Catheter

Abstract

To provide a catheter enabling the release of a medicinal liquid in the form of microdroplets as close as possible to the pulmonary tracts, preferentially in the trachea.SOLUTION: A catheter 1 for delivering a medicinal liquid or powder in spray form into the trachea of a subject, comprises a deformable catheter body 2 including a spray device for releasing, as a spray, a liquid or powder introduced into the catheter, the body being configured to receive an optical fiber so as to generate an image of a zone in the longitudinal direction of the body, and to allow this optical fiber to be removed before the body is discarded.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present invention relates to a catheter and system for administering microdroplets into the trachea of ​​a subject, particularly an immature subject. [Background technology]

[0002] Today, one in eight babies in the United States and about one in 14 babies in Europe are born prematurely. Approximately 20% of these premature babies suffer from respiratory distress syndrome, known by the acronym RDS. RDS can cause fetal death if the fetus is not cared for immediately, especially within the first hour after birth.

[0003] Indeed, the earlier a fetus is born (before 37 weeks of gestation), the less prepared it is to face the outside world. A rapid increase in lung volume occurs during the third trimester of pregnancy. In parallel, miniaturization of the alveolar walls allows for an increase in surface area for gas exchange. Premature interruption of this maturation process leads to alterations in respiratory function and lung physiology.

[0004] Care of premature infants with RDS typically involves the administration of surfactant and early oxygen, but existing methods of administering liquid surfactant to the airways have several drawbacks.

[0005] The first drawback is the amount of liquid surfactant administered into the lung tract, which can cause a drowning effect in babies. In fact, the amount administered to premature babies corresponds to an adult dose of approximately 200 mL or 2.5 mL per kg of subject.

[0006] A second drawback is that the methods used are invasive.

[0007] In practice, a laryngoscope is used to access the laryngeal inlet. This is particularly difficult in premature infants, as the inlet is very narrow. This procedure is tricky and difficult to perform even for experienced physicians. Furthermore, this entry is painful for the infant. Therefore, analgesia and / or sedation are often required to alleviate the infant's pain and facilitate the procedure. The problem then becomes the administration of analgesics and / or sedatives, which can be very difficult for premature infants.

[0008] The third drawback is the child's tolerance during the administration of surfactants, which are generally administered in liquid form at the level of the trachea and can cause a drowning effect in children. Surfactants can cause complications such as discomfort due to reduced oxygenation and a slowed heart rhythm. Therefore, the administration of liquids must be careful and is often interrupted in case of discomfort in the baby.

[0009] To overcome these drawbacks, WO 2015 / 059037 is known to describe a system for administering a drug containing a pulmonary surfactant, which includes a catheter including a first channel suitable for delivering a flow of a drug solution into the pharyngeal region of a subject and a second channel for delivering a flow of pressurized gas, the connection between the first and second channels allowing for atomization of the drug solution at the junction between the liquid and the pressurized gas. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] International Publication No. 2015 / 059037 Summary of the Invention [Problem to be solved by the invention]

[0011] However, this type of device always requires the use of a laryngoscope to guide the catheter and suffers from all of the drawbacks mentioned above.

[0012] Furthermore, this type of catheter requires two channels to provide gas and medication flow at the distal end of the catheter, so the catheter must be very wide and may not be suitable for insertion beyond the vocal cords of a premature infant.

[0013] Finally, this type of catheter allows for the administration of nebulized medication in the pharyngeal region; this very upstream region allows some of the surfactant to pass through the esophagus, which reduces the efficacy of the medication, increases the volume of fluid to be infused, and increases infusion times, often exceeding 1 minute, or even 10-15 minutes.

[0014] Another drawback of this type of catheter results from the fact that some of the medicinal solution is blocked at the level of the infant's vocal cords, thereby preventing the medicinal solution from reaching the lungs.

[0015] The present invention aims to provide a catheter and system for administering medical fluids while avoiding the cited drawbacks of the prior art. [Means for solving the problem]

[0016] One object of the present invention is to provide a catheter that allows the release of liquid medicine in the form of microdroplets as close as possible to the pulmonary tract, preferentially in the trachea.

[0017] Another object of the present invention is to enable quicker and easier navigation of a catheter through the larynx of an untrained subject without resorting to a laryngoscope or other invasive methods. Another object of the present invention is to enable one person to perform the procedure on the subject.

[0018] Another object of the present invention is to provide a system that allows for the care of premature infants suffering from respiratory distress syndrome without resorting to analgesia or sedation of the premature infant.

[0019] Another object of the present invention is to provide a system that allows for the treatment of respiratory distress syndrome while minimizing the impact on the patient's ventilatory support parameters.

[0020] Another object of the present invention is to provide a catheter that is inexpensive and easy to manufacture and use.

[0021] The present invention relates to a catheter for delivering a medicinal liquid or powder in the form of a spray into the trachea of ​​a subject, the catheter comprising a deformable body including a spray device for releasing the liquid or powder introduced into the catheter as a spray, the catheter body further comprising an optical system configured to generate an image of a zone, the zone being located in an extension of the distal end of the catheter.

[0022] According to one example, the zones are located longitudinally of the body from the distal end of the catheter.

[0023] The present invention also relates to a catheter for delivering a liquid medicament in the form of microdroplets into the trachea of ​​a subject, the catheter including a deformable body with a movable element that translates beyond the body of the catheter, the movable element including a spray device that expels a liquid introduced into the catheter in the form of microdroplets, the catheter body further including an optical system configured to generate an image of the distal end of the movable element at a position of movement.

[0024] The present invention also relates to a catheter for delivering a medicinal liquid or powder in the form of a spray into the trachea of ​​a subject, such as a premature infant subject, the catheter being designed to be inserted into the trachea via the subject's vocal cords and including a deformable body containing a spray device that releases a liquid or powder introduced into the catheter as a spray, the catheter body further including a lumen for the passage of an optical system configured to generate an image of a zone, the zone being located in an extension of the distal end of the catheter and including a drive member that bends the catheter body along a predetermined direction.

[0025] The deformation of the catheter body may be, for example, an elastic deformation or a deformation ensured by a mechanical link of the angular, pivot or swivel link type.

[0026] According to one embodiment, the catheter body includes a support that maintains the optical system. By extension, the catheter body can be understood as a body that includes the optical system. The present invention also relates to an embodiment in which the optical system is detachable from the catheter body. The present invention advantageously allows for the delivery of medicinal fluids into the trachea, i.e., beyond the vocal cords, when the catheter is introduced via the mouth or via the nasal cavity. The present invention also advantageously allows for the elimination of the need for a laryngoscope. In fact, the practitioner can easily introduce the extremity of the body by guiding the distal portion and, optionally, by visualizing the optical image. This embodiment thus allows for the free analgesia or sedation of a premature infant connected to a laryngoscope before providing care. The present invention makes it possible to provide a catheter that does not have the cited drawbacks of the prior art.

[0027] In one embodiment, the catheter comprises a first member that drives the translation of the movable element, and the translation distance of the movable element can be driven over a range of positions including from 0.5 cm to 2 cm or from 0.5 cm to 4.5 cm.

[0028] This embodiment advantageously allows for the treatment of immature subjects by inserting the movable element into the trachea via the vocal cords while the catheter body is in the larynx.

[0029] In one embodiment, the catheter includes a second member that drives the orientation of the distal portion of the catheter body together with the proximal portion of the body to control the orientation of the distal portion in a predetermined direction. The drive member allows for driving, actuating, or controlling this orientation.

[0030] According to this embodiment, the orientation of the distal portion of the catheter body can be controlled or remotely adjusted to facilitate guidance of the distal portion of the catheter body within the larynx. The practitioner can visualize the optical system image to identify the location of the laryngeal inlet and to activate the orientation of the catheter head to guide it through the laryngeal inlet. Thus, the present invention facilitates catheter introduction into the larynx, reduces trauma to the subject, and allows for the elimination of the need for a laryngoscope, without the drawbacks of the prior art.

[0031] In one embodiment, the catheter includes a positioning piece intended to cooperate with the subject's mouth, the positioning piece extending at least partially radially around the body of the catheter to form a buccal support that restricts (or is designed to restrict) the amount of air passing outside the catheter between the inside and outside of the mouth. The buccal support also makes it possible to maintain the catheter in the axis of the pharynx and facilitates catheter guidance.

[0032] In one embodiment, the positioning piece is translatably moveable on the catheter body, hi one embodiment, the positioning piece comprises a guide that directs the introduction of the catheter into the airway of said subject.

[0033] The positioning piece functions as a pivot point, which advantageously allows the practitioner to easily guide the catheter body.

[0034] The positioning piece can also ensure at least a partial airtight seal against air from the subject's mouth. The leak-tightness of the positioning piece improves the efficiency of the respiratory assistance system for premature infants, particularly when the respiratory assistance system is introduced nasally.

[0035] The translational freedom of the positioning piece has the advantage that the pivot point which said positioning piece forms in cooperation with the opening allows for improved guidance of the body at the start of insertion.

[0036] Finally, this component provides a support point for the catheter, thereby freeing one hand for the operator to manipulate and guide the catheter.

[0037] In one embodiment, the catheter includes a liquid passage channel that emerges at the end of the spray device.

[0038] In one embodiment, the nebulizer device is designed to deliver a liquid medication in the form of an aerosol or a powder medication in the form of an aerosol or mist.

[0039] In one embodiment, the spray device includes: an insert disposed inside the passage channel and extending longitudinally along the passage channel, the insert having an outer surface including at least one substantially helical groove extending from a proximal end of the insert to a distal end of the insert, the insert being suitable for passage of the medicinal solution; a chamber for receiving said volume of medicinal solution at the outlet of the groove of the insert; A channel for pressurizing a quantity of liquid medicine in an opening disposed in the extension of said chamber.

[0040] Such a spray device has the advantage that it can produce an aerosol by pressurizing the liquid medicine.

[0041] In one embodiment, the passage channel further comprises a stopper limiting the translational movement of the insert, which advantageously makes it possible to secure the position of the insert in the passage channel despite the flow of pressurized liquid.

[0042] In one embodiment, the optical system is located at the distal end of the catheter body.

[0043] The lumen through which the optical system (6) passes is designed to receive an optical fiber extending along the lumen. The optical fiber can extend along the lumen, preferentially to the distal end of the catheter body. In one embodiment, the optical fiber passage lumen includes a transparent, leak-tight wall at the distal end of the catheter body that protects the optical fiber passage lumen from contamination by the external environment. Preferentially, the wall is a sterile wall. In one embodiment, the optical fiber is also designed to illuminate a zone located in the distal extension of the catheter.

[0044] In one embodiment, the distal end of the body has a rounded shape that advantageously facilitates reducing trauma to the subject during contact between the distal end of the body and the subject's airway.

[0045] In one embodiment, the outer diameter of the catheter body intended for insertion into a subject's airways is substantially between 1 mm and 5 mm, or substantially less than 5 mm, preferably less than 3 mm. One advantage of this diameter is that it allows for catheter insertion into the airways of premature infants as needed.

[0046] The present invention also relates to a medical system comprising a catheter according to the invention and including a command unit, the command unit comprising a reservoir for receiving a quantity of medicinal liquid and a device for commanding the administration of the medicinal liquid and for driving (or for driving) the high-pressure pump.

[0047] The reservoir includes means for controlling the temperature of the liquid or powdered medication within the reservoir.

[0048] In one embodiment, the medical system includes a device for detecting and / or measuring the subject's respiratory cycle, and the administration of the medicinal fluid by the command device is synchronized with the subject's respiratory cycle. The administration of the medicinal fluid may advantageously be performed during the subject's respiratory cycle.

[0049] This synchronization advantageously allows for enhanced transport of the medicinal solution in the form of microdroplets to the alveoli of the lungs thanks to the subject's breathing, reducing its excretion by the respiratory tract from the trachea.

[0050] In one embodiment, the medical system further includes a ventilator for respiratory assistance of the subject.The medical system can include a display screen for displaying an image of the optical system.

[0051] In one embodiment, the command unit comprises means for actuating the second member to drive the catheter.

[0052] The present invention also relates to an intubation system including an intubation probe, which includes a catheter according to the present invention. The catheter is then designed to be inserted at least partially into the intubation probe. The system advantageously allows the practitioner to quickly introduce the intubation probe by sliding it along the catheter during use. The intubation probe can therefore be inserted much faster into the larynx than with a laryngoscope, and allows the subject to be protected from cardiopulmonary stress if severe discomfort occurs to the subject.

[0053] Other features and advantages of the present invention will become apparent upon reading the following detailed description and upon reference to the accompanying drawings. [Brief explanation of the drawings]

[0054] [Figure 1A] FIG. 1 is a transparent view of a catheter body according to a first embodiment of the present invention. [Figure 1B] 10 is a cross-sectional view of a catheter body in which a passage channel includes concentric portions in a retracted position. [Figure 2A] FIG. 10 is a perspective view of a catheter body including a concentric portion where the passage channel moves distally beyond the catheter body. [Figure 2B] FIG. 10 is a cross-sectional view of a catheter body including a concentric portion where the passage channel is translated beyond the catheter body. [Figure 3] 1 is a cross-sectional view of a catheter body according to a first embodiment of the present invention. [Figure 4]FIG. 10 is a cross-sectional view of a catheter body according to a second embodiment in which the body includes an activation wire and a ventilation lumen. [Figure 5] 1 is a perspective view of a medical system including a catheter according to an embodiment of the present invention, wherein the catheter body includes an orientable portion and the system includes a display means. [Figure 6] 10A and 10B are cross-sectional views of a movable element of a passage channel according to one embodiment, which allows for delivery of a medicinal solution in the form of an aerosol. [Figure 7] 1 is a diagram of a subject into which the distal portion of the catheter body is introduced. [Figure 8] A diagram showing a catheter rod being introduced into a subject up to the larynx. [Figure 9] Close-up view of the distal end of the catheter body in the larynx facing the vocal cords. [Figure 10] Close-up view of the catheter rod with the distal end in the larynx facing the vocal cords and the movable element being introduced through the vocal cords into the trachea. [Figure 11] A close-up of the drug solution being sprayed into the trachea in the form of tiny droplets. [Figure 12] Close-up of the distal end of the catheter inserted through the vocal cords into the trachea. [Figure 13] FIG. 4 is a cross-sectional view of a catheter body according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0055] In the remainder of the description, the following terms should be understood in light of the following definitions:

[0056] "Distal" is understood to mean the side of the catheter furthest from the point where the practitioner holds the catheter during use.

[0057] "Proximal" is understood to mean the side of the catheter nearest the point that the practitioner holds the catheter during use.

[0058] "Channel" is understood to mean an artificial conduit that allows the transport of liquids.

[0059] "Lumen" shall mean an opening extending along the longitudinal axis of a catheter body.

[0060] "Microdroplets" or "microdrops" is intended to mean droplets of liquid separated by air or gas, the diameter of these droplets being between 1000 μm and 5 μm.

[0061] "Atomization" means that a liquid or solid substance is broken down into very fine particles. In the case of a liquid, atomization results in the generation of minute droplets. If it is a solid substance, atomization leads to the generation of particles of the substance, for example in the form of a powder.

[0062] In one embodiment, "nebulization" can include atomization or aerosolization.

[0063] "Nebulization" is understood to mean the spraying of fine droplets by contact of a liquid with a pressurized gas.

[0064] "Aerosolization" is understood to mean a spray of fine droplets produced when pressurized liquid is passed through a conduit, the outlet of which has a shape particularly favorable for the production of fine droplets.

[0065] The present invention relates to a catheter 1 including a catheter body 2 for administering a medicinal solution into the trachea of ​​a premature infant. The present invention makes it possible to treat respiratory distress syndrome secondary to lung immaturity, which requires the administration of surfactant, as well as all pulmonary pathologies requiring the administration of medicinal solutions into the pulmonary tract. Among these other pulmonary pathologies, noteworthy are pulmonary hemorrhage, pneumonia, bronchopulmonary dysplasia, and persistent respiratory failure in chronically ventilated patients. The present invention also makes it possible to treat neonates exhibiting secondary surfactant degradation or defects in its recycling.

[0066] In one embodiment, the liquid medicine may be replaced with a powder medicine, and the spray is a powder medicine spray.

[0067] The present invention also relates to a medical system 300 including the catheter 1 according to the present invention.

[0068] Catheter Rod The proximal part of the main body 2 can be connected to a command center 100, also called a command unit. The command center 100 can include a user interface. According to different embodiments, the command center can be connected to a computer and a memory. The command center can distribute instructions to command members, calculate values ​​of state variables to generate various alerts, and store configuration information.

[0069] The body 2 of the catheter 1 preferentially has a rod shape.

[0070] The body 2 extends longitudinally to its distal end 14. The body 2 is flexible or elastically deformable. A flexible body advantageously allows for avoiding damage to the tissues of the premature infant, in particular the tissues of the airway and the pharynx 202. According to one example, the body 2 of the catheter 1 comprises sufficient rigidity to allow the latter to be guided from the actuator, and sufficient flexibility to allow the body to bend, if necessary, so that it can move past the vocal cords to and through the trachea. The body 2 of the catheter 1 is considered to be deformable, for example, so that its curvature can be elastically modified.

[0071] The outer diameter of the main body 2 must be small enough for use in premature infants. The diameter of the main body 2 must be small enough to be inserted through the vocal cords and into the trachea of ​​a subject, particularly a premature subject. According to one embodiment, the outer diameter of the main body 2 is suitable for insertion into a conventional intubation probe. Preferably, the outer diameter of the main body 2 is comprised between 5 mm and 1 mm, preferably between approximately 3 mm and 2 mm. A diameter of less than 3 mm or less than 2.5 mm allows the catheter to be used in premature infants already intubated with an endotracheal probe without an auxiliary channel. In fact, the diameter of a premature infant's trachea can be as small as 2 to 3 mm. Premature infants can benefit from this type of medicinal spray.

[0072] The length of the main body 2 is preferably less than 50 cm, or between 10 cm and 30 cm.

[0073] The body 2 extends from a proximal end (not shown) to a distal end 14 .

[0074] The body 2 of the catheter 1 is preferentially designed for single use. Preferably, the catheter body is designed to receive an optical fiber and allow the optical fiber to be removed before the body 2 of the catheter 1 is discarded.

[0075] The present invention also relates to a medical system 300. The medical system includes a command unit 100. The command unit 100 is configured to be connected to a catheter 1 according to the present invention. The command unit preferably includes a user interface that allows control of the catheter 1. After use, the catheter 1 or the catheter body may be detached from the command unit 100 and discarded. In this case, when a new catheter 1 is to be used, it is then connected to the command unit.

[0076] The body 2 contains within its volume a number of conduits or lumens which extend longitudinally of the body.

[0077] The conduit or lumen preferentially extends to the distal end 14 of the body 2 and / or from the proximal end of the body 2 .

[0078] Preferably, the distal end 14 of the catheter 1 has a substantially round shape. A substantially round shape advantageously allows for a reduced risk of trauma to the subject during insertion of the catheter.

[0079] Passing Channel The body 2 includes a first passage lumen 31. The catheter 1 includes a fluid passage 3 channel disposed at least partially within the first lumen 31.

[0080] The passage channel 3 is configured to transport a liquid medicine from a reservoir. In this case, the proximal end of the passage channel 3 is preferentially connected to a liquid medicine storage section. Instead of the liquid medicine, a powder, gel, or paste can be used.

[0081] According to one example, the passage channel 3 comprises a tube disposed inside the passage lumen 31. In another embodiment, the passage channel 3 is a conduit formed by the passage lumen 31. The surface of the passage lumen comprises, for example, an internal coating that facilitates transport of the medicinal solution. The internal coating may also enable chemical protection of the medicinal solution from the wall of the lumen 31.

[0082] In a first embodiment, the passage channel 3 includes a movable element 5. The movable element 5 is capable of transporting a medicinal solution within its internal volume. The movable element 5 translates relative to the body 2 of the catheter 1. The movement can be commanded preferentially from the proximal end by a drive member.

[0083] The movable element 5 is designed to release the medicinal liquid in the form of microdroplets through a distal opening 501. The distal opening 501 of the movable element 5 is fluidly connected to the passage channel 3.

[0084] The movable element 5 preferentially includes a distal end designed to reduce trauma to the subject in the event of contact between the airway and the distal end of the movable element 5. Preferably, the distal end of the movable element includes a rounded or curved portion.

[0085] Distal migration The movable element 5 of the passage channel 3 is translatable relative to the distal end 14 of the body 2 or relative to the optics 6 of the body 2 .

[0086] Preferably, the movable element 5 translates beyond the body 2 to a translation position. The movable element translates beyond the body 2 of the catheter 1 by at least 5 cm, and very preferentially over a distance of more than 0.5 cm or 1 cm. In one embodiment, the movable element 5 can be actuated over a range of positions beyond the body 2 comprised between 0.5 cm and 5 cm. In one embodiment, in the most translated position, the distal end of the movable element 5 is at a distance between 0.5 cm and 2 cm or 0.5 cm and 4.5 cm from the distal end 14 of the body.

[0087] As shown in FIGS. 2A and 2B, the movable element 5 of the passage channel 3 is displaced beyond the end 14 of the body 2 of the catheter 1.

[0088] According to one embodiment, the diameter of the movable element 5 in the passage channel 3 is smaller than the diameter of the body 2 of the catheter 1. This allows the movable element 5 to be integrated into the passage channel 3. One advantage of the free translation of the movable element 5 is that it can penetrate through the vocal cords 204 of the premature infant 200 and into the trachea 203. The free translation, understood as a mechanical free translation, can be activated and commanded by the operator. Advantageously, a predetermined distance can be preconfigured. According to another example, the operator deploys the movable part in a stepwise manner, in particular thanks to the optical system arranged on the catheter. Another advantage is that the movable element 5 can be advanced from the passage channel 3 into the imaging zone of the optical system 6. This facilitates the driving of the movement and ensures real-time control of the delivery of the medicinal solution.

[0089] The movable element 5 is at least movable between a retracted position within the body 2 of the catheter 1 (see Figures 1A and 1B) and a moved position in which at least a portion of the movable element 5 extends beyond the passage lumen 31 and the catheter body 2 (see Figures 2A and 2B).

[0090] Another advantage is that the movable element 5 of the passage channel 3 can be stored in a retracted position to reduce the risk of damage or deformation of the movable element 5 when inserting the main body 2 of the catheter 1 into the airway of the subject 200.

[0091] 1B and 2B, the passage channel 3 includes at least a portion 32 concentric with the passage lumen 31. The concentric portion 32 includes the movable element 5.

[0092] The concentric portion 32 is translatable within the passage lumen 31 .

[0093] In one embodiment not shown, the passage channel 3 comprises at least two telescopic concentric portions 32 .

[0094] The flexible concentric sections are translatable relative to one another in the passage lumen, which has the advantage of allowing for a longer projection length of the movable element and increased stiffness of the passage channel portion outside the body 2 of the catheter 1.

[0095] System for displacing passage channels The catheter 1 may include a first member that drives the movement of the movable element 5. The first drive member may include a control rod. Preferably, the control rod (not shown) is connected to the concentric portion 32. The control rod may extend through the proximal end of the body 2 of the catheter 1. The control rod allows the practitioner to displace the concentric portion 32 by actuating said control rod.

[0096] The first drive member is capable of commanding the movement of the movable element 5. The first drive member makes it possible to move the movable element and / or the concentric portion 32 beyond the catheter body of the means for distally displacing the passage channel 3 relative to the body 2 of the catheter 1.

[0097] For example, if the passage channel 3 includes multiple retractable concentric sections 32, the first drive member enables the retractable sections to move parallel to each other so that the movable element protrudes from the body 2 of the catheter 1.

[0098] The command unit 100 preferably comprises a first command member. The command member is connected to the first drive member. The command unit can control the displacement of the first drive member and the distal portion 5 of the passage channel 3. For this purpose, an indicator of the catheter's position or placement can be displayed. According to an exemplary embodiment in which the distal portion of the catheter includes a force feedback sensor, the command member can automatically stop the translational deployment of the movable element when the movable element encounters an obstacle, such as the wall of the throat or trachea, the vocal cords, or any other part of the organ. In this case, the command unit 100 can emit a sound or warning to inform the operator.

[0099] In an alternative embodiment, the spray device 50 is fixed relative to the distal end 14 of the catheter body. The spray device 50 may be positioned at the distal end of the passage channel 3 to spray an extension of the distal end of the catheter body. This layout also allows the spray device to be delivered through the lumen of the passage channel. In this embodiment, the catheter body 2 is designed to be insertable into the trachea through the subject's vocal cords, with a preference for premature infants.

[0100] Microdroplet spray The movable element 5 includes a spray device 50 .

[0101] In one embodiment, the atomizing device 50 is designed to atomize powders, particularly powdered medicines.

[0102] In a second preferred embodiment, the spray device 50 is designed to release the liquid medicament in the form of fine droplets.

[0103] In a first alternative, the microdroplets of the medicinal liquid are obtained by atomization. The body 2 of the catheter 1 comprises a channel for transporting a flow of pressurized gas. The catheter is then designed so that the pressurized gas encounters the medicinal liquid near the distal opening of the passage channel 3. The pressurized gas makes it possible to atomize or spray the medicinal liquid into microdroplets.

[0104] The liquid medicine is then sprayed into the trachea in the form of atomized microdrops.In this first variant, the body 2 of the catheter 1 has a lumen capable of carrying gas.

[0105] In a second alternative shown in Figure 6, microdroplets of a medical liquid are administered in the form of an aerosol. The aerosol is generated when pressurized liquid passes through a conduit whose outlet has a particular shape favorable for the generation of microdroplets.

[0106] In the particular example shown in FIG. 6, the spray device 50 of the passage channel 3 comprises aerosolization means 502, 503, 504, 506, 501 for expelling the liquid medicine in the form of an aerosol.

[0107] The aerosolization means comprises an insert 502 disposed entirely elongate within the passage channel 3 .

[0108] The insert 502 includes an outer surface. The outer surface includes at least one groove 503 wound around the outer surface of the insert 502. The at least one groove 503 is suitable for the passage of a medicinal solution. The groove 503 is preferentially spiral. The at least one groove 503 extends from the proximal end to the distal end of the insert 502.

[0109] The top of the outer surface of the insert 502 between two consecutive passages of the at least one groove 503 is in contact with the inner surface 508 of the passage channel 3 or forms an airtight seal to force the medicinal liquid to follow the at least one groove 503. This allows the medicinal liquid to pass through the groove 503 between the outer surface of the insert 502 and the inner surface 508 of the passage channel 3.

[0110] The aerosolization means preferentially comprises a receiving chamber 505 in the passage channel 3. The receiving chamber is located at the exit and end of the groove 503 of the insert 502. Preferably, the receiving chamber is located between the insert and the distal end of the spray device 50.

[0111] The spray device 50 preferably includes a distal opening 501 at the distal end of the spray device 50 .

[0112] The aerosolization means also includes an outlet channel 509. The outlet channel 509 extends into the extension of the receiving chamber. The outlet channel 509 is suitable for the passage of the medicinal liquid. The outlet channel 509, in particular, allows for pressurization of the medicinal liquid due to its profile. In one embodiment, the profile of the channel includes at least a first portion connected to the receiving chamber, which portion decreases in the distal direction. The profile of the outlet channel 509 includes a second portion connected to the distal opening 501, which portion is substantially constant. In one embodiment, the first portion is adjacent to the second portion.

[0113] In one embodiment, the outlet channel 509 is formed by a contoured body 504. The contoured body 504 is disposed within the passage channel 3 between the tip 501 of the passage channel 3 and the insert.

[0114] The diameter of the distal opening 501 is preferentially comprised between 20 μm and 100 μm, very preferentially between 40 μm and 80 μm. In one embodiment, the diameter of the distal opening 501 is comprised between 20 μm and 250 μm, especially when the volume of the generated microdroplets is large.

[0115] When the liquid medicine in the passage channel 3 is pressurized by the pump, the liquid is forced along the spiral groove 503 between the outer surface of the insert 502 and the inner surface 508 of the passage channel 3. The groove 503 acts as a swirl generator. At the outlet of the spiral groove 503, the liquid medicine permeates into the storage chamber 505, and its flow direction follows a generally circular path along the inner circumference of the passage channel 3.

[0116] At the distal end of chamber 505, the swirling liquid encounters an exit channel 509 where an interface is formed between the swirling liquid in receiving chamber 505 and the ambient atmosphere at opening 501. Aerosol generation then occurs at the distal end of opening 501 characterized by the emission of microdroplets.

[0117] The shape of the aerosol can be modified as a function of the pressure applied to the drug liquid, the angle of rotation of the liquid within the chamber, the geometry of the chamber, and the geometry of the body and distal opening.

[0118] The spray device 50 may further include a stopper 506 that limits the translational movement of the insert 502 .

[0119] The spray device 50 may further include a stopper 507 that limits the translational movement of the contoured body 504 .

[0120] The stops 506, 507 advantageously allow the passage channel 3, the insert 502 and the body 504 to maintain their position within the passage channel 3 despite the pressure of the medical fluid in the distal direction of the passage channel 3.

[0121] In one embodiment, the movable element comprises a plurality of spray devices 50 in parallel. By increasing the number of spray devices 50, the flow rate of the medicinal liquid emitted by the microdroplets can be increased. The catheter can also comprise several movable elements 5 in parallel, each of which comprises a spray device 50.

[0122] Surfactant administration The medical system 300 includes a reservoir of a medicinal solution intended to be administered to a subject. The reservoir is fluidly connected to the passage channel 3. The medicinal solution preferably includes a surfactant. The surfactant may preferably include a composition containing diluted pig lung extract. Alternatively, an artificial surfactant may be used. In general, any surfactant that allows for efficient treatment of respiratory distress syndrome may be used.

[0123] Preferably, the medicinal fluid reservoir includes a means for heating the medicinal fluid. One advantage is that it reduces the viscosity of the medicinal fluid, allowing it to pass more easily through the small-diameter passage channel 3 and improve the miniaturization of the catheter. Another advantage is that the medicinal fluid is delivered to the airway of the subject at a temperature close to the subject's body temperature. For this purpose, the medical system 300 can include a temperature regulation means for reaching a target temperature value for the medicinal fluid in the reservoir.

[0124] In one embodiment not shown, the reservoir comprises a syringe, and the heating means may then comprise a heating band arranged around the reservoir of the syringe.

[0125] The reservoir is fluidly connected to a pump, which is preferentially a high-pressure pump. Advantageously, this pump allows the medicinal liquid in the passage channel 3 to be pressurized. By pressurizing the medicinal liquid in the passage channel, it is possible to administer it in the form of an aerosol. High pressure consists of a pressure between 80 bar and 200 bar, preferentially between 100 bar and 180 bar, very preferentially between 120 bar and 160 bar. Alternatively, the pressure may be comprised between 80 bar and 350 bar, especially for the most critical diameter of the distal opening.

[0126] The pump is connected to a pump command device that can command the activation of the pump and its intensity.

[0127] In one embodiment, the pump's command device may be commanded by the practitioner. Preferably, the pump's command device includes a "pistol" type trigger or another type of command.

[0128] In another embodiment, the reservoir contains a powdered medicine. The powdered medicine preferably contains a surfactant. In particular, the surfactant may include a composition containing diluted pig lung extract. Artificial surfactants may also be used. Generally, any surfactant that allows for efficient treatment of respiratory distress syndrome may be used.

[0129] The present invention also relates to a medical system and catheter in which the medicinal solution passage channel 3 is fixed relative to the catheter body. In this embodiment, the movable element is not free to translate or is absent. The spray device 50 for discharging the medicinal solution in the form of fine droplets is similar to that described above. In this embodiment, the catheter body has a diameter small enough to pass through the vocal cords. Preferably, the diameter of the catheter body is less than 2.5 mm for neonatal use and less than 5 mm for adult use.

[0130] Respiratory cycle measurement In one embodiment, the medical system 300 includes a device for measuring the respiratory cycle of the subject 200. The device for measuring the respiratory cycle of the subject 200 includes, for example, a sensor of the subject's breathing and / or a sensor of thoracic expansion.

[0131] The device for measuring the respiratory cycle of the subject 200 may include an air sensor or an airflow variation sensor. The sensor may be placed at the level of the subject's airway, for example, at the level of the subject's nasal or oral passages. Alternatively, the sensor may be placed on a channel connected to the subject's airway.

[0132] In another embodiment, the device for measuring the respiratory cycle of the subject 200 includes at least one electrical impulse sensor positioned to capture electrical impulses of the respiratory muscles, in particular the diaphragm. Such a sensor advantageously allows detecting the electrical signals that cause muscle activity and thus allows detecting the inhalation or exhalation phase in advance.

[0133] The device for measuring the breathing cycle of the subject 200 may also include optical systems (not shown) that allow for detection of the subject's inhalation and exhalation cycles.

[0134] Preferably, the command device is configured to administer the medicinal fluid in synchronization with the respiratory cycle of the subject. The command device is then connected to a device that measures the respiratory cycle of the subject 200. For example, the command device can be configured to uniquely command the administration of the medicinal fluid during the inhalation phase of the respiratory cycle of the subject.

[0135] This synchronization advantageously allows for enhanced transport of the medicinal solution in the form of microdroplets to the lungs thanks to the subject's breathing, reducing its excretion by the respiratory tract from the trachea.

[0136] In alternative embodiments, the spray device may be replaced by a collection device, in particular by suction or by a device that delivers a liquid or a paste or a gel.

[0137] camera The body 2 of the catheter 1 is provided with an optical system 6. The optical system is preferentially constructed or arranged to generate an image of the distal end of the movable element 5 in a translational position.

[0138] The optical system may include a camera or a micro-camera.

[0139] The optical system preferentially comprises an optical fiber, the optical fiber having a distal end located on or near the distal end 14 of the body 2.

[0140] Preferably, the optical system is constructed or arranged to generate an image of the distal end of the movable element 5 in a translational position or an image at the level of the distal end of the movable element 5 in a translational position.

[0141] In one embodiment, the optical system 6 is located near or at the level of the distal end 14 of the body 2. The body 2 comprises a second lumen 4 through which means for connecting the optical system 6, such as an electrical cable or an optical fiber, pass.

[0142] Preferably, the optical system 6 is positioned to capture an image of a zone facing the distal end 14 of the body 2. The optical system 6 is positioned to capture an image of a zone longitudinally of the body 2 of the catheter 1. In this way, the practitioner can advantageously visualize the subject's glottis during the advancement of the catheter through the subject's passageway. This visualization advantageously allows valuable intervention time to be gained, particularly during procedures in which the subject is treated as an emergency. Once the catheter body has passed the vocal cords, the optical system also allows visualization of the bifurcation between the two bronchial origins (also called the carina) in order to position the distal end of the catheter at an appropriate distance from this bifurcation.

[0143] The lumen 4 through which the optical fiber passes is called the fiber optic lumen and extends longitudinally within the body 2 of the catheter 1. The fiber optic lumen 4 may extend from the proximal end of the body 2 to the distal end 14 of the body 2 or to the optical system 6.

[0144] The proximal end of the optical fiber is connected to a signal processor that generates an image from the optical fiber signal.

[0145] Optical fibers have the advantage of being smaller in volume than cameras, and the device for processing the luminescent signal is located outside the body 2 or at the proximal end.

[0146] In another embodiment, not shown, the optical fiber extends toward the outer wall of the catheter body 2. The optical fiber can then be maintained against the wall by different fixing means, such as rails, grooves or ribs formed on the surface of the catheter body 2.

[0147] In another alternative embodiment not shown, the body 2 comprises wireless transmission means for transmitting the images captured by the optical system 6 .

[0148] The catheter 1 may include means for orienting the shot zone of the optical system 6. These orienting means may be preferentially commanded remotely. The orienting means allow the orientation of the optical system 6 to be changed during use of the catheter 1. For this purpose, the optical system 6 may be mounted on a pivot or swivel link.

[0149] The catheter 1 may comprise means for displacing the optical system 6 relative to the body 2. The optical system may be translationally movable relative to the body 2 of the catheter 1. For this purpose, it may be integral with a translating (or movable) rod.

[0150] The optical system is preferentially configured to acquire images in the visible range. In alternative embodiments, the optical system may be monochromatic. It may be configured to acquire images in black and white or, for example, in the infrared frequency range.

[0151] In a preferred embodiment, the optical fiber is translatable within lumen 4 for passage of the optical fiber. This mobility advantageously allows the catheter to be used for a single use while preserving the optical fiber for later use in a second catheter according to the invention.

[0152] In this embodiment, the lumen 4 through which the optical fiber passes includes a leak-tight wall at its distal end. The leak-tight wall allows for the separation of the optical fiber and the lumen 4 for the passage of the optical fiber from the external environment of the catheter. The leak-tight wall allows for the protection of the optical fiber from contamination, advantageously allowing for the reuse of the optical fiber without the need to decontaminate the optical fiber between uses. The leak-tight wall also ensures the sterility of the optical fiber. The leak-tight wall is preferentially transparent to allow image capture by the distal end of the optical fiber. Here, "transparent" means transparent to light rays captured by the optical system. These light rays can therefore include light rays in the visible range, infrared light, or other light rays.

[0153] illumination Preferably, the catheter 1 includes a light source 7. The light source 7 is arranged to illuminate at least a portion of the zone captured by the optical system 6. The light source 7 may include one or more light-emitting diodes. The light source 7 is connected to a supply cable. The body 2 of the catheter 1 may have a third lumen 11 formed inside the body 2. At least a portion of the supply cable of the light source 7 is then arranged inside the third lumen 11. According to one embodiment, a lumen allowing for the transport of an electrical cable or an optical fiber may also be used to transport the electrical supply of the light source.

[0154] The light source 7 advantageously allows for emitting light to illuminate the zone captured by the optical system 6, allowing the practitioner to visualize the zone in front of the distal end 14 of the catheter body 2. This facilitates guiding the catheter body into the larynx 206.

[0155] The light source 7 is designed to emit light that is detectable by the optical system 6. For example, if the optical system 6 is an infrared camera, the light source 7 may include an infrared light source.

[0156] In a preferred embodiment, the light source is an optical fiber for image capture. The optical fiber then serves a dual role as both the light source for image capture and the light source. One advantage is that it avoids the need for an additional lumen in the catheter body 2 to pass the light source, thereby increasing the catheter's compactness. Another advantage is that it reduces the number of manipulations required before the single-use catheter must be discarded.

[0157] The optical fiber can be used such that a first radial portion of its cross section is configured to emit light and a second radial portion is configured to capture an image. For example, the outer ring of the optical fiber cross section is used as the light source. For this purpose, suitable means are provided at the level of the proximal end of the optical fiber. In this example, the inner portion of the outer ring is used as the image capture.

[0158] System for controlling optical means According to one embodiment, the medical system 300 further comprises a device for controlling the optical system, by means of which the activation of the optical system 6 and / or the light source 7 can be controlled.

[0159] The medical system can include information transmission means, in particular a display screen 101. This display screen 101 can display images captured by the optical system 6 of the catheter 1 in real time.

[0160] According to one embodiment, the user interface comprises an interface for commanding the optical means. The command interface comprises commands for activating and / or adjusting the intensity of the light source 7 and / or the optical system 6. The command interface of the optical means is configured to allow the operator to freely control the orientation and / or displacement of the optical system 6. This control is ensured, for example, by means of numerical commands. Alternatively, the control is ensured by mechanical commands, for example by means of a handle.

[0161] According to one exemplary embodiment, the display device generates numerical indications superimposed on the acquired images. These indications are, for example, the contours of organs such as the vocal cords. These contours can be generated using shape recognition algorithms. One interest is to improve the operator's ability to read information within limited time intervals. According to another example, distance and direction indicators are displayed to improve the visibility of the ongoing situation. This may be, for example, the translation distance of the movable element or the orientation or deflection of the distal part of the catheter. According to another example, indicators are superimposed on the acquired images indicating the duration of the intervention, an indication of the volume stimulated / expired by the subject, etc.

[0162] Deflection part The catheter body 2 includes a second drive member that drives the distal portion 81 of the body 2 of the catheter 1 at the proximal portion 82 of the body 2, thereby enabling the orientation of the distal portion 81 to be controlled in a predetermined plane and / or a predetermined direction.

[0163] In one embodiment, the catheter body 2 includes at least one orientable portion 8. The orientable portion 8 is designed to bend in a predetermined plane and / or in a predetermined direction. Preferably, the orientable portion is designed to bend in a controlled manner when the orientable portion is activated. The catheter 1 includes activation means 9 for activating and controlling the bending or curvature of the orientable portion 8.

[0164] By "controlled manner" we mean that the practitioner can adjust the curvature angle or angles between the distal and proximal portions 81, 82 of the catheter body 2 over a predetermined range. Thus, the practitioner can incrementally increase or decrease the orientation angle of the distal portion 81 between two extremes in a predetermined plane.

[0165] Advantageously, by controlling the angle of orientation of the distal portion 81, the body 2 of the catheter 1 can be inserted into the subject's larynx 206 without the use of a laryngoscope.

[0166] The maximum angular bending of the body in a given plane is at least 45°, preferably at least 70°.

[0167] In one embodiment shown in FIGS. 4 and 5, the second drive member comprises an activation wire 9 positioned along the catheter, for example within the body 2 of the catheter 1 .

[0168] The activation wire 9 may be disposed inside a longitudinal lumen of the body 2 of the catheter 1. The longitudinal lumen and activation wire 9 are radially offset relative to the longitudinal axis of the body 2 of the catheter 1. This radial offset advantageously allows for reorientation of the distal portion 81 of the catheter body 1 within a predetermined plane, which plane includes the longitudinal axis of the body 2 of the catheter 1 and the longitudinal axis of the lumen containing the activation wire 9.

[0169] According to one embodiment, catheter 1 includes anchor 12. Anchor 12 is a zone at which activation wire 9 is translationally blocked relative to body 2 of catheter 1. At a minimum, anchor 12 translationally prevents movement of the wire in the proximal direction relative to body 2 of catheter 1.

[0170] According to one example, the anchor 12 is arranged at the level of the distal end 14 of the body 2 of the catheter 1. Alternatively, the anchor 12 is made inside the body 2, between the distal end of the orientable part 8 and the distal end 14 of the body 2.

[0171] The anchor 12 may be attached by, for example, gluing or crimping. The anchor 12 may comprise a wire block, block or knot between the distal end of the body 2 and the retaining means.

[0172] According to another embodiment, the activatable wire 9 is arranged along the outer surface of the body 2 of the catheter 1, and the outer surface is provided with passage means for the activatable wire 9. The passage means is preferentially fixed to the outer surface of the body 2 to avoid arcing effects of the activatable wire when bending.

[0173] When activation wire 9 is pulled, a traction force is exerted in the proximal direction at the level of anchor 12 along the length of body 2. This force can advantageously cause the orientable portion of body 2 of catheter 1 to bend and can also create an orientation angle between distal portion 81 and proximal portion 82 of catheter body 2 in a given plane.

[0174] In another embodiment, shown in FIG. 13 , the second drive member includes a preformed tube 9 within the lumen 20 of the catheter body 2. The preformed tube 9 extends within the orientation lumen 20 of the catheter body 2. The tube is preformed to include a preformed portion that assumes a curved shape when the tube is at rest, creating an angle between the portions of the tube on either side of this portion in a predetermined plane. The second drive member also includes a rigid rod 22 extending within the cavity of the preformed tube 9. The rigid rod 22 has a substantially straight shape when at rest. The rigid rod 22 has a stiffness greater than that of the preformed tube 9. Preferably, the rigid rod 22 extends from the proximal end of the preformed tube 9 to at least the preformed portion or to a point located between the preformed portion and the distal end of the preformed tube 9. The rigid rod may be removable from the preformed tube.

[0175] Thus, inserting the rod into the cavity of the preformed tube 9 causes the preformed tube 9 to deform to the shape of the rigid rod 22. When the rigid rod 22 is removed, the preformed tube 9 tends to resume its shape at rest, exerting a force on the catheter body. This force advantageously allows the orientable portion of the catheter body to collapse, forming an orientation angle in a predetermined plane between the distal portion 81 and the proximal portion 82 of the main body 2 of the catheter 1, as shown in FIG. 5. Preferably, the preformed tube is capable of deforming the distal portion of the catheter by between 20° and 40°.

[0176] This embodiment advantageously allows for control of the bend angle in a given plane of the distal end of the catheter body by incrementally removing the rigid rod from the preformed tube.

[0177] The preformed tube preferentially comprises a plastic or metal material, and the rigid rod is preferably a steel type metal.

[0178] The orientable portion 8 may comprise at least one zone whose stiffness is less than the stiffness of the distal portion 81 or the proximal portion 82 of the body 2. This stiffness allows for a better appearance of the zone of weakness and for a better curvature of the orientable portion 8. The orientable portion 8 may also inherently comprise lateral zones of the orientable portion 8 that have a stiffness less than the stiffness of the rest of the body 2. These lateral zones allow for a better curvature of the body 2 in a given plane that includes said lateral zones.

[0179] In one embodiment, the orientable section 8 of the catheter body extends over a length of between 20 mm and 30 mm. This flexibility of the tip has the advantage of facilitating passage of the catheter 1 between the nasopharynx and oropharynx.

[0180] The zone of reduced stiffness may be constituted by a material that is less stiff than the material of the rest of the body 2, or by a cavity.

[0181] Preferably, said lateral zone is contained in a plane containing the longitudinal axis of the body 2 and the lumen containing the activatable wire 9. This configuration advantageously allows the orientable portion 8 to fold back in a given plane during activation.

[0182] In a first example, activation is produced by traction on the activation wire 9. By means of a more or less strong traction force, the orientation of the distal part 81 in a given plane can be controlled.

[0183] In the second example, the activation wire 9 is a wire made of a shape memory alloy. The catheter 1 also includes a means for passing an electric current through the shape memory alloy wire. The activation of the shape memory alloy wire is achieved by applying a voltage to the wire. By applying a voltage, the temperature of the wire can be increased by the Joule effect until the phase change temperature of the shape memory alloy wire is reached.

[0184] Activation of the shape memory alloy wire initiates a predetermined curvature of the wire, and the orientation angle of the distal portion 81 can then be controlled by temperature or voltage applied to the shape memory alloy wire.

[0185] These examples are not intended to limit the invention which may include other means of actuating a controlled curvature in a predetermined plane of the distal portion 81 relative to the proximal portion 82 of the body 2. In one embodiment, the orientable portion 8 extends between 2 cm and 5 cm.

[0186] In one embodiment, the distal end of the orientable portion is located between 15 mm and 100 mm from the distal end of the body 2 of the catheter 1 .

[0187] In one embodiment, the catheter body 2 comprises at least two second actuation members that allow the orientation of the distal section 81 to be actuated in at least two different predetermined planes and / or in at least two different predetermined directions. This solution can be realized, for example, by combining two wires, each of which can be activated in a given plane. According to another exemplary embodiment, two associated wires can have shape memory, said shape memory wires having different alloys and specific preforms.

[0188] Preferably, the catheter includes markings that indicate to the user the direction of a predetermined plane in which the body 2 is about to deform. The markings may be applied to the proximal portion and / or the outer surface of the catheter.

[0189] System for activating orientable portions In one embodiment, the medical system 300 also includes a means for actuating the drive member. The activation means can be designed to exert a traction force on the activatable wire 9. If the activatable wire 9 is a wire made of a shape memory alloy, the activation means is designed to generate a tension force across the length of the shape memory alloy wire.

[0190] The driving means can also control the angle of curvature of the orientable portion 8 by adjusting the strength of the traction force or current applied to the activatable wire 9 .

[0191] The user interface may comprise an interface for commanding the orientation of the distal part 81 of the body 2 of the catheter 1. This interface is connected to said activation means and makes it possible to command said activation means and to command the activation of the curvature of said orientable part and to control this curvature.

[0192] When the drive member includes a preformed tube and a rigid rod, as described above, actuation of the drive member may be accomplished by removal of the rigid rod, preferentially by removal of the preformed tube or the proximal end of the catheter body.

[0193] The drive member and optics advantageously allow for rapid insertion of the distal end 14 through the epiglottis and into the subject's larynx. Indeed, the practitioner can easily locate the junction between the larynx and the esophagus and activate the curvature of the body up to that junction to penetrate the body 2 into the larynx.

[0194] ventilation When administering medication to a premature infant, it is often necessary to assist the infant's breathing.

[0195] The body 2 of the catheter 1 may be designed to be at least partially inserted into an intubation probe. Respiratory assistance may be provided by a mask or probe inserted through the nose independently of the catheter 1.

[0196] In this embodiment, the catheter body 1 can be easily used on an already intubated patient by inserting the catheter 1 through an intubation probe. The present invention relates to an intubation probe adapted to receive the above-mentioned catheter 1. The adaptation can be achieved by elements within the intubation probe having guiding ergonomics, or alternatively by physical means intended to guide the movement of the catheter 1 within the probe. The intubation probe is provided at its distal end with means for connection to a ventilation device, such as a respirator or any other respiratory support device.

[0197] Another advantage of the probe that can be coupled to the catheter of the present invention is that, when the catheter is introduced into the subject's larynx and used to deliver the spray, the subject can be quickly intubated. In this case, the intubation probe is positioned upstream of the catheter and can slide freely along the body 2 of the catheter 1. This option is particularly interesting in the event of cardiac and / or respiratory abnormalities in the subject. In this case, the catheter 1 is already in the subject's larynx, making the use of a laryngoscope unnecessary.

[0198] Alternatively, the body 2 of the catheter 1 may include within its interior volume a ventilation lumen 10. The ventilation lumen 10 is preferentially connected by its proximal portion to a ventilator, air pump, or respiratory assistance system. The ventilation lumen 10 preferentially extends to the distal end 14 of the catheter body 2.

[0199] The ventilation lumen 10 advantageously allows for systems to be integrated with the catheter 1 to assist ventilation, allowing practitioners caring for premature infants to perform fewer procedures before initiating the administration of medicinal fluids. The ventilation lumen 10 advantageously allows for maintaining respiratory support for the subject during the administration of medicinal fluids. The ventilation lumen 10 also allows for the introduction of a suction tube therethrough, for example, to aspirate secretions from the subject.

[0200] ventilation system In embodiments in which the catheter 1 includes a ventilation system, a device for measuring the subject's respiratory cycle is connected to the ventilation device. The ventilation device is connected to the intubation probe or ventilation lumen 10. Preferably, the ventilation system's air pump is connected to the means for measuring the respiratory cycle. The ventilation system is configured to operate in synchronization with the subject's respiratory cycle. This synchronization advantageously assists the subject's breathing and allows for advantageous delivery of microdroplets to the subject's 200 lungs, and more particularly to the alveoli of the subject's 200 lungs.

[0201] Positioning piece In one embodiment, the body 2 of the catheter 1 includes a positioning piece 13. The positioning piece 13 is configured to cooperate with the mouth 201 of the subject 200. The positioning piece may be designed to be partially or completely introduced into the mouth 201 of the subject 200.

[0202] The positioning piece 13 extends at least partly radially around the body 2 of the catheter 1 .

[0203] The positioning piece 13 provides buccal support and is designed to limit the amount of air that passes outside the catheter 1 between the inside of the mouth 201 and the outside of the mouth 201.

[0204] The positioning piece 13 may be placed on the mouth 201 of the subject 200 or may be placed within the mouth 201 of the subject 200 .

[0205] The positioning piece 13 ensures at least a partial airtight seal through the subject's mouth, which has the advantage of improving the efficiency of the respiratory assistance device when administering a medicinal solution, regardless of whether the respiratory assistance device passes through the nose of the subject 200 or the catheter 1.

[0206] In one embodiment, the positioning piece 13 comprises a guide that directs the introduction of the catheter 1 into the airway of the subject 200. The guide may comprise an inner wall of the positioning piece 13. The wall is intended to come into contact with a surface of the body 2 of the catheter 1.

[0207] The positioning piece 13 acts as a pivot point, which advantageously allows the practitioner to easily guide the catheter body.

[0208] The positioning piece 13 may be arranged to slide along the body 2 of the catheter 1. When the positioning piece 13 cooperates with the port 201, the body 2 can move in translation relative to it. This translational freedom has the advantage that the positioning piece 13 in cooperation with the port 201 forms a pivot point which can improve the guiding of the body 2 during insertion.

[0209] The positioning piece 13 is preferentially made of a material that can facilitate airtightness of the positioning piece 13. The positioning piece 13 may be made of a plastic or elastic material that is compatible for use in contact with a patient. In one embodiment, the positioning piece is made of an expandable material. The shape of the positioning piece 13 may be designed so that it enters the mouth 201 of the subject and remains in the mouth 201 of the subject 200 during the intervention.

[0210] In one embodiment, the positioning piece 13 includes a stopper 131 on a proximal portion of the positioning piece. The stopper 131 on the positioning piece 13 is advantageous because it can prevent the subject from swallowing the positioning piece. Another advantage of the stopper 131 on the positioning piece 13 is that it facilitates movement of the main body 2 relative to the positioning piece 13.

[0211] In one embodiment, the positioning piece 13 is designed to allow movement within the intubation probe. Indeed, once the distal end 14 of the body 2 is within the larynx 206, it is necessary to be able to quickly introduce the intubation probe in case of subject discomfort. In practice, the intubation probe is slid around the catheter. Therefore, the positioning piece 13 is designed to allow such sliding and to allow the passage of air through the intubation probe.

[0212] In one embodiment, the positioning piece 13 is comprised in a mask intended to be attached to the head of the subject so as to isolate the mouth and nose from the external environment in a leak-tight manner, and the mask may comprise an opening to allow passage of a catheter according to the invention in a leak-tight manner.

[0213] Command Center The command center 100 preferentially includes one or more of the following elements: - a reservoir containing a fixed amount of liquid or powdered medicine; - a device for commanding the administration of medicinal fluids, which drives a high-pressure pump; - Ventilators to assist the subject in breathing; - a device for measuring the subject's respiratory cycle; - activation means for controlling the angle of curvature of said orientable portion 8; - an interface for commanding the orientation of the distal part 81; - Optical control device.

[0214] The command center 100 may include a user interface. According to various embodiments, the command center may be connected to a computer and memory. The command center may distribute instructions to command members, calculate values ​​of state variables to generate various alerts, and store configuration information.

[0215] The command center 100 can be equipped with isolation means, which advantageously make it possible to avoid microbial contamination of the command center between two interventions, in particular after exchanging a catheter.

[0216] The medical system 300 is preferably equipped with a connection device that allows a reversible connection between the catheter 1 and the command center 100 .

[0217] Embodiments of the present invention 7 to 11 illustrate a method of administering a medical fluid using a medical system 300 or catheter 1 as described above.

[0218] 7, the proximal portion 82 of the main body 2 of the catheter 1 is inserted into the mouth 201 of the subject 200. The insertion is performed by the practitioner.

[0219] The practitioner can then bring the positioning piece 13 into cooperation with the mouth 201 of the subject 200. The positioning piece allows for improving the efficiency of the ventilation system. The positioning piece 13 also allows for the practitioner to help guide the body 2 by forming a support or pivot point. The body 2 is pushed forward through the pharynx 202 by the practitioner.

[0220] In a second step, the practitioner activates, via the user interface, a member that drives the orientation of the distal portion 81. The orientable portion 8 then begins to bend in a predetermined plane. The distal portion 81 is oriented in the predetermined plane relative to the proximal portion 82.

[0221] Once the main body 2 is folded, the practitioner can control the position of the distal end 14 by means of the screen 101. The practitioner can adjust the orientation of the distal portion until the entrance to the larynx 206 or the entrance to the esophagus 205 is visualized on the screen 101. Once the entrance to the larynx 206 is visualized, the practitioner can introduce the distal end 14 of the main body 2 into the larynx 206.

[0222] Once the distal end 14 of the body 2 has been introduced into the larynx 206, the practitioner can deactivate the second drive member, which relieves the curvature of the orientable section, allowing the body 2 of the catheter 1 to regain flexibility and enter the larynx 206.

[0223] The means for driving the orientation of the distal portion 81, the optical system 6 and the display means advantageously make it possible to guide the distal end 14 of the body 2 of the catheter 1 into the larynx 206 of the subject without the use of a laryngoscope and with minimal pain to the subject 200.

[0224] As shown in FIGS. 8 and 9, the body 2 of the catheter 1 is advanced into the respiratory tract until the distal end 14 of the body 2 of the catheter 1 arrives in front of the vocal cords 204 of the subject 200.

[0225] The practitioner can control the advancement of the catheter 1 up to the entrance of the vocal cords 204 via a screen 101 which displays the image taken by the optical system 6 .

[0226] In the first embodiment shown in Fig. 10, when the distal end 14 of the body 2 of the catheter 1 faces the vocal cords 204, the movable element 5 of the passage channel 3 is advanced translationally beyond the body 2 of the catheter 1. The movable element 5 is advanced until the distal end of the movable element 5 passes the vocal cords, as shown in Fig. 12. Preferably, the distal end of the movable element 5 is advanced into the trachea 203 of the subject 200. The optical system 6 is positioned to capture an image of the zone including the vocal cords 204 and the movable element 5 of the passage channel 3. Thus, using the screen 101, the practitioner can guide the movable element between the two vocal cords.

[0227] As shown in FIG. 11, once the movable element 5 is positioned within the trachea 203, the practitioner can administer medicinal liquid in the form of microdroplets 207 into the subject's trachea 203 through the distal opening 501.

[0228] In a second alternative embodiment shown in FIG. 12, the distal end 14 of the catheter body 1 is advanced so that the catheter body passes through the vocal cords 204.

[0229] The optical system 6 is positioned to capture an image of the zone including the vocal cords 204. Thus, using the screen 101, the practitioner can guide the catheter body 2 between the two vocal cords 204. Once the distal end 14 is positioned within the trachea 203, the practitioner can administer a medicinal liquid in the form of microdroplets into the subject's trachea through the distal opening.

[0230] The administration of the medicinal fluid can be achieved by activation of a pump connected to a reservoir of the medicinal fluid. As mentioned above, the medicinal fluid may be administered in synchronization with the respiratory cycle of the subject 200, and preferably, the medicinal fluid is administered only during the inspiratory cycle of the subject 200.

[0231] In this way, the medicinal liquid is administered into the subject's trachea 203 in the form of microdroplets 207, favoring its distribution in the subject's lungs while avoiding the "drowning" effect that the subject 200 may experience when administering the liquid without the use of a laryngoscope.

[0232] As previously mentioned, liquid medication can be replaced by powdered medication delivered into the trachea in nebulized form.

[0233] Other Applications The catheter body according to the invention is preferentially designed to be inserted through the vocal cords into a narrow channel such as the trachea of ​​a premature newborn, the diameter of which can reach 2 or 3 mm.

[0234] Those skilled in the art will understand that such a catheter designed to be inserted into the trachea through the vocal cords of a premature newborn can be used for similar purposes, such as in reproductive and urinary applications. In particular, the diameter of the catheter body can allow for insertion of the catheter body through the urethra and / or fallopian tubes. "Designed to be inserted into the trachea through the vocal cords of a premature newborn" is interpreted to mean that the catheter body is constructed so that its dimensions can be inserted into small blood vessels or channels of a size similar to that of a premature newborn's trachea, such as the urethra, cerebral vessels, or fallopian tubes.

[0235] The catheter according to the invention also allows for laparoscopic applications, such as in the ORL, gastrointestinal tract, end-peritoneal or thoracic cavity. The catheter body is preferentially designed to be inserted into narrow channels of less than 10 mm or 5 mm, very preferentially less than 3 mm.

Claims

[Claim 1] A catheter for delivering a medicinal liquid or powder in the form of a spray into the trachea of ​​a subject, such as a premature infant, the catheter comprising: a deformable body designed to be inserted into the trachea via the subject's vocal cords; and a spray device for expelling liquid or powder introduced into the catheter as a spray; the catheter body further comprising a first lumen for passing an optical system for generating an image of a zone located at an extension of the distal end of the catheter; and a drive member for bending the catheter body along a predetermined direction.

Images