Product dispensing head, dispensing device comprising such a dispensing head, and method for positioning such a dispensing device

Abstract

Product dispensing head, dispensing device comprising such a dispensing head, and method for positioning such a dispensing device. The present invention relates to a nasal dispensing head (10) for fluid products, having two contact areas (13, 14) on a patient's face, which together impose a dispensing direction (A11) of the product into one of the patient's nostrils, and a surface (15) configured to receive at least one finger of the user. The two contact areas (13, 14) are positioned between a distal end (12) of the dispensing head, configured to be inserted into the patient's nostril, and the surface (15). A first contact area (13), of the two contact areas (13, 14), is a raised feature configured to fit into the philtrum groove of the patient. Figure for the abstract: 1

Description

Title of the invention: Product dispensing head, dispensing device comprising such a dispensing head, and method for positioning such a dispensing device

[0001] The invention relates to a nasal product dispensing head, a product dispensing device comprising a nasal dispensing head, and a method for positioning a product dispensing device.

[0002] The technical field of the invention is that of the distribution of product into a nostril of a patient, more precisely into the nasal cavity located beyond the nasal valve, particularly into the olfactory zone of the nasal cavity, located in the upper part of the nasal cavity, in which are present the ramifications of the olfactory nerve connected to the brain via the olfactory bulb. Previous art

[0003] The art is known in the state of the art, particularly from document WO2018 / 109409A1, of a nasal dispensing device and a separate positioning element in which the dispensing device is incorporated. The positioning element includes support areas designed to bear against different parts of the face, such as the forehead, the bridge of the nose, the upper lip, or the patient's ears, in order to adjust the correct position of the positioning element relative to the patient's head. Furthermore, the positioning element includes an area designed to receive the user's fingers to activate the dispensing of the product via the nasal dispensing device. Such a positioning element requires support areas relatively far from the nose, particularly the forehead or the ears, raising issues of ergonomics, storage, and transport.Furthermore, the use of such a positioning device, at the time of activation, requires that the fingers be in contact with the nostrils, between the nostrils and the positioning device, leading to the risk of altering the position of the dispensing device and thus losing the desired orientation of the dispensing device relative to the patient's head.

[0004] Prior art is also known, through US patent 11,266,799 B2, of a nasal dispensing device comprising a cone with a flat side, facilitating placement of the cone against the septum of either of the patient's nostrils, and a depth stop, allowing a predetermined insertion depth of the cone into the nostril. Such a device does not allow for adequate and secure positioning of the device because, even when correctly positioned against the septum, the cone allows orientations of the dispensing device in which the product will not be able to reach the olfactory area. Presentation of the invention

[0005] The invention aims to provide a compact nasal dispensing head allowing optimal positioning of the nasal dispensing head to reach a targeted area in the nasal cavity, for example the olfactory area.

[0006] To this end, the invention relates to a nasal dispensing head for a fluid product, equipped with two contact areas on a patient's face, which together impose a direction of product distribution into one of the patient's nostrils, and a surface configured to receive at least one finger of the user. The two contact areas are positioned between a distal end of the dispensing head, configured to be inserted into the patient's nostril, and the surface. According to the invention, a first contact area is a raised feature configured to fit into the philtrum groove of the patient.

[0007] The philtrum is the median and vertical groove on the cutaneous surface of the upper lip of an individual.

[0008] Thus, when the user places the two support areas on the patient's face, with the first support area in the philtrum groove, the distribution direction is optimal to reach the targeted area.

[0009] Furthermore, the position of the two support zones, between the distal end and the surface configured to receive a user's finger, allows the user to place at least one of their fingers on this surface without disturbing the position of the support zones on the patient's face. This reduces the risk of losing the optimal orientation of the dispensing device at the moment of activation by the user's finger(s).

[0010] The user may be the patient or another person, for example a healthcare professional.

[0011] A patient is defined as the individual on whom the support areas of the distribution head are pressed and one of whose nostrils receives the distal end of the distribution head.

[0012] The user is defined as the individual who takes control of the distribution device equipped with the distribution head, positions the latter and activates the device to trigger the distribution.

[0013] In most cases, the user is also the patient.

[0014] It may happen that the user is a different person from the patient, for example in the case where the patient requires help.

[0015] The term "distal" refers to that which is on the side of the distribution orifice and the term "proximal" refers to the opposite side. Advantageously, your distribution head is configured to be connected to a device equipped with at least one reservoir containing one or more doses of product to be dispensed, preferably a pharmaceutical product, to form a dispensing device. Preferably, the dispensing head includes a sealed connection element configured to cooperate hermetically with the device.

[0016] Alternatively, the sealed connection element can be carried by the device or partly by the distribution head and partly by the device.

[0017] The tight connection can be achieved by clamping a cylinder in a bore, by the presence of a circumferential sealing ring, by adding an O-ring in a circumferential groove of a cylinder or bore, by clamping two flat surfaces, by adding a flat gasket between two flat surfaces, or a combination of these solutions.

[0018] The product to be distributed can be a liquid, such as a solution or a suspension, or a solid, for example in powder form.

[0019] The device, to which the dispensing head is connected, may include, for example, a pump, a valve, a piston sliding in the tank or a system delivering a gas and the product to be dispensed, or any other liquid or powder dispensing mechanism known to those skilled in the art.

[0020] A pump is understood to be a device capable of drawing in and expelling a fluid.

[0021] A valve is understood to be a device capable of selectively retaining and releasing a pressurized fluid. The valve can be metering if, during the action releasing the fluid, the quantity of fluid released is independent of the duration of valve actuation, or continuous if the quantity of fluid released depends on the duration of valve actuation.

[0022] The product can be dispensed via the dispensing head in the form of a spray, a jet, or an aerosol. A product presented in this form more easily reaches the targeted area, for example, the olfactory area.

[0023] The term “aerosol” refers to the dispersion of particles of a liquid, a solution or a solid in a gas.

[0024] The term "spray" refers to a type of aerosol in which the dispersion is approximately conical. Typically, the cone of a spray has an opening angle between 0 degrees and 120 degrees.

[0025] The expression "between... and..." should be understood as including the bounds of the interval thus defined.

[0026] The term "jet" refers to a spray in which the dispersion cone has a narrow opening angle, preferably between 0 degrees and 15 degrees. The particles, in this case, may be fused or joined together in a continuous line of material.

[0027] Advantageously, the product is distributed in the form of an approximately conical jet, the dispersion cone of which has an opening angle between 0 degrees and 15 degrees, preferably between 0 and 10 degrees, more preferably between 0 and 5 degrees. This allows a larger quantity of the product to reach the olfactory area.

[0028] Preferably, the product is distributed in a single direction.

[0029] Preferably, the dispensing head comprises at least one dispensing orifice positioned near the distal end of the dispensing head and through which the product is dispensed toward the target area. Preferably, the dispensing orifice is positioned on the distal end of the dispensing head, preferably on a distal surface of the distal end, said distal surface being able to include at least one recess. Advantageously, the dispensing orifice is positioned in the recess of the distal surface of the dispensing head.

[0030] Advantageously, the dispensing head comprises a single dispensing orifice defining an orifice axis. Preferably, the orifice is cylindrical or frustoconical of revolution about the orifice axis. Advantageously, the dispensing head has a distal portion of generally frustoconical shape defining an axis of the distal portion, and a proximal portion. Preferably, the orifice is positioned on the axis of the distal portion of the dispensing head. Such a distal portion of generally frustoconical shape facilitates the insertion of the distal tip into the patient's nostril.

[0031] Preferably, the proximal portion is generally cylindrical in shape.

[0032] Advantageously, the proximal portion of the distribution head is connected to the device.

[0033] Advantageously, the proximal portion is hollow and configured to receive the device, preferably configured to surround a part of the reservoir.

[0034] Thus, the whole thing is more compact and easier to handle for the user.

[0035] Advantageously, the surface configured to receive at least one finger of The user is supported by the proximal portion. This support can be provided by at least one radial protrusion, preferably two radial protrusions distributed on either side of the proximal portion of the dispensing head. The surface may have raised features, for example straight ribs, configured to improve the user's finger's grip on said surface.

[0036] Advantageously, the relief of the patient's first support area is a rib. A rib is understood to be a long, slender projection or a ridge. A relief in the form of a rib has a shape complementary to that of the patient's philtrum sulcus, facilitating the positioning of the relief within the latter.

[0037] Preferably, the rib extends in a direction that allows for optimal orientation of the distribution direction relative to the user's nostril. This increases the chances of reaching the targeted area, for example the area olfactory.

[0038] Preferably, the rib has a length between 10 millimeters and 30 millimeters, preferably between 15 millimeters and 25 millimeters.

[0039] Advantageously, when the distribution orifice is positioned on the axis of the distal portion of the distribution head, the distance between this axis and the distal end of the rib, measured in the plane perpendicular to the axis, is between 8 millimeters and 16 millimeters.

[0040] In a preferred mode, the second support area is a substantially concave surface configured to bear against the upper lip, next to the patient's philtrum. By "substantially concave," it is understood that the concave surface may have irregularities.

[0041] The second, substantially concave support area allows it to better conform to the shape of the upper lip and to position the distribution head in relation to the patient's nostril.

[0042] A "substantially concave surface" is understood to mean a surface curved inwards. This concave surface may be a cylindrical surface, a spherical surface, or several adjacent flat or curved surfaces inscribed within a substantially concave surface.

[0043] Alternatively, the second bearing area is a rib. In this case, preferably, the rib forming the second bearing area is a rib symmetrical to the rib forming the first bearing area.

[0044] In a preferred mode, the second support zone rests essentially on the so-called white lip part of the upper lip.

[0045] In a preferred mode, the first support zone and the second support zone are adjacent. The dispensing head is thus compact while allowing optimal positioning on the patient's face to obtain a distribution direction well oriented towards the targeted area.

[0046] In a preferred mode, the dispensing head includes a third support area configured to butt against the columella or the alar rim of the patient's nostril or both.

[0047] In this way, the depth of insertion of the distal end of the delivery head into the patient's nostril is controlled, improving positioning as well as the comfort of the treatment for the patient.

[0048] Preferably, the third support surface is a flat surface extending perpendicularly with respect to the axis of the distal portion.

[0049] Preferably, the distance between the distal end of the distribution head and the third support zone is between 12 millimeters and 24 millimeters, more preferably between 16 millimeters and 20 millimeters. Thus, the distribution head is compatible with a wide range of different nose shapes and promotes product distribution to the targeted area.

[0050] Advantageously, the third support zone is located between the distal end and the first and second support zones.

[0051] Advantageously, the third support zone can be included on at least one fin, preferably two fins extending on either side of the distal portion of the distribution head.

[0052] In a preferred mode, the dispensing head is symmetrical with respect to at least one plane including the orifice axis. This simplifies handling of the dispensing head because such symmetry prevents the user from incorrectly positioning it. The symmetry also allows the user to dispense the product into one nostril and then the other without having to turn the device over or change their grip.

[0053] Advantageously, the distal end is shaped like a truncated cone, the distal end of which includes a flat surface. This flat surface limits contact with the inside of the nostril, more specifically limiting contact with the cartilage of the nasal septum, and thus avoids constricting the patient's nose when the delivery head is in place. Preferably, the flat surface extends along a plane defining an angle of between 5 degrees and 15 degrees with respect to the plane of symmetry.

[0054] Such positioning with respect to the plane of symmetry makes it possible to ensure that the flat surface is opposite the nasal septum of the patient.

[0055] Advantageously, the distal end comprises two flats distributed on either side of the distal end symmetrically to the plane of symmetry.

[0056] Advantageously, the first and second support zones are arranged on an adjustable portion that is movable in translation and rotation relative to the distal end of the dispensing head, allowing the distribution direction within the patient's nostril to be varied. This makes it possible to adapt the distribution direction to the patient and better target the desired area within the patient's nasal cavity.

[0057] The adjustable portion may include an adjustment mechanism for changing the position or orientation, or both, of the adjustable portion relative to the distal end of the distribution head. This adjustment mechanism may, for example, include mechanisms comprising a worm gear cooperating with a rack, a pressure screw, ratchets, or any system known to those skilled in the art for changing a position or orientation, or both.

[0058] Advantageously, the dispensing head includes at least one orientation indicator configured to assist the user in pre-orienting the dispensing head in the desired dispensing direction before placing it in contact with the patient's face. The user pre-orients the dispensing head according to this indicator and then places the relief forming the first support zone in the philtrum groove of the patient and finally supports the second support zone on the patient's face.

[0059] Preferably, the orientation indicator is a mark defining a direction, such as an arrow that can be printed, engraved, or molded with the dispensing head. Such an orientation indicator makes it easier for the user to read the desired orientation.

[0060] In a preferred mode, the distribution head includes an added element, the first support zone and the second support zone being positioned on the added element.

[0061] In this way, several attachments of different shapes and sizes can be offered, particularly according to the patient's anatomy. In this embodiment, the dispensing head includes a support onto which the attachment is mounted. Preferably, the attachment is removably fixed to the support.

[0062] The term "removable" refers to the fact that the added element can be detached from the support or replaced on the support by an action of the user without damage. For example, the added element can be detached from the support by a mechanical action, for example, pulling towards the distal end.

[0063] Advantageously, the added element can be custom-made for the patient. It can be dimensioned from measurements taken on the patient using a technique known to those skilled in the art, or from a mold of the facial area between the edge of the nostrils and the upper lip, so that the two support areas conform as closely as possible to the patient's face. Preferably, such an added element is obtained by an additive manufacturing method, for example, stereolithography or fused deposition modeling.

[0064] Preferably, the support includes the surface configured to receive at least one finger of the user.

[0065] Advantageously, the attached element includes a positioning device that fixes the position of the attached element relative to the support. Thus, once attached, the attached element has a fixed position relative to the support.

[0066] Advantageously, the support includes a complementary positioning member cooperating with the positioning member of the added element to fix the position of the added element relative to the support.

[0067] Advantageously, the positioning member includes at least one rib formed on the attached element and cooperating with a groove formed on the support.

[0068] Advantageously, the positioning member comprises a shoulder on the attached element configured to cooperate with a complementary shoulder on the support so as to provide an axial stop for the attached element relative to the support. In this way, the axial stop produced is capable of withstanding significant forces.

[0069] Advantageously, the complementary positioning member of the support includes a groove.

[0070] Thus, the rib formed on the added element cooperates with the groove formed on the support.

[0071] The rib and groove can be axial or vertical. Axial means a direction parallel to a longitudinal axis of the distribution head and vertical means a direction going from the distal end to the proximal end.

[0072] Advantageously, the ribs and grooves are each two or more in number, preferably two. Such a number of ribs and grooves limits the risk of unwanted displacements, particularly if the distribution head is subjected to stresses, for example during transport.

[0073] Advantageously, the proximal end of the rib forms, together with the proximal end of the groove, an axial stop for the attached element relative to the support. In this way, the positioning member and the complementary positioning member formed respectively by the rib and the groove are arranged in a compact manner.

[0074] Alternatively, the positioning member includes a flat on the internal surface of the bore of the added element configured to cooperate with a complementary positioning member comprising a flat on the external surface of the support.

[0075] In an alternative mode, the external surface of the support and the internal surface of a bore of the distribution head are frustoconical with the same angle, the axial stop is formed by the cooperation of the two surfaces.

[0076] In an alternative mode, the positioning member comprises a cavity provided with at least one flat.

[0077] Advantageously, the support includes a projection forming a complementary flat that cooperates with the flat of the positioning member to block the element attached to the support from rotating.

[0078] Alternatively, the support comprises at least two radial ribs whose ends cooperate with the flat of the positioning member to lock the attached element in rotation relative to the support.

[0079] Alternatively, the support includes at least one rib whose side cooperates with the flat of the positioning member to block the element attached to the support from rotating.

[0080] Advantageously, the added element includes a retaining member configured to removably hold the added element relative to the support. Thus, the risk of unintentional detachment of the added element is reduced.

[0081] Advantageously, the support includes a complementary retaining member configured to cooperate with the retaining member to ensure the removable retention of the attached element relative to the support.

[0082] The retaining member may include a protruding relief such as a gadroon, a complete or incomplete circumferential bead, a clip, an elastic arm or any other protruding relief capable of ensuring the removable retention of the attached element in relation to the support.

[0083] Alternatively, the retaining member may include a recessed relief, a hollow, a complete or incomplete circumferential groove or any other recessed relief capable of ensuring the removable retention of the attached element in relation to the support.

[0084] The additional retaining member may include a recessed relief, a hollow, a complete or incomplete circumferential groove, or any other recessed relief capable of cooperating with the retaining member to ensure the removable retention of the attached element relative to the support.

[0085] Alternatively, the complementary retaining member may include a protruding relief such as a gadroon, a complete or incomplete circumferential bead, a clip, an elastic arm or any other protruding relief capable of cooperating with the retaining member to ensure the removable retention of the attached element relative to the support.

[0086] Advantageously, the reported element includes the third support area configured to abut against the columella, the alar rim of the patient's nostril, or both. Thus, different insertion depths of the distal end of the distribution head into the nostril can be proposed depending on the patient's anatomy.

[0087] In a preferred mode, the support includes the distribution orifice.

[0088] Advantageously, the support includes the distal end of the distribution head and, optionally, the distribution orifice.

[0089] Advantageously, the attached element includes a through bore configured to be traversed by the distal end carried by the support when the attached element is attached to the support.

[0090] Advantageously, the added element is positioned below the distal end carried by the support.

[0091] In an alternative mode, the reported element includes the distal end.

[0092] Advantageously, the reported element includes a truncated conical portion configured to be inserted inside the patient's nostril.

[0093] Advantageously, the reported element includes a frustoconical portion configured to be in contact with the inside of the user's nostril, the frustoconical portion being arranged around the support.

[0094] Alternatively, the distribution head is configured to be reported on a distribution nozzle, said distribution nozzle comprising the distribution orifice and being configured to be connected to the distribution member.

[0095] The invention also relates to a product distribution device comprising a distribution head as previously described and assembled to a device equipped with a reservoir for containing the product to be distributed.

[0096] Advantageously, the dispensing device is configured to dispense the product by a mechanical action of the user on the dispensing head, causing the activation of the dispensing mechanism, for example a pump or a valve, which will cause the dispensing of the product initially contained in the reservoir.

[0097] Advantageously, the mechanical action is a translation of the dispensing head relative to the device containing the reservoir, preferably a translation that tends to bring the distal end of the dispensing head closer to the reservoir. Alternatively, the product dispensing can be triggered by a user action on a part of the device, for example, pressing an activation button.

[0098] Another object of the invention is a method for positioning a dispensing device as previously described, the method comprising at least the following steps: a. Place at least one finger on the surface configured to receive at least one finger of the user and the thumb under the proximal end of the dispensing device, b. Insert the distal end of the delivery head into one of the patient's nostrils, c. Place the first support area in the patient's philtrum groove. d. Place the second support area on the patient's upper lip, next to the patient's philtrum.

[0099] Advantageously, this process includes a complementary step, implemented between steps a. and b., consisting of pre-orienting the distribution device according to the orientation indicator, when the latter is present. Brief description of the figures

[0100] The features and advantages of the invention will become more apparent from the following detailed description, made with reference to the drawings given by way of non-limiting examples and in which: - [Fig.1] Fig.1 is a perspective view of a distribution device according to the invention, equipped with a distribution head according to a first embodiment; - [Fig.2] Fig.2 is a perspective view from another angle, from below. of the distribution head of the distribution device of the [Fig.1]; - [Fig. 3] [Fig. 3] is an exploded perspective top view of a head of distribution according to a second embodiment; - [Fig. 4] Fig. 4 is a perspective view from below of an added element belonging to the head of distribution of the [Fig.3]; - [Fig.5] The [Fig.5] is an exploded perspective top view of a distribution head according to a third embodiment; - [Fig.6] The [Fig.6] is a perspective view from below of an added element belonging to the distribution head of the [Fig.5]; - [Fig. 7] [Fig. 7] is a top perspective view of a dis distribution according to the invention equipped with a distribution head according to a fourth embodiment; and - [Fig.8] The [Fig.8] is a top perspective view of a distribution head according to a fifth embodiment. Detailed description

[0101] The following embodiments are examples. Although the description refers to one or more embodiments, this does not mean that the features apply only to a single embodiment. Simple features from different embodiments can also be combined to provide other embodiments.

[0102] The distribution direction characteristics in the patient's nostril to reach the targeted area, for example the olfactory area, are well known to those skilled in the art, notably through document WO2021 / 066195A1, the article "The Influence of Spray Properties on Intranasal Deposition" published in volume 20, number 4 of the "Journal of Aerosol Medicine" in 2007, and the article "Personalized Medicine in Nasal Delivery: The Use of Patient-Specific Administration Parameters To Improve Nasal Drug Targeting Using 3D-Printed Nasal Replica Casts" published in 2018 in volume 15 of "Mol. Pharmaceutics".

[0103] Products, particularly pharmaceuticals, that can be dispensed using the dispensing device may be used for the treatment or prevention of neurological disorders, neurodegenerative diseases such as Alzheimer's, Huntington's, and Parkinson's diseases, or the treatment or prevention of brain tumors, autoimmune diseases, type I and II diabetes, depression, obesity including hypothalamic obesity, memory impairments, hypogonadotropic hypogonadism, multiple sclerosis, autism, maternal neglect, dementia, anorexia, opiate addiction, schizophrenia, migraines, head injuries, strokes, cluster headaches, pain including cancer-related pain, glioblastoma, hypopituitarism, sleep apnea, and epilepsies, of acromegaly or non-allergic irritant rhinitis.

[0104] Products, particularly pharmaceuticals, that can be distributed using the distribution device include, for example, formulations containing at least one active ingredient such as corticosteroids, glucocorticoids, peptides, proteins, hormones, active ingredients of biological origin, cells including stem cells, nucleotide-based active ingredients such as DNA, RNA or oligonucleotides, active ingredients with a molecular weight of up to 1500 Da, terpenes, cannabinoids, polysaccharides, vaccines, enzymes, antibodies, antivirals, probiotics or nutritional formulations or mixtures thereof.

[0105] Products, particularly pharmaceuticals, that can be distributed using the dispensing device include, for example, formulations containing at least one active ingredient such as insulin, oxytocin, glutathione, glucagon, zolmitriptan, sumatriptan, frovatriptan, rizatriptan, eletriptan, naratriptan, almotriptan, ketorolac, zavegapant, lidocaine, ketamines including esketamine, temozolomide, safinamide, pimavanserin, dexmedetomidine, midazolam, levodopa, empagliflozin, diazepam, clonazepam, psilocybin, fentanyl, sufentanil, hydromorphone, oxymorphone, morphine, ocrelizumab, da-clizumab, aducanumab, gantenerumab, bapineuzumab, solanezumab, ofatumumab amiloride, capsaicin, naloxone, dimethyl fumarate, epinephrine;atropine, metoclopramide, edaravone, valbenazine, imipramine, amitriptyline, nortriptyline, deutetrabenazine, nusinersen, bupropion, isocarbazide, aripiprazole, brexpiprazole, cariprazine, eslicar-bazepine, flutemetamol, vortioxetine, gadoteric acid, clomipramine, fluoxetine, phenelzine, fluvoxamine, sertraline, citaprolam, escitaprolam, levomilnacipran, vilazodone, doxepin, selegiline, tranylcypromine, mirtazapine, vortioxetine, duloxetine, desvenlafaxine, paroxetine, the orexins, leptin, camptothecin, olanzapine, risperidone, venlafaxine, zonisamide, estradiol, ropinirole, tetrahydrocannabinol, cannabidiol, valproic acid, rivastigmine, topiramate, in any of its derived or analogous forms such as salts, hydrates, solvates, isomers or esters. ;

[0106] Figure 1 illustrates a dispensing device 1 comprising a dispensing head 10 according to a first embodiment of the invention connected to a device having a reservoir 2 containing the product to be dispensed, preferably a liquid pharmaceutical product. The dispensing device 1 is configured to generate a jet by a mechanical action by a user on the dispensing head 10, causing the activation of the dispensing mechanism, for example a pump or a valve, and the dispensing of the product.

[0107] In the device shown in [Fig. 1], the device with the reservoir 2 is connected to the proximal side of the distribution head 10. The mechanical action is a translation of the distribution head 10 relative to the device with the reservoir 2, preferably a translation which tends to bring a distal end 12 of the distribution head 10 closer to the reservoir 2.

[0108] In this embodiment, the product is distributed via a distribution orifice 11 located at the distal end 12 of the distribution head 10.

[0109] The distribution orifice 11 is, in this example, a cylindrical hole of revolution about an orifice axis AIL

[0110] Alternatively, the distribution orifice 11 is frustoconical in revolution about an orifice axis.

[0111] The distribution head 10 comprises a first support zone 13 and a second support zone 14. The first support zone 13 and the second support zone 14 jointly impose a distribution direction in the patient's nostril when the distribution head is in place in the nostril.

[0112] In practice, the distribution direction is substantially aligned with the AIL orifice axis

[0113] The first support area 13 is a rib 131 which forms a relief and has a rounded ridge whose shape is complementary to that of the patient's philtrum sulcus. For example, the radius of the ridge of the rib 131 may be between 1 millimeter and 2 millimeters. Thus, the relief formed by the rib 131 is configured to fit into the patient's philtrum sulcus.

[0114] In the first embodiment illustrated in Figures 1 and 2, the distribution head 10 has two ribs 131 distributed symmetrically along a plane of symmetry P10 of the distribution head 10, this plane of symmetry P10 comprising the orifice axis AIL

[0115] In this embodiment, the second support zone 14 is a substantially concave surface 141 formed between the ribs 131. The ribs 131 are adjacent to the substantially concave surface 141.

[0116] The dispensing head 10 includes a surface 15 configured to receive at least one finger of the user. The user can thus press the surface 15 when necessary.

[0117] In this embodiment, the surface 15 configured to receive at least one finger of the user is carried by at least one radial protrusion 151. Preferably, the surface 15 is positioned on the distal side of each radial protrusion 151. Preferably the distribution head 10 has two radial protrusions 151 located on either side of the distribution head 10 and together defining the surface 15, as illustrated in [Fig. 1].

[0118] In an unrepresented embodiment of the invention, the distribution head 10 may include a single, circumferential radial protrusion, this single, circumferential radial protrusion comprising the surface 15.

[0119] Advantageously, the radial protrusion 151 or protrusions is positioned at the proximal end of the distribution head 10.

[0120] In this example, the distribution head 10 includes a cavity 16 configured to receive a part of the device, preferably a part of the reservoir 2. The cavity 16 is carried by a proximal face of the distribution head 10. The cavity 16 is cylindrical in this example.

[0121] As illustrated in [Fig.2], the bottom of the cavity 16 includes a sealed connection interface 17 with the device, configured to receive in a sealed manner an element of the device through which the product exits the reservoir 2. By way of non-limiting example, this element of the device may be a tube.

[0122] In this example, the watertight connection interface 17 is a cylindrical sleeve 171 defining a cavity 172 at the bottom of which is a conduit 173 connecting the cavity 172 to the distribution port 11.

[0123] In this example, the cylindrical sleeve 171 is configured to be mounted tightly around the device element when this element is positioned in the cavity 172, so that the tightness between the cylindrical sleeve 171 and the device element prevents leakage of the liquid.

[0124] As illustrated in the example in [Fig. 1], the dispensing head 10 includes a third support area 18 configured to abut against the columella or the alar rim of the patient's nostril, or both. The third support area 18 is formed by a surface 181 transverse to the axis of orifice A1 and extending radially outward from the dispensing head 10 so as to form a shoulder configured to abut against the columella or the alar rim of the patient's nostril, or both. In this example, a distance d18, measured parallel to the axis of orifice A1, between the distal end 12 and the transverse surface 181 is between 12 and 24 millimeters, preferably between 16 and 20 millimeters.

[0125] In this example, the distribution head comprises a distal portion 19 and a proximal portion 20. The distal portion 19 is generally frustoconical in shape, coaxial with the distribution orifice 11, i.e. centered on the axis of orifice Ail, and comprises the distal end 12. The distal portion 19 is configured to be inserted into the patient's nostril.

[0126] The shoulder formed by the transverse surface 181 extends around the distal portion 19 and a radial distance between the distal portion 19 and the point of the transverse surface 181 furthest from the distal portion is at least 2 millimeters.

[0127] The proximal portion 20 is generally cylindrical in shape and includes the surface 15. Preferably the proximal portion 20 includes the two radial protrusions 151.

[0128] The first support zone 13 and the second support zone 14 are positioned between the distal portion 19 and the proximal portion 20 of the distribution head 10.

[0129] As illustrated in [Fig. 1], the distal end 12 may include at least one flat 21, preferably two flats 21 distributed on either side of the plane of symmetry P10. Advantageously, the flats are inclined with respect to the plane of symmetry P10. Preferably, an angle α formed by each flat 21 with the plane of symmetry P10 is between 5 degrees and 15 degrees.

[0130] In this example, the distribution head 10 is obtained by a plastic injection molding process.

[0131] According to an example of use of a dispensing device 1 according to the first embodiment, illustrated by figures 1 and 2, the user, for example a healthcare professional, connects the dispensing head 10 via the sealed connection interface 17 to the device equipped with the reservoir 2 containing the product to be dispensed, thus forming the dispensing device 1.

[0132] The user can then take hold of the dispensing device 1, preferably by placing the index and middle fingers of their hand on the surface 15 configured to receive the user's fingers and carried by the two radial protrusions 151, and the thumb of their hand below the reservoir 2, which in this example protrudes from the proximal end of the dispensing head 10. The user is then ready to position the dispensing device 1 in the patient's nostril.

[0133] The user can then insert the distal end 12 into a nostril of the patient, then place one of the ribs 131 forming the first support area 13 in the philtrum groove of the patient, and finally place the substantially concave surface 141, forming the second support area 14, on the upper lip, next to the patient's philtrum. Optionally, the user can push the distal end 12 into the patient's nostril until the third support area 18 abuts against the patient's columella or the alar rim of the patient's nostril, or both. The distribution device 1 is then optimally positioned so that the product sent along the distribution direction into the nostril can reach the targeted area, for example the olfactory area of ​​the nasal cavity, located in the upper part of the nasal cavity, in which are present the branches of the olfactory nerve directly connected to the brain via the olfactory bulb.

[0134] The user then presses the dispensing head 10 towards the reservoir 2 to trigger the dispensing of the product into the patient's nostril.

[0135] The second embodiment illustrated by figures 3 and 4 will now be described.

[0136] Only the differences and specificities compared to the first embodiment are detailed. Any element or feature not explicitly mentioned is incorporated in this embodiment.

[0137] In the second embodiment, the distribution head 10 includes an added element 30, the first bearing area 13, formed by the rib 131, and the second bearing area 14, formed by the substantially concave surface 141, being positioned on the added element 30. In this example, the distribution head 10 also includes a support 40 comprising the surface 15 and on which the added element 30 is attached.

[0138] In this example, the distal end 12 and the distribution orifice 11 are carried by the support 40. The flats 21 are also carried by the support 40.

[0139] The added element 30 can be detached from the support 40 by the user, for example by a mechanical action such as a manual pull by the user towards the distal end 12.

[0140] The added element includes a through bore 301, configured to surround a part of the support 40. The bore 301 illustrated in [Fig.4] is cylindrical and centered on a bore axis A301 which coincides with the orifice axis Ail in the added configuration of the added element 30 on the support 40.

[0141] Alternatively, the bore 301 may be of elliptical cross-section or of any other form complementary to the part of the support 40 which it surrounds.

[0142] In this embodiment, the added element 30 is symmetrical with respect to a plane of symmetry P30 which includes the bore axis A301.

[0143] In this example, the added element 30 comprises a portion of general hemicylindrical shape, with the same axis as the bore 301, as well as a portion having a regular trapezoidal projection in a plane perpendicular to the plane of symmetry P30 and arranged so that it is parallel to the direction of distribution when the added element 30 is attached to the support 40.

[0144] In this example, the ribs 131 form the sides of the trapezoid and surround the substantially concave surface 141.

[0145] As illustrated in the example of Figures 3 and 4, the added element 30 includes a positioning member 302 which imposes the position of the added element 30 relative to the support 40. In this example, the positioning member 302 includes two longitudinal ribs 3021, positioned on the inner surface of the bore 301 and distributed on each side of the bore axis A301.

[0146] In embodiments not shown, the added element 30 may have a single rib or a number of ribs strictly greater than two, preferably regularly distributed around the bore axis A301 on the inner surface of the bore 301.

[0147] As illustrated in [Fig. 3], the support 40 may include a posi- additional function 401 comprising two longitudinal branches 4011 configured to receive the two ribs 3021 of the added element 30 and to rotationally secure the added element 30 and the support 40. Only one groove 4011 is visible in [Fig.3], the other groove being symmetrical to the one visible with respect to the axis of orifice Ail.

[0148] In this embodiment, the proximal end of each rib 3021 is configured to butt against the proximal end of the corresponding groove 4011, in order to impose the axial position of the added element 30 relative to the support 40, along the coincident axes Ail and A301.

[0149] Each rib 3021 may include a chamfer 3021A on its proximal end intended to facilitate the assembly of the rib 3021 in the corresponding groove 4011 of the support 40.

[0150] In this embodiment, the retention of the added element 30 relative to the support 40 is achieved by an interference between the internal diameter of the bore 301 and the external surface of the support 40 around which the bore 301 is placed.

[0151] In this embodiment, the support 40 includes a distal portion 402 of generally frustoconical shape coaxial with the distribution orifice 11, i.e. centered on the axis of orifice Ail.

[0152] The ribs 4011 are positioned on the outer surface of the proximal portion 402.

[0153] In this example, the transverse surface 181 forming the third support zone 18 is carried by a distal surface of the added element 30.

[0154] The added element 30 is, in this example, produced by plastic injection.

[0155] The support 40 is, in this example, made by plastic injection.

[0156] According to an example of the use of a dispensing device 1 according to the second In this embodiment, illustrated by Figures 3 and 4, the user, for example a healthcare professional, places the insert 30, previously selected according to the patient's anatomy, onto the support 40, first aligning the bore 301 with the distal portion 402 of the support 40, i.e., aligning the bore axis A301 with the orifice axis A1, and then aligning each rib 3021 of the insert 30 with its corresponding groove 4011 of the support 40. Once this step is completed, the user slides the insert 30 around the support 23 in the proximal direction until the proximal end of the ribs 3021 abuts against the proximal end of the grooves 4011. The dispensing head 10 is then ready for use. The subsequent usage steps are similar to those of the first embodiment.

[0157] The third embodiment illustrated by figures 5 and 6 will now be described.

[0158] Only the differences and specific features compared to the second embodiment are detailed. Any element or characteristic not explicitly mentioned is incorporated into this embodiment.

[0159] In this embodiment, the distribution head 10 includes an added element 50 comprising the distal end 12 and the distribution orifice 11.

[0160] The first bearing zone 13, formed by the rib 131, and the second bearing zone 14, formed by the substantially concave surface 141, are positioned on the added element 50.

[0161] As illustrated by [Fig.5], the distribution head includes a support 60 on which the attached element 50 is attached.

[0162] A60 is noted as a longitudinal axis of the support 60.

[0163] As shown in the example of [Fig.5], the attached element 50 comprises a distal portion 501 of generally frustoconical shape configured to be in contact with the inside of the user's nostril, the distal end 12 of the distribution head 10 being carried by the distal portion 501 of the attached element 50. The distal frustoconical portion 501 is arranged around the support 60.

[0164] The rib 131 and the substantially concave surface 141 are positioned on a proximal portion 502 of the added element 50.

[0165] The added element 50 is symmetrical about a plane of symmetry P50 containing the orifice axis AIL

[0166] In this example, the reported element 50 comprises two ribs 131 symmetrical with respect to the plane of symmetry.

[0167] In this embodiment and as illustrated in [Fig. 6], the attached element 50 comprises a cavity 503 configured to receive a portion of the support 60. In this example, the cavity 503 is provided on the proximal portion 502, preferably on a proximal face 5021 of the proximal portion 502. Preferably, the cavity 503 is generally cylindrical in shape, rotating about a cavity axis A503 perpendicular to the proximal face 5021.

[0168] The proximal portion 502 of the attached element 50 comprises a portion of general hemicylindrical shape, as well as a portion having a regular trapezoidal projection along a plane perpendicular to the plane of symmetry P50 and arranged so that it is parallel to the axis of orifice AIL. In this example, the ribs 131 form the sides of the trapezoid and surround the substantially concave surface 141.

[0169] In this example, the attached element 50 comprises a positioning member 504 formed by at least one flat 5041 positioned in the cavity 503 and parallel to the axis of the cavity 503. Preferably, the positioning member 504 comprises two flats 5041 distributed on each side of the cavity axis A503, as illustrated in [Fig. 6]. Advantageously, the two flats 5041 are symmetrical with respect to the plane of symmetry P50.

[0170] As illustrated in [Fig. 6], the add-on element 50 includes a sealing connection interface 505 with the support 60, this sealing connection interface 505 being formed by a bore 5051 having a bottom 5051A. In this example, the bore 5051 is located at the bottom of the cavity 503. The add-on element 50 includes a conduit 506 configured to carry the fluid from the sealing connection member 505 to the distribution port 11. The conduit 506 opens at the bottom 5051A of the bore 5051.

[0171] In this embodiment, the support 60 is generally cylindrical in shape and revolves around the support axis A60.

[0172] In this example, the support 60 carries a conduit 173 through which a product can flow from the reservoir 2 of an apparatus of the same type as that illustrated for the first embodiment.

[0173] In this example, the conduit 173 connects the watertight connection interface 17 of the support 60 to the bore 5051 of the watertight connection member 505 of the added element 50.

[0174] The support 60 illustrated in [Fig.5] comprises, at its distal end, a flat surface 601, transverse to the longitudinal axis A60 of the support 60 and from which extends a cylindrical rod 602 of revolution around the longitudinal axis A60 of the support 60.

[0175] In this example, the conduit 173 opens at the distal end of the rod 602.

[0176] The distal end of the rod 602 of the support 60 is configured to fit into the bore 5051 of the added element 50 so as to create a sealed connection linking the conduit 173 of the support 60 to the conduit 506 of the added element 50, thus creating a fluidic path from the sealed connection interface 17 with the device to the distribution port 11. Preferably, the sealed connection is achieved by clamping between the outer lateral surface of the rod 602 and the inner lateral surface of the bore 5051.

[0177] In an unrepresented embodiment of the invention, a circumferential sealing ring may be present on the outer lateral surface of the rod 602 or the inner lateral surface of the bore 5051.

[0178] In this embodiment, the support 60 includes a complementary positioning member 603 formed by at least two ribs 6031, preferably four radial ribs 6031 formed from material with both the transverse flat surface 601 and the rod 602. These radial ribs 6031 are configured to cooperate with the flats 5041 of the added element 50 to lock the added element 50 in rotation about the coincident axes A60 and A503 relative to the support 60.

[0179] In this embodiment, the positioning member 504 comprises the face proximal 5021 of the added element 50, visible on [Fig.6], which is configured to butt against the transverse flat surface 601 of the support 60, visible on [Fig.5], to define the axial position of the added element 50 relative to the support 60, along the coincident axes A60 and A503.

[0180] Thus the cooperation of the flats 5041 and the proximal face 5021 of the added element 50 with respectively the ribs 6031 and the transverse flat surface 601 of the support 60 jointly imposes a fixed position of the added element 50 with respect to the support 60.

[0181] In this embodiment, the retaining member comprises the rod 602 of the support 60 which is constrained in the bore 5051 of the added element 550, so as to retain the added element 50 in a removable position relative to the support 60.

[0182] In this example, the transverse flat surface 181 forming the third support zone 18, is carried by the distal face of the proximal portion 502 of the added element 50.

[0183] The added element 50 is, in this example, produced by plastic injection.

[0184] The support 60 is, in this example, made by plastic injection.

[0185] According to an example of the use of a dispensing device 1 according to the third In this embodiment, the user places the insert 50, previously selected according to the patient's anatomy, onto the support 60 by first aligning the flats 5041 of the insert 50 with the ribs 6031 of the support 60. The user then axially pushes the insert 50 towards the support 60 until the proximal face 5021 of the insert 50 abuts against the transverse flat surface 601 of the support 60. During this movement, the bore 5051 of the insert 50 receives the rod 602 of the support 50, creating a leak-proof connection between the insert 50 and the support 60. In this way, the conduit 506 of the insert 50 and the conduit 173 of the support 60 are in fluidic connection. The distribution head 10 is then ready for use.

[0186] The subsequent usage steps are similar to those of the first and second embodiments.

[0187] The fourth embodiment illustrated by [Fig.7] will now be described.

[0188] Only the differences and specific features compared to the first embodiment are detailed. Any element or characteristic not explicitly mentioned is incorporated into this embodiment.

[0189] The device of the fourth embodiment differs from that of the first embodiment in that it includes an orientation indicator 70 configured to give an indication to the user on the quality of the orientation of the device relative to the patient's nostril.

[0190] In this example, the orientation indicator is formed by a relief 701, recessed or projecting, defining an orientation axis A70 and positioned on the outer surface of the distribution head 10 so that it is visible to the user.

[0191] The dispensing head 10 comprises an identical number of orientation indicators and sets of support zones. A set of support zones is understood to mean a first support zone 13 and a second support zone 14 jointly imposing a direction of product distribution into the patient's nostril. In the example of [Fig. 7], the dispensing head 10 comprises four sets of support zones and four orientation indicators 70, each formed by a relief 701, two visible in [Fig. 7] and two others on the opposite side not visible in [Fig. 7].

[0192] An example of the use of a distribution head 10 equipped with an orientation indicator 70 according to the fourth embodiment will now be described.

[0193] In this example, the user first selects the dispensing head 10 that they believe best matches the patient's anatomy. The user then places the two support areas of the dispensing head 10 on the patient's face to impose the distribution direction into the patient's nostril. The orientation indicator, here the relief 701, is then visible on the side of the dispensing head 10 without the radial protrusion 151. The user can then confirm the orientation of the relief 701 to confirm the choice of dispensing head model or select another one with a different first support area 13 and second support area 14, imposing a different distribution direction into the patient's nostril.

[0194] In an unrepresented variant, the distribution head 10 may cumulatively comprise a reported element, as described in the second and third embodiments, and a direction indicator 70, as described in the fourth embodiment.

[0195] In this variant, the orientation indicator 70 is carried by the attached element or the support or both. The use of a distribution head 10 according to this variant is similar to that of the fourth embodiment.

[0196] The fifth embodiment illustrated by [Fig.8] will now be described.

[0197] Only the differences and specificities compared to the first embodiment are detailed. Any element or characteristic not explicitly mentioned is incorporated into this embodiment.

[0198] This fifth embodiment differs from the first embodiment in that the transverse surface 181 of the third support zone 18 is carried by two fins 1811. The fins 1811 extend radially from the distal portion 19 of the distribution head 10 and are distributed symmetrically with respect to the plane of symmetry P10 of the distribution head, defined as in the first embodiment.

[0199] The present invention has been described with reference to various embodiments advantageous, but it is understood that a person skilled in the art can make any modifications to it, without going outside the scope of the present invention.

[0200] Reference list

[0201] 1 Dispensing device

[0202] 2 Reservoir

[0203] 10 Distribution Head

[0204] 11 Distribution port

[0205] 12 Distal end

[0206] 13 First support zone

[0207] 131 Rib

[0208] 14 Second support zone

[0209] 141 Substantially concave surface

[0210] 15 Surface configured to be pressed by a user's finger

[0211] 151 Radial protrusion

[0212] 16 Cavity

[0213] 17 Waterproof connection interface

[0214] 171 Sheath

[0215] 172 Cavity

[0216] 173 Conduit

[0217] 18 Third support zone

[0218] 181 Transverse surface

[0219] 1811 Ailette

[0220] 19 Distal portion

[0221] 20 Proximal portion

[0222] 21 Flat

[0223] 30 Added element second embodiment

[0224] 301 Bore

[0225] 302 Positioning element

[0226] 3021 Positioning organ ribs

[0227] 3021A Rib chamfer

[0228] 40 Support second embodiment

[0229] 401 Complementary positioning element

[0230] 4011 Grooves

[0231] 402 Distal portion

[0232] 50 Added element third embodiment

[0233] 501 Distal portion of the attached element 50

[0234] 502 Proximal portion of the reported element 50

[0235] 5021 Proximal face of the proximal portion 502

[0236]

[0237]

[0238]

[0239]

[0240]

[0241]

[0242]

[0243]

[0244]

[0245]

[0246]

[0247]

[0248]

[0249] 503 Cavity 504 Positioning member for the added element 50 5041 Flat surface 505 Sealing connection interface for the added element 50 5051 Bore 5051A Bottom of the bore 5051 506 Conduit 60 Support for third embodiment 601 Transverse flat surface 602 Rod 603 Additional positioning member 6031 Rib 70 Orientation indicator 701 Relief

Claims

Claims

1. Nasal dispensing head (10) for a fluid product provided with two support zones (13, 14) on the face of a patient, which jointly impose a dispensing direction (A1 1) of the product in a nostril of the patient, and a surface (15) configured to receive at least one finger of the user, the two support zones (13, 14) being positioned between a distal end (12) of the dispensing head configured to be introduced into the nostril of the patient and the surface (15), characterized in that a first support zone (13), among the two support zones (13, 14), is a relief configured to be housed in the groove of the philtrum of the patient.

2. Dispensing head according to the preceding claim in which the relief of the first support zone (13) is a rib (131).

3. A dispensing head according to any preceding claim, wherein the second bearing area is a substantially concave surface (14) configured to bear on the upper lip, next to the patient's philtrum.

4. Dispensing head according to any one of the preceding claims, in which the first support zone (13) and the second support zone (14) are adjacent.

5. A dispensing head according to any preceding claim, wherein the dispensing head (10) comprises a third bearing area (18) configured to abut against the columella or the alar rim of the patient's nostril or both.

6. Dispensing head according to any one of the preceding claims, which comprises a single orifice defining an orifice axis, and which is symmetrical with respect to at least one plane (P 10) including the orifice axis (A1 1).

7. Dispensing head according to any one of the preceding claims, which comprises an added element (30; 50), the first support zone (13) and the second support zone (14) being positioned on the added element (30; 50).

8. Dispensing head according to claim 7 wherein the dispensing head comprises a support (40; 60) comprising the surface (15) configured to receive at least one finger of the user, and on which the added element (30; 50) is attached.

9. Dispensing head according to the preceding claim in which the added element (30; 50) comprises a positioning member (302; 504) imposing the position of the added element (30; 50) relative to the support (40; 60)

10. A dispensing head according to claim 7 wherein the insert (50) comprises the distal end (12) of the dispensing head (10).

11. Dispensing head according to the preceding claim in which the attached element (50) comprises a dispensing orifice (11) for the product in the patient's nostril.

12. Dispensing head according to claim 9 in which the positioning member (302) comprises at least one rib (3021) provided on the attached element (30) and cooperating with a groove (4011) provided on the support (40).

13. A dispensing head according to claim 8, wherein the insert (50) comprises a frustoconical portion (501) configured to be in contact with the inside of the user's nostril, the frustoconical portion being arranged around the support (60).

14. A dispensing head according to claim 7, wherein the insert (50) comprises a third bearing area (18) configured to abut against the columella and / or the alar rim of the patient's nostril.

15. A dispensing head according to any preceding claim, comprising at least one orientation indicator (70) configured to assist the user in orienting the dispensing head in the dispensing direction.

16. Dispensing head according to the preceding claim, in which the orientation indicator (70) is a mark (701) defining an axis (A70).

17. A product dispensing device (1) comprising a dispensing head (10) according to any one of the preceding claims and a dispensing apparatus provided with a reservoir (2), the dispensing head (10) being assembled on the dispensing apparatus.

18. Method for positioning a dispensing device (1) according to claim 17, characterized in that it comprises at least the following steps: a. placing the index finger and the middle finger on the surface (15) configured to receive at least one finger of the user and the thumb in below the product tank (2), b. insert the distal end (12) of the dispensing head (10) into a nostril of the patient, c. place the first support area (13) in the patient's philtrum groove, d. place the second support area (14) on the patient's upper lip, next to the patient's philtrum.

Images