WO2020113349A1

WO2020113349A1 - Device for conditioning respriatory gases in patients with a tracheostomy

Info

Publication number: WO2020113349A1
Application number: PCT/CL2018/050121
Authority: WO
Inventors: Ivan CARO PINTO; Macarena SÁNCHEZ RAMART; María Ignacia SÁEZ AGURTO
Original assignee: Pontificia Universidad Católica De Chile; Hospital Dr. Exequiel González Cortés
Priority date: 2018-12-05
Filing date: 2018-12-05
Publication date: 2020-06-11

Abstract

The invention relates to a device (1) for conditioning respiratory gases in patients with a tracheostomy, which permits the internal flow volume to be adjusted and which is securely coupled to the cannula of the patient and accommodates a pair of HME filters (heat and moisture exchanger), wherein the device comprises means for controlling the internal flow volume, formed by a casing (10) having a central chamber (13) and two lateral respiratory chambers (12, 12') with displacement guides (20) via which a filter support (30) is moved axially, increasing or decreasing the internal volume of the device, and the device also comprises means for connecting the device to the cannula of the patient via radial compression of a grooved elastomeric connector (50) which is adapted to the external surface of the cannula and is compressed by an external rigid connector (40) connected to the casing of the device by means of a thread.

Description

RESPIRATORY GAS CONDITIONING DEVICE IN PATIENTS

WITH TRACHEOSTOMY DESCRIPTIVE MEMORY

The invention that is the subject of the present invention patent application is applicable in the medical field, specifically refers to a device for conditioning respiratory gases in patients with tracheostomy that allows regulating the interior tidal volume.

PREVIOUS ART DESCRIPTION

In the normal breathing process, inspired air conditioning occurs, which is the process by which a gas is heated and humidified as it passes through the airway to arrive in optimal alveolar conditions. Although the gas acquires temperature and humidity along the route by the airway, the main area where inspired air heating occurs is the nose.

The temperature of the nasal mucosa is around 32 ° C, and although the contact time between the inspired air and the nasal mucosa is short, it is sufficient to transfer heat to it. On the other hand, the nose has great potential to regulate blood perfusion and thus counterbalance the loss of heat in inspiration. In addition, the air circulates through a narrow duct generating turbulent flow that optimizes heating, humidification and filtering. During expiration, the humidity of the exhaled air is partially conserved by condensation on the mucosa due to the temperature difference. About 25% of the heat and humidity is recovered during exhalation. As the temperature of the inspired gas increases as it travels through the airway, at the alveolar-capillary interface it is at body temperature (37 ° C), with 100% relative humidity and 44mg / L absolute humidity.

When a gas does not pass through the upper respiratory tract under physiological conditions, such as in people with an artificial airway, the inspired air is prevented from coming into contact with the mucosa of the upper airway, affecting its conditioning; situation that occurs specifically in a patient tracheostomized or tubed to receive mechanical ventilation.

Tracheostomy is a surgical procedure performed to create an opening inside the trachea, through an incision made in the neck, and the insertion of an endotracheal tube or tracheostomy tube to facilitate the passage of air to the lungs. . Its objective is to restore the airway, allowing adequate respiratory function. It is basically composed of an endotracheal tube or internal cannula and an external cannula or mother cannula, which has external flanges that remain in contact with the patient's skin and prevent the external cannula from migrating inward; A universal adapter emerges on the tab (it is 15 mm in diameter) where a path for mechanical ventilation or other types of accessories is connected, such as a heat and humidity exchanger device in the case of patients who have their respiratory system bottom in good condition and therefore not connected to mechanical respirators. In the case of patients who have a tracheal tube, the air does not enter through the nose or through the mouth, so it is not hot or humid; This can cause thick, dry, bloody mucus. This mucus can block the airways and could make it difficult to breathe through the tracheal tube.

To humidify, heat and filter the air that the stomized tracheo patient breathes, he is provided with a humidification system that can be active (mechanical respirator) or can be passive, normally called a heat and humidity exchanger filter (HME, for its Heat and Moisture Exchanger). These systems have the ability to exchange the flow of a gas within a circuit, it collects and retains the expired heat and humidity of the patient, and returns them in the next inspiration, containing within the system a filter that can be sponge or pressed paper.

Also during inspiration, air is filtered, removing most of the contaminants, optimizing gas exchange and protecting lung tissue. Contaminating particles, including pathogens, are trapped, neutralized, and transported to the upper airway.

Whatever the device of choice, it must inevitably meet the minimum requirements to supply the function of the upper airway, which according to the American

Association for Respiratory Care are:

30mg / L absolute humidity, 34 ° C temperature and 100% relative humidity for HME.

Passive humidifiers are mandatory in patients with artificial airways, to avoid hypothermia, alteration of the epithelium of the airways, bronchospasm, atelectasis and airway obstruction. For its correct use, it is necessary to possess the necessary knowledge about the technical specifications, advantages and disadvantages of each of these devices, since the conditioning of inspired gases represents a key intervention in patients with artificial airways. Incorrect device selection or inappropriate settings can negatively impact clinical results.

For patients with artificial airways and who use HME air conditioner, it is difficult to achieve the natural balance between humidity level and temperature in relation to their own respiratory capacity, therefore, an inadequate size conditioning device can provide excessive humidity, therefore, the temperature may not be adequate, especially if the patient presents an increase in the respiratory rate. Excess moisture modifies the physical characteristics of the mucus, which being very aqueous it cannot be displaced into the upper airway by the mucociliary system, so it tends to accumulate in the lower respiratory system, obstructing the airway, increasing the risk of infection and compromising lung compliance.

On the other hand, with respect to the temperature of the inhaled air, it is well known that breathing cold air increases bronchial reactivity and bronchial spasm events in susceptible patients. In addition to jeopardizing the patient's life, events of broncho spasm force the use of inhaled pharmacotherapy, which implies a higher cost and infectious risks in the patient.

In the state of the art it is possible to find two large groups of humidity heat exchangers, the first are those active systems, which are used as part of a mechanical ventilation circuit, which is arranged between the patient's intubation route and a flexible duct attached to the mechanical fan; they are normally in the form of a disc or drum with in-line inlet and outlet in a single axis, as described, for example, in the US patent document US-8,176,916 (B2) of COVIDIEN AG, published the year

2012 referring to a filter device and / or HME for respiratory circuits comprising a condensation trap, it is disclosed that the device includes an upper cover suitable for connecting to ventilation means, a lower cover suitable for connecting to a tracheal tube or tracheostomy of a patient, a filter and / or HME element arranged between the upper cover and the lower casing and a condensation screen arranged in front of the filter.

Something similar to the above is described in US patent US-5,701,891 to

NELLCOR PURITAN BENNETT INC, published in 1997, showing a heat exchanger medium that can be incorporated into a heat and humidity exchanger. The heat exchanger medium includes an elongated yarn-bonded olefin sheet. The sheet can be covered with a hydrophilic coating and a desiccant.

As you can see, the documents just mentioned refer to humidifying devices for application in ventilation circuits, which correspond to the first group of solutions on conditioning of breathing gas; The other group of solutions corresponds to those devices that are used in patients who have a tracheal stomy, that have a stoma with an external connection cannula installed and that are for domestic use, not connected to a mechanical ventilator.

These moisture heat exchangers (HME) are more widely used and less complex. They are simple condensers made with foam elements disposable, synthetic fiber or paper, with a considerable surface area that manages to generate an effective temperature gradient through the device, delivering heat with each inspiration.

An example of this type of solutions is described in the US patent US-9,604,027 to SMITHS GROUP PLC, published in 2017, where an HME is disclosed that has exchange elements at the opposite ends of a tubular casing and a port central for connection to a tracheal tube. An oxygen port is located in the center, with most of it inside a recess on the outside of the case and extends at right angles to the length of the case. A large suction opening aligns with the hole that opens into the tracheal tube and is covered by a hinged flap when not in use.

A similar device is also described in US patent US-

6,968,841 from MALLINCKRODT HOLDINGS BV, published in 2005, which indicates a device for the passive humidification of stomized tracheo patients or intubated patients, which comprises an external body that forms an opening for connection with the patient and is connected to a patient seat. a filter element that is connected to the outside, the device further comprising, on the outer body, a coupling for connection to an oxygen supply duct terminating near the outside of the filter element.

One of the main problems with these types of known devices has to do with the scarce availability of adequate sizes for each group of patients that allow more precise control of tidal volume and dead space. When this is not adequate, it can cause excessive increase in dead space and CO ₂ retention, which is again inspired by the patient. It is considered dead space at full volume that forms part of the airway where inspired and expired gases circulate without participating in the process of gas exchange with blood.

The problem that causes dead space in the therapy of critically ill patients is that during expiration, these volumes fill with CO ₂ that comes from the alveolar units, turning into "stale" gas that will be inhaled in the next inspiration. In this way, the patient is ventilated with a volume of gas that is not totally fresh, but has a CO ₂ content that can be considerable depending on the relationship between dead space and the tidal volume with which the patient or the patient is being ventilated. normal breathing tidal volume of a stomized tracheo patient.

Especially in neonatal patients, the effect of dead space is considerable because the volumes of the instruments such as flow sensors and diameter adapters are in the same order as the small lung volumes, managing in some cases to exceed them.

It is recommended that the dead space volume does not exceed one third of the expected tidal volume for the patient and, depending on the patient in which it is to be used, the dead space and tidal volume values change.

The following table shows the tidal volume used according to age, while the second table refers to the recommended respiratory rates for applying mechanical ventilation in children.

For this specific problem, it is possible to find products available in different sizes on the market for different tidal volumes and / or different dead space needs, however, there are only standardized sizes, usually for three age groups, for neonates up to 1 to 2 months of age, pediatric from 1 month to 14 years of age and for adults from 14 years of age.

Thus, to achieve these volumes the current devices have 3 formats, to achieve the volume in premature infants they have a 7 ml vacuum space, for pediatric patients of

10ml and for adults of 15ml which suggests that for a range of "newborn" to "pediatric patient of 14 years" the same filter of 10 ml of vacuum is used.

It has been possible to verify that the existing devices do not cover the needs of some intermediate age groups, such as the case of children between 6 months and 5 years, who are the most affected, since the devices for neonates result from a very low performance because they are very small, whereas existing devices for pediatric use are very large, increasing the dead space in relation to the lung capacity of these patients.

On the other hand, these devices are part of hospital therapies, often emergency, so that a hospital or public health care facility implies having to have, simultaneously, the entire range of possible sizes to be applied. with different types or sizes of patients.

It is considerable to think about the enormous number of devices that the public health system must have to provide patients with these devices, especially since these devices require daily changes, sometimes more than one daily, and it is a long-term therapy that can easily exceed two years of treatment or even be for life.

Taking into account the essential problem of dead space, there are age ranges of users who are not having dedicated or customized devices according to the tidal volume requirement in relation to their lung capacity or their requirements for adequate humidification and temperature levels, since these latter conditions are generated from the relationship between the user's breathing rate and the capacity or volume of the HME device, especially in simple devices that do not have electromechanical means or additional ways of applying steam or heat to warm the air; We are talking about its application in patients with spontaneous breathing, not connected to a mechanical ventilator, so the temperature and humidification levels are generated only by the condensation of the exhaled gas vapor and by the residence of the air in ducts or confined spaces that allow Maintain the outlet temperature from the airways. Other problems arising from the improper use of this type of humidifying filters or heat humidity exchangers (HME) is that sometimes injuries occur in the airway, because they include means of union with the cannula that involve the risk of detachment of the HME device. Normally the device is installed under pressure embedded around the tracheostomy tube that emerges from the patient's neck area, sometimes it happens that the connector of the device accumulates secretions or fluid that decreases the pressure contact of the union, so it can be easily detached if the child or adult unintentionally throws it away. There are other cases in which the connector is stuck to the cannula and when it is detached for replacement or also if the patient pulls it involuntarily, the device drags the endotracheal tube or tracheostomy tube with it.

For all of the above, the present invention overcomes the problems not solved in the prior art, proposing a device that is a heat and humidity exchanger filter (HME) capable of providing a wide range of performance, so that it can be applied for any age just by making some adjustments, which also represents the advantage that at the industrial level a single device is manufactured that is suitable for all types of users.

Additionally, the device of the present invention also overcomes the problem of connection with the tracheostomy cannula, providing a secure connector, but at the same time easy to handle for its removal and replacement without risk of the cannula coming out or having They have to perform a strong traction maneuver to be able to detach it and thus pull the cannula inserted into the patient's neck, generating pain or injuries.

Still another problem that occurs is that sometimes the devices do not allow to easily visualize and verify the conditions during their use; it is not clearly known if the air is entering and conditioning with the necessary temperature and humidity to give an adequate benefit, this mainly because they are made of non-translucent or semi-translucent materials, without being able to observe the internal behavior of the air flow.

DESCRIPTION OF THE INVENTION

The main objective of the present invention is to provide an HME heat and humidity exchanger device for stomized tracheo patients, which allows its use in a wide range of ages, therefore, patient sizes, such as neonates, pediatrics and adults, providing means for adjusting the tidal volume inside the apparatus.

Another objective of the present invention is to provide an HME device that allows its connection with the patient's cannula in a way that facilitates its installation and uninstallation, being able to be operated by anyone without further training, facilitating daily replacement of the device, avoiding having to pull the cannula at the risk of it coming off or causing pain in the patient.

Still another objective of this invention is to provide an HME device that allows its operation to be clearly visualized, so that it does not require advanced knowledge to know that it is working correctly when conditioning the air.

Another object of the invention is to provide an HME device that favors the condensation of the water vapor coming from the patient's exhalation, increasing its residence in the device to be used as an inhaled air conditioner. Thus, the present invention proposes a device comprising a housing with respiratory chambers with means for adjusting the internal tidal volume of the apparatus and means for connecting the device to the patient's cannula.

The respiratory chambers house a standard or conventional filter for this class of devices, such as filters of polymeric material, foam type, of pressed or rolled paper.

The casing is a hollow rigid body with opposite open ends, it can be of any geometric shape that favors a fluid passage of air and, at the same time, it facilitates its manufacture, but preferably the casing is of a cylindrical straight shape.

Inside, two lateral respiratory chambers and a central chamber are defined, all of them aligned on the longitudinal axis of the housing, so that the inspired air enters through each of the lateral chambers and mixes in the central chamber with the residual air. expiration that comes tempered and moistened from inside the patient.

The side chambers house the standard filters by means of a filter support piece that connects to each side chamber, which will be explained later; while the central chamber of the housing corresponds to the space provided between the lateral chambers inside the housing; On each of its sides, where the lateral chambers begin, there is a diagonal transverse partition, which serves both to retain the filter, preventing it from migrating into the airway, and to increase the condensation surface of the gases and improve air humidity conditioning. The casing further comprises a smaller frontal portion, arranged perpendicular to the longitudinal axis, which can take any suitable form to direct the air, however, in a preferred embodiment, this smaller frontal portion is also cylindrical, presenting a frontal opening with a circular channel interior holding a safety valve.

This safety valve is formed by an elastomeric disc, of the diaphragm type, which has diagonal cuts that define fins that are flexed with air pressure and facilitate their expulsion in the event of internal overpressure, as happens with coughing episodes. This valve also allows the insertion of some accessory, such as a catheter to access the patient's airway, without the need to disassemble the entire device.

The casing further comprises a smaller rear portion, opposite the front, which is also oriented perpendicular to the longitudinal axis of the casing; This posterior portion has an opening on its posterior face to connect with the connection means to the cannula that will be described later.

Said smaller posterior portion allows a lateral connection with an accessory oxygen pathway, so that it has a small tube-shaped extension where the oxygen supply can be mounted just before passing to the patient's cannula.

The means for regulating the internal tidal volume of the device allow an axial enlargement or reduction of the lateral respiratory chambers, where this change in the internal volume is carried out because a set of displacement guides are arranged inside each lateral chamber. the axial movement of a filter holder, which counts with complementary means of axial displacement with respect to the lateral chambers of the housing.

The set of displacement guides are strategically placed to allow the filter support to advance axially in or out of the lateral chamber and to be fixed in certain positions, defining, in this set of displacement guides, sections of axial advance -which are the longitudinal sections- and circumferential displacement sections as a turn -which are the perpendicular sections- where their position is also fixed.

The displacement guides are formed by a plurality of grooves or grooves distributed sequentially, interspersed with each other with a longitudinal section and a perpendicular section, where a first longitudinal section originates from each open end of the lateral chambers, where the support is introduced filter.

The filter supports comprise a body that is complementary to the shape of the lateral chambers of the housing, but is preferably cylindrical; They comprise an interior cavity where the filter is housed, with a distal face, which is on the outside, and is crosslinked with perforations or cuts to let the air pass, but at the same time, retain the filter housed inside. Opposite to this distal face, it presents an open proximal face, through which the filter is inserted.

Said complementary axial displacement means that are present in the filter supports, comprise at least two radial projections whose shape and dimensions fit the width of the set of camera displacement guides and with this, allow the Filter supports move in a guided way in or out of the lateral chambers, increasing or reducing the volume of the device.

Said radial projections can be arranged on the inner edge of the open proximal face of the filter support, while the set of displacement guides can be arranged on the outer surface of the lateral chambers; however, in a preferred embodiment of the invention, said radial projections are arranged on the outer edge of the open proximal face of the filter holder, while the set of displacement guides are arranged on the inner surface of the lateral chambers.

In an alternative embodiment of the means for adjusting the internal tidal volume of the device, the set of displacement guides that wind the axial movement of the filter support, comprise a thread arranged on the inner surface of the lateral chambers of the housing; while the complementary means in the filter supports also comprise a thread that is arranged on its outer surface; so that in operation, the filter supports move axially within the chambers exerting a twisting motion.

As indicated at the beginning, the device has connecting means to the patient's cannula, this fixation being a temporary state, since the device must be completely replaced on a daily basis and sometimes, more than once a day, as in the cases of patients affected by problems that cause them to generate many secretions.

These connecting means operate through a radial compression fixation around the patient's cannula, in the manner of a compressible jaw. These means comprise a rigid connector and an elastomeric adapter that is arranged inside the rigid connector and at the same time, outside the patient's cannula.

The rigid connector is cylindrical in shape with a proximal end through which it joins the posterior opening of the posterior minor portion of the housing and comprises an open distal end on whose inner surface it has a single thread, only half a turn. The size of this connector is in relation to the standard size of the cannulas - normally

15mm in diameter- and with the size of the elastomer adapter; As for the height of that piece, it is recommended that it have the lowest possible height or at least not higher than the cannula, so that the device is configured as a low-profile device that does not protrude too far from the patient's throat, at least not beyond what is necessary, making it a more comfortable device.

The elastomeric adapter of the connecting means has a flat ring shape whose inner diameter is slightly larger than the outer diameter of the standard cannula mantle. Said outer mantle of the ring comprises single thread of only half a turn, has a distal end and a proximal end, where this adapter comprises a plurality of longitudinal notches that start from the distal end and extend close to the proximal end, forming sections of flexible wall, due to the elastomer material. The interior surface of these wall sections of the adapter has radial projections that remain in contact with the exterior surface of the patient's cannula and allow the adapter to be fixed in a non-slip manner, acting as embedded teeth.

The thread inside the rigid connector matches the thread in the mantle of the elastomeric adapter, so that when that rigid connector rotates and advances outside the adapter, makes the flexible wall sections flex radially, reducing the internal diameter of the adapter until it conforms to the cannula and since the material is elastomer, it allows a compression to be generated that makes the fixation like a seal; thus, the device cannot be easily loosened and pulled out, but rather requires a half reverse rotation of the device around the cannula to be released from the elastomer adapter and, in turn, this adapter when released from compression by the rigid connector, It opens its fringed walls and is easily movable to remove it from around the cannula.

The parts that make up the device are made of polymeric material, preferably of high translucency and colorless, allowing to clearly see if the device is working, which is verified if water vapor accumulates on the inner surface of the housing from the exhaled air that It comes with higher temperature and higher degree of humidity.

As mentioned in the description of the prior art, each patient has different tidal volume requirements according to their respiratory capacity and the size of their organs, which are divided in a standardized way between neonatal, pediatric and adult patients.

Regarding the main objective, which is to be able to regulate or adjust the internal tidal volume of the device, so that with a single manufactured device the needs of a wide range of patients' age can be met, the device that is the reason for This invention can gradually modify the internal cavity, increasing or decreasing the tidal volume, which due to its adjustment means formed by the set of axial displacement guides and the projections of the filter support allows different relative positions to be configured between them. In operation, the device can be configured according to a different tidal volume, where in order to obtain the smallest possible size, the filter supports must be at their internal displacement stop touching the transverse partition of the central chamber. Meanwhile, in order to achieve the greatest possible internal volume, the filter supports must be displaced axially outwards from the lateral chambers in their external stop configured by the outermost perpendicular section of the set of displacement guides.

Eventually, the filter supports can be moved interchangeably between one side chamber and another, that is, it is not necessary that the displacement be symmetrical for both side chambers, so that the range of intermediate positions increases even more.

The set of displacement guides that are present in the device can have a plurality of sections on each side, but it must at least offer two axial positions on each side, such that the filter support can be displaced at least between a stop position Inner for minimum tidal volume and an outer stop position for maximum tidal volume.

In a configuration such as the one just indicated, three different settings can be achieved that give effect to three different tidal volumes from a single device that can be applied to three different age groups, such as neonates, pediatrics and adults. In detail, a first tidal volume, which would be the minimum size, would be achieved if both filter supports are completely inserted up to the internal stop given by the transverse partitions of the central chamber. Then an intermediate tidal volume would be achieved if only one of the filter holders were moved axially to its outermost position and finally, the third tidal volume, which would be the largest, would be achieved if both filter supports are moved outwards and fixed in their outermost position.

In an alternative embodiment of the device, the guide assembly can offer three axial positions on each side, so that the different combinations generate five different tidal volumes from a single device, combining the position of the filter holder in each of the three positions in each side camera of the device. Thus it could be used by five different age groups, such as neonates (from 0 to 28 days), minor pediatric (from 29 days to 24 months), older pediatric (2 years to 5 years), school-adolescent (from 6 years to 18 years) and adults (from 18 years).

In other alternative embodiments, the device could have two versions available, one with the aforementioned capacities, and a second with capacities from 10ml to 15ml. In this way, the former could be used by younger age groups, such as neonates (from 0 to 28 days), minor pediatric (from 29 days to 24 months), older pediatric (2 years to 5 years) and The second could be used by the older age groups, school-adolescent (from 6 years to 18 years) and adults (from 18 years).

The classification just exposed is only by way of example, it is not rigid, since more than the age of the patient, what matters is its size and respiratory capacity.

Other embodiments of the invention may include more than three axial positions per side, increasing the diversity of tidal volume sizes and hence, increasing the possibility of application in patients with different requirements. As explained above, the different axial positions that the filter support can adopt with respect to the lateral chamber where it is attached, will depend on the set of displacement guides, where the longitudinal sections will allow axial displacement along the camera, while the perpendicular sections will generate the stopping points of the advance and fixation of the filter support.

Each of the pieces of the device, although preferably the housing, the rear connector and the filter supports must be made of a high translucency and colorless material, such as a polycarbonate or medical grade silicone, since it is this characteristic that would allow that the user can verify the operation, since a correct operation of the device causes the interior walls of the device to fog due to the condensation of the water vapor contained in the tempered respiratory flow that comes from the patient's route; therefore, a dry surface appearance is an indicator that it is not working properly, either because there is significant leakage in some area or because the tidal volume is not adequate for the patient.

DESCRIPTION OF THE FIGURES

A detailed description of the invention will be carried out in conjunction with the figures that form an integral part of this presentation, where:

Figure 1 shows a front isometric view of the device.

Figure 2 shows a front isometric view of the device casing.

Figure 3 shows a partial section iso metric view of the device casing.

Figure 4 shows an enlarged isometric view in detail of the front area of the device. Figure 5 shows an exploded isometric view of the device, where the component parts can be seen separately.

Figure 6 shows a partial sectional front isometric view of the device casing.

Figure 7 shows a partial sectional rear isometric view of the device casing.

Figure 8 shows an exterior isometric view of a filter holder and filter.

Figure 9 shows an interior isometric view of a filter holder

Figure 10 shows a partial sectional rear isometric view of the housing and of a filter holder of the device.

Figure 11 shows a bottom plan view of the device.

Figure 12 shows a rear isometric view of the device with the rear connector and elastomer adapter.

Figure 13 shows a rear isometric view of the device with the rear rigid connector without the elastomer adapter.

Figure 14 shows a rear isometric view of the elastomeric adapter.

Figure 15 shows a side elevation view of the elastomer adapter.

Figure 16 shows a front elevation view of the elastomer adapter.

Figure 17 shows a posterior isometric view of the device with a partial section of the posterior rigid connector.

Figure 18 shows a top plan view of the device with the elastomer adapter offset outward.

Figure 19 shows a front view of the device in a first operating position with the minimum capacity of internal tidal volume. Figure 20 shows a front view of the device in a first operating position with the maximum volume capacity of the current interior.

Figure 21 shows a front isometric view of the device with a partial section of the cameras and front area of the housing according to an alternative embodiment.

Figure 22 shows a front isometric view of the device with a partial section of the cameras and front area of the housing, showing the filter holder according to an alternative embodiment.

DETAILED DESCRIPTION OF THE INVENTION

A detailed description of the invention will now be made, with reference to a preferred embodiment, which does not constitute an application of its scope; understanding that any modality is part of this invention while it is under the same inventive concept.

The present invention relates to a respiratory gas conditioning device in patients with tracheostomy that allows adjusting the internal tidal volume, is securely attached to the patient's cannula, and houses a pair of HME filters (A)

(heat and humidity exchanger).

As seen in FIG. L, the device (1) comprises a casing (10); regulating means (20,30) of the internal tidal volume and connecting means (40, 50) for fixing by radial compression of the device (1) to the patient's cannula (not illustrated).

As best seen in FIG. 2, the casing (10) comprises a hollow rigid body (101) with open ends (102, 102 ') opposite each other, inside which two chambers are defined respiratory laterals (12, 12 ') having an inner surface (121) and an outer surface

(122). The casing further comprises a central respiratory chamber (13), all the chambers (12, 12 'and 13) being aligned on the longitudinal axis of the casing (10). Said lateral chambers (12, 12 ’) form part of the means for regulating the interior tidal volume of device (1), which is produced by axial expansion of said chambers.

Represented in FIG. 3, the central chamber (13) corresponds to the space provided between the lateral chambers (12, 12 ’), and a transverse partition is provided on each of its sides

(131, 131 ’) diagonal to the inner section of the housing.

As can best be seen in FIG. 4, the casing (10) also includes a smaller frontal portion (14) with a frontal opening (141) where a safety valve (142) is provided, formed by a diaphragm-type elastomeric disk that it has diagonal cuts (143) that define fins (144) that are flexed in or out.

Now considering FIG. 5, the aforementioned means of regulating the internal tidal volume of the device are formed by a set of axial displacement guides (20) arranged in said lateral chambers (12,12 ') of the housing and by a pair of supports

(30) of filters (A) with complementary means of axial displacement with respect to the lateral chambers of the housing.

As best seen in FIG. 6 and FIG. 7, the set of axial displacement guides

(20) are formed by a plurality of straight recesses distributed sequentially and interspersed with each other by longitudinal sections (201) and transverse sections (202) to the longitudinal axis of the housing, where a first longitudinal section (2011) is born from each end open (102, 102 ') of the side chambers. Preferably, the set of axial displacement guides (20) are arranged in each lateral chamber (12, 12 ') in number of two longitudinal sections (201) interspersed with two perpendicular sections (202).

As seen in FIG. 8 and FIG. 9, the filter supports (30) comprise a rigid body (300) complementary to the shape of the lateral chambers of the housing, with an external surface (301), a cavity interior (302) where the filter (A) is housed; it also has a distal face (303) crosslinked to let the air pass and retain the filter (A) inside it and an open proximal face (304) to introduce said filter; the complementary means for axial displacement of the supports (30) comprise radial projections (305).

As illustrated in FIG. 10, these radial ribs (305) fit into the set of travel guides and allow the filter holders (30) to move axially in or out of the side chambers (12, 12 ') when moving through the longitudinal sections (201) and fixing its axial advance by fitting into the perpendicular sections (202). As seen in the same figure, the radial projections (305) of the supports (30) are arranged on the outer edge of the proximal face (304), while the set of displacement guides

(20) are arranged on the inner surface (121, 121 ’) of the side chambers (12, 12’).

In FIG. 11 it can be seen that the casing (10) also comprises a smaller rear portion (15) with a rear opening (151) and to that smaller rear portion (15) an accessory duct (60) is attached to introduce gases into the device. Now, leaning on FIG. 12, it is possible to see that the connecting means for fixing by radial compression to the patient's cannula comprise a rigid connector (40) and an elastomer adapter (50) that is arranged inside the rigid connector and to its time, outside the patient's cannula (not shown).

As illustrated in FIG. 13, this rigid connector (40) is a cylindrical body

(400) with a proximal end (401) through which it is attached to the casing (10) and an open distal end (402), with an inner surface (403) having thread (404).

Meanwhile, as seen in FIG. 14 and FIG. 15, the elastomer adapter (50) is a flat ring-shaped body (500) with an inner surface (501), an outer mantle (502) with a thread. (503), a distal end (504) and a proximal end (505), where this body has a conical trunk shape with a larger diameter (508) at the distal end (504) and a smaller diameter at the proximal end (505), best illustrated in FIG. 15.

This adapter (50) comprises a plurality of longitudinal notches (506) that start from the distal end (504) and extend close to the proximal end (505).

As can best be seen in FIG. 16, between the longitudinal notches (506) of the elastomeric adapter (50), sections of flexible wall (507) are formed that flex radially with respect to the outer mantle of the patient's cannula, shrinking the larger diameter (508) of the adapter (50) until it conforms to said outer surface of the cannula. Meanwhile, the inner surface (501) of the adapter (50), in the wall sections (507), has radial projections (509) that remain in contact with the outer surface of the cannula. As best seen in FIG. 17, the thread (503) of the elastomer adapter (50) is complementary to the thread (404) of the rigid connector (40) and they are half a turn.

In consideration of FIG. 18, it is seen that the rigid connector (40) is attached to the casing (10) by its proximal end (401) that splices with the posterior opening (151) of the posterior minor portion (15) of the casing.

The parts that make up the housing (10), the filter supports (30), the rigid rear connector (40) and the elastomer adapter (50) of the device are made of high translucency material.

In operation, the device can be configured according to a different interior tidal volume, where to obtain the minimum possible size the filter supports (30) must be on an internal stop inside the lateral chambers (12,12 ') touching the transverse partitions (131,131 '), as seen in FIG. 19 to achieve the greatest possible internal volume, the filter supports (30) must be axially displaced out of the lateral chambers (12,12'), as well as seen in FIG. 20.

In an alternative embodiment of the device's interior tidal volume regulation means, illustrated in FIG. 21 and FIG. 22, the set of displacement guides that wind the axial movement of the filter support (30), comprise a thread threaded (70) disposed on the inner surface (121,121 ') of the side chambers (12,12') of the casing (10); while the complementary means in the filter supports (30) also comprise a thread (80) that is arranged on its outer surface (301); so that in operation, the filter supports (30) move axially within the lateral chambers (12,12 ’) exerting a forward or backward turning movement.

Claims

1. Respiratory gas conditioning device (1) in patients with tracheal stomy that allows adjusting the internal tidal volume, is securely attached to the patient's cannula and houses a pair of HME (A) filters (heat and humidity exchanger) ,

CHARACTERIZED because it comprises a casing (10) with internal respiratory chambers (12, 12 ’, 13); regulation means (20, 30) of the interior tidal volume by axial expansion of the respiratory chambers; and connecting means (40, 50) for radial compression fixation of the device (1) to the patient's cannula.

2. Device (1), according to claim 1, CHARACTERIZED in that the housing

(10) comprises a rigid hollow body (101) with open ends (102, 102 ') opposite each other, inside which two lateral chambers (12, 12') are defined, each with an inner surface (121, 121 ' ) and an outer surface (122,122 ') and by a central chamber

(13), all aligned on the longitudinal axis of the casing (10), where said lateral chambers

(12, 12 ') are part of the means for regulating the interior tidal volume of the device (1) and each one houses a filter (A), while the casing also comprises a smaller front portion (14) with a front opening (141 ) and a smaller posterior portion (15) with a posterior opening (151).

3. Device (1), according to claim 2, CHARACTERIZED in that the central chamber (13) corresponds to the space provided between the lateral chambers (12, 12 '), and a transverse partition (131) is arranged on each of its sides , 131 ') diagonal to the inner section of the casing (10).

Device (1), according to claim 2, CHARACTERIZED in that in the front opening (141) of the front portion (14) of the casing (10) there is provided a safety valve (142) formed by an elastomeric disc Diaphragm type that has diagonal cuts (143) that define fins (144) that are flexed.

5. Device (1), according to claim 1, CHARACTERIZED in that said means for regulating the internal tidal volume comprise a set of axial displacement guides (20) arranged in said lateral chambers (12, 12 ') of the casing ( 10) and by a pair of filter supports (30) (A) with complementary means of axial displacement with respect to the side chambers (12, 12 ') of the casing (10).

6. Device (1), according to claim 5, CHARACTERIZED in that the set of axial displacement guides (20) are formed by a plurality of straight recesses distributed sequentially and intercalated with each other between longitudinal sections (201) and sections perpendicular (202) to the longitudinal axis of the casing (10), where a first longitudinal section (2011) arises from each open end (102, 102 ') of the lateral chambers (12,

12 ’).

7. Device (1), according to claim 6, CHARACTERIZED because preferably in each lateral chamber (12, 12 ') the set of axial displacement guides (20) are at least two longitudinal sections (201) interspersed with two sections perpendicular (202).

8. Device (1), according to claim 6, CHARACTERIZED because preferably in each lateral chamber (12,12 ') the set of axial displacement guides

(20) are three longitudinal sections (201) interspersed with three perpendicular sections (202).

9. Device (1), according to claim 5, CHARACTERIZED in that the supports

Filters (30) comprise a rigid body (301) complementary to the shape of the lateral chambers (12, 12 ') of the housing, with an internal cavity (302) where the filters (A) are housed, one face distal (303) crosslinked to let air pass and retain the filter (A) inside and an open proximal face (304) to introduce said filter.

Device (1), according to claims 5 and 6, CHARACTERIZED in that said complementary means for axial displacement of the supports (30) comprise at least two radial projections (305) that fit into the set of displacement guides (20 ) and allow the filter supports (30) to move axially in or out of the lateral chambers (12, 12 ') when moving through the longitudinal sections (201) and fixing their advance by fitting in the perpendicular sections ( 202).

11. Device (1), according to any of the preceding claims,

CHARACTERIZED in that said radial projections (305) are arranged on the outer edge of the open proximal face (304) of the filter support, while the set of displacement guides (20) are arranged on the inner surface (121, 121 ') of the side chambers (12, 12 ').

12. Device (1), according to any of the preceding claims,

CHARACTERIZED because said radial projections (305) are arranged on the edge inside the open proximal face (304) of the filter support, while the set of displacement guides (20) are arranged on the outer surface (122, 122 ') of the lateral chambers (12,12').

13. Device (1), according to claim 5, CHARACTERIZED in that the means for regulating the interior tidal volume comprise a thread (70) arranged on the interior surface (121,121 ') of the lateral chambers (12,12' ) of the housing (10); while the complementary means in the filter supports (30) comprise a thread

(80) that is arranged on its outer surface (301) of the filter supports (30).

Device (1), according to claim 1, CHARACTERIZED in that the connecting means for fixing by radial compression to the patient's cannula comprise a rigid connector (40) and an elastomer adapter (50) that is arranged inside the connector rigid (40) and, in turn, outside the patient's cannula.

15. Device (1), according to claim 14, CHARACTERIZED in that the rigid connector (40) is a cylindrical body (400) with a proximal end (401) whereby it is attached to the housing (10) and one end distal open (402), comprising with an inner surface

(403) having thread (404).

16. Device (1) according to claim 14, CHARACTERIZED in that the elastomeric adapter (50) is a body in the form of a flat ring (500), with an internal diameter (508), with an internal surface (501), and an outer mantle (502) with thread (503), one distal end

(504) and a proximal end (505), where this adapter comprises a plurality of longitudinal notches (506) that start from the distal end (504) and extend close to the proximal end (505).

17. Device (1), according to claim 16, CHARACTERIZED in that between the longitudinal notches (506) of the elastomer adapter (50) sections of flexible wall (507) are formed that are flexed radially with respect to the outer mantle of the patient cannula, shrinking the inner diameter (508) of the adapter (50) until it conforms to said outer surface of the patient cannula.

18. Device (1), according to claim 16, CHARACTERIZED in that the inner surface (501) of the adapter (50), in the wall sections (507) has radial projections

(509) that remain in contact with the outer surface of the patient's cannula.

19. Device (1), according to any of the previous claims,

CHARACTERIZED because the thread (503) of the elastomer adapter (50) is complementary to the thread (404) of the inner surface (403) of the rigid connector (40).

20. Device (1), according to any of the preceding claims,

CHARACTERIZED because the thread (404) of the rigid connector (40) and the thread

(503) of the elastomer adapter (50) are half a turn.

21. Device (1), according to any of the preceding claims,

CHARACTERIZED in that an accessory duct (60) is attached to the smaller rear portion (15) of the housing (10) to introduce gases into the device.

22. Device (1), according to any of the preceding claims,

CHARACTERIZED in that the rigid connector (40) is joined to the housing (10) by its proximal end (401) that splices with the posterior opening (151) of the posterior minor portion

(15) of the housing (10).

23. Device (1), according to any of the preceding claims,

CHARACTERIZED because the parts that make up the housing (10), the filter supports (30), the rigid rear connector (40) and the elastomer adapter (50) of the device are made of polymeric material.

24. Device (1), according to any of the preceding claims,

CHARACTERIZED because the parts that make up the casing (10), the filter supports (30), the rigid rear connector (40) and the elastomer adapter (50) of the device are made of high translucency polymeric material.