Patent Description:
The present invention relates to the field of medical devices and in particular concerns a multifunction connector for connecting a non-invasive ventilation face mask to a ventilation system.

Non-invasive ventilation (NIV) is a type of (mechanical) artificial ventilation used for patients with acute respiratory failure without the use of invasive techniques, such as orotracheal intubation or tracheostomy. The patient is fitted with a face mask connected to a ventilation system which supplies a gas flow to the mask and, therefore, to the patient.

The mask is connected to the ventilation system via a connector having, in general, an inlet connectable to a ventilation apparatus, an oxygen supply nozzle connectable to an oxygen supply pipe, and an outlet connectable to the mask.

In general, different connectors are required according to specific needs, or the use of different accessories in order to have at one's disposal the interfaces required by different patients. This requires the manufacture and management of various parts and components, with consequent complications and costs.

Furthermore, the need to select a specific connector and/or fit specific accessories may cause a loss of time while treating patients in an emergency.

Furthermore, known connectors that require the use of accessories and/or adapters are relatively bulky in size and weight and have protruding and/or irregular parts; when these connectors are placed on the patient's chest, as is common, they can therefore cause discomfort.

Furthermore, in most known connectors, the inlet and outlet ports consist of fixed nozzles, so that the flexible tubes connected to these nozzles remain perpendicular to the connector; however, this configuration may cause the tubes to bend, reducing the flowrate of fluid within them and potentially causing serious problems for the patient.

The document <CIT> discloses a connector for connecting a non-invasive ventilation face mask to a ventilation system. The connector comprises an inlet connectable to the ventilation system and an outlet connectable to the ventilation mask. A connection portion of the outlet is shaped so as to be joined to a joint of the ventilation mask by means of a conical coupling. The connector further comprises an expiratory outlet and a pressure line port configured to be coupled to a pressure sampling line.

The document <CIT> discloses a multifunction connector for connecting an oxygen mask to a nebulizer. The multifunction connector includes a mask outlet port, a nebulizer inlet port, a metered-dose inhaler (MDI) port and an oxygen delivery port.

The document <CIT> discloses a MDI ventilator assembly for use in a ventilator circuit for administering medication to a patient. The MDI ventilator assembly comprises a housing defining an interior space to allow an aerosolized drug to expand within the interior space before being inhaled by a patient. The housing defines an inhalation port for connection to a ventilator system, an exhalation port, a patient port for connection to an endotracheal or tracheostomy tube, a MDI receptacle for receiving a MDI container, a temperature probe port and a pressure probe port.

The present invention aims to solve the above-mentioned problems, in particular by providing a connector that simplifies and speeds up treatments requiring non-invasive ventilation of a patient in an emergency.

The present invention therefore relates to a multifunction connector for a ventilation face mask as defined in essential terms in the appended claim <NUM> and, in its additional features, in the dependent claims.

The connector of the invention consists of a multifunctional interface between a face mask and the non-invasive ventilation units, resulting in the following advantages with respect to the known technique.

The connector of the invention brings together several functionalities in one single device, allowing for a more rapid intervention when connecting patients to a ventilation system. The connector of the invention also allows for more stable treatment: by combining several functions, in particular allowing drugs to be administered via the MDI inlet, the connector of the invention avoids having to interrupt the ventilation circuit when drugs must be administered to the patient.

The connector of the invention also allows to reduce the risks of infection during treatment of respiratory diseases as it is not necessary to open the ventilation circuit to add any function.

The connector of the invention also allows to reduce the possibility of connection errors, given that the connector is provided with all the necessary accessories for the various functions.

The connector of the invention is advantageously provided with joint elements having different diameters chosen from various standards, so as to be easily and effectively connected to the various devices used in the healthcare sector.

In preferred embodiments, the oxygen inlet and the flow reading outlet are provided with rotating joints, so as to avoid excessive bending of the flexible tubes and to ensure the best air support for the patient.

Furthermore, the oxygen inlet and the flow reading outlet are provided with different removable joints that can only be fitted in the correct position, thus reducing the risk of incorrect connections.

Furthermore, the possibility of detaching the joints allows for an effective cleaning and sterilisation of all the parts of the connector.

In a version intended in particular for non-ventilated masks, the connector is additionally provided with an expiratory outlet for the emission of carbon dioxide. Advantageously, the expiratory outlet is positioned laterally on the body of the connector to prevent the contaminated air emitted by the patient from being directed towards the healthcare professionals and to reduce airborne contamination by optionally also allowing direct coupling of a HEPA filter.

The various functional elements are arranged so as to leave one side of the connector free of protrusions, offering greater comfort to the patient.

The connector of the invention can be manufactured in a simple and economical way and is compact and lightweight. In terms of logistics, it significantly reduces the number of parts in storage and in healthcare institutions will simplify ordering procedures.

Further characteristics and advantages of the present invention will become clear from the following description of a nonlimiting embodiment thereof, with reference to the figures of the accompanying drawings, in which:.

<FIG> and <FIG> designate, as a whole, with <NUM> a multifunction connector for a non-invasive ventilation face mask, usable to connect the mask to a ventilation system.

In particular, the connector <NUM> shown in <FIG> is intended for non-ventilated masks; further on, and with reference to <FIG>, a variation specifically intended for ventilated masks is instead described.

The connector <NUM> comprises a base body <NUM>, preferably consisting of a monolithic piece in polymer material, for example polycarbonate. Preferably, in accordance with common practice in the healthcare sector, the body <NUM> is made of a transparent or semi-transparent blue colored polymer material, to visually identify the type of connector intended for non-ventilated masks (whereas for ventilated masks a transparent or semi-transparent white or otherwise non-coloured material is used).

The body <NUM> is substantially a tubular body extending along a longitudinal axis A between two open axial ends <NUM>, <NUM> and having a lateral wall <NUM> closed around the axis A and delimiting an internal duct <NUM>.

The connector <NUM> is provided with a plurality of functional connection elements <NUM> projecting from the body <NUM> and comprising in particular:.

With reference also to <FIG>, the inlet <NUM> is positioned at the end <NUM> of the body <NUM> and comprises an axial opening <NUM>, positioned at the end <NUM> along the axis A and communicating with the duct <NUM>; and a tubular connection portion <NUM> of the body <NUM> positioned around the opening <NUM> and shaped so as to be joined to a tube connected to the ventilation system, for example by means of a conical coupling.

The outlet <NUM> is positioned at the end <NUM> of the body <NUM> and comprises an axial opening <NUM>, positioned at the end <NUM> and communicating with the duct <NUM> and substantially aligned along the axis A at the opening <NUM> of the inlet <NUM>; and a tubular connection portion <NUM> of the body <NUM> positioned around the opening <NUM> and shaped so as to be joined to a joint of the mask M by means of a conical coupling. In the illustrated example, the connection portion <NUM> comprises a radially outer sleeve 24a and a radially inner sleeve 24b, coaxial around the axis A and radially spaced from one another.

For example, the connection portions <NUM>, <NUM> define respective joint elements for conical couplings, for example, according to ISO <NUM>-<NUM> standard.

For example (but not necessarily), the connection portion <NUM> of the inlet <NUM> defines a standard M22 male joint element according to ISO <NUM>-<NUM> standard (male element <NUM> in diameter). In the connection portion <NUM> of the outlet <NUM>, the radially outer sleeve 24a defines a standard M22 male joint element according to ISO <NUM>-<NUM> standard (male element <NUM> in diameter), and the radially inner sleeve 24b defines a standard F15 female joint element according to ISO <NUM>-<NUM> standard (female element <NUM> in diameter).

With reference also to <FIG>, the oxygen inlet <NUM> and the flow reading outlet <NUM> comprise respective radial openings <NUM> formed through the lateral wall <NUM> of the body <NUM> and communicating with the duct <NUM>; and respective rotating joints <NUM> projecting from the lateral wall <NUM>.

The joints <NUM> are connected in a rotatable manner to respective guide portions <NUM> which protrude integrally from the body <NUM> and are made integrally with the body <NUM>; in particular, the joints <NUM> are rotatable with respect to the respective guide portions <NUM> around respective rotation axes R1, R2 perpendicular to the axis A.

In particular, each of the joints <NUM> is fastened to the respective guide portion <NUM> by means of a bayonet coupling so as to be axially fastened to the guide portion <NUM> and rotatable with respect thereto around the respective rotation axis R1, R2 and to be detachable from the guide portion <NUM> to allow removal of the joint <NUM> from the body <NUM>.

Each guide portion <NUM> comprises an inner collar <NUM> protruding from the lateral wall <NUM> around the opening <NUM>; and an outer collar <NUM> radially surrounding the collar <NUM> on the outside. The collars <NUM>, <NUM> are concentric around the axis R1 or the axis R2 and delimit a groove <NUM> between them. The collar <NUM> has a portion of peripheral rim <NUM> bent radially inwards (i.e., towards the respective axis R1, R2).

Each of the joints <NUM> is substantially L-shaped and comprises a coupling portion <NUM>, partially housed inside the collar <NUM> of the respective guide portion <NUM>; a nozzle <NUM> connected to the coupling portion <NUM> and folded by <NUM>° with respect thereto; and a radially outer annular portion <NUM>, externally surrounding the coupling portion <NUM> and engaging the annular groove <NUM> of the respective guide portion <NUM>.

The annular portion <NUM> has radial through slots <NUM> which communicate with an annular space defined between the coupling portion <NUM> and the annular portion <NUM> and which have the aim of facilitating cleaning and sterilisation.

The annular portion <NUM> is fastened to the collar <NUM> by means of an annular end edge <NUM> which engages the groove <NUM>; the edge <NUM> axially fastens to the edge portion <NUM> of the collar <NUM> and has a circumferential break <NUM> to allow insertion into the groove <NUM>.

In this manner, the joint <NUM> is detachable from the body <NUM> for operations of cleaning, sterilisation, etc..

The guide portions <NUM> are different from one another and the respective joints <NUM> are consequently different from one another and shaped to engage only the respective guide portion <NUM>, thus avoiding assembly errors.

The oxygen inlet <NUM> and the flow reading outlet <NUM> are provided with respective plugs <NUM>, preferably consisting of respective monolithic pieces in elastomeric material, for example TPE (thermoplastic elastomer).

Each of the plugs <NUM> comprises a cap <NUM>, shaped so as to be fitted over an end portion of a nozzle <NUM> of the respective joint <NUM> to close the nozzle <NUM> in an airtight manner; and a joining band <NUM> projecting from a side of the cap <NUM> and having an end slit <NUM> fastened to the respective joint <NUM> so as to hold the plug <NUM> on the joint <NUM>.

If the oxygen inlet <NUM> and/or the flow reading outlet <NUM> are not used, the respective nozzles <NUM> can be closed with the plugs <NUM>, preventing infectious agents, dust and other external particles from entering the ventilation circuit and preventing air leaks which may reduce the flowrate required by the patient.

In the illustrated embodiment, the openings <NUM> are substantially side-by-side on the lateral wall <NUM> and therefore the oxygen inlet <NUM> and the flow reading outlet <NUM>, as well as the respective joints <NUM>, are side-by-side on the body <NUM>; the joints <NUM> are rotatable around respective rotation axes R1, R2 parallel to each other.

With reference also to <FIG>, the MDI inlet <NUM> comprises a radial opening <NUM> formed through the lateral wall <NUM> of the body <NUM> and communicating with the duct <NUM> through a nozzle <NUM> protruding into the duct <NUM>; and a connection sleeve <NUM> formed integrally with the body <NUM> (therefore being part of the monolithic body <NUM>) and extending from the lateral wall <NUM> around the opening <NUM> along an axis B.

In particular, the MDI inlet <NUM> is positioned on the lateral wall <NUM> in a position angularly staggered by <NUM>° with respect to the oxygen inlet <NUM> and the flow reading outlet <NUM>; the MDI inlet <NUM> extends along the B axis which is substantially perpendicular to the A axis and the axes R1, R2.

The MDI inlet <NUM> is configured to receive and engage a metered-dose inhaler (MDI) device D, for example in the form of a canister (shown schematically in <FIG>).

Preferably, the MDI inlet <NUM> is provided with a flexible fastening ring <NUM> in elastomeric material, fitted on an end edge of the sleeve <NUM> and having a flexible radially inner annular lip <NUM>, which makes the MDI inlet <NUM> adaptable to different diameters of the metered-dose inhaler devices (typically in canister form) and prevents the entry of external agents by adhering to the lateral wall of the canister. The lip <NUM> cooperates, in use, with an outer lateral surface of the metered-dose inhaler device D housed in the sleeve <NUM>.

The MDI inlet <NUM> is also provided with a plug <NUM> to close the MDI inlet <NUM>.

The plug <NUM> is preferably made integrally with the fastening ring <NUM> to form a monolithic piece in elastomeric material, for example TPE (thermoplastic elastomer).

The plug <NUM> is connected to the fastening ring <NUM> by a flexible tongue <NUM> and is shaped so as to engage with a peripheral rim <NUM> of the fastening ring <NUM> to close the fastening ring <NUM> and therefore the sleeve <NUM>.

Advantageously, the plug <NUM> also comprises a flexible strap <NUM> extending laterally from the fastening ring <NUM> and is provided with an end slit <NUM> to be engaged with a pin <NUM> projecting from the lateral wall <NUM> of the body <NUM>, so as to retain the assembly formed by the fastening ring <NUM> and the plug <NUM> on the body <NUM>.

The expiratory outlet <NUM> is used to expel from the body <NUM> a flow of air exhaled by the patient (flow of carbon dioxide) and is connectable to a filter F (schematically illustrated in <FIG>), for example a HEPA filter.

In particular, the expiratory outlet <NUM> comprises a set of radial holes <NUM> formed through the lateral wall <NUM> of the body <NUM> and communicating with the duct <NUM>; and a connection sleeve <NUM>, formed integrally with the body <NUM> (therefore being part of the monolithic body <NUM>) and extending from the lateral wall <NUM> along an axis C so as to surround the set of holes <NUM>.

The sleeve <NUM> is shaped so as to define a joint element, for example, a joint element according to ISO <NUM>-<NUM> standard (in particular, an M15 male element <NUM> in diameter), connectable to an external element, for example a HEPA filter.

In the preferred embodiment illustrated, the expiratory outlet <NUM> is positioned on the lateral wall <NUM> in a position angularly staggered by <NUM>° with respect to the MDI inlet <NUM> and opposite to the oxygen inlet <NUM> and the flow reading outlet <NUM>; the expiratory outlet <NUM> extends along an axis C which is substantially perpendicular to the axis A and to the axis B and parallel to the axes R1, R2.

The oxygen inlet <NUM>, the flow reading outlet <NUM>, the MDI inlet <NUM> and the expiratory outlet <NUM> are arranged on three sides of the body <NUM>, leaving a fourth side devoid of protrusions, i.e. where no functional elements <NUM> are positioned which protrude from that side of the body <NUM> (meaning as sides of the body <NUM> respective lateral portions of the body <NUM> generically facing respective planes parallel to the axis A and orthogonal to each other).

The body <NUM> therefore has a side devoid of protrusions (i.e. protruding functional elements <NUM>), which can be placed on or beside the patient's body without causing discomfort.

Advantageously, one or more arrows <NUM> (<FIG>) are provided on the body <NUM> indicating the direction of the ventilation flow towards the patient, to facilitate the use of the connector <NUM> by providing the healthcare professionals with an immediate indication of the correct mounting direction of the connector <NUM> with respect to the patient's face mask.

For example, the body <NUM> has a pair of arrows <NUM> arranged on opposite sides of the body <NUM>, preferably raised or engraved on an outer lateral surface of the body <NUM>.

A version of the connector of the invention specifically intended for use with ventilated masks is illustrated in <FIG>, in which details similar or the same as those already described are indicated by the same numbers.

Also in this embodiment, the connector <NUM> comprises a base body <NUM>, preferably consisting of a monolithic piece of polymeric material, for example polycarbonate. Preferably, in accordance with common practice in the healthcare sector, the body <NUM> is made of transparent or semi-transparent non-coloured (substantially white) polymer material, to visually identify the type of connector intended for ventilated masks.

With respect to what has been described above, the connector <NUM> differs in that: it is devoid of the expiratory outlet <NUM> (the body <NUM> therefore has no further lateral holes for expelling air/CO2); and the outlet <NUM> for connection to the mask has a connection portion <NUM> formed by a single sleeve 24c instead of a pair of coaxial sleeves.

For example, but not necessarily, the sleeve 24c defines a standard F22 female connecting element according to ISO <NUM>-<NUM> standard (whereas in the connector for non-ventilated masks, the connection portion <NUM> comprises a radially outer sleeve 24a defining a standard M22 male connecting element, and a radially inner sleeve 24b defining a standard F15 female connecting element).

As already described above, therefore, also in this embodiment, the connector <NUM> is provided with:.

Claim 1:
A multifunction connector (<NUM>) for non-invasive ventilation face masks, configured for connecting a non-invasive ventilation face mask to a ventilation system; comprising a substantially tubular base body (<NUM>) extending along a longitudinal axis (A) between two opposite open axial ends (<NUM>, <NUM>) and having a lateral wall (<NUM>) closed around the axis (A) and delimiting an internal duct (<NUM>); the connector (<NUM>) being provided with a plurality of functional connection elements (<NUM>) projecting from the body (<NUM>) and comprising:
- an inlet (<NUM>) connectable to a ventilation system and an outlet (<NUM>) connectable to a ventilation mask, positioned at respective opposite axial ends (<NUM>, <NUM>) of the body (<NUM>) and comprising respective tubular connection portions (<NUM>, <NUM>) of the body (<NUM>); the connection portion (<NUM>) of the outlet (<NUM>) being shaped so as to be joined to a joint of the ventilation mask by means of a conical coupling;
- an oxygen inlet (<NUM>) connectable to an oxygen supply pipe;
- a flow reading outlet (<NUM>) connectable to a flow measuring device;
- an MDI inlet (<NUM>) configured to receive and engage a metered-dose inhaler device.