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WO2002009799A1 - Bougie - Google Patents

Bougie Download PDF

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Publication number
WO2002009799A1
WO2002009799A1 PCT/GB2001/003427 GB0103427W WO0209799A1 WO 2002009799 A1 WO2002009799 A1 WO 2002009799A1 GB 0103427 W GB0103427 W GB 0103427W WO 0209799 A1 WO0209799 A1 WO 0209799A1
Authority
WO
WIPO (PCT)
Prior art keywords
bougie
tip
lumen
adjacent
obturated
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/GB2001/003427
Other languages
English (en)
Inventor
David William Green
Stuart Ian Wallace
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to AU2001275723A priority Critical patent/AU2001275723A1/en
Publication of WO2002009799A1 publication Critical patent/WO2002009799A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • A61J15/0023—Gastrostomy feeding-tubes inserted by using a sheath
    • 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. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0411—Special features for tracheal tubes not otherwise provided for with means for differentiating between oesophageal and tracheal intubation
    • A61M2016/0413—Special features for tracheal tubes not otherwise provided for with means for differentiating between oesophageal and tracheal intubation with detectors of CO2 in exhaled gases
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes

Definitions

  • Present invention relates to an improved bougie and to a method of ascertaining its in-use position either in the trachea prior to endotracheal intubation (ETI) or the upper oesophagus prior to upper gastrointestinal tract (GIT) end scopy or gastric
  • Traditional bougies are well known to comprise a solid rod of a. gum elastic material which combines stiffness with flexibility at body temperatures; usually with a smooth distal end angled at about 40° about 3.5cm from the distal tip.
  • a lubricated bougie is directed past the epiglottis and into the larynx and thence into the trachea; usually with the use of a laryngoscope.
  • a sterile, single use device for local anaesthesia of the larynx area and referred to as a 'laryng-o-jet' (IMS) is also available.
  • IMS 'laryng-o-jet'
  • This tube is integral with a syringe filled with 4ml of lignocaine at 4% W/V.
  • This device is provided with a hollow tube curved and
  • US-A-5052836 relates to an endotrachael replacement device which does not require an outer tube which is non-traumatic to nasal structures.
  • W095/11716 relates to an endotrachael tube with a carbon dioxide sensor attached, and
  • WO 88/06908 relates to an endotrachael tube assembly including an introducer tube but which is genuinely complex.
  • the present invention provides in one aspect therefore a single use bougie comprising a catheter with a first lumen extending from a proximal toward a distal end, said lumen being provided over at least a major proportion of its length and being provided with an obturated tip adjacent the distal end, and at or adjacent its proximal end means for the connection of one or more associated devices, characterised by a hollow stiffener insertable within the first lumen and by an obturated tip which is exteriorly substantially non-traumatising to nasal structures.
  • a single use bougie comprising a catheter with a first lumen extending from a proximal to a distal end, said lumen extending over a major proportion of the length of catheter and being provided with an obturated tip adjacent the distal end, and at or adjacent its proximal end means for connection to one or more: devices associated therewith; characterised by a proximal portion substantially in register with the lumen, and with a distal portion substantially in register with a tip portion, the arrangement being such that the proximal portion cannot coil up upon its self, and wherein the distal portion substantially is non- traumatic to nasal or pharyngeal structures.
  • the bougie of the invention may therefore comprise one or a plurality of apertures connected between the first catheter lumen and the exterior as desired.
  • Other devices maybe used and these include a carbon dioxide (CO2) monitoring device, a syringe device or a cap.
  • CO2 carbon dioxide
  • the lumen confers on the bougie a non-traumatic resilience which is desirable for its purpose, while the stiffener which may be malleable, provides an elastic memory which allows the bougie to be steered by rotation as desired.
  • connection means should be such that it is small enough to fit within an endotracheal intubation tube so that tube can be 'railroaded' down the bougie towards the larynx and trachea or indeed towards the oesophagus if required.
  • a conventional luer-lock arrangement at its proximal end is suitable.
  • the bougie of the invention may be made of one or more plastics materials, so long as the softer of materials is to the exterior.
  • a single use bougie comprising a first catheter with a lumen over at least a major proportion of its length, at least one or a plurality or apertures adjacent the obturated tip, said apertures connecting the lumen with the exterior at its distal end, and at or adjacent its proximal end a CO2 monitoring device.
  • a method of determining the position of a bougie tip when in-situ within a patient comprising a first catheter lumen extending over a major proportion of its length and an aperture adjacent an obturated tip, connecting said lumen to the exterior, and at or adjacent its proximal end a CO2 monitoring device; comprising the steps, of a) inserting the bougie past the epiglottis b) connecting the proximal tip to a CO2 monitoring device, and, c) monitoring the CO2 output to ascertain if CO2 is present. If CO2 is present the bougie is located within the trachea and if not it is located in the oesophagus.
  • the device of the present invention it is also possible using the device of the present invention to 'steer' the bougie tip into the trachea or the oesophagus using the CO2 monitor, particularly if the hollow stiffening member, for example, is formed of nylon or polypropylene which is malleable as discussed above.
  • the bougie of the invention can be used in anaesthetising the larynx, trachea or the oesophagus in ETI or endoscopy.
  • the device may also be used for operative nasogastric intubation. It is normally placed after endotracheal intubation. It may be inserted via the nasal or oral route. It is not intended that the device is left in-situ for more than a few hours e.g. for use during surgical procedures but not for use in the ward.
  • the soft tip ensures there is minimal trauma to the delicate nasal and/or posterior pharygeal structures whilst the stiffener which may be made of nylon or polypropylene allows easy passage down the oesophagus and avoids coiling.
  • the exterior tube or catheter may be formed of a soft plastics material for example a medical grade PVC whereas the interior tube may be formed of nylon or polypropylene. Thus insertion is facilitated.
  • Fig.1 shows in diagrammatic plan a bougie in accordance with the present invention
  • Fig.2 shows the bougie of the present invention insetted into a patient in part - vertical cross-section
  • Fig.2a shows an enlarged view of section of Fig 2 in vertical cross-section
  • Fig.3 shows arrangement of Fig 2 utilising an ETI tube
  • Fig.3a shows an enlarged section of Fig 3 in vertical cross-section
  • Fig.4 shows an enlarged vertical cross-section of the device monitoring CO2 expression using the present invention
  • Fig.5 shows a diagrammatic plan view of a bougie according to claim 1 with a stiffener internal thereto with the tip (6) of the bougie being other than in the plane of the drawing.
  • a hollow bougie (1) provided with a luer- 5 lock (2) at i ts proximal end, and a lumen (3) extending from the luer-lock (2) to just short of obturated tip (6).
  • the bougie of the invention also provides a curved portion (4) adjacent the obturated tip (6) and a plurality of apertures (5) communicating between the lumen (3) and the exterior.
  • the luer-lock (2) can be associated v/ith a syringe for l o anaesthetic (11) (eg. Lignocaine).
  • Syringe ( 11 ) is secured to the bougie ( 1 ) via the luer-lock (2).
  • the patient shown generally at (10) is supine on the operating table with his head upon a pillow (9).
  • a laryngoscope (7) is inserted into the buccal cavity in accordance with usual practice and the bougie ( 1) is positioned
  • the positioning of the bougie (6) can be closely monitored by using a capnograph (21).
  • a capnograph (21) As will appreciated a by- product of respiration is carbon dioxide and this can be readily measured.
  • the utilisation of a bougie comprising a lumen allows carbon dioxide to be monitored on a one off or continuous basis.
  • CO2 levels on the capnograph (21) rise and fall with respiration the tip (6) will be in the trachea whereas if it does not do so the tip (6) will be in the oesophagus.
  • a CO2 indicating strip may be used to indicate the presence of CO2 above a base value.
  • a patient (10) is provided vertical section with a nasal cavity (14) which is essentially left undisturbed.
  • the tip of the bougie (6) is introduced via the buccal opening (15) and into the buccal cavity (16) and then via the posterior pharynx (17) so that the tip (6) then passes the epiglottis (18) and in this particular instance is advanced into the trachea (20).
  • the tip (6) of the bougie (1) may be positioned in the oesophagus in some applications.
  • the luer-lock (2) of the bougie (1) can be connected to a CO2 monitor (21) via a sampling tube (22).
  • the bougie (1) is provided with a curved portion (4) adjacent its tip (6). This allows the operator to 'steer' the bougie tip (6) merely by rotating the bougie (1).
  • the capnograph (21) it is only necessary that the surgeon ascertain whether CO2 is present or not to ascertain whether the tip of the bougie is in the oesophagus or the trachea.
  • anaesthetic can be dispensed and it is only then necessary to remove the syringe from the luer-lock assembly to 'railroad' the intubation tube (12) over the bougie before withdrawing the bougie.
  • a stiffened bougie With reference to Fig.5 there is shown in plan view a stiffened bougie.
  • the bougie of Fig.1 is provided with a stiffener (23) formed for example of nylon 66.
  • the stiffener (23) has an outer diameter of about 3.5mm whereas the outer diameter of a bougie has a value of about .0mm and is formed of medical grade PVC or polypropylene.
  • nylon 66 for example has an elastic memory and accordingly is malleable to the extent that an operator can bend it to the desired shape for a particular patient.
  • the invention therefore relates to a sterile bougie according 1o claims 1 or 2 as herein after set forth, to a bougie comprising CO2 monitoring device, and to a method of determining a position of a bougie when in-situ within a patient.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne une bougie jetable (1) comprenant un cathéter doté d'une première lumière (3) s'étendant d'une extrémité proximale (2) à une extrémité distale (6), la lumière occupant une majeure partie de la longueur de la bougie et comportant un embout bouché adjacent à l'extrémité distale ou proximale. La bougie comporte également des organes permettant de fixer un ou plusieurs dispositifs associés. L'invention se caractérise par un raidisseur creux (23) pouvant s'introduire dans ladite lumière par un embout bouché (6) extérieur permettant de ne pas traumatiser les structures pharyngiennes, laryngiennes ou nasales, ou par une partie épaisse coincidant sensiblement avec la lumière (3) et une partie fine coincidant sensiblement avec la partie d'extrémité (4). L'arrangement est réalisé de telle sorte que la partie épaisse ne peut s'enrouler sur elle-même et que la partie fine est sensiblement non traumatisante aux structures pharyngiennes, laryngiennes ou nasales (17, 18).
PCT/GB2001/003427 2000-07-31 2001-07-30 Bougie Ceased WO2002009799A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001275723A AU2001275723A1 (en) 2000-07-31 2001-07-30 Bougie

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0018743A GB0018743D0 (en) 2000-07-31 2000-07-31 Improved Bougie
GB0018743.5 2000-07-31

Publications (1)

Publication Number Publication Date
WO2002009799A1 true WO2002009799A1 (fr) 2002-02-07

Family

ID=9896676

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2001/003427 Ceased WO2002009799A1 (fr) 2000-07-31 2001-07-30 Bougie

Country Status (3)

Country Link
AU (1) AU2001275723A1 (fr)
GB (2) GB0018743D0 (fr)
WO (1) WO2002009799A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006034097A1 (fr) * 2004-09-21 2006-03-30 Sherwood Services Ag Indicateur de mise en place de tube gastrique
WO2007093786A1 (fr) * 2006-02-15 2007-08-23 Owen Greenings & Mumford Limited Bougie
WO2007134562A1 (fr) * 2006-05-18 2007-11-29 Universitätsklinikum Schleswig-Holstein Dispositif d'intubation endotrachéale
GB2454018A (en) * 2007-10-26 2009-04-29 Dr David W Green Introducer device for bougie tube
WO2011039434A1 (fr) 2009-10-02 2011-04-07 Deltalyo & Valmy Canule pour un dispositif d'anesthesie laryngo-tracheale
ES2357208A1 (es) * 2010-12-20 2011-04-20 Administracion De La Comunidad Autonoma De Euskadi Dispositivo para la administración local de anestésicos en la vía aérea.
GB2499656A (en) * 2012-02-26 2013-08-28 Mohammed Faig Abad Alrazak Tracheal tube with closed distal end
US9919119B2 (en) 2013-07-31 2018-03-20 Shannon Sovndal Gum elastic bougie introducer with tactile depth and orientation indicator
CN114288506A (zh) * 2021-10-09 2022-04-08 上海矿星生物科技中心 头端角度可调的气管插管换管器及应用

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1988006908A1 (fr) 1987-03-17 1988-09-22 Toelle Gerhard Hugo Accessoire de sport
WO1988006903A1 (fr) * 1987-03-17 1988-09-22 Nakhgevany Karim B Tube endotracheal
US5052836A (en) 1988-12-20 1991-10-01 Sanyo Electric Co., Ltd. Printer
US5078701A (en) * 1990-10-05 1992-01-07 Bissell Medical Products, Inc. Wire guided intestinal catheter
US5188100A (en) * 1991-09-09 1993-02-23 New York University Apparatus for facilitating tracheostomy tube replacement
US5279610A (en) * 1992-11-06 1994-01-18 Cook Incorporated Oroesophageal, instrument introducer assembly and method of use
WO1995011716A1 (fr) 1993-10-26 1995-05-04 The Regents Of The University Of California Tube endotracheal et detecteur integre de co2 de fin d'expiration
EP0803263A2 (fr) * 1996-04-25 1997-10-29 Smiths Industries Public Limited Company Dispositif d'introduction et ses éléments

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4402684A (en) * 1981-09-16 1983-09-06 The Kendall Company Cannula with soft tip
EP0854739A1 (fr) * 1995-10-10 1998-07-29 Cardiac Pathways Corporation Modulation de la forme de catheters a l'aide d'un tube interieur mobile
US5700252A (en) * 1995-11-01 1997-12-23 Klingenstein; Ralph James Lumen-seeking nasogastric tube and method
GB2316321B (en) * 1996-08-21 2000-04-05 Smiths Industries Plc Medical tube assemblies
NL1003984C2 (nl) * 1996-09-09 1998-03-10 Cordis Europ Katheter met inwendige verstijvingsbruggen.

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1988006908A1 (fr) 1987-03-17 1988-09-22 Toelle Gerhard Hugo Accessoire de sport
WO1988006903A1 (fr) * 1987-03-17 1988-09-22 Nakhgevany Karim B Tube endotracheal
US5052836A (en) 1988-12-20 1991-10-01 Sanyo Electric Co., Ltd. Printer
US5078701A (en) * 1990-10-05 1992-01-07 Bissell Medical Products, Inc. Wire guided intestinal catheter
US5188100A (en) * 1991-09-09 1993-02-23 New York University Apparatus for facilitating tracheostomy tube replacement
US5279610A (en) * 1992-11-06 1994-01-18 Cook Incorporated Oroesophageal, instrument introducer assembly and method of use
WO1995011716A1 (fr) 1993-10-26 1995-05-04 The Regents Of The University Of California Tube endotracheal et detecteur integre de co2 de fin d'expiration
EP0803263A2 (fr) * 1996-04-25 1997-10-29 Smiths Industries Public Limited Company Dispositif d'introduction et ses éléments

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006034097A1 (fr) * 2004-09-21 2006-03-30 Sherwood Services Ag Indicateur de mise en place de tube gastrique
WO2007093786A1 (fr) * 2006-02-15 2007-08-23 Owen Greenings & Mumford Limited Bougie
WO2007134562A1 (fr) * 2006-05-18 2007-11-29 Universitätsklinikum Schleswig-Holstein Dispositif d'intubation endotrachéale
GB2454018A (en) * 2007-10-26 2009-04-29 Dr David W Green Introducer device for bougie tube
WO2011039434A1 (fr) 2009-10-02 2011-04-07 Deltalyo & Valmy Canule pour un dispositif d'anesthesie laryngo-tracheale
FR2950812A1 (fr) * 2009-10-02 2011-04-08 Deltalyo & Valmy Canule pour un dispositif d'anesthesie laryngo-tracheale
ES2357208A1 (es) * 2010-12-20 2011-04-20 Administracion De La Comunidad Autonoma De Euskadi Dispositivo para la administración local de anestésicos en la vía aérea.
GB2499656A (en) * 2012-02-26 2013-08-28 Mohammed Faig Abad Alrazak Tracheal tube with closed distal end
US9919119B2 (en) 2013-07-31 2018-03-20 Shannon Sovndal Gum elastic bougie introducer with tactile depth and orientation indicator
US11065409B2 (en) 2013-07-31 2021-07-20 Shannon Sovndal Gum elastic bougie introducer with tactile depth and orientation indicator
CN114288506A (zh) * 2021-10-09 2022-04-08 上海矿星生物科技中心 头端角度可调的气管插管换管器及应用

Also Published As

Publication number Publication date
GB0018743D0 (en) 2000-09-20
GB0118527D0 (en) 2001-09-19
GB2368023A (en) 2002-04-24
AU2001275723A1 (en) 2002-02-13

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