Tracheal tube cuff sleeve through which a fluid channel conduit extends

Abstract

The present invention relates to a cuff (1) for a tracheal tube device, the cuff (1) being elastically deformable and extending between an inner surface (3) about an axis (A) and an outer surface (5) about the inner surface (3), the cuff (1) comprising an inner wall defining a conduit (13, 15) extending through the cuff, the cuff (1) being configured to transition from a deflated state to an inflated state by injecting a fluid into the conduit (13, 15) such that the outer surface (5) moves away from the axis.

Description

Technical Field

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

[0002] More specifically, this invention relates to an improved cuff for endotracheal intubation devices, such as for endotracheal intubation or for tracheostomy or stoma cannulas. The invention also relates to an endotracheal intubation device including such a cuff and a method for monitoring the inflation status of such a cuff. Background Technology

[0003] Mechanical ventilation is a widely used and effective solution for artificially supplying oxygen to patients with respiratory failure and for removing carbon dioxide released from the respiratory system. Other purposes of mechanical ventilation include reducing the respiratory effort of ventilated patients and treating potentially life-threatening conditions such as hypoxemia, hypercapnia, arterial hypooxygenation, and acute respiratory acidosis.

[0004] The term "invasive mechanical ventilation" (IMV) is generally used to refer to mechanical ventilation that involves inserting an artificial airway device into a patient (as opposed to non-invasive ventilation, which typically uses a breathing mask). Invasive mechanical ventilation is particularly used for acute or chronic respiratory failure, or to maintain the function of a patient's airway during procedures such as intubation in the intensive care unit or operating room.

[0005] Several types of instruments provide an artificial airway at the trachea for connection to a mechanical respirator for gas exchange.

[0006] An endotracheal tube is designed to be inserted into the trachea through a patient's mouth or nose without the need for surgery. This type of tube is primarily used for adult or pediatric patients with acute respiratory failure. To ensure a seal in the distal airways—that is, to prevent communication of fluids, air, or liquids between these distal airways and the upper airways (particularly the pharynx and larynx)—the endotracheal tube is typically equipped with a cuff that runs along the tube. When the cuff inflates and comes into contact with the trachea, it ensures a seal in the airway.

[0007] This cuff sleeve allows for fluid and bacteriological isolation of the tracheobronchial tree. The use of a cuff sleeve is particularly recommended to protect the patient's lungs from backflow and contamination by oral and digestive secretions. The cuff sleeve provides an airway seal and prevents air leakage around the intubation tube, thus allowing for controlled volume and pressure administration to the patient. This pressure / volume protocol is fundamental to the treatment of patients with respiratory failure, regardless of age or etiology / pathology.

[0008] On the other hand, the tracheostomy cannula is not inserted through the patient's natural airway, but rather through a stoma (surgical opening that opens the trachea outwards) in the trachea. This solution is particularly suitable for patients with chronic respiratory failure who require long-term mechanical ventilation. For the same reasons as conventional intubation described above, the tracheostomy cannula is usually also equipped with a cuff.

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

[0010] However, for non-surgical patients who undergo invasive mechanical ventilation, invasive mechanical ventilation is associated with a hospital mortality rate greater than 35%. Furthermore, there is a significant long-term morbidity in patients who are allowed to return home after a respiratory failure event.

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

[0012] On the one hand, the inhalation of even small amounts of contaminated oropharyngeal secretions can cause bronchopulmonary disease (known as "ventilator-acquired pneumonia," or VAP). Complications of invasive mechanical ventilation are believed to account for more than 30% of cases attributable to this acquired bronchopulmonary disease. These leaks of oral secretions into the tracheobronchial system and deep lungs are due to inadequate sealing of the endotracheal tube cuff. This inadequate sealing is caused by unintended folds in the outer surface of the cuff, creating microchannels through which oral secretions (i.e., oropharyngeal secretions on the "mouth" side of the cuff) can pass. The phenomenon of wrinkles on the outer surface of the cuff is specifically described in the publication "Laventilation mécanique, de la physiologie à la Pratique: quelle sonde, quelcircuit, quel ventilateur? [Mechanical ventilation, from physiology to practice: which tube, which circuit, which ventilator?]", Anesthésie & Réanimation, Vol. 4, No. 2, March 2018, pp. 180-189 (see document). Figure 1 (Page 182).

[0013] A known solution to overcome the inadequate seal of the balloon sheath is to use an additional suction system that collects oral secretions above the proximal end of the balloon sheath. However, such suction systems cause additional pain to the patient and require maintenance.

[0014] On the other hand, excessive pressure applied to the tracheal wall by the outer surface of the cuff can cause severe damage to the tracheal mucosa and submucosa. Tracheal injury caused by overinflation of the cuff can impair blood circulation to the tracheal mucosa, leading to pressure wounds and possible complications such as necrosis, or, in the case of scarring, tracheal stenosis. Stenosis is a specific type of scarring that reduces the diameter of the trachea and can complicate breathing.

[0015] The usual solution for maintaining optimal cuff pressure sufficient to keep the distal airway sealed while being restricted to prevent tracheal injury is to manually monitor and adjust the air pressure inside the cuff. It is estimated that up to eight manual cuff pressure adjustments per day are required to keep the cuff pressure within the recommended range. However, the need for frequent adjustments increases the workload of hospital staff and poses a risk of human error.

[0016] Newer systems exist, including, for example, the NOSTEN® system, which allows for better control of the cuff pressure, particularly adaptive control of that pressure. However, these systems use standard cuffs with insufficient sealing. Therefore, these systems cannot completely prevent oral secretions from leaking into the tracheobronchial system and lungs.

[0017] It should be noted that during invasive ventilation, the patient's tracheobronchial system is in a closed loop with the ventilator. The tracheobronchial system becomes isolated from the external environment. Bronchial secretions on the lung side of the cuff cannot be expelled towards the external environment, for example, by being swallowed through pharyngeal clearing. Regular tracheal suctioning must then be performed (at least every four hours), which involves opening the loop, sliding a probe into the patient's throat, and suctioning the accumulated secretions. This procedure is invasive and damaging to the trachea. Furthermore, intubated patients are often ventilated at excessive pressure on the lung side (even at the end of expiration) to maximize alveolar exchange, which then leads to a vacuum, reducing alveolar exchange and the patient's respiratory quality. Summary of the Invention

[0018] In view of the above, there is a need for an improved cuff device for endotracheal intubation compared to existing cuffs; to reduce the risk of tracheal injury to patients, especially during mechanical ventilation, while ensuring a satisfactory seal between the patient's distal airway and upper respiratory tract.

[0019] Preferably, the desired endotracheal intubation device includes a cuff that allows for easy adjustment of pressure on the trachea to reduce the workload of hospital staff during mechanical ventilation.

[0020] There is also a need for an endotracheal intubation cuff that adapts its radial pressure to certain patient movements and actions, such as in response to a patient’s coughing or swallowing efforts.

[0021] There is also a need for an endotracheal intubation device that can autonomously expel oral and pharyngeal secretions from the patient to avoid contamination of the distal airway by the secretions and to reduce or eliminate the need for endotracheal aspiration (i.e., aspiration of bronchial secretions).

[0022] To meet these needs, a first aspect of the invention relates to a cuff for an endotracheal intubation device, the cuff being elastically deformable and extending between an inner surface about an axis and an outer surface about the inner surface, the cuff including an inner wall defining a conduit through the cuff, the cuff being configured to transition from a deflated state to an inflated state by moving the outer surface away from the axis through the conduit by injecting fluid into it.

[0023] This airbag sheath is advantageously and optionally complemented by the following different features, used individually or in combination:

[0024] - When the airbag sleeve is in the deflated state, the ratio of the thickness between the inner and outer surfaces to the width of the outer surface is greater than 10%, preferably 20%;

[0025] - For each pipe, when the airbag is inflated, the ratio of the pipe size to the closest distance between the pipe and the outer surface is less than or equal to 100%, preferably 50%;

[0026] - The inner and outer surfaces have cylindrical shapes defined by axial directions parallel to the axis, and the inner and outer surfaces have at least partially circular cross-sections in planes orthogonal 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.

[0027] - The pipe has a main direction parallel to the axis, and the pipe preferably extends parallel to the axis from the proximal end of the airbag sleeve to the distal end of the airbag sleeve;

[0028] - The pipe has a main direction parallel to the circumferential direction relative to the axis, and the pipe preferably extends around the axis in an arc;

[0029] - The airbag sleeve consists of different independently controllable tubing groups located in sections of the airbag sleeve, with the sections placed in pairs adjacent to each other and sequentially along the axis;

[0030] - When the airbag sleeve is configured in the deflated state, the thickness between the inner and outer surfaces is less than or equal to 1 mm, preferably 0.5 mm; and

[0031] - The airbag sheath is mainly formed of synthetic polymer materials, preferably silicone resin or polyurethane.

[0032] The present invention also relates to an endotracheal intubation device configured to form an artificial airway in a patient's trachea, the intubation device comprising:

[0033] -Artificial resuscitation tube,

[0034] - As shown in the airbag sleeve, the airbag sleeve is installed on the artificial respiration tube so that the inner surface surrounds the tube.

[0035] This device advantageously and optionally includes a pressure sensor located downstream of the airbag sheath relative to the head-to-tail direction, the sensor being configured to acquire pressure measurements representing the patient’s coughing effort.

[0036] Finally, the present invention covers a method for controlling such an endotracheal intubation device, the method comprising moving the outer surface by injecting fluid into a first tubing group and a second tubing group, thereby changing the inflation state of the outer surface.

[0037] This method advantageously and optionally includes detecting excessive pressure in the trachea, and when the device includes a pressure sensor located downstream of the cuff in a head-to-tail direction, movement is triggered based on the detected excessive pressure, the sensor being configured to acquire a pressure measurement representing the patient’s coughing effort. Attached Figure Description

[0038] Other features and advantages of the invention will become apparent from the following description, which is illustrative and non-limiting only and must be read with reference to the accompanying drawings, wherein:

[0039] Figures 1 to 3 These are schematic diagrams of airbag sleeves according to different embodiments of the present invention;

[0040] Figure 4 This is a schematic diagram of an endotracheal intubation device according to an embodiment of present invention 1; and

[0041] Figure 5 This is a schematic diagram of the movement of the outer surface of the airbag sleeve. Detailed Implementation

[0042] Inflatable sleeve for endotracheal intubation devices

[0043] According to a first aspect, the present invention relates to a cuff 1 for an endotracheal intubation device. The cuff 1 is configured to be installed in the artificial breathing tube of the endotracheal intubation device.

[0044] refer to Figures 1 to 3 The airbag sleeve 1 extends along axis A or central axis between the proximal end P and the distal end D.

[0045] When the airbag sleeve 1 slides on the tube of the intubation device, the central axis of the airbag sleeve corresponds to the axis of the tube.

[0046] When the cuff attached to the tube is inserted into the patient's trachea, the central axis corresponds to the approximate direction of the trachea's extension, also known as the "cranio-caudal" direction.

[0047] The proximal end corresponds to the "mouth side" of the airbag sheath.

[0048] The distal end corresponds to the "bronchial or lung side" of the airbag sheath.

[0049] The radial and circumferential directions are defined by the central axis.

[0050] For example, in Figure 1 In the diagram, at the proximal end P of the airbag sheath, a radial direction R1 orthogonal to the central axis A and a circumferential direction C1 orthogonal to both the radial direction R1 and the central axis A are shown. Similarly, in Figure 1 In the diagram, at the distal end D of the airbag sleeve, a radial direction R2 orthogonal to the central axis A and a circumferential direction C2 orthogonal to both the radial direction R2 and the central axis A are shown.

[0051] The airbag sleeve extends radially from the inner surface 3 to the outer surface 5 relative to the central axis. The inner surface 3 surrounds the central axis A. The outer surface 5 surrounds the inner surface 3.

[0052] For example, and as Figure 1 and Figure 3 As shown, the outer surface 5 and the inner surface 3 are two cylinders with circular cross-sections, and their axes are the central axis. Then, the airbag sleeve 1 has the shape of a hollow tube, which has a cross-section in the form of an annulus in the radial plane (i.e., orthogonal to the central axis A).

[0053] The thickness 11 of the airbag sheath is defined as the radial distance between the inner surface 3 and the outer surface 5. (Reference) Figure 1 Thickness 11 is defined, for example, along the radial direction R1 at the proximal end P of the airbag sheath. When the outer surface 5 and the inner surface 3 are two cylinders with circular cross-sections whose axes are the central axis, thickness 11 is the radial thickness of the annulus.

[0054] The width 9 of the outer surface is defined as the distance between two points where the outer surface and the radial direction intersect. These two points are separated by a central axis. (Reference) Figure 1 The width 9 is defined, for example, at the distal end D of the airbag sleeve along the radial direction R2. When the outer surface 5 and the inner surface 3 are two cylinders with circular cross-sections whose axes are the central axis, the width of the outer surface is the outer diameter of the annulus.

[0055] The airbag sleeve 1 is elastically deformable.

[0056] Advantageously, the airbag sheath has an elastic deformation rate of 10% or greater.

[0057] More advantageously, the airbag sheath has an elastic deformation rate of 20% or greater.

[0058] Even more advantageously, the airbag sheath has an elastic deformation rate of 30% or greater.

[0059] The elastic deformation rate of an object between its neutral and deformed states is defined here as the ratio of the difference between the object's length in the deformed state and its length in the neutral state to the object's length in the neutral state. Deformation is elastic if the object in the deformed state can reversibly return to the neutral state, and especially if there is no fracture or plastic deformation of the object.

[0060] In particular, the airbag sheath can be made of elastomers, especially polyurethane, silicone resin and mixtures thereof.

[0061] Preferably, the airbag sheath can be formed primarily, i.e., more than 50% by mass, of a synthetic polymer material, preferably silicone resin.

[0062] The airbag sleeve 1 includes an inner wall defining a conduit 13, 15 or channel extending through the airbag sleeve.

[0063] The airbag sleeve includes, for example, a total of 4 to 20, preferably 8 to 12, tubes, but their number may vary more or less.

[0064] Each pipe extends into the airbag sleeve 1 between the inner surface 3 and the outer surface 5. Each pipe extends in the principal direction such that its dimension in the principal direction is significantly larger than its dimensions in other directions. The cross-section of the pipe can be defined at any point as the intersection between the pipe and a plane orthogonal to the principal direction at that point.

[0065] The cross section corresponds to a flat surface that has a self-closed perimeter, which is curved or formed by different straight line segments.

[0066] The dimensions of a pipe are the characteristic dimensions of its cross-section; they can be defined, for example, as the diameter of the largest sphere that can be inserted into the pipe without deformation.

[0067] Therefore, the size of a pipe is its lateral dimension in a plane orthogonal to the main direction of the pipe.

[0068] The main direction can be constant, in which case the pipe is straight. The main direction can vary continuously along the pipe, in which case the pipe is curved. The pipe can also include straight sections and curved sections.

[0069] The airbag sleeve is configured to transition from a deflated state to an inflated state by injecting fluid into each channel, causing the outer surface to move away from the axis, i.e., to move radially toward the outside of the airbag sleeve.

[0070] When fluid is injected into a pipe, the pipe is pressurized, causing the pipe's cross-section to increase.

[0071] When fluid is no longer injected into the pipe, the airbag sleeve changes from an inflated state to a deflated state.

[0072] The deformation of the airbag sleeve during fluid injection into the pipeline is reversible. In other words, once the fluid is removed, the airbag sleeve returns to its initial deflated state.

[0073] The calibration fluid injection produces calibrated, predictable, and reproducible airbag sleeve deformation.

[0074] The fluid injected into the tubing of the airbag sleeve to achieve this type of conversion can be a liquid, a gas, or a mixture of liquid and gas. Different liquids or gases can be used alone or in combination.

[0075] Preferably, the fluid is

[0076] - Air (this is known as pneumatic operation).

[0077] - or water (this is called hydraulic operation).

[0078] To inject fluid, the fluid injection rate and / or pressure and / or fluid injection volume can be controlled.

[0079] The shape of the cuff can be controlled by injecting fluid (gas or liquid) into the tubing that passes through it. In this configuration, the cuff can transition from a deflated to an inflated state, with the outer surface of the cuff moving radially outward. This cuff, inserted into the patient's trachea in the deflated state, can then be inflated while its outer surface contacts the trachea. The presence of multiple tubing allows for the distribution and homogenization of the inflation area within the cuff. This cuff provides a better seal between the patient's distal and upper airways than existing technologies.

[0080] According to the first option, it can be required that when the airbag sleeve is in the deflated state, the ratio of the thickness between the inner surface 3 and the outer surface 5 to the width 9 of the outer surface 5 is greater than 10%, preferably 20%.

[0081] This ratio reduces the risk of wrinkles on the outer surface during airbag inflation.

[0082] According to the second option, optionally in combination with the first option, each conduit may be required to have a dimension smaller than the nearest distance between the conduit 13, 15 and the outer surface 5. More precisely, the ratio between the dimension of the conduit 13, 15 and the nearest distance between the conduit 13, 15 and the outer surface 5 may be less than or equal to 100%, and preferably 50%.

[0083] This ratio allows for the limitation of bulges and protrusions forming on the outer surface of the tube during inflation. Therefore, the airbag sheath's sealing performance is improved compared to existing technologies.

[0084] The deflated state allows the airbag sleeve surrounding the tube to slide into the trachea.

[0085] In the inflated state, the outer surface of the airbag sheath contacts the trachea, and the airbag sheath surrounds the tube inside the trachea. The contact between the outer surface of the airbag sheath and the trachea is more uniform than in the prior art. The pressure of the airbag sheath on the trachea is applied more uniformly than in the prior art.

[0086] It should be noted that in this configuration, the inner surface faces the tube. The distance between the central axis and the inner surface is maintained at or greater than the radius of the tube, ensuring that the tube's diameter is not reduced by the airbag sleeve.

[0087] For this purpose, the tube can be significantly stiffer than the airbag sheath, or the airbag sheath can be configured such that, regardless of the configuration of the airbag sheath, the distance between the central axis and the inner surface always remains equal to or slightly greater than the radius of the tube.

[0088] The balloon cuff described above can also be found in the placement of coronary artery, artery, cardiac, or venous stents in interventional radiology or cardiology. The fact that pressure is applied more evenly to the surface of the balloon cuff is a very relevant factor for this type of application.

[0089] Preferably, when the airbag sleeve is configured in the deflated state, the thickness between the inner and outer surfaces can be selected to be less than or equal to 2 mm, or 1 mm, or 0.5 mm. Conventionally, the tube has a diameter less than or equal to 1 mm. The "tube + deflated airbag sleeve" assembly has an outer width that depends on the thickness between the inner and outer surfaces: this outer width of the "tube + deflated airbag sleeve" assembly can be less than 5 mm, or 3 mm, or 2 mm.

[0090] Geometry of the insufflation sleeve for endotracheal intubation devices

[0091] The inner surface 3 and the outer surface 5 can have different shapes. In a non-limiting manner, the shapes of these surfaces can be:

[0092] - A cylinder defined by an axial direction parallel to the axis, such that the inner and outer surfaces have circular cross-sections in a plane orthogonal to the axis, or

[0093] - A cylinder defined by the axial direction, such that the inner and outer surfaces have elliptical cross-sections in a plane orthogonal to the axis, or

[0094] - A cylinder defined by an axial direction, such that the inner and outer surfaces have cross-sections with flat regions in a plane orthogonal to the axis.

[0095] In a preferred embodiment, the outer surface 5 and the inner surface 3 are two cylinders with circular cross-sections, the axis of which is the central axis. In other words, the inner and outer surfaces have cylindrical shapes defined by the axial direction, and the inner and outer surfaces have circular cross-sections in a plane orthogonal to the axis.

[0096] Then, the airbag sleeve 1 has the shape of a hollow tube, which has a cross-section in the form of an annulus in the radial plane (i.e., orthogonal to the central axis A).

[0097] Advantageously, in this preferred embodiment, and 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 orthogonal to a direction radial to 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 lies between the outer surface 5 and the axis A.

[0098] The flat region 7 corresponds to an angular range in a radial plane orthogonal to the axis, which is advantageously included between 20° and 100°, or even more advantageously between 40° and 80°.

[0099] The cuff, including this flat area, has a shape that is more suitable for the tracheal anatomy, making the insertion and inflation of the cuff less invasive to the patient.

[0100] Geometry of the tubing network in the airbag sheath

[0101] Regardless of the geometry of the inner and outer surfaces of the airbag sheath, the tubing can take different shapes between these two surfaces.

[0102] In the first embodiment of the airbag sleeve's conduit, and referring to... Figure 1 At least a portion of the conduit 13 has a principal direction parallel to the axis, meaning that the dimension of the conduit along the axis is significantly larger than the dimension of the conduit along other directions. These conduits preferably extend parallel to the axis from the proximal end P of the airbag sheath to the distal end D of the airbag sheath. When these conduits are pressurized, the technical effect associated with this feature is to achieve inflation of the airbag sheath in the circumferential direction rather than the axial direction, which causes expansion of the airbag sheath section.

[0103] As an option in this first embodiment of the airbag sleeve's conduit, the conduit 13, extending parallel to the axis, is configured such that when the airbag sleeve is in a deflated state, for each pair of adjacent conduits, the angular distance in the radial plane between the two adjacent conduits is equal to a predetermined distance. In other words, the angular difference in the radial plane separating the two adjacent conduits is constant about the axis.

[0104] In the second embodiment of the airbag sleeve's conduit, and referring to... Figure 3 At least a portion of the conduit has a principal direction parallel to the circumferential direction (or equivalently orthogonal radially) relative to the axis, meaning that the dimension of the conduit in the circumferential direction is significantly larger than its dimensions in other directions (particularly the axial and radial directions). These conduits 15a, 15b, and 15c extend perpendicular to the axis, preferably in the form of an arc around the axis. When these conduits are pressurized, the technical effect associated with this feature is to achieve inflation of the airbag in the axial direction, rather than in the circumferential direction.

[0105] As an option in this second embodiment of the airbag sleeve conduit, conduits 15a, 15b, and 15c extending parallel to the circumferential direction are configured such that, when the airbag sleeve is in the deflated state, the axial distance along the axis for each pair of adjacent conduits is equal to a predetermined distance. In other words, the axial distance along the axis separating the two adjacent conduits is constant along the axis.

[0106] The two pipeline modes presented here are compatible with each other.

[0107] Specifically, the pipes can be divided into at least two groups:

[0108] - The first pipe assembly, having a main direction parallel to the axis, and

[0109] - The second pipe group has a main direction parallel to the circumferential direction.

[0110] These two sets can be independently controlled to control the pressurization of the injected fluid. In other words, fluid can be injected into the first set of pipes while fluid is not injected into the second set of pipes.

[0111] The first set, in particular, ensures the deployment of the airbag sleeve and the seal between the upstream and downstream sides of the airbag sleeve.

[0112] More generally, pipelines can be organized into different groups, which can be independently controlled with respect to the pressurization of the fluid injected into them.

[0113] Specifically, independently controllable groups can be organized into segments of the airbag sheath placed sequentially along the axis of the airbag sheath. These groups are located within segments of the airbag sheath, which are adjacent in pairs and placed continuously along the axis.

[0114] For example, and refer to Figure 3 The airbag sheath may include a second group of channels having a main direction parallel to the circumferential direction. The second group is formed by three subgroups 15a, 15b, and 15c of channels placed in three different axial regions, which are defined by the following:

[0115] -Proximal P,

[0116] - The first intermediate point I1 is axially located between the proximal end P and the distal end D.

[0117] - The second intermediate point I2, which is axially located between the first intermediate point I1 and the distal end D, and

[0118] -Remote D.

[0119] The first region Z1, or proximal region, of the airbag sheath is defined between the proximal end P and the first midpoint I1. The second region Z2, or central region, of the airbag sheath is defined between the two midpoints I1 and I2. The third region Z3, or distal region, of the airbag sheath is defined between the second midpoint I2 and the distal end D.

[0120] In this scenario, all pipes in a subgroup reside within one of the regions, and each region comprises only one of three pipe subgroups, as follows:

[0121] -Proximal pipe subgroup 15a in proximal region Z1

[0122] - Central pipe subgroup 15b in central region Z2, and

[0123] - The distal pipe subgroup 15c in the distal region Z3.

[0124] More generally, an airbag can include n subgroups of pipes in n regions, where n is greater than 3.

[0125] More generally, the airbag can include 2n groups of pipes in n regions, where n is greater than or equal to 3, and each region includes two independent groups of pipes.

[0126] According to this option, each area defined above corresponds to an axial portion of the airbag sleeve, which can be inflated or deflated independently of adjacent portions.

[0127] The independent tubular assembly of the airbag sleeve sections, arranged continuously along the airbag sleeve axis, enables peristaltic movement of the airbag sleeve. The outer surface of the airbag sleeve can then be driven by peristaltic wave motion propagating along the axis.

[0128] This is especially true if the airbag sleeve includes three separate tube sub-groups in the second group.

[0129] Finally, according to a variant, it is possible that:

[0130] - The main network, which covers the entire airbag sheath and ensures a complete seal of the airbag sheath, includes, for example, a first group of pipes with a main direction parallel to the axis, and

[0131] A secondary network, comprising a second group of pipes having a main direction parallel to the circumferential direction, the second group being formed by three subgroups, the three subgroups being independently controllable according to the area of ​​the airbag sleeve continuously placed along the axis of the airbag sleeve.

[0132] For example, the main network includes longitudinal channels for deploying the airbag sheath, and the secondary network includes circular channels for peristaltic pumping. The main network and the secondary network are not fluidly connected to each other.

[0133] Endotracheal intubation device

[0134] According to the second aspect, and referring to Figure 4 The present invention relates to a device 10 configured to form an artificial airway at the trachea 19 of a patient, the device 10 being referred to as an endotracheal intubation device.

[0135] The trachea 19 is confined within the patient's esophagus 20.

[0136] The intubation device 10 includes:

[0137] -Artificial resuscitation tube 17,

[0138] - As described above, the airbag sleeve 1.

[0139] The airbag sheath 1 is installed on the artificial respiration tube 17 such that its inner surface surrounds the tube. Then, the central axis of the airbag sheath corresponds to the axis of the tube.

[0140] The tube 17 of the endotracheal intubation device 10 may include an endotracheal tube, a tracheostomy cannula, or a tracheostomy cannula.

[0141] This device 10 can be used to implement spontaneous breathing, that is, without a mechanical ventilation module.

[0142] This device can be used to perform artificial respiration, that is, it has a mechanical ventilation module that fixes the flow of fluid through the artificial respiration tube.

[0143] In this second case, the device includes a mechanical ventilation module 20, which comprises:

[0144] - A reservoir 24 containing pressurized fluid, connected to a pipe in the airbag sleeve.

[0145] - Control device 23, which controls fluid reservoir 24 to apply a specific pressure to the fluid, so that airbag sleeve 1 can be in a deflated or inflated state, and

[0146] - Fluid connection 21, which is located between the control device 23 and the airbag sleeve.

[0147] When the airbag sleeve 1 includes several sets of pipes whose pressure can be independently adjusted, the control device 23 is independently fluidly connected to each set of pipes.

[0148] In a particular embodiment, the intubation device further includes a pressure sensor 25 positioned downstream of the cuff in a head-to-tail direction, i.e., between the cuff and the patient's lungs once the cuff has been placed in the trachea.

[0149] In other words, once the airbag is placed in the trachea, the airbag is positioned between the pressure sensor 25 and the patient's mouth.

[0150] Pressure sensor 25 can be configured to be placed after the airbag sheath has been placed in the trachea:

[0151] -The distal end D of the airbag sheath, or

[0152] - against the inner wall of the trachea, or

[0153] - At the distal end of the tube, that is, at the pulmonary end of the tube,

[0154] - Or even between the outer surface of the tube and the inner surface of the airbag sleeve.

[0155] Pressure sensor 25 is configured to acquire a measurement of excess pressure in the trachea.

[0156] Excessive stress can indicate a patient's coughing effort.

[0157] Pressure sensor 25 is connected to control device 23, which controls the reservoir of fluid under pressure so that excess pressure measurement is transmitted to mechanical ventilation module 20.

[0158] Pressure sensor 25 can be a piezoelectric sensor.

[0159] Methods for controlling endotracheal intubation devices - peristaltic movement

[0160] Based on the third aspect, a method for controlling the endotracheal intubation device is proposed.

[0161] In the first step, preparations are made to insert the intubation device 10 into the patient's trachea.

[0162] For this purpose, the airbag sleeve 1 is installed on the tube 17 of the device 10. The control device 23 is adjusted so that the airbag sleeve 1 is configured to be in its deflated state.

[0163] Optionally, the pressure sensor 25 is positioned downstream of the airbag sleeve relative to the head-to-tail direction, extending from the distal end D side of the airbag sleeve.

[0164] In the second step, the cuff 1 installed on tube 17 is inserted into the patient's trachea 19.

[0165] Once the device 10 has been placed in the appropriate position, the control device 23 is adjusted in the third step so that the airbag sleeve is configured to be in its inflated state.

[0166] The airbag sheath described so far also allows for specific movements of the structure to be induced from the injected fluid based on variables such as the flow rate, volume, or pressure of the injected fluid over time. The induced movement can correspond to the injection or extraction of fluid from the pipe. It can also correspond to the alternation between the injection and extraction of fluid within the pipe.

[0167] When the airbag sleeve includes channels of independently controllable tissues distributed along an axis in a continuous region, the control method may further include movement of the airbag sleeve surface according to at least one traveling wave along the axis of the airbag sleeve.

[0168] In terms of shape and movement, many variations of this method are possible to control the outer surface of the airbag sheath.

[0169] In one example, the airbag sheath includes:

[0170] - The first pipe assembly, having a main direction parallel to the axis, and

[0171] - The second pipe group has a main direction parallel to the circumferential direction.

[0172] These two sets are controlled independently regarding the pressurization of the fluid injected into them. In other words, fluid can be injected into the first set of pipes while fluid is not injected into the second set of pipes.

[0173] The first set, in particular, ensures the deployment of the airbag sleeve and the seal between the upstream and downstream sides of the airbag sleeve.

[0174] These two sets enable the outer surface to be moved by injecting fluid into the first set of pipes and injecting fluid into the second set of pipes, thereby changing the inflation state of the outer radial surface.

[0175] refer to Figure 5 The second airbag tubing assembly comprises three tubing sub-assemblies with independently controllable fluid injection: a proximal sub-assembly in the proximal region Z1, a central sub-assembly in the central region Z2, and a distal sub-assembly in the distal region Z3, as described above. The following three sub-steps illustrate possible examples of variations.

[0176] In the first sub-step, such as Figure 5 As shown in S1, the control device is adjusted so that the airbag sleeve is configured in a first transition state, wherein the distal terminal group in region Z3 of the pipeline is deflated, and the central and proximal terminal groups in regions Z1 and Z2 are inflated.

[0177] In the second sub-step, such as Figure 5 As shown in S2, the control device is adjusted so that the airbag sleeve is configured in a second transition state, wherein the central subgroup in region Z2 of the pipeline is deflated, and the distal and proximal terminal groups in regions Z1 and Z3 are inflated.

[0178] In the third sub-step, such as Figure 5 As shown in S3, the control device is adjusted so that the airbag sleeve is configured in a third transition state, wherein the near terminal group in region Z1 of the pipeline is deflated, and the central and far terminal groups in regions Z2 and Z3 are inflated.

[0179] This movement causes bronchial secretions to be transported or transferred from the distal to the proximal side of the balloon sheath and into the nasopharynx.

[0180] This at least partially spares patients the dangerous and painful process of manually aspirating secretions.

[0181] The movement induced on the surface of the cuff has a specific characteristic of inducing the transport or transfer of tracheal secretions by having an internal / external orientation that allows them to be brought above the cuff, where they can then be easily aspirated without impairing the patient's ventilation. Despite the peristaltic movement, the cuff maintains its seal: regardless of the stage of movement, a portion of the outer surface of the cuff is always in contact with the trachea.

[0182] The mechanical ventilation module 20 can be configured such that this movement of the outer surface occurs at a regular 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 can vary over time. Therefore, it will be adjusted for the same patient over time.

[0183] When the device includes a pressure sensor, the monitoring method may include detecting excessive pressure in the trachea.

[0184] When the sensor detects this situation, the information is transmitted to the control device, which then triggers the peristaltic movement.

[0185] Because the natural phenomenon of coughing in the trachea is synchronized with the movement of the outer surface of the cuff, the amount of bronchial secretions discharged is greater.

[0186] The mechanical ventilation module 20 can be configured so that the movement of the outer surface is the result of movement under zero totality, that is, the movement of the outer surface will not cause displacement of the airbag sleeve structure or tube relative to the trachea.

Claims

1. A cuff (1) for an endotracheal intubation device, the cuff (1) being elastically deformable and extending between an inner surface (3) about an axis (A) and an outer surface (5) about the inner surface (3), the cuff (1) including an inner wall defining a conduit (13, 15) through the cuff, the cuff (1) being configured to move the outer surface (5) away from the axis by injecting fluid into the conduit (13, 15) to change from a deflated state to an inflated state.

2. The airbag sleeve (1) according to claim 1, wherein, When the airbag sleeve is in the deflated state, the ratio of the thickness between the inner surface (3) and the outer surface (5) to the width of the outer surface (5) is greater than 10%, preferably 20%.

3. The airbag sleeve (1) according to any one of claims 1 or 2, wherein, For each pipe (13, 15), when the airbag sleeve is inflated, the ratio of the size of the pipe (13, 15) to the closer distance between the pipe (13, 15) and the outer surface (5) is less than or equal to 100%, preferably 50%.

4. The airbag sleeve (1) according to any one of claims 1 to 3, wherein, The inner surface (3) and the outer surface (5) have a cylindrical shape defined by an axial direction parallel to the axis (A), and the inner surface (3) and the outer surface (5) have at least a partially circular cross-section in a plane orthogonal to the axis (A). Preferably, the outer surface (5) has a flat region (7) extending along the entire outer surface (5) in the axial direction in a plane parallel to the axis (A).

5. The airbag sleeve (1) according to any one of claims 1 to 4, wherein, The pipe (13) has a main direction parallel to the axis, and the pipe (13) preferably extends from the proximal end (P) of the airbag sleeve (1) to the distal end (D) of the airbag sleeve (1) parallel to the axis (A).

6. The airbag sleeve (1) according to any one of claims 1 to 5, wherein, The pipe (15) has a main direction parallel to the circumferential direction relative to the axis, and the pipe (15) preferably extends in an arc around the axis (A).

7. The airbag sleeve (1) according to any one of claims 1 to 6, comprising different independently controllable tubing groups located in sections of the airbag sleeve, the sections being adjacent in pairs and placed sequentially along the axis.

8. The airbag sleeve (1) according to any one of claims 1 to 7, wherein, When the airbag sleeve is configured to be in the deflated state, the thickness between the inner surface (3) and the outer surface (5) is less than or equal to 1 mm, and preferably 0.5 mm.

9. The airbag sleeve (1) according to any one of claims 1 to 8, wherein the airbag sleeve is mainly formed of a synthetic polymer material, preferably formed of silicone resin or polyurethane.

10. An endotracheal intubation device (10) configured to form an artificial airway in a patient's trachea, the intubation device comprising: -Artificial respiration tube (17). - The airbag sleeve (1) according to any one of claims 1 to 9 is mounted on the artificial respiration tube (17) such that the inner surface (3) surrounds the tube (17).

11. The endotracheal intubation device (10) according to claim 10, the intubation device (10) further comprising a pressure sensor (25) located downstream of the cuff (1) in a head-to-tail direction, the pressure sensor (25) being configured to acquire a pressure measurement representing the patient’s coughing effort.

12. A control method for an endotracheal intubation device (10), wherein the endotracheal intubation device (10) is the endotracheal intubation device (10) according to claim 10, the method comprising the following steps: The outer surface (5) is moved by injecting fluid into the first group of pipes (13, 15) and by injecting fluid into the second group of pipes (13, 15) to change the inflation state of the outer surface (5).

13. The control method according to claim 12, wherein the endotracheal intubation device (10) is adopted according to claim 11, the method comprising detecting excessive pressure in the trachea, the movement being initiated based on the detected excessive pressure.

Images