Endotracheal balloon cuff with extended fluid passage duct

Abstract

The present 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) having an inner wall defining ducts (13, 15) passing through the balloon cuff, and the balloon cuff (1) being configured to transition from a deflated state to an inflated state by injecting fluid into the ducts (13, 15) such that the outer surface (5) moves away from the axis.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices for forming and maintaining an artificial respiratory pathway in a patient's trachea, particularly for invasive mechanical ventilation (IMV).

[0002] More specifically, the present invention relates to a tracheal intubation device, such as an endotracheal tube or an improved balloon cuff for a tracheostomy or a stoma cannula. The present invention also relates to a tracheal intubation device having such a balloon cuff and a method for monitoring the inflated state of such a balloon cuff.

Background Art

[0003] Mechanical ventilation is a widely used and effective solution for artificially supplying oxygen to patients with respiratory failure and removing carbon dioxide released by the respiratory system. Other purposes of mechanical ventilation are to reduce the respiratory effort of the ventilated patient and to treat potentially life-threatening conditions of the patient such as hypoxemia, hypercapnia, inadequate arterial oxygenation, and acute respiratory acidosis.

[0004] The term "invasive mechanical ventilation" (IMV) is commonly used to indicate mechanical ventilation in which an artificial airway device is inserted into the patient's body (in contrast to non-invasive ventilation which usually uses a breathing mask). Invasive mechanical artificial ventilation is used to maintain the function of the patient's airway, particularly in acute or chronic respiratory failure, or during procedures such as intubation in an intensive care unit or an operating room.

[0005] There are several types of instruments for providing an artificial airway in the trachea for connection to a ventilator in order to perform gas exchange.

[0006] Endotracheal tubes are intended to be inserted into the trachea through the patient's mouth or nose, without necessarily requiring surgical intervention. Such tubes are primarily used in adult or pediatric patients with acute respiratory failure. To ensure a seal of the distal airways, i.e., to prevent the transfer of fluids, air, or liquids between these distal airways and the upper airways (particularly the pharynx and larynx), endotracheal tubes are often equipped with a balloon cuff positioned along the tube. When the balloon cuff inflates and makes contact with the trachea, a seal of the airway is ensured.

[0007] Such balloon cuffs allow for fluid and bacteriological isolation of the bronchial tree. Balloon cuffs are particularly recommended to protect the patient's lungs from reflux and contamination by oral and digestive secretions. This balloon cuff provides an airway seal, prevents air leakage around the endotracheal tube, and allows for control of the volume and pressure administered to the patient. This pressure / volume regime is fundamental in the treatment of respiratory failure in patients, regardless of age or underlying pathology.

[0008] On the other hand, a tracheostomy cannula is inserted not through the patient's natural airway, but through the tracheostomy (a surgical opening that opens the trachea outward). This solution is particularly suitable for patients with chronic respiratory failure who require long-term mechanical ventilation. Tracheostomy cannulas also typically come with a balloon cuff for the same reasons as conventional endotracheal tubes.

[0009] Invasive mechanical ventilation can significantly improve the life expectancy of patients with acute respiratory failure.

[0010] However, the in-hospital mortality rate for non-surgical patients receiving invasive mechanical ventilation exceeds 35%. Furthermore, patients permitted to go home after a respiratory failure event have a significantly higher long-term morbidity rate.

[0011] This significant mortality rate is partly linked to two shortcomings of the current endotracheal balloon cuff.

[0012] On the other hand, microinhalation of contaminated oropharyngeal secretions can cause bronchopneumonia (known as "ventilator-induced pneumonia" or VAP). More than 30% of complications of invasive mechanical ventilation are thought to be due to such acquired bronchopneumonia. Leakage of these oral secretions into the bronchial system and deep lungs is due to inadequate sealing of the endotracheal balloon cuff. Inadequate sealing is caused by undesirable folds on the outer surface of the balloon cuff, which form microchannels through which oral secretions, i.e., oropharyngeal secretions on the "mouth" side of the balloon cuff, can pass. The phenomenon of folds on the outer surface of the balloon cuff is specifically described in Non-Patent Literature 1 (see Figure 1 on page 182).

[0013] A known solution to overcome inadequate sealing of the balloon cuff is to use an additional suction system to collect oral secretions above the proximal end of the balloon cuff. However, such a suction system causes further pain to the patient and requires maintenance.

[0014] On the other hand, excessive pressure applied to the tracheal wall by the outer surface of the balloon cuff can cause severe damage to the tracheal mucosa and submucosa. Tracheal damage due to overinflation of the balloon cuff can impair blood circulation to the tracheal mucosa and lead to potential complications such as compression wounds and, in the case of necrosis or scarring, tracheal stenosis. Stenosis is a specific type of scarring of the trachea that can reduce its diameter and make breathing difficult.

[0015] The usual solution for maintaining an optimal balloon cuff pressure sufficient to maintain a distal airway seal while being restricted to avoid causing tracheal injury is to manually monitor and adjust the air pressure within the balloon cuff. It is estimated that up to eight manual balloon cuff pressure adjustments per day are necessary to maintain the balloon cuff pressure within the recommended range. However, the need for frequent adjustments increases the workload of hospital staff and carries a risk of human error.

[0016] Recently, systems such as the NOSTEN® system have emerged, which allow for better control of balloon cuff pressure, particularly adaptive control of this pressure. However, these systems use standard balloon cuffs with insufficient sealing properties. Therefore, these systems do not completely prevent leakage of oral secretions into the bronchial system and lungs.

[0017] When performing invasive ventilation, it should be noted that the patient's bronchial system is placed within the ventilation device and closed circuit. The bronchial system is isolated from the external environment. Bronchial secretions on the lung side of the balloon cuff cannot be eliminated to the external environment, for example, by swallowing through coughing. Furthermore, it is essential to perform tracheal suctioning regularly at least every four hours, which involves opening the circuit, sliding a probe into the patient's throat, and aspirating accumulated secretions. This procedure is invasive and can damage the trachea. In addition, intubated patients, who are normally ventilated, experience vacuuming at the end of the expiratory action to maximize alveolar exchange, which reduces alveolar exchange and the patient's respiratory quality. [Prior art documents] [Non-patent literature]

[0018] [Non-Patent Document 1] “La ventilation mecanique, de la physiology a la pratique : quelle sonde, quel circuit, quel ventilateur ? [Mechanical ventilation, from physiology to practice: which tube, which circuit, which ventilator?],” Anesthesie & Reanimation, Volume 4, Issue 2, March 2018, pp. 180-189 [Overview of the project]

[0019] From the above perspective, there is a need for an endotracheal intubation balloon cuff device that is an improvement over existing cuffs and reduces the risk of tracheal injury, especially in patients undergoing mechanical ventilation, while ensuring a sufficient seal between the patient's distal and upper airways.

[0020] Preferably, the requested tracheal intubation device includes a balloon cuff that allows for easy adjustment of pressure to the trachea in order to reduce the workload of hospital staff during mechanical ventilation.

[0021] For example, there is a further need for endotracheal balloon cuffs in which radial pressure is adapted according to the specific patient's movements and actions in response to the patient's efforts to cough or swallow.

[0022] Furthermore, tracheal intubation devices that can autonomously drain oral and pharyngeal secretions from patients are needed to avoid contamination of the distal airway by these secretions and to reduce or eliminate the need for tracheal suctioning, i.e., suctioning of bronchial secretions.

[0023] To satisfy these needs, a first aspect of the present invention relates to a balloon cuff for a tracheal intubation device, the balloon cuff being elastically deformable and extending between an inner surface surrounding an axis and an outer surface surrounding the inner surface, the balloon cuff having an inner wall defining a duct through the balloon cuff, and the balloon cuff being configured to transition from a deflated state to an inflated state by injection of fluid into the duct such that the outer surface moves away from the axis.

[0024] Such balloon cuffs, either alone or in combination, are advantageously and optionally supplemented by the following different properties: - When the balloon cuff is in a deflated state, the ratio of the thickness between the inner surface and the outer surface to the width of the outer surface is greater than 10%, preferably 20%; - For each duct, when the balloon cuff is inflated, the ratio of the duct size to the shorter distance between the duct and the outer surface is 100% or less, preferably 50%; - The inner surface and the outer surface have a cylindrical shape defined by an axial direction parallel to the axis, the inner surface and the outer surface have a cross-section that is at least partially circular in a plane perpendicular to the axis, and preferably, the outer surface has a flat region that extends axially along the entire outer surface in a plane parallel to the axis; - The duct has a main direction parallel to the axis, and the duct preferably extends parallel to the axis from the proximal end of the balloon cuff to the distal end of the balloon cuff; - The duct has a main direction parallel to the circumferential direction with respect to the axis, and the duct preferably extends in an arc around the axis; - The balloon cuff includes different groups of ducts that can be controlled independently, the groups are located in sections of the balloon cuff, the sections are in pairs and are arranged continuously along the axis; - The thickness between the inner surface and the outer surface is 1 mm or less, preferably 0.5 mm, when the balloon cuff is configured in a contracted state; and - The balloon cuff is mainly formed of a synthetic polymer material, preferably silicone or polyurethane.

[0025] The present invention also relates to a tracheal intubation device configured to form an artificial airway in a patient's trachea, the intubation device comprising: - A breathing tube, and - A balloon cuff as presented above, attached to the breathing tube such that the inner surface surrounds the tube.

[0026] Such a device advantageously and optionally comprises a pressure sensor downstream of the balloon cuff with respect to the head-tail direction, the sensor being configured to acquire a pressure measurement value representing the effort of the patient to cough.

[0027] Finally, the present invention includes a method of controlling such a tracheal intubation device, the method comprising setting movement on the outer surface by injecting fluid into the first group of ducts and injecting fluid into the second group of ducts in order to modify the inflated state of the outer surface.

[0028] Such a method may optionally include the detection of excess pressure in the trachea, and the movement is triggered as a function of the detected excess pressure when the device is equipped with a pressure sensor downstream of the balloon cuff with respect to the craniocaudal direction, and the sensor is configured to acquire a pressure measurement representing the patient's coughing effort. [Brief explanation of the drawing]

[0029] Other features and advantages of the present invention will become apparent from the following description, which is purely illustrative and non-limiting and should be read with reference to the accompanying drawings.

[0030] [Figure 1] This is a schematic diagram of a balloon cuff according to a different embodiment of the present invention. [Figure 2] This is a schematic diagram of a balloon cuff according to a different embodiment of the present invention. [Figure 3] This is a schematic diagram of a balloon cuff according to a different embodiment of the present invention. [Figure 4] This is a schematic diagram of a tracheal intubation device according to one embodiment of the present invention. [Figure 5] This is a schematic diagram of the movement of the outer surface of the balloon cuff. [Modes for carrying out the invention]

[0031] Balloon cuff for tracheal intubation device

[0032] According to a first aspect, the present invention relates to a balloon cuff 1 for an endotracheal intubation device. The balloon cuff 1 is configured to be attached to the ventilator tube of an endotracheal intubation device.

[0033] Referring to Figures 1 to 3, the balloon cuff 1 extends along axis A or the central axis between the proximal end P and the distal end D.

[0034] When balloon cuff 1 slides over the tubing of the intubation device, the central axis of the balloon cuff corresponds to the axis of the tubing.

[0035] When the balloon cuff attached to the tube is inserted into the patient's trachea, the central axis corresponds to the general direction of tracheal extension, also known as the "craniocaudal direction."

[0036] The proximal end corresponds to the "oral side" of the balloon cuff.

[0037] The distal end corresponds to the "bronchial or lung side" of the balloon cuff.

[0038] The radial and circumferential directions are defined from the central axis.

[0039] For example, in Figure 1, the proximal end P of the balloon cuff shows a radial direction R1 perpendicular to the central axis A, and a circumferential direction C1 perpendicular to both the radial direction R1 and the central axis A. Similarly, in Figure 1, the distal end D of the balloon cuff shows a radial direction R2 perpendicular to the central axis A, and a circumferential direction C2 perpendicular to both the radial direction R2 and the central axis A.

[0040] The balloon cuff extends radially with respect to the central axis from the inner surface 3 to the outer surface 5. The inner surface 3 surrounds the central axis A. The outer surface 5 surrounds the inner surface 3.

[0041] For example, as shown in Figures 1 and 3, the outer surface 5 and the inner surface 3 are two cylinders with a circular cross-section whose axis is the central axis. The balloon cuff 1 has the shape of a hollow tube with a circular ring-shaped cross-section in the radial plane, that is, perpendicular to the central axis A.

[0042] The thickness 11 of the balloon cuff is defined as the radial distance between the inner surface 3 and the outer surface 5. Referring to Figure 1, the thickness 11 is defined, for example, along the radial direction R1 at the proximal end P of the balloon cuff. When the outer surface 5 and the inner surface 3 are cylindrical with a circular cross-section whose axis is the central axis, the thickness 11 is the radial thickness of the circular ring.

[0043] The width 9 of the outer surface is the radial distance between two intersections of the outer surface and the radial direction. The two intersections are separated by the central axis. Referring to Figure 1, the width 9 is defined, for example, by the radial R2 at the distal end D of the balloon cuff. If the outer surface 5 and the inner surface 3 are two cylinders with a circular cross-section whose axis is the central axis, then the width of the outer surface is the outer diameter of the circular ring.

[0044] The balloon cuff 1 is elastically deformable.

[0045] Advantageously, the balloon cuff has an elastic deformation rate of 10% or more.

[0046] More advantageously, the balloon cuff has an elastic deformation rate of 20% or more.

[0047] Furthermore, the balloon cuff has an elastic deformation rate of 30% or more.

[0048] The elastic rate of deformation of an object between its neutral and deformed states is defined here as the ratio of the difference between the length of the deformed object and the length of the neutral object to the length of the neutral object. A deformation is elastic if the deformed object can be reversibly returned to its neutral state, particularly without fracture or plastic deformation of the object.

[0049] In particular, balloon cuffs can be made from elastomers, especially polyurethane, silicone, and mixtures thereof.

[0050] Preferably, the balloon cuff can be formed of a synthetic polymer material, preferably silicone, mainly, i.e., more than 50% by mass.

[0051] The balloon cuff 1 has an inner wall that defines a duct 13, 15 or channel extending through the balloon cuff.

[0052] The balloon cuff has a total number of ducts, for example, between 4 and 20, preferably between 8 and 12, but the number can vary more or less.

[0053] Each duct extends within the balloon cuff 1 between the inner surface 3 and the outer surface 5. Each duct extends in a principal direction such that the dimensions of the duct in the principal direction are significantly larger than those in other directions. The cross-section of the duct can be defined at any point in the duct as the intersection of the duct and a plane perpendicular to the principal direction at that point.

[0054] The cross-section corresponds to a flat surface that is closed around its periphery, which is either curved or formed by different straight segments.

[0055] The size of a duct is a characteristic size of its cross-section; for example, it can be defined as the diameter of the largest sphere that can be inserted into the duct without deformation.

[0056] Therefore, the size of a duct is the lateral dimension of the duct in a plane perpendicular to the main direction of the duct.

[0057] The main direction can be constant, in which case the duct is straight. The main direction can change continuously along the duct, in which case the duct is curved. The duct may also include straight and curved sections.

[0058] The balloon cuff is configured to transition from a deflated state to an inflated state by injecting fluid into each duct so that the outer surface moves away from the axis, i.e., moves radially toward the outside of the balloon cuff.

[0059] When the fluid is injected into the duct, the duct is pressurized so that its cross-sectional area increases.

[0060] When no more fluid is injected into the duct, the balloon cuff changes from an inflated state to a deflated state.

[0061] The deformation of the balloon cuff during fluid injection into the duct is reversible. In other words, the balloon cuff returns to its initial deflated state once the fluid is removed.

[0062] Calibrating the fluid injection process results in calibrated, predictable, and reproducible balloon cuff deformation.

[0063] The fluid injected into the balloon cuff duct to obtain this type of deformation may be a liquid, a gas, or a mixture of liquids and gases. Different liquids or gases may be used individually or in combination.

[0064] Preferably, the fluid is - Air (this is called pneumatic operation), - Or water (this is called hydraulic operation).

[0065] To inject fluid, it is possible to control the fluid injection rate and / or pressure and / or fluid injection volume.

[0066] The shape of the balloon cuff can be controlled by injecting a fluid (gas or liquid) through a duct. In this case, the balloon cuff can move from a deflated state to an inflated state, and the outer surface of the balloon cuff moves radially outward. Such a balloon cuff, inserted into the patient's trachea in a deflated state, can then be inflated so that its outer surface contacts the trachea. The presence of several ducts allows for the distribution and homogenization of the area of ​​inflation within the balloon cuff. Such a balloon cuff provides a better seal between the patient's distal airway and upper airway than the conventional art.

[0067] According to the first option, when the balloon cuff is in a deflated state, it is possible to require that the ratio of the thickness between the inner surface 3 and the outer surface 5 to the width 9 of the outer surface 5 be 10% or more, preferably 20%.

[0068] Such a ratio allows for a reduction in the risk of folds on the outer surface during balloon cuff inflation.

[0069] According to the second option, optionally in combination with the first option, it is possible to require that in each duct, the size of ducts 13 and 15 be less than the closest distance between ducts 13 and 15 and the outer surface 5. More precisely, it is possible to require that the ratio between the size of ducts 13 and 15 and the closest distance between ducts 13 and 15 and the outer surface 5 be 100% or less, preferably 50%.

[0070] This ratio allows for the formation of bulges and protrusions on the outer surface of the duct during its expansion. This improves the sealing of the balloon cuff compared to the conventional technique.

[0071] The deflated state allows the balloon cuff surrounding the tube to slide into the trachea.

[0072] In the inflated state, the outer surface of the balloon cuff contacts the trachea, and the balloon cuff surrounds the tube within the trachea. The contact between the outer surface of the balloon cuff and the trachea is more uniform than in the conventional technique. The pressure of the balloon cuff on the trachea is applied more uniformly than in the conventional technique.

[0073] In this case, it should be noted that the inner surface faces the tube. The distance between the central axis and the inner surface remains greater than or equal to the tube's radius so that the tube's diameter does not decrease due to the action of the balloon cuff.

[0074] For this purpose, the tube may be considerably more rigid than the balloon cuff, or the balloon cuff may be configured such that, regardless of the balloon cuff's configuration, the distance between the central axis and the inner surface always remains equal to or slightly greater than the tube's radius.

[0075] The balloon cuff presented above may also find potential applications in the placement of coronary artery, artery, heart, or venous stents in the fields of interventional radiology or cardiology. The fact that pressure is applied more uniformly to the balloon cuff surface is a highly relevant factor for this type of application.

[0076] Preferably, when the balloon cuff is configured in a deflated state, the thickness between the inner and outer surfaces can be selected to be 2 millimeters or less, or 1 millimeter or 0.5 millimeters. Conventionally, the tube has a diameter of 1 millimeter or less. The "tube + deflated balloon cuff" assembly has an outer width that depends on the thickness between the inner and outer surfaces: this outer width of the "tube + deflated balloon cuff" assembly can be less than 5 millimeters, or take values ​​of 3 millimeters or 2 millimeters.

[0077] Balloon cuff shape for tracheal intubation device

[0078] The inner surface 3 and the outer surface 5 may have different shapes. These surfaces may have, but are not limited to: - The inner and outer surfaces may be cylindrical, defined by an axial direction parallel to the axis, such that they have a circular cross-section in a plane perpendicular to the axis, or - The inner and outer surfaces may be cylindrical, defined by the axial direction, such that they have an elliptical cross-section in a plane perpendicular to the axis, or - The inner and outer surfaces may be cylindrical, defined by the axial direction, such that they have sections with flat regions in a plane perpendicular to the axis.

[0079] In a preferred embodiment, the outer surface 5 and the inner surface 3 are two cylindrical shapes with a circular cross-section whose axis is the central axis. In other words, the inner surface and the outer surface are cylindrical shapes defined by their axial direction, and the inner surface and the outer surface have a circular cross-section in a plane perpendicular to the axis.

[0080] Furthermore, the balloon cuff 1 has the shape of a hollow tube with a circular ring-shaped cross-section in a radial plane perpendicular to the central axis A.

[0081] Advantageously, in this preferred embodiment, referring to Figure 2, the outer surface has a flat region 7 that extends axially along the entire outer surface in a plane parallel to the axis. The flat region 7 defines a flat surface that is parallel to the axis and perpendicular to the radial direction of the axis. The shortest distance separating the flat region 7 from the axis is greater than the radius of the inner surface 3, such that the inner surface 3 is located between the outer surface 5 and axis A.

[0082] The flat region 7 corresponds to an angular range in the radial plane perpendicular to the axis, which is advantageously comprised of angles between 20° and 100°, and even more advantageously comprised of angles between 40° and 80°.

[0083] Balloon cuffs that include such flat areas have a shape that better conforms to the anatomical structure of the trachea, making the insertion and inflation of the balloon cuff into the trachea less traumatic for the patient.

[0084] Geometric shape of the duct network inside the balloon cuff

[0085] Regardless of the geometric shapes of the inner and outer surfaces of the balloon cuff, the duct can take on different shapes between these two surfaces.

[0086] In a first embodiment of the balloon cuff duct, referring to Figure 1, at least a portion of the duct 13 has a principal direction parallel to the axis, i.e., the dimensions of the duct along the axis are significantly larger than the dimensions of the duct along other directions. These ducts preferably extend parallel to the axis from the proximal end P of the balloon cuff to the distal end D of the balloon cuff. When these ducts are pressurized, the technical effect associated with this characteristic is to achieve expansion of the balloon cuff in the circumferential direction rather than the axial direction, which induces expansion of the cross-section of the balloon cuff.

[0087] As an option for this first embodiment of the balloon cuff duct, the duct 13 extending parallel to the axis is configured such that, when the balloon cuff is in a deflated state, for each group of two adjacent ducts, the angular distance in the radial plane between the two adjacent ducts is equal to a predetermined distance. In other words, the angular difference in the radial plane separating the two adjacent ducts is constant around the axis.

[0088] In a second embodiment of the balloon cuff duct, referring to Figure 3, at least a portion of the duct has a principal direction parallel to—or equally perpendicular to—the circumferential direction with respect to the axis. That is, the dimensions of the circumferential duct are significantly larger than the dimensions of the duct in other directions, particularly the axial and radial directions. These ducts 15a, 15b, and 15c extend perpendicular to the axis, preferably in an arc around the axis. When these ducts are pressurized, the technical effect associated with this characteristic is that the balloon cuff is expanded axially rather than circumferentially.

[0089] As an option for this second embodiment of the balloon cuff duct, ducts 15a, 15b, and 15c extending parallel to each other in the circumferential direction are configured such that, when the balloon cuff is in a deflated state, the axial distance along the axis between each group of two adjacent ducts is equal to a predetermined distance. In other words, the axial distance along the axis separating two adjacent ducts is constant along the axis.

[0090] The two duct modes presented here are compatible with each other.

[0091] In particular, the ducts consist of at least two groups: - A first group of ducts having a principal direction parallel to the axis, and - A second group of ducts having a principal direction parallel to the circumferential direction, It can be separated into:

[0092] These two groups can be controlled independently with respect to their pressurization by the injected fluid. In other words, the fluid can be injected into the first group of ducts without injecting any fluid into the second group of ducts.

[0093] The first group, in particular, can ensure the deployment of the balloon cuff and the sealing between the upstream and downstream sides of the balloon cuff.

[0094] More generally, ducts can be organized into different groups that can be independently controlled with respect to their pressurization by the fluid being injected.

[0095] In particular, independently controllable groups can be organized into sections of the balloon cuff that are arranged continuously along the axis of the balloon cuff. The groups are arranged in sections of the balloon cuff, and the sections are arranged in pairs and continuously along the axis.

[0096] For example, referring to Figure 3, the balloon cuff may have a second group of ducts having a principal direction parallel to the circumferential direction, and the second group is: - Proximal end P, - A first midpoint I1 located axially between the proximal end P and the distal end D, - A second midpoint I2 located axially between the first midpoint I1 and the distal end D, and - Distal end D, It is formed from three subgroups 15a, 15b, and 15c of ducts arranged in three different axial zones defined by [the specified method].

[0097] The first zone Z1, or proximal zone, of the balloon cuff is defined between the proximal end P and the first midpoint I1. The second zone Z2, or central zone, of the balloon cuff is defined between the two midpoints I1 and I2. The third zone Z3, or distal zone, of the balloon cuff is defined between the second midpoint I2 and the distal end D.

[0098] In this case, all ducts within a subgroup are located in one of the zones, and each zone contains only one of the three subgroups of ducts, where: - Proximal subgroup of duct 15a in proximal zone Z1, - The central subgroup of duct 15b in central zone Z2, and - Distal subgroup of duct 15c within distal zone Z3.

[0099] More generally, a balloon cuff may have n subgroups of ducts, greater than 3, within n zones.

[0100] More generally, a balloon cuff may have groups of 2n ducts within n zones of 3 or more, where each zone contains two independent groups of ducts.

[0101] According to this option, each zone defined above corresponds to an axial portion of the balloon cuff that can be inflated or deflated independently of the adjacent portion.

[0102] A group of independent ducts organized according to sections of the balloon cuff, arranged continuously along the axis of the balloon cuff, enables the realization of peristaltic motion of the balloon cuff. The outer surface of the balloon cuff can be driven by peristaltic wave motion propagating along the axis.

[0103] This is especially true when the balloon cuff contains three subgroups of independent ducts within the second group.

[0104] Finally, according to one variation, the following is possible: - A main network of ducts that covers the entire balloon cuff and ensures the overall seal of the balloon cuff, for example, a first group of ducts having a main direction parallel to the axis, and - A second network having a second group of ducts having a principal direction parallel to the circumferential direction, wherein the second group is formed by three independently controllable subgroups according to zones of balloon cuffs arranged continuously along the axis of the balloon cuffs.

[0105] For example, the main network has longitudinal channels for balloon cuff deployment, and the second network has circular channels for peristaltic pumping. The main network and the second network are not in fluid communication with each other.

[0106] Endotracheal intubation device

[0107] According to a second aspect, with reference to Figure 4, the present invention relates to a device 10, called a tracheal intubation device, configured to form an artificial airway in a patient's trachea 19.

[0108] The trachea 19 is defined within the patient's esophagus 20.

[0109] The intubation device 10 is - Artificial respiration tube 17, - It has a balloon cuff 1 as described above.

[0110] The balloon cuff 1 is attached to the ventilator tube 17 such that its inner surface surrounds the tube. The central axis of the balloon cuff consequently corresponds to the axis of the tube.

[0111] The tube 17 of the tracheal intubation device 10 may have an endotracheal tube, a tracheostomy cannula, or a tracheostomy cannula.

[0112] Such a device 10 can be used to perform spontaneous breathing, that is, without a mechanical ventilation module.

[0113] Such devices can be used to perform artificial respiration, that is, in conjunction with a mechanical ventilation module that fixes the flow of fluid through the ventilator tube.

[0114] In this second case, the device is: - A reservoir 24 for fluid under pressure connected to the balloon cuff duct, - A control device 23 controls the fluid reservoir 24 to apply a specific pressure to the fluid so that the balloon cuff 1 can be placed in a deflated or inflated state, - A fluid connection part 21 between the control device 23 and the balloon cuff, It has a mechanical ventilation module 20.

[0115] If the balloon cuff 1 has several groups of ducts whose pressure can be adjusted independently, the control device 23 is fluidly connected independently to each group of ducts.

[0116] In certain embodiments, the intubation device further includes a pressure sensor 25 positioned downstream of the balloon cuff with respect to the craniocaudal direction, i.e., positioned between the balloon cuff and the patient's lung once the balloon cuff is placed in the trachea.

[0117] In other words, once the balloon cuff is positioned in the trachea, it is positioned between the pressure sensor 25 and the patient's mouth.

[0118] The pressure sensor 25 is detected after the balloon cuff is placed inside the trachea: - Facing (against) the distal end D of the balloon cuff, or - Facing the inner wall of the trachea, or - At the distal end of the tube, i.e., at the lung end of the tube, - Even between the outer surface of the tube and the inner surface of the balloon cuff, It can be configured to be positioned in a certain way.

[0119] The pressure sensor 25 is configured to acquire measurements of excess pressure in the trachea.

[0120] Excessive pressure may indicate the patient's effort to cough.

[0121] The pressure sensor 25 is connected to a control device 23 that controls the reservoir of fluid under pressure so that the excess pressure measurement is transmitted to the mechanical ventilation module 20.

[0122] The pressure sensor 25 may be a piezoelectric sensor.

[0123] Methods for controlling tracheal intubation devices - peristalsis

[0124] According to a third embodiment, a method for controlling a tracheal intubation device is proposed.

[0125] In the first step, the intubation device 10 is prepared to be inserted into the patient's trachea.

[0126] For this purpose, the balloon cuff 1 is attached to the tube 17 of the device 10. The control device 23 is adjusted so that the balloon cuff 1 is configured in its deflated state.

[0127] Optionally, a pressure sensor 25 is positioned downstream of the balloon cuff in the head-to-tail direction and protrudes from the balloon cuff on the distal end D side of the balloon cuff.

[0128] In the second step, the balloon cuff 1 attached to the tube 17 is inserted into the patient's trachea 19.

[0129] Once the device 10 is positioned correctly, the control device 23 is adjusted in a third step so that the balloon cuff is configured in its inflated state.

[0130] The balloon cuff described above also allows for the induction of specific movement of the structure from the injected fluid as a function of variables such as the flow rate, volume, or pressure of the injected fluid over time. The induced movement can correspond to either the injection or withdrawal of fluid from the duct. The movement can also correspond to the alternation between the injection and withdrawal of fluid within the duct.

[0131] If the balloon cuff includes different groups of independently controllable, organized channels distributed in a continuous zone along the axis, the control method may also include the movement of the balloon cuff surface following at least one traveling wave along the axis of the balloon cuff.

[0132] Many variations are possible regarding the shape and movement for controlling the outer surface of the balloon cuff.

[0133] In one example, a balloon cuff is, - A first group of ducts having a principal direction parallel to the axis, - A second group of ducts having a principal direction parallel to the circumferential direction.

[0134] These two groups are independently controlled with respect to pressurization by the injected fluid. In other words, fluid can be injected into the first group of ducts without injecting fluid into the second group of ducts.

[0135] The first group, in particular, ensures the deployment of the balloon cuff and the sealing between the upstream and downstream sides of the balloon cuff.

[0136] These two groups allow the outer surface to be moved by injecting fluid into the first group of ducts and into the second group of ducts, respectively, in order to correct the expansion state of the outer radial surface.

[0137] Referring to Figure 5, the second group of balloon cuff ducts has three subgroups of ducts that can be independently controlled with respect to fluid injection, as described above: a proximal subgroup in the proximal zone Z1, a central subgroup in the central zone Z2, and a distal subgroup in the distal zone Z3. The following three substeps illustrate possible variations.

[0138] In the first substep shown in S1 of Figure 5, the control device is adjusted to configure the balloon cuff to a first transition state in which the distal subgroup in zone Z3 of the duct contracts and the central and proximal subgroups in zones Z1 and Z2 expand.

[0139] In the second substep shown in S2 of Figure 5, the control device is adjusted to configure the balloon cuff into a second transition state in which the central subgroup in zone Z2 of the duct contracts and the distal and proximal subgroups in zones Z1 and Z3 expand.

[0140] In the third substep shown in S3 of Figure 5, the control device is adjusted to configure the balloon cuff to a third transition state in which the proximal subgroup of the duct in zone Z1 contracts and the central and distal subgroups in zones Z2 and Z3 expand.

[0141] This movement results in the passage or movement of bronchial secretions from the distal to the proximal surface of the balloon cuff and into the nasopharynx.

[0142] This, at least partially, protects the patient from the dangerous and painful procedure of manually aspirating secretions.

[0143] The movement induced on the surface of the balloon cuff has the specific characteristic of inducing the passage or movement of tracheal secretions by having an internal / external orientation that allows the tracheal secretions to be carried upwards on the balloon cuff, where they are easily aspirated without impairing the patient's ventilation. The balloon cuff maintains its seal despite peristaltic movement: regardless of the phase of movement, a portion of the outer surface of the balloon cuff is always in contact with the trachea.

[0144] It is possible to configure the mechanical ventilation module 20 such that this movement of the outer surface occurs at a constant rate corresponding to the flow of pulmonary secretions produced by the patient. This flow varies from patient to patient and depends largely on the patient's lung function. It also depends on the patient's specific disease and may change over time. Therefore, it is adapted over time for the same patient.

[0145] If the device has a pressure sensor, the monitoring method may include detecting excessive pressure in the trachea.

[0146] When this is detected by the sensor, the information is transmitted to the control unit, which then triggers the next step of peristalsis.

[0147] The natural phenomenon of coughing in the trachea is synchronized with the movement of the outer surface of the balloon cuff, resulting in greater expulsion of bronchial secretions.

[0148] The mechanical ventilation module 20 can be configured such that the movement of the outer surface results in a zero-sum movement, meaning that the movement of the outer surface does not induce displacement of the balloon cuff structure or the tube relative to the trachea.

Claims

1. A balloon cuff for an endotracheal intubation device, wherein the balloon cuff is elastically deformable and extends between an inner surface surrounding an axis and an outer surface surrounding the inner surface, the balloon cuff has an inner wall defining a duct passing through the balloon cuff, and the balloon cuff is configured to transition from a deflated state to an inflated state by injecting fluid into the duct such that the outer surface moves away from the axis.

2. When the balloon cuff is in the contracted state, the ratio of the thickness between the inner surface and the outer surface to the width of the outer surface is greater than 10%, preferably 20%. The balloon cuff according to claim 1.

3. For each of the ducts, when the balloon cuff is inflated, the ratio of the size of the duct to the closer distance between the duct and the outer surface is 100% or less, preferably 50%. The balloon cuff according to claim 1.

4. The inner surface and the outer surface have a cylindrical shape defined by an axial direction parallel to the axis, and the inner surface and the outer surface have at least a partially circular cross-section in a plane perpendicular to the axis, preferably the outer surface has a flat region extending along the entire outer surface in the axial direction in a plane parallel to the axis. The balloon cuff according to claim 1.

5. The duct has a principal direction parallel to the axis, and preferably extends parallel to the axis from the proximal end of the balloon cuff to the distal end of the balloon cuff. The balloon cuff according to claim 1.

6. The duct has a principal direction parallel to the circumferential direction with respect to the axis, and preferably extends in an arc shape around the axis. The balloon cuff according to claim 1.

7. Having different groups of independently controllable ducts, the groups located in the sections of the balloon cuff, the sections being continuous in pairs and arranged continuously along the axis, The balloon cuff according to claim 1.

8. The thickness between the inner surface and the outer surface is 1 mm or less, preferably 0.5 mm, when the balloon cuff is in the contracted state. The balloon cuff according to claim 1.

9. The balloon cuff is mainly formed of a synthetic polymer material, preferably silicone or polyurethane. The balloon cuff according to claim 1.

10. A tracheal intubation device configured to form an artificial airway in a patient's trachea, wherein the tracheal intubation device is: - A ventilator tube, - A balloon cuff according to any one of claims 1 to 9, wherein the balloon cuff is attached to the ventilator such that its inner surface surrounds the ventilator, Endotracheal intubation device.

11. The tracheal intubation device further includes a pressure sensor downstream of the balloon cuff in the craniocaudal direction, and the pressure sensor is configured to acquire a pressure measurement representing the patient's coughing effort. The tracheal intubation device according to claim 10.

12. A method for controlling a tracheal intubation device according to claim 10, the method comprising setting movement on the outer surface by injecting fluid into a first group of the duct and into a second group of the duct in order to correct the expansion state of the outer surface.

13. The tracheal intubation device is the tracheal intubation device according to claim 11, wherein the method includes detecting an excess pressure in the trachea, and the movement is initiated as a function of the detected excess pressure. The method according to claim 12.

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