WO1991012845A1 - Tracheal tube assemblies - Google Patents

Tracheal tube assemblies Download PDF

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Publication number
WO1991012845A1
WO1991012845A1 PCT/GB1991/000235 GB9100235W WO9112845A1 WO 1991012845 A1 WO1991012845 A1 WO 1991012845A1 GB 9100235 W GB9100235 W GB 9100235W WO 9112845 A1 WO9112845 A1 WO 9112845A1
Authority
WO
WIPO (PCT)
Prior art keywords
inner cannula
outer tube
cannula
tube
patient end
Prior art date
Application number
PCT/GB1991/000235
Other languages
French (fr)
Inventor
Timothy John Jay Inglis
Michael Ronald Millar
Original Assignee
Smiths Industries Public Limited Company
University Of Leeds Industrial Services Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smiths Industries Public Limited Company, University Of Leeds Industrial Services Limited filed Critical Smiths Industries Public Limited Company
Priority to DE69107376T priority Critical patent/DE69107376T2/en
Priority to EP91904016A priority patent/EP0474802B1/en
Publication of WO1991012845A1 publication Critical patent/WO1991012845A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0427Special features for tracheal tubes not otherwise provided for with removable and re-insertable liner tubes, e.g. for cleaning

Definitions

  • This invention relates to tracheal tube assemblies of the kind having an outer tube an inner cannula that is insertable within and removable from the outer tube.
  • Tracheal tube assemblies are described, for example, in US 3948274, GB 2056285B, GB 1099277, GB 125754, WO 90/04992, FR 2539998A, DE 72467, DE 1268313, EP 0107779A, US 4817598, US 3659612, US 4009720, US 3088466, US 4315545, US 2765792, US 3169529, US 3263684, US 3334631, US 3587589, US 3688774, US 3731692, US 3889688, US 3948273, US 3973569, US 3987798, US 4033353, US 4045058, US 4235229, US 4471776, US 4593690.
  • the inner surface of tracheal tubes tends to accumulate a film of respiratory secretions and bacteria.
  • This film can obstruct the bore of the tube and reduce gas flow along it. It has been found that the film can also act as a site for build up of bacteria in quantities sufficient to cause infection if dislodged from the tube and subsequently inhaled.
  • the use of an inner cannula which is periodically removed and replaced, can reduce these effects but brings with it disadvantages. In particular, the thickness of the wall of the inner cannula will itself reduce the effective bore of the tube.
  • the inner cannula is preferably made of material to which secretions will cling without becoming dislodged into the bronchii and that these materials, such as PVC, tend to have a relatively high coefficient of friction. These materials also tend to be relatively flexible, so that the cannula wall must be made thick enough to prevent kinking on insertion.
  • a tracheal tube assembly of the above-specified kind characterised in that the inner cannula has at its patient end an external diameter that is greater than that of the major part of the inner cannula, that the external diameter at the patient end is at least equal to the internal diameter of the outer tube such that the inner cannula seals with the outer tube at its patient end, and that the external diameter of the major part of the inner cannula is less than the internal diameter of the outer tube so that the inner cannula is freely insertable along the outer tube.
  • the patient end of the inner cannula is preferably deformable radially, before insertion in the outer tube the external diameter of the patient end of the inner cannula being greater than the internal diameter of the outer tube.
  • the inner cannula is preferably flared outwardly at the patient end and may be of a plastic material.
  • the inner cannula may have an inner surface to which respiratory secretions will cling and an outer surface of a different material with a lower coefficient of friction than the inner surface.
  • the inner surface may be of PVC and the outer surface of polyolefine.
  • the patient end of both the inner cannula and the outer tube may be bevelled.
  • Figure 1 is a sectional side elevation of a part of the assembly
  • Figure 2 is an enlarged side elevation section of a part of the assembly.
  • Figure 3 is a transverse sectional view along the line III - III of Figure 2.
  • the assembly comprises an outer endotracheal tube
  • the outer tube 1 is of a constant radius curvature along its length and is made of PVC or a similar plastics material. At its forward, patient end, the tube 1 has a bevelled, open tip 10 which, in use, is located in the trachea of the patient. Close to the forward end, a cuff
  • tube II embraces the tube which is inflatable via a lumen 12 extending along the wall of the tube which communicates with an inflation line 13 and connector 14.
  • a flange 15 is connected to the rear, machine end of tube 1 where it emerges from the mouth of the patient.
  • the inner cannula 2 is of the same length as the outer tube 1 and in preformed with the same curvature.
  • the inner cannula 2 is a coextrusion of two different materials.
  • the outer layer 20 is of a relatively low friction plastics- material such as a polyolefine, for example, a low density polyethylene or polypropylene.
  • the inner layer 21 is of a material with a higher coefficient of friction but which enables respiratory secretions and bacteria to cling to it.
  • the inner layer 21 may be of the same material as the outer tube 1, namely PVC.
  • Various different factors determine the degree to which secretions will cling to the inner layer 21. For example, a highly polar material will improve adhesion as will the presence of microscopic surface formations. A hydrophilic material may also provide a better site for adhesion of the secretions.
  • the outer layer 20 is more rigid that the inner layer 21 which is relatively flexible.
  • the inner cannula 2 is of circular shape and of the same external diameter along the major part of its length, which is slightly less than the internal diameter of the outer tube.
  • the clearance between the inner cannula and the outer tube is sufficient to enable the inner cannula to be freely inserted and removed without substantially reducing the internal diameter and hence the gas passage through the assembly. Insertion is further facilitated by the low friction outer surface of the cannula.
  • the cannula 2 is flared outwardly to form a portion 22 which, in its natural state, before insertion in the outer tube 1, has an external diameter slightly greater than the internal diameter of the outer tube.
  • the cannula 2 has a coupling 23, the forward end of which mates with the machine end of the outer tube 1.
  • the rear end of the coupling is provided with a female luer tapered recess 24 that is adapted to receive a cooperating coupling (not shown) connected to a patient ventilator.
  • the forward end of the inner cannula 2 is pushed into the machine end of the outer tube 1, the bevel at the forward end of the cannula serving to aid initial insertion into the tube.
  • the deformable nature of the inner cannula allows its forward portion 22 to be deformed inwardly by contact with the inside of the tube. In this way, the portion 22 forms a sliding, wiping seal with the tube 1 as it is pushed along it.
  • the friction produced by contact of the portion 22 with the tube 1 is relatively small because of the small area of contact, so that there is little impediment to insertion.
  • the forward portion 22 of the inner cannula is a close, sealing fit with the bore of the tube 1 at its patient end.
  • the inner cannula 2 is periodically removed, when accumulated secretions have built up, and replaced by a new cannula, without the need to remove the outer tube.
  • the inner cannula 2 is removed at least once every twelve hours and preferably more frequently, such as every six hours. Conveniently, the cannula is replaced once every time there is a change in shift of nursing staff.
  • inner cannulae have been replaced only when secretions have reached the stage of threatening to block passage through the assembly, such as, once a day, or every other day. The importance of more frequent replacement in reduced bacterial infection has not heretofore been appreciated.
  • the outer layer 20 of the inner cannula 2 is of a more rigid material than the inner layer 21, it enables the cannula to be made with a thinner wall than would be possible if it were made entirely from the material of the inner layer, and without the risk of the cannula kinking on insertion. It will be appreciated that the inner cannula 2 need not be a coextrusion but that the inner or outer surface could be provided by treating or coating with a different material.
  • the assembly could be a tracheostomy tube assembly instead of an endotracheal tube assembly.

Abstract

A tracheal tube assembly has an outer tube (1) and an inner cannula (2) with a patient end (22) that is flared outwardly to a diameter greater than the internal diameter of the outer tube. When inserted in the outer tube, the patient end of the inner cannula is deformed inwardly and forms a wiping seal. The remainder of the inner cannula (2) has an external diameter less than the internal diameter of the outer tube (1) so that it is readily inserted. The inner cannula may be coextruded with an outer layer (20) of a low friction material such as a polyolefine.

Description

Tracheal tube assemblies.
This invention relates to tracheal tube assemblies of the kind having an outer tube an inner cannula that is insertable within and removable from the outer tube.
With such assemblies, the inner cannula is removed and replaced periodically when secretions have built up on the cannula to an extent that there is a risk of blockage. Tracheal tube assemblies are described, for example, in US 3948274, GB 2056285B, GB 1099277, GB 125754, WO 90/04992, FR 2539998A, DE 72467, DE 1268313, EP 0107779A, US 4817598, US 3659612, US 4009720, US 3088466, US 4315545, US 2765792, US 3169529, US 3263684, US 3334631, US 3587589, US 3688774, US 3731692, US 3889688, US 3948273, US 3973569, US 3987798, US 4033353, US 4045058, US 4235229, US 4471776, US 4593690.
The inner surface of tracheal tubes, in use, tends to accumulate a film of respiratory secretions and bacteria. This film can obstruct the bore of the tube and reduce gas flow along it. It has been found that the film can also act as a site for build up of bacteria in quantities sufficient to cause infection if dislodged from the tube and subsequently inhaled. The use of an inner cannula which is periodically removed and replaced, can reduce these effects but brings with it disadvantages. In particular, the thickness of the wall of the inner cannula will itself reduce the effective bore of the tube. This can be mitigated by making the external diameter of the inner cannula as close as possible to the internal diameter of the tube and making the cannula wall is as" thin as possible in order to maximize the diameter of the gas passage through the tube assembly. It is also important to prevent passage of secretions between the outside of the cannula and the inside of the outer tube. A close fitting inner cannula can, however, be difficult to insert because of friction with the bore of the tube. This can make inner cannula prone to kinking, especially if the wall of the cannula is thin. This difficulty is aggravated by the fact that the inner cannula is preferably made of material to which secretions will cling without becoming dislodged into the bronchii and that these materials, such as PVC, tend to have a relatively high coefficient of friction. These materials also tend to be relatively flexible, so that the cannula wall must be made thick enough to prevent kinking on insertion.
It is an object of the present invention to provide an improved tracheal tube assembly. According to the present invention there is provided a tracheal tube assembly of the above-specified kind, characterised in that the inner cannula has at its patient end an external diameter that is greater than that of the major part of the inner cannula, that the external diameter at the patient end is at least equal to the internal diameter of the outer tube such that the inner cannula seals with the outer tube at its patient end, and that the external diameter of the major part of the inner cannula is less than the internal diameter of the outer tube so that the inner cannula is freely insertable along the outer tube.
The patient end of the inner cannula is preferably deformable radially, before insertion in the outer tube the external diameter of the patient end of the inner cannula being greater than the internal diameter of the outer tube. The inner cannula is preferably flared outwardly at the patient end and may be of a plastic material. The inner cannula may have an inner surface to which respiratory secretions will cling and an outer surface of a different material with a lower coefficient of friction than the inner surface. The inner surface may be of PVC and the outer surface of polyolefine. The patient end of both the inner cannula and the outer tube may be bevelled. An endotracheal tube 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 sectional side elevation of a part of the assembly;
Figure 2 is an enlarged side elevation section of a part of the assembly; and
Figure 3 is a transverse sectional view along the line III - III of Figure 2.
The assembly comprises an outer endotracheal tube
I of conventional construction and an inner cannula 2 which is insertable in, and removable from, the outer tube.
The outer tube 1 is of a constant radius curvature along its length and is made of PVC or a similar plastics material. At its forward, patient end, the tube 1 has a bevelled, open tip 10 which, in use, is located in the trachea of the patient. Close to the forward end, a cuff
II embraces the tube which is inflatable via a lumen 12 extending along the wall of the tube which communicates with an inflation line 13 and connector 14. A flange 15 is connected to the rear, machine end of tube 1 where it emerges from the mouth of the patient.
The inner cannula 2 is of the same length as the outer tube 1 and in preformed with the same curvature. The inner cannula 2 is a coextrusion of two different materials. More particularly, the outer layer 20 is of a relatively low friction plastics- material such as a polyolefine, for example, a low density polyethylene or polypropylene. The inner layer 21 is of a material with a higher coefficient of friction but which enables respiratory secretions and bacteria to cling to it. In this respect, the inner layer 21 may be of the same material as the outer tube 1, namely PVC. Various different factors determine the degree to which secretions will cling to the inner layer 21. For example, a highly polar material will improve adhesion as will the presence of microscopic surface formations. A hydrophilic material may also provide a better site for adhesion of the secretions.
Figure imgf000008_0001
The outer layer 20 is more rigid that the inner layer 21 which is relatively flexible.
The inner cannula 2 is of circular shape and of the same external diameter along the major part of its length, which is slightly less than the internal diameter of the outer tube. The clearance between the inner cannula and the outer tube is sufficient to enable the inner cannula to be freely inserted and removed without substantially reducing the internal diameter and hence the gas passage through the assembly. Insertion is further facilitated by the low friction outer surface of the cannula.
At its patient end, the cannula 2 is flared outwardly to form a portion 22 which, in its natural state, before insertion in the outer tube 1, has an external diameter slightly greater than the internal diameter of the outer tube. At its machine end, the cannula 2 has a coupling 23, the forward end of which mates with the machine end of the outer tube 1. The rear end of the coupling is provided with a female luer tapered recess 24 that is adapted to receive a cooperating coupling (not shown) connected to a patient ventilator.
In use, the forward end of the inner cannula 2 is pushed into the machine end of the outer tube 1, the bevel at the forward end of the cannula serving to aid initial insertion into the tube. The deformable nature of the inner cannula allows its forward portion 22 to be deformed inwardly by contact with the inside of the tube. In this way, the portion 22 forms a sliding, wiping seal with the tube 1 as it is pushed along it. The friction produced by contact of the portion 22 with the tube 1 is relatively small because of the small area of contact, so that there is little impediment to insertion. When fully inserted, the forward portion 22 of the inner cannula is a close, sealing fit with the bore of the tube 1 at its patient end. In this way, there is little risk of secretions passing between the inner cannula 2 and the outer tube 1. The nature of the inner surface 21 of the cannula 2 is such that respiratory secretions and bacteria will readily cling to it with only a low risk of dislodgement.
The inner cannula 2 is periodically removed, when accumulated secretions have built up, and replaced by a new cannula, without the need to remove the outer tube. The inner cannula 2 is removed at least once every twelve hours and preferably more frequently, such as every six hours. Conveniently, the cannula is replaced once every time there is a change in shift of nursing staff. Previously, inner cannulae have been replaced only when secretions have reached the stage of threatening to block passage through the assembly, such as, once a day, or every other day. The importance of more frequent replacement in reduced bacterial infection has not heretofore been appreciated.
Because the outer layer 20 of the inner cannula 2 is of a more rigid material than the inner layer 21, it enables the cannula to be made with a thinner wall than would be possible if it were made entirely from the material of the inner layer, and without the risk of the cannula kinking on insertion. It will be appreciated that the inner cannula 2 need not be a coextrusion but that the inner or outer surface could be provided by treating or coating with a different material. The assembly could be a tracheostomy tube assembly instead of an endotracheal tube assembly.

Claims

1. A tracheal tube assembly having an outer tube and an inner cannula that is insertable within and removable from the outer tube, characterised in that the inner cannula (2) has at its patient end (22) an external diameter that is greater than that .of the major part of the inner cannula, that the external diameter at the patient end is at least equal to the internal diameter of the outer tube (1) such that the inner cannula (2) seals with the outer tube (1) at its patient end (10) and that the external diameter of the major part of the inner cannula (2) is less than the internal diameter of the outer tube (1) so that the inner cannula (2) is freely insertable along the outer tube.
2. A tracheal tube assembly according to Claim 1, characterised in that the patient end (22) of the inner cannula (2) is deformable radially, and that before insertion in the outer tube the external diameter of the patient end (22) of the inner cannula (2) is greater than the internal diameter of the outer tube 1.
3. A tracheal tube assembly according to Claim 1 or 2, characterised in that the inner cannula (2) is flared outwardly at the patient end (22) .
4. A tracheal tube assembly according to anyone of the preceding claims, characterised in that the inner cannula is of a plastics material.
5. A tracheal tube assembly according to any one of the preceding claims, characterised in that the inner cannula (2) has an inner surface (21) to which respiratory secretions will cling, and an outer surface (20) of a different material with a lower coefficient of friction than the inner surface.
6. A tracheal tube assembly according to Claim 4 or 5, characterised in that the inner surface (21) is of PVC.
7. A tracheal tube assembly according to any one of Claims 4 to 6, characterised in that the outer surface is of a polyolefine.
8. A tracheal tube assembly according to any one of the preceding claims, characterised that the patient end of both the inner cannula (2) and the outer tube (1) are bevelled.
PCT/GB1991/000235 1990-02-21 1991-02-15 Tracheal tube assemblies WO1991012845A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
DE69107376T DE69107376T2 (en) 1990-02-21 1991-02-15 COMPOSED TRACHEAL TUBE.
EP91904016A EP0474802B1 (en) 1990-02-21 1991-02-15 Tracheal tube assemblies

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB909003857A GB9003857D0 (en) 1990-02-21 1990-02-21 Medico-surgical tube assemblies
GB9003857.1 1990-02-21

Publications (1)

Publication Number Publication Date
WO1991012845A1 true WO1991012845A1 (en) 1991-09-05

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PCT/GB1991/000235 WO1991012845A1 (en) 1990-02-21 1991-02-15 Tracheal tube assemblies

Country Status (8)

Country Link
US (1) US5119811A (en)
EP (1) EP0474802B1 (en)
JP (1) JP2851944B2 (en)
AU (1) AU7326891A (en)
CA (1) CA2063583A1 (en)
DE (1) DE69107376T2 (en)
GB (1) GB9003857D0 (en)
WO (1) WO1991012845A1 (en)

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US5184611A (en) * 1991-01-04 1993-02-09 Smiths Industries Public Limited Company Tracheal tube assemblies and liners
US5287852A (en) * 1993-01-13 1994-02-22 Direct Trends International Ltd. Apparatus and method for maintaining a tracheal stoma
GB2323292A (en) * 1997-03-18 1998-09-23 Smiths Industries Plc Laryngeal mask assembly
US6698428B2 (en) 1996-11-06 2004-03-02 Archibald I. J. Brain Endotracheal tube construction
US6705318B1 (en) 1999-04-09 2004-03-16 Archibald I. J. Brain Disposable LMA
US6792948B2 (en) 2003-01-22 2004-09-21 Archibald I. J. Brain Laryngeal mask airway device with airway tube having flattened outer circumference and elliptical inner airway passage
US6918388B2 (en) 1997-07-25 2005-07-19 The Laryngeal Mask Company Limited Intubating laryngeal mask
US7004169B2 (en) 1999-10-07 2006-02-28 Indian Ocean Medical Inc. Laryngeal mask with large-bore gastric drainage
US7134431B2 (en) 2003-09-08 2006-11-14 Indian Ocean Medical Inc. Laryngeal mask airway device with position controlling tab
US7156100B1 (en) 1998-10-06 2007-01-02 The Laryngeal Mask Company Ltd. Laryngeal mask airway device
US9265904B2 (en) 2009-07-06 2016-02-23 Teleflex Life Sciences Artificial airway
US9498591B2 (en) 2005-05-27 2016-11-22 The Laryngeal Mask Company Ltd. Laryngeal mask airway device with a support for preventing occlusion
US9528897B2 (en) 2009-08-13 2016-12-27 Chimden Medical Pty Ltd Pressure indicator
US9675772B2 (en) 2010-10-15 2017-06-13 The Laryngeal Mask Company Limited Artificial airway device
US9694150B2 (en) 1998-08-13 2017-07-04 The Laryngeal Mask Company Limited Laryngeal mask airway device
US9974912B2 (en) 2010-10-01 2018-05-22 Teleflex Life Sciences Unlimited Company Artificial airway device
US10549054B2 (en) 2011-02-02 2020-02-04 Teleflex Life Sciences Unlimited Company Artificial airway
US10576229B2 (en) 2009-03-03 2020-03-03 The Laryngeal Mask Company Limited Artificial airway device
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USD699348S1 (en) 2010-01-27 2014-02-11 Orlando Morejon Handle
US20110186052A1 (en) * 2010-02-01 2011-08-04 Orlando Morejon Cleaning assembly for an endotracheal tube
US20110197894A1 (en) * 2010-02-18 2011-08-18 Orlando Morejon Endotracheal tube cleaning apparatus
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GB201303553D0 (en) 2013-02-28 2013-04-10 Smiths Medical Int Ltd Tracheostomy tube assemblies and inner cannulae
GB201303554D0 (en) 2013-02-28 2013-04-10 Smiths Medical Int Ltd Tracheostomy tube assemblies and inner cannulae
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US10279137B1 (en) 2014-06-27 2019-05-07 Orlando Morejon Connector assembly for a medical ventilator system
US11395897B1 (en) 2014-06-27 2022-07-26 Orlando Morejon Connector assembly for a medical ventilator system
GB201510231D0 (en) 2015-06-11 2015-07-29 Smiths Medical Int Ltd Tracheostomy tube assemblies and inner cannulae
GB201510230D0 (en) 2015-06-11 2015-07-29 Smiths Medical Int Ltd Tracheostomy tube assemblie and inner cannulae
GB201512674D0 (en) 2015-07-15 2015-08-26 Smiths Medical Int Ltd Tracheostomy tube assemblies and inner cannulae
GB201515450D0 (en) 2015-08-29 2015-10-14 Smiths Medical Int Ltd Tracheostomy tube assemblies and inner cannulae
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Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5184611A (en) * 1991-01-04 1993-02-09 Smiths Industries Public Limited Company Tracheal tube assemblies and liners
US5287852A (en) * 1993-01-13 1994-02-22 Direct Trends International Ltd. Apparatus and method for maintaining a tracheal stoma
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DE69107376T2 (en) 1995-06-14
US5119811A (en) 1992-06-09
JP2851944B2 (en) 1999-01-27
AU7326891A (en) 1991-09-18
DE69107376D1 (en) 1995-03-23
GB9003857D0 (en) 1990-04-18
EP0474802B1 (en) 1995-02-15
EP0474802A1 (en) 1992-03-18
JPH05504082A (en) 1993-07-01
CA2063583A1 (en) 1991-08-22

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