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    • 专利摘要:
    An insertion tube 12 for a flexible bronchoscope (1) for use in intensive care procedures includes a proximal portion (121), a distal portion (122), a docking pedestal camera (124) at the distal end of the distal portion (122) and at least one connecting and transmitting wire (125) extending from the camera docking stand (124) along from the insertion tube (12) to the proximal end of the proximal portion (121); each of the proximal and distal portions (121, 122) having an inside diameter of at least 2 mm, preferably at least 2.1 mm, forming a suction channel and an outside diameter; wherein the outer diameter of the proximal portion (121) is at most 4 mm and the length of the proximal portion (121) is at least 20 cm, preferably at least 25 cm, preferably at least minus 30 cm, preferably at least 35 cm. The invention also relates to a flexible bronchoscope (1) comprising such an insertion tube 12, a method of selecting an insertion tube for the flexible bronchoscope and a method of using the flexible bronchoscope.
    公开号:BE1023973B1
    申请号:E2016/5567
    申请日:2016-07-06
    公开日:2017-09-28
    发明作者:Antoine Guillon
    申请人:INSERM (Institut National de la Santé et de la Recherche Médicale)；Universite De Tours Francois Rabelais；Chru De Tours；
    IPC主号:
    专利说明:

    INSERTION TUBE FOR SOFT BRONCHOSCOPE
    Technical Field of Invention
    The present invention relates to the technical field of bronchoscopy and the tools for performing bronchoscopy. In particular, the present invention relates to the technical field of the bronchoscope, especially a flexible bronchoscope for use in intensive care procedures using an endotracheal tube and its components. The invention also relates to methods of selecting an insertion tube for the bronchoscope and use of the bronchoscope. State of the art
    Flexible bronchoscopes are mandatory tools in intensive care units. They are essential for optimal management of ventilated patients (mechanically), and are used for both diagnostic and therapeutic purposes. They include a suction channel to extract secretions produced inside the lung, and optical fibers that guide the light to and from the operative site.
    Bronchoscopy in ventilated patients, i.e. patients who can breathe normally without artificial assistance, are generally safe and do not present any particular technical problems [Lindholm CE, Turner, Terzi, 1-3].
    However, when patients can not breathe on their own, an intensive care procedure must be followed and the patient must be intubated to provide mechanical ventilation: air (or other gas mixture) is introduced into the patient's lungs under positive pressure by an endotracheal tube. At the time of intubation of the patient, the size of the endotracheal tube, i.e. length and diameter, is usually selected according to the morphology of the patient and not for the purpose of being able to insert a flexible bronchoscope if this is needed later. In fact, not all patients received in the intensive care unit need bronchoscopy, and for intubated patients for a long period of time, endotracheal tubes with dimensions adapted to their morphology are less invasive and, as such, minimize medical complications.
    In some cases, it is necessary to perform bronchoscopy on mechanically ventilated patients, especially when secretions fill their lungs. In order to extract secretions, flexible bronchoscopes have a suction channel.
    However, bronchoscopy during intensive care procedures is more delicate since it involves inserting a flexible bronchoscope into the endotracheal tube with which the patient is intubated. As such, the bronchoscope can significantly affect ventilation because it partially obstructs the passage of gas flow into the endotracheal tube and increases resistance in the endotracheal tube and lungs, thereby limiting the inspiratory and expiratory flow rate. [Lawson RW, 4], thus leading to potentially life-threatening situations, in particular, because the rapid decrease in expiratory flow results in a volume of air trapped inside the lung and can lead to ultimately to a pneumothorax [Nay MA, 5]. Indeed, pneumothorax cases have been reported in the two major observational studies that examined the safety of bronchoalveolar lavage performed with a flexible bronchoscope in mechanically ventilated patients [Turner, Steinberg 2, 6].
    In addition, bronchoscopy may present a particular challenge in patients with acute respiratory distress syndrome (ARDS): the occurrence of pneumothorax in mechanically ventilated patients with ARDS occurs in approximately 6.5 to 12% of cases [Anzuetto, Gamon 7, 8]. Patients with ARDS require ventilation strategies that protect the lungs to prevent ventilator-induced lung injury [Molooney 9].
    To make fiber optic bronchoscopy safer for intubated patients, narrower bronchoscopes have been developed [Diaz Fuentes, 10]. However, the reduction in the width of existing bronchoscopes consists in reducing the width of the suction channel because of the presence of optical fibers in the walls of flexible bronchoscopes. Optical fibers are needed to visualize the operative site inside the patient's body. The presence of optical fibers makes the thinning of the walls impossible.
    Thus, as noted above, intubated patients have thick secretions that must be removed from the lung. A narrower suction channel makes it almost impossible to extract secretions or bronchoalveolar lavage.
    As a result, existing solutions are unsatisfactory and there is still a need to improve soft bronchoscopes. Summary of the invention
    An object of the invention is thus to overcome at least one of the disadvantages of the state of the art. More particularly, an object of the invention is to provide a flexible bronchoscope that allows both to be used with an endotracheal tube and has a sufficient suction capacity. For these purposes, the present invention provides an insertion tube for a flexible bronchoscope for use during an intensive care procedure using an endotracheal tube, which has a proximal portion, a distal portion, a pedestal, securing camera at the distal end of the distal portion and at least one connecting and transmitting wire extending from the camera docking stand, along the insertion tube to the proximal end of the proximal part; each of the proximal and distal portions having an inside diameter of at least 2 mm, preferably at least 2.1 mm, forming a suction channel and an outside diameter; wherein the outer diameter of the proximal portion is at most 5 mm, preferably at most 4.6 mm, preferably at most 4 mm, the length of the proximal portion being at least 20 cm, preferably at least 25 cm, preferably at least 30 cm, preferably at least 35 cm.
    The present invention also provides an insertion tube for a flexible bronchoscope for use during an intensive care procedure using an endotracheal tube having a luminal cross section and a length, the insertion tube having a proximal portion intended to remain within the endotracheal tube, a distal portion extending out of the endotracheal tube, a camera docking pedestal at the distal end of the distal portion and a linkage and transmission extending from the camera docking stand, along the insertion tube to the proximal end of the proximal portion; each of the proximal and distal portions having an internal diameter of at least 2 mm, preferably at least 2.1 mm, forming a suction channel and an outside diameter, the outer diameter of the proximal portion being at most 5 mm, preferably at most 4 mm; wherein the proximal portion has a selected outer cross section so that the difference in area between the cross section of the endotracheal tube lumen and the outer cross section is at least 20 mm 2, preferably at least 23 mm 2 mm 2, preferably at least 29 mm 2; wherein the proximal portion is longer than the endotracheal tube length. The invention also provides an insertion tube for a flexible bronchoscope for use during a critical care procedure, which includes a proximal portion, a distal portion, and a camera docking pedestal at the level of the distal end of the distal portion and a connecting wire extending from the camera docking stand, along the insertion tube to the proximal end of the proximal portion; each of the proximal and distal portions having an inside diameter of at least 2 mm, preferably at least 2.1 mm, forming a suction channel and an outside diameter; wherein the outer diameter of the proximal portion is 4 mm, the length of the proximal portion being at least 30 cm.
    Such insertion tubes make it possible to ensure that the cross section of the passage of air is sufficient between the endotracheal tube and the insertion tube to ventilate the intubated patient with a minimized risk while allowing effective extraction of the secretions from the inside of the patient's lung, also with a minimized risk.
    In one embodiment of one of the above insertion tubes, the distal portion has an outer cross section wider than the outer cross section of the proximal portion.
    Additionally or alternatively, the insertion tube further includes a light source docking pedestal at the distal end of the distal portion.
    The insertion tube described above is used as a component of a flexible bronchoscope for use in intensive care procedures. Advantageously, this flexible bronchoscope further comprises a camera permanently stowed or releasably stowed to the camera docking station. Advantageously, this flexible bronchoscope further comprises a light source permanently stowed or releasably stowed to the light source docking base when the insertion tube is provided with such a base. This flexible bronchoscope further advantageously comprises a handle provided with a deflection control, the handle being permanently connected or releasably connectable to the proximal end of the proximal portion of the insertion tube.
    In another aspect of the present invention, there is provided a method of selecting an insertion tube for a flexible bronchoscope for use during an intensive care procedure using an endotracheal tube. In this method, the endotracheal tube has a luminal cross section and a length, and the insertion tube has a proximal portion having an outer cross-section, a distal portion, and a camera docking pedestal at the distal end. the distal portion and a connecting and transmitting wire extending from the camera docking pedestal along the insertion tube to the proximal end of the proximal portion; wherein the insertion tube is selected such that the difference in area between the cross section of the lumen of the endotracheal tube and the outer cross section is at least 20 mm 2, preferably at least 23 mm 2, preferably at least 29 mm 2, and so that the proximal portion is longer than the length of the endotracheal tube.
    The endotracheal tube generally has a length of 20 cm, 30 cm or more.
    The endotracheal tube may have an internal diameter of respectively 6.5 mm, 7 mm, 7.5 mm and 8 mm, the outer diameter of the proximal portion of the selected insertion tube thus being respectively at most 4.10 mm, 4.85 mm, 5.55 mm, 6.21 mm, preferably respectively at most 3.60 mm, 4.44 mm, 5.19 mm, 5.89 mm.
    Preferably, the outer diameter of the proximal portion of the selected insertion tube is 4 mm.
    Still in another aspect of the present invention, a method of using a flexible bronchoscope as described above is provided. This method comprises the steps of: - selecting an insertion tube for the flexible bronchoscope according to the corresponding method described above; - insert the flexible bronchoscope into the endotracheal tube at least until the distal part of the insertion tube is completely out of the endotracheal tube.
    Drawings Further objects, advantages and features of the present invention will be apparent from reading the following description of exemplary embodiments and illustrated with reference to the accompanying illustrative but nonlimiting drawings, of which: FIG. a schematic representation of a flexible bronchoscope according to the invention inserted into an endotracheal tube; Fig. 2 is a diagram showing the percentage of the minute ventilation versus baseline (minute ventilation measured without soft bronchoscope inserted into the endotracheal tube) for healthy lungs at a PIPmax of 60 cm 2 O 2;
    Figure 3 is a diagram showing the percentage of minute ventilation versus baseline for lungs with ARDS at a PIPmax of 60 C111H2O; Figure 4 is a diagram showing the difference in PEEP in the lungs after insertion of a flexible bronchoscope into the endotracheal tube, relative to the baseline for healthy lungs at a PIPmax 100 cmH20; Fig. 5 is a diagram showing the difference in PEEP in the lungs after insertion of the flexible bronchoscope into the endotracheal tube, relative to the baseline for lungs with ARDS at 100 cmH 2 PIPmax; Figure 6 is a diagram showing the aspiration rate in a bronchoscope with the insertion tube of the invention and in a pediatric bronchoscope at a vacuum level of -150 mmHg; and Fig. 7 is a diagram showing the aspiration rate in a bronchoscope with the insertion tube of the invention and in a pediatric endoscope at a vacuum level of -300 mmHg.
    Description of the invention
    The insertion tube of the invention is a component of a flexible bronchoscope which is dedicated to use during an intensive care procedure using an endotracheal tube. As mentioned earlier, endotracheal tubes vary in size, especially in length and internal diameter. In order to allow sufficient ventilation, it is important to correctly select the insertion tube. An endotracheal tube typically has an elongated body having a lumen therein.
    The insertion tube of the invention is described below with reference to FIG.
    The insertion tube 12 has a proximalel21 portion, a distalel22 portion, a camera docking stand 124 and at least one connecting and transmitting wire 125.
    In the present description, the words "proximal" and "distal" are two opposite terms and considered with respect to the operator and not with respect to the patient. The term "proximal" is understood to mean closer to the operator's hand, while "distal" is understood to mean further away from the operator's hand.
    The proximal portion 121 is intended to remain in the endotracheal tube 2 while the distal portion 122 is intended to extend outside the endotracheal tube 2 during use. Each of the proximal and distal portions 122 of the insertion tube 12 has an inner diameter delimiting a suction channel 123 and an outer diameter. The inner diameter of the proximal distal portion 122 is at least 2 mm, preferably at least 2.1 mm.
    The outer diameter of the proximal portion 121 is at most 5 mm, at most 4.5 mm, preferably at most 4 mm. The length of the proximal portion 121 is at least 20 cm, preferably at least 25 cm, preferably at least 30 cm, preferably at least 35 cm.
    Alternatively, the proximal portion 121 has an outer cross section defined by the outer diameter selected so that the difference in area between the cross section of the lumen of the endotracheal tube (defined by its inside diameter) and the outer cross section is at least 20 mm 2, preferably at least 23 mm 2, preferably at least 29 mm 2. The proximal portion 121 also needs to be longer than the length of the endotracheal tube 2, and the inner diameters that form a suction channel 123 of the two proximal 121 and distal 122 portions of the insertion tube 12 are from minus 2 mm, preferably at least 2.1 mm.
    The dimensions of the distal portion 122 of the insertion tube 12 that are not mentioned above must be sufficient to accommodate a miniaturized camera and for the distal portion 122 to be inserted into the endotracheal tube 2 through the proximal end of the endotracheal tube. 2 and so at the distal end of the endotracheal tube 2. As only the proximal portion 121 of the insertion tube 12 is responsible for the obstruction of the air flow path in the endotracheal tube 2, the outer diameter Distal portion 122 does not need to meet other requirements than those mentioned above. Thus, the distal portion 122 may have an outer cross section wider than the outer cross section of the proximal portion 121 particularly to receive a miniaturized camera, or in other words an outer diameter wider than the outer diameter of the For example, the outer diameter of the distal portion 122 is less than 5.3 mm while being larger than the outer diameter of the proximal portion 121. The length of the distal portion 122 is preferably 8 cm or less.
    The camera docking stand 124 is located at the distal end of the distal portion 122. The camera docking stand 124 is for receiving a miniaturized camera 16 for acquiring an image of the operating site inside the patient's body. The camera docking stand 124 is preferably integrated in the wall of the distal portion 122, e.g. a small non-through hole provided at the end of the distal portion 122, the cross section of which is chosen such that the miniaturized camera 16 to be stowed inside thereof fits perfectly, without play. Preferably, the depth of the small non-through hole corresponds to the length of the miniaturized camera 16 to be stowed inside thereof. As such, the camera docking stand 124 is positioned side by side with respect to the suction channel 123. The use of a miniaturized camera 16 for visualization at the operating site requires only one wire. link and transmission 125 which extends along the insertion tube 12, optionally outside the insertion tube 12 but preferably in the wall of the insertion tube 12 or integrated therewith, since the camera docking station 124 to the proximal end of the proximal portion 121.
    It is not necessary to have optical fibers, which are usually incorporated into the wall of a flexible bronchoscope of the state of the art, which made it impossible to thin the wall of the insertion tube 12. On the other hand, in the insertion tube 12 according to the invention, the connecting and transmission wire 125 makes it possible to have a thinner wall for the insertion tube 12, thus making it possible to reduce the outside diameter of the tube. insertion 12 and the simultaneous presence of a suction line 123 wide.
    The link and transmission wire 125 both powers the miniaturized camera 16 and transmits the data acquired by the miniaturized camera 16, for example to a computer system for processing and displaying the data. Here, the insertion tube 12 is described with only a connecting and transmitting wire 125, however, it is possible to provide a wire for connecting, i.e. supplying electricity, the miniaturized camera 16 and another wire for transmitting the data acquired by the miniaturized camera 16. The term "connecting wire and transmission" includes the direction of a wire dedicated to the link and another wire dedicated to the transmission. The outer diameter of the connecting and transmitting wire is preferably 1 mm or less. When there is a wire dedicated to the link and another wire dedicated to the transmission, the outer diameter of each of these son is preferably 1 mm or less.
    The insertion tube 12 is typically free of optical fibers that are used to transport light from the distal portion 122 to the proximal portion 121 so as to obtain an image of the operative site. Indeed, the image data are transmitted from the miniaturized camera 16 by the transmission wire 125.
    The insertion tube 12 also generally comprises two guide cables which extend over the entire length of the insertion tube 12, preferably integrated in the wall of the insertion tube 12. Each of the guide cables comprises a connecting end for connection to the handle (see below), the other end being placed in the distal portion 122. These guide wires are sufficiently thin so that their integration into the wall of the insertion tube 12 is not a limiting factor for the suction channel. The outer diameter of the guidewires is preferably 0.5 mm or less.
    The insertion tube 12 may further include a light source docking station 126 at the distal end of its distal portion 122 to receive a light source 17. The insertion tube 12 may further comprise a power supply wire 127 for supplying electricity to the light source 17, possibly outside the insertion tube 12 but preferably in the wall of the insertion tube 12 or integrated therewith. The outer diameter of the power supply wire is preferably 1 mm or less.
    The insertion tube 12 may be used as a component of a flexible bronchoscope 1. Advantageously, the insertion tube 12 is disposable, thereby forming a disposable portion of the flexible bronchoscope 1.
    The flexible bronchoscope 1 may further comprise a camera 16, preferably a miniaturized camera 16. The camera 16 can be permanently docked to the camera docking station 124. In such a case, the insertion tube 12 is provided with the camera 16 and, if disposable, the camera 16 is also a disposable camera. Alternatively, the camera 16 may be releasably stowed to the camera docking station 124. For the connection of the camera 16 to the link and transmission wire 125, a connection may be provided on the camera docking station 124. which is used to simultaneously connect and fix the camera 16 on the camera docking stand 124. The camera 16 typically has a lens coupled to light sensors. The light sensors are then connected to an output port connected to the transmission wire 125.
    The flexible bronchoscope 1 may further comprise a light source 17. The light source 17 is typically an LED system comprising at least one LED, preferably a white LED system (s). The light source 17 may be permanently stowed to the light source docking station 126. In such a case, the insertion tube 12 is provided with a source of light 16 and, if disposable, the light source 17 is also a disposable light source. Alternatively, the light source 17 can be releasably stowed to the light source docking station 126. For the connection of the light source 17 to the power supply wire 127, a connection can be provided on the base light source securing device 126 which is used to simultaneously connect and fix the light source 17 on the light source docking station 126. The combined use of a miniaturized camera and a source of light light placed directly at the distal portion of the insertion tube provides one of the best results, especially because the outer diameter of the proximal portion can be reduced up to 4 mm and below, while the need for fiber optics in the bronchoscope of the state of the art excluded this innovation. In addition, the use of a miniaturized camera and a light source makes it possible to manage, without bulky and bulky apparatus, the production of light and the treatment of the light received from the operating site in image data.
    The flexible bronchoscope 1 advantageously comprises a handle 14 provided with a deflection control. The deflection control controls the other ends of the guidewires in two opposite directions (e.g., up / down or right / left) or in two pairs of opposite directions, a pair of opposing directions preferably being normal to the other pair opposite directions. In one embodiment, the handle 14 is permanently connected to the proximal end of the proximal portion 121 of the insertion tube 12. In such a case, the insertion tube 12 is provided with the handle 14. Alternatively the handle 14 can be releasably connected to the proximal end of the proximal portion 121 of the insertion tube 12.
    Table 1 below summarizes the different possibilities:
    Table 1: Possible combinations
    The term "releasably" means that the elements are intended to be connected to each other and detached from each other by the user. The term "permanently" means that the elements are not intended to be detached from each other by the user.
    The different embodiments of the table above have different advantages. For example, in Embodiment A, it is possible to provide a handle and a camera that are reusable; only the insertion tube is disposable. This reduces the task of cleaning the insertion tube between uses for different patients. The handle and the camera are preferably reusable because of their manufacturing costs.
    In Embodiment D, both the handle and the camera are permanently connected to the insertion tube. This reduces the task of mounting the bronchoscope prior to use, which can be very useful in emergency situations when prompt medical help is needed to save the patient's life.
    A method of selecting an insertion tube for a flexible bronchoscope for use in an intensive care procedure using an endotracheal tube having a luminal cross-section and a length is described below.
    This method is intended to be used with the insertion tube described above. The method includes selecting the insertion tube such that the difference in area between the cross section of the lumen of the endotracheal tube and the outer cross section of the proximal portion of the insertion tube is at least 20 mm 2 preferably at least 23 mm 2, preferably at least 29 mm 2, and so that the proximal portion is longer than the length of the endotracheal tube.
    In the case of an endotracheal tube having a length of 20 cm, 30 cm or more, the proximal portion of the insertion tube should be at least 20 cm, 30 cm or more, respectively.
    When the endotracheal tube has an internal diameter of respectively 6.5 mm, 7 mm, 7.5 mm and 8 mm, the outer diameter of the proximal portion of the selected insertion tube thus being respectively at most 4.10 mm, 4.85 mm, 5.55 mm, 6.21 mm, preferably respectively at most 3.60 mm, 4.44 mm, 5.19 mm, 5.89 mm, preferably at most 2.31 mm, respectively mm, 3.48 mm, 4.40 mm, 5.20 mm.
    In a preferred embodiment, the outer diameter of the proximal portion of the selected insertion tube is 4 mm. This appears to be an optimal diameter that can be used with most existing endotracheal tubes.
    A method of using the flexible bronchoscope according to the invention comprises the steps of: - selecting an insertion tube for the flexible bronchoscope according to the method described above; and - insert the flexible bronchoscope into the endotracheal tube at least until the distal portion of the insertion tube is completely out of the endotracheal tube.
    In the case where the bronchoscope is supplied as a kit, the different components of the bronchoscope are mounted with each other before inserting the flexible bronchoscope into the endotracheal tube.
    Examples
    Flexible bronchoscopes with insertion tubes having a proximal portion of various outer diameters were tested in endotracheal tubes of various inner diameters.
    Four different endotracheal tubes with different inner diameters were used: 6.5 mm; 7.0 mm; 7.5 mm and 8.0 mm in diameter (referred to as "EXT X.X" in the figures). Six different insertion tubes were tested, the proximal portion of which had an outer diameter of 5.3 mm, 4.6 mm, 4.0 mm, 3.3 mm and 2.6 mm.
    Table 2 shows the difference between the cross section of the lumen of the endotracheal tube used and the external cross section of the proximal portion of the insertion tube used.
    (values are in mm and mm2) * Comparative examples
    Table 2: Difference in area between the cross section of the endotracheal tube lumen and the outer cross section of the proximal portion of the insertion tube
    All combinations were tested on a high fidelity breathing simulator (Model 5600i, Dual Adult Pneuview System, Michigan Instruments, Grand Rapids, USA). This breathing simulator simulates respiratory mechanisms in adults with normal pulmonary compliance and airway resistance (hereafter referred to as "healthy lungs") and pathological pulmonary function corresponding to acute respiratory distress syndrome (referred to herein as "healthy lungs"). after "SDRA lungs").
    The parameters for the SDRA lungs were based on the PROSEVA | Guerin, ll] study and corresponded to a severe ARDS according to the Berlin definition criteria. An EVITA XL ventilator (Drager Medical GmBH, Lübeck, Germany) was used for mechanical ventilation; it was connected to the endotracheal tube (hereinafter referred to as "ETT") and to the lung model using standard ventilator tubing, and a volume-controlled ventilation mode was used.
    A simulation of ventilation for healthy lungs was performed as follows: a respiratory volume at 550 ml, a respiratory rate at 14 / min, a positive end-expiratory pressure (PEEP) at 5 cmH2O (4.90 mbar) , an inspiratory flow (IF) at 60 L / min, a compliance at 100 mL / cmH2O (101.97 mL / mbar), an inspiratory / exhalation time ratio at 0.5.
    A simulation of ventilation for ARDS lungs was performed as follows: a respiratory volume at 380 ml, a respiratory rate at 27 / min, a PEEP at 10 cmH2O (9.81 mbar), an IF at 60 L / min, compliance at 35 mL / cmH2O (35.69 mL / mbar), an inspiratory / exhalation time ratio of 0.5.
    In practice, when a flexible bronchoscope is in place in a mechanically ventilated patient, the high pressure limit is often increased to a maximum value to maintain ventilation. For testing purposes, the high pressure limit (PIPmax) was first arbitrarily set to 60 cmH2O (58.84 mbar) and the efficiency of mechanical ventilation was observed. The effectiveness of mechanical ventilation is measured by the minute ventilation, evaluated by the spirometer of the ventilator.
    The results are shown in Figure 2 for "healthy lungs" and in Figure 3 for "ARDS lungs", where measured VM minute ventilations are given as a percentage of baseline minute ventilations, e.g. without the flexible bronchoscope inserted into the endotracheal tube.
    Minute breakdowns were considered "unmodified" if the VM is 95 to 100% of the baseline, "acceptable" if the VM is 75 to 95% of the baseline and "significantly changed" if the VM is less than 75% of the baseline.
    The lung model provided measurements for alveolar pressures with a manometer, which were used to determine total PEEP. The increase in PEEP in the lungs (total PEEP - initial PEEP) was measured after increasing the high pressure limit to the maximum value.
    The two peak peak inspiratory pressure levels were thus 60 cmH 2 O (58.84 mbar) and 100 cmH 2 O (98.07 mbar).
    The results are shown in Figure 4 for "healthy lungs" and in Figure 5 for "ARDS lungs".
    An increase equal to or less than 2 cmH2O (1.96 mbar) of total PEEP is considered clinically acceptable.
    For "healthy lungs", when PIPmax was set at 60 cmEbO with a 5.3 mm bronchoscope, ventilation was "unmodified" only for the 8.0 mm endotracheal tube, and "significantly modified" for the other endotracheal tubes (60% of the VM were delivered with the 7.5 mm endotracheal tube, 40% of the VM with the 7.0 mm endotracheal tube, and ventilation was not possible with an endotracheal tube of 6 , 5 mm). With a 4.6 mm bronchoscope, ventilation was "unmodified" for the 7.5 mm endotracheal tube, "acceptable" for the 7.0 mm endotracheal tube, and was "significantly modified" for the endotracheal tube 6.0 mm. With a 4.0 mm bronchoscope, ventilation was "unmodified" for 7.0 mm and 7.5 mm endotracheal tubes, and was "acceptable" for the 6.5 mm endotracheal tube. For all smaller bronchoscope sizes, ventilation was "unmodified" for all endotracheal tubes.
    When the PIPmax was set to 100cmH2O, the lung was effectively ventilated but the total PEEP increased proportionally, leading to an equivalent increase in plateau pressure. Specifically, the delivered volume was unchanged from baseline after bronchoscopes were inserted, except for the 5.3 mm bronchoscope in the 6.5 mm and 7.0 mm endotracheal tubes and the 4 bronchoscope. , 6 mm in the endotracheal tube of 6.5 mm. However, total PEEP and plateau pressure increased immediately after insertion of a 5.3 mm bronchoscope under all conditions. With the 4.6 mm bronchoscope, total PEEP Δ was only clinically acceptable for 7.5 and 8.0 mm endotracheal tubes. With a bronchoscope of 4.0 mm (or narrower), total ΔΡΕΕΡ was clinically acceptable for all endotracheal tubes, except for 6.5 mm endotracheal tubes. The increase in plateau pressure was almost identical to the increase in PEEP under all conditions.
    Regarding the ARDS lungs, when PIPmax was set at 60 cmt-fO, with a 5.3 mm bronchoscope, ventilation was only possible with 7.5 mm or 8 mm endotracheal tubes, and was "significantly modified" for the 7.5 mm endotracheal tube; ventilation was impossible with the smaller endotracheal tubes. With the 4.6 mm bronchoscope, ventilation was "unmodified" with the 7.5 mm endotracheal tube, "significantly modified" with the endotracheal tube 7.0 mm and impossible with an endotracheal tube of 6, 5 mm.
    When PEPmax was set at 100 cmH 2 O, recovery of delivered volume was identical to that of the "healthy lungs" condition (see above); however, total PEEP has increased significantly and led to an equivalent rise in plateau pressure. With a 5.3 mm bronchoscope, total ΔΡΕΕΡ and plateau pressure increased immediately under all conditions. The total ΔΡΕΕΡ was clinically acceptable only with an 8.0 mm endotracheal tube, and the total ΔΡΕΕΡ was +5 cmH20 with a 7.5 mm endotracheal tube, and +6 cmH20 with an endotracheal tube of 7.0 mm. With a 4.6 mm bronchoscope, total ΔΡΕΕΡ was clinically acceptable for 7.5 mm and 8.0 mm endotracheal tubes; total ΔΡΕΕΡ increased by +4 cmH20 with an endotracheal tube of 7.0 mm and +7 cmH20 with an endotracheal tube of 6.5 mm. With a bronchoscope of 4.0 mm, total PEEP Ala was clinically acceptable for endotracheal tubes of 7.0 mm to 8.0 mm, and was +3 cmH20 with a 6.5 mm endotracheal tube. For all smaller sizes, total ΔΡΕΕΡ was clinically acceptable for all endotracheal tubes. In all these conditions, the change in plateau pressure was equal to the increase in PEEP.
    The authors of the present invention have shown that although the insertion tube in the pediatric bronchoscope may have a narrower diameter compared to the bronchoscope used for adults, its suction channel is not wide enough to ensure effective suction when used for adults. Indeed, they compared the efficiency of the suction channel in the bronchoscope comprising the insertion tube of the present invention with that of a pediatric bronchoscope (model FI-10RBS, Pentax, Hamburg, Germany). This pediatric bronchoscope had an external insertion tube diameter of 3.5 mm and an internal diameter of 1.3 mm (suction channel). The insertion tube of the present invention had an outer diameter at the proximal portion of 3.6 mm and 5.3 mm at the distal portion, which was about 2 cm long. The inside diameter was 2.1 mm (suction channel).
    In order to test the capacity of the suction channel of each soft bronchoscope, the suction flow rate was measured with two vacuum levels, -150 mmHg and -300 mmHg, using a Lagoon 600 device from Air Liquid Medical System, Puteaux, France and measuring the time required to aspirate 100 mL of sterile water (from Versylène Fresenus, Louviers, France) or 100 mL of viscous water to simulate thick secretions. The viscous water was obtained from a dilution of 3% ultrasonic gel (Uni'gel, Aseptin Med, Quint Fonsegrives, France) in water. Each experiment was repeated three times; the average values of the suction flow rate are presented.
    A high fidelity respiratory simulator (Model 5600i, Dual Adult Pneuview System, Michigan Instruments, Grand Rapids, USA) has been used to simulate the respiratory mechanisms of adults with pathological pulmonary function corresponding to severe ARDS. The parameters for the SDRA lung were based on the PROSEVA study [11] and corresponded to a severe ARDS according to the Berlin definition criteria [12]. An EVITA XL ventilator (Dräger Medical GmBH, Lübeck, Germany) was used for mechanical ventilation; it was connected to the endotracheal tube and the pulmonary model using standard ventilator tubing. In accordance with guidelines for the management of ventilator settings [13] for severe ARDS, a volume-controlled ventilatory mode with a respiratory volume of 380 mL, a respiratory rate of 27 min-1, PEEP at 10 cmH20 an inspiratory flow rate of 60 L / min and an inspiratory time of 0.5 were used. The compliance of the artificial lungs was 35 mL / cmH2O. In practice, when a bronchoscope is in place in a ventilated patient, the high pressure limit is often increased to a maximum value to maintain ventilation. Initially, the inspiratory pressure limit was arbitrarily set to 60 cmH20 and ventilation efficiency was observed. The inspiratory pressure limit was then increased to a maximum value (100 cmH2O).
    Bronchoscopes were evaluated in endotracheal tubes with inner diameters of 6.5, 7.0, 7.5 and 8.0 mm (Mallinckrodt, Covidien, Tullamore, Ireland). Therefore, 8 bronchoscope / ETT combinations were tested. Measurements were taken both with and without the bronchoscopes in place, and repeated 3 times for each combination. The experiments were performed three times; the average values after a pass of 1 minute are presented.
    Animal experiments were carried out with piglets (Gros blanc, aged 2 to 3 months) according to the rules of Council Directive 86/609 of the European Economic Community of 24 November 1986. The protocol was approved by the "Ethics Committee in Animal Experiment Val-de-Loire" (n ° 00028.01). Animals were sedated with xylazine (2mg / kg) and ketamine (20mg / kg), then anesthetized with inhaled isoflurane. After tracheal intubation using a 7.0 mm endotracheal tube, the animals' lungs were mechanically ventilated with a Fabius Tiro ventilator (Drager, Telford, PA, USA). Note that piglets of this age have low pulmonary compliance compared to that of a human (<40 cmH2O / mL).
    At the vacuum level of -150 mmHg, the suction flow rate provided by the pediatric bronchoscope was clearly less than the bronchoscope provided with the insertion tube of the invention (nearly half as effective) as shown in FIG. 6: bronchoscope of the invention: 247 + 5 mlVmin for water and 176 ± 8 ml / min for viscous fluid; and pediatric bronchoscope: 147 + 2 mL / min for water and 100 + 2 mL / min for viscous fluid.
    The decrease in the vacuum level from -150 to -300 mmHg slightly increased the aspiration rate of the pediatric bronchoscope but was not a solution for a significant increase in its suction performance (Figure 7): bronchoscope of the 444 + 19 mL / min for water and 392 ± 13 mL / min for viscous fluid; and pediatric endoscope: 198 + 4 mL / min for water and 158 + 4 mL / min for viscous fluid. References 1. Lindholm CE, Ollman B, Snyder J, et al. "Flexible fiberoptic bronchoscopy in critical care medicine. Diagnosis, Therapy and Complications. "Critical Care Medicine 1974; 2: 250-61. 2. Turner JS, Willcox PA, Hayhurst MD, et al. "Fiberoptic bronchoscopy in the intensive care unit - a prospective study of 147 procedures in 107 patients." Critical Care Medicine 1994; 22: 259-64. 3. Terzi E, Zarogulidis K, Kougioumtzi I, et al. "Acute respiratory distress syndrome and pneumothorax." Journal of Thoracic Disease 2014; 6: S435-S442. 4. Lawson RW, Peters JI, Shelledy DC. "Effects of Fiberoptic Bronchoscopy During Mechanical Ventilation in a Lung Model." Chest 2000; 118: 824-31. 5. Nay MA, Mankikian J, Garot D, et al. "Investigation of a cause-effect relationship between flexible bronchoscopy and pneumothorax in patients with severe ARDS." European Journal of Anaesthesiology 2015 (in press). 6. Stemberg KP, Mitchell DR, Maunder RJ et al. "Safety of bronchoalveolar lavage in patients with adult respiratory distress syndrome." The American Journal of Respiratory Disease 1993; 148: 556-61. 7. Anzueto A, Frutos-Vivar F, Esteban A, et al. "Incidence, risk factors and outcome of barotrauma: a multivariate analysis." Intensive Care Med 2004; 30: 612-9. 8. Gammon RB, MS Shin, Buchalter SE. "Pulmonary Barotrauma in Mechanical Ventilation. Pattern and risk factors. "Chest 1992; 102: 568-72. 9. Molooney ED, Griffiths MJ. "Protective ventilation of patients with acute respiratory distress syndrome." British Journal of Anesthesia 2004; 92: 261-70. 10. Diaz Fuentes G, Venkatram SK. "Role of Flexible-Bronchoscopy in Pulmonary and Critical Care Practice." Global Perspectives on Bronchoscopy 2012. http://www.intechopen.com/books/global-perspectives-on-bronchoscopv/role-of-flexible-br onchoscopv-in -pulmonary-and-critical-care-practice (accessed 12/05/2015) 11. Guérin C, Reignier J, Richard JC, 'Beuret P, Gacouin A, Boulain T, et al. "Prone positioning in severe acute respiratory distress syndrome." N Engl J Med. 2013; 368: 2159-68. 12. ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, BT Thompson, Ferguson ND, Caldwell E, et al. "Acute respiratory distress syndrome: the Berlin Definition". JAMA. 2012; 307: 2526-33. 13. Bein T, Grasso S, Moerer O, Quintei M, Guerin C, Already M, et al. "The standard of care of patients with ARDS: ventilatory settings and rescue therapies for refractory hypoxemia". Intensive Care Med. 2016 42: 699-711.
    权利要求:
    Claims (12)
    [1]
    claims
    An insertion tube (12) for a flexible bronchoscope (1) for use in intensive care procedures, having a proximal portion (121), a distal portion (122), a stent camera (124) at the distal end of the distal portion (122) and at least one connecting and transmitting wire (125) extending from the camera docking pedestal (124) along the insertion tube (12) to the proximal end of the proximal portion (121); each of the proximal and distal portions (121, 122) having an internal diameter of at least 2 mm, preferably at least 2.1 mm, forming a suction channel (123) and an outside diameter; wherein the outer diameter of the proximal portion (121) is at most 4 mm, the length of the proximal portion (121) being at least 20 cm, preferably at least 25 cm, preferably at least minus 30 cm, preferably at least 35 cm.
    [2]
    2. Insertion tube (12) for a flexible bronchoscope (1) for use during a critical care procedure using an endotracheal tube (2) having a cross section of light and a length, the tube insert 12 having a proximal portion (121) for remaining within the endotracheal tube (2), a distal portion (122) extending out of the endotracheal tube (2), a pedestal camera lashing (124) at the distal end of the distal portion (122) and at least one connecting and transmitting wire (125) extending from the camera docking pedestal (124); along the insertion tube 12 to the proximal end of the proximal portion (121); each of the proximal and distal portions (121, 122) having an internal diameter of at least 2 mm, preferably at least 2.1 mm, forming a suction channel (123) and an outer diameter, the outer diameter the proximal portion (121) being at most 4 mm; wherein the proximal portion (121) has a selected outer cross section so that the difference in area between the cross section of the lumen of the endotracheal tube (2) and the outer cross section is at least 20 mm 2, preferably at least 23 mm 2, preferably at least 29 mm 2; wherein the proximal portion (121) is longer than the length of the endotracheal tube (2).
    [3]
    The insertion tube 12 of claim 1 or claim 2, wherein the distal portion (122) has an outer cross section larger than the outer cross section of the proximal portion (121).
    [4]
    The insertion tube (12) according to any one of claims 1 to 3, further comprising a light source securing pedestal (127) at the distal end of the distal portion (122).
    [5]
    A flexible bronchoscope (1) for use in intensive care procedures, comprising the insertion tube (12) according to any one of claims 1 to 3.
    [6]
    6. Flexible bronchoscope (1) according to claim 4, further comprising a camera (16) permanently secured or releasably stowed to the camera docking station (124).
    [7]
    The flexible bronchoscope (1) according to claim 5 or claim 6, wherein the insertion tube (1) comprises a light source securing base (127) at the distal end of the distal portion. (122), and wherein the flexible bronchoscope further comprises a light source (17) permanently secured or releasably attachable to the light source docking station (127).
    [8]
    8. flexible bronchoscope (1) according to any one of claims 5 to 7, further comprising a handle (14) provided with a deflection control, the handle (14) being permanently connected or connectable in a manner releasable at the proximal end of the proximal portion (121) of the insertion tube 12.
    [9]
    A method of selecting an insertion tube for a flexible bronchoscope for use during an intensive care procedure using an endotracheal tube having a lumen cross section and a length, wherein the tube insertion comprises a proximal portion having an outer cross section, a distal portion and a camera docking pedestal at the distal end of the distal portion, and a connecting and transmitting wire extending from the pedestal base securing a camera along the insertion tube to the proximal end of the proximal portion; wherein the insertion tube is selected so that the difference in area between the cross section of the lumen of the endotracheal tube and the outer cross section is at least 20 mm 2, preferably at least 23 mm 2, preferably at least 29 mm 2, and so that the proximal portion is longer than the length of the endotracheal tube.
    [10]
    The method of claim 9, wherein the endotracheal tube has a length of 20 cm, 30 cm or more.
    [11]
    The method of claim 9 or claim 10, wherein the endotracheal tube has an inner diameter of 6.5 mm, 7 mm, 7.5 mm and 8 mm, respectively, the outer diameter of the proximal portion of the tube. selected insertion thus being at most 4 mm, preferably at most 3.60 mm.
    [12]
    The method of using the flexible bronchoscope (1) according to claim 5, comprising the steps of: - selecting an insertion tube for the flexible bronchoscope according to the method of claim 9 or 11; - insert the flexible bronchoscope into the endotracheal tube at least until the distal part of the insertion tube is completely out of the endotracheal tube.
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    同族专利:
    公开号 | 公开日
    BE1023973A1|2017-09-27|
    WO2017005768A1|2017-01-12|
    FR3038507A1|2017-01-13|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    WO2014068958A1|2012-10-30|2014-05-08|パナソニック株式会社|Endoscope and insertion part for endoscope|
    WO2019212755A1|2018-05-02|2019-11-07|Cook Daniel J|Disposable bronchoscope and method of use|
    法律状态:
    2018-01-10| FG| Patent granted|Effective date: 20170928 |
    2019-04-01| MM| Lapsed because of non-payment of the annual fee|Effective date: 20180731 |
    优先权:
    申请号 | 申请日 | 专利标题
    EP15306102.3|2015-07-06|
    EP15306102|2015-07-06|
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