Humidification device for medical gases

Abstract

Humidification device (1) for a medical gas, in particular a bubble humidifier for oxygen therapy, comprising: a container (2) for receiving a liquid, which has an opening (5) closed by a cap (8) and a bubbler (3) extending inside, and comprises an airflow supply path (p) extending through the cap (8) between an inlet system (11) for a medical gas and the bubbler (3), characterized in that the cap (8) comprises a first section (8a) connected to the opening (5) and a second rotating section (8b) coupled to the first section (8a), which can rotate about an axis in a manner of free-running motion and has a receiving seat (10) for an inlet system (11) for a medical gas, which is suitable for connection with a flow meter,wherein the inlet system (11) for a medical gas is inserted into the receiving seat (10) of the second section (8b) of the cap (8) by means of a snap-lock connection device.

Description

Field of the invention

[0001] The present invention relates generally to a humidification device for humidifying a medical gas, and more particularly to a bubble humidifier for oxygen therapy.

[0002] The invention also relates to a kit comprising the humidification device and separately at least one inlet system for connection to the feed gas stream, typically via a flow meter. State of the art

[0003] Gas humidification devices are systems that allow the relative humidity of a gas to be increased, both in a hospital environment and at home, such as oxygen. The latter, in fact, is usually available at a humidity level too low to be directly used in long-term continuous oxygen therapy treatments and tolerated by a patient. In this regard, it should be noted that if the inhaled gas is not properly humidified, it can damage the mucous membranes of the respiratory tract and cause severe discomfort to the patient. Therefore, during oxygen therapy treatments, it is necessary to ensure adequate humidification of the inhaled gas, especially for patients who require high oxygen flow or who complain of particularly dry respiratory tracts.On the other hand, excessive humidification can also lead to patient injuries such as burns, mucosal diseases, elevated body temperature, and the like. For these reasons, humidification devices have been proposed, for example, the so-called bubbling type, which can modify the relative humidity of the medical gas, especially oxygen, through enrichment, thus making it inhalable for the patient. A bubbling humidification device for oxygen therapy typically comprises a container made of polycarbonate, for example, which has an inlet opening for connection to the dosing system for a low-pressure medical gas via a flow meter and an outlet for administering the humidified oxygen to the patient (through nasal cannulas, face masks, and the like).Inside the container is a certain amount of liquid, usually sterile demineralized water, through which the medical gas is bubbled at the inlet via an internal bubbler (or diffuser). The gas leaving the device therefore has a higher and improved relative humidity than the incoming gas, making it inhalable for the patient.

[0004] Although prior art humidification devices perform their task in a substantially satisfactory manner by producing the humidified gas in accordance with the requirements necessary to protect and improve the patient's health, they have some drawbacks that have not yet been resolved.

[0005] As mentioned above, a humidifier for effervescing oxygen therapy is connected to the medical gas distribution system, typically via a flowmeter. The latter is a device that allows the precise quantification of the oxygen flow to be delivered to the patient. The main disadvantage, therefore, lies in the fact that the connection between the humidifier and the flowmeter is made through a humidifier inlet system (e.g., a ring nut and / or a threaded system), which must have specific dimensions compatible with the corresponding flowmeter outlet system, already present as a fixed element in the gas supply system.In other words, the inlet system of the humidifier and the outlet system of the flowmeter must have dimensions and measurements that allow the two elements to be connected in a stable and effective manner for therapeutic treatment. Consequently, the choice of the type of humidifier depends on the type of flowmeter already present and commonly used, for example, in the hospital structure hosting the patient. In this regard, there is currently no common standard that allows the attachment of humidifiers to be adapted to any type or model of flowmeter.Manufacturers of humidification devices must therefore prepare and make available a range of models that differ primarily in the type and size of the inlet system, which entails a significant increase in production and storage costs.

[0006] Another disadvantage of prior art medical gas humidifiers is that the interconnection with the flowmeter blocks the humidifier's free rotation along its own axis. This restriction of movement is disadvantageous, particularly in cases where the orientation of the gas exiting the humidifier needs to be adjusted, for example, to better calibrate the direction of the medical gas flow to the patient during therapeutic treatment, either for convenience or for spatial reasons.

[0007] US 4,011,288 A describes a humidification device for a medical gas comprising an upper section for connection to the gas stream with limited freedom of movement, which cannot be rotated along its own axis under operating conditions. The described device is characterized in that the sterility conditions of the solution contained therein are maintained for as long as possible, thus avoiding possible contamination with the environment.

[0008] US 3,724,454 A discloses a humidification device and a portable atomizer that can be used even in the absence of a power source. Such a device has a rigid closure and a non-rotatable system equipped with a fixed attachment specific to the selected gas line, thus eliminating the possibility of adapting the device to any gas line.

[0009] The technical problem according to the present invention is therefore to develop a humidification device for a medical gas, in particular of the bubbling type for oxygen therapy, which has structural and functional features capable of eliminating the above-mentioned disadvantages and which is also easy to use for health professionals, with low production costs. Summary of the invention

[0010] The above-mentioned technical problems are solved by a humidification device for a medical gas, in particular a bubble humidifier for oxygen therapy, comprising: a container for holding a liquid, which has an opening closed by a cap and a bubbler extending inside, and an air supply path extending through the cap between an inlet system for a medical gas and the bubbler, and which is characterized in that the cap comprises a first portion connected to the opening and a second circumferential portion coupled to the first portion, which can rotate in an idle manner about an axis and has a receiving seat for a medical gas inlet system suitable for connection to a flow meter,wherein the inlet system for a medical gas is inserted into the receiving seat of the second portion of the cap by a snap-fit ​​connection device.

[0011] Further features and advantages of the humidifying device according to the invention will become clear from the following description of some embodiments, given as illustrative and non-limiting examples, with reference to the accompanying drawings. Short description of the drawings Fig. 1a, Fig. 1b, Fig. 1c show three views: a front view, a side view and a top view, respectively, of a medical gas humidification device according to the present invention; Fig. Figure 2 is a perspective view with portions detached of the humidification device of Fig. 1; Fig. Figure 3 is a perspective view of a detail of the humidification device of Fig. 1; Fig. Figure 4 is a perspective view of another detail of the humidification device of Fig. 1; Fig. Figure 5 is a perspective view of another detail of the humidification device of Fig. 1. Detailed description

[0012] With reference to the accompanying figures, 1 represents a humidification device according to the present invention, which in the present case practically consists in particular of a bubbling humidification device for oxygen therapy.

[0013] The humidification device 1 comprises a main hollow body 2, which functions as a container for a liquid, with an upper opening 5 closed by a cap 8, which is connected to a bubbler (or diffuser) 3 used to bubble inlet oxygen. The main hollow body 2 can be manufactured by injection blow molding of a polymer material, for example, polycarbonate.

[0014] With reference to the Fig. 1a-c, Fig. 2 and Fig. 4, the main hollow body 2 has a cup shape with a transverse hollow opening 4, which serves as a handle, and an upper opening 5 for connection to the carbonator 3.

[0015] With particular reference to Fig. 2, the bubbler 3 has a section in the form of a cylindrical collar 6 with a blind bottom, formed by two concentric circular units. Extending from the cylindrical collar 6 with a blind bottom is an elongated section in the form of a small hollow tube 7, through which the gas is bubbled toward the interior of the main hollow body 2. The cylindrical collar 6 with a blind bottom has an inner diameter corresponding to that of the upper opening 5 of the main hollow body 2.

[0016] The small hollow tube 7, in turn, has a first (upper) end 7a, which is firmly connected to the cylindrical collar 6, and a second opposite (lower) end 7b, which fits inside the main hollow body 2 of the device 1. The two ends 7a and 7b allow the passage of the inlet gas from the end 7a, with subsequent bubbling of the gas leaving the end 7b. When the bubbler 3 is inserted into the main hollow body 2, the end 7b is placed inside the main hollow body 2 and is therefore in contact with the aqueous liquid contained therein. The end 7b may have a diameter larger than the end 7a, for example, to facilitate the discharge of the gas and thus increase the efficiency of the device. In this regard, and with reference to Fig. 2, the end 7b of the small hollow tube 7 of the bubbler 3 may have a cylindrical shape with holes of increasing diameters.

[0017] To realize the humidification device 1, the bubbler 3 is inserted between the first portion 8a of the cap 8 and the upper opening 5 of the main hollow body 2. When the main hollow body 2 and the cap 8 are connected to each other, the cylindrical collar 6 is connected to the upper opening 5 of the main hollow body 2, while the small hollow tube 7 is completely inserted inside the main hollow body 2. The latter therefore has a depth substantially comparable to or even greater than the length of the small hollow tube 7 and contains a quantity of aqueous liquid consisting entirely of sterile demineralized water, so that the end 7b is at least partially immersed in the same.

[0018] It should be noted that seals (O-rings) 14 are positioned at the interface formed between the upper opening 5 and the cylindrical collar 6 and between the cylindrical collar 6 and the first portion 8a of the cap 8.

[0019] In this regard, it should be noted that the cap 8 consists of a first (lower) portion 8a, and that a second rotatable portion 8b (which is arranged higher and opposite to the portion 8a) is attached thereto and can perform an idle movement.

[0020] The first and second sections 8a and 8b are connected to each other by locking connection devices 9, for example in the form of a collar of two halves.

[0021] With reference to Fig. 2, the second portion 8b may have a substantially cylindrical shape and includes a receiving seat 10 adapted to receive the inlet system 11. In particular, the receiving seat 10 has a shape and size suitable for containing the portion 11b, which is connected by a snap fit to the cap of the inlet system 11, allowing the passage of gas toward the interior of the main hollow body 2 of the humidification device by passing through the bubbler 3.

[0022] A snap-lock device is provided on the surface of the receiving seat 10, which engages with a corresponding mating device provided on the portion 11b communicating with the cap. When the inlet system 11 is snapped into the receiving seat 10 of the second rotatable portion 8b of the cap 8, the locking device and the mating device practically establish a stable connection between the system 11 and the cap 8.

[0023] The first portion 8a of the cap 8 is substantially in the shape of a hollow truncated cone, on whose lateral surface there is a spout 12 for connection to the system for delivering the gas to the patient, such as cannulas or masks, and on whose upper surface there is a system 8c for connection to the second portion 8b by means of the locking connection device 9. The system 8c is in the shape of a hollow cylinder, the upper part of which has a size and shape conforming to the locking connection device 9 for connection to the second portion 8b. As shown in Fig. 3, the portion 8a may comprise anti-slip features 8d, for example along a portion of the outer surface, shaped as irregularities such as grooves or protrusions to facilitate the connection (or separation) movement with the bubbler 3 and with the main hollow body 2.

[0024] As in Fig. As illustrated in Figure 5, the spout 12 has a hollow cylindrical shape that communicates with the inside of the main hollow body 2 through a slit 13 provided on the outer edge of the cylindrical collar 6 of the bubbler 3 and positioned in correspondence with the small hollow tube 7. Due to this, the incoming gas is bubbled through the bubbler 3 into the liquid present inside the main hollow body 2 and then flows out of the spout 12 through the slit 13 via a preferential path. In this way, a path for incoming gas (extended along the bubbler 3) and a gas path at the outlet (through the slit 13 and the spout 12) are created, which are separate and independent. Referring to Fig. 3, the nozzle 12 may have a cylindrical shape with a decreasing diameter, whereby the tightness during the connection, for example with cannulas or small tubes intended to convey the output gas towards the patient, can be better achieved by surface inserts.

[0025] It will be clear to those skilled in the art that the nozzle 12 should be oriented to avoid any constrictions or obstructions caused by the device that delivers the oxygen exiting the humidifier, and in particular by bending the gas delivery tube relative to the patient. It is therefore advantageous to maintain a certain freedom of movement of the humidifier once it has been connected to the flowmeter, so that, unlike prior art humidifiers, it is possible to rotate the device, for example, rotating the nozzle 12 in a manner appropriate and best adapted to the patient's position.

[0026] As for the cap 8, it can be connected to the main hollow body 2 either by a screw locking or, preferably, a locking system, or even more preferably, by a half-turn. In this case, a suitable locking device and a counter-device are provided on the first rotatable portion 8a and the outer surface of the upper opening 5, respectively, as shown in Fig. 5 shown.

[0027] It should be noted that the shape of the cap 8, with two sections 8a and 8b rotatably connected to each other, allows the formation of a rotatable upper section of the humidification device, comprising the locking connection device 9, the second rotatable section of the cap 8b, and the inlet system 11. The upper rotatable section is a structurally independent element, practically capable of freely rotating along its vertical longitudinal axis independently of the remaining section of the humidification device 1 in an idle motion. In this regard, the term "idler," as mentioned herein, indicates a worm screw rotation that can occur in both directions of rotation, either clockwise or counterclockwise. Such movement is even further facilitated by the presence of the hollow opening 4, as described in detail below.The possibility of rotation together with the ease of performing such a movement allows to change the orientation of the humidification device 1 of the present invention, with particular consideration of the direction of the spout 12, even during the oxygen therapy treatment.

[0028] In this regard, it should be noted that the humidification device 1 for a medical gas, in particular a bubble humidifier for oxygen therapy of the present invention, in addition to the advantage resulting from the fact that the cap 8 comprises a first portion 8a and a second portion 8b rotatably attached to the first portion 8a, as mentioned above, is also characterized in that the second portion 8b has a receiving seat 10 of an inlet system 11 of the gas, arranged for connection to a source of low-pressure medical gas via the flow meter.

[0029] With reference to Fig. 3, the inlet system 11 may be in the shape of a "T" in which the horizontal section is disc-shaped and has a circular concentric opening, from which a vertical section extends perpendicularly, having a hollow cylindrical shape. The interior of the hollow cylindrical shape forms a section 11a for connection to the flow meter, while the exterior forms a section 11b for connection to the second section 8b of the cap.

[0030] In the present case, the flowmeter connection section 11a is a female threaded connection system intended for connection to the flowmeter's male threaded connection system. The diameter of section 11a and the frequency and size of the internal threads are such that they allow connection to the male threaded connector at the flowmeter's output, thus connecting the humidification device of the invention 1 to the medical inlet gas flow.

[0031] Instead, the section 11b for connection to the second section 8b of the cap has a diameter and shape that are substantially independent of the diameter of the section 11a for connection to the flow meter. The section 11b has a snap-lock connection device, with a corresponding mating device present in the receiving seat 10. The device and mating device engage with each other when the inlet system 11 is placed in the receiving seat 10, thus creating a stable connection.

[0032] The inlet system 1 is therefore snapped into the second portion 8b of the cap 8 and can be conveniently selected by the operator depending on the male threaded connector at the outlet of the flowmeter already operating in the medical gas line. It is therefore clear that the operator is able to quickly and directly connect the present humidification device 1 to essentially any type of flowmeter by simply selecting the inlet system 11 having a suitable portion 11a for connection to the flowmeter.

[0033] As will be appreciated by those skilled in the art, the possibility of realizing the inlet system 11 by using polymer materials such as polycarbonate and the like further advantageously makes it possible to obtain a connection system with a particularly low weight.

[0034] Once connected to the flowmeter, and consequently to the medical gas distribution line, the humidification device 1 of the present invention can humidify the incoming oxygen gas streams and can then be rotated about its vertical longitudinal axis, for example, to better align the exit direction of the humidified gas or to better visualize other components that may be connected between the device and the flowmeter, such as, for example, pressure gauges or the like.

[0035] In this regard, and with reference to Fig. 4, it should be noted that the main hollow body 2 has a hollow transverse through-hole 4, preferably forming a double handle of the easy-grip type. Such a transverse hollow hole 4 is preferably obtained with two communicating surfaces 4a and 4b and traverses the main hollow body 2 in the transverse direction (that is, substantially perpendicular to a hypothetical vertical longitudinal axis). As a result, the humidification device 1 is easy to handle by the operator, thus allowing improved use and comfort. Such a double handle can in fact have ergonomic shapes and dimensions that allow the use of three or even four fingers of one hand and is therefore particularly useful, especially when needed to move or rotate the humidification device during use.Due to the rotating upper portion of the present invention (as described above) and the transverse hollow opening 4, which can form a double handle for easy gripping, the operator is able to perform virtually any directional movements using, for example, only one hand, even after the connection of the humidifying device 1 to the flow meter has been completed.

[0036] With reference to Fig.2, the transverse hollow opening 4 can be provided with anti-slip features 4c, for example, in different colors and / or materials, primarily intended to further improve the grip of the humidification device 1. The anti-slip features 4c are preferably designed in the form of jaws, i.e., with a shape and dimensions that match the shape and size of the transverse hollow opening. The anti-slip features 4c can have irregularities on their surface, for example, in the form of grooves or elevations, which are typically used to enlarge or improve the contact surface with the operator's fingers and to achieve gripping in an even easier and safer manner. Such anti-slip features 4c, with a shape that is integral with the transverse hollow opening 4, can be connected to one another by means of a snap-lock system, or preferably a bayonet-type system.Therefore, advantageously, such anti-slip devices 4c may be particularly useful when, for example, cleaning, replacement and / or precise treatment thereof is required, or also to distinguish the devices 4c from other portions of the container or similar devices.

[0037] In addition to the anti-slip devices 4c, the main hollow body 2 may also comprise a locking stand 4d, which is useful for increasing the stability and support area of ​​the humidifying device 1 of the invention.

[0038] The present invention also relates to a kit 14 comprising at least one inlet system 11 separate from the other components of the humidification device 1, as described above. In the present case, such a kit 14 may include a plurality of inlet systems 11 with flowmeter connection sections 11a, comprising female threaded systems of various sizes, and is therefore adaptable to the snap-fit ​​section of the male threaded system present on the flowmeter.

[0039] The kit 14 may include one or more intake systems 11 packaged separately or together. Generally, the kit parts 14 may be packaged individually and then stored in a container for storage, or they may be packaged together and stored in the container.

[0040] In any case, the operator can easily use the components included in the kit 14 and realize the humidification device 1 that is most suitable for the flow meter used with the medical device.

[0041] Finally, as is clear from the above description, the humidification device 1 of the invention allows the use of configurations adaptable to different hospitals or home care settings where therapeutic treatment with oxygen therapy is carried out. Thanks to the possibility of using interchangeable inlet systems 11, the present invention can be connected to virtually any type of flow meter available on the market and already positioned in the gas flow installation. Furthermore, thanks to the possibility of rotation, the device of the invention can be used in a more suitable and convenient manner according to the patient's needs (for example, with reference to their position with respect to humidification) or for spatial reasons.

[0042] A person skilled in the art can make numerous modifications and variations to such a humidification device 1 as described above in order to meet specific requirements, all of which, however, are within the scope of the protection of the invention as defined by the following claims.

Claims

[1] Humidification device (1) for a medical gas, in particular a bubble humidifier for oxygen therapy, comprising: a container (2) for holding a liquid, which has an opening (5) closed by a cap (8) and a bubbler (3) extending inside and comprises an air flow supply path (p) extending through the cap (8) between an inlet system (11) for a medical gas and the bubbler (3), characterized byin that the cap (8) comprises a first section (8a) connected to the opening (5) and a second circumferential section (8b) coupled to the first section (8a), which can rotate about an axis in an idle manner and has a receiving seat (10) for an inlet system (11) for a medical gas suitable for connection to a flow meter, wherein the inlet system (11) for a medical gas is inserted into the receiving seat (10) of the second section (8b) of the cap (8) by a snap-fit ​​connection device. [2] Humidifying device (1) according to the preceding claims, wherein the second circumferential portion (8b) is coupled to the first portion (8a) by a locking connection device (9). [3] Humidification device (1) according to the preceding claims, wherein the inlet system (11) for a medical gas, the second portion (8b) of the cap (8) and the locking connection device (9) form a structurally independent element which can rotate about a vertical longitudinal axis. [4] Humidification device (1) according to the preceding claims, wherein the inlet system (11) for a medical gas has a section (11a) forming a connection system provided with a female thread for connection to the flow meter. [5] Humidification device (1) according to the preceding claims, wherein the inlet system (11) for a medical gas has a portion (11b) for connection to the cap (8) forming a snap-fit ​​connection system. [6] Humidifying device (1) according to the preceding claims, wherein the cap (8) is connected to the opening (5) by a screw, snap-lock or half-turn locking system. [7] Humidifying device (1) according to the preceding claims, wherein the container (2) for receiving a liquid has a transverse cavity (4), preferably a transverse double-handle cavity of the through-type. [8] Humidifying device (1) according to the preceding claims, wherein the transverse cavity (4) forming a double-handle transverse cavity of the through-type comprises ergonomic handles (4c) in the form of jaws. [9] Humidification device (1) according to the preceding claims, wherein the ergonomic handles (4c), which have a shape and dimensions which are integral with the transverse hollow opening (4), are mutually connected and locked to one another by means of a bayonet system. [10] Humidifying device (1) according to the preceding claims, wherein the container (2) for holding a liquid is equipped with a locking base (4d). [11] Humidifying device (1) according to claims 8-10, wherein the ergonomic handles (4c) and / or the locking base (4d) have irregularities on their surface, which are particularly designed to improve gripping.

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