WO2018215728A1 - Tubes medico-chirurgicaux - Google Patents

Tubes medico-chirurgicaux Download PDF

Info

Publication number
WO2018215728A1
WO2018215728A1 PCT/GB2018/000072 GB2018000072W WO2018215728A1 WO 2018215728 A1 WO2018215728 A1 WO 2018215728A1 GB 2018000072 W GB2018000072 W GB 2018000072W WO 2018215728 A1 WO2018215728 A1 WO 2018215728A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
marker
alloy
tube according
shaft
Prior art date
Application number
PCT/GB2018/000072
Other languages
English (en)
Inventor
Timothy Bateman
Andrew Thomas Jeffrey
Christopher John WOOSNAM
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 WO2018215728A1 publication Critical patent/WO2018215728A1/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
    • 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
    • A61M16/0409—Special features for tracheal tubes not otherwise provided for with mean for closing the oesophagus
    • 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
    • A61M16/0415—Special features for tracheal tubes not otherwise provided for with access means to the stomach
    • 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
    • A61M16/0434—Cuffs
    • 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
    • A61M16/0434—Cuffs
    • A61M16/0443—Special cuff-wall materials
    • 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
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia

Definitions

  • This invention relates to medico-surgical tubes substantially of a plastics material.
  • Tracheal tubes are used to enable ventilation or respiration of a patient. Endotracheal tubes are inserted to the trachea via the mouth or nose. Tracheostomy tubes are 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. Various types of different tracheal tubes are presently available to suit different needs. Tracheostomy tubes are also available with an inner cannula, which can be removed and replaced periodically to prevent secretions building up and to avoid the need to replace the tube itself. Tracheostomy tubes can be inserted by different techniques, such as the surgical cut-down procedure carried out in an operating theatre or a percutaneous dilatation procedure, which may be carried out in emergency situations.
  • Tracheostomy tubes are generally used for more long-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 that extends outwardly on opposite sides of the tube.
  • Tracheal tubes often have a sealing cuff towards their patient end. When inflated the cuff seals between the outside of the tube and the inside of the trachea so that gas flow is confined along the inside of the tube.
  • US5499625 describes a tube with an x-ray opaque stripe interrupted by openings in the tube.
  • US362593, US3725522 and US3755525 describe tubes that are entirely of an x-ray opaque plastics or have an x-ray opaque tip moulded on to the shaft.
  • US3529633 describes a tube of an x-ray opaque material having a transparent stripe along its length.
  • US3042045 and USRE25788 describe tubes with an x-ray opaque stripe.
  • US4657024 describes a tube with an x-ray opaque layer between two outer layers.
  • US3589368 describes a tube with a fused ring of x-ray opaque plastics.
  • US8381730 and US285715 describe tubes with an x-ray opaque line.
  • WO9400174 describes a tube with a bonded tip of an x-ray opaque plastics.
  • GB2329841 describes a tube where the sealing cuff is attached with an x-ray opaque adhesive.
  • GB1513495 describes a tube where the cuff inflation line is closed by a rod of x-ray opaque plastics.
  • EP2648792 describes an
  • angioplasty balloon including a film of an x-ray opaque material.
  • Other arrangements are described in: US6378523, US6568393, US3190290, US3295527, US3314430, US3605750, GB2328878, US2008230070, US5429617, US9242058 and US8978657.
  • x-ray opaque plastics material A problem with these previous tubes using an x-ray opaque plastics material is that such materials are not highly opaque and do not contrast well in an x-ray image against the surrounding anatomy.
  • x-ray markers of metal can be highly visible in an x-ray image they have the disadvantage of not being suitable for use in an MRI environment. This is a real problem because a ventilated patient may need an unexpected, emergency MRI examination. If the tube by which the patient is ventilated is not MRI compatible it has to be removed and replaced with one that is compatible, which takes time and delays examination and treatment. This problem is not confined to tracheal tubes but exists with other medico- surgical tubes.
  • a medico-surgical tube of the above-specified kind characterised in that the tube includes an x-ray opaque marker including an MRI-compatible metal alloy, and that at least substantially 90% of the alloy is comprised of cobalt, chromium, tungsten and nickel.
  • the alloy preferably comprises at least 50% cobalt and at least 40% comprised of chromium, tungsten and nickel.
  • the marker may be in the form of a ring of the alloy attached with a plastics shaft of the tube towards its patient end.
  • the ring is preferably embedded in plastics material of the shaft so that no part of its surface is exposed.
  • the marker could be in the form of a slug inserted in a cuff inflation line of the tube to close off the patient end of the inflation line.
  • the marker could be provided by a region in the plastics material containing multiple discrete elements of the alloy, such as in the form of particles, flakes or microspheres of the alloy.
  • the medico- surgical tube is preferably a tracheal tube such as a tracheostomy tube.
  • Figure 1 is a perspective view of the tracheostomy tube
  • Figure 2 is an enlarged cross-sectional view of the patient end of the tube.
  • the tracheostomy tube comprises a curved shaft 10 of circular section with a patient end 12 adapted to be located within the trachea of the patient.
  • the shaft 10 has a conventional sealing cuff 13 towards its patient end, which is inflated by means of an inflation lumen 14 extending along the shaft.
  • the lumen 14 opens at its patient end 15 within the cuff 13 and connects towards its machine end 16 with a small bore inflation tube 17 terminated by a combined inflation indicator and valve 18.
  • the shaft 10 is moulded or extruded and is bendable but relatively stiff, being made of a plastics material such as PVC or silicone.
  • the machine end 20 of the shaft 10 is adapted, during use, to locate externally of the tracheostomy opening formed in the patient's neck.
  • the machine end 20 of the shaft 10 is bonded into a hub or connector 21 having a conventional 15mm male tapered outer surface 22.
  • the connector 21 is adapted to make a removable push fit in a conventional 15mm female connector (not shown) at one end of a breathing tube extending to a ventilator or anaesthetic machine.
  • the machine end of the tube 1 cpuld be left open to atmosphere when the patient is breathing spontaneously.
  • the tracheostomy tube 1 also includes a raclially-extending support flange 23 adapted to lie against the skin surface of the neck on either side of the tracheostomy stoma.
  • the flange 23 has openings 24 at opposite ends for attachment to a neck strap (not shown) used to support the tube with the patient's neck.
  • the patient end 12 of the shaft 10 includes an x- ray marker 30 in the form of an x-ray opaque ring of a selected metal alloy that is highly opaque to x-rays but is compatible with MRI machines.
  • the ring 30 is circular with an internal diameter slightly greater than the internal diameter of the shaft 10 and an outer diameter slightly less than the outer diameter of the shaft.
  • the ring 30 is set back a small distance, around 1mm, from the patient end 12 of the shaft 10 so that it is entirely embedded in the plastics material of the shaft with no part of its metal surface exposed.
  • the ring 30 could be attached with the shaft in various different ways. For example, the shaft could be extruded, cut to length and then its patient end could be heated to cause it to flow around the ring marker in a suitable mould.
  • the marker ring could be moulded into a plastics ring that was subsequently attached to the patient end of the shaft.
  • the marker ring could, instead, simply be swaged onto a groove around the outside of the tube.
  • the marker ring could be mounted in a groove adjacent a shallow step on the outside of the tube and overlaid by a collar of the sealing cuff, the step ensure a smooth continuation of the tube with the cuff.
  • the marker could be formed as a helical reinforcement wire extending along the tube or just the patient end of the tube so that it serves the dual purpose of reinforcing the tube and providing an x-ray visible marker.
  • the marker 30 is made from an alloy predominantly (at least 90%) of cobalt, chromium, tungsten and nickel with smaller amounts of other materials, namely carbon, iron, manganese, phosphorus, silicon and sulphur, not all of which need be present.
  • the alloy may be Cobalt Alloy L-605, which is non-magnetic and corrosion resistant. This alloy has been found to give a clear contrast in an x-ray image.
  • the alloy is also compatible with MRI imaging machines in that the magnetic fields do not induce any significant forces or torques on the marker, do not cause any significant heating of the marker and the marker does not cause any significant distortion of the magnetic fields that could degrade the image produced.
  • the marker take the form of a ring since it could have other forms.
  • the marker could be in the form of a cylindrical plug or slug bonded into the machine end of the cuff inflation line 14 and serve the dual purpose of both closing the machine end of the inflation line and providing an x-ray patient end marker.
  • the marker could take the form of multiple, discrete elements of the alloy, such as in the form of small particles, flakes or solid microspheres.
  • the invention is not confined to tracheal tubes but could be used in other medico- surgical tubes.

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

Le tube de trachéotomie de l'invention comprend une tige en plastique (10) présentant à son extrémité patient (12) un marqueur aux rayons X (30). Le marqueur se présente sous la forme d'un anneau en alliage métallique opaque aux rayons X mais non magnétique, de sorte qu'il est compatible avec un équipement d'imagerie IRM. L'alliage est, de préférence, constitué d'au moins 50% de cobalt et de 40% de cobalt, de chrome, de tungstène et de nickel.
PCT/GB2018/000072 2017-05-24 2018-04-20 Tubes medico-chirurgicaux WO2018215728A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1708308.0A GB201708308D0 (en) 2017-05-24 2017-05-24 Medico-surgical tubes
GB1708308.0 2017-05-24

Publications (1)

Publication Number Publication Date
WO2018215728A1 true WO2018215728A1 (fr) 2018-11-29

Family

ID=59220568

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2018/000072 WO2018215728A1 (fr) 2017-05-24 2018-04-20 Tubes medico-chirurgicaux

Country Status (2)

Country Link
GB (1) GB201708308D0 (fr)
WO (1) WO2018215728A1 (fr)

Citations (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US285715A (en) 1883-09-25 Edwaed weston
US362593A (en) 1887-05-10 Thimble
US3042045A (en) 1958-07-02 1962-07-03 David S Sheridan Medico-surgical tubes having integral connectors formed in their ends
US3190290A (en) 1962-02-08 1965-06-22 Brunswick Corp Intercostal catheters
US3295527A (en) 1964-04-10 1967-01-03 Sheridan Corp Intercostal catheter
US3314430A (en) 1964-04-10 1967-04-18 Brunswick Corp Sump drain catheter
US3529633A (en) 1967-10-23 1970-09-22 Bard Inc C R X-ray opaque tubing having a transparent stripe
US3589368A (en) 1969-02-07 1971-06-29 David S Sheridan Postsurgical tubes with capped proximal end
US3605750A (en) 1969-04-07 1971-09-20 David S Sheridan X-ray tip catheter
US3725522A (en) 1969-09-23 1973-04-03 D Sheridan Method of manufacture of balloon-type catheters
US3755525A (en) 1971-07-12 1973-08-28 D Sheridan Method of making multiple lumen tubing for medico surgical tubes
GB1513495A (en) 1976-10-04 1978-06-07 Mallinckrodt Inc Endotracheal tubes
US4657024A (en) 1980-02-04 1987-04-14 Teleflex Incorporated Medical-surgical catheter
WO1994000174A1 (fr) 1992-06-26 1994-01-06 Vygon Sonde endotracheale a embout rapporte
US5429617A (en) 1993-12-13 1995-07-04 The Spectranetics Corporation Radiopaque tip marker for alignment of a catheter within a body
US5499625A (en) 1994-01-27 1996-03-19 The Kendall Company Esophageal-tracheal double lumen airway
GB2328878A (en) 1997-09-02 1999-03-10 Smiths Industries Plc Medico-surgical tube with radiopacque component
GB2329841A (en) 1997-09-30 1999-04-07 Smiths Industries Plc Medico-surgical tube with x-ray opaque marker
US6378523B1 (en) 2000-03-15 2002-04-30 Evergreen Medical Incorporated Endotracheal tube having a beveled tip and orientation indicator
US20080230070A1 (en) 2007-03-20 2008-09-25 Felix Gregorian Endotracheal Tube with Radiopaque Distal End Marker
US20130025602A1 (en) * 2011-07-29 2013-01-31 Nellcor Puritan Bennett Llc Tracheal tube positioning devices and methods
US8381730B2 (en) 2009-01-29 2013-02-26 Covidien Lp Medical device and technique for using the same
EP2648792A1 (fr) 2011-06-03 2013-10-16 C.R. Bard, Inc. Ballonnet médical radio-opaque
US20130289705A1 (en) * 2012-04-26 2013-10-31 Medtronic Vascular, Inc. Radiopaque Enhanced Nickel Alloy for Stents
US8978657B2 (en) 2010-07-29 2015-03-17 Covidien Lp Dual-lumen tracheal tube with shaped lumen divider

Patent Citations (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US285715A (en) 1883-09-25 Edwaed weston
US362593A (en) 1887-05-10 Thimble
US3042045A (en) 1958-07-02 1962-07-03 David S Sheridan Medico-surgical tubes having integral connectors formed in their ends
US3190290A (en) 1962-02-08 1965-06-22 Brunswick Corp Intercostal catheters
US3295527A (en) 1964-04-10 1967-01-03 Sheridan Corp Intercostal catheter
US3314430A (en) 1964-04-10 1967-04-18 Brunswick Corp Sump drain catheter
US3529633A (en) 1967-10-23 1970-09-22 Bard Inc C R X-ray opaque tubing having a transparent stripe
US3589368A (en) 1969-02-07 1971-06-29 David S Sheridan Postsurgical tubes with capped proximal end
US3605750A (en) 1969-04-07 1971-09-20 David S Sheridan X-ray tip catheter
US3725522A (en) 1969-09-23 1973-04-03 D Sheridan Method of manufacture of balloon-type catheters
US3755525A (en) 1971-07-12 1973-08-28 D Sheridan Method of making multiple lumen tubing for medico surgical tubes
GB1513495A (en) 1976-10-04 1978-06-07 Mallinckrodt Inc Endotracheal tubes
US4657024A (en) 1980-02-04 1987-04-14 Teleflex Incorporated Medical-surgical catheter
WO1994000174A1 (fr) 1992-06-26 1994-01-06 Vygon Sonde endotracheale a embout rapporte
US5429617A (en) 1993-12-13 1995-07-04 The Spectranetics Corporation Radiopaque tip marker for alignment of a catheter within a body
US5499625A (en) 1994-01-27 1996-03-19 The Kendall Company Esophageal-tracheal double lumen airway
GB2328878A (en) 1997-09-02 1999-03-10 Smiths Industries Plc Medico-surgical tube with radiopacque component
GB2329841A (en) 1997-09-30 1999-04-07 Smiths Industries Plc Medico-surgical tube with x-ray opaque marker
US6568393B2 (en) 2000-03-15 2003-05-27 Evergreen Medical Incorporated Endotracheal tube having a beveled tip and orientation indicator
US6378523B1 (en) 2000-03-15 2002-04-30 Evergreen Medical Incorporated Endotracheal tube having a beveled tip and orientation indicator
US20080230070A1 (en) 2007-03-20 2008-09-25 Felix Gregorian Endotracheal Tube with Radiopaque Distal End Marker
US8381730B2 (en) 2009-01-29 2013-02-26 Covidien Lp Medical device and technique for using the same
US8978657B2 (en) 2010-07-29 2015-03-17 Covidien Lp Dual-lumen tracheal tube with shaped lumen divider
EP2648792A1 (fr) 2011-06-03 2013-10-16 C.R. Bard, Inc. Ballonnet médical radio-opaque
US20130025602A1 (en) * 2011-07-29 2013-01-31 Nellcor Puritan Bennett Llc Tracheal tube positioning devices and methods
US9242058B2 (en) 2011-07-29 2016-01-26 Covidien Lp Tracheal tube positioning devices and methods
US20130289705A1 (en) * 2012-04-26 2013-10-31 Medtronic Vascular, Inc. Radiopaque Enhanced Nickel Alloy for Stents

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Publication number Publication date
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