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EP1984054A1 - Bougie - Google Patents

Bougie

Info

Publication number
EP1984054A1
EP1984054A1 EP07705195A EP07705195A EP1984054A1 EP 1984054 A1 EP1984054 A1 EP 1984054A1 EP 07705195 A EP07705195 A EP 07705195A EP 07705195 A EP07705195 A EP 07705195A EP 1984054 A1 EP1984054 A1 EP 1984054A1
Authority
EP
European Patent Office
Prior art keywords
bougie
outer tube
inner tube
tube
bougie according
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.)
Withdrawn
Application number
EP07705195A
Other languages
German (de)
English (en)
Inventor
Paul Wightman
David Green
Stuart 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.)
Owen Greenings and Mumford Ltd
Original Assignee
Owen Greenings and Mumford Ltd
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 Owen Greenings and Mumford Ltd filed Critical Owen Greenings and Mumford Ltd
Publication of EP1984054A1 publication Critical patent/EP1984054A1/fr
Withdrawn legal-status Critical Current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
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/085—Gas sampling
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • 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)

Definitions

  • This invention relates to a bougie, that is an elongate flexible element designed to be introduced into the body of a patient through, for example, the buccal cavity or the nasal cavity.
  • a bougie that is an elongate flexible element designed to be introduced into the body of a patient through, for example, the buccal cavity or the nasal cavity.
  • the term 'bougie' is used to cover devices designed to remain in place such as an endotracheal tube, gastric decompression or gastric drainage tubes, as well as those devices used temporarily as a guide to aid insertion of other medical appliances such as endotracheal tubes, etc.
  • Traditional bougies comprise a rod of a gum elastic material which combines stiffness with flexibility at body temperatures.
  • a bougie When used for endotracheal intubation, a bougie is directed past the epiglottis and into the larynx and thence into the trachea usually with the use of a laryngoscope. When the bougie has been correctly positioned, an endotracheal tube can be railroaded over it through the larynx and into the trachea. However, it is often difficult to determine whether the bougie tip has actually entered the trachea (correct) or the oesophagus (incorrect).
  • WO02/09799 describes a single use bougie comprising a catheter with a lumen extending from a connector at a proximal end to an obturated tip with lateral apertures through which gas may pass and through which the gaseous environment adjacent the end of the device may be sampled.
  • appliances and instruments used in medical procedures are single use.
  • the appliance it is preferred for the appliance to be multi-functional to reduce the number of different items that have to be stocked for theatre use.
  • a bougie which has sufficient shape memory for it to be used as a traditional bougie for endotracheal intubation or as a tube for passing fluids, solids etc to or from the interior of the patient's body.
  • One of the problems posed to the anaesthetist, who is normally responsible for this procedure, is to be able to shape and steer the tip of the bougie towards the intended destination.
  • the anaesthetist Before insertion into the body, the anaesthetist will normally bend the bougie towards a required curved shape and this often involves pronounced inclination at the tip to provide a coude tip. In order to steer the bougie correctly, it is important that the anaesthetist be able to twist the bougie clockwise/anticlockwise and for this rotational movement to be transmitted through to the tip.
  • this invention provides a bougie for being inserted into the body of a patient, said bougie comprising:- an inner tube defining a flow passage extending from a proximal end to a distal end thereof; an outer tube generally surrounding said inner tube, and anti-rotation means provided between said inner tube and said outer tube to prevent rotation between the two; the inner tube, outer tube and anti-rotation means providing a malleable, plastically deformable property at least in a generally distal region whereby said bougie may be bent to a required shape, and retain said shape at least temporarily, to assist insertion thereof into a body cavity of the patient.
  • the structure and flexural characteristics of the appliance mean that it can be used as a standard type of bougie making use of the shape memory, or as a drainage tube such as a gastric decompression tube.
  • the anti-rotation means comprise one or more ribs extending along at least part of the length of one of said tubes and being received in a respective groove in the other thereof.
  • the ribs may be conveniently provided on the inner tube, and a plurality of ribs may be equispaced around the inner or outer tube as the case may be.
  • the arrangement of the inner and outer tubes and the anti-rotation means preferably allows slight longitudinal sliding movement between the inner and outer tubes.
  • the bougie Whilst the bougie is intended to be shaped along its length to suit the physiology of the procedure and the patient, it is particularly preferred for the bougie to be arranged so that the tip thereof can be bent to retain an angular deflection of at least 40°, thereby provide a coude tip of minimum 40°.
  • the inner tube preferably stops short of the distal end of the outer tube, whereby the distal end of said outer tube projecting beyond said inner tube acts as a relatively flexible atraumatic tip.
  • the outer tube is made of a soft, flexible, rubber-like material such as PVC.
  • the inner tube may be made from a stiffer material but one capable of retaining an applied curved shape, such as high-density polyethylene.
  • the length of the outer tube that projects to provide said atraumatic tip is no greater than 15mm and more preferably equal to about
  • the dimension of 12.5mm is particularly preferred as if the dimension is significantly greater, the tip is too floppy to use as a bougie and this also makes it difficult to form a coude tip shape. With shorter length tips, the tip loses its soft nature which provides the atraumatic feature.
  • the distal end of the outer tube is obturated and the portion thereof projecting beyond said inner tube is provided with a plurality of apertures.
  • the apertures preferably are of a maximum dimensional diameter which is less than the inner transverse dimension of the flow passage of the inner tube, to prevent passage into the interior of the tube of material likely to block the inner tube.
  • the apertures conveniently are of the order of 1.5mm in diameter.
  • a female luer is connected to the proximal end of the bougie and in flow communication with said passage.
  • the outer dimension of the female luer is preferably less than 6.5mm.
  • a connector device is removably connectable to said female luer to allow connection thereof in use to a suction device.
  • the bougie is packaged with said connector device in suitable sterile packaging so as to allow the device to be adapted for use as a standard bougie or as a gastric tube on removal from the packaging.
  • Figure 1 is a side view of a multi-function intubating bougie in accordance with this invention
  • Figure 2 is a detailed cross-sectional view on the proximal end thereof
  • Figure 3 is a detailed cross-sectional view on the distal end thereof
  • Figure 4 is a section view through the atraumatic tip of the bougie taken on lines iv-iv, and
  • Figure 5 is a section view taken further up the bougie on lines v-v.
  • the device shown in the drawings is intended to be used as a multifunction intubating bougie, capable of being used as an endotrachael tube (ET) intubating introducer or as a gastric decompression tube according to the particular requirement.
  • ET endotrachael tube
  • the illustrated bougie 10 has a proximal end 12 and a distal end 14.
  • the bougie is made up of an inner cylindrical tube 16 which, in this embodiment, is made of a high density polyethylene material.
  • An outer tube 18 surrounds the inner tube 16 and, in this embodiment, is made of PVC material.
  • the inner tube is provided with three equi-spaced ribs 20 which are received in corresponding longitudinal grooves 22 provided in the outer tube.
  • the ribs 20 interlock in the grooves 22 to prevent relative rotation between the inner and outer tubes 16, 18, whilst still allowing slight relative longitudinal movement.
  • the inner tube 16 stops short of the outer tube 18 to provide an atraumatic tip region 24.
  • the soft rubber nature of the outer tube 18 means that the tip is likely to yield if it collides with a tissue wall, thereby avoiding or reducing the likelihood of damage. It should be noted that perforation of the oesophagus or gut is very dangerous.
  • the length of the atraumatic tip region 24 is approximately 12.5mm.
  • the tip 24 is provided with four holes for the suction of gas or gastric fluid. In this embodiment the diameter of the holes is about 1.5mm, which is smaller than the internal diameter of the inner tube 16 and so the holes 26 act as a filter to prevent particles entering the inner tube of size likely to block it.
  • the material properties of the outer tube, the sizing and spacing of the holes 26 and the wall thickness are designed so that the tip retains its shape and does not unduly distort or crease on insertion (apart of course from inadvertent collision with a tissue wall).
  • the outer tube stops short of the inner tube as shown and a female luer 28 is bonded to the inner and outer tubes.
  • the luer connection is dimensioned so that a 6.5mm endotracheal tube (the smallest applicable tube) can pass over it.
  • the luer 28 allows attachment to a gas sample line and thence to a capnograph so that correct placement of the bougie can be detected by monitoring for presence/absence of CO 2 .
  • a suction connector 30 Releasably connected to the female luer 28 is a suction connector 30 which allows the bougie to be connected to a suction device for use e.g. in gastric decompression.
  • the suction connector 30 will be packaged in suitable sterile packaging together with the remainder of the bougie.
  • the bougie may also include distance markers 32 to assist the anaesthetist.
  • the anaesthetist having removed the device from the packaging will apply or discard the suction connector 30 as necessary and then shape the bougie according to the physiology of the patient and the procedure. This will often involve applying a kink or inclination at the distal end so that the last 20 to 25mm are inclined at an angle of somewhere between 40° to 65° to provide a conde tip.
  • a kink or inclination at the distal end so that the last 20 to 25mm are inclined at an angle of somewhere between 40° to 65° to provide a conde tip.
  • the interlocking ribs and grooves 20, 22 provide excellent steerability and the longitudinal slippage between the inner and outer tubes allows the bougie to be bent and to hold a suitable curve. Normally the anaesthetist will apply rotation to the bougie by gripping it about half way along its length and then rotating.
  • the interlock feature ensures that the required degree of rotation is transmitted through to rotation at the tip with little or no backlash. This is useful particularly in instances where a coude tip has been formed because it helps in correct placement in the trachea.
  • the two part nature of the device produces the atraumatic tip region but this also produces the softness of the device when rotated.

Landscapes

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

Abstract

Bougie (10) constituée d'un tube extérieur (18) entourant un tube intérieur (16). Des moyens anti-rotation sous la forme de nervures (20) équidistantes sur le tube intérieur (16) sont reçus dans des rainures longitudinales (22) correspondantes pratiquées dans le tube extérieur (18). Les nervures (20) s'emboîtent dans les rainures (22) pour empêcher toute rotation relative entre les tubes (16,18) intérieur et extérieur, de sorte qu'une rotation peut être appliquée d'une extrémité à l'autre avec un jeu faible ou inexistant, tout en permettant un léger glissement longitudinal lorsque la bougie est mise en forme par flexion.
EP07705195A 2006-02-15 2007-02-14 Bougie Withdrawn EP1984054A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0603010.0A GB0603010D0 (en) 2006-02-15 2006-02-15 Bougie
PCT/GB2007/000508 WO2007093786A1 (fr) 2006-02-15 2007-02-14 Bougie

Publications (1)

Publication Number Publication Date
EP1984054A1 true EP1984054A1 (fr) 2008-10-29

Family

ID=36141855

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07705195A Withdrawn EP1984054A1 (fr) 2006-02-15 2007-02-14 Bougie

Country Status (3)

Country Link
EP (1) EP1984054A1 (fr)
GB (1) GB0603010D0 (fr)
WO (1) WO2007093786A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2357208B1 (es) * 2010-12-20 2012-02-28 Administracion De La Comunidad Autonoma De Euskadi Dispositivo para la administración local de anestésicos en la vía aérea.
US9919119B2 (en) 2013-07-31 2018-03-20 Shannon Sovndal Gum elastic bougie introducer with tactile depth and orientation indicator
USD752213S1 (en) 2013-09-13 2016-03-22 Lothian Health Board Flexible tracheal intubation bougie and catheter with color-coded depth indicators
JP2015181886A (ja) * 2014-03-26 2015-10-22 テルモ株式会社 医療用チューブ、バルーンカテーテル、及び医療用チューブの製造方法
ES2848321T3 (es) 2014-09-17 2021-08-06 Richard M Levitan Canalizador para intubación con tubo traqueal
GB2547017B (en) 2016-02-04 2021-08-04 Intersurgical Ag Improvements to intubation aids
CN114176770B (zh) * 2021-12-31 2023-01-24 华科精准（北京）医疗科技有限公司 一种冷却套管和冷却装置

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2758089B1 (fr) * 1997-01-06 1999-03-05 Georges Boussignac Procede et dispositif pour echanger des sondes respiratoires dans la trachee d'un patient
WO2002002171A2 (fr) * 2000-06-29 2002-01-10 Minitube Of America, Inc. Catheter en plastique coextrude
GB0018743D0 (en) * 2000-07-31 2000-09-20 Wallace Stuart I Improved Bougie
US6530914B1 (en) * 2000-10-24 2003-03-11 Scimed Life Systems, Inc. Deflectable tip guide in guide system

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2007093786A1 *

Also Published As

Publication number Publication date
WO2007093786A1 (fr) 2007-08-23
GB0603010D0 (en) 2006-03-29

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Legal Events

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Inventor name: GREEN, DAVID

Inventor name: WALLACE, STUART

Inventor name: WIGHTMAN, PAUL

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