Patent Application
20240261551
This invention relates to microneedle patch applicator systems, docking platforms, applicator and microneedle patches, as well as methods of mounting microneedle patches on applicator and methods of applying microneedle patches.
A common technique for delivering drugs from a subject across a biological barrier is the use of a hypodermic needle, such as those used with standard syringes or catheters, to transport drugs across (through) the skin. While effective for this purpose, hypodermic needles generally cause pain; local damage to the skin at the site of insertion; bleeding, which increases the risk of disease transmission; and a wound sufficiently large to be a site of infection. The withdrawal of bodily fluids or other samples, such as for diagnostic purposes, using a conventional hypodermic needle has these same disadvantages. Hypodermic needle techniques also generally require administration by one trained in its use. The needle technique also is undesirable for long term, controlled continuous drug delivery.
Another delivery technique is the transdermal patch, which usually relies on diffusion of the drug across the skin. However, this method is not useful for many drugs, due to the poor permeability (i.e. effective barrier properties) of the skin. The rate of diffusion depends in part on the size and hydrophilicity of the drug molecules and the concentration gradient across the stratum corneum. Few drugs have the necessary physiochemical properties to be effectively delivered through the skin by passive diffusion. Lontophoresis, electroporation, ultrasound, and heat (so-called active systems) have been used in an attempt to improve the rate of delivery. While providing varying degrees of enhancement, these techniques are not suitable for all types of drugs, failing to provide the desired level of delivery. In some cases, they are also painful and inconvenient or impractical for continuous controlled drug delivery over a period of hours or days. Attempts have been made to design alternative devices for active transfer of drugs, or analyte to be measured, through the skin.
As an alternative transdermal delivery technique, microneedle patches have been developed. Microneedle patches are patches with, very small, structures, typically shorter than 1 mm, which can be pressed onto the skin of a subject and pierce the skin, see e.g. McConville, Aaron et al. “Mini-Review: Assessing the Potential Impact of Microneedle Technologies on Home Healthcare Applications.” Medicines (Basel, Switzerland) vol. 5,2 50. 8 Jun. 2018, incorporated herein by reference. Through the pierced skin, drugs or other substances may then be delivered into the body of the subject, or alternatively samples be taken from the body.
Although various types of applicators for microneedle patches are known, such as from European Patent EP 2 906 285, up to now their performance is unsatisfactory for many applications. In particular, for applicators manufactured without a pre-mounted microneedle patch, it is difficult for the person applying the microneedle patch to the subject to mount the microneedle patch on the applicator without damaging the microneedles or contaminating the sterile parts of microneedle patch.
The present invention provides microneedle patch applicator systems, docking platforms, applicators and microneedle patches, as well as methods of mounting microneedle patches on applicator and methods of applying microneedle patches as described in the accompanying claims. Specific embodiments of the invention are described in the dependent claims.
These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.
Further details, aspects and embodiments of the invention will be described, by way of example only, with reference to the drawings. In the drawings, like reference numbers are used to identify like or functionally similar elements. Elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale.
Because the illustrated embodiments of the present invention may for the most part, be implemented using materials and shapes known to those skilled in the art, details will not be explained in any greater extent than that considered necessary for the understanding and appreciation of the underlying concepts of the present invention and in order not to obfuscate or distract from the teachings of the present invention.
Referring to
The microneedle patch 3 can be coupled to the applicator 4 while the microneedle patch 3 is in a pre-application state, in which the microneedle patch 3 is not ready for application to a skin 5 of a subject. In the illustrated examples, for instance, in the pre-application state the microneedles 33 cannot penetrate the skin and/or the microneedle patch cannot be attached to the skin, in this example because the microneedles 33 and/or the skin-adhesive surface 34 of the microneedle patch 3 are covered by a removable part 30 of the microneedle patch. The pre-application state can be the original, factory condition of the microneedle patch 3 but alternatively some operations may have taken place, e.g. such as taking the microneedle patch 3 out of a packaging. The patch 3 also has a ready-for application state in which the microneedle patch 3 is ready for application to the skin of a subject. In the shown example, in this state the microneedles 33 and/or the skin-adhesive surface 34 are exposed, allowing the skin to be penetrated and/or to attach the patch to the skin.
Using the system 1, a microneedle patch 3 can be mounted on the applicator 4 and the microneedle patch 3 can be transferred from the pre-application state into the ready-for application state. The system allows to mount microneedle patch on the applicator with little risk of damaging the microneedles or contaminating the microneedles, e.g. without the user touching the microneedle patch 3. In particular, if the system is implemented with a docking platform, docking the microneedle patch 3 is a relatively simple operation, which is performed with microneedle patch not ready for application while with the applicator the microneedle patch 3 is not only taken from the docking platform 20 and mounted, but also brought into the ready-for-application state. The risk of damaging the microneedles or contaminating microneedle patch is therefore limited.
In the shown example, the microneedle patch 3 can be docked on the docking platform 20 while in the pre-application state, and once docked be coupled to the applicator 4. In an alternative embodiment, for instance, the applicator 4 may e.g. pick the patch 3 directly, for example using a snap-fit connection which interlocks with the microneedle patch 3 when the applicator 4 is placed over the patch.
Upon or after being coupled to the applicator 4, the microneedle patch 3 may be transferred into the ready-for-application state. For example, the applicator 4 may comprise a manipulator which manipulates the microneedle patch 3 to be ready for application or, as in this example, the applicator 4 and docking platform 2 may collaborate to transfer the patch.
The transfer may be a one-way transfer, as in the shown examples, but in an alternative example the system 1 may be implemented to bring the microneedle patch 3 from the ready-for application state into a not-ready-for-application state as well, e.g. the pre-application state or another not-ready-for-application state. For example, one or more of the applicator, docking station, or a separate tool may be implemented to further take the microneedle patch 3 from the skin after application, e.g. when substances from the subject have been collected, and the docking platform 20 be implemented to hold a cover which attaches to the removed patch 3 when the applicator 4 positions the patch 3 on the cover, to allow the microneedle patch 3 to be brought back from the ready-for application state into a sealed state in which at least the microneedles of the patch 3 are covered to avoid contamination of the samples collected, and/or to protect anyone from contamination with the substances on the samples when handling the patch.
To mount the microneedle patch 3 on the applicator, the applicator 4 comprises a coupling interface 40 for coupling to the microneedle patch 3. As explained in more detail with reference to
It will be apparent that once coupled, the microneedle patch 3 is to remain coupled to the applicator until applied to the skin and is to be separated from the applicator while remaining applied to the skin. In this example, the microneedle patch 3 remains coupled to the coupling interface until application to the skin. In alternative implementations the microneedle patch 3 may, while remaining retained to the applicator, be uncoupled and coupled to other parts inside the applicator, e.g. as part of a series of manipulations that bring the microneedle patch into a state ready-for-application, before application to the skin.
The applicator is arranged to transfer the microneedle patch from the pre-application state into a state ready-for-application, such that the microneedle patch is in the ready-for-application state when the microneedle patch is coupled to the applicator and the applicator has been moved out of the coupling position. This allows to avoid touching or other manual acts by the user of the system that risk to damage the microneedles or contaminate the microneedles for instance. The applicator may then be used to apply the microneedle patch 3 to the skin 5 of a subject.
It will be apparent though that alternatively the applicator may by itself bring the patch 3 into the state ready-for-application. For example, the applicator may comprise a manipulator which holds cover 39 in position relative to the sheath 41, e.g. by an interlock with a snap-fit connector of the applicator 4, while the remainder of the patch is moved further inwards into the sheath, for instance. In the shown example though, the docking platform 20 and the applicator 4 are arranged to collaborate to automatically transfer the microneedle patch 3 from the pre-application state into the ready-for-application state. The microneedle patch 3 will in this example in the ready-for-application state when all of the following conditions (iii)-(iv) are met:
For instance, the docking platform 20 and the applicator 4 may be arranged to transfer the microneedle patch 3 into the ready-for application state without any human contact to the microneedle patch 3 at all. The system may allow to separate the removable part 30 and expose the microneedle(s) 33 without the user touching the microneedle patch 3. The risk of contamination of the microneedle patch 3 prior to application of the microneedle patch 3 to the skin 5 of the subject can therefore be reduced.
To ensure a proper positioning and/or orientation of the applicator 4 in the coupling position, the system 1 may comprise a guide 29 for the applicator 4. The guide 29 defines a predetermined path for moving the applicator 4 from an initial position in which the applicator 4 engages with the docking platform 20 into the coupling position. The applicator 4 may be freely movable relative to the docking platform 20 when not engaged with the guide 29. In the example for instance, the applicator 4 comprises a sheath 41 which can slide over the platform 20. The outer shape of the platform 20 thus defines the path along which the applicator 4 moves. In this example the outer shape is a straight cylinder, which can for example have an outer diameter 90% or more, but less than 100%, of the inner diameter of the sheath 41. The guide 29 in this example thus defines a straight path which extends from the top 22 downwards to the point whether the platform 20 is maximally admitted into the sheath 41, which is the point illustrated in
In this respect, the docking platform 20 and the applicator 4 may be movable relative to each other to bring the applicator 4 into and out of the coupling position by manual force of the user only. In such a case, there is no need to e.g. provide batteries or other power sources to drive a motor or other non-human powered actuation. This in turn allows for a system 1 which is always available to the user. The docking platform 20 and the applicator 4 can for example be arranged to transfer the microneedle patch 3 from the pre-application state into the ready-for application when a predetermined manual manipulation of the docking platform 20 and/or the applicator 4 is performed by the user. E.g. as in the examples, this transfer may take place during moving the applicator 4 manually out of the coupling position. Alternatively, this transfer may take place when the applicator is manually placed into the coupling position. In the latter case, for instance, a cover may be automatically cut that covers a part of the patch, e.g. a skin-adhesive surface, to leave the part exposed.
The docking platform 20 may be implemented in any manner suitable to dock the microneedle patch 3 and to cooperate with the applicator 4 to transition microneedle patch from the pre-application state to the ready-for application state. As illustrated in
In the shown example, the docking platform 20 has a top side 22 on which the microneedle patch 3 can be positioned. To that end the top side 22 is in this example shaped as a table 26 on which the microneedle patch 3 can be placed. As explained below in more detail, the table 26 supports a removable part 30 of the patch 3. The table 26 may comprise a depression 27 for admitting the removable part 30. The depression may have a shape complementary to the microneedle side 3 of the patch. The table 26 is in this example provided with a bowl-shaped depression 27 located at the position corresponding to that of the microneedles of the patch 3. When the patch is docked, the microneedles are thus suspended above the depression 27. Thereby, the microneedles have some limited freedom of movement which allows to avoid damage to the microneedles during operation of the system 1. In this example, the microneedles are shielded and separated from the depression by the cover, and the depression allows the cover to move into the depression instead of being pushed against the microneedles. In an implementation, the depression 27 may be accessible by fingers of the user to remove (parts of) the patch 3. E.g. cover 39 may be removed from the docking platform after the cover has been separated from the patch. by popping the cover from beneath out of the latch 25, for example.
In this example, the removable part 30 has to be removed to bring the microneedle patch 3 into the ready-for-application state. As shown, the removable part 30 may for example inhibit the proper use of the microneedles 33, and in this example covers them. The covered microneedles 33 cannot penetrate the skin, and the microneedle patch 3 is therefore not ready for application. Additionally, or alternatively, the removable part 30 may e.g. render the microneedle patch 3 non-adhesive such that the microneedle patch cannot be tacked to the skin. The latch 25 retains the removable part 30 on the docking platform 20 when the applicator 4 is moved out of the coupling position, and the microneedle patch 3 is taken from the docking platform 20. The patch 3 is thus brought into the ready-for-application state.
Shown in
In this example, the patch 3 comprises a backing 35 located at the applicator coupling side 32 of the patch. The backing 35 is provided with a coupling interface 38, formed in this example by a knob. At the microneedle side 31, the patch 3 is provided with one or more microneedles 33. In this example, the backing 35 is provided at the microneedle side 31 with a microneedle plate 36 from which the microneedles project. Outside the region covered by the microneedle plate 36, the backing 35 has a skin-adhesive surface 34 which completely or partially is covered with a biocompatible adhesive, more specifically a dermatologically acceptable skin-adhesive.
At the microneedle side 31 the removable part 30 is present, which can be separated from the backing 35 in this example. The removable part 30 comprises a cover 39 which in the pre-application state covers at least a part of the microneedle side 31, and in this example covers the skin-adhesive surface 34 and the microneedles 33. The cover 39 forms a protective spacing in which the microneedles 33 are present, as shown the side of the cover 39 facing the microneedles side 31 forms together with the backing 35 a sealed-off chamber in which the needles 33 are admitted.
As shown, the outside of the cover 39 can be shaped to engage with the latch 25. In this example, the cover is profiled, and more specifically provided with a projecting rim 300 which in the direction from the application coupling side 32 to the microneedles side 31 is at a distance from the base of the cover, and which projects from the cover in a projecting direction perpendicular to this direction.
Although other shapes are possible, as can more clearly be seen in
As shown, the interface 40 comprises coupling blocks 400. The coupling blocks 400 couple to the interface 38 when the applicator 4 is in the predetermined position. In this example, the blocks 400 are prior to coupling, spaced apart and even when the interface 40 is placed against the interface 38 do not establish the coupling. However, by moving the applicator 4 into the predetermined position, the coupling blocks 400 are brought closer to each other such that the blocks 40 will clamp a protruding part of the interfaced 38 between them. In this example, for instance the interface 38 comprises a knob which can be positioned in the spacing between the blocks 400, and the blocks 400 are moved towards each other to grab the knob, thereby creating an interlocking between the interfaces 38,40.
In the shown example, prior to coupling, the blocks 400 may be kept spaced apart by a resiliently or plastically deformable element. In
In
In the shown example, the interface 40 has an initial position and is moved into the interlocking state by bringing the applicator 4 into the predetermined position, as illustrated in
Further indicated in
Although alternatively, e.g. a battery or other pre-charged power-source may be used depending on the specific type of actuator, in the present example the storage 43 is initially empty and the energy is stored therein by bringing the applicator 4 in the predetermined position. To that end, the applicator 4 may comprise a transducer 44 for converting kinetic energy of the applicator 4 into potential energy stored in the energy storage 43. As illustrated in
Referring now to
In the shown examples the fastener 28 is not moved by the sheath but alternatively, the sheath fastener 28 may be arranged to cooperate with the sheath 41 to be moved inwards upon sliding the sheath 41 over the top-side and thereby latch the removable part 30 on the docking platform 20. For instance, the bend shape illustrated in
Referring to
The movement of the movable platform 46 is used to store energy in the applicator which upon application on the skin is used to actuate movement of the movable platform 46 towards the skin. To that end, in the shown example the energy storage 43 comprises a bias spring 430 which is resiliently deformed by the movement of the movable platform 46, storing the potential energy upon bringing the applicator 4 into the predetermined position. The shown example has a spring latch 431 for latching the spring in deformed state when the microneedle patch 3 is transferred to the state ready-for-application and for releasing the spring to relax and actuate the movement of the movable platform 46 upon a point in time selected by the user, to place the microneedle onto the skin 5 and penetrate the skin 5 with the microneedle(s) 33.
As illustrated in
As indicated in
The example of
Referring to
In the shown example, the coupling is a mechanical coupling, caused by parts of the applicator moving to establish an interlocking with the coupling 38 of the microneedle patch 3. The coupling interface 40 may automatically couple to the microneedle patch 3 in another manner when conditions (i) and (ii) are met. For example, the applicator 4 may have an adhesive, magnetic or electrostatic surface which contacts a surface of the microneedle patch, and which exerts a coupling force on the microneedle patch once the applicator is in the predetermined position. The coupling force is preferably smaller than the adhesive force between the microneedle patch and the skin. In addition, the coupling force is preferably stronger than the force that holds the the microneedle patch 3 to the dock. In the shown example for instance, the coupling force is preferably larger than the binding between the removable part and the other parts of the microneedle patch 3.
As illustrated in
Referring to
To apply the microneedle patch 3, the applicator 4 may be brought in a position suitable for applying the microneedle patch 3 on a selected part of the skin 5 of the subject, as is illustrated in
With the applicator 4 in the selected position, the microneedle patch 3 may be applied to the skin 5. To that end a movement of the microneedle patch 3 relative to the skin 5 may be actuated. In
As e.g. shown in
The microneedle patch 3 may generally be of any type suitable to perform operations between the microneedles 33 and the body of the subject, e.g. administer a pharmaceutically active substance to the subject, or collect, through the microneedles, a substance from the subject, e.g. dermally or transdermally, sense properties of the body or modify the body (e.g. by heating of, or sending electrical current into, the perforated area of the skin). The microneedle patch may comprise a reservoir for storing the substance to be delivered to or collected from the subject. The reservoir may e.g. store a pharmaceutically active ingredient, and the reservoir can for instance be connected to the microneedles for controlled transdermal release of the pharmaceutically active ingredient into the subject.
To perform the operations, microneedle patch 3 can be placed on the skin of a subject with the skin-adhesive surface contacting the skin, e.g. with an applicator as described above. The skin may have been stretched before placing microneedle patch or be stretched during placement. The microneedles 33 of the microneedle patch may upon, or after, contacting the skin penetrate at least the epidermis of the skin. For example, the microneedles may perforate the stratum corneum without piercing through, or pierce through the stratum corneum, and any intermediate layers, until into one of the following skin layers (without piercing that layer): stratum lucidum, stratum granulosum, stratum spinonsum, stratum basale, basement membrane, papillary dermis, reticular dermis.
The microneedle patch 3 may be of a type to be applied by a medical practitioner or be used to self-administer by a subject. In this respect, the subject can be a human or an animal. The microneedle patch may e.g. be applied on a part of the body of the subject selected from the group: head, ear, neck, limb, arm, upper arm, lower arm, hand, leg, upper leg, lower leg, foot, torso, chest, abdomen, pelvic region, back, shoulders, buttocks. For example, the microneedle patch 3 may be applied to the inside of the lower arm. Thereby, a relatively low amount of force is needed to penetrate the skin, since the skin is relatively thin in that area, and additionally few preparations are required because this body part has not that much hair. The applicator 4 may be adapted to the thickness of the skin of the selected body part, and e.g. to exert more force on the microneedle patch if the applicator is for a part with relatively thick skin layers, such as at a buttock, compared to the force of an applicator for a part with relatively thin skin layers, such as an ear. In case of self-administration, the body part is preferably within reach of the hands of the subject.
When the microneedle patch 3 is applied, the microneedles 33 perforate the skin, allowing substances to be exchanged between microneedle patch 3 and the skin. For example, pharmaceutically active ingredients or other substances may be administered through the skin barrier into the body or substances from the body collected into microneedle patch through the skin barrier. The administered substances can e.g. dissolve into the surrounding skin tissue and diffuse to the microcirculation of the skin for example or penetrate deeper into the body.
Generally speaking, the microneedle patch 3 may have any suitable type and number of microneedles. In
The microneedles 33 may e.g. be solid, coated, hollow, bio-degradable or non-bio-degradable, or a mixture thereof, and have any other characteristics suitable for the specific implementation. The microneedles may be non-degradable needles with the pharmaceutically active ingredient embedded therein, such as porous needles which release an ingredient from the pores or, of needles where the ingredient diffuses out of the needle into the skin tissue, just to give some examples. In
The microneedles 33 may have any suitable length and diameter. For example, a diameter of several tens to several hundreds of micrometres and/or a length of several tens, a few hundreds to a few thousands of micrometres have found to be suitable. Since the microneedle is relatively small in diameter and length as compared to the conventional needles, the activation of the nociceptors in the skin is reduced and preferably avoided completely. Thus, significant alleviation of pain experience by the subject can be obtained when dermally or transdermally administering drugs or taking samples from the subject. The physical damage to the skin is minimal as a consequence of the small dimensions of the needles. Preferably, the dimensions are such that, under non-occlusive conditions, the perforations close once the microneedles are removed within less than 2 days, preferably less than 1 day, such as in less than 10 hours, for example in several hours. The perforations may be micropores, e.g. of a diameter less than 500 micrometre.
The microneedle patch 3 may comprise, as illustrated in
In this example, the carrier 37 is provided at the microneedle side 31 with a skin adhesive surface 34. In the pre-application state, the skin-adhesive surface 34 is covered, whereas in the ready-for-application state the surface 34 is exposed. The surface is coated in this example with a dermatologically acceptable type of adhesive, suitable to attach the microneedle patch 3 onto the skin 5 by the stiction of the skin-adhesive surface 34. The microneedle(s) 33 projects relative to the skin adhesive surface 34 out of the microneedle patch 3 at the microneedle side 31.
At the side opposite to the microneedle side 31, the carrier 37 is provided with a coupling interface 38 compatible with the coupling interface 40 of the applicator 4. In this example the coupling interface is shaped as a knob provided which the moving parts of the coupling interface 40 can grab and hold.
As shown, in this example the carrier 37 is disk-shaped but other shapes, such as rectangular or polygonal are also possible. The carrier 37 is in this example a multi-layer carrier, which comprises as a top layer a disk-shaped backing 35, which is separated from the microneedle side by a microneedle plate 36. In this example, the microneedle plate 36 is circumferentially enclosed by a flat annulus, which is provided with the skin-adhesive surface 34. The annulus may be flush with the microneedle plate 36 and the microneedle(s) project from the microneedle plate 36.
The removable part 30 comprises a cover 39 which in the pre-application state covers at least a part of the microneedle side 31, and which may be separated from the microneedle patch 3 after conditions (i) and (ii) have been met by the applicator 4, e.g. when the application removes the microneedle patch 3 from the docking platform 20. The cover 39 may be non-destructively releasably attached to the carrier 37 and engages when docked in the pre-application state with the latch 25 of the docking platform 20. The cover 39 may be arranged to be separated from the carrier 37 when a predetermined force may be exerted on the carrier 37 by the applicator 4 while the cover 39 may be held onto the docking platform 20, as explained above.
In this example, the cover 39 covers at least the tacking parts of the skin-adhesive surface 34. The exposed surface of the cover facing away from the skin-adhesive surface 34 is non-adhesive. Thus, the cover 39 prevents the patch 34 from sticking unintendedly prior to application. The part 39 covers the microneedles 33 of microneedle patch as well. The cover 39 thus allows to ensure that the microneedles are not contaminated with hazardous substances or micro-organisms prior to use. Shortly before applying microneedle patch 3 to the skin, the microneedle patch 3 may be brought into the ready for application state, in this example the cover 39 may then be removed to expose the adhesive surface 200, and the microneedles 330, by fulfilling conditions (iii) and (iv).
The cover 39 may generally be shaped in any manner suitable for the specific type of patch. In this example, the cover 39 covers the microneedle(s) 33 and is provided with a depression 391 in which the microneedle 33 can be admitted. The cover 39 has a contact area 390 outside the depression 391 which contacts the microneedle side 31, in this example which abuts in the pre-application state to the annulus 34. In the pre-application state, the microneedles project out of the microneedle side 31 beyond contact area 390 into the depression 391.
Referring now to
As illustrated in the left hand side of
Referring now to
Referring now to
The docking station 2 may also be without the base 21, and for example comprise a grip 24 for holding the docking station 2 manually in position while moving the applicator 4 out of the predetermined position, as is illustrated in
For instance, using the example of
Referring now to
As illustrated in
The system 1 may be provided e.g. with or without the microneedle patch 3. For example, the microneedle patch 3 may be present in the package in which the system 1 may be provided. Alternatively, or additionally, the microneedle patch 3 may be provided separately. The system 1 may comprise a set of microneedle patches in the pre-application state.
The microneedle of the microneedle patch 3 may be sterile in the pre-application state. The system 1 may comprise a sterile package in which the microneedle patch 3 is provided, with at least the microneedle 33 or array 330 being sterile. The package may be provided with instructions to perform a method of applying the microneedle patch 3 with the system 1, such as described above.
In example A, the microneedles are removed from the applied patch 3 while the remaining parts of microneedle patch 3 are kept in place on the skin 5. These parts inhibit relaxation of the skin 5 in the shielded, open region 332. Thus, undesired closure of the perforations 51 due to the relaxation can be reduced, and the conditions of applying substances can be more controlled.
In the example B of
In the example C, microneedle patch 3 is provided with microneedles made of a bio-degradable material, for instance soluble into the skin tissue, with a pharmaceutically active ingredient embedded therein. The ingredient may e.g. by embedded in a matrix but likewise inside the microneedle a separate reservoir filled with a formulation containing the pharmaceutically active ingredient may have been provided. The microneedles are not actively removed but bio-degrade. When the microneedles dissolve into the skin tissue or otherwise bio-degrade after application of microneedle patch 3, the pharmaceutically active ingredient embedded in the microneedles is released in the regions 52.
In the example D of
In the foregoing specification, the invention has been described with reference to specific examples of embodiments of the invention. It will, however, be evident that these are merely illustrative to elucidate the invention, and that various modifications and changes can be made without departing from the broader scope of the invention as set forth in the appended claims.
For example, the system can further comprise a package in which the applicator and/or the docking platform are provided, and e.g. of a suitable packaging material such as plastic. The package may be a sterile package and alternatively or additionally be provided with instructions as to how to dock microneedle patch on the docking system and/or how to mount the docked patch on the applicator and/or how use and place the applicator on a skin, as well as with instructions of treatment of a condition such as dosing and frequency of application for a specific condition. The package can e.g. be a sterile sealed bag of a suitable material, such as plastic. In such a case, the microneedle patches may be separately, and optionally individually, packaged.
Also, the microneedles may pierce completely through a layer or penetrate into the layer without piercing through the layer. The microneedles may for example penetrate deeper into the skin, and pierce through the epidermis, until into the dermis or into the hypodermis subcutis. The microneedles can for example penetrate the dermis until into the papillary dermis or until into the reticular dermis. The microneedles can e.g. pierce the stratum corneum, and any intermediate layers, until into one of the following skin layers without piercing that layer: stratum lucidum, stratum granulosum, stratum spinonsum, stratum basale, basement membrane, papillary dermis, reticular dermis. Preferably, but not necessarily, the penetration of the microneedle(s) does not activate nociceptors in the skin, or at least not above the threshold the subject perceives a sensation of pain.
Moreover, the terms “front,” “back,” “top,” “bottom,” “over,” “under” and the like in the description and in the claims, if any, are used for descriptive purposes and not necessarily for describing permanent relative positions. It is understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments of the invention described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein.
However, other modifications, variations and alternatives are also possible. The specifications and drawings are, accordingly, to be regarded in an illustrative rather than in a restrictive sense.
In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word ‘comprising’ does not exclude the presence of other elements or steps then those listed in a claim. Furthermore, the terms “a” or “an,” as used herein, are defined as one or more than one. Also, the use of introductory phrases such as “at least one” and “one or more” in the claims should not be construed to imply that the introduction of another claim element by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim element to inventions containing only one such element, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an.” The same holds true for the use of definite articles. Unless stated otherwise, terms such as “first” and “second” are used to arbitrarily distinguish between the elements such terms describe. Thus, these terms are not necessarily intended to indicate temporal or other prioritization of such elements The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to advantage.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2028261 | May 2021 | NL | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/NL2022/050259 | 5/12/2022 | WO |
