APPLICATOR FOR DELIVERING AT LEAST ONE DOSE OF A COMPOSITION INTO A BODILY TRACT OF A USER AND ASSOCIATED METHOD

Abstract

APPLICATOR FOR DELIVERING AT LEAST ONE DOSE OF A COMPOSITION INTO A BODILY TRACT OF A USER AND ASSOCIATED METHOD The invention relates to an applicator (100) for delivering at least one dose of a composition into a bodily tract of a user, a refill (30) for such an applicator (100), a kit comprising such an applicator (100) and at least one such refill (30) and a method for administering at least one dose of a composition into a bodily tract of the user. Abstract figure: Fig. 1

Description

Title of the invention: APPLICATOR FOR DELIVERING AT LEAST ONE DOSE OF A COMPOSITION INTO A BODILY TRACT OF A USER AND ASSOCIATED METHOD FIELD OF THE INVENTION

[0001] The present invention relates to the field of applicators for delivering a composition. In particular, the invention relates to an applicator for delivering at least one dose of a composition into a bodily tract of a user. The invention also relates to a refill for such an applicator, a kit comprising such an applicator and at least one such refill, and a method for administering at least one dose of the composition into a bodily tract of the user.

[0002] The invention applies to the administration of all kinds of compositions intended to be injected into bodily tracts. In particular, the invention applies to the administration of compositions into bodily tracts that are difficult to access. The invention applies in particular to the administration of a composition intended to form a barrier within the bodily tract. STATE OF THE ART

[0003] Urinary tract infections are very common in women. They can affect different parts of the urinary system, including the bladder (cystitis), urethra (urethritis), ureters, and sometimes the kidneys (pyelonephritis).

[0004] Common symptoms associated with UTIs include a burning sensation during urination, frequent urination, cloudy or foul-smelling urine, and sometimes fever when the infection reaches the kidneys.

[0005] Generally, women are more likely to develop urinary tract infections than men due to their shorter urethra, which facilitates the migration of bacteria. It is estimated that up to 50% of women will experience at least one urinary tract infection during their lifetime.

[0006] Urinary tract infections in women can be caused by many factors including sexuality, pregnancy, menopause or even diabetes.

[0007] There are many means of prevention such as promoting good hygiene, regular bladder emptying, adequate hydration, and avoiding known risk factors.

[0008] There are also medical solutions such as antibiotic treatments for curative or preventive purposes. However, prolonged use of antibiotics increases the risks of developing allergies, intolerance, altering the microbiota and developing antibiotic resistance.

[0009] Similarly, medical-surgical interventions such as intravesical instillations, meatotomy or dilation are risky and present an uncertain outcome for the patient.

[0010] To date, there is no solution that can ensure reproducible, long-lasting and risk-free effectiveness. Indeed, all means of prevention, and in particular those mentioned above, have an overall unfavorable benefit-risk balance, often very variable and unpredictable depending on the individual. Typically, it is estimated that approximately 20% to 30% of women who have had cystitis will have a recurrence within the following six months.

[0011] There is therefore a real need to find an effective prevention solution to limit the occurrence of urinary tract infections and their recurrences.

[0012] In particular, there is a need for a prevention solution that can be implemented by the user himself.

[0013] However, the urethra is a bodily passage that is difficult to reach and visualize by the user himself.

[0014] There is therefore also a need for a prevention solution to facilitate access and optionally visualization of the urethral region, including the meatus, the external orifice of the urethra.

[0015] More generally, the technical problem that the invention seeks to solve is to obtain a device that makes it possible to facilitate access to a bodily route by a user who would, for example, wish to administer a composition to himself. SUMMARY

[0016] The invention relates to an applicator for delivering at least one dose of a composition into a bodily tract of a user, the applicator comprising:

[0017] - a hollow body extending along a longitudinal axis, the hollow body comprising a proximal end and a distal end;

[0018] - a piston positioned in the hollow body, the piston extending along the axis longitudinal between a first end and a second end, the first end being intended to be actuated by the user to slide the piston along the longitudinal axis between a high position and a low position,

[0019] - a refill comprising: • an internal reservoir including at least one dose of the composition, • a distal tip connected to the internal reservoir, the distal tip being configured to deliver the at least one dose into the body pathway, • a guide surface extending along the longitudinal axis, the guide surface at least partially delimiting the internal reservoir,

[0020] the applicator having a mounted state, in which the refill is mounted on the distal end of the hollow body, the second end of the piston comprising a pushing member configured to slide in the guide surface in order to deliver the at least one dose.

[0021] According to the invention, a bodily pathway designates a conduit, natural or artificial, connecting an exterior of the body and an organ located inside the human body or a cavity opening onto the exterior of the human body by at least one opening. Typically, the bodily pathway may be a natural conduit such as the nasal passage, the auditory canal, the oral cavity, the vagina or the anus. The bodily pathway may also be an artificial conduit provided for the passage of a syringe, a cannula, a probe or a catheter. For example, the bodily pathway is a conduit provided by a syringe to a vein or an artery, a tracheal conduit which crosses the neck region to reach the trachea or an intracranial conduit, which crosses the cranium to reach the brain. The bodily pathway may in particular be the urethra. Alternatively, the bodily pathway may be a wound or a bedsore.

[0022] According to the invention, the composition may be a composition for therapeutic, preventive or curative purposes. For example, the composition is a saline solution, an antibiotic or an analgesic, or an anesthetic composition. The composition is, for example, a dose of valium delivered intrarectally by a third party or a composition intended for dental application, or a dose for intra-auricular instillation delivered in place of a dropper of the prior art, which is much less precise. Alternatively, the composition may be for diagnostic purposes, such as a composition comprising a contrast agent injected for medical imaging. The composition may also be a composition intended to form a barrier in the body. For example, the composition may aim to temporarily or permanently seal an artery, a vein, a wound or a bedsore to stop bleeding.Advantageously, the composition may also aim to form a temporary barrier in the urethra in order to prevent infections linked to the rise of pathogenic microorganisms along the urethra. The composition may be placed temporarily and for example be evacuated during urination. The composition may be in various forms and states. For example, the composition may be a gel, a paste or a liquid.

[0023] The composition is notably characterized by its properties of adhesion to the walls of the body pathway, its detachment, its persistence, its persistence, its non-migration below a certain force applied to said composition. The composition can also be characterized by its antibacterial effect.

[0024] In other words, the applicator according to the invention is sized to facilitate the administration of the composition into the body by the user. itself. No external intervention is then necessary and in particular no intervention by medical personnel. The ergonomics of the applicator allows for safe action by the user despite the fact that the bodily route is difficult to access and potentially difficult to visualize. In particular, the distal tip is adapted to easily penetrate the bodily route, while limiting the pain caused. Alternatively, the applicator according to the invention is sized to facilitate the administration of the composition by a third party without requiring the intervention of medical personnel.

[0025] According to other aspects of the invention, the applicator according to the invention comprises one or more of the features described in the following embodiments, taken individually or in all possible combinations.

[0026] According to a first embodiment, the piston comprises an end portion forming the thrust member, the end portion being configured to penetrate into the internal reservoir.

[0027] In this embodiment, the pushing member is configured to penetrate directly into the internal reservoir of the refill. The pushing member thus comes into direct contact with the composition to push it out of the refill. Contamination of the composition is thus advantageously avoided.

[0028] According to a second embodiment, the refill comprises a transmission member mounted in the guide surface so as to slide in the internal reservoir, the transmission member being arranged to be in contact with the thrust member at least when the piston is actuated to slide from the high position to the low position.

[0029] In this embodiment, the pushing member is configured to push the transmission member, which in turn penetrates into the internal reservoir of the refill. In practice, the refill is provided so that the transmission member is pre-inserted into the guide surface and thus closes the upper opening of the internal reservoir. The composition is thus never exposed to the external environment and does not risk being contaminated. In particular, the composition never comes into direct contact with the piston, which limits cross-contamination between applications of the different doses of composition.

[0030] According to one embodiment, the piston may comprise a guide portion, positioned between the first end and the second end, the guide portion being configured to come into contact with an internal wall of the hollow body so as to guide the sliding of the piston within the hollow body.

[0031] The applicator according to the invention may be monolithic, that is to say that the hollow body and the refill form a single piece.

[0032] Alternatively, according to one embodiment, the refill is removably mounted on the distal end of the hollow body. This latter embodiment allows for longer and more environmentally friendly use, since it allows only the refill to be changed when all the composition has been consumed.

[0033] The refill can be mounted on the hollow body thanks to the cooperation of complementary locking members positioned on the refill and the hollow body.

[0034] According to one embodiment, the refill is mounted on the distal end of the hollow body by cooperation between at least one male locking member and at least one female locking member positioned on the hollow body and the refill, a first angular position allowing the male locking member to be introduced into the female locking member, and a second angular position, different from the first angular position, allowing locking of the male locking member in the female locking member.

[0035] According to one embodiment, the first end of the piston comprises a connection member configured to cooperate with a display element allowing a display of a region of the body pathway when the display element is mounted on the connection member.

[0036] The visualization member allows better visualization of the bodily route by the user and helps to facilitate access to the bodily route by the user who wishes to self-administer the composition.

[0037] According to another aspect, the invention relates to a refill for an applicator as described above, in which the refill comprises:

[0038] - an internal reservoir including at least one dose of the composition,

[0039] - a distal tip connected to the internal reservoir, the distal tip being configured to deliver said at least one dose into the body,

[0040] - a guide surface extending along the longitudinal axis, the guide surface delimiting at least in part the internal reservoir,

[0041] the refill being configured to be mounted on the distal end of the hollow body of the applicator so that the second end of the piston comprising the pushing member can slide in the guide surface in order to deliver the at least one dose.

[0042] According to one embodiment, the refill further comprises a transmission member mounted in the guide surface so as to slide in the internal reservoir, the transmission member being configured to be in contact with the thrust member at least when the piston is actuated to slide from the high position to the low position.

[0043] The refill is thus provided so that the transmission member is pre-inserted into the guide surface and thus closes the upper opening of the internal reservoir. The composition is thus never exposed to the external environment and does not risk being contaminated. In particular, the composition never comes into direct contact with the piston, which limits cross-contamination between applications of the different doses of composition.

[0044] According to one embodiment, the refill is configured to be mounted on the distal end of the hollow body by cooperation between at least one male locking member and at least one female locking member positioned on the hollow body and the refill, a first angular position allowing the male member to be introduced into the female member, and a second angular position, different from the first angular position, allowing locking of the male member in the female member.

[0045] According to another aspect, the invention relates to a kit comprising an applicator as described previously and at least one refill as described previously.

[0046] According to one embodiment, the kit further comprises a visualization element configured to allow visualization of a region of the body pathway when the visualization element is mounted on the connection member.

[0047] In particular, the visualization element makes it possible to improve the comfort of the user by increasing his ability to visualize the region of the body route. This applies to the user who wishes to administer the composition himself or to a third party who wishes to visualize a body route that is difficult to access, such as, for example, the interior of the oral cavity.

[0048] According to one embodiment, the kit further comprises a box intended to contain at least the applicator, the at least one refill and the display element.

[0049] According to another aspect, the invention relates to a method for delivering at least one dose of a composition with the applicator described above, the method comprising the actuation, by the user, of the first end of a piston of the applicator, so as to slide the piston along a longitudinal axis between a high position and a low position, a thrust member included in the second end of the piston being configured to slide in the guide surface in order to deliver the at least one dose via a distal tip.

[0050] According to one embodiment, the method is a method of delivering at least one dose of a composition intended to form a barrier in a bodily pathway.

[0051] According to one embodiment, the method is a method of delivering at least one non-therapeutic and non-prophylactic dose of a composition intended to form a barrier in a bodily pathway.

[0052] For example, the composition is intended to form an impermeable barrier to at least one of sound, air, water, particles, odors, gases, bodily fluids such as saliva, urine, tears, sweat, mucus or vaginal secretions and other sexual fluids. The composition may also form a plug at the cervix to limit the flow of blood flow caused by menstruation. The composition may also aim to improve comfort during sexual intercourse by lining the walls of the bodily passageway. The composition may also aim to improve ocular comfort. The composition may also aim to limit sweating.

[0053] According to another aspect, the invention relates to a method of preventing at least one infection in at least one bodily pathway in a subject, the method comprising administering at least one dose of a composition into the at least one bodily pathway of the subject with an applicator as described above, so as to form a barrier in the at least one bodily pathway.

[0054] According to the invention, the administration can be carried out in one or more bodily routes of the subject. Similarly, several administrations can take place at several injection sites of the bodily route. DESCRIPTION OF FIGURES

[0055] [Fig. 1] is an exploded view of an applicator according to a first embodiment of the invention,

[0056] [Fig.2] is an exploded view of an applicator according to a second embodiment of the invention,

[0057] [Fig.3] is a perspective view of the hollow body of the applicator of [Fig.2],

[0058] [Fig.4] is a front view of the piston of the applicator of [Fig.2],

[0059] [Fig.5] is a side view of the piston of the applicator of [Fig.2],

[0060] [Fig.6] is a front view of the piston of the applicator of [Fig.l],

[0061] [Fig.7] is a front sectional view of the refill of the applicator of [Fig.2],

[0062] [Fig.8] is a perspective view of the refill of [Fig.7],

[0063] [Fig.9] is a front sectional view of the refill of the applicator of [Fig.l],

[0064] [Fig. 10] is a front sectional view of the applicator of [Fig.l], in which the refill is visible,

[0065] [Fig. 11] is a front view of the transmission member of the applicator of [Fig.2],

[0066] [Fig. 12] is a front sectional view of an applicator according to a third embodiment, comprising a transmission member according to a second embodiment,

[0067] [Fig. 13] is a perspective view of the applicator cap of [Fig.2],

[0068] [Fig. 14] is a front sectional view of the plug of [Fig. 13],

[0069] [Fig. 15] is a top view of the cap of [Fig. 13],

[0070] [Fig. 16] is a front view of the display member of [Fig.2],

[0071] [Fig. 17] is a perspective view of the applicator of [Fig.l], cooperating with a the display organ of [Fig. 16],

[0072] [Fig. 18] is a side view of the applicator and viewing member of [Fig.17],

[0073] [Fig. 19] is a front view of the kit according to one embodiment of the invention, and

[0074] [Fig.20] is a perspective view of the kit of [Fig. 18], according to a configuration of easel. ILLUSTRATIVE EMBODIMENTS OF THE INVENTION

[0075] The following detailed description will be better understood when read in conjunction with the drawings. For purposes of illustration, the applicator of the invention is shown in preferred embodiments. It should be understood, however, that the present invention is not limited to the arrangements, structures, features, embodiments and aspects specifically shown hereinafter. The drawings are not necessarily to scale and are not intended to limit the scope of the claims to the embodiments shown. Accordingly, it should be understood that where features recited in the appended claims are followed by reference signs, such signs are included solely for the purpose of enhancing the intelligibility of the claims and in no way limit their scope.

[0076] As illustrated in [Fig.l] and [Fig.2], the applicator 100, 101 according to the invention has a hollow body 10, within which a piston 20 slides. The piston 20 cooperates directly or indirectly with a refill 30 in order to deliver at least one dose of a composition 37 into a bodily route. The applicator 100, 101 may for example have a total length of between 5 cm and 30 cm.

[0077] As illustrated in [Fig. 3], the hollow body 10 has an envelope extending around an axis A and taking for example the form of a cylinder or a hollow flattened cylinder. The envelope thus defines an external wall 14 and an internal wall 15 intended to receive the piston 20.

[0078] The envelope typically has a thickness of between 0.5 mm and 5 mm, a height of between 50 mm and 70 mm, and preferably a height of 63.5 mm.

[0079] The envelope may have a diameter which decreases between a proximal end 11 and a distal end 12. The proximal end 11 may have a flared shape, the width of which is between 20 mm and 30 mm, typically 25 mm, and the distal end 12 may have a narrower width, between 10 mm and 20 mm, typically 15 mm.

[0080] The hollow body 10 further has an upper opening intended to receive the piston 20 and in particular the head 25 of the piston. The hollow body 10 also has a lower opening intended to allow the passage of the second end 22 of the piston and in particular the thrust member 27, outside the hollow body 10. Alternatively, the lower opening can be configured to allow the passage of a transmission member 40.

[0081] The hollow body 10 also has at least one locking member 13 allowing the cooperation and blocking of a refill 30 on the hollow body 10.

[0082] The hollow body 10 can be made of a lightweight, biocompatible material that is resistant to frequent use, such as Styrene-based polymers (e.g. Acrylonitrile butadiene styrene (ABS), Poly(styrene / butadiene) (SB), Acrylonitrile styrene acrylate (ASA)) or polypropylene, polyethylene, polyester, polycarbonate, polyamide, aluminum, stainless steel, ceramics or certain natural species such as wood. It can for example be obtained by a molding, machining, sintering, electroforming or material addition process such as 3D printing.

[0083] As illustrated in [Fig.4], [Fig.5] and [Fig.6], the piston 20 extends along an axis A' which coincides with the axis A when the piston 20 is mounted in the hollow body 10. The piston 20 extends along the axis A' between a first end 21 and a second end 22 over a height of between 60 mm and 80 mm, typically 70 mm.

[0084] At the first end 21, the piston 20 has a head 25 intended to be held in the hand and actuated by the user, for example by pressing at least one finger on the head 25. The head 25 may have a cylinder shape with a diameter of between 15 mm and 25 mm, typically 22.5 mm and a thickness of between 1 mm and 5 mm. The head 25 may have any other shape allowing actuation by the user and sliding in the hollow body 10 without changing the invention.

[0085] The head 25 may also have one or more material recesses making it possible to lighten the structure and limit the quantity of material used for its manufacture.

[0086] At the second end 22, the piston has a terminal portion 26 forming a thrust member 27 intended to cooperate directly or indirectly with the refill 30 to deliver at least one dose of the composition 37.

[0087] In the embodiment of [Fig.6], the thrust member 27 has, for example, a tapered shape whose length is at least 10 times greater than its width. The thrust member 27 thus extends over a length of between 10 mm and 30 mm and has a width of between 0.5 mm and 3 mm. The thrust member 27 can take a parallelepiped shape or a tubular or flattened tubular shape.

[0088] The piston 20 of the embodiment of [Fig. 6] is configured to cooperate directly with a refill 30 and more precisely to penetrate directly into an internal reservoir 33 of the refill 30 to exert a force allowing the expulsion of the dose of the composition 37 present in the internal reservoir 33. For this purpose, the pushing member 27 is preferably sized to slide in the internal reservoir 33. The pushing member 27 thus comes into contact with the internal wall of the internal reservoir 33, as illustrated for example in [Fig. 10]. In order to minimize the friction of the thrust member 27 against the internal wall of the internal reservoir 33, a coating, for example made of Teflon, or a surface treatment may be added to the thrust member 27. Similarly, the dimensions of the thrust member 27 and of the internal reservoir 33 are preferably chosen in order to minimize the lateral movements of the thrust member 27, thus reducing the friction.

[0089] In the embodiment of [Fig.4] and [Fig.5], the thrust member 27 has a wider and shorter shape than in the embodiment of [Fig.6]. The thrust member 27 thus extends over a length of between 5 mm and 30 mm and has a width of between 2 mm and 5 mm, typically 3.5 mm. The thrust member 27 may take a parallelepiped shape or a tubular or flattened tubular shape.

[0090] The piston 20 of the embodiment of Figures 4 and 5 is configured to cooperate with a transmission member 40, which is itself configured to penetrate directly into the internal reservoir 33 of the refill 30 to exert a force allowing the expulsion of the dose of the composition 37 present in the internal reservoir 33. For this purpose, the lower end of the thrust member 27 comprises a bearing surface configured to optimize the transfer of the thrust exerted on the piston 20 to the transmission member 40. The cooperation between the thrust member 27 and the transmission member 40 can be carried out by simple contact or by a locking system such as a screwing system, ratchet, snap-fastening, bayonet, lever locking, magnet or a combination of the systems mentioned above.

[0091] Between the first end 21 and the second end 22 of the piston 20, there is a guide portion 23 configured to guide the sliding of the piston 20 within the hollow body 10. For this purpose, the guide portion 23 has at least one section 29 with an enlarged diameter of between 15 mm and 25 mm. The sections 29 of the guide portion 23 are dimensioned to come into contact with the internal wall 15 of the hollow body 10, as illustrated for example in [Fig. 10]. In order to minimize the friction of the sections 29 against the internal wall 15 of the hollow body 10, a coating for example made of Teflon, a surface treatment and / or a lubricant may be added. on sections 29. Similarly, the dimensions of sections 29 and of the internal wall 15 are preferably chosen so as to minimize lateral movements of the piston 20, thus reducing friction.

[0092] When mounted in the hollow body 10, the piston 20 can slide to a high position, in which the first end 21 and in particular the head 25 of the piston 20 protrudes by a first distance from the proximal end 11 of the hollow body 10. The first distance is between 5 mm and 35 mm. In this high position, the thrust member 27 can be completely retracted into the distal end 12 of the hollow body 10 and not protrude from the distal end 12. Alternatively, the thrust member 27 can protrude from the distal end 12 of the hollow body 10 by a length of between 5 mm and 35 mm. Typically, the thrust member 27 can be at a first length of between 5 mm and 35 mm from the distal end 12.

[0093] The piston 20, when actuated by the user, slides to a low position, in which the first end 21 and in particular the head 25 of the piston 20 protrudes by a second distance from the proximal end 11 of the hollow body 10. The second distance is less than the first distance and is between 5 mm and 35 mm. In the low position, the pushing member 27 according to the embodiment of [Fig. 1] protrudes from the distal end 12 by a length of between 5 mm and 35 mm. The pushing member 27 according to the embodiment of [Fig. 2] does not protrude from the distal end 12 but is brought closer to the distal end 12 compared to the high position. Typically, the pushing member 27 is at a second length of between 5 mm and 35 mm from the distal end 12, the second length being smaller than the first length.According to other embodiments, when passing between the high position and the low position, the pushing member 27 can either remain within the hollow body 10, or exit the hollow body 10, or already be exited from the hollow body 10 from the high position and move away from the distal end 12 of the hollow body 10 when passing to the low position.

[0094] The piston 20 can be made in one piece or in several elements secured together. Similarly, the piston 20 can be made of one or more materials, preferably light, biocompatible and resistant to frequent use, such as Styrene-based polymers (eg Acrylonitrile butadiene styrene (ABS), Poly(styrene / butadiene) (SB), Acrylonitrile styrene acrylate (ASA)) or even polypropylene, polyethylene, polyester, polycarbonate, polyamide, aluminum, stainless steel, ceramics or certain natural species such as wood.

[0095] The piston 20 can be obtained by a molding, machining, sintering, electroforming or material addition process such as 3D printing.

[0096] As illustrated in [Fig.7], [Fig.8], [Fig.9] and [Fig. 10], the refill 30 comprises an internal reservoir 33 comprising at least one dose of the composition 37.

[0097] The dose has a volume of between 0.05 mL and 10 mL. Preferably, the internal reservoir 33 is configured to contain a single dose. Alternatively, the internal reservoir 33 may be configured to deliver multiple doses.

[0098] The internal reservoir 33 is in the form of an enclosure, for example of tubular shape, extending along an axis A”, which coincides with the axis A when the refill is mounted on the hollow body 10. The internal reservoir 33 has a height of between 5 mm and 35 mm and an internal diameter of between 1 mm and 5 mm, and preferably 2.5 mm. The internal reservoir 33 is delimited at an upper end by a guide surface 31.

[0099] According to a first embodiment, illustrated in [Fig. 9] and [Fig. 10], the guide surface 31 is in the form of an opening through which the pushing member 27 penetrates to come into direct contact with the composition 37 contained in the internal reservoir 33. The pushing member 27 thus slides over a distance of between 5 mm and 20 mm in the internal reservoir 33 so as to push the composition 37 out of the internal reservoir 33 and in particular in the direction of a distal tip 32.

[0100] According to a second embodiment, illustrated in [Fig.7] and [Fig.8], the guide surface 31 is in a tubular form, extending along the axis A”, which coincides with the axis A when the refill is mounted on the hollow body 10. The guide surface 31 thus extends the internal reservoir 33. For this purpose, the guide surface 31 may have the same internal diameter as the internal diameter of the internal reservoir 33. The guide surface 31 does not, however, contain composition 37. The guide surface 31 also has a height of between 5 mm and 35 mm.

[0101] The guide surface 31 may be configured to receive a transmission member 40 and allow it to slide along an internal wall of the transmission member 40 and also in the internal reservoir 33. The transmission member 40 thus slides over a distance of between 5 mm and 20 mm in the guide surface 31 and the internal reservoir 33, so as to push the composition 37 out of the internal reservoir 33 and in particular in the direction of the distal tip 32.

[0102] The refill 30 further comprises a distal tip 32 connected to the internal reservoir 33 and configured to deliver the dose into the body pathway. For this purpose, the tip is sized to allow, if necessary, its secure penetration into the body pathway in order to guarantee delivery of the entire dose without losses.

[0103] In the case of application of the urethra, as illustrated in Figures 7 and 8, the distal tip 32 has a substantially tubular shape with a length of between 4 mm and 10 mm and preferably 7 mm, with an external diameter of between 2 mm and 4 mm and preferably 3.3 mm and with an internal diameter of between 0.2 mm and 1.5 mm, typically 1 mm. The distal tip 32 preferably has rounded edges and fillets instead of edges, so as to ensure user comfort when inserting the distal tip 32 into the body passage.

[0104] The distal tip 32 may have a guard intended to stop the progression of the distal tip 32 in the body pathway at a sufficient insertion distance for administration. The guard is an additional element making it possible to inform the user about the safety of his action.

[0105] Furthermore, the distal tip 32 is preferably covered with a lubricating fluid to facilitate insertion of the distal tip 32 into the body passage. The distal tip 32 may also have a garment, for example made of Teflon, or a surface treatment to minimize friction.

[0106] According to one embodiment, the assembly formed by the hollow body 10 and the refill is monolithic so that when the internal reservoir 33 is empty, the entire applicator 100, 101 is changed.

[0107] Alternatively, the refill 30 may be removable so that it is possible to change the refill 30 when the internal reservoir 33 is empty.

[0108] For this purpose, the refill 30 has at least one locking member 34 allowing the refill 30 to cooperate and be locked on the hollow body 10.

[0109] The cooperation between the refill 30 and the hollow body 10 can for example be carried out by a screwing, ratchet, snap-fastening, bayonet, lever locking, magnet or a combination of the systems mentioned above.

[0110] For this purpose, the refill 30 may be provided with female locking members cooperating with male locking members positioned on the hollow body 10 or conversely, the refill 30 may be provided with male locking members cooperating with female locking members positioned on the hollow body 10.

[0111] Typically, the cooperation between the refill 30 and the hollow body 10, as illustrated in [Fig.l] and [Fig.2] is carried out by inserting male locking members 34 positioned on the refill 30 into female locking members positioned on the hollow body 10, then rotating the male locking members of the refill 30 through an angle of between 0 degrees and 90 degrees in the female locking members of the hollow body 10, between a first angular position and a second angular position.

[0112] To do this, the male locking members 34 are for example fins (see [Fig.9]) or lugs (see [Fig.8]) positioned on the periphery of the refill 30, typically at the level of the external casing of the internal reservoir 33. These fins and lugs are designed to fit into complementary grooves or cavities present on the female locking member of the hollow body 10. Typically, the locking members of the hollow body 10 are locking lugs preventing the removal of the refill 30 when the male locking members 34 are in the second angular position.

[0113] The locking mechanism may in particular be designed to be easily operated with one hand, if necessary.

[0114] Additionally, the refill 30 may include elements 35 intended for the attachment of a cap 60 to cover the distal tip 32.

[0115] The refill 30 may also comprise a seal 70 located in the guide surface 31. The seal 70 makes it possible to guarantee a seal necessary for precise control of the dosage of the composition 37 administered, as well as to maintain the sterility of the composition 37.

[0116] The refill 30 can be made in one piece or in several elements secured together. Similarly, the refill 30 can be made of one or more materials, preferably light, biocompatible and resistant to frequent use, such as Styrene-based polymers (eg Acrylonitrile butadiene styrene (ABS), Poly(styrene / butadiene) (SB), Acrylonitrile styrene acrylate (ASA)) or even polypropylene, polyethylene, polyester, polycarbonate, polyamide, aluminum, stainless steel, ceramics or certain natural species such as wood.

[0117] The refill 30 can be obtained by a molding, machining, sintering, electroforming or material addition process such as 3D printing.

[0118] As illustrated in [Fig.11] and in [Fig.12], the transmission member 40 is configured to be in contact with the thrust member 27 at least when the piston 20 is actuated to slide from the high position to the low position.

[0119] For this purpose, the transmission member 40 has a body 41 of substantially tubular shape, with a length of between 10 mm and 20 mm, typically 14 mm and a diameter of between 2 mm and 4 mm. The body 41 is preferably sized to slide in the internal reservoir 33. The body 41 thus comes into contact with the internal wall of the internal reservoir 33, as illustrated for example in [Fig. 12]. In order to minimize the friction of the body 41 against the internal wall of the internal reservoir 33, a coating for example made of Teflon or a surface treatment can be added to the body 4L. Similarly, the dimensions of the body 41 and the internal reservoir 33 are preferably chosen in order to minimize the lateral movements of the body 41, thus reducing the friction.

[0120] The transmission member 40 may have an upper part intended to come into contact with the piston 20, in particular via a receiving surface 45 configured to optimize the transfer of the thrust exerted by the piston 20, via the bearing surface of the thrust member 27, on the transmission member 40. The transmission member 40 also has a lower part intended to come into contact with the composition 37.

[0121] At the upper part, the transmission member 40 may further have guide elements cooperating with complementary guide elements positioned on the guide surface 31.

[0122] Typically, the guide elements of the transmission member 40 are fins 34 intended to slide in grooves 38 formed along the axis A” of the guide surface 31 (see [Fig.8]). Preferably, the fins 34 do not exceed the width of the grooves 38 so that the user cannot actuate the transmission member 40 and deliver the dose of the composition 37 without the aid of the piston 20.

[0123] At the lower part, the transmission member 40 may for example have a terminal portion 44 of cylindrical, curved or even conical shape.

[0124] The transmission member 40 preferably has a narrowing 43 allowing the addition of a seal 70, as illustrated on the applicator 102 of [Fig. 12]. The seal 70 makes it possible to guarantee a seal necessary for precise control of the dosage of the composition 37 administered.

[0125] The transmission member 40 can be made in one piece or in several elements secured together. Similarly, the transmission member 40 can be made of one or more materials, preferably light, biocompatible and resistant to frequent use, such as Styrene-based polymers (eg Acrylonitrile butadiene styrene (ABS), Poly(styrene / butadiene) (SB), Acrylonitrile styrene acrylate (ASA)) or even polypropylene, polyethylene, polyester, polycarbonate, polyamide, aluminum, stainless steel, ceramics or certain natural species such as wood.

[0126] The transmission member 40 can be obtained by a molding, machining, sintering, electroforming or material addition process such as 3D printing.

[0127] As illustrated in [Fig.l] and 2, [Fig.13], [Fig.14] and [Fig.15], the applicator 100, 101 may include a cap 60 configured to cover the distal tip 32 and thus protect it from contamination. The cap 60 also prevents the lubricant covering the distal tip 32 from drying out during a minimum shelf life of the refill 30. The cap 60 advantageously attaches tightly to the refill 30.

[0128] For this purpose, the cap 60 has a substantially parallelepipedal external envelope 61. Roundings and fillets may be present in place of the edges. The lower end of the cap 60 is closed, while the upper end of the cap 60 has an opening configured to cooperate with the refill 30 to fix the cap 60 on the refill 30. To do this, the upper end of the cap 60 has a shape complementary to the elements 35 positioned on the refill 30. The cap 60 can thus be force-fitted around the elements 35. Alternatively, a locking mechanism can be integrated to strengthen the connection between the cap 60 and the refill 30. This locking mechanism can, for example, take the form of notches or grooves.

[0129] The lower end includes a projection 62 having a height of between 7 mm and 10 mm, typically equal to or slightly less than the height of the distal tip 32. The projection has a shape complementary to the shape of the distal tip 32 and is configured to prevent the lubricant present on an external wall of the distal tip 32 from drying out.

[0130] At the center of the lower end, the stopper 60 has a lug 63 whose diameter is sized to penetrate a portion of the length of the distal tip 32 and plug the distal tip 32, thus preventing the composition 37 from escaping from the refill 30 or drying out and also preventing the composition 37 from coming into contact with the lubricant present on the external wall of the distal tip 32.

[0131] The cap 60 can be made of a deformable, biocompatible material that is resistant to frequent use, such as Styrene-based polymers (e.g. Acrylonitrile butadiene styrene (ABS), Poly(styrene / butadiene) (SB), Acrylonitrile styrene acrylate (ASA)) or polypropylene, polyethylene, polyester, polycarbonate, polyamide, aluminum, stainless steel, ceramics or certain natural species such as wood. It can for example be obtained by a molding, machining, sintering, electroforming or material addition process such as 3D printing.

[0132] The applicator 100, 101 according to the invention can cooperate with a display element 50 allowing the user himself to display the region of the body pathway which is the site of administration of the composition 37. The display element 50 thus aims to facilitate self-administration by the user himself or by a third party of the composition 37, in particular in areas which are difficult to access and display.

[0133] As illustrated in [Fig.16], [Fig.17] and [Fig.18], the viewing element 50 typically comprises a viewing area 52 occupied by a mirror or a screen on which at least one image captured by a camera integrated into the viewing element 50 is retransmitted. The viewing area 52 has for example a circular shape with a diameter between 55 mm and 65 mm, preferably 60 mm. The viewing area 52 is integrated into a support 51 configured to protect the viewing area 52 from shocks and other risks of damage. The support 51 has for example a circular or oval shape with a diameter greater than the diameter of the viewing area 52, for example between 45 mm and 75 mm, preferably 70 mm.

[0134] Alternatively, the viewing element may comprise two elements: a first element comprising a camera that can be arranged so as to image the administration area and a second element comprising a screen for viewing the administration area. For example, the camera is arranged directly on the applicator 100, 101, 102. The two elements may be independent so that the second element can be positioned at eye level to facilitate user comfort. The second element may for example be a smartphone or a tablet.

[0135] The display element 50 further has a thickness of between 3 mm and 5 mm.

[0136] The support 51 is extended by a connecting member 53 in the form of a tubular rod with a length of between 5 mm and 12 mm and a diameter of between 1 mm and 10 mm, preferably 5 mm.

[0137] To cooperate with the display element 50, the head 25 of the piston 20 comprises a connection member 24 allowing the display element 50 to be mounted on the head 25 of the piston 20. Preferably, the display element 50 is mounted so as to be held on the head 25, while allowing the display element 50 to be oriented by the user to improve the viewing of the administration zone of the composition 37.

[0138] As illustrated in [Fig. 5], the connection member 24 is an orifice passing through the head 25. The orifice may take a polygonal shape, but preferably, to allow the orientation of the display element 50, the orifice has a circular shape with a diameter of between 3 mm and 10 mm. In order to reinforce the retention of the display element 50 in the orifice, the latter may extend over a thickness greater than the thickness of the head 25, in particular via a tubular reinforcement 28 visible in [Fig. 5]. The tubular reinforcement extends over a length of between 1 mm and 3 mm, so that the total length of the orifice is between 5 mm and 12 mm.

[0139] The display element 50 may have a notch (not shown) on the connecting member 53. The notch also makes it possible to extend the stroke of the piston and optionally to guarantee a certain degree of rotation of the display element 50 once the piston 20 has completely retracted into the body 10 and the dose of composition 37 has been delivered.

[0140] Advantageously, the display element 50 is oriented so as to form an angle α of between 5 degrees and 25 degrees defined between a longitudinal axis M of the display element 50 and the vertical V. This angle allows optimal viewing of the body path by the user.

[0141] The invention also relates to a kit 1000 illustrated in [Fig. 19] and [Fig. 20]. The kit 1000 comprises the applicator 100, 101 and at least one refill 30. As for example, the kit 1000 may comprise one refill 30, two refills 30, three refills 30 or even five refills 30 and up to ten refills 30, as illustrated in Figures 19 and 20. The refills 30 may be packaged in packaging to guarantee the user the absence of contamination of the composition 37 contained in the refills 30.

[0142] Optionally, the kit 1000 may also include the display element 50 and / or a lamp 80.

[0143] The various constituent elements of the kit 1000 may be packaged in a box 1001 comprising a base 1002 and a cover 1003 connected by at least one hinge 1004. The base 1002 may for example comprise the light 80 and the display element 50, while the cover 1003 may comprise the applicator 101 and the refills 30. The closed box 1001 may have a parallelepiped or cylindrical shape, with a length of between 100 mm and 150 mm, a width of between 100 mm and 140 mm and a thickness of between 30 mm and 50 mm.

[0144] The various constituent elements of the kit1000 can be held in the box 1001 using holding elements 1006 such as deformable lugs.

[0145] The hinge 1004 of the box 1001 can be pivoted between an angle of between 0 degrees and 330 degrees so that the box 1001 can be positioned as an easel, the upper faces 1007, 1008 of the base 1002 and the cover 1003 being configured to rest on a flat surface such as a table or the floor. The box, in its easel configuration, can then be positioned so as to be able to orient the viewing element 50 and / or the lamp 80, still held in the box 1001 by means of the holding elements 1006, towards the region of the body pathway, in order to allow the user to better view the body pathway and thus facilitate the insertion of the applicator 100, 101.Typically, a locking system may allow the cabinet to be positioned in the easel configuration so that the viewing element 50 integrated into the base 1002 or the cover 1003 allows optimal viewing of the body path.

[0146] When using the applicator 100, 101, a user takes a refill 30 and mounts it on the hollow body 10. Optionally, to do this, he can open the packaging of the refill 30 and / or remove the cap 60. The piston is then armed in the high position. The user then inserts the distal tip 32 into the body passage. To do this, the user can use the display element 50 and / or the lamp. Then, the user presses on the head 25 of the piston 20, so as to slide the piston 20 in the hollow body 10, from the high position to the low position, thus releasing the dose of the composition 37 into the body passage. Once the dose has been delivered, the user can remove the used refill 30 and discard it.

Claims

Claims

1. Applicator (100, 101, 102) for delivering at least one dose of a composition (37) into a body passage of a user, the applicator (100, 101, 102) comprising: - a hollow body (10) extending along a longitudinal axis (A), the hollow body (10) comprising a proximal end (11) and a distal end (12); - a piston (20) positioned in the hollow body (10), the piston (20) extending along the longitudinal axis (A) between a first end (21) and a second end (22), the first end (21) being intended to be actuated by the user to slide the piston (20) along the longitudinal axis (A) between a high position and a low position, - a refill (30) comprising: • an internal reservoir (33) including at least one dose of the composition (37), • a distal tip (32) connected to the internal reservoir,the distal tip being configured to deliver said at least one dose into the body pathway, • a guide surface (31) extending along the longitudinal axis (A), the guide surface at least partly delimiting the internal reservoir (33), the applicator (100, 101, 102) having a mounted state, in which the refill (30) is mounted on the distal end (12) of the hollow body (10), the second end (22) of the piston (20) comprising a thrust member (27) configured to slide in the guide surface (31) in order to deliver the at least one dose.,

2. Applicator (100, 101, 102) according to claim 1, wherein the piston (20) comprises an end portion (26) forming the thrust member (27), the end portion (26) being configured to penetrate into the internal reservoir (33).

3. Applicator (100, 101, 102) according to claim 1, in which the refill (30) comprises a transmission member (40) mounted in the guide surface (31) so as to slide in the reservoir internal (33), the transmission member (40) being arranged to be in contact with the thrust member (27) at least when the piston (20) is actuated to slide from the high position to the low position.

4. Applicator (100, 101, 102) according to one of claims 1 to 3, wherein the piston (20) comprises a guide portion (23), positioned between the first end (21) and the second end (22), the guide portion (23) being configured to come into contact with an internal wall (15) of the hollow body (10) so as to guide the sliding of the piston (20) within the hollow body (10).

5. Applicator (100, 101) according to one of claims 1 to 4, in which the refill (30) is removably mounted on the distal end (12) of the hollow body (10).

6. Applicator (100, 101, 102) according to one of claims 1 to 5, wherein the refill (30) is mounted on the distal end (12) of the hollow body (10) by cooperation between at least one male locking member (13) and at least one female locking member (34) positioned on the hollow body (10) and the refill (30), a first angular position allowing the male locking member (13) to be introduced into the female locking member (34), and a second angular position, different from the first angular position, allowing locking of the male locking member (13) in the female locking member (34).

7. Applicator (100, 101, 102) according to one of claims 1 to 6, in which the first end (21) of the piston (20) comprises a connection member (24) configured to cooperate with a display element (50) allowing a display of a region of the body pathway when the display element (50) is mounted on the connection member (24).

8. Refill (30) for applicator (100, 101, 102) according to one of claims 1 to 7, in which the refill (30) comprises: - an internal reservoir (33) including at least one dose of the composition (37), - a distal tip (32) connected to the internal reservoir (33), the distal tip (32) being configured to deliver said at least one dose into the body, - a guide surface (31) extending along the longitudinal axis (A), the guide surface (31) at least partially delimiting the internal reservoir (33), the refill (30) being configured to be mounted on the distal end (12) of the hollow body (10) of the applicator (100, 101, 102) so that the second end (22) of the piston (20) comprising the pushing member (27) can slide in the guide surface (31) in order to deliver the at least one dose.

9. Refill (30) according to claim 8, wherein the refill (30) further comprises a transmission member (40) mounted in the guide surface (31) so as to slide in the internal reservoir (33), the transmission member (40) being configured to be in contact with the thrust member (27) at least when the piston (20) is actuated to slide from the high position to the low position.

10. Refill (30) according to one of claims 8 or 9, wherein the refill (30) is configured to be mounted on the distal end (12) of the hollow body (10) by cooperation between at least one male locking member (13) and at least one female locking member (34) positioned on the hollow body (10) and the refill (30), a first angular position allowing the male member (13) to be introduced into the female member (34), and a second angular position, different from the first angular position, allowing locking of the male member (13) in the female member (34).

11. Kit (1000) comprising an applicator (100, 101, 102) according to one of claims 1 to 7 and at least one refill (30) according to one of claims 8 to 10.

12. The kit (1000) of claim 11, wherein the kit (1000) further comprises a viewing element (50) configured to enable viewing of a region of the body pathway when the viewing element (50) is mounted on the connecting member (24).

13. Kit (1000) according to claim 11 or 12, wherein the kit (1000) further comprises a case (1001) intended to contain at least the applicator (100, 101, 102), the at least one refill (30) and the display element (50).

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