EP4076129A1

EP4076129A1 - Catheter comprising a spraying device and a control unit

Info

Publication number: EP4076129A1
Application number: EP20835802.8A
Authority: EP
Inventors: Eric Dumas De La Roque; Michael FAYON
Original assignee: Centre Hospitalier Universitaire de Bordeaux; Universite de Bordeaux
Current assignee: Centre Hospitalier Universitaire de Bordeaux; Universite de Bordeaux
Priority date: 2019-12-18
Filing date: 2020-12-18
Publication date: 2022-10-26
Also published as: FR3105004A1; JP2023506639A; WO2021123195A1; CN115038372A; FR3105004B1; US20230011654A1; KR20220119417A

Abstract

Disclosed is a catheter (1) for delivering a drug liquid or a powder in a sprayed form into the trachea of a subject, said catheter comprising a deformable body (2) comprising a spraying device for expelling, in the form of a spray, a liquid or powder introduced into the catheter, the catheter body having a lumen (4) for penetration by an optical device (6) to generate an image.

Description

Title: CATHETER INCLUDING A SPRAYING DEVICE AND A PILOT UNIT

Field of the invention

The invention relates to a catheter and a system for delivering microdroplets into the trachea of a subject, particularly a premature subject.

State of the art

Today, one in eight births in the United States and about one in fourteen in Europe is premature. About 20% of these premature babies suffer from respiratory distress syndrome, known by the acronym SDR. The latter is likely to cause death of the baby if the baby is not taken care of immediately, especially within an hour of birth.

Indeed, the earlier the baby is born (before the 37 week gestation period), the less ready his body is to face the outside world. Lung capacity increases rapidly in the third trimester of pregnancy. At the same time, the refinement of the alveolar walls of the lungs allows an increase in the gas exchange surface. Any early interruption of this maturation process can lead to impaired respiratory function and lung physiology.

The management of premature infants with RDS generally requires the administration of a surfactant as well as initial oxygenation. However, the administration of liquid surfactant to the respiratory tract with existing methods has several drawbacks.

A first drawback is the amount of liquid surfactant administered into the pulmonary tract which causes a drowning effect for the baby. In fact, the volume administered to the premature infant is equivalent for an adult to a volume of approximately 200mL or 2.5mL per kilogram of the subject.

A second drawback is that the method used is invasive.

It is indeed necessary to approach the entry of the larynx by a laryngoscope. The entrance to the larynx is very narrow, especially in premature subjects. This gesture is delicate and difficult to perform, even for an experienced practitioner. Moreover, this intrusion is also painful for the child. It therefore often involves analgesia and / or sedation to reduce the child's pain and facilitate the procedure. Then arises the problem of administration of an analgesic and / or sedative, which can be very difficult for premature babies.

A third disadvantage is the tolerance of the child during the administration of the surfactant which is generally administered in liquid form in the trachea, generating a drowning effect in the child. The surfactant can cause complications such as discomfort by reducing oxygenation or slowing the heart rate. The administration of the liquid should therefore be careful and often discontinuous if the baby is unwell. In an attempt to remedy these drawbacks, patent document WO2015 / 059037 is known describing a system for administering a drug comprising a pulmonary surfactant comprising a catheter comprising a first channel adapted to deliver a flow of medicinal liquid into the pharyngeal region of the subject and a second channel for conveying a flow of pressurized gas. A connection between the first and second channel allows nebulization of the medicated liquid at the cross between the liquid and the pressurized gas.

However, this type of device still requires the use of a laryngoscope to guide the catheter, involving all of the aforementioned drawbacks.

In addition, this type of catheter requires two channels to deliver gas flow and medicated liquid to the distal end of the catheter. The catheter must therefore be very wide and may not be suitable for its introduction beyond the vocal cords in premature subjects. Finally, this type of catheter allows the administration of a nebulized medicinal liquid in the pharyngeal region, this region very upstream allows part of the surfactant to pass through the esophagus, which reduces the effectiveness of the drug and requires increasing the volume of liquid to be injected as well as the injection time often exceeding 1 minute, or even 10 to 15 minutes.

Another disadvantage of this type of catheter results from the fact that part of the medicated fluid is blocked at the level of the vocal cords of the child, thus preventing the medicated fluid from reaching the lungs. The present invention aims to provide a catheter and a system for administering a medicinal liquid which overcome the drawbacks of the cited prior art.

An objective of the invention is to provide a catheter allowing the release of a medicinal liquid in the form of microdroplets as close as possible to the pulmonary passages, preferably in the trachea.

Another object of the invention is to allow simplified guidance of the catheter in the larynx of a premature subject without recourse to a laryngoscope or other invasive method and in a more rapid manner. In addition, the invention aims to enable an operation to be performed on the subject by a single person.

Another object of the invention is to provide a system allowing the management of a premature infant suffering from respiratory distress syndrome without resorting to analgesia or sedation of the premature subject. Another object of the invention is to provide a system for the treatment of respiratory distress syndrome while minimizing its impact on the patient's ventilatory support parameters.

Another object of the invention is to provide a catheter which is inexpensive and simple to manufacture and use. Summary of the invention

The invention relates to a catheter for delivering a medicinal liquid or a powder in spray form into the trachea of a subject, characterized in that said catheter comprises a deformable body having a spray device for expelling a liquid or a powder introduced into the trachea. A catheter in sputtering form, said catheter body further comprising an optic configured to generate an image of an area, said area being located in the extension of the distal end of said catheter.

In one example, the area is located in a longitudinal direction of the body from the distal end of the catheter.

The invention also relates to a catheter for delivering a medicinal liquid in the form of microdroplets into the trachea of a subject. The catheter comprises a deformable body in which a mobile element moves in translation beyond the body of the catheter. The movable element comprises a spray device for expelling a liquid introduced into the catheter in the form of microdroplets. Said catheter body further comprises an optic configured to generate an image of the distal end of the movable member in the translated position.

The invention also relates to a catheter for delivering a medicated liquid or powder in spray form into the trachea of a subject, such as a premature newborn subject. Said catheter is designed to be inserted into the trachea through the vocal cords of the subject and comprises a deformable body having a spray device for expelling a liquid or a powder introduced into the catheter in the form of a spray, said catheter body comprising, in furthermore, a light for the passage of an optic arranged to generate an image of a zone, said zone being situated in the prolongation of the distal end of said catheter and comprising a pilot member for the folding of the catheter body according to a predetermined orientation.

The deformation of the body of the catheter can be, for example, an elastic deformation or a deformation provided by a mechanical connection of the angular connection type, a pivot connection or a ball joint.

According to one embodiment, the body of the catheter includes a support for holding an optic. By extension, the body of the catheter can be understood as a body comprising an optic. The invention also relates to embodiments in which the optic is removable from the body of the catheter. The invention advantageously makes it possible to deliver a medicinal liquid into the trachea, that is to say beyond the vocal cords when the catheter is introduced through the mouth or through the nose. The invention also advantageously makes it possible to dispense with the use of a laryngoscope. Indeed, the practitioner can easily introduce the end of the body by guiding the distal part and optionally by viewing the images from the optic. This embodiment thus makes it possible to overcome, before treatment, analgesia or sedation of the premature baby linked to the laryngoscope. The invention makes it possible to provide a catheter overcoming the cited drawbacks of the prior art.

In one embodiment, the catheter comprises a first member for controlling a translation of the mobile element, the translation distance of the mobile element being controllable in a range of positions between 0.5 cm and 2 cm or between 0.5 cm and 4.5 cm. This embodiment advantageously makes it possible to treat a premature subject by inserting the movable element into the trachea through the vocal cords when the catheter body is in the larynx.

In one embodiment, the catheter includes a second member for controlling an orientation of a distal portion of the catheter body with a proximal portion of said body so as to control said orientation of the distal portion in a predetermined direction. The steering body makes it possible to pilot, trigger or control this orientation.

This embodiment advantageously makes it possible to facilitate the guiding of the distal part of the catheter body in the larynx by adjusting the orientation of the distal part in a controlled and remote manner. The practitioner can view the optic images to locate the entrance to the larynx and trigger the orientation of the catheter head to guide the catheter head through the entrance to the larynx. The invention thus makes it possible to overcome the drawbacks of the prior art, to accelerate the introduction of the catheter into the larynx, to reduce the trauma to the subject and to dispense with the use of a laryngoscope.

In one embodiment, the catheter comprises a positioning piece intended to cooperate with the mouth of a subject, said positioning piece extending radially at least partially around the body of the catheter to form a limiting (or designed to) buccal support. limit) the volume of air passing outside the catheter between the inside and outside of the mouth. The buccal support also allows the catheter to be held in line with the pharynx to facilitate guidance of the catheter. In one embodiment, the positioning part is movable in translation on the body of the catheter. In one embodiment, the positioning piece includes a guide for directing the introduction of the catheter into the airways of said subject.

The positioning piece acts as a pivot point. This pivot point advantageously makes it possible to facilitate the guidance of the catheter body by the practitioner.

Said positioning piece also makes it possible to ensure at least partial airtightness through the subject's mouth. Sealing of the positioning piece improves the efficiency of the support system respiratory system of the premature infant, especially when the respiratory support system is introduced through the nasal passage.

The translational freedom of the positioning part advantageously makes it possible to improve the guidance of the body from the start of insertion thanks to the pivot point formed by said positioning part in cooperation with the mouth.

Finally, this part provides a point of support for the catheter allowing the operator to free a hand to manipulate the catheter to guide it.

In one embodiment, the catheter has a channel for passing liquid through the end of the spray device.

In one embodiment, the spray device is configured to deliver a medicated liquid in aerosol form or medicated powder in aerosol or spray form.

In one embodiment, the spray device comprises:

• an insert arranged inside the passage channel and extending longitudinally along the passage channel, said insert having an outer surface comprising at least one substantially helical groove extending from the proximal end to the distal end of the insert and adapted for the passage of the medicated liquid;

• a chamber for receiving said volume of medicated liquid from a groove in the insert;

• a channel pressurizing a volume of medicinal liquid within an orifice arranged in the extension of said chamber.

Such a spray device advantageously makes it possible to produce an aerosol by putting the medicinal liquid under pressure.

In one embodiment, the passage channel further comprises a stop limiting the translational movements of the insert. This stop advantageously makes it possible to secure the position of the insert in the passage channel despite the flow of pressurized liquid.

In one embodiment, said optic is arranged at the distal end of the body of the catheter. The light for the passage of an optic (6) is adapted to receive an optical fiber extending along said light. The optical fiber can extend along said lumen, preferably to the distal end of the catheter body. In one embodiment, the optical fiber passage lumen comprises, at the distal end of the catheter body, a transparent and sealed wall to protect the optical fiber passage lumen from contamination from the external environment. Preferably, the wall is a sterile wall. In one embodiment, the optical fiber is also designed to illuminate an area located in the distal extension of the catheter.

In one embodiment, the distal end of the body includes a rounded shape. This rounded shape advantageously reduces the trauma to the subject upon contact between the distal end of the body and the subject's airways. In one embodiment, the outside diameter of the catheter body intended to be inserted into the respiratory tract of the subject is between substantially 1 mm and 5 mm or is less than substantially 5 mm, preferably less than 3 mm. An advantage of this diameter is to be able to insert the catheter possibly into the airways of a premature newborn.

The invention also relates to a medical system comprising a catheter according to the invention, and comprising a control unit. The control unit includes a reservoir for accommodating a volume of medicated liquid, and a medicated liquid delivery control device driving (or for controlling) a high pressure pump. the reservoir comprises means for controlling the temperature of the medicinal liquid or of the medicinal powder in the reservoir.

In one embodiment, the medical system includes a device for detecting and / or measuring the subject's breathing cycle, the administration of the medicated liquid by the controller being synchronized with the subject's breathing cycle. The administration of the medicated liquid can advantageously be carried out during the inspiratory phase of the subject.

This synchronization advantageously makes it possible to promote the transport of the medicinal liquid in the form of microdroplets towards the alveoli of the lung thanks to the breathing of the subject and decrease its expulsion by the airways out of the trachea.

In one embodiment, the medical system further includes a ventilation device for assisting breathing of the subject. The medical system may include a display screen for displaying the images of the optic.

In one embodiment, the control unit comprises means for actuating the second driver of the catheter.

The invention also relates to an intubation system comprising a catheter according to the invention and includes an intubation probe. The catheter is then designed to be inserted at least in part into the intubation tube. Said system advantageously allows the practitioner, when using the catheter, to quickly introduce an intubation probe by sliding the intubation probe along the catheter. The intubation probe is then, in the event of serious discomfort in the subject, much faster to insert into the larynx than with a laryngoscope and allows the subject to be secured at the cardiorespiratory level.

Brief description of the figures

Other characteristics and advantages of the invention will emerge on reading the following detailed description, with reference to the appended figures, which illustrate:

[Fig. 1 A]: a transparent view of a catheter body according to a first embodiment of the invention.

[Fig. 1 B]: a sectional view of the catheter body in which the passage channel comprises a concentric portion in the retracted position.

[Fig. 2A]: a perspective view of a catheter body according to the first embodiment in which the passage channel is translated in the distal direction beyond the catheter body.

[Fig. 2B]: a sectional view of the catheter body in which the passage channel comprises a concentric portion in a translated position beyond the catheter body.

[Fig. 3]: a sectional view of the section of the body of the catheter according to a first embodiment of the invention. [Fig. 4]: a sectional view of the section of the catheter body according to a second embodiment in which the body comprises an activation wire and a ventilation lumen.

[Fig. 5]: a perspective view of a medical system comprising a catheter according to an embodiment of the invention in which the catheter body comprises an orientable portion and in which the system comprises display means.

[Fig. 6]: a sectional view of the movable element of the passage channel according to one embodiment for delivering the medicated liquid in the form of an aerosol.

[Fig. 7]: a diagram of a subject with the distal portion of the catheter body inserted.

[Fig. 8]: a diagram of a subject in which the catheter shaft is introduced to the larynx. [Fig. 9]: an enlarged view in which the distal end of the catheter body is in the larynx in front of the vocal cords.

[Fig. 10]: An enlarged view in which the distal end of the catheter shaft is in the larynx in front of the vocal cords and the movable member is introduced into the trachea through the vocal cords. [Fig. 11]: an enlarged view in which the medicated liquid is sprayed into the trachea in the form of microdroplets.

[Fig. 12]: an enlarged view in which the distal end of the catheter is inserted into the trachea through the vocal cords.

[Fig. 13]: a sectional view of the section of the body of the catheter according to another embodiment of the invention.

detailed description

In the remainder of the description, the following terms should be understood in the light of their definition below: By "distal" is meant the side furthest from a point of the catheter held by the practitioner during its use.

By "proximal" is meant the side closest to a point of the catheter held by the practitioner during its use.

The term “channel” is understood to mean an artificial duct making it possible to convey a liquid. The term “lumen” is understood to mean an orifice extending along the longitudinal axis of the body of the catheter.

By "microdroplets" or "microdrops" is meant drops of liquid separated by air or a gas, the diameter of these drops being between 1000pm and 5pm.

By “spray” is meant a liquid or solid substance broken down into very fine particles. In the case of a liquid substance, the spraying results in the generation of microdroplets. In the case of a solid substance, the spraying results in the generation of particles of material, for example in the form of a powder.

In one embodiment, the "spray" can include nebulization or aerosolization.

By "nebulization" is meant the spraying of microdroplets by the meeting of a liquid and a gas under pressure.

By "aerosolization" is meant the spraying of microdroplets produced when a pressurized liquid passes through a conduit, the outlet of which comprises a shape particularly favorable to the creation of microdrops.

The invention relates to a catheter 1 comprising a catheter body 2 for delivering a medicinal fluid, in particular into the trachea of a premature subject. The invention makes it possible to treat the respiratory distress syndrome secondary to pulmonary immaturity requiring the administration of surfactant, but also all pulmonary pathologies requiring the administration of a medicinal liquid, in the pulmonary tract. Among these other pulmonary pathologies, one can note pathologies such as pulmonary hemorrhage, pneumonia, bronchopulmonary dysplasia and prolonged respiratory failure in chronically ventilated patients. The invention also makes it possible to treat newborns with secondary deterioration of the surfactant or a defect in its recycling.

In one embodiment, the medicated liquid can be replaced with a medicated powder. The spray is then a spray of a medicinal powder.

The invention also relates to a medical system 300 comprising said catheter 1 according to the invention. Catheter rod

The proximal part of the body 2 can be connected to a control unit 100, also called a control unit. The control unit 100 may include a user interface. According to different embodiments, the control unit can be coupled with a computer and a memory. The control unit then makes it possible to deliver instructions to a control unit, to calculate values of state variables to generate various alerts and to store configuration information.

The body 2 of the catheter 1 preferably has the shape of a rod.

The body 2 extends longitudinally to its distal end 14. The body 2 is flexible or elastically deformable. A flexible body advantageously makes it possible not to damage the tissues of the premature infant, in particular the tissues of the respiratory tract and the tissues of 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 it. an actuator and sufficient flexibility to bend said body so that it can move into the throat, larynx, pharynx and then possibly beyond the vocal cords to and through the trachea. It is considered that the body 2 of the catheter 1 is deformable from the stage where its curvature is modifiable, for example elastically.

The outer diameter of body 2 should be small enough for use in premature infants. The diameter of the body 2 should be small enough for its insertion into the trachea through the vocal cords of a subject, especially a premature subject. According to one embodiment, the outside diameter of the body 2 is adapted to be inserted into a conventional intubation probe. Advantageously, the outside diameter of the body 2 is between 5 mm and 1 mm, preferably between approximately 3 mm and 2 mm. A diameter less than 3 mm or less than 2.5 mm makes it possible to reserve the possibility of also using the catheter in a premature newborn already intubated with an endotracheal tube without an accessory channel. Indeed, the diameter of the trachea of a premature newborn can go down to 2 or 3 mm. The premature newborn can thus benefit from the spraying of the drug. The length of the body 2 is preferably less than 50 cm or between 10 cm and 30 cm.

Body 2 extends from a proximal end (not shown) to a distal end 14.

The body 2 of the catheter 1 is preferably designed to be disposable. Preferably, the catheter body is designed to receive an optical fiber and to be able to withdraw this optical fiber before discarding the body 2 of the catheter 1.

The invention also relates to a medical system 300. The medical system includes a control unit 100. The control unit 100 is designed to be connected to the catheter 1 according to the invention. The control unit advantageously comprises a user interface allowing control of the catheter 1. Once in use, the catheter 1 or the catheter body can be disconnected from the control unit 100 and discarded. In this case, a new catheter 1 is then connected to the control unit when it is used again.

The body 2 comprises several conduits or lights in its volume. The conduits or lumens extend in the longitudinal direction of the body.

The conduits or lumens extend preferentially to the distal end 14 of the body 2 and / or preferentially from the proximal end of the body 2.

Preferably, the distal end 14 of the catheter 1 comprises a substantially rounded shape. The substantially rounded shape advantageously allows the catheter to reduce the risk of trauma to the subject during catheter insertion.

Passage channel

The body 2 comprises a first passage opening 31. The catheter 1 comprises a passage channel 3 for a liquid, arranged at least in part in the first lumen 31.

The passage channel 3 is designed to transport a medicated liquid from a reservoir. The proximal end of the passage channel 3 is, in this case, preferably connected to a reservoir of medicinal liquid. The medicated liquid can be replaced with a medicated powder, gel or paste. According to one example, the passage channel 3 comprises a pipe arranged inside the passage lumen 31. In an alternative embodiment, the passage channel 3 is a duct formed by the passage lumen 31. The surface of the passage lumen includes, for example, an interior liner to facilitate the transport of the medicated liquid. The inner liner can also chemically protect the medicinal liquid from the walls of the lumen 31.

In a first embodiment, the passage channel 3 comprises a movable element 5. The movable element 5 is able to transport the medicinal liquid in its internal volume. The mobile element 5 moves in translation with respect to the body 2 of the catheter 1. The translation is preferably controllable from the proximal end by means of a control member.

The movable member 5 is designed to discharge the medicinal liquid through a distal port 501 in the form of microdroplets. The distal port 501 of the movable member 5 is fluidly connected to the passage channel 3.

The mobile element 5 preferably comprises a distal end designed to reduce the trauma of the subject in the event of contact between the respiratory tract and the distal end of the mobile element 5. Preferably, the distal end of the mobile element comprises a rounded or curved portion.

Translation of the distal part

The movable element 5 of the passage channel 3 is free in translation with respect to the distal end 14 of the body 2 or with respect to an optic 6 of the body 2.

Preferably, the mobile element 5 moves in translation beyond the body 2 to a translated position. The mobile element moves beyond the body 2 of the catheter 1 over at least 5 cm, very preferably over a distance greater than 0.5 cm or 1 cm. In one embodiment, the movable element 5 is controllable in a range of positions beyond the body 2 of between 0.5 cm and 5 cm. In one embodiment, in its most translated position, the distal end of the movable element 5 is at a distance, counted from the distal end 14 of the body, between 0.5 cm and 2 cm or between 0 , 5 and 4.5 cm. As illustrated in Figures 2A and 2B, the movable member 5 of the passage channel 3 is moved beyond the end 14 of the body 2 of the catheter 1.

According to one embodiment, the diameter of the movable element 5 of the passage channel 3 is smaller than the diameter of the body 2 of the catheter 1. This solution makes it possible to integrate the mobile element 5 within the passage channel 3. An advantage of the free translation of the mobile element 5 is to be able to penetrate into the trachea 203 through the vocal cords 204 of the premature baby 200. The free translation is understood as a mechanically free translation, but which can be activated and controlled by a command from an operator. Advantageously, a predefined distance can be preconfigured. According to another example, the operator deploys the mobile part while following the progress step by step, in particular thanks to the optics arranged on the catheter. Another advantage is to be able to move the movable element 5 of the passage channel 3 into an image capture zone of the optics 6. The control of the translation is therefore facilitated and the real-time control of the delivery of the drug solution is assured.

The movable element 5 is movable at least between a retracted position inside the body 2 of the catheter 1 (see Figures 1A and 1B) and a translated position where at least a portion of the movable element 5 is extends beyond passage lumen 31 and catheter body 2 (see Figures 2A and 2B).

Another advantage is to be able to keep the movable element 5 of the passage channel 3 in the retracted position to reduce the risks of breakage or deformation of the movable element 5 during the insertion of the body 2 of the catheter 1 into the airways. of topic 200.

In one embodiment illustrated in Figures 1B and 2B, the passage channel 3 comprises at least one portion 32 concentric with the passage lumen 31. The concentric portion 32 includes the movable element 5.

The concentric portion 32 is movable in translation inside the passage opening 31.

In an embodiment not shown, the passage channel 3 comprises at least two concentric telescopic portions 32.

The telescopic concentric portions are movable in translation in the passage lumen and with respect to each other. The concentric portions advantageously allow the increase of the protrusion length of the movable element as well as the rigidity of the part of the passage channel outside the body 2 of the catheter 1.

Passage channel displacement system

The catheter 1 may include a first member for controlling the translation of the movable member 5. The first member for steering may include a control rod. Preferably, a control rod (not shown) is connected to the concentric portion 32. The control rod can extend the proximal end of the body 2 of the catheter 1. The control rod allows the practitioner to move the concentric portion 32. by actuating said control rod.

The first control member makes it possible to control the movement of the movable element 5. The first control member makes it possible to cause the movable element and / or the concentric portion 32 to evolve beyond the catheter body of the means for activating the movement. of the passage channel 3 relative to the body 2 of the catheter 1 in the distal direction.

For example, if the passage channel 3 comprises several concentric telescopic portions 32, the first control member allows the telescopic portions to evolve in translation with respect to one another so that the mobile element protrudes from the body 2 of the catheter 1. .

The control unit 100 preferably comprises a first control member. The control unit is connected to the first control unit. The controller controls the first driver and the movement of the distal portion 5 of the passage channel 3. For this purpose, indicators of position or deployment of the catheter can be displayed. According to an exemplary embodiment in which the distal part of the catheter comprises a force feedback sensor, the control member can automatically stop the translational deployment of the mobile element when it encounters an obstacle such as the wall of the body. throat or windpipe, a vocal cord or any other part of an organ. The control unit 100 can in this case emit a sound or an alert informing the operator.

In an alternative embodiment, the spray device 50 is fixed relative to the distal end 14 of the catheter body. The spray device 50 can be arranged at the distal end of the passage channel 3 so as to spray in the extension of the distal end of the body. catheter. This arrangement also makes it possible to supply the spraying device with the lumen of the passage channel. In this embodiment, the catheter body 2 is designed to be able to be inserted into the trachea through the vocal cords of a subject, preferably a premature baby subject.

Micro droplet spraying

The movable element 5 comprises a spray device 50.

In one embodiment, the spray device 50 is designed to spray a powder, in particular a drug powder.

In a second preferred embodiment, the spray device 50 is designed to expel a medicinal liquid in the form of microdroplets.

In a first variant not shown, the microdroplets of medicinal liquid are obtained by nebulization. The catheter body 2 then comprises a channel for transporting a flow of pressurized gas. The catheter is then designed so that the pressurized gas meets the medicated liquid near the distal orifice of the passage channel 3. The pressurized gas allows the medicated liquid to nebulize or atomize into microdroplets.

The medicated liquid is then sprayed into the trachea in the form of nebulized microdrops. In this first variant, the body 2 of the catheter 1 includes a lumen for channeling the gas.

In a second variant shown in Figure 6, the microdrops of medicated liquid are administered in the form of an aerosol. An aerosol is produced when a pressurized liquid passes through a conduit, the outlet of which comprises a particular shape favorable to the creation of microdrops.

In a particular example illustrated in FIG. 6, the spraying device 50 of the passage channel 3 comprises aerosolization means 502, 503, 504, 506, 501 for expelling the medicinal liquid in the form of an aerosol.

The aerosolization means comprise an insert 502 which is generally elongated and arranged inside the passage channel 3.

Insert 502 includes an outer surface. Said outer surface comprises at least one groove 503 wrapped around the outer surface of the insert 502. The at least one groove 503 is adapted for the passage of the medicated liquid. The groove 503 is preferably helical. The at least one groove 503 extends from the proximal end to the distal end of the insert 502.

The tops of the outer surface of the insert, between two successive passages of the at least one groove 503 are in contact with the internal surface 508 of the passage channel 3 or form a seal to force the medicinal liquid to follow the at least one groove 503. The medicated liquid thus passes through the grooves 503 between the outer surface of the insert 502 and the inner surface 508 of the passage channel 3.

The aerosolization means preferably comprise, in the passage channel 3, a reception chamber 505. The reception chamber is arranged at the outlet of a groove 503 of the insert 502 and the end. Preferably, the receiving chamber is arranged between the insert and the distal end of the spray device 50.

The spray device 50 includes a distal orifice 501, preferably at the distal end of the spray device 50.

The aerosolization means also include an outlet channel 509. The outlet channel 509 extends in the extension of the reception chamber. The outlet channel 509 is suitable for the passage of the medicated liquid. The outlet channel 509 allows the pressurization of the medicinal liquid, in particular through its profile. In one embodiment, the profile of the channel comprises at least a first portion, connected to the reception chamber, the section of which decreases in the distal direction. The profile of the outlet channel 509 includes a second portion, connected to the distal orifice 501, the cross section of which is substantially constant. In one embodiment, the first portion is adjacent to the second portion.

In one embodiment, the outlet channel 509 is formed by a profiled body 504. The profiled body 504 is arranged inside the passage channel 3 between the distal end 501 of the passage channel 3 and the insert.

The diameter of the distal orifice 501 is preferably between 20 μm and 100 μm, very preferably between 40 μm and 80 μm. In one embodiment, the diameter of the distal port 501 is between 20 µm and 250 mίp, in particular when the volume of microdroplets to be produced is greater.

When the medicated liquid in the passage channel 3 is pressurized by a pump, the liquid is forced to follow the helical 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 vortex generator. At the exit of the helical groove 503, the medicinal liquid enters the reception chamber 505 and the direction of the flow is substantially a circular path following the internal circumference of the passage channel 3.

At the distal end of the chamber 505, the rotating liquid meets the outlet channel 509 in which an interface is created between the liquid swirling in the receiving chamber 505 and the ambient atmosphere of the orifice 501. The generation aerosol is then carried out at the distal end of the orifice 501 characterized by the ejection of microdroplets.

The shape of the aerosol can be changed depending on the pressure exerted on the medicinal liquid, the angle of rotation of the liquid in the chamber, the geometry of the chamber, and the geometry of the body and distal orifice.

The spraying device 50 may further include a stop 506 limiting the translational movements of the insert 502.

The spraying device 50 may further include a stop 507 limiting the translational movements of the profiled body 504.

The stops 506, 507 advantageously make it possible to maintain in position in the passage channel 3, the insert 502 and the body 504 despite the pressure of the medicinal liquid in the distal direction of the passage channel 3.

In one embodiment, the movable member includes several spray devices in parallel. By increasing the number of spray devices 50, the flow rate of drug liquid expelled from the microdroplets is increased. The catheter can also comprise several movable elements 5 in parallel each comprising a spray device 50.

Surfactant administration

The medical system 300 includes a reservoir of medicated fluid for administration to the subject. The tank is connected fluidly to the passage channel 3. The medicinal liquid preferably comprises a surfactant. The surfactant can preferably comprise a composition comprising a diluted pig lung extract. Alternatively, an artificial surfactant can be used. In general, any surfactant allowing the effective treatment of respiratory distress syndrome can be used.

Preferably, the reservoir of medicinal liquid comprises means for heating the medicinal liquid. One advantage is to reduce the viscosity of the medicinal liquid, facilitating its passage through a passage channel 3 of small diameter, thus improving the miniaturization of the catheter. Another advantage is that it delivers medicated fluid closer to the subject's body temperature into the subject's airways. For this purpose, the medical system 300 may include means for regulating the temperature in order to reach a target temperature value of the medicinal liquid in the reservoir.

In an embodiment not shown, the reservoir comprises a syringe. The heating means can then comprise a heating collar, arranged around the reservoir of the syringe.

The reservoir is fluidly connected to a pump. The pump is preferably a high pressure pump. The pump advantageously makes it possible to put the medicinal liquid under high pressure inside the passage channel 3. The placing under high pressure of the medicinal liquid inside the passage channel makes it possible to generate an administration in the form of an aerosol. . By high pressure is meant a pressure between 80 bars and 200 bars, preferably between 100 bars and 180 bars, very preferably between 120 bars and 160 bars. Alternatively, the pressure can be between 80 bars and 350 bars, particularly for the largest distal orifice diameters.

The pump is connected to a pump controller. The pump controller controls the activation of the pump and its intensity.

In one embodiment, the pump control device can be controlled by the practitioner. Preferably, the pump control device comprises a trigger of the “gun” type or another type of control. In an alternative embodiment, the reservoir comprises a drug powder. The drug powder preferably comprises a surfactant. In particular, the surfactant can comprise a composition comprising a diluted pig lung extract. Alternatively, an artificial surfactant can be used. In general, any surfactant allowing the effective treatment of respiratory distress syndrome can be used.

The invention also relates to a medical system and a catheter in which the passage channel 3 for the medicinal liquid is fixed relative to the catheter body. In this embodiment, the mobile element is not free in translation or does not exist. The spray device 50 for expelling the medicinal liquid in the form of microdroplets is the same as that described above. In this embodiment, the catheter body has a diameter small enough to allow its passage through the vocal cords. Preferably, the diameter of the catheter body is less than 2.5 mm for application to newborns or less than 5 mm for application to an adult subject.

Breath cycle measurement

In one embodiment, the medical system 300 includes a subject breathing cycle measuring device 200. The subject breathing cycle measuring device 200 includes, for example, subject breathing sensors and / or a rib cage enlargement sensor.

The subject's breathing cycle measurement device 200 may include an air sensor or an air flow change sensor. The sensor can be arranged in the airways of the subject, for example in the nasal or oral passages of the subject. Alternatively, the sensor can be arranged on a channel connected to the subject's airways.

In another embodiment, the device for measuring the breathing cycle of the subject 200 may include at least one electrical pulse sensor. The electrical impulse sensor is arranged to pick up the electrical impulses of the respiratory muscles, in particular the diaphragm. Such a sensor advantageously makes it possible to detect the electrical signals causing muscle activity, and therefore an inspiration or expiration phase in advance. The device for measuring the breathing cycle of the subject 200 may also include an optic (not shown) allowing the detection of the inspiration and expiration phases of the subject.

Preferably, the control device is configured to administer the medicated liquid in synchronization with the breathing cycle of the subject. The controller is then connected to the subject's breathing cycle measuring device 200. For example, the controller can be configured to control the administration of the medicated liquid only during the inspiration phases of the subject's breathing cycle. .

This synchronization advantageously makes it possible to promote the transport of the medicinal liquid in the form of microdroplets to the lungs thanks to the breathing of the subject and to reduce its expulsion by the respiratory passages out of the trachea.

In an alternative embodiment, the spray device can be replaced by a sampling device, in particular by suction or by a device for delivering a liquid or a paste or a gel.

Camera

The body 2 of the catheter 1 comprises an optic 6. The optic is preferably configured or arranged to generate an image of the distal end of the mobile element 5 in the translated position.

The optic can include a camera or a micro-camera.

The optic preferably comprises an optical fiber. The optical fiber has a distal end arranged on or near the distal end 14 of the body 2.

Preferably, the optic is configured or arranged to generate an image of the distal end of the mobile element 5 in the translated position or at the distal end of the mobile element 5 in the translated position.

In one embodiment, the optic 6 is arranged near or at the level of the distal end 14 of the body 2. The body 2 then comprises a second lumen 4 for the passage of a connection means of the optic 6. , such as an electric cable or an optical fiber.

Preferably, the optic 6 is arranged to capture images of a zone facing the distal end 14 of the body 2. The optic 6 is arranged to capture images of an area in the longitudinal direction of the body 2 of the catheter 1. In this way, the practitioner can advantageously visualize the subject's glottis as the catheter advances through the subject's pathways. This visualization advantageously makes it possible to save precious intervention time, in particular during a gesture to treat the subject urgently. Once the catheter body has passed through the vocal cords, the optics also make it possible to visualize the bifurcation between the two source bronchi (also called the carina) in order to place the distal end of the catheter at an appropriate distance from this bifurcation.

The lumen 4 for the passage of an optical fiber, called the optical fiber lumen, extends longitudinally inside the body 2 of the catheter 1. The optical fiber lumen 4 can extend from the proximal end of the body. 2, to the distal end 14 of the body 2 or to the optic 6.

The proximal end of the optical fiber is coupled to a signal processing device for generating an image from the signals from the optical fiber.

The optical fiber has the advantage of being less bulky than a camera, the device for processing the light signal being disposed outside or at the proximal end of the body 2.

In an alternative embodiment not shown, the optical fiber extends against the outer wall of the body 2 of the catheter. The optical fiber can then be held against the wall by various fixing means, such as a rail, a groove or a rib made on the surface of the body 2 of the catheter.

In another alternative embodiment not shown, the body 2 comprises wireless transmission means for transmitting the images taken by the optic 6.

The catheter 1 may include means for orienting the viewing zone of the optic 6. These orientation means are preferably controllable remotely. The orientation means allow the orientation of the optic 6 to be changed during use of the catheter 1. For this purpose, the optic 6 can be mounted on a pivot or ball joint.

The catheter 1 may also include means for moving the optic 6 relative to the body 2. The optic may be suitable for move in translation relative to the body 2 of the catheter 1. For this purpose, it may be integral with a rod moving (or able to move) in translation.

The optics are preferably configured to acquire images in the visible range. In alternative embodiments, the optics can be monochromatic. It can be configured to acquire images in black and white or for example in an infrared frequency range.

In a preferred embodiment, the optical fiber is movable in translation in the lumen 4 for the passage of the optical fiber. This mobility advantageously allows the catheter to be used for single use while retaining the optical fiber for later use in a second catheter according to the invention.

In this embodiment, the lumen 4 for the passage of the optical fiber comprises, at its distal end, a sealed wall. The sealed wall isolates the optical fiber and the lumen 4 for the passage of the optical fiber from the environment outside the catheter. The sealed wall protects the optical fiber from contamination and advantageously allows the reuse of the optical fiber without having to decontaminate it between two uses. The sealed wall also guarantees the sterility of the optical fiber. The sealed wall is preferably transparent to allow image capture by the distal end of the optical fiber. By "transparent" is meant here transparent to the light rays captured by the optics. These rays can thus comprise rays in the visible range, infrared rays or the like.

Lighting

Preferably, the catheter 1 comprises a light source 7. The light source 7 is arranged so as to illuminate at least part of the area captured by the optic 6. The light source 7 can comprise one or more light-emitting diodes. The light source 7 is connected to a power cable. The body 2 of the catheter 1 can comprise a third lumen 11 formed inside the body 2. The power cable of the light source 7 is then arranged at least in part inside the third lumen 11. According to one embodiment, the light making it possible to route an electric cable or an optical fiber can be shared to carry the power supply to the light source.

The light source 7 advantageously makes it possible to emit a light to illuminate the area captured by the optic 6 and allow the practitioner to view the area in front of the distal end 14 of the body 2 of the catheter. This makes it easier to guide the catheter body within the larynx 206.

The light source 7 is adapted to emit light detectable by the optic 6. For example, the light source 7 may include an infrared light source if the optic 6 is an infrared camera.

In a preferred embodiment, the light source is the optical fiber for image capture. The optical fiber then plays the two roles of optics for image capture and light source. One advantage is that it avoids the creation of additional lumen in the catheter body 2 for the passage of a light source, thereby increasing the miniaturization of the catheter. Another advantage is to reduce the number of manipulations before disposing of the single-use catheter.

The optical fiber can be used so that a first radial portion of its section is configured to emit light and a second radial portion to capture images. For example, the outer ring of the fiber optic section is used as a light source. For this, adequate means are provided at the proximal end of the optical fiber. In this example, the section portion inside the outer ring is used as an image capture.

Optical means control system

According to one embodiment, the medical system 300 further comprises an optics control device. The optics control device controls the optics 6 and / or the activation of the light source 7.

The medical system may include a means of transmitting information, in particular a display screen 101. The display screen 101 makes it possible to display in real time the images captured by the optic 6 of the catheter 1.

According to one embodiment, the user interface comprises an interface for controlling the optical means. Command interface comprises a control for the activation and / or adjustment of the intensity of the light source 7 and / or of the optics 6. The control interface of the optical means is configured to make available to an operator a control of the orientation and / or the displacement of the optic 6. This control is ensured, for example, by a digital control. Alternatively, the control is provided by a mechanical control, for example, by means of a joystick.

According to an exemplary embodiment, the display generates digital indications superimposed on the acquired image. These indications are, for example, organ contour lines, such as the vocal cords. These contour lines can be generated from a shape recognition algorithm. One interest is to improve the reading of information which must be done within a time interval constrained for the operator. According to another example, distance and orientation indicators are displayed in order to improve the readability of the current situation. This may be, for example, the translational distance of the movable member or the orientation of the distal portion of the catheter, or even the prongable portion. According to another example, indicators are displayed superimposed on the acquired image indicating intervention times, indications of volumes inspired / expired by the subject, etc.

Bequillable portion

The body 2 of the catheter comprises a second steering member. The second control member makes it possible to control an orientation of a distal part 81 of the body 2 of the catheter 1 with a proximal part 82 of said body 2 so as to control said orientation of the distal part 81 in a predetermined plane and / or in a predetermined direction.

In one embodiment, the catheter body 2 comprises at least one orientable portion 8. This orientable portion 8 is designed to be curved in a predetermined plane and / or in a predetermined direction. Preferably, the orientable portion is designed to be bent in a controlled manner when this orientable portion is activated. The catheter 1 comprises activation means 9 for triggering and controlling the folding or the curvature of the orientable portion 8.

By “in a controlled manner” is meant that the practitioner is able to adjust the angle of curvature or the angle between the distal part 81 and the part. proximal 82 of the catheter body 2 over a predetermined range. The practitioner can thus progressively increase or decrease the angle of orientation of the distal part 81 between two extremums in the predetermined plane.

Advantageously, controlling the angle of orientation of the distal portion 81 allows the body 2 of the catheter 1 to be inserted into the subject's larynx 206 without the use of a laryngoscope.

The maximum bending angle of the body in the predetermined plane is at least 45 °, preferably at least 70 °.

In one embodiment shown in Figures 4 and 5, the second pilot member comprises an activation wire 9 arranged along the catheter, for example, inside the body 2 of the catheter 1.

The activation wire 9 can be arranged inside a longitudinal lumen of the body 2 of the catheter 1. Said longitudinal lumen and the activation wire 9 are preferably radially off-center with respect to the longitudinal axis of the body 2 of the catheter. catheter 1. This radial offset advantageously makes it possible to promote the change in orientation of the distal part 81 of the catheter body 1 in a predetermined plane. The predetermined plane then comprises the longitudinal axis of the body 2 of the catheter 1 and the longitudinal axis of the lumen including the activation wire 9.

According to one embodiment, the catheter 1 comprises an anchor 12. The anchor 12 is a zone at which the activation wire 9 is blocked in translation with respect to the body 2 of the catheter 1. At a minimum, the anchor 12 blocks in translation the movement of the wire in the direction proximal to the body 2 of the catheter 1.

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. According to an alternative, the anchor 12 is made inside the body 2, between the distal end of the catheter. orientable portion 8 and the distal end 14 of the body 2.

The anchoring 12 is achieved, for example, by gluing or by crimping. The anchor 12 can also include an obstacle, an obstruction or a knot in the wire between the distal end of the body 2 and a retention means.

According to another embodiment, the activatable wire 9 is arranged along the outer surface of the body 2 of the catheter 1. The outer surface then comprises means of passage of the activatable wire 9. The means of passage are preferably fixed to the outer surface of the body 2 to avoid the arcing effects of the activatable wire during bending.

When the activatable wire 9 is pulled, a tensile force at the anchor 12 in the longitudinal direction of the body 2 is exerted in the proximal direction. This force advantageously makes it possible to bend the orientable portion and to create an angle of orientation between the distal part 81 and the proximal part 82 of the body 2 of the catheter 1 in the predetermined plane.

In an alternative embodiment illustrated in FIG. 13, the second pilot member comprises a preformed tube 9 in a lumen 20 of the catheter body 2. The preformed tube 9 extends into an orientation lumen 20 of the catheter body 2. The tube is preformed so that it comprises a preformed portion which, when the tube is at rest, assumes a curved shape, inducing an angle between the parts of the tube on either side of this portion in a predetermined plane. The second control member also comprises a rigid rod 22 extending into the cavity of the preformed tube 9. The rigid rod 22 has a substantially rectilinear shape at rest. The rigidity of the rigid rod 22 is greater than that of the preformed tube 9. Preferably, the rigid rod 22 extends from the proximal end of the preformed tube 9, at least to the preformed portion or to a point located between the preformed portion and the distal end of the preformed tube 9. The rigid rod can be removable from the preformed tube.

In this way, when the rod is inserted into the cavity of the preformed tube 9, the preformed tube 9 deforms to take the shape of the rigid rod 22. When the rigid rod 22 is withdrawn, the preformed tube 9 then tends to resume its function. forms at rest and applies force to the catheter body. This force advantageously makes it possible to bend the orientable portion of the catheter body and to create an orientation angle between the distal part 81 and the proximal part 82 of the body 2 of the catheter 1 in the predetermined plane as illustrated in FIG. 5. Preferably, the preformed tube allows a deformation of the distal part of the catheter between 20 and 40 °.

This embodiment advantageously makes it possible, by gradually withdrawing the rigid rod from the preformed tube, to control the bending angle of the distal end of the catheter body in the predetermined plane. The preformed tube preferably comprises a plastic or metallic material. The rigid rod preferably comprises a metal of the steel type.

The orientable portion 8 can comprise at least one zone the rigidity of which is less than the rigidity of the distal 81 or proximal 82 part of the body 2. This rigidity makes it possible to promote the appearance of a zone of weakness and to promote the curvature on the body. the orientable portion 8. The orientable portion 8 can comprise a rigidity less than the rigidity of the rest of the body 2 only on a lateral zone of the orientable portion 8. These lateral zones make it possible to advantageously promote the curvature of the body 2 in a predetermined plane comprising said lateral zone.

In one embodiment, the steerable portion 8 of the catheter body extends over a length of between 20mm and 30mm. The crutch thus advantageously makes it possible to facilitate the passage of the catheter 1 between the nasopharynx and the oropharynx.

The lower stiffness zones may comprise a material less rigid than the material of the rest of the body 2 or by cavities.

Preferably, said lateral zone is included in the plane comprising the longitudinal axes of the body 2 and of the lumen comprising the activatable wire 9. This configuration advantageously promotes the folding of the orientable portion 8 in a predetermined plane during activation.

In a first example, the activation is generated by the traction of the activatable wire 9. By a more or less strong traction, it is possible to control the orientation of the distal part 81 in the predetermined plane.

In a second example, the activatable wire 9 is a shape memory alloy wire. The catheter 1 then also comprises means for passing a current along the shape memory alloy wire. Activation of the shape memory alloy wire is accomplished by energizing the wire. Powering up increases the temperature of the wire by the Joule effect until it reaches a phase change temperature of the shape memory alloy wire.

Activation of the shape memory alloy wire triggers a predetermined curvature of the wire. The orientation angle of the distal portion 81 can then be controlled by temperature or by the electrical voltage applied to the shape memory alloy wire. These examples do not limit the invention which may include any other means for triggering by activation, a controlled curvature in a predetermined plane of the distal part 81 of the body 2 with respect to the proximal part 82. In one embodiment, the portion orientable 8 extends between 2 cm and 5 cm.

In one embodiment, the distal end of the steerable portion is disposed between 15mm and 100mm from the distal end of the body 2 of the catheter 1.

In one embodiment, the body 2 of the catheter comprises at least two second piloting members making it possible to control the orientation of the distal part 81 in at least two different predetermined planes and / or in at least two different predetermined directions. This solution can be achieved for example from two combined son and each being activatable in a given plane. According to another exemplary embodiment, the two associated son may be shape memory, said shape memory son having different alloys and particular preforms.

Preferably, the catheter includes a mark to indicate to the user the direction of the predetermined plane in which the body 2 will be deformed. The mark may be placed on a proximal portion and / or on the exterior surface of the catheter

Swivel portion activation system

In one embodiment, the medical system 300 also includes a means for actuating the pilot unit. The actuating means may be designed to exert a tensile force on the activatable wire 9. In the case where the activatable wire 9 is a shape memory alloy wire, the actuating means is designed to generate a tension on the wire. the length of the shape memory alloy wire.

The actuating means also makes it possible to control the angle of curvature of the orientable portion 8 by adjusting the tensile force or the intensity of the current imposed on the activatable wire 9.

The user interface may include an interface for controlling the orientation of the distal portion 81 of the body 2 of the catheter 1. This interface is connected to the actuating means and controls said actuating means and makes it possible to control the triggering of the curvature of the orientable portion as well as to control this curvature. When the pilot member comprises a preformed tube and a rigid rod as described above, the actuation of the pilot member can be effected by the withdrawal of the rigid rod. The withdrawal is preferably carried out by the proximal end of the preformed tube or of the catheter body.

The steering member and the optic advantageously allow rapid insertion of the distal end 14 into the subject's larynx through the epiglottis. Indeed, the practitioner can easily locate the branch between the larynx and the esophagus and activate the curvature of the body at said branch to make the body 2 enter the larynx.

Ventilation

When administering medicated fluid to a premature infant, it is very often necessary to assist the premature infant's breathing.

The body 2 of the catheter 1 can be designed to be inserted at least in part into an intubation tube. Breathing assistance can also be provided by a mask or a probe inserted through the nose independently of the catheter 1.

In this embodiment, the catheter body 1 can be easily used on an already intubated patient by inserting the catheter 1 through the intubation probe. The invention therefore relates to an intubation probe adapted to accommodate said catheter 1. The adaptation can be achieved by an element inside the intubation probe having guiding ergonomics or even a physical means intended to guide the movements of the catheter 1 within the probe. The intubation probe comprises at its distal end a means for being connected to a ventilation device such as a respirator or any other device to aid breathing.

When a catheter is introduced into a subject's larynx and used to deliver a spray, another advantage of a catheter-capable probe of the invention is that it can rapidly intubate the subject. Indeed, in this case, the intubation probe can be positioned upstream of the catheter and free to slide along the body 2 of the catheter 1. This option is particularly interesting in the event of cardiac and / or respiratory anomalies of the subject. The use of a laryngoscope is then unnecessary since catheter 1 is already in the subject's larynx.

Alternatively, the body 2 of the catheter 1 may include a ventilation lumen 10 in its internal volume. The ventilation light 10 is connected to a ventilator, an air pump or a respiratory support system, preferably by its proximal part. The ventilation lumen 10 preferably extends to the distal end 14 of the catheter body 2.

The ventilation lumen 10 advantageously makes it possible to integrate a ventilation assistance system with the catheter 1. The practitioner taking care of the premature baby then has fewer operations to perform before starting the administration of the medicinal liquid. The ventilation lumen 10 advantageously maintains respiratory support to the subject during administration of the medicated liquid. The ventilation lumen 10 also allows the introduction of a suction tube through said lumen, for example to aspirate the subject's secretions.

Ventilation system

In the embodiment where the catheter 1 comprises a ventilation system, the device for measuring the breathing cycle of the subject is connected to the ventilator. The ventilator is connected to an intubation probe or to the ventilation lumen 10. Preferably, the air pump of the ventilation system is connected to the means for measuring the respiratory cycle. The ventilation system is configured to operate in synchronization with the subject's breathing cycle. This synchronization advantageously makes it possible to assist the breathing of the subject as well as to promote the delivery of the microdrops in the lungs of the subject 200, more particularly in the alveoli of the lungs of the subject 200.

Positioning piece

In one embodiment, the body 2 of the catheter 1 comprises a positioning piece 13. The positioning piece 13 is designed to cooperate with the mouth 201 of the subject 200. The positioning piece can be designed to be partially or fully inserted. in the mouth 201 of the subject 200.

The positioning piece 13 extends radially at least partially around the body 2 of the catheter 1.

The positioning piece 13 forms a mouth support. The positioning part 13 is designed to limit the volume of air passing outside the catheter 1 between the inside of the mouth 201 and the outside of the mouth 201. The positioning piece 13 may be designed to be placed on the mouth 201 of the subject 200 or inside the mouth 201 of the subject 200.

Said positioning part 13 makes it possible to ensure at least partial sealing through the subject's mouth. This seal advantageously improves the efficiency of the respiratory support system during the administration of the medicated fluid regardless of whether the respiratory support system passes through the subject's nose 200 or through the catheter 1.

In one embodiment, the positioning part 13 comprises a guide for directing the introduction of the catheter 1 into the respiratory tract of the subject 200. The guide may comprise the internal walls of the positioning part 13. These walls are intended to be used. in contact with the surface of the body 2 of the catheter 1.

The positioning piece 13 acts as a pivot point. This pivot point advantageously makes it possible to facilitate the guidance of the catheter body by the practitioner.

The positioning piece 13 can be arranged to slide along the body 2 of the catheter 1. Once the positioning part 13 cooperates with the mouth 201, the body 2 is movable in translation with respect to said part. The freedom in translation advantageously makes it possible to improve the guiding of the body 2 during insertion thanks to the pivot point formed by said positioning part 13 in cooperation with the mouth 201.

Said positioning part 13 is preferably made of a material making it possible to facilitate the sealing of said positioning part 13. The positioning part 13 can be made of plastic or of an elastic material compatible with use in contact with patients. In one embodiment, the positioning piece is made of an expandable material. The shape of the positioning piece 13 can be designed so as to fit said piece 13 into the subject's mouth 201 and to remain in the subject's mouth 201 200 during the procedure.

In one embodiment, the positioning part 13 comprises a stop 131 on the proximal portion of the positioning part. The stop 131 of the positioning part 13 advantageously makes it possible to prevent the subject from swallowing said positioning part. Another advantage of the stop 131 of the positioning part 13 is to facilitate the translation of the body 2 relative to the positioning part 13.

In one embodiment, the positioning piece 13 is designed to allow translation within an intubation probe. Indeed, once the distal end 14 of the body 2 is in the larynx 206, it may be necessary to be able to quickly introduce an intubation probe if the subject is unwell. In practice, the intubation probe is slid around the catheter. The positioning part 13 therefore allows such sliding and is designed to allow the passage of air through the intubation probe.

In one embodiment, the positioning piece 13 is included in a mask intended to be mounted on the subject's head so as to seal off the mouth and nose from the external environment. The mask may include an orifice for the passage of the catheter according to the invention in a sealed manner.

Command center

The control unit 100 preferably comprises one or more of the following elements:

- a reservoir for accommodating a volume of a drug solution or a volume of drug powder;

- a device for controlling the administration of the medicinal liquid controlling a high pressure pump;

- the ventilation device for the subject's breathing assistance;

- the device for measuring the subject's breathing cycle;

- the actuating means for controlling the angle of curvature of the orientable portion 8;

- the interface for controlling the orientation of the distal part 81;

- the optical control device.

The control unit 100 may include a user interface. According to different embodiments, the control unit can be coupled with a computer and a memory. The control unit then makes it possible to deliver instructions to a control unit, to calculate the values of state variables to generate various alerts and to store configuration information. The control unit 100 can include isolation means. The isolation means advantageously make it possible to avoid microbial contamination of the control unit, in particular between two operations after having replaced the catheter.

The medical system 300 preferably comprises a connection device allowing a reversible connection between the catheter 1 and the control unit 100.

Methods of carrying out the invention

Figures 7 to 11 illustrate a method of administering a medicated liquid through the use of a medical system 300 or a catheter 1 as described above.

In a first step illustrated in Figure 7, the distal portion 82 of the body 2 of the catheter 1 is inserted into the mouth 201 of the subject 200. The insertion is done by the practitioner.

The practitioner can then cause the positioning part 13 to cooperate with the mouth 201 of the subject 200. The positioning part will make it possible to improve the efficiency of the ventilation system. The positioning piece 13 will also help the practitioner to guide the body 2 by creating a support or a pivot point. Body 2 is pushed by the practitioner to progress through pharynx 202.

In a second step, the practitioner, through the user interface, activates the control organ for the orientation of the distal part 81. The orientable portion 8 then begins to curve in the predetermined plane. The distal portion 81 takes an orientation in a predetermined plane relative to the proximal portion 82.

As the body 2 bends, the practitioner can control the position of the distal end 14 with the screen 101. The practitioner can adjust the orientation of the distal part until he visualizes the position. larynx entry 206 or esophagus entry 205 on screen 101. Once larynx entry 206 is viewed, the practitioner can insert distal end 14 of body 2 into larynx 206.

Once the distal end 14 body 2 has been introduced into the larynx 206, the practitioner can deactivate the second control member. The curvature imposed on the orientable portion is relaxed. The body thus regains its flexibility and can progress in the larynx 206 by a push on the body 2 of the catheter 1. The means for controlling the orientation of the distal part 81, the optic 6 and the display means advantageously make it possible to guide the distal end 14 of the body 2 of the catheter 1 in the larynx 206 of the subject without using a laryngoscope and by minimizing the subject's pain 200.

As illustrated in Figures 8 and 9, the body 2 of the catheter 1 is advanced through the airways 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.

The practitioner can control the advance of the catheter 1 to the entrance of the vocal cords 204 by the screen 101 showing the images taken by the optic 6.

In a first embodiment illustrated in FIG. 10, once the distal end 14 of the body 2 of the catheter 1 is opposite the vocal cords 204, the movable element 5 of the passage channel 3 is advanced in translation beyond of the body 2 of the catheter 1. The movable element 5 is advanced until the distal end of the movable element 5 passes through the vocal cords as illustrated in FIG. 12. Preferably, the distal end of the The movable element 5 is advanced into the trachea 203 of the subject 200. The optic 6 is arranged to capture images of an area comprising the vocal cords 204 and the movable element 5 of the passage channel 3. Using of the screen 101, the practitioner can therefore guide the mobile element between the two vocal cords.

As illustrated in Figure 11, once the movable member 5 is disposed in the trachea 203, the practitioner can deliver the medicated liquid in the form of microdroplets 207 into the subject's trachea 203 through the distal port 501.

In a second alternative embodiment illustrated in Figure 12, the distal end 14 of the catheter body 1 is advanced to pass the catheter body through the vocal cords 204.

The optic 6 is arranged to capture images of an area comprising the vocal cords 204. Using the screen 101, the practitioner can therefore guide the body 2 of the catheter between the two vocal cords 204. Once l At the distal end 14 disposed in the trachea 203, the practitioner can deliver the medicated fluid in the form of microdroplets into the subject's trachea through the distal port. Administration of the medicated fluid can be accomplished by activating the pump connected to the reservoir of medicated fluid. As explained above, the medicated liquid can be administered in synchronization with the breathing cycle of the subject 200, preferably, the medicated liquid is administered only during the inspiration phases of the subject 200.

The medicated liquid is thus administered into the subject's trachea 203 in the form of microdroplets 207, advantageously promoting its dispersion in the subject's lungs by avoiding the "drowning" effect that the subject 200 might experience in the event of administration of a. liquid and without the use of a laryngoscope.

As already introduced, the medicated liquid can be substituted for a medicated powder delivered into the trachea in pulverized form.

Other applications

The catheter body according to the invention is preferably designed to be inserted into a narrow channel such as the trachea of a premature newborn baby through his vocal cords. The diameter of such a trachea can reach 2-3 mm.

One skilled in the art will understand that such a catheter designed to be inserted into the trachea through the vocal cords of the premature newborn subject could be used for similar applications such as genital and urinary applications. In particular, the diameter of the catheter body may allow its insertion through the urethra and / or fallopian tubes. By "designed to be inserted into the trachea through the vocal cords of a premature newborn subject" is meant that the catheter body is dimensionally constructed so that it can be inserted into vessels or channels. narrow in size similar to the trachea of a premature newborn such as the urethra, cerebral vessels, or fallopian tubes.

The catheter according to the invention also allows its use in ENT, digestive, endoperitoneal or endothoracic applications by laparoscopy. The catheter body is preferably designed to be inserted into narrow channels less than 10 mm or 5 mm, very preferably less than 3 mm.

Claims

Catheter (1) for delivering a medicinal liquid or powder in spray form into the trachea (203) of a subject (200) such as a premature newborn, characterized in that said catheter (1) comprises a deformable body (2) designed to be inserted into the trachea through the vocal cords of the subject (200) and comprising a spray device (50) for expelling a liquid or a powder introduced into the catheter (1) as a spray, said catheter body (2) (1) further comprising a first lumen (4) for the passage of an optic (6) for generating an image of an area located in the extension of the distal end of said catheter (1) and comprising a pilot member for folding the catheter body in a predetermined orientation.

2. Catheter (1) according to claim 1, characterized in that the catheter body (2) comprises a second lumen defining a passage channel (3) for supplying the spray device (50) and a third lumen (20) comprising the pilot unit (9).

3. Catheter (1) according to claim 1 or claim 2, characterized in that said control member allows to control an orientation of a distal part (81) of the body (2) of the catheter (1) with a proximal part (82) of said body (2) so as to control said orientation of the distal portion (81) in a predetermined direction.

4. Catheter according to any one of the preceding claims, comprising a positioning piece (13) intended to cooperate with the mouth (201) of a subject (200), said positioning piece (13) extending radially at least. partially around the body (2) of the catheter (1) to form an oral support designed to limit the volume of air passing outside the catheter (1) between the interior and exterior of the mouth.

5. Catheter according to claim 4, characterized in that the positioning part (13) is movable in translation on the body of the catheter.

6. Catheter (1) according to claim 4 or claim 5, characterized in that the positioning piece (13) comprises a guide for directing the introduction of the catheter (1) into the respiratory tract of said subject (200).

7. Catheter (1) according to any one of the preceding claims, characterized in that the spray device (50) comprises aerosolization means (501, 502, 503, 504, 506) for expelling the medicated liquid under the aerosol form.

8. Catheter according to claim 1, characterized in that the control member comprises:

^■ a preformed tube (9) extending into an orienting lumen (20) of the catheter body;

^■ a rigid rod (22) removable extending into the cavity of the preformed tube (9); the preformed tube being designed so that it comprises a preformed portion which, when the removable rigid rod is withdrawn, assumes a curved shape, inducing an angle between the parts of the tube on either side of this portion in a predetermined plan.

9. Catheter (1) according to any one of the preceding claims, characterized in that said lumen (4) for the passage of an optic (6) is adapted to receive an optical fiber extending along said lumen up to 'at the distal end (14) of the body (2) of the catheter (1).

10. Catheter (1) according to the preceding claim, characterized in that the passage lumen (4) of optical fiber comprises, at the distal end (14) of the catheter body (2), a transparent and sealed wall to protect the light (4) for the passage of the optical fiber of contamination from the external environment.

11. Catheter (1) according to one of the preceding claims, characterized in that said optical fiber is also designed to illuminate an area situated in the distal extension of the catheter (1).

12. A medical system (300) comprising a catheter (1) according to one of the preceding claims, and comprising a control unit (100), said control unit (100) comprising:

^■ a reservoir to accommodate a volume of medicated liquid or a medicated powder,

^■ an administration control device respectively of the medicinal liquid or powdered medicament to drive a high pressure pump.

13. A medical system (300) according to claim 12, characterized in that it comprises a display screen (101) for displaying the images of the optic (6).

14. The medical system (300) of claim 12, wherein the reservoir comprises means for controlling the temperature of the medicated liquid or the medicated powder in the reservoir.

15. An intubation system, characterized in that it comprises a catheter according to one of claims 1 to 11 and an intubation probe, said probe being designed to accommodate said catheter (1) being able to move within said probe.