WO2015110773A1 - Ensembles tube de trachéotomie et canule interne - Google Patents

Ensembles tube de trachéotomie et canule interne Download PDF

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Publication number
WO2015110773A1
WO2015110773A1 PCT/GB2014/000519 GB2014000519W WO2015110773A1 WO 2015110773 A1 WO2015110773 A1 WO 2015110773A1 GB 2014000519 W GB2014000519 W GB 2014000519W WO 2015110773 A1 WO2015110773 A1 WO 2015110773A1
Authority
WO
WIPO (PCT)
Prior art keywords
inner cannula
fibres
cannula according
tracheostomy tube
shaft
Prior art date
Application number
PCT/GB2014/000519
Other languages
English (en)
Inventor
Andrew Thomas Jeffrey
Original Assignee
Smiths Medical International 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 Medical International Limited filed Critical Smiths Medical International Limited
Publication of WO2015110773A1 publication Critical patent/WO2015110773A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0427—Special features for tracheal tubes not otherwise provided for with removable and re-insertable liner tubes, e.g. for cleaning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0205—Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent

Definitions

  • This invention relates to inner cannulae of the kind for tracheostomy tube assemblies.
  • Tracheostomy tube assemblies commonly include an outer tube and an inner tube or cannula that is a removable fit within the outer tube.
  • the inner cannula can be removed and replaced periodically to ensure that the passage through the assembly does not become blocked by secretions. This avoids the need to remove the outer tube frequently.
  • the inner cannula presents various problems because it must be thin walled and a close fit within the outer tube so as to provide a large bore and thereby limit the resistance to flow of gas along the assembly. It must, however, also be sufficiently stiff to be inserted in the outer tube without buckling or kinking. Further, it is advantageous if these inner cannulae can be left in place in the tracheostomy tube as long as possible since this reduces the frequency of replacement and interruption of the breathing circuit. It also reduces how often the patient has to be subjected to the discomfort of replacing the inner tube. The frequency at which the inner cannula has to be replaced is dependent on how quickly bacteria or a biofilm builds up on its surface.
  • inner cannula there are various different forms of inner cannula.
  • WO94/01156 and WO2004/101048 describe inner cannulae made of PTFE.
  • EP1938857 describes an arrangement of tracheostomy tubes and inner cannulae where the hubs of the inner cannulae of different sizes are shaped differently so that they will only fit in the appropriate tracheostomy tube.
  • EP2224985 describes an arrangement for attaching a hub to the shaft of an inner cannula.
  • GB2056285 describes an inner cannula having a wall corrugated both externally and internally and a longitudinal groove or other reinforcement member traversing at least some of the corrugations.
  • US4817598 describes a smooth-walled inner cannula having a ring-pull formation at its rear, machine end.
  • US5119811 describes an inner cannula with a flared patient end and formed of two layers of different materials.
  • US5386826 describes an inner cannula with an outer helical filament or layer of low friction material.
  • US5983895 describes an inner cannula with straight sections at opposite ends joined by an intermediate curved section.
  • US6019753 describes an inner cannula with two elongate regions of different flexibility so that the cannula has a plane of preferential bending.
  • US6019753 describes an inner cannula having a shaft formed with slots to make it more flexible, the slots being covered by an outer thin sheath.
  • US6135110 describes a curved inner cannula that is retained with the outer tube by means of a rotatable spring fitting.
  • PCT/GB2014/000042 describes an inner cannula having a corrugated outer surface and a smooth inner surface.
  • PCT/GB2014/000043 describes an inner cannula with an off-centre bore.
  • an inner cannula of the above-specified kind characterised in that the inner cannula is formed substantially by a tubular shaft of spun polymeric fibres.
  • the shaft of the inner cannula is preferably porous to liquids.
  • the fibres may have a diameter less than about 100 microns and preferably have a diameter of about 1 micron.
  • the polymeric fibres may include a material having anti-bacterial properties, such as silver nanoparticles or heparin.
  • the fibres may be of a material including ePTFE.
  • the tubular shaft may be formed by laying the fibres around a mandrel and then heat treating the fibres so they bond with one another.
  • the fibres may be made by a technique selected from a group consisting of: electro-spinning, electro-spraying, coaxial electrospinning, emulsion electrospinning and melt electrospinning.
  • a tracheostomy tube assembly including an outer tracheostomy tube and an inner cannula according to the above one aspect of the present invention inserted within the outer tube and being removable therefrom.
  • Figure 1 is a side elevation view of a tracheostomy tube assembly including an inner cannula
  • Figure 2 is a side elevation view of the inner cannula
  • Figure 3 ⁇ sectional view through the inner cannula along the line ⁇ - ⁇ of
  • the tracheostomy assembly comprises an outer tracheostomy tube 1 and a removable inner cannula 20 inserted within the outer tube.
  • the outer tube 1 has a shaft 10 with a straight forward section 11, a straight rear section 12 and a curved intermediate section 13 linking the forward and rear sections.
  • the outer tube could have a natural straight shape and be flexible to accommodate the anatomy of the tracheostomy.
  • Other shape tubes are also possible.
  • An inflatable sealing cuff 14 embraces the forward section 11 close to the patient end 15 of the tube, the cuff being inflated via an inflation lumen 16 extending within the wall thickness of the shaft 10 and connected at its machine or rear end with a combined connector and inflation indicator 17.
  • the outer tube 1 At its rear end the outer tube 1 has a hub 18 and flange 19 to which a retaining tape can be fastened for securing the tube with the patient's neck.
  • the inside of the hub 18 is formed with keying flats (not shown), of the kind described in EP1938857, adapted to prevent an inner cannula of the wrong size being fully inserted.
  • the outer tube 1 typically has an internal diameter between about 6mm and 10mm, and a length between 60mm and 200mm.
  • the inner cannula 20 is formed substantially by a shaft 21, which has a hub 22 bonded to its rear or machine end 23.
  • the shaft 21 is a tubular structure formed entirely by a lattice of spun polymeric fibres 24 along its length and through its wall thickness.
  • the fibres may be made by any conventional technique, such as electro-spinning, electro-spraying, coaxial electrospinning, emulsion electrospinning or melt electrospinning.
  • the fibres are nanofibres may be substantially of ePTFE or Tyvek.
  • the fibres 24 are preferably microfibers or nanofibres and have a diameter in the range from less than about 1 micron to about 100 microns, preferably being towards the lower end of this range.
  • the fibres 24 are coated with an anti-bacterial substance, such as silver nanoparticles or heparin, either before or after the fibres are formed into the tubular structure of the cannula.
  • the material from which the fibres are made could include an anti-bacterial substance within it.
  • Other therapeutic substances could be added to or coated on the fibre material.
  • the construction of the shaft 21 is preferably such that it is porous to liquids so that secretions contacting the inner or outer surface of the cannula 20 can seep into the depth of the wall of the cannula.
  • the secretions come into contact with a larger surface area of the fibre material and thereby are exposed to contact with a greater amount of any anti-bacterial substance in the fibres. It is not essential for the cannula to be porous since the fibre structure would still give its surface a relatively large effective surface area compared with a conventional moulded or extruded cannula and thereby lead to a greater exposure to the anti-bacterial substance.
  • the fibres 24 can be oriented as desired and laid in multiple layers having different orientations to produce any desired pattern.
  • the tubular structure of the cannula 20 may be woven fibres 24 or the fibres could be structured in other ways.
  • the fibres 24 may be uniaxially aligned with one another or could be aligned in a lattice or with multiple layers that could be random.
  • Different layers may be formed of fibres of different materials or different properties, or individual layers could be made up of blends of fibres of differing materials or properties. In this way, by appropriately choosing the technique, materials, lattice structure and number of layers the strength, flexibility and kink resistance of the shaft can be tailored as desired. It is also possible to modify these properties along the length of the shaft and around its circumference.
  • the shaft 21 could be formed by laying fibres 24 around a mandrel (not shown) such as by weaving, wrapping or braiding and then heat treating the wrapped mandrel so that the fibres bond with one another. The shaft could then be slid off the mandrel and bonded at one end to the hub 22, which is moulded of a plastics material.
  • the hub 22 has a smooth external surface, the portion 31 at its forward end being shaped to fit into a 15 mm connector.
  • the hub 22 has a keying portion 32 provided with flats 33 of the kind described in EP1938857 adapted to fit with corresponding formations in the hub 18 of the outer tube 1.
  • the rear end of the hub 22 has a ring-pull formation 34 of the kind described in US4817598, which facilitates removal of the inner cannula 20 from the outer tube 1 after use.
  • the fibre construction of the inner cannula 20 enables it to be given the desired flexibility, axial stiffness and resistance to buckling and kinking during insertion into the outer tube 1.
  • the bore through the inner cannula 20 can be smooth so as to minimise any turbulence in flow along the assembly and to facilitate the sliding of devices (such as a suction catheter or endoscope) along the inside of the inner cannula.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Selon l'invention, une canule interne (20) d'un tube de trachéotomie (1) possède une tige (21) composée de fibres polymères filées (24) dont le diamètre est inférieur à environ 100 microns et est de préférence égal à environ 1 micron. Les fibres (24) peuvent être composées d'un matériau comprenant de l'ePTFE et peuvent présenter des propriétés anti-bactériennes. La canule interne (20) est poreuse et peut laisser passer des liquides.
PCT/GB2014/000519 2014-01-21 2014-12-18 Ensembles tube de trachéotomie et canule interne WO2015110773A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1401024.3 2014-01-21
GBGB1401024.3A GB201401024D0 (en) 2014-01-21 2014-01-21 Tracheostomy tube assemblies and inner cannulae

Publications (1)

Publication Number Publication Date
WO2015110773A1 true WO2015110773A1 (fr) 2015-07-30

Family

ID=50239267

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2014/000519 WO2015110773A1 (fr) 2014-01-21 2014-12-18 Ensembles tube de trachéotomie et canule interne

Country Status (2)

Country Link
GB (1) GB201401024D0 (fr)
WO (1) WO2015110773A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016198817A1 (fr) 2015-06-11 2016-12-15 Smiths Medical International Limited Ensembles de tubes de trachéotomie et canules internes
WO2016198818A1 (fr) 2015-06-11 2016-12-15 Smiths Medical International Limited Ensembles de tubes de trachéotomie et canules internes
WO2017037404A1 (fr) 2015-08-29 2017-03-09 Smiths Medical International Limited Canules internes et ensemble tube pour trachéostomie
WO2017046550A1 (fr) * 2015-09-15 2017-03-23 Smiths Medical International Limited Tubes et leur fabrication

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5529062A (en) * 1995-05-02 1996-06-25 Byrd; Timothy N. Tracheostomy tube holder and associated tube holding method
US5666950A (en) * 1992-07-10 1997-09-16 Kapitex Healthcare Ltd. Filter device for a tracheostoma
WO1999053989A1 (fr) * 1998-04-22 1999-10-28 Sims Portex Inc. Tube de tracheotomie

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5666950A (en) * 1992-07-10 1997-09-16 Kapitex Healthcare Ltd. Filter device for a tracheostoma
US5529062A (en) * 1995-05-02 1996-06-25 Byrd; Timothy N. Tracheostomy tube holder and associated tube holding method
WO1999053989A1 (fr) * 1998-04-22 1999-10-28 Sims Portex Inc. Tube de tracheotomie

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HOSUN LIM: "A review of spun bond process", JOURNAL OF TEXTILE AND APPAREL, TECHNOLOGY AND MANAGEMENT, vol. 6, 31 December 2010 (2010-12-31), pages 1 - 13, XP002736635, Retrieved from the Internet <URL:http://ojs.cnr.ncsu.edu/index.php/JTATM/article/view/513/602> [retrieved on 20150302] *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016198817A1 (fr) 2015-06-11 2016-12-15 Smiths Medical International Limited Ensembles de tubes de trachéotomie et canules internes
WO2016198818A1 (fr) 2015-06-11 2016-12-15 Smiths Medical International Limited Ensembles de tubes de trachéotomie et canules internes
WO2017037404A1 (fr) 2015-08-29 2017-03-09 Smiths Medical International Limited Canules internes et ensemble tube pour trachéostomie
WO2017046550A1 (fr) * 2015-09-15 2017-03-23 Smiths Medical International Limited Tubes et leur fabrication

Also Published As

Publication number Publication date
GB201401024D0 (en) 2014-03-05

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