base 51 has a circular section with a waisted central region 52 formed with flats 53 around its circumference to improve the grip on the enclosure 50 between finger and thumb. The machine end 54 of the base 51 is open so that the machine end 40 of the inflation indicator 37 is accessible for inflation or deflation. At its opposite, patient end 55 the outer surface of the base 51 is formed with two opposite locking formations or notches 56 and 57.

[0027] The protector enclosure 50 is completed by a second part 60 in the form of a transparent cylindrical sleeve. The sleeve 60 is moulded of a stiff, transparent plastics material and is circular in section with an open machine end 62 having an outwardly projecting annular rim 63 the external diameter of which is such that it snaps into an internal retaining groove (not shown) around the inside of the base 51. The patient end 64 of the sleeve 60 is closed apart from a small opening 65 just large enough to receive the inflation line 31. The sleeve 60 also has two diametrically opposite slots 66 and 67 extending longitudinally of the sleeve. One slot 66 opens at its machine end into the open machine end 62 of the sleeve 60 and opens at its opposite end into the small patient-end opening 65 of the sleeve. The other slot 67 is shorter and terminates before the machine end opening 62 and the patient end opening 65. The longer slot 66 enables the sleeve 60 to be slid onto the inflation line 31 sideways and also gives the sleeve some resilience so that it can be squeezed to reduce the diameter at its machine end 62 and enable this to be inserted into the patient end of the base 51. The sleeve 60 also has two locking features 68 and 69 on opposite sides of its outer surface, midway between the two slots 66 and 67 and about half way along the length of the sleeve. The locking features 68 and 69 are shaped to clip onto the two notches 56 and 57 on outside of the base 51. Engagement of the locking features 68 and 69 on the sleeve 60 with the notches 56 and 57 on the base 51 prevents the sleeve rotating relative to the base.

[0028] The protective enclosure 50 could be permanently fitted onto the inflation indicator 37 by applying a bonding agent to the machine end of the sleeve 60 so that it becomes securely and permanently bonded to the base part 51. Alternatively, the sleeve 61 need not be bonded to the base 51 so that the protector 50 can be removed from the inflation indicator 37 when necessary.

[0029] The protector enclosure 50 is fitted on the inflation indicator 37 by first sliding the inflation line 31 sideways through the long slot 66 of the sleeve 61 at a location spaced a short distance away from the inflation balloon. The sleeve 61 is then oriented so that the opposite slots 66 and 67 align with the edges of the inflation balloon 38. The sleeve 61 can then be threaded rearwardly along the inflation line 31 and along the outside of the inflation indicator 37 as far as it will go. The assembly of the inflation indicator 37 and sleeve 61 is then slid rearwardly into the patient end of the base 51, aligning the locking features 68 and 69 on the sleeve with the notches on the base. The sleeve 61 is squeezed at the same time to compress the slots 66 and 67 so as to enable the rim 63 to enter the base 51 and then open into the internal retaining groove when released. Instead of loading the sleeve 61 onto the inflation indicator 37 first it would be possible to insert the inflation indicator into the base first and then slide the sleeve over and along the inflation indicator into the base.

[0030] With the inflation indicator 37 contained within the protective enclosure 50 the balloon 38 can inflate and deflate in the usual manner and the state of inflation of the indicator can be viewed through the transparent sleeve 60. If the child patient should chew on the assembly, the inflation indicator 37 will not be damaged because it is protected by the protector 50.

[0031] The protector 50 can be readily fitted to a conventional inflation indicator of a tracheostomy tube without the need for any special tools. The protector could be provided separately of the tracheostomy tube and assembled on the inflation indicator by the user, if needed. The protector need not be fitted by a clinical specialist but can be fitted by a child's carer at home as needed.

[0032] The protector could be provided with features specifically designed for the patient to chew so that he does not chew other parts of the protector. One example of a protector 150 with such features is shown in FIGS. 5 and 6 where the base 151 is integrally moulded with two projecting chew flanges 180 and 181. The flanges 180 and 181 are substantially flat and circular with three small protrusions 182 and 183 spaced around their edge. Both flanges 180 and 181 project outwardly of the base 151. One flange 180 has an axis normal to its plane extending parallel to the axis of the base 151. The other flange 181 has an axis normal to its plane extending orthogonally to the axis of the base 151. The patient can easily chew on these flanges 180 and 181 without causing any damage to the inflation indicator.