Tracheal intubation balloon cuff through which fluid passage ducts extend

Abstract

The invention relates to a balloon cuff (1) for a tracheal intubation device, the balloon cuff (1) being elastically deformable and extending between an inner surface (3) surrounding an axis (A) and an outer surface (5) surrounding the inner surface (3), the balloon cuff (1) comprising inner walls that define ducts (13, 15) that extend through the balloon cuff, the balloon cuff (1) being configured to go from a deflated state to an inflated state by injecting a fluid into the ducts (13, 15) such that the outer surface (5) moves away from the axis.

Description

[0001] Description

[0002] Title of the invention: Tracheal intubation balloon crossed by fluid passage conduits

[0003] FIELD OF THE INVENTION

[0004] The present invention falls within the technical field of medical devices for creating and maintaining an artificial respiration pathway in the trachea of ​​a patient, in particular for invasive mechanical ventilation (or VMI).

[0005] The invention relates more specifically to an improved balloon for a tracheal intubation device, for example for an endotracheal intubation tube or for a tracheostomy or stoma cannula. The invention also relates to a tracheal intubation device comprising such a balloon and a method for controlling an inflation state of such a balloon.

[0006] STATE OF THE ART

[0007] Mechanical ventilation is a widespread and effective solution for artificially providing oxygen to patients with respiratory failure and for removing carbon dioxide from the respiratory system. Other goals of mechanical ventilation are to reduce the respiratory effort for the ventilated patient and to treat potentially fatal conditions such as hypoxemia, hypercapnia, arterial oxygen deficiency, and acute respiratory acidosis.

[0008] The term "invasive mechanical ventilation" (or IMV) is commonly used to refer to mechanical ventilation in which an instrument creating an artificial airway is inserted into the patient's body (as opposed to non-invasive ventilation, which generally uses a breathing mask). Invasive mechanical ventilation is used in cases of acute or chronic respiratory failure, or to maintain the functionality of the patient's airway during an intervention, such as during intubation in intensive care or in the operating room.

[0009] There are several types of instruments that create an artificial airway in the trachea, for connection to a mechanical respirator to perform gas exchange.

[0010] The endotracheal tube is intended to be inserted through the patient's mouth or nose into the trachea, without necessarily performing a surgical procedure. Such a tube is mainly used in adult or pediatric patients with acute respiratory failure. To ensure the sealing of the distal airways, that is to say to prevent fluid, air or liquid communication between these distal airways and the upper airways (notably pharynx, larynx), the endotracheal tube is often equipped with a balloon placed along the tube. The airway seal is ensured when the balloon is inflated and placed in contact with the trachea. Such a balloon allows the tracheobronchial tree to be fluidically and bacteriologically isolated. A balloon-tipped tube is particularly recommended to protect the patient's lungs against reflux and contamination by oral and digestive secretions.This balloon, which seals the airways, prevents air leaks around the intubation tube, thus allowing control of the volumes and pressures administered to the patient. This pressure / volume regime is fundamental in the treatment of respiratory failure in patients regardless of their age or the underlying pathology.

[0011] The tracheostomy tube, on the other hand, is inserted not through the patient's natural airway, but through a stoma in the trachea (a surgically made opening, opening the trachea to the outside). This solution is particularly suitable for patients suffering from chronic respiratory failure, for whom mechanical ventilation is implemented on a long-term basis. Tracheostomy tubes are also commonly equipped with a cuff for the same reasons mentioned above in relation to conventional intubation tubes.

[0012] Invasive mechanical ventilation can significantly improve the vital prognosis of patients with acute respiratory failure.

[0013] However, invasive mechanical ventilation is associated with an in-hospital mortality rate of over 35% for non-surgical patients receiving invasive mechanical ventilation. In addition, there is significant long-term morbidity for patients discharged home after the respiratory failure event.

[0014] This high mortality is partly linked to two shortcomings of current tracheal intubation balloons.

[0015] On the one hand, micro-inhalations of contaminated oropharyngeal secretions can cause bronchopneumopathy (known as "ventilator-associated pneumonia" or VAP). It is considered that more than 30% of complications of invasive mechanical ventilation are attributable to such acquired bronchopneumopathy. These leaks of oral secretions into the tracheobronchial system and the deep lung are due to an insufficient seal of the tracheal intubation cuff. The insufficient seal is caused in particular by unwanted wrinkling of the external surface of the cuff, digging micro-channels through which oral secretions, i.e. oropharyngeal secretions on the "mouth" side of the cuff, can pass.The phenomenon of wrinkling of the external surface of the balloon is described in particular in the publication “Mechanical ventilation, from physiology to practice: which probe, which circuit, which ventilator?”, Anesthesia & Resuscitation, Volume 4, Issue 2, March 2018, pp. 180-189 (see Figure 1 of this document, page 182).

[0016] A known solution to insufficient cuff sealing is the use of additional suction systems that collect oral secretions above the proximal end of the cuff. However, such suction systems cause additional pain for patients and require maintenance. Furthermore, excessive pressure exerted by the external surface of the cuff on the tracheal wall can cause serious damage to the tracheal mucosa and submucosa. Tracheal damage due to hyperinflation (excessive inflation) of the cuff can impair blood flow to the tracheal mucosa, causing pressure ulcers and possible complications such as necrosis or, if scarring occurs, tracheal stenosis. Stenosis is a specific scarring of the trachea that reduces its diameter and can complicate breathing.

[0017] The usual solution for maintaining optimal cuff pressure, sufficient to maintain a distal airway seal while limiting it so as not to cause tracheal injury, is to monitor and manually adjust the air pressure inside the cuff. It is estimated that to maintain cuff pressure within the recommended ranges, up to eight manual cuff pressure adjustments per day are necessary. However, the need for frequent adjustments increases the workload for hospital staff, and there is a risk of human error.

[0018] There are newer systems, such as the NOSTEN® system, which allow for better control of cuff pressure, including adaptive pressure control. However, these systems use standard cuffs that are not sufficiently airtight. These systems therefore do not completely prevent leakage of oral secretions into the tracheobronchial system and the lungs.

[0019] It should be noted that when invasive ventilation is established, the patient's tracheobronchial system is placed in a closed circuit with the ventilation machine. The tracheobronchial system becomes isolated from the external environment. Bronchial secretions, on the lung side of the cuff, cannot be eliminated to the external environment, for example by swallowing by clearing the throat. It is then essential to regularly perform - at least every four hours - tracheal suctioning, which consists of opening the circuit, inserting a probe into the patient's throat and suctioning the accumulated secretions. This procedure is invasive and damaging to the trachea. In addition, the intubated patient, who is normally ventilated with overpressure on the lung side - even at the end of expiration - to maximize alveolar exchange, then experiences a depression that degrades alveolar exchange and the quality of the patient's breathing.

[0020] STATEMENT OF THE INVENTION

[0021] In view of the above, there is a need for a tracheal intubation cuff device that is improved over the existing one; reducing the risks of tracheal injury to the patient, particularly during mechanical ventilation, while ensuring a satisfactory seal between the distal airways and the patient's upper airways.

[0022] Preferably, the desired tracheal intubation device comprises a cuff whose pressure exerted on the trachea is easily adjustable, so as to reduce the workload of hospital personnel during mechanical ventilation. There is an additional need for a tracheal intubation cuff whose radial pressure adapts according to certain movements and actions of the patient, for example in response to a coughing or swallowing effort of the patient.

[0023] A tracheal intubation device is also sought that is capable of autonomously expelling the patient's oropharyngeal secretions, so as to avoid contamination of the distal airways by said secretions and to reduce or eliminate the need for tracheal suction, i.e. the aspiration of bronchial secretions.

[0024] To address these needs, the invention relates in a first aspect to a balloon for a tracheal intubation device, the balloon being elastically deformable and extending between an inner surface surrounding an axis and an outer surface surrounding the inner surface, the balloon comprising inner walls which define conduits passing through the balloon, the balloon being configured to transition from a deflated state to an inflated state by an injection of a fluid into the conduits such that the outer surface moves away from the axis.

[0025] Such a balloon is advantageously and optionally completed by the following different characteristics taken alone or in combination: a ratio of a thickness, when the balloon is in the deflated state, between the internal surface and the external surface over a width of the external surface is greater than 10%, and preferably 20%; for each conduit, a ratio of a size of the conduit, when the balloon is in the inflated state, over a closest distance between the conduit and the external surface is less than or equal to 100%, and preferably 50%; the internal surface and the external surface have cylindrical shapes defined by an axial direction parallel to the axis, the internal surface and the external surface having at least partly circular sections in a plane orthogonal to the axis, preferably the external surface has a flat extending all along the external surface in the axial direction in a plane parallel to the axis;conduits have a main direction parallel to the axis, the conduits extending parallel to the axis preferably from a proximal end of the balloon to a distal end of the balloon; conduits have a main direction parallel to a circumferential direction relative to the axis, the conduits preferably extending in an arc around the axis; the balloon comprises different groups of independently controllable conduits, the groups being located in sections of the balloon, the sections being contiguous two by two and placed successively along the axis; the thickness between the internal surface and the external surface is less than or equal to 1 millimeter and preferably 0.5 millimeter, when the balloon is configured in the deflated state;and the balloon is formed predominantly of synthetic polymer material, preferably silicone or polyurethane. Also provided is a tracheal intubation device configured to form an artificial airway in the trachea of ​​a patient, the intubation device comprising:;

[0026] - an artificial respiration tube,

[0027] - a balloon as just presented, the balloon being mounted on the artificial respiration tube, so that the internal surface surrounds the tube.

[0028] Such a device advantageously and optionally comprising a pressure sensor downstream of the balloon relative to the craniocaudal direction, the sensor being configured to acquire a pressure measurement representative of a coughing effort of the patient.

[0029] Finally, the invention covers a method of controlling such a tracheal intubation device, the method comprising moving the outer surface by injecting fluid into a first group of conduits and by injecting fluid into a second group of conduits, so as to modify a swelling state of the outer surface.

[0030] Such a method advantageously and optionally comprising a detection of excess pressure in the trachea, the movement being triggered as a function of the detected excess pressure, when the device comprises a pressure sensor downstream of the balloon relative to the craniocaudal direction, the sensor being configured to acquire a pressure measurement representative of a coughing effort of the patient.

[0031] DESCRIPTION OF FIGURES

[0032] Other characteristics and advantages of the invention will emerge from the following description, which is purely illustrative and non-limiting, and must be read in conjunction with the appended drawings in which: Figures 1 to 3 are schematic representations of a balloon according to different embodiments of the invention; Figure 4 is a schematic representation of a tracheal intubation device according to an embodiment of the invention 1 and Figure 5 is a schematic representation of a movement of the external surface of the balloon.

[0033] DETAILED DESCRIPTION OF THE INVENTION

[0034] Balloon for a tracheal intubation device

[0035] According to a first aspect, the invention relates to a balloon 1 for a tracheal intubation device. The balloon 1 is configured to be mounted on an artificial respiration tube of the tracheal intubation device.

[0036] Referring to Figures 1 to 3, a balloon 1 extends along an axis A, or central axis, between a proximal end P and a distal end D.

[0037] When the balloon 1 is slid over a tube of an intubation device, the central axis of the balloon corresponds to the axis of the tube. The central axis corresponds when the balloon, mounted on the tube, is inserted into the trachea of ​​a patient to the general direction of extension of the trachea also called "cranio-caudal" direction.

[0038] The proximal end corresponds to the “mouth side” of the balloon.

[0039] The distal end corresponds to the “bronchi or lung side” of the balloon.

[0040] From the central axis, radial directions and circumferential directions are defined.

[0041] For example, in Figure 1, there is shown at the proximal end P of the balloon a radial direction R1 orthogonal to the central axis λ and a circumferential direction C1 orthogonal to the radial direction R1 and to the central axis λ. Similarly, in Figure 1, there is shown at the distal end D of the balloon a radial direction R2 orthogonal to the central axis λ and a circumferential direction C2 orthogonal to the radial direction R2 and to the central axis λ.

[0042] The balloon extends radially relative to the central axis from an inner surface 3 to an outer surface 5. The inner surface 3 surrounds the central axis λ. The outer surface 5 surrounds the inner surface 3.

[0043] For example, and as shown in Figures 1 and 3, the external surface 5 and the internal surface 3 are two cylinders with a circular section whose axis is the central axis. The balloon 1 then has the shape of a hollow tube which has in a radial plane, that is to say a plane orthogonal to the central axis A, a section in the form of a circular ring.

[0044] A thickness 11 of the balloon is defined as the distance in a radial direction between the internal surface 3 and the external surface 5. With reference to FIG. 1, the thickness 11 is for example defined in the radial direction R1 at the proximal end P of the balloon. When the external surface 5 and the internal surface 3 are two cylinders with a circular section whose axis is the central axis, the thickness 11 is the radial thickness of the circular ring.

[0045] A width 9 of the external surface is defined as the distance in a radial direction between the two points of intersection of the external surface and the radial direction. The two points of intersection are separated by the central axis. With reference to Figure 1, the width 9 is for example defined in the radial direction R2 at the distal end D of the balloon. When the external surface 5 and the internal surface 3 are two cylinders with a circular section whose axis is the central axis, the width of the external surface is the external diameter of the circular ring.

[0046] Balloon 1 is elastically deformable.

[0047] Advantageously, the balloon has an elastic deformation rate greater than or equal to 10%.

[0048] More advantageously, the balloon has an elastic deformation rate greater than or equal to 20%.

[0049] Even more advantageously, the balloon has an elastic deformation rate greater than or equal to 30%.

[0050] An elastic deformation rate of an object between a neutral state and a deformed state is defined here as a ratio of the difference between a length of the object in the deformed state and a length of the object in the neutral state to the length of the object in the neutral state. The deformation is elastic if the object in the deformed state can reversibly return to the neutral state, and in particular without rupture or plastic deformation of the object.

[0051] In particular, the balloon can be made of elastomer, in particular polyurethane, silicone, and their mixtures.

[0052] Preferably, the balloon may be formed mainly, i.e. more than 50% by mass, from synthetic polymer material, preferably silicone.

[0053] The balloon 1 includes internal walls which define conduits 13, 15 or channels which pass through the balloon.

[0054] The balloon comprises, for example, a total number of conduits between 4 and 20, preferably between 8 and 12, but their number can be variable, up or down.

[0055] Each duct extends in the balloon 1 between the inner surface 3 and the outer surface 5. Each duct extends in a principal direction such that the dimension of the duct in the principal direction is significantly greater than in the other directions. A cross-section of the duct can be defined at any point in the duct as the intersection between the duct and a plane orthogonal to the principal direction at that point.

[0056] The cross section corresponds to a flat surface which has a perimeter closed on itself, a perimeter which is curved or formed of different rectilinear segments.

[0057] The size of a duct is a characteristic size of the cross-section of the duct, it can be defined for example as the diameter of the largest sphere that can be inserted into the duct without deformation.

[0058] The size of the duct is therefore the transverse dimension of the duct in a plane orthogonal to the main direction of the duct.

[0059] The main direction can be constant and in this case the duct is straight. The main direction can vary continuously along the duct and in this case the duct is curved. The duct can also include straight and curved portions.

[0060] The balloon is configured to transition from a deflated state to an inflated state by injecting a fluid into each conduit such that the outer surface moves away from the axis, i.e., it moves radially outward from the balloon.

[0061] When fluid is injected into a conduit, the conduit is pressurized so that the cross-sectional area of ​​the conduit increases.

[0062] When fluid is no longer injected into the conduits, the balloon changes from an inflated to a deflated state.

[0063] The transformation of the balloon during fluid injection into the conduits is reversible. In other words, the balloon returns to its initial deflated state once the fluid is removed. Calibrating the fluid injection allows for balloon deformations that are calibrated, predictable, and reproducible.

[0064] The fluid injected into the balloon conduits to achieve this type of transformation can be liquid, gas, or a mixture of liquid and gas. Different liquids or gases can be used alone or in combination.

[0065] Preferably the fluid is

[0066] - either air (we speak of pneumatic operation),

[0067] - either water (we speak of hydraulic operation).

[0068] To inject the fluid, it is possible to control a fluid injection flow rate and / or pressure and / or fluid injection volume.

[0069] The shape of the balloon can be controlled by injecting a fluid (gas or liquid) into the conduits passing through it. In doing so, the balloon can move from a deflated state to an inflated state, with the outer surface of the balloon moving radially outward. Such a balloon inserted into the patient's trachea in a deflated state can then be inflated, with the outer surface coming into contact with the trachea. The presence of several conduits makes it possible to distribute and homogenize the inflation zones in the balloon. Such a balloon provides a seal between the distal airways and the upper airways of the patient that is better than in the prior art.

[0070] According to a first option, it is possible to impose that the ratio of the thickness, when the balloon is in the deflated state, between the internal surface 3 and the external surface 5 on the width 9 of the external surface 5 is greater than 10%, and preferably 20%.

[0071] Such a ratio helps reduce the risk of folding in the external surface during balloon inflation.

[0072] According to a second option, possibly cumulative with the first option, it is possible to impose for each conduit that the size of the conduit 13, 15 is less than a closest distance between the conduit 13, 15 and the external surface 5. More precisely, it is possible to impose that the ratio between the size of the conduit 13, 15 and the closest distance between the conduit 13, 15 and the external surface 5 is less than or equal to 100%, and preferably 50%.

[0073] Such a ratio makes it possible to limit the formation of bulges and bumps in the external surface opposite the conduit during inflation of this conduit. The sealing of the balloon is thus improved compared to the prior art.

[0074] The deflated state allows the balloon surrounding the tube to slide into the trachea.

[0075] The inflated state allows the outer surface of the balloon to be brought into contact with the trachea, the balloon surrounding the tube in the trachea. The contact between the outer surface of the balloon and the trachea is more homogeneous than in the prior art. The pressure of the balloon on the trachea is applied more homogeneously than in the prior art.

[0076] It should be noted that in this case the internal surface is opposite the tube. The distance between the central axis and the internal surface remains greater than or equal to the radius of the tube so that the diameter of the tube is not reduced by the action of the balloon. For this purpose, the tube can be significantly stiffer than the balloon, or the balloon can be configured so that regardless of the configuration of the balloon, the distance between the central axis and the internal surface always remains equal to, or slightly greater than, the radius of the tube.

[0077] The balloon presented above can also find a possible application in the placement of stents at the coronary, arterial, cardiac, venous level in the fields of radiology or interventional cardiology. The fact that the pressure is applied more homogeneously to the surface of the balloon is an element of interest that is quite relevant for this type of application.

[0078] Preferably, the thickness between the inner surface and the outer surface may be chosen to be less than or equal to 2 millimeters, or 1 millimeter or even 0.5 millimeters, when the balloon is configured in the deflated state. A tube typically has a diameter less than or equal to 1 millimeter. The 'tube + deflated balloon' assembly has an external width which depends on the thickness between the inner surface and the outer surface: this external width of the 'tube + deflated balloon' assembly may take a value less than 5 millimeters, or 3 millimeters or even 2 millimeters.

[0079] Balloon geometries for a tracheal intubation device

[0080] The inner surface 3 and the outer surface 5 may have different shapes. In a non-limiting manner, the shape of these surfaces may be:

[0081] - cylindrical defined by an axial direction parallel to the axis, so that the internal surface and the external surface have circular sections in a plane orthogonal to the axis, or

[0082] - cylindrical defined by the axial direction, so that the internal surface and the external surface have elliptical sections in a plane orthogonal to the axis, or

[0083] - cylindrical defined by the axial direction, so that the internal surface and the external surface have a section with a flat in a plane orthogonal to the axis.

[0084] In a preferred embodiment, the outer surface 5 and the inner surface 3 are two cylinders with a circular section whose axis is the central axis. In other words, the inner surface and the outer surface have cylindrical shapes defined by the axial direction, the inner surface and the outer surface having circular sections in a plane orthogonal to the axis.

[0085] The balloon 1 then has the shape of a hollow tube which has in a radial plane, that is to say a plane orthogonal to the central axis A, a section in the shape of a circular ring.

[0086] Advantageously, in this preferred embodiment, and in relation to FIG. 2, the external surface has a flat 7 which extends along the entire external surface in the axial direction in a plane parallel to the axis. The flat 7 defines a planar surface parallel to the axis and orthogonal to a direction radial to the axis. The shortest distance separating the flat 7 and the axis is greater than the radius of the internal surface 3, so that the internal surface 3 is located between the external surface 5 and the axis A. The flat 7 corresponds to an angular extent in a radial plane orthogonal to the axis advantageously between 20° and 100°, and even more advantageously between 40° and 80°.

[0087] A balloon with such a flattened surface has a shape more suited to the anatomy of the trachea so that insertion and inflation of the balloon into the trachea are less traumatic for the patient.

[0088] Geometries of the conduit network in the balloon

[0089] Regardless of the geometry of the inner and outer surfaces of the balloon, the conduits can take different shapes between these two surfaces.

[0090] In a first embodiment of the conduits of the balloon, and in relation to FIG. 1, at least a portion of the conduits 13 have a main direction parallel to the axis, that is to say that the dimension of the conduit along the axis is significantly greater than the dimension of the conduit along the other directions. These conduits extend parallel to the axis preferably from the proximal end P of the balloon to the distal end D of the balloon. The technical effect associated with this characteristic is to obtain, when these conduits are pressurized, an inflation of the balloon in the circumferential direction, rather than in the axial direction, which induces an expansion of the section of the balloon.

[0091] As an option of this first embodiment of the balloon conduits, the conduits 13 which extend parallel to the axis are configured so that, when the balloon is in the deflated state, for each group of two adjacent conduits an angular deviation in a radial plane between the two adjacent conduits is equal to a predetermined deviation. In other words, the angular deviation in a radial plane which separates two adjacent conduits is constant around the axis.

[0092] In a second embodiment of the conduits of the balloon, and in relation to Figure 3, at least a portion of the conduits have a main direction parallel to a circumferential direction - or equivalently orthoradial - relative to the axis, that is to say that the dimension of the conduit in the circumferential direction is significantly greater than the dimension of the conduit in the other directions, in particular the axial direction and the radial direction. These conduits 15a, 15b and 15c extend perpendicular to the axis, preferably in an arc around the axis. The technical effect associated with this characteristic is to obtain, when these conduits are pressurized, an inflation of the balloon in the axial direction, rather than in the circumferential direction.

[0093] As an option of this second embodiment of the balloon conduits, the conduits 15a, 15b and 15c which extend parallel to the circumferential direction are configured so that, when the balloon is in the deflated state, for each group of two adjacent conduits an axial deviation along the axis is equal to a predetermined deviation. In other words, the axial deviation along the axis which separates two adjacent conduits is constant along the axis.

[0094] The two conduit modes presented here are compatible with each other. In particular, the conduits can be separated into at least two groups: a first group of conduits which have a main direction parallel to the axis and a second group of conduits which have a main direction parallel to the circumferential direction.

[0095] These two groups can be independently controlled in terms of their pressurization by the injected fluid. In other words, the fluid can be injected into the conduits of the first group without injecting the fluid into the conduits of the second group.

[0096] The first group can in particular ensure the deployment of the balloon and the seal between the upstream and downstream of the balloon.

[0097] More generally, the conduits can be organized into different groups which can be controlled independently with regard to their pressurization by the injected fluid.

[0098] In particular, independently controllable groups can be organized according to sections of the balloon placed successively along the axis of the balloon. The groups are located in the sections of the balloon, the sections being contiguous two by two and placed successively along the axis.

[0099] For example, and in relation to Figure 3, the balloon may comprise a second group of conduits which have a main direction parallel to the circumferential direction, the second group being formed of three subgroups 15a, 15b and 15c of conduits placed in three different axial zones defined by: the proximal end P, a first intermediate point 11 located axially between the proximal ends P and distal D, a second intermediate point I2 located axially between the first intermediate point 11 and the distal end D, and the distal end D.

[0100] The first zone of the balloon Z1, or proximal zone, is defined between the proximal end P and the first intermediate point 11. The second zone Z2 of the balloon, or central zone, is defined between the two intermediate points 11 and I2. The third zone of the balloon Z3, or distal zone, is defined between the second intermediate point I2 and the distal end D.

[0101] In this case, all the ducts of a subgroup are located in one of the zones and each zone comprises only one of the three subgroups of ducts, namely here: a proximal subgroup of ducts 15a in the proximal zone Z1, a central subgroup of ducts 15b in the central zone Z2, and a distal subgroup of ducts 15c in the distal zone Z3.

[0102] More generally, the balloon may comprise a number n greater than 3 of subgroups of conduits in a number n of zones. Even more generally, the balloon may comprise a number 2n, with n greater than or equal to 3 of groups of conduits in a number n of zones, each zone comprising two independent groups of conduits.

[0103] According to this option, each zone defined above corresponds to an axial portion of the balloon which can be inflated or deflated independently of the neighboring portions.

[0104] The groups of independent conduits organized according to sections of the balloon placed successively along the axis of the balloon allow a peristaltic movement of the balloon to be implemented. The external surface of the balloon can then be animated by a peristaltic wave movement propagating along the axis.

[0105] This is especially the case if the balloon includes three independent conduit subgroups in the second group.

[0106] Finally, according to a variant, there can be:

[0107] - a main network of conduits which covers the entire balloon and which ensures overall sealing of the balloon, for example a first group of conduits which have a main direction parallel to the axis and

[0108] - a secondary network comprising a second group of conduits which have a main direction parallel to the circumferential direction, the second group being formed of three subgroups which can be controlled independently according to zones of the balloon successively placed along the axis of the balloon.

[0109] For example, the primary network includes longitudinal channels for balloon deployment and the secondary network includes circular channels for peristaltic pumping. The primary network and the secondary network do not communicate fluidically with each other.

[0110] Tracheal intubation device

[0111] According to a second aspect, and in relation to FIG. 4, the invention relates to a device 10 configured to form an artificial airway at the level of the trachea 19 of a patient, referred to as a tracheal intubation device.

[0112] Trachea 19 is defined in the patient's esophagus 20.

[0113] The intubation device 10 comprises:

[0114] - an artificial respiration tube 17,

[0115] - a balloon 1 as previously presented.

[0116] The balloon 1 is mounted on the artificial respiration tube 17 so that the internal surface surrounds the tube. The central axis of the balloon then corresponds to the axis of the tube.

[0117] The tube 17 of the tracheal intubation device 10 may comprise either an endotracheal tube, a tracheostomy tube or a tracheostomy tube. Such a device 10 may be used to implement spontaneous breathing, i.e. without a mechanical ventilation module.

[0118] Such a device can be used to implement artificial respiration, i.e. with a mechanical ventilation module that fixes the flow of fluid through the artificial respiration tube.

[0119] The device comprises in this second case a mechanical ventilation module 20 comprising: a reservoir 24 of pressurized fluid connected to the conduits of the balloon, a control device 23 which controls the reservoir 24 of fluid to apply a particular pressure to the fluid so that the balloon 1 can be put in the deflated or inflated state, and a fluid connection 21 between the control device 23 and the balloon.

[0120] When the balloon 1 comprises several groups of conduits whose pressure can be independently adjusted, the control device 23 is fluidically connected independently to each group of conduits.

[0121] In a particular embodiment, the intubation device further comprises a pressure sensor 25 placed downstream of the balloon relative to the craniocaudal direction, that is to say - once the balloon is placed in the trachea - between the balloon and the patient's lungs.

[0122] In other words, once the balloon is placed in the trachea, the balloon is placed between the pressure sensor 25 and the patient's mouth.

[0123] The pressure sensor 25 can be configured to be placed, once the balloon is placed in the trachea: against the distal end D of the balloon, or against an internal wall of the trachea, or at the distal end of the tube - that is to say at the end of the tube on the lung side - or between the external surface of the tube and the internal surface of the balloon.

[0124] The pressure sensor 25 is configured to acquire a measurement of overpressure in the trachea.

[0125] The overpressure may be representative of a coughing effort by the patient.

[0126] The pressure sensor 25 is connected to the control device 23 which controls the pressurized fluid reservoir so that the overpressure measurement is conveyed to the mechanical ventilation module 20.

[0127] The pressure sensor 25 may be a piezoelectric type sensor.

[0128] Tracheal Intubation Device Control Method - Peristaltic Movement

[0129] According to a third aspect, a method for controlling a tracheal intubation device is provided. In a first step, the intubation device 10 is prepared for insertion into the patient's trachea.

[0130] For this purpose, the balloon 1 is mounted on the tube 17 of the device 10. The control device 23 is adjusted so that the balloon 1 is configured in its deflated state.

[0131] Optionally, a pressure sensor 25 is arranged downstream of the balloon relative to the cranio-caudal direction protruding from the balloon on the side of the distal end D of the balloon.

[0132] The balloon 1 mounted on the tube 17 is, in a second step, inserted into the patient's trachea 19.

[0133] Once the device 10 is placed in a suitable location, the control device 23 is adjusted in a third step so that the balloon is configured in its inflated state.

[0134] The balloon as described so far also allows specific movements of the structure to be caused by the injected fluid depending on variables such as the flow rate, volume or pressure over time of this injected fluid. The induced movement can correspond to an injection but also to a withdrawal of the fluid from the conduits. The movement can also correspond to an alternation between injection and withdrawal of fluid in the conduits.

[0135] When the balloon comprises different groups of independently controllable organized channels distributed into successive zones along the axis, the control method may further comprise moving the surface of the balloon according to at least one progressive wave along the axis of the balloon.

[0136] Many variations in the process are possible in terms of shapes and movements to animate the external surface of the balloon.

[0137] In one example, the balloon includes a first group of conduits that have a main direction parallel to the axis and a second group of conduits that have a main direction parallel to the circumferential direction.

[0138] These two groups are independently controlled in terms of their pressurization by the injected fluid. In other words, the fluid can be injected into the conduits of the first group without injecting the fluid into the conduits of the second group.

[0139] The first group is used in particular to ensure the deployment of the balloon and the seal between the upstream and downstream of the balloon.

[0140] These two groups allow movement of the external surface by injection of fluid inside the first group of conduits and by injection of fluid inside the second group of conduits, so as to modify a state of swelling of the external radial surface.

[0141] Referring to Figure 5, the second conduit group of the balloon comprises three independently controllable conduit subgroups with respect to fluid injection: a proximal subgroup in the proximal zone Z1, a central subgroup in the central zone IL, and a distal subgroup in the distal zone Z3, as shown above. The following three substeps illustrate a possible example of variation.

[0142] In a first sub-step, illustrated S1 in figure 5, the control device is adjusted so that the balloon is configured in a first transition state in which the distal subgroup in zone Z3 of conduits is deflated, the central subgroup and the proximal subgroup in zones Z1 and Z2 are inflated.

[0143] In a second sub-step, illustrated S2 in figure 5, the control device is adjusted so that the balloon is configured in a second transition state in which the central subgroup in zone Z2 of conduits is deflated, the distal subgroup and the proximal subgroup in zones Z1 and Z3 are inflated.

[0144] In a third sub-step, illustrated S3 in Figure 5, the controller is set so that the balloon is configured in a third transition state in which the proximal subgroup of conduits in zone Z1 is deflated, the central subgroup and the distal subgroup in zones Z2 and Z3 are inflated.

[0145] Such movement produces a transit or transfer of bronchial secretions from the distal face of the balloon to the proximal face and the nasopharynx.

[0146] This spares the patient, at least in part, the manual aspiration of secretions, which is a dangerous and painful procedure.

[0147] The movement induced on the surface of the balloon has the particularity of inducing a transit or transfer of tracheal secretions by having an internal / external orientation which allows them to be brought above the balloon where they will then be easily aspirated without harming the patient's ventilation. The balloon maintains its seal despite the peristaltic movement: there is always a part of the external surface of the balloon in contact with the trachea, whatever the phase of the movement.

[0148] The mechanical ventilation module 20 can be configured so that this movement of the external surface occurs at a regular rate that corresponds to the flow rate of pulmonary secretions generated by the patient. This flow rate varies from one patient to another and depends largely on the patient's lung function. It also depends on the patient's condition and can change over time. It will therefore be adapted over time for the same patient.

[0149] When the device comprises a pressure sensor, the control method may comprise detecting an overpressure in the trachea.

[0150] When this is detected by the sensor, the information is communicated to the control device which then triggers the stages of the peristaltic movement.

[0151] The evacuation of bronchial secretions is then greater, the natural phenomenon of coughing in the trachea being synchronized with the movement of the external surface of the balloon.

[0152] It is possible to configure the mechanical ventilation module 20 so that this movement of the external surface presents a resultant of the movements implemented with zero sum in the sense that the movement of the external surface does not induce any displacement of the balloon structure or the tube relative to the trachea.

Claims

CLAIMS 1. Balloon (1) for a tracheal intubation device, the balloon (1) being elastically deformable and extending between an inner surface (3) surrounding an axis (A) and an outer surface (5) surrounding the inner surface (3), the balloon (1) comprising inner walls which define conduits (13, 15) passing through the balloon, the balloon (1) being configured to transition from a deflated state to an inflated state by an injection of a fluid into the conduits (13, 15) such that the outer surface (5) moves away from the axis.

2. Balloon (1) according to claim 1 wherein a ratio of a thickness, when the balloon is in the deflated state, between the inner surface (3) and the outer surface (5) over a width of the outer surface (5) is greater than 10%, and preferably 20%.

3. Balloon (1) according to any one of claims 1 to 2 wherein, for each conduit (13, 15), a ratio of a size of the conduit (13, 15), when the balloon is in the inflated state, to a closest distance between the conduit (13, 15) and the external surface (5) is less than or equal to 100%, and preferably 50%.

4. Balloon (1) according to any one of claims 1 to 3 wherein the internal surface (3) and the external surface (5) have cylindrical shapes defined by an axial direction parallel to the axis (A), the internal surface (3) and the external surface (5) having at least partly circular sections in a plane orthogonal to the axis (A), preferably the external surface (5) has a flat (7) extending along the entire length of the external surface (5) in the axial direction in a plane parallel to the axis (A).

5. Balloon (1) according to any one of claims 1 to 4 in which conduits (13) have a main direction parallel to the axis, the conduits (13) extending parallel to the axis (A) preferably from a proximal end (P) of the balloon (1) to a distal end (D) of the balloon (1).

6. Balloon (1) according to any one of claims 1 to 5 in which conduits (15) have a main direction parallel to a circumferential direction relative to the axis, the conduits (15) preferably extending in an arc of a circle around the axis (A).

7. Balloon (1) according to any one of claims 1 to 6 comprising different groups of independently controllable conduits, the groups being located in sections of the balloon, the sections being contiguous two by two and placed successively along the axis.

8. Balloon (1) according to any one of claims 1 to 7, wherein the thickness between the inner surface (3) and the outer surface (5) is less than or equal to 1 millimeter and preferably 0.5 millimeter, when the balloon is configured in the deflated state.

9. Balloon (1) according to any one of claims 1 to 8, the balloon being formed mainly from synthetic polymer material, preferably silicone or polyurethane.

10. A tracheal intubation device (10) configured to form an artificial airway in the trachea of a patient, the intubation device comprising: - an artificial respiration tube (17), - a balloon (1) according to any one of claims 1 to 9, the balloon (1) being mounted on the artificial respiration tube (17), so that the internal surface (3) surrounds the tube (17).

11. Tracheal intubation device (10) according to claim 10, the intubation device (10) further comprising a pressure sensor (25) downstream of the balloon (1) relative to the craniocaudal direction, the sensor (25) being configured to acquire a pressure measurement representative of a coughing effort of the patient.

12. A method of controlling a tracheal intubation device (10), the tracheal intubation device (10) being in accordance with claim 10, the method comprising moving the external surface (5) by injecting fluid into a first group of conduits (13, 15) and by injecting fluid into a second group of conduits (13, 15), so as to modify a swelling state of the external surface (5).

13. Control method according to claim 12, the tracheal intubation device (10) being taken in accordance with claim 11, the method comprising a detection of an overpressure in the trachea, the movement being triggered as a function of the detected overpressure.

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