The present invention concerns a dispenser of liquids for medical uses. In particular, the present invention concerns a liquid dispenser comprising a membrane body provided with at least one nozzle in apical position. In further detail, the present invention concerns a gravity feed liquid dispenser provided with at least two nozzles designed to effectively spray human or animal body cavities.
The sector of dispensers of solutions, including medical solutions, comprises dispensers that can be used for washing the inside of human and animal body cavities with said solutions, including the nasal cavities, the oral cavity, the vaginal cavity and the outer ear canal, without minimizing the multiple uses of said devices.
A large part of said dispensers have been conceived and designed for washing the nasal cavities. The nasal cavities form the uppermost part of the respiratory tract and are separated by the nasal septum, which is an osteo-cartilaginous wall coated by mucosa. Each cavity is split into areas having different anatomical shapes according to their functions. A brief description of these areas is provided below.
The area of the nasal vestibule is the outermost part of the nose. The nasal vestibule is medially delimited by a rigid component, the nasal septum, and delimited laterally and at the top by an elastic component, the wings of the nose. The structures that compose the nasal vestibule give it the shape of an oval or elliptical funnel, the coronal section area of which tapers from the outside towards the inside. The nasal vestibule has the function of conveying the air inhaled towards the nasal cavity. The valve area: the nasal valve or ostium internum is the transition point between the nasal vestibule and the nasal cavity. The upper part of the valve area is called nasal valve, and consists of the junction between the rigid component, namely the nasal septum, arranged medially, and the elastic component of the wing of the nose, arranged supero-laterally. It is the elastic structure that regulates the direction and flow rate of the air currents, during both inhalation and exhalation. The area of the nasal conchae: each nasal cavity communicates at the front with the nasal vestibule through the nasal valve and at the rear with the nasopharynx through the choanal area; medially it is delimited by the nasal septum and laterally by the lateral wall from which bony convolutions called nasal turbinates, which are covered by a highly vascularized and innervated mucosa. There are generally 3 nasal turbinates in each nasal cavity—lower, middle and upper; they are positioned between the nasal septum and the lateral wall of the nasal cavity and delimit irregular spaces called lower meatus, middle meatus and upper meatus respectively. In the upper and middle part of the nasal cavity, below the cribriform plate, the air space of which is reduced to a width of 1-2 mm, is the olfactory region, located above the middle nasal turbinate, between the nasal septum and the lateral wall. The olfactory region is covered by olfactory epithelium, present only in this region. Each nasal cavity communicates, through small ducts, with the respective paranasal sinuses: the maxillary sinuses, the frontal sinuses and the anterior ethmoid sinuses are connected to the middle meatus; the rear ethmoid sinuses and the sphenoid sinuses open into the upper meatus.
The choanal area is the terminal part of the nasal cavity through which each nasal cavity communicates with the nasopharyngeal area. The nasopharyngeal area is very important since it communicates with the cavity of the middle ear through the Eustachian tube and due to the presence of the adenoid tissue.
The nasal mucosa consists of a pseudo-stratified epithelium in which the majority of the cells are ciliated cells, caliciform cells and basal cells; the epithelium rests on a basal membrane and the latter on the plate in which capillaries, arterio-venous anastomoses, seromucous glands and cavernous sinusoids are present. The cilia are immersed in a “sol” aqueous fluid, produced by the anterior serous glands, by the seromucous glands, by the transudate of the vessels and by the condensed water of the exhaled air; on the surface there is a very thin layer of sticky mucus, a sort of “gel” produced by the caliciform cells and by the seromucous glands. The pH of the nasal mucosa is approximately 5.5-6.5. The cilia move rhythmically at a frequency of 16/sec i.e., 1000/min, determining the movement of the mucous surface layer towards the oropharynx which, in normal conditions, takes place in approximately 12 min (the transport speed is extremely variable from 3 to 25 mm/min); in children the mucous is carried towards the adenoids, increasing contact with the immune system. The mucociliary system serves to humidify, warm and cleanse the inhaled air. The body temperature is ideal for the ciliary movement. The temperature influences the mucociliary system: between 32° C. and 40° C. the ciliary movement reaches maximum functionality and remains constant. The mucociliary system constitutes a natural barrier which has the function of protecting against pathogens and cleansing the inhaled substances.
In normal conditions the nasal cavities perform the function of conditioning the inhaled air, warming it, humidifying it and cleansing it, and the exhaled air, reabsorbing heat and humidity. The turbinates enable these functions by giving the respiratory air a turbulent motion so as to increase the surface inside the nasal cavity in contact with the air.
On the other hand, washing of the nasal cavities is performed by causing the washing solution to flow inside one of the two nasal cavities, keeping the head tilted forward. The solution will flow out from the other nasal cavity after passing through the nasopharynx, having mechanically removed any pathological secretions present. The pressure at which the solution is introduced into the nasal cavity must be limited in order not to damage the mucosa that covers the entire nasal cavity. Throughout the nasal washing the user must keep his/her head tilted forward and breathe through the mouth which must remain open. This prevents even small quantities of the solution getting into the lower airways causing coughing or breathing difficulty which, in the most serious cases, can lead to bronchospasm. From the above description, it is evident that nasal washes are not suitable for very young patients, who tend not to tolerate invasive treatments, especially when the required application times are long. For this reason, in babies and non-collaborative patients it is preferable to administer solutions, including medical solutions, inside the nasal cavities in the form of spray, aerosol or micronized douche. In order for these applications to be effective, the washing liquid, in its path inside the nasal cavity, must be able to spray all the anatomical structures it encounters on its way passing through the nasopharynx and discharging the used washing liquid through the other nasal cavity. It is useful to specify that the pressure value at which the washing liquid is supplied must be sufficient to remove any pathological secretions inside the nasal cavities while not damaging the anatomical structures that compose the mucosa covering the entire nasal cavity, so as not to negatively interfere with the protective action of the mucociliary system.
Of the known devices, the most effective ones are those that implement the teachings contained in the European Patent EP 0814747 of the applicants, which are considered incorporated in the present description for the sake of practicality, where the delivery pressure of the liquid is determined exclusively by gravity. With particular reference to said patent EP '747, a given quantity of the liquid used to perform the nasal washing, or washing of any other body cavity, is contained in a container, a bag or a tank, having given capacity. Said container is connected by a flexible tube to a dispenser, which is shaped to be inserted alternatively inside the two nostrils; the container must be kept above the reclined head of the user throughout the washing operation. Therefore, the pressure of the liquid during the washing is always proportional to the difference in level between the free surface of the liquid in the container and the height of the dispenser inserted in the nostrils. Considering that the length of the tube connecting the container to the dispenser is approximately 60 cm, the washing pressure corresponding to the level difference will be approximately 0.055-0.060 atmospheres, therefore very low and compatible with the mucociliary system.
Again according to the patent EP '747, the dispenser has a dome-shaped body constructed symmetrically with respect to two median planes that cross in a central axis. Of these median planes, one is frontal and the other is sagittal, and to each of them corresponds an axis of symmetry of given extension for the sections transversal to the central axis of said dome-shaped body. Said geometric conformation is compatible with that of the nostrils and, therefore, the dispenser can be pushed into the nasal vestibule and nasal valve to the point where the outer wall of the dome-shaped body adheres univocally and appropriately to the inner walls of said anatomical structures. The dispenser has three channels, the axes of which lie on the median plane to which the major axis of the dome-shaped body corresponds. Each channel ends in a conical-shaped apical portion which opens at the apex of the dome-shaped body with a hole, so that the holes corresponding to the three channels are aligned on the major axis of the dispenser.
The dispenser cited in the patent EP '747 has the drawback that when the quantity of liquid in the tank decreases, the water column that pushes the liquid downwards, and therefore the driving force acting on the liquid, drops. In particular, when the liquid level drops, the three jets coming out of the three holes tend to join, so that said jet is no longer able to spray all the anatomical structures that compose the nasal cavity safeguarding the integrity of the mucociliary system.
The above drawback has pushed the applicants to consider even more advanced embodiments of the dispensers, which guarantee that all the areas inside the nasal cavity are sprayed by the washing liquid even when the level of the liquid contained in the container/bag/tank decreases and, likewise, the pressure of the liquid pertaining to the dispenser, determined by gravity.
The present invention concerns a liquid dispenser for medical uses. In particular, the present invention concerns a liquid dispenser comprising a membrane body provided with at least one nozzle in apical position. In further detail, the present invention concerns a gravity feed liquid dispenser provided with at least two nozzles designed to effectively spray human or animal body cavities. Aim of the present invention is to provide a gravity feed dispenser which is without the drawbacks described above and which therefore allows liquid solutions to be dispensed in the form of single jets oriented constantly towards the lower, middle and upper meatus of the nasal cavities even when the pressure of the liquid fed to the dispenser drops due to the progressive emptying of the container containing the liquid, resulting from reduction in the level of the liquid in the container and, therefore, the force of gravity that pushes the liquid through the dispenser nozzles.
According to the present invention a simple inexpensive dispenser is provided which allows liquid solutions to be dispensed in the form of single jets towards the lower, middle and upper meatus of the nasal cavities, where said jets remain separate even when the pressure of the liquid inside the container drops due to the progressive emptying of said container, said emptying causing progressive reduction of the force of gravity acting on the washing liquid.
The problems illustrated above are solved by the present invention according to at least one of the following claims.
According to some embodiments of the present invention a liquid dispenser for medical uses is provided in which a first membrane body is shaped symmetrically with respect to a first frontal median plane and to a second sagittal median plane intersected in a central axis and is delimited at the top by a dome which is axially delimited by a base portion and by a top of given shape; a second body being carried by said first body inside said dome in a position concentric with said axis; said second body having a lower hollow portion concentric with said axis and an upper portion engaged by a first and a second duct ending in said dome, with a first nozzle and a second nozzle respectively; each of said first and second nozzles being arranged between said first frontal median plane and said second sagittal median plane.
According to one embodiment, said first and second nozzles are arranged at the same radial distance from said central axis on planes parallel to said second sagittal median plane.
According to one embodiment said first and second ducts have respective longitudinal axes parallel to said central axis and arranged at substantially identical distances from said central axis.
According to one embodiment said longitudinal axes of said first and second ducts lie on said first plane or are arranged on a plane which is centred on the central axis and is inclined with respect to said first frontal median plane and second sagittal median plane.
According to one embodiment said top is faceted and has a central flat portion transversal to said axis and four faces that extend from said flat portion around said axis; two first faces of said four faces being of equal shape and extension, in addition to being arranged symmetrically with respect to said median plane, and two faces of said four faces being of equal shape and extension, in addition to being arranged symmetrically with respect to said second median plane.
According to one embodiment, each of said first and second nozzles are obtained in each of said second faces at the back of a respective outer edge.
According to one embodiment said upper portion is engaged by a third duct concentric with said central axis; said third duct ending with a third nozzle obtained centrally in said central flat portion.
According to one embodiment, said third duct extends inside said lower portion; said first, second and third ducts extend from said base portion to said top.
According to one embodiment, said upper portion has a cylindrical portion which is concentric with said axis and is contained inside said lower portion to define with the latter an axial cylindrical guide for an end portion of a cylindrical supply duct of said liquid.
According to one embodiment, said cylindrical portion has an outer shell provided with two longitudinal grooves coaxial with the said first and second ducts to define, in use, a supply channel for each said first and second ducts when said end portion of said cylindrical duct couples with said cylindrical guide.
According to one embodiment, said lower portion is hollow and is provided with a central chamber concentric to said axis.
According to one embodiment, said lower portion is hollow and is provided with a common central chamber supplying said first, second and third ducts.
According to some embodiments of the present invention, a gravity feed liquid dispenser for medical uses is provided in which a first membrane body has at the top a dome axially delimited by a base portion and by a top of given shape provided with a central axis positioned at the intersection of a first frontal median plane and a second sagittal median plane; a second body being carried internally by said first body; said second body having a lower hollow portion concentric with said central axis and an upper portion engaged by a first duct and by a second duct, both ending in said dome, with a first and a second nozzle respectively; said first and second ducts having respective terminal sections which end in said first and second nozzles with outlet direction which, moving away from said first plane, is distant point by point from said second plane by a length greater than or equal to the distance of the corresponding said first and second nozzles from said second plane.
According to one embodiment, said first and second nozzles are arranged at the same radial distance from said central axis.
According to one embodiment, each said first and second duct has in sequence a first cylindrical portion, a trapezoidal narrowing and a substantially cylindrical terminal section inclined with respect to said first plane.
According to one embodiment, each said first and second duct has an intermediate section arranged between said narrowing and said terminal section.
According to one embodiment, each said terminal section is parallel to said second plane.
According to one embodiment, each said terminal section is inclined with respect to said second plane.
According to one embodiment, said top is faceted and has a central flat portion transversal to said axis and four faces that extend from said flat portion around said axis; two first faces of said four faces having the same shape and extension, in addition to being arranged symmetrically with respect to said median plane, and two faces of said four faces having equal shape and extension, in addition to being arranged symmetrically with respect to said second median plane.
According to one embodiment, each of said first and second nozzles are obtained in each of said second faces at the back of a respective outer edge.
According to one embodiment, said upper portion is engaged by a third duct concentric with said central axis; said third duct ending with a third nozzle obtained in said central flat portion.
According to one embodiment, said third duct extends inside said lower portion; said first, second and third ducts extend from said base portion to said top.
According to one embodiment, said upper portion has a cylindrical portion concentric with said axis and contained inside said lower portion to define with the latter an axial cylindrical guide for an end portion of a cylindrical supply duct of said liquid.
According to one embodiment, said cylindrical portion has an outer shell provided with two longitudinal grooves coaxial with said first and second ducts to define, in use, a supply channel for each said first and second ducts when said end portion of said cylindrical duct couples with said cylindrical guide.
According to one embodiment, said lower portion is hollow and is provided with a central chamber concentric with said axis.
According to one embodiment, said lower portion is hollow and is provided with a common central chamber for supplying said first, second and third ducts.
According to one embodiment, a dispensing set is provided comprising a bag containing medical liquid and provided with a delivery outlet for said liquid; a flexible duct being connected to said delivery outlet in a fluid-tight manner; characterized in that said flexible duct has one end connected to a dispenser as described above.
The invention will be better described with reference to some non-limiting embodiments in the attached figures, in which:
bis is a view from below of
ter is a view on an enlarged scale of a detail of
bis is a sectional view of
In
The dispenser 1 comprises a first membrane body 10 shaped symmetrically with respect to a first frontal median plane M and a second sagittal median plane N which identify in plan four quadrants I, II, III, IV, in a similar manner to the Cartesian plane of analytical geometry. The indications of these quadrants are shown in boxes in
To each of the lines of the median planes M and N corresponds an axis of symmetry for the sections transversal to the central axis of the same first body 10, so that overall the dispenser 1 has a geometric conformation compatible with that of the nostrils, therefore suitable to be easily inserted in both and contained by them in a fluid-tight manner. Without conditioning the scope of the present invention, the first membrane body 10 can be made of pressure-deformable plastic material, for example, but not limited to, PVC, silicone or any other material having equivalent mechanical characteristics, or can be made of rigid plastic material, for example, but not limited to, ABS.
With particular reference to
The crown 100 is provided with a pair of projections 102 symmetrically opposed with respect to the first frontal median plane M and oriented substantially parallel to the second sagittal median plane N. The presence of these projections 12 is optional for implementation of the dispenser 1 according to the following description.
The dome 12 is axially delimited by a base portion 12′, in turn delimited by the crown 100, and by a substantially faceted convex apical portion/top 12″ which has a central flat portion 120 transversal to the axis A and four faces that extend from the flat portion 120 around the axis A transversally to the first frontal and second sagittal median planes M and N. Of these four faces, two first faces 122 are opposed, having the same shape and extension, in addition to being arranged symmetrically with respect to the median plane M; two second faces 124 are opposed, having the same shape and extension, in addition to being arranged symmetrically with respect to the second median plane N. With particular reference to
The second body 20 has a hollow lower portion 22 which is also concentric with the axis A and an upper portion 28 connected to the dome 12. With particular reference to
The lower portion 22 and upper portion 28 are engaged by a first duct 280 and by a second duct 280′ terminating in the same dome 12 with a first nozzle 2800 and a second nozzle 2800′ respectively where the first nozzle 2800 and the second nozzle 2800′ are respectively arranged between the first frontal median plane M and the second sagittal median plane N at the same radial distance from the central axis A and on planes parallel to the second sagittal median plane N, therefore in a similar manner to the Cartesian plane in the II and IV quadrants in
Furthermore, the first and the second duct 280/280′ have respective longitudinal axes A280/A280′ which are parallel to the central axis A in addition to being arranged at substantially identical distances from said central axis A; they lie on the plane M throughout the part contained in the lower portion 22 and the first part of the upper portion 28, while the end parts of the first and second ducts 280/280′ are inclined with respect to the first frontal median plane M but lie on planes parallel to the second sagittal median plane N, opening into the respective first and second nozzles 2800/2800′ (
Further to the above description, the first and second ducts 280/280′ have respective terminal sections 2822/2822′ that terminate in the first and second nozzles 2800/2800′ with outlet direction (shown by a dash-dot line terminating in an arrow in
Again further to the above description, considering that the two terminal sections 2822 and 2822′ exit from the dome 12 with opposite directions, and that each corresponding jet is emitted by gravity from the nozzles 2800 and 2800′, each jet moves away from the first frontal median plane M/central axis A shaped in a substantially cylindrical manner and, in any case, determined by the cross section of the terminal section 2822/2822′ and by the shape of the nozzle 2800/2800′, while keeping a distance from the second sagittal median plane N, and in particular parallel to the latter, also when the pressure drops due to the progressive decrease in the liquid column contained in the bag S, therefore independently of the current value of the gravity acting on the liquid in the bag S.
Each of the first and second nozzles 2800/2800′ is obtained in one of the second faces 124 at the back of a respective outer edge, so that they are inclined with respect to the first frontal median plane M, from which they move away towards the top 12″. The terminal sections 2822 and 2822′ of the first duct 280 and second duct 280′ are inclined with respect to the first frontal median plane M but lie on planes parallel to the second sagittal median plane N, so that the jets delivered by the first and second nozzles 2800/2800′ remain parallel to the second sagittal median plane N and are inclined with respect to the first frontal median plane M, from which said jets move away (
Again with reference to
The cylindrical portion 27 has an outer shell 271 provided with two longitudinal grooves 272 coaxial with the first and second ducts 280/280′ to define, in use, with the cylindrical body CC installed (an outline of which is visible only in
The use of the dispenser 1 can be easily understood from the above description and does not require further explanation. However, it may be useful to specify that the first body 10 is shaped to easily treat the nasal cavities; in fact, the dome 12 is shaped to be inserted at least partially inside a nostril to be treated; in this way the external wall of the dome 12 adheres to the internal walls of the nostril, widening them so that the first and the second nozzles 2800 and 2800′ (of the first and second ducts 280 and 280′) and the third nozzle 2800″ are positioned at the inlet of the nasal cavity. With the dome 12 of the dispenser 1 held firm in the position described above, said dispenser 1 can deliver medical liquid in the form of substantially cylindrical jets with filiform dimension. The experimental tests carried out showed that the lateral jets and the central jet remain constantly separate throughout the washing phase and that this situation remains unchanged even when the pressure of the washing liquid drops, considering that the pressure of the liquid is produced exclusively by the force of gravity and therefore by the level difference between the free surface of the liquid contained in the tank and the nozzles described above of the dispenser 1. Without limiting the scope of the present invention, the medical liquid contains physiological solution.
It may also be useful to specify that, further to the above description, considering that a connection portion of the first and second ducts 280 and 280′ is contained in the lower portion 22 of the second body 20 and has reduced section when the guide 270 is engaged by the cylindrical body CC, in use, the liquid delivered to the first and second ducts 280 and 280′ undergoes, in use, an expansion upstream of the respective first and second nozzles 2800/2800′ and downstream of the portion of the first and second ducts 280/280′ contained in the lower portion 22 of the second body 20.
Lastly it is clear that variations can be made to the dispenser 1 described and illustrated above without departing from the scope of the present invention.
For example, with reference to
The dispenser 1′ differs from the dispenser 1 described above due to the fact that the lower portion 22 is provided with a cylindrical seat 24 which is concentric to the axis A and is delimited at the top by a cylindrical portion with reduced diameter which is at the base of a tapered portion 26 clearly visible in
It is therefore evident that in said case the jets emitted from the first and second nozzles 2800/2800′ of
With reference to
In particular, in the lower portion 22 and approximately as far as the first half of the upper portion 28, the axes of the first, second and third ducts 280, 280′, 280″ lie arranged on a plane centred on the central axis A but inclined both with respect to the first frontal median plane M and with respect to the second sagittal median plane N, as can be clearly seen in
Furthermore, considering the upper half of the upper portion 28, the first and the second ducts 280/280′ remain parallel to the axis A and have a section with decreasing section for approximately one third of said part of the upper portion 28. Said section with decreasing section is analogous to the narrowing 2820/2820′ of
It should be noted that the terminal sections 2822 and 2822′ of the first and second ducts 280/280′ of this embodiment of the present invention proceed towards the top 12″ according to divergent outlet directions, visible in
In particular, it is useful to specify that terminal sections 2822 and 2822′ can be constructed either curved or rectilinear without modifying the scope of the present invention or producing a different result in terms of divergence of the jets emitted from the respective first and second nozzles 2800 and 2800′.
With reference to
Unlike the version of
With particular reference to
In addition, the first and second ducts 280 and 280′ are identical, obtained inside the upper portion 28 and are rotated with respect to each other by 180° so that they are polarly symmetrical with respect to the central axis A. In particular, as can be seen in
Further to the above description, it can be understood that a dispenser shaped like any one of the dispensers 1, 1′, 1″, 1′″ 1″″, therefore provided with two lateral nozzles 2800 and 2800′ arranged on opposite sides of a median plane and, possibly, of a central nozzle 2800′″ inserted in a set comprising a bag S containing medical liquid and a flexible tube CF that connects an outlet BE of the bag S to the dispenser 1 by the sole action of the gravitational force acting on the liquid column, allows, in use, the delivery of two or three jets which remain separate as they move away from the top 12″ of said dispenser 1, 1′, 1″, 1′″ 1″″, allowing integral spraying of the mucosa that covers the entire nasal cavity even when the level of the free surface of the liquid contained in the tank S, and therefore the pressure acting on the washing liquid, drops.
Number | Date | Country | Kind |
---|---|---|---|
102020000000160 | Jan 2020 | IT | national |
202020000001048 | Mar 2020 | IT | national |
This patent application is a U.S. National Phase Application under 35 U.S.C. § 371 of International Patent Application No. PCT/IB2021/050094, filed on Jan. 7, 2021, which claims priority from Italian patent application no. 102020000000160, filed on Jan. 8, 2020 and Italian patent application no. 2020200000001048, filed on Mar. 4, 2020, the entire disclosure of which is incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/IB2021/050094 | 1/7/2021 | WO |