GB2542640A - Bougie introducer - Google Patents

Bougie introducer Download PDF

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Publication number
GB2542640A
GB2542640A GB1517170.5A GB201517170A GB2542640A GB 2542640 A GB2542640 A GB 2542640A GB 201517170 A GB201517170 A GB 201517170A GB 2542640 A GB2542640 A GB 2542640A
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Prior art keywords
bougie
introducer
tube
aperture
patient
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GB2542640B (en
GB201517170D0 (en
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Anthony Oliver Michael
Martin Sparrow Robert
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Individual
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Individual
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    • 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
    • A61M16/0488Mouthpieces; Means for guiding, securing or introducing the 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

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (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)
  • Otolaryngology (AREA)
  • Endoscopes (AREA)

Abstract

A bougie introducer for introducing a bougie into a patient's trachea is provided. The bougie introducer comprises a tube 102 having: a proximal section 114 configured to be held, in use, by a user; and a distal section 108 comprising a curved portion and being configured to be inserted, in use, at least partially into the patient's oropharynx. The sections of the tube are proportioned so that, in use, the proximal section can be held by the user whilst the curved portion curves around the bend from the patient's oral cavity to the oropharynx. The proximal section has an aperture 112 along its length so that in use the user can manipulate, through the aperture, a bougie (202, fig 2) inserted into the tube and thereby advance the bougie distally through the bougie introducer and into the patient's trachea.

Description

BOUGIE INTRODUCER
FIELD OF THE INVENTION
[0001] The invention relates to mechanical ventilation in the field of medicine, and finds particular application in enabling an endotracheal tube to be inserted into a patient’s trachea for surgery or intensive care.
BACKGROUND
[0002] During surgery and intensive care, it is important to secure an airway for mechanical ventilation safely and successfully when putting the patient under general anaesthesia. Patients often have an unusual pathology or an unusual shape to their head or neck, which can make it difficult to straighten the airway and insert an endotracheal tube into the trachea. Securing a difficult airway can not only be challenging for the operator, but also increases risks of trauma and delay in oxygenating the patient, with potentially disastrous consequences.
[0003] Over the years there has been considerable investment into improving the ergonomics of airway technology, resulting in increased awareness and use of videolaryngoscopy and fibreoptic techniques. Despite these advances, there is still a long way to go towards a solution that is safe, cheap, and ergonomic, and that has the capacity to be used immediately in an unanticipated airway emergency.
[0004] The invention aims to address at least some of these problems.
SUMMARY OF THE INVENTION
[0005] According to a first aspect of the invention, there is provided a bougie introducer (hereinafter ‘introducer’) for introducing a bougie into a patient’s trachea. The introducer comprises a tube having: a proximal section configured to be held, in use, by a user; and a distal section comprising a curved portion and being configured to be inserted, in use, at least partially into the patient’s oropharynx. The sections of the tube are proportioned so that, in use, the proximal section can be held by the user whilst the curved portion curves around the bend from the patient’s oral cavity to the oropharynx. The proximal section has an aperture along its length so that in use the user can manipulate, through the aperture, a bougie inserted into the tube and thereby advance the bougie distally through the introducer and into the patient’s trachea.
[0006] Preferred features of the introducer are described and defined in the detailed description of the invention and the dependent apparatus claims. The preferred features of the introducer may be combined as appropriate, as would be apparent to a skilled person.
[0007] According to a second aspect of the invention, there is provided a method of manufacturing an introducer for introducing a bougie into a patient’s trachea. The method comprises providing a tube having: a proximal section configured to be held, in use, by a user; and a distal section comprising a curved portion and being configured to be inserted, in use, at least partially into the patient’s oropharynx. The sections of the tube are proportioned so that, in use, the proximal section can be held by the user whilst the curved portion curves around the bend from the patient’s oral cavity to the oropharynx. The proximal section has an aperture part-way along its length so that in use the user can manipulate, through the aperture, a bougie inserted into the tube and thereby advance the bougie distally through the introducer and into the patient’s trachea.
[0008] Preferred features of the method are described and defined in the detailed description of the invention and the dependent method claims. The preferred features of the method may be combined as appropriate, as would be apparent to a skilled person.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Embodiments of the invention will now be described, by way of example, with reference to the appended drawings of which:
Figure 1 is a perspective view of an introducer according to the invention;
Figure 2 is a perspective view of the introducer of Figure 1 being held in an operator’s right hand and being loaded with a bougie;
Figure 3 is a perspective view of the introducer of Figure 1 being held in an operator’s right hand, in which a bougie has been advanced further into the introducer compared with Figure 2;
Figure 4 is a perspective view of the introducer of Figure 1 being held in an operator’s right hand and fully loaded with a bougie, and of laryngoscope being held in the operator’s left hand;
Figure 5 is a perspective view of the introducer of Figure 1 and the laryngoscope of Figure 4 in position over a patient before being inserted into the patient’s mouth and oropharynx;
Figure 6 is a cross-section of the introducer of Figure 1 loaded with a bougie and the laryngoscope of Figure 4 inserted into a patient’s oropharynx;
Figure 7 is a perspective cut-away view of a further introducer according to the invention having an inner formation of three corrugations;
Figure 8 is a perspective cut-away view from a different angle of the introducer of Figure 6;
Figure 9 is a cross-section of a further introducer according to the invention having an inner formation of four corrugations;
Figure 10 is a cross-section of part of a further introducer according to the invention having an inner formation of four corrugations and an outwardly extending outer formation, and being loaded with a bougie; and
Figure 11 is a cross-section of part of a further introducer according to the invention having an inner formation and an inwardly extending outer formation and being loaded with a bougie.
[0010] Common reference numerals are used throughout the figures to indicate similar features.
DETAILED DESCRIPTION OF THE INVENTION
[0011] It is established practice to use a straight flexible rod such as a gum elastic bougie to intubate a patient during surgery. The bougie is inserted into the patient’s trachea and an endotracheal tube is fed or railroaded over the bougie with the bougie sliding inside the lumen of the endotracheal tube. In this way, the bougie acts as a guide for inserting the endotracheal tube into the patient’s trachea. Once the endotracheal tube is in place, the bougie is retracted from the endotracheal tube and put aside.
[0012] In order to insert the bougie into the patient’s trachea, the clinician tips the patient’s head back and holds the patient’s tongue out of the way using a laryngoscope. The aim is to obtain a direct line of sight to the glottis and insert the bougie through the vocal cords and into the trachea. Once the bougie has been inserted through the vocal cords it is advanced along the trachea, often until it reaches the division in the trachea. At this point the clinician will receive tactile feedback, known as feeling a “hold up” sign, indicating that the distal tip of the bougie has reached the division of the trachea and should not be pushed any further to avoid injuring the trachea or bronchi. This method is called direct laryngoscopy because the clinician is using the laryngoscope to lift the tongue out of the way, and may have a direct line of sight to the vocal cords.
[0013] Direct laryngoscopy is not always chosen because patients often have an unusual pathology or an unusual shape to their head or neck which may make visualising the glottis difficult. Often, the clinician can gain a direct view of the epiglottis but no further. If a direct line of sight to the glottis cannot be achieved, a video laryngoscope with a camera at the tip may be used for visualising the glottis on a screen. Although the glottis can be visualised on a screen, a bougie may be needed to obtain access to the trachea around a “blind comer”.
[0014] It can be difficult to insert a bougie around a blind comer, particularly in the small space around the videolaryngoscope inside the oropharyngeal area. To encourage the bougie to pass round the blind comer and into the larynx, some bougies have been manufactured to have a bent tip. Such bougies are inserted in an orientation in which the bent tip faces the anterior walls of the oropharynx, larynx and trachea. Once the bougie has entered the trachea, the clinician can locate it on the way down by feeling the clicks of the bent tip against the cartilage rings of the trachea. The clinician can also feel for the hold up sign when the tip of the bougie reaches the division of the trachea to know when to stop. Although the clicks are useful for locating the bougie on the way down, there is a tendency for the bent tip to be pressed onto the anterior wall of the trachea, or in a blind passage become lodged elsewhere in the glottis, placing the patient at risk of trauma, bleeding and oedema.
[0015] To further encourage the bougie around the blind comer, some clinicians add a gentle curve by bending the bougie about 10cm-15cm from the advancing tip. This helps to get the bougie past the tongue. Although it is helpful to add a gentle distortion to the bougie in this way, the flexibility of the bougie can make it difficult to manipulate the bougie from the end the clinician is holding. When the clinician tries to coax the bougie into the glottis, small changes in directional pressure at the proximal end can lead to much larger and more distorted moments of the tip, with the potential for kinking of the bougie in the patient’s mouth.
[0016] Stiffer bougies are more easily manipulated from the end the clinician is holding. However, these are more likely to induce trauma to the patient.
[0017] It has been found unexpectedly that a suitably shaped tubular guide for guiding a bougie into the patient’s trachea enables a straight, flexible bougie, such as a gum elastic bougie, to be conveniently inserted into the patient’s trachea without the risks associated with stiff bougies or bougies having a manufactured bent tip. The tubular guide also prevents the flexible bougie from kinking and distorting as described above This technique is somewhat counterintuitive because aids such as bougies are for guiding the insertion of another object and it is not normally expected that they themselves could benefit from an aid to be inserted.
[0018] An introducer 100 according to a first embodiment of the invention is shown in Figure 1. The introducer 100 comprises a tube 102 having a substantially straight proximal section 104 and a distal section 106 which comprises a curved portion 108.
[0019] The proximal section 104 of the introducer 100 is configured to be held, in use, by a clinician (or other user) and the distal section 106 of the introducer 100 is configured to be inserted, in use, at least partially into a patient’s oropharynx. The introducer 100 is shaped so that when its distal tip 110 is inside the patient’s oropharynx, the proximal section 104 lies partially outside the patient’s mouth, being held by the clinician, and partly over the patient’s tongue, and the curved portion 108 of the distal section 106 curves around the bend from the patient’s oral cavity to the oropharynx.
[0020] As can be seen from Figure 1, the proximal section 104 of the introducer 100 has an aperture 112 part-way along its length. The aperture 112 provides the clinician with access to the inside of the tube 102 for manipulating a bougie that has been inserted into the introducer 100 through the proximal tip 114 of the tube 102.
[0021] All introducers according to the invention may be provided in different sizes. For example, the introducers may be provided in one or more adult sizes and in one or more paediatric sizes. The introducer may also be provided in different veterinary sizes for veterinary medicine. It is to be appreciated that the different sizes may not be scale models of each other but rather will be suitably dimensioned for the anatomy of the patient.
[0022] For example, in the embodiment of Figure 1, the introducer 100 may be dimensioned as follows. In a size suitable for an adult, the distance along the length of the introducer 100 from the proximal tip 114 to the distal tip 110 may for example be 24cm. In embodiments of a variety of sizes including adult and paediatric sizes, this length may suitably be between 15cm and 30cm. In an adult size, the width of the proximal section 104 of the introducer 100 may for example be 1.6cm. In embodiments of a variety of sizes including adult and paediatric sizes, this width may suitably be between 1cm and 3cm. In an adult size, the width of the proximal tip 114 and/or distal tip 110 may for example be 1cm. In embodiments of a variety of sizes including adult and paediatric sizes, this width may suitably be between 0.5cm and 2.5cm. In an adult or paediatric size, the angle between the longitudinal axis of the proximal section 104 and the longitudinal axis of the distal section 106 may for example be 37 degrees. In various embodiments including adult sizes and paediatric sizes, this angle may suitably be between 30 degrees and 50 degrees. In adult or paediatric sizes, the thickness of the wall of the tube 102 may for example be 0.2cm. In various embodiments including adult sizes and paediatric sizes, this thickness may suitable be between 0.1cm and 0.3cm.
[0023] To operate the introducer 100, the clinician can first load it with a bougie. Referring to Figure 2, this is achieved by inserting a bougie 200 into the tube 102 of the introducer through its proximal tip 114. When the advancing tip 202 of the bougie 200 reaches the vicinity of the aperture 112, the clinician can manipulate the bougie 200 through the aperture 112 using his thumb, as shown. By pressing the bougie 200 and using friction between the bougie 200 and his thumb, the clinician can manipulate the bougie 200 and thereby advance the bougie 200 distally though the introducer 100 towards the distal tip 110. As a result, once the bougie 200 has been advanced to reach the aperture 112, the clinician can manipulate the bougie 200 using just one hand.
[0024] Figure 3 shows the bougie 200 after it has been advanced further along the introducer 100 in this way.
[0025] When the bougie reaches the curved portion 108 of the distal section 106 of the introducer 100, there is a tendency for it to be flexed in such a way that it is biased towards an upper aspect of the inner surface of the proximal section 104 of the tube 102. This creates a frictional contact between the bougie 200 and the inner surface the tube 102 that must be overcome in order to advance the bougie 200 distally within the introducer 100. By pressing the bougie 200 with his thumb through the aperture 112 to manipulate the bougie 200, the clinician at least partially disengages the bougie 200 from the inner surface of the tube 102 thereby at least partially overcoming the frictional contact between the bougie 200 and the tube 102. This enables the clinician to advance the bougie 200 along the introducer 100 using a smaller force than would be required if the bougie 200 were being manipulated from its proximal end. The aperture 112 thus enables the bougie 200 to be advanced through the introducer 100 with a smaller force and thereby reduces the risk of trauma to the patient.
[0026] The aperture 112 also advantageously enables the clinician to advance the bougie 200 through the introducer 100 using one hand only, as shown. This frees up the clinician’s other hand for operating other instruments such as a laryngoscope.
[0027] As can be seen from Figures 2 and 3, the aperture 112 may be elongated along the length of the introducer 100. In other words, the aperture 112 may be a slot oriented in the longitudinal direction of the proximal section 104. Figures 2 and 3 also show how providing this elongated aperture improves the usability of the introducer 100. As the clinician presses down on the bougie 200 through the aperture 112 with his thumb, he is able to advance the bougie 200 towards the distal section 110 of the introducer 100. Since the maintain the applied force on the bougie 200, as the bougie 200 is advanced distally. Thus, the clinician’s thumb moves with the bougie 200 until his thumb makes contact with the distal end of the slot. The clinician can then release his thumb and re-apply force on the bougie 200 at the other end of the slot and thereby further advance the bougie 200 distally in the introducer 100. The same principle applies if the clinician wishes to retract the bougie 200 proximally. The clinician can move his thumb (or other digit) in the aperture 112 in a proximal direction of the introducer 112, whilst applying a depressing force on the bougie 200, so as to retract the bougie 200 in a proximal direction inside the introducer 100 until the thumb makes contact with the proximal end of the slot. This movement, in either direction, can be repeated again and again as necessary. It is believed that the optimal length of elongated aperture is about 2.5cm to 4cm.
[0028] As shown, the aperture 112 is located on the opposite side of the introducer 100 to the direction in which the curved portion 108 curves. It is believed that from the point of view of the clinician operating the introducer 100, this is an ergonomic location of the aperture 112. However, in other embodiments of the invention the aperture may be located elsewhere in the proximal section, for example on the same side of the introducer 100 to the direction in which the curved portion 108 curves. For example, the aperture may be arranged so that the index finger of the clinician can manipulate the bougie.
[0029] To insert an endotracheal tube into the patient’s trachea, the clinician can first advance the bougie 200 through the introducer 100 until the advancing tip 202 of the bougie 200 is in the vicinity of the distal section 106 of the introducer 100, as shown in Figure 4. With the bougie 200 advanced into the introducer 100 in this way, the introducer 100 may be said to be loaded. Holding the loaded introducer 100 in one hand, the clinician’s other hand is free to hold a laryngoscope 400. The patient’s tongue 500 can then be held back using the blade 402 of die laryngoscope 400, while the loaded introducer 100 is operated by the clinician’s other hand.
[0030] To achieve this, the patient’s head is tipped back as shown in Figure 5, and the tongue 500 is held back by the blade 402 of the laryngoscope 400. The introducer 100 may be held over the patient’s head, as shown (clinician’s hands and bougie 200 not shown), before its distal section 106 is advanced through the patient’s oral cavity 502 and into the oropharynx 504.
[0031] Figure 6 shows in cross section the loaded introducer 100 positioned, in use, with its distal section 106 in the patient’s oropharynx 504 and the blade 402 of the laryngoscope 400 holding the patient’s tongue 500 out of the way (clinician’s hands not shown). Once this arrangement has been achieved, the clinician can further advance the bougie 200 through the introducer 100 by manipulating the bougie 200 through the aperture 112 of die introducer 100. The curved portion 108 of the introducer 100 enables the bougie 200 to be guided around the bend from the patient’s oral cavity 502 to the oropharynx 504. This is particularly advantageous when a direct view of the glottis is not available and the clinician has to advance the bougie 200 around a blind comer.
[0032] In order for the bougie 200 to reach the patient’s trachea 600, it may be necessary for the clinician to manipulate the bougie 200 through the aperture 112 by advancing and retracting the bougie to move it forwards and backwards as various parts of the patient’s anatomy are encountered. For example, the clinician will be able to feel if the advancing tip 202 of the bougie 200 is pressing against a wall of the oropharynx 504 and will be able to adjust the approach by retracting the bougie 200 slightly, reorienting the introducer 100, and advancing the bougie 200 again in an adjusted orientation.
[0033] The curved portion 108 of the introducer helps to guide the bougie around the bend of the patient’s oral cavity 502 to the oropharynx 504, past the epiglottis 602, and into the trachea 600.
[0034] In some embodiments of the invention there is provided an introducer similar to the first embodiment but having an inner formation of an inner surface of the proximal section of the tube. The inner formation extends into the lumen of the tube and is located so that, in use, a clinician can press a bougie inside the introducer through the aperture and thereby press the bougie against the inner formation. This reduces the friction between the bougie and the introducer because in at least part of the proximal section of the tube the bougie does not contact the inner surface of the tube but only contacts the inner formation. Since the friction is reduced, the clinician can manipulate the bougie through the aperture and thereby advance the bougie distally through the introducer with a reduced force.
[0035] For example, a cut-away of an introducer 700 according to a second embodiment of the invention is shown in Figures 7 and 8. The introducer 700 comprises an inner formation 702 comprising three corrugations 704, 706 and 708 extending into the lumen of the tube opposite the aperture 112. As described below, providing the inner formation opposite the aperture has the benefit of allowing the clinician to press the bougie directly on the formations through the aperture. Furthermore, as described below this arrangement may have manufacturing benefits. Nevertheless, the inner formation could be provided elsewhere along the length of the proximal section, not opposite the aperture, and have similar friction reducing benefits. The corrugations 704, 706 and 708 provide a support framework against which the clinician can manipulate a bougie, whilst maintaining a low level of friction between the bougie and the inner formation 702 by virtue of the spacings 710 and 712 between the corrugations 704, 706 and 708.
[0036] Each of the corrugations 704, 706 and 708 has a smooth surface so that, in use, a bougie inserted into the tube that is pressed by the user through the aperture is pressed against the smooth surface of each of the corrugations 704, 706, 708. The smooth surfaces of the inner formation 702 also help maintain friction between the bougie and the inner formation 702 at a low level, thereby making it possible for the clinician to manipulate the bougie through the aperture 112 to advance the bougie through the introducer 700 using a reduced force.
[0037] Another characteristic of the corrugations 704, 706 and 708 is that they are compressible and therefore provide the clinician with some give when manipulating a bougie against the inner formation 702. This helps the clinician to exert precise control over the bougie when manipulating it through the aperture 112 of the introducer 700. The compressibility of the corrugations 704, 706 and 708 is provided at least in part by their hollow form and their material, such as high density polyethylene.
[0038] An introducer 900 according to a third embodiment of the invention is shown in cross section in Figure 9. The introducer 900 is similar to the introducer 700 of the second embodiment except that its inner formation 902 comprises four corrugations 904, 906, 908 and 910. The corrugations 904, 906, 908 and 910 of the introducer 900 are identical to those of the introducer 700.
[0039] Although the inner formations 702 and 902 of the introducers 700 and 900 are located opposite the aperture 112, in other embodiments the inner formation may be translated along the length of the proximal section and may take other shapes, for example, a ring or a partial ring or bumps projecting into the lumen from the inner surface of the tube. In some embodiments the inner formation may not be corrugated or hollow but may still be compressible, for example by comprising an otherwise compressible material or structure.
[0040] In some embodiments of the invention there is provided an introducer similar to the first and second embodiments but also having an outer formation of an outer surface of the proximal section of the tube. In use, the clinician can apply counter-pressure by engaging the outer formation with his forefinger much like engaging a trigger while his thumb manipulates the bougie through the aperture. This enables the clinician to apply counter-pressure against which the bougie may be advanced distally through the introducer which aids controlled manipulation of the bougie for making fine adjustments to its position.
[0041] For example, a portion of an introducer 1000 according to a fourth embodiment of the invention is shown in cross section in Figure 10. Like the introducer 900, the introducer 1000 has an inner formation 902 with four corrugations 904, 906, 908 and 910 opposite the aperture 112. However, unlike the introducer 900 the introducer 1000 also has an outer formation 1002 extending away from a central axis of the proximal section of the tube. The bougie 200 is advanced distally from right to left in Figure 10. The outer formation 1002 has a steeply inclined distal surface 1004 against which the clinician’s forefinger can apply a counter-pressure much like using a trigger.
[0042] In other embodiments, the invention provides a second outer formation proximal to the first outer formation against which the clinician can exert counter-pressure against retracting the bougie 200. This enables the clinician to retract the bougie 200 if required in a finely controlled manner whilst negotiating the path of the bougie 200 towards the patient’s trachea 600.
[0043] In some embodiments, the invention provides an introducer having an inner formation but no outer formation.
[0044] In other embodiments, the invention provides an introducer having an outer formation that extends into the lumen of the tube and has a proximal surface against which the clinician can apply counter-pressure using his forefinger against which the bougie 200 may be advanced. The outer formation extending into the lumen may also have a distal surface against which the clinician can apply counter-pressure against which the bougie 200 may be retracted.
[0045] In some embodiments the outer formation comprises a textured portion of the outer surface of the proximal section of the tube. This provides friction and therefore enables the clinician to apply some counter-pressure against advancing and retracting the bougie 200 through the introducer. The textured portion may also provide a tactile guide for the clinician to orient the introducer, for example if it is located directly opposite the aperture.
[0046] The invention also provides other embodiments having other combinations of the different inner and outer formations described.
[0047] Furthermore, the invention provides embodiments in which the inner and outer formations are formed by one and the same formation comprising a portion of the tube wall shaped to protrude into the lumen. For example, a portion of an introducer 1100 according to a fifth embodiment of the invention is shown in cross section in Figure 11. The introducer 1100 has an inner formation and an outer formation, both of which are provided by a formation comprising a portion 1102 of the tube wall shaped to protrude into the lumen of the tube. The bougie 200 is advanced distally from left to right in Figure 11. The portion 1102 has a curved portion against which the clinician can apply counter-pressure using his forefinger when advancing the bougie 200. The bougie 200 may be advanced distally through the introducer 1100 against this counter-pressure. The curved portion also aids insertion of the bougie 200 into the introducer: if it were inserted towards a flat surface such as the distal portion 1104 it would be likely to get stuck at the flat surface and be more difficult to insert past the portion 1102. When retracting the bougie, the clinician may apply counter-pressure against the distal portion 1104 using his forefinger for retracting the bougie 200 in a controlled manner.
[0048] Introducers according to the invention may conveniently be manufactured as one piece by a moulding process, for example blow moulding. The material of the introducers is sufficiently stiff, once set, to enable the introducer to perform its guiding function for guiding a bougie. Suitable materials include plastics (for example polyethylene), metal, and ceramics. Alternatively, it may be convenient to provide the aperture by punching a hole in a suitably moulded tube having the required proximal and distal sections. If punching the aperture, it may be simple and inexpensive to punch straight through the preformed tube, thereby creating two apertures in the introducer directly opposite each other.
[0049] It is expected that providing the inner formation opposite the aperture will be beneficial for manufacturing the introducer. In any case, when made by a plastics moulding process, the mould may form both the aperture and the inner formation features from the same mould component. For instance, it is conceived that a moulding core, which moves during the moulding process in a perpendicular direction relative to the cavity surface forming the proximal section of the tube, may be used to form the aperture. This same core can be shaped so that it reaches over the entire width or diameter of the tube and can then form, on its top surface, a cavity that will produce the inner formations. Conceivably then, the moulding tool may consist of the tube forming mould halves and a sliding core that forms the aperture and the inner formations from one side of the tube mould. In this way, the undercuts that would be needed to form inner formations not directly opposite the aperture can be avoided.
[0050] Naturally, all of the inner formations described above could be formed in this manner.
[0051] It will be understood that the above description of preferred embodiments is given by way of example only and that various modifications may be made by those skilled in the art. Although various embodiments have been described above, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention as defined in the appended claims.

Claims (15)

1. A bougie introducer for introducing a bougie into a patient’s trachea, the bougie introducer comprising a tube having: a proximal section configured to be held, in use, by a user; and a distal section comprising a curved portion and being configured to be inserted, in use, at least partially into the patient’s oropharynx, wherein: the sections of the tube are proportioned so that, in use, the proximal section can be held by the user whilst the curved portion curves around the bend from the patient’s oral cavity to the oropharynx; and the proximal section has an aperture along its length so that in use the user can manipulate, through the aperture, a bougie inserted into the tube and thereby advance the bougie distally through the bougie introducer and into the patient’s trachea.
2. A bougie introducer according to claim 1, wherein the aperture is located on the opposite side of the bougie introducer to the direction in which the curved portion curves.
3. A bougie introducer according to claim 1 or 2, comprising an inner formation of an inner surface of the proximal section of the tube, the inner formation extending into the lumen of the tube and being located so that, in use, a user can press a bougie inside the bougie introducer through the aperture and thereby press the bougie against the inner formation.
4. A bougie introducer according to claim 3, wherein the inner formation is located opposite the aperture.
5. A bougie introducer according to claim 3 or 4, wherein at least part of the inner formation has a smooth surface so that, in use, a bougie inserted into the tube that is pressed by the user through the aperture is pressed against the smooth surface of the inner formation.
6. A bougie introducer according to claim 3, 4 or 5, wherein at least part of the inner formation is compressible.
7. A bougie introducer according to any preceding claim, comprising an outer formation of an outer surface of the proximal section of the tube so that, in use, the user can apply counter-pressure by engaging the outer formation with the user’s forefinger while the user’s thumb manipulates the bougie through the aperture.
8. A bougie introducer according to claim 7, wherein the outer formation extends away from a central axis of the proximal section.
9. A bougie introducer according to claim 7, wherein the outer formation extends into the lumen of the tube.
10. A bougie introducer according to claim 9 when dependent on claim 3, wherein the inner formation and the outer formation comprise a portion of the tube wall shaped to protrude into the lumen of the tube.
11. A bougie introducer according to claim 7, wherein the outer formation comprises a textured portion of the outer surface of the proximal section of the tube.
12. A method of manufacturing a bougie introducer for introducing a bougie into a patient’s trachea, the method comprising providing a tube having: a proximal section configured to be held, in use, by a user; and a distal section comprising a curved portion and being configured to be inserted, in use, at least partially into the patient’s oropharynx, wherein: the sections of the tube are proportioned so that, in use, the proximal section can be held by the user whilst the curved portion curves around the bend from the patient’s oral cavity to the oropharynx; and the proximal section has an aperture part-way along its length so that in use the user can manipulate, through the aperture, a bougie inserted into the tube and thereby advance the bougie distally through the bougie introducer and into the patient’s trachea.
13. A method according to claim 12, comprising providing the tube as one piece by moulding.
14. A method according to claim 12, comprising providing the aperture by a punching operation on a tube not having an aperture.
15. A method according to claim 14, comprising providing a second aperture by the punching operation.
GB1517170.5A 2015-09-28 2015-09-28 Bougie introducer Expired - Fee Related GB2542640B (en)

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US20170157349A1 (en) * 2015-12-08 2017-06-08 Boyi Gao Device for gripping and directing bougies for intubation
WO2019136127A1 (en) * 2018-01-05 2019-07-11 Medrobotics Corporation Introducer for articulatable probe
US11724053B2 (en) 2020-04-01 2023-08-15 Boyi Gao Device for gripping and securing an intubation bougie

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GB2454018A (en) * 2007-10-26 2009-04-29 Dr David W Green Introducer device for bougie tube
WO2011012677A1 (en) * 2009-07-29 2011-02-03 Schoenhage Kai Intubation instrument
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GB2454018A (en) * 2007-10-26 2009-04-29 Dr David W Green Introducer device for bougie tube
WO2011012677A1 (en) * 2009-07-29 2011-02-03 Schoenhage Kai Intubation instrument
US20110077466A1 (en) * 2009-09-25 2011-03-31 Spectrum Health Innovations, LLC Laryngoscope guide and related method of use

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170157349A1 (en) * 2015-12-08 2017-06-08 Boyi Gao Device for gripping and directing bougies for intubation
US10272217B2 (en) * 2015-12-08 2019-04-30 Boyi Gao Device for gripping and directing bougies for intubation
WO2019136127A1 (en) * 2018-01-05 2019-07-11 Medrobotics Corporation Introducer for articulatable probe
US11724053B2 (en) 2020-04-01 2023-08-15 Boyi Gao Device for gripping and securing an intubation bougie

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GB201517170D0 (en) 2015-11-11

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