SE542450C2 - Applicator device for epicuteanous administration of medicaments - Google Patents

Abstract

An applicator device (100) for a medicament in paste, semi liquid or liquid form is disclosed. The applicator device (100) comprises a sleeve (101) with a distal end (102), configured for output of the medicament. The medicament can be confined in a lumen (103) and pressurized to move towards the distal end (102). An annular flange (104) is arranged at the distal end (102) of the sleeve (101) to form an applicator surface to be positioned towards the skin of a user for distribution of the medicament on the skin. A membrane (106) is configured to be permeable to the medicament. The membrane (106) is arranged across the lumen (103) at the distal end (102) and configured to be deflected from a plane (107) in which the applicator surface of the annular flange (104) extends when the medicament is subjected to a user induced pressure.

Description

lO APPLICÅTOR DEVICE FOR EPICUTEANOUS ADMINISTRATION OFMEDICAMENTS Technical Field The present invention relates to an applicator device for epicutaneousadministration of a medicament in paste, semi liquid or liquid form.

Background A medicament in paste, semi liquid or liquid form, e.g. a cream, ointments,or liquid plaster, may be applied to the skin of a patient, i.e. administeredepicutaneusly, to initiate transdermal administration of an active drug of themedicament to cause systemic exposure, or to cause a local effect, e.g.alleviate local pain, improve wound healing or anaesthetize a skin area. Such amedicament is normally stored in a tube or a small cup. Typically, the userejects the medicament from the tube, applies it on the skin and smears it overan area with a finger or hand. There are several disadvantages with thisprocess. For example, the user, which may be a nurse or doctor, may sufferundesired exposure to active drugs. Furthermore, the medicament may becontaminated with micro-organisms by the contact with the person handling themedicament.

SE 1530112-0 discloses a disposable container, comprising an open firstend, provided with a closing cover, suitable for output of a medicine in paste orsemi liquid form. An annular flange at the open first end is arranged to form anattach surface for a closing cover and to form an applicator for the distribution ofthe medicine to the skin of a user. The annular flange further comprises a partwith a straight edge for manipulation of the medicine. Disadvantages of thedevice according to SE 1530112-0 include, for example, an undesirable risk ofscraping the skin of the patient with the outer peripheral edge of the annularflange, or with the inner edge constituting the transition between the open firstend and the annular flange, during application of the medicine. Not only may thepatient feel discomfort at such an event, e.g. when a sensitive burn wound inneed of treatment is scraped. The risk of secondary infections is also increaseddue to the scraped skin. lO Hence, an improved applicator device for epicutaneous administration ofmedicaments would be advantageous, in particular allowing for avoiding moreof the above-mentioned problems, including providing for safer handling andadministration of epicutaneous medicaments.

Summary Accordingly, examples of the present invention preferably seek to mitigate,alleviate or eliminate one or more deficiencies, disadvantages or issues in theart, such as the above-identified, singly or in any combination by providing anapplicator device according to the appended patent claims.

According to a first aspect, an applicator device for a medicament in paste,semi liquid or liquid form is provided. The applicator device comprises a sleevewith a distal end, configured for output of the medicament, and a lumen, inwhich the medicament can be confined. ln use and when the medicament ispressurized, it moves towards the distal end. The lumen extends in alongitudinal direction between the distal end and an opposite proximal end. Amembrane configured to be permeable to the medicament is arranged acrossthe lumen at the distal end and configured to be deflected from a plane, whenthe medicament is subjected to a user induced pressure. The plane is extendingperpendicular to the central axis of the applicator device and comprising a distalpoint, being the most distal point of the sleeve or any extension thereof.

According to a second aspect, an applicator device is provided comprisingan applicator device according to the first aspect, further comprising an annularflange arranged at the distal end of the sleeve. Such an angular flange may, forexample, advantageously be used as an attachment surface of e.g. aremovable sealing cover that protects the membrane and optionally themedicament from the environment upon storage.

According to a third aspect, an applicator device is provided comprising anapplicator device according to the first aspect or the second aspect, wherein thelumen ends at a second surface at the proximal end, whereby the secondsurface and the sleeve forms a confined cavity being open towards the distalend. Such a confined cavity may, for example, advantageously be used for longterm storage of medicaments therein, more advantageously when combined lO with e.g. a removable sealing cover that seals the distal end from theenvironment.

According to a fourth aspect, an applicator device is provided comprisingan applicator device according to the first aspect or the second aspect, whereinthe proximal end is configured to be engaged with a dispensing end of acontainer configured to hold medicament. Advantageously, an applicator deviceaccording to this fourth aspect may, for example, be used in combination withcontainers, used currently for storage of medicaments, to provide the user withan improved way of application without having to discard presently availablecontainers.

Further examples of the invention are defined in the dependent claims,wherein features for the second, third and fourth aspect of the disclosure is asfor the first aspect mutatis mutandis.

Some examples of the disclosure provide for an applicator device whereinat least part of the sleeve adjacent the proximal end is flexible and/or tapers in adirection from the distal end to the proximal end. Such embodiments of thesleeve may advantageously, for example, provide the applicator device withfeatures which make it user friendly and/or which enable increased access tothe comprised medicament.

Some additional examples of the disclosure provide for an applicatordevice wherein the membrane is configured to be substantially impermeable tothe medicament until a defined pressure is applied at a defined pressurethreshold. Such a substantially impermeable membrane may advantageouslyprevent undesired leakage from the applicator device until a user controlledincreased pressure triggers release of medicament therefrom. lt should be emphasized that the term "comprises/comprising" when usedin this specification is taken to specify the presence of stated features, integers,steps or components but does not preclude the presence or addition of one ormore other features, integers, steps, components or groups thereof.

Brief Description of the Drawings These and other aspects, features and advantages of which examples ofthe invention are capable of will be apparent and elucidated from the following lO description of examples of the present invention, reference being made to theaccompanying drawings, in which; Fig. 1a is a schematic illustration of an applicator device 100, in aperspective view, showing an annular flange 104, a distal point 105 and amembrane 106, at the distal end 102, and a second surface 110 at the proximalend 109, connected to the distal end 102 via a sleeve 101, according toexamples of the disclosure; Fig. 1b is a schematic illustration of the applicator device of Fig. 1a, inanother perspective view, according to examples of the disclosure; Fig. 2a is a view from the side of an applicator device 100 in a state of lowinternal pressure, showing a lumen 103, a confined cavity 111, a plane 107,which plane 107 is extending perpendicular to the longitudinal direction 108 ofthe applicator device 100, and a membrane 106, which membrane 106 is inpartial immediate connection to and located essentially proximally relative theplane 107, according to examples of the disclosure; Fig. 2b is the applicator device 100 of Fig. 2a in a state of high internalpressure, wherein medicament in the inner space of the applicator device 100 ismediating this high internal pressure to force the membrane 106 to attain aconvex configuration in partial immediate connection to and located essentiallydistally relative the plane 107, according to examples of the invention; Fig. 3a is a view from the side of an applicator device 100, with an openproximal end 109 adapted for mechanical connection by aid of e.g. internalthreads (not shown) of the inside surface 112 with a container 200 comprisingmedicament, according to examples of the invention; Fig 3b is the applicator device 100 of Fig. 3a in mechanical sealedconnection with a container 200, having an open dispensing end 201 andcomprising medicament and being put in a state of high internal pressure by auser (not shown), whereby the high internal pressure of the combined internalvolume leads to an outwards convex configuration of membrane 106 distallyrelative the plane 107, according to examples of the invention; Fig. 4a is a view from the side of an applicator device 100 comprising acutting element 113, with an open proximal end 109 adapted for mechanicalconnection by aid of e.g. internal threads (not shown) of the inside surface 112with a container 200 comprising medicament, according to examples of theinvenfion; Fig 4b is the applicator device 100 of Fig. 4a in mechanical sealedconnection with a container 200, having a dispensing end 201 which has been lO opened by penetration of the cutting element 113 through a previouslyprotecting covering film (not shown) and comprising medicament and being putin a state of high internal pressure by a user (not shown), whereby the highinternal pressure of the combined internal volume leads to an outwards convexconfiguration of membrane 106 distally relative the plane 107, according toexamples of the invention; Fig. 5 is the applicator device 100 and container 200 of Fig. 4b, comprisingan additional sealing unit 114 which prevents medicament to leak out of thecombined internal volume through any other exit but the membrane 106,according to examples of the invention; Fig. 6a and 6b are illustrations of an applicator device 100 being mountedto a container 200, in which the distal end 102 is provided with a protectivecover 6, which protective cover 6 is removably adhered to the distal surface ofannular flange 104 whereby membrane 106 is protected from contact with theenvironment, according to examples of the invention; Fig. 7a is a view from the side of an applicator device 100 in a state of lowinternal pressure, showing an annular flange 104 with a backwards bentconfiguration and a membrane 106, which membrane 106 is in partialimmediate connection to and located essentially proximally relative the plane107, according to examples of the disclosure; Fig. 7b is the applicator device 100 of Fig. 7a in a state of high internalpressure, wherein medicament in the inner space of the applicator device 100 ismediating this high internal pressure to force the membrane 106 to attain aconvex configuration with a curvature which is essentially in agreement andaligns smoothly with the curvature of the annular flange 104, according toexamples of the invention; Fig. 8a is a view from the side of an applicator device 100 in a state of lowinternal pressure, showing a distal end 102 with a rounded-off peripheral edge,according to examples of the invention; and Fig 8b is a view from the distal end 102 of the applicator device 100 of Fig.8a, further provided with a protective cover 6, removably adhered to therounded-off peripheral edge of the distal end 102, according to examples of theinvenfion.

Detailed Description lO Specific examples of the invention will now be described with reference tothe accompanying drawings. This invention may, however, be embodied inmany different forms and should not be construed as limited to the examplesset forth herein; rather, these examples are provided so that this disclosure willbe thorough and complete, and will fully convey the scope of the invention tothose skilled in the art. The terminology used in the detailed description of theexamples illustrated in the accompanying drawings is not intended to be limitingof the invention. ln the drawings, like numbers refer to like elements.

The applicator device 100 according to the invention essentially comprisesa sleeve 101 with a lumen 103 and a distal end 102, provided with a membrane106. l\/ledicament in the form of e.g. a paste, semi liquid or liquid may be placedin the inner volume of the applicator device 100, preferably such that the entireor the major part of this volume comprises such medicament. The membrane106 is essentially permeable to the form of medicament in the inner volume,when the same is subjected to a pressure which exceeds the external pressure.When the pressure in the inner volume is essentially equal to the externalpressure, the medicament may essentially be prevented from passage throughthe membrane 106, by employment of an accordingly suitable adaptedmembrane 106. The inner volume may not, when the applicator device 100 is inuse, be in connection with the external environment such that gas or liquid maybe exchanged with the same by any other means than through the membrane106. ln a state of low internal pressure, i.e. a state in which the internal pressureof the inner volume is equal to or lower than the external pressure, themembrane 106 may attain a spatial configuration in which the major part of it islocated immediately proximal relative a plane 107, which plane 107 isperpendicular to the extension of the applicator device 100 and comprising themost distal point of the sleeve 101 or any extension thereof. The applicatordevice 100 is adapted such its inner volume or the inner volume of a container200 connected thereto, may be decreased by a user. For example, the sleeve101, a second surface 110 of the applicator device 100 or a container 200connected thereto may be flexible, such as e.g. made of a flexible plastic ormetallic material known in the art. Upon a user induced pressure on such aflexible part, a state of high internal pressure is attained, i.e. a state in which theinternal pressure of the inner volume is higher than the external pressure. Sucha pressure difference causes the membrane 106, which may be resilient, tobend outwards from the applicator device 100. Hence, it may deflect from the lO plane 107 such that it becomes a site of the most distal point of the applicatordevice 100. Preferably, the distal end 102 or any extension thereof, such as e.g.an annular flange 104, may be adapted by a suitable design and spatialconfiguration, as known in the art, such that the surface of the deflectedmembrane 107, in such a state of high internal pressure, becomes the mostaccessible and suitable part of the applicator device 100 for direct contact withthe patient. Due to the permeable nature of the membrane 106 in combinationwith a state of high internal pressure, medicament is transferred from the innervolume through the membrane 106, whereby it becomes accessible on theouter surface of the membrane 106. ln practice, the user, e.g. a nurse or thepatient, may be provided with an applicator device 100 comprising medicamentin its internal volume. After removal of an optional protective cover 6, the usermay press a suitable flexible area of the applicator device 100, whereby theinternal pressure is increased, causing the membrane 106 to deflect outwardsand the medicament to become accessible on it outer surface. Typically, it maybecome obvious to the user by visual inspection, that the outer surface of themembrane 106 comprise medicament and its deflected nature may serve asfurther guidance for the following administration procedure. The outer surface ofthe membrane 106 and the medicament thereon may thereafter be applied tothe area of administration, e.g. a wound, an area of infection or normal skin,while maintaining a high internal pressure in the inner volume of the applicatordevice 100. l\/ledicament may thereby continuously leak out onto the outersurface of the membrane 106, to be transferred to the area of administrationthrough a smearing action. Throughout this process, medicament confined inlumen 103 moves in a longitudinal direction 108 towards the distal end 102.

According to one embodiment, the applicator device 100 may be providedwith a second surface 110 at the proximal end 109. A confined cavity 111 isthereby defined by this second surface 110, the sleeve 101 and the inner areaof the membrane 106. The volume of this confined cavity 111 may be adaptedmatch the volume of one dose of medicament to be administered, whereby theapplicator device 100, advantageously, may serve for one-time-useadministration of one dose of the medicament.

According to one embodiment, the proximal end 109 of the applicatordevice 100 may be configured, such as e.g. being provided with internalthreads, to be engaged with a dispensing end 201 of a container 200 configuredto hold medicament. Such a container 200 may be a standard tube with astandard dispensing end 201, such as e.g. a threaded dispensing end 201, lO currently used for normal storage of medicaments in the form of pastes orsimilar. The applicator device 100 may thus, advantageously, be employed foradministration of medicaments contained in current standard tubes with aminimization of the risk of e.g. undesired exposure to the medicament.

According to one embodiment, the proximal end 109 of the applicatordevice 100 may be configured to puncture a sealing film, element or surface ofa container 200 configured to hold medicament, when being engaged with thedispensing end 201 thereof. Current standard containers or tubes, used forstorage of medicaments in the form of pastes or similar, are commonly providedwith such a protective sealing film, element or surface for the enablement oflong term storage. For example, the applicator device 100 may be provided witha cutting element 113 configured to puncture a sealing surface 202 of thedispensing end 201 when the proximal end 109 is engaged with the dispensingend 201, such as e.g. when the dispensing end 201 is threaded onto or into theproximal end 109.

According to one embodiment, the applicator device 100 may comprise asealing unit 114 arranged inside the sleeve 101. This may be configured forapposition against the dispensing end 201 when the proximal end 109 isengaged with the dispensing end 201.

According to one embodiment, the applicator device 100 may be providedwith internal threads, for engagement with a threaded dispensing end 201, acutting element 113, for the puncturing of a sealing surface 202 of thedispensing end 201 and, optionally, with a sealing unit 114. Such a combinationallows, advantageously, for employment the applicator device 100 in theadministration of medicaments contained in a large subset of current standardtubes.

According to one embodiment, the proximal end 109 of the applicatordevice 100 may be configured to be engaged with a container 200 configured tohold medicament, by being force-fit to the dispensing end 201 of the same. Forexample, an inside surface 112 of at least part of the lumen 103 may beconfigured to be force-fit to the dispensing end 201 when the inside surface 112is pushed towards the dispensing end 201.

According to one embodiment, the membrane 106 may be configured tobe substantially impermeable to the medicament until a defined pressure isapplied at a defined pressure threshold. The skilled person will provide asuitably configured membrane 106 on basis of the understanding that it shouldremain substantially impermeable under user imposed pressures that may be lO the result of the user holding or moving the applicator device 100 for purposesother than the desire to apply medicament onto the patient. The skilled personwill furthermore readily understand which user applied force is a force that theuser may conveniently apply when having a desire to apply medicament ontothe patient, to configure the membrane 106 accordingly.

According to one embodiment, the membrane 106 may be resilient andcomprise pores and/or apertures. Suitable materials for construction of such amembrane 106 are well known in the art and include, for example, medicalrubber, resilient plastics or the like. The skilled person may be guided in theselection of material and design by the following desirable main properties:resilience to enable deflection from plane 107 at a high pressure state, pressuredependent permeability to enable throughput of medicament in a high pressurestate and no or minor throughput in a low pressure state, medical grade qualityto minimize the risk of undesired patient effects and inertness towards themedicament.

According to one embodiment, the applicator device 100 may be providedwith a flexible annular flange 104. Such a flexible annular flange 104 may,advantageously, minimize the risk of undesired mechanical interaction with thepatients skin during application of medicament, while simultaneously facilitatean even spread of the same.

The present invention has been described above with reference to specificexamples. However, other examples than the above described are equallypossible within the scope of the invention. The different features and steps ofthe invention may be combined in other combinations than those described.The scope of the invention is only limited by the appended patent claims. l\/lore generally, those skilled in the art will readily appreciate that allparameters, dimensions, materials, and configurations described herein aremeant to be exemplary and that the actual parameters, dimensions, materials,and/or configurations will depend upon the specific application or applicationsfor which the teachings of the present invention is/are used.

Claims (12)

1. An applicator device (100) for a medicament in paste, semi liquid orliquid form, comprisinga sleeve (101) comprising a distal end (102) configured for output of the medicament, a lumen (103) in which the medicament can be confined, in use, andpressurized to move towards the distal end (102), wherein the lumen (103)extends in a longitudinal direction (108) between the distal end (102) and anopposite proximal end (109), a membrane (106) configured to be permeable to the medicament,and an annular flange (104) provided with a protective cover (6) which isremovably adhered to the distal surface thereof, which annular flange (104) isarranged at the distal end (102) of the sleeve (101),wherein-the membrane (106) comprises a resilient material and a porous structurehaving pores within a defined size interval and/or a plurality of apertures havinga defined diameter; -the membrane (106) is arranged across the lumen (103) at the distal end (102)and configured to be defiected distally from and relative a plane (107), whichplane (107) is extending perpendicular to the longitudinal direction (108) of theapplicator device (100) and comprising a distal point (105), being the most distalpoint of the sleeve (101) or any extension thereof, when the medicament issubjected to a user induced pressure, i.e. the applicator device (100) being in astate of high internal pressure; -the membrane (106) has a convex configuration when the applicator device(100) is in a state of high internal pressure; and -the membrane (106) is in a spatial configuration in which the major part of it islocated immediately proximal relative the plane (107), when the applicatordevice (100) is in a state of low internal pressure, in which state of low internalpressure the inner volume of the applicator device (100) is equal to or lowerthan the external pressure.

2. Applicator device according to claim 1, wherein the lumen (103) ends ata second surface (110) at the proximal end (109), whereby the second surface (110) and the sleeve (101) forms a confined cavity (111) being open towardsthe distal end (102).

3. Applicator device according to any one of claim 1, wherein the proximalend (109) is configured to be engaged with a dispensing end (201) of acontainer (200) configured to hold medicament.

4. Applicator device according to claim 3, wherein the proximal end (109)is configured to be force-fit to the dispensing end (201).

5. Applicator device according to claim 4, wherein an inside surface (112)of at least part of the lumen (103) is configured to be force-fit to the dispensingend (201) when the inside surface (112) is pushed towards the dispensing end(201).

6. Applicator device according to any one of the precedingclaims, wherein at least part of the sleeve (101) adjacent the proximal end (109)is flexible and/or tapers in a direction from the distal end (102) to the proximalend (109).

7. Applicator device according to claim 3, wherein the proximal end (109)comprises a locking mechanism, such as threads, for interlocking with thedispensing end (201).

8. Applicator device according to any one of claims 3 to 7, comprising acutting element (113) configured to puncture a sealing surface (202) of thedispensing end (201) when the proximal end (109) is engaged with thedispensing end (201).

9. Applicator device according to claim 8, comprising a sealing unit (114)arranged inside the sleeve (101) and configured for apposition against thedispensing end (201) when the proximal end (109) is engaged with thedispensing end (201), whereby the sealing surface is fluidly sealed from thesleeve (101) when punctured.

10. Applicator device according to any one of the precedingclaims, wherein the membrane (106) is configured to be substantially impermeable to the medicament until a defined pressure is applied at a definedpressure threshold.

11. Applicator device according to any one of the precedingciaims, wherein the membrane (106) has a curvature being convex in adirection towards the skin when deflected from the plane (107).

12. Applicator device according to any one of the precedingciaims, wherein the annular flange (104) is flexible.