EP3911402A1

EP3911402A1 - Applicator

Info

Publication number: EP3911402A1
Application number: EP19813260.7A
Authority: EP
Inventors: Michael Kulik; Thorsten Fehr; Stefan Erlhofer
Original assignee: LTS Lohmann Therapie Systeme AG
Current assignee: LTS Lohmann Therapie Systeme AG
Priority date: 2019-01-17
Filing date: 2019-11-26
Publication date: 2021-11-24
Also published as: BR112021012476A2; WO2020148008A1; CN113316468B; JP2022517651A; DE102019200557A1; US20220072290A1; CA3125799A1; CN113316468A; JP7556863B2

Abstract

The invention relates to an applicator (100) for the application of a microarray (22). The applicator (100) comprises a housing (104) and a plunger-type element (102) that can move within said housing (104) to accelerate the microarray (22). The applicator (100) additionally comprises a target force trigger (110), and said target force trigger (110) secures the plunger-type element (102) in relation to the housing (104) and releases the movement thereof when the target force is applied. The invention also relates to an application system (1000) for application of a microarray (22), comprising such an applicator (100) and a microarray (22) or a microarray receiving portion (10), preferably connected to a microarray receiving portion cluster (60), having a microarray (22). The microarray (22) or the microarray receiving portion (10) are arranged relative to the applicator (100) and/or connected to the applicator (100) such that the plunger-type element (102) is able to apply the microarray (22).

Description

ADDlikator

The invention relates to an applicator for applying a microarray and an application system for applying a microarray.

Microarrays have a multiplicity of microneedles, which are usually arranged on a carrier element, such as a patch, a plaster or the like, or are connected to a carrier element. Such microarrays have a high number of microneedles, for example 500-600 needles per cm ² . The needles have a short length, so that when the microneedles are pressed into the skin of a patient, the needles only penetrate into the skin to such an extent that nerves and blood vessels are not touched by needle tips if possible. The microneedles have an active ingredient or a medicament. The corresponding active ingredient can be applied to a surface of the needle or can be arranged in the needles. It is preferred that the needles be made from a material that dissolves in the patient's skin.

The problem with the application of microarrays in human skin is that the insertion of the microneedles into the skin must be reproducible, in particular to ensure reliable drug delivery. The insertion of the microneedles must also be independent of the user or patient, since otherwise reproducibility would not be guaranteed. In particular, the insertion of the microneedles should also be independent of the nature of the skin, so that a certain depth of penetration is always ensured. In addition, there are microarray concepts and applicator concepts nowadays that are not coordinated with one another. For example, some microarrays cannot be applied using a large number of applicators.

The object of the invention is to provide an applicator for applying a microarray, with which the reproducibility of the introduction of the microarray is improved. Another object of the invention is to provide an application system for applying a microarray that enables easier handling.

The tasks are solved according to the invention by an applicator with the features of claim 1 and by an application system with the features of claim 14.

The applicator according to the invention is an applicator for applying a microarray. The application is, in particular, the puncture, also referred to as piercing the microneedles of the microarray, and / or a pressurization of the microarray, preferably for long-term application. The microarray to be applied is in particular part of a microarray recording. The applicator has a, preferably cylindrical, housing. The cylindrical shape of the housing is, in particular, a circular cylindrical shape or an, in particular square, rectangular cylindrical shape. A stamp is movably arranged within the housing. In the starting position, the stamp is preferably fixed relative to the housing, this fixing being in particular designed to be detachable. The mobility of the stamp within the housing serves to accelerate the microarray and / or to transmit power to the microarray. The acceleration and / or power transmission serves to apply the microarray. Furthermore, the applicator has a target force release. The target force Loose fixes the stamp relative to the housing, this fixing being removed when the force is applied to the target force release, and the stamp is released in this way. The plunger is thus preferably movable relative to the housing after at least the target force has been applied to the target force trigger. The target force release is preferably a construction element seen before by constructional design and / or mechanical device. In particular, the target force trigger can have a device that specifically and predictably fails when a, in particular defined, target force is applied.

In a preferred embodiment, the target force at which the target force triggers corresponds at least, in particular exactly, to an application force of the microarray. The application force is preferably the least necessary force, particularly preferably the optimal force to apply the microarray. It is preferably an optimal puncture force for piercing the microarray. In a preferred embodiment, the target force release is designed such that it releases the stamp when the optimal application force is applied. This has the advantage that on the one hand the applicator releases the microarray for application when the desired force is applied and on the other hand this same desired force also serves to apply the microarray.

The applicator preferably has an actuating surface for releasing the desired force. The task of the target force is, in particular, the transmission or action of the target force for actuating the target force trigger. It is preferred that the actuating surface is accessible from outside the applicator. The actuating surface can be actuated in particular by hand, for example via one or more fingers of a user and / or by means of a device. For example, a user can press the actuating surface with a finger and thus exert a force. Preferably, the Actuating surface connected to the stamp, in particular a one-piece connection, which can also be referred to as an integral connection, is preferred. Accordingly, the actuating surface can in particular be part of the stamp. In particular, the actuating surface is located on the side opposite the side of the stamp which acts on the microarray for application.

It is preferred that the punch is pretensioned, in particular in the starting position. As a result, preferably after the stamp is released by the desired force release, the stamp is moved independently, in particular without external influences, due to the tension. The pretension is in particular such that it brings about a movement of the stamp, so that an application, preferably with an optimal application force, takes place. The preload is applied directly or indirectly to the punch. The applicator preferably has a pretensioning device for generating the pretension. The prestressing device is provided in particular between the housing and the punch. It is also possible for the pretensioning device to be connected to the punch, in particular in one piece. The pretensioning device preferably has a spring plate, in particular in accordance with the design of a "snap frog". In the embodiment with a spring plate, it is preferred that the stamp has the spring plate, in particular that the stamp is connected to the spring plate, preferably in one piece. Alternatively or in addition, it is possible that the prestress is due to an inner material stress, in particular due to an inner material stress of the stamp. The internal material tension is preferably based on a material pairing. According to this, it is possible for the pretensioning device to have a bimetal. The material pairing is preferably carried out via two materials, in particular in plate form, which are preferably connected to one another by means of an adhesive and / or soldered connection. It is preferred that one or both of the materials have a prestress, preferably a bend. In addition, it is preferably possible that the material tension is due to a frozen internal stress, which in the An injection molding process for manufacturing is generated. By means of frozen internal stress, it is in particular possible to use only a single material. It is possible for the pretensioning device to have a spring device, in particular a spring, for generating the pretension. It is also possible that the prestressing is accomplished by means of thermal tension, in particular thermal tensioning of the prestressing device and / or the stamp.

In a preferred embodiment, the stamp is, at least essentially, rigid. In particular, it is possible for the stamp to have a rigid base body and additionally flexible elements, such as, for example, a bead and / or groove which is preferably external. The bead and / or the groove is preferably flexible. The rigid design of the stamp is particularly stiff and / or inflexible. The rigid version has the advantage over non-rigid versions that a more precise and therefore reproducible target force release can be implemented.

In particular, the stamp has a convex structure, preferably in one piece, connected to the same. The convex structure is preferably on the side of the stamp which is guided to act on the microarray. By means of the convex structure, it is advantageously possible to transmit a point force, in particular to the microarray to be applied.

In a preferred embodiment, the target force release has a predetermined breaking point and / or a fit. It is particularly preferred that the target force release is a predetermined breaking point and / or a fit. The fit has, in particular, a bead and / or a groove, the groove and / or the bead preferably being flexible. In particular, the predetermined breaking point and / or the fit between the housing and the punch is arranged. Thus, the housing preferably has a first part of the predetermined breaking point and / or the fit, for example bead or groove, and the stamp has a second part of a predetermined breaking point and / or a fit, e.g. B. bead or groove.

Instead of or in addition to the predetermined breaking point and / or fit, it is also preferably possible for the predetermined force trigger to have a clamp and / or a spring-loaded retaining device, which acts in particular on the stamp.

In a preferred embodiment, the applicator has a joint device, in particular for the defined mobility of the stamp relative to the housing. In particular, the joint device is a solid state steering device.

The joint device preferably has a sliding joint and / or a screw joint and / or a swivel joint and / or a ball joint. The thrust joint is, for example, a slideway, in particular a cylinder-shaped one. The cylindrical shape is preferably a circular cylindrical shape or a, in particular square, rectangular cylindrical shape. This slideway is designed in particular within the housing, so that the stamp can slide in this slideway. The swivel joint is preferably an articulated joint or a hinge. It is preferred that the swivel joint and / or ball joint are provided on one side of the housing.

In particular, it is possible for the joint device to pretension the stamp. It is preferred here that the joint device has the pretensioning device and / or an internal material tension.

It is preferred that the applicator has a holding device for fixing the stamp. This fixing of the stamp with the holding device takes place in particular after the movement of the stamp has been released by the desired force. trigger. The holding device preferably fixes the punches in, in particular completely, deflected position. The fully deflected position corresponds in particular to the applied position of the microarray. The holding device is preferably a snap-in device, in particular a snap-in hinge and / or a snap lock. Alternatively or additionally, a groove and / or a bead is also possible as a holding device, the groove and / or bead preferably being of flexible design.

In particular, the microarray is connected directly or indirectly to the stamp. The microarray is preferably connected to the stamp, in particular by gluing, for example by means of the patch of the microarray. On the other hand, it is possible that the stamp only comes into contact with the microarray due to the movement.

In a preferred embodiment, the applicator has a connecting device for connecting the applicator to a microarray receptacle and / or an application site. The application site is preferably a person's skin. The microarray recording is in particular a microarray recording described below.

The connecting device has in particular a thread and / or a plug-in connection and / or a form-fitting connector and / or a flange and / or a bayonet-type connector and / or a magnetic connector, in particular a magnet, and / or a Klebever connecting device and / or a tab and / or a loop. When the connection device is designed as a thread and / or plug-in connection and / or form-locking connection piece and / or flange and / or a Bajo nice-closure connection piece and / or a magnetic connection piece, it is preferred that these are designed such that they correspond with a corresponding counterpart of the microarray receptacle Can work together and establish such a connection. When it is designed as an adhesive connection device, it is preferred that an adhesive connection of the applicator to the microarray receptacle and / or the application site can be established. In the case of the design as a flap and / or loop, it is preferred that the flap and / or the loop can be folded around a body part, for example the arm of a user, and in this way a connection or fastening of the applicator, preferably with a connected microarray an application site can be manufactured.

The application system according to the invention for applying a microarray has an applicator as described above. In addition, the application system has a microarray and / or a microarray recording, preferably connected to a microarray recording cluster, with a microarray. The microarray or the microarray receptacle are arranged in relation to the applicator and / or connected to the applicator in such a way that the stamp can apply the microarray. If the application system has a microarray recording which is with a microarray recording cluster, preferably part of this microarray recording cluster, the applicator is preferably only connected to this one microarray recording of the microarray recording cluster and / or arranged accordingly. The application system according to the invention has the advantage that the ap plicator and microarray are matched, for example a platform concept can be implemented.

In a preferred embodiment, the microarray recording is a microarray recording for storing a microarray and / or handling a microarray and / or guiding a microarray during the application. The microarray receptacle preferably has a first side, where the first page is preferably the top of the microarray receptacle. This first page is, in particular, the side that repels the application site, in particular the skin. In addition, the microarray receptacle preferably has a second side, preferably an underside, this side being in particular the side facing the skin. The microarray receptacle preferably has a support structure which is designed to be connected to an application site. The application site is particularly preferably the skin of a user. The carrier structure thus preferably has the contact surface of the microarray holder with the skin. This con tact surface can in particular be designed to be adhesive. Thus, the micro array recording can be glued to the contact surface of the support structure on the skin. Furthermore, the microarray receptacle preferably has a support surface connected to the support structure. In a preferred embodiment, this support surface is ausgebil det as a particularly round or rectangular plate. The carrier surface is preferably designed with an essentially two-dimensional surface. The microarray is preferably connected to the support surface. The connection between the microarray and the carrier surface can in particular take place in such a way that a patch of the microarray is glued and / or welded to the carrier surface. On the other hand, an embodiment is also possible in which the microarray is formed in one piece with the support surface, also to be referred to as integral. It is possible that the microstructures, preferably the microneedles of the microarray, are attached directly to the support surface. It is preferred that the support structure is designed and / or is connected to the support surface in such a way that in the initial state there is a spacing of the support surface and the microarray from the application site. The carrier surface can be designed such that it represents a sterile barrier, in particular towards the first side. Furthermore, the microarray receptacle preferably has a joint device, referred to as a microarray receptacle joint device, between the support surface and the support structure. The microarray receiving joint device is preferably designed in such a way that it enables the microarray connected to the support surface to move relative to the support structure. This relative movement of the micro array relative to the support structure takes place in such a way that the movement takes place along the extent of the microstructures, preferably in the case of microneedles, of the microarray. In other words, the microarray is preferably connected to the support structure in such a way that it is supported on the support surface via the microarray receiving joint device in such a way that in particular the distance between the microarray and the skin is overcome by movement and thus an application of the microarray into the skin takes place. The microarray receptacle joint device is designed in such a way that it only allows movement along the extent of the microstructures. However, an embodiment is also possible in which additional movements, such as in particular tilting or transverse movements, are possible. The microarray receptacle joint device can be designed such that it only allows one-sided movement, in particular towards the skin. On the other hand, the microarray receptacle joint device can also be designed in such a way that it allows movement on both sides, in particular back and forth. The carrier structure preferably forms a, in particular cylindrical, housing of the microarray receptacle. The cylindrical shape of the housing can preferably have a circular or rectangular, in particular quadrati cal, or oval base.

In a preferred embodiment, the microarray receptacle joint device has at least one first solid body joint, referred to as the first microarray receptacle solid body joint. The first microarray recording solid body joint is preferably formed in one piece with the support surface. If there is a one-piece design consisting of a microarray recording fixed body joint and support surface, it is in particular possible for the microarray to be connected directly to the microarray recording fixed body joint. A one-piece design of the microarray and the microarray receptacle solid body joint is also possible here. In addition to the first microarray recording solid body joint, the microarray recording joint device preferably has a second solid body joint, referred to as the second microarray recording solid body joint. In this case, it is preferred that the first microarray recording solid joint and the second microarray recording solid joint are arranged essentially parallel to one another. The second microarray receptacle solid joint in particular forms an action surface for, preferably external, actions on the microarray receptacle. In particular, the second microarray receptacle solid joint can be designed such that it can be moved from the outside. It is preferred that the second microarray recording solid joint moved in this way can act on the first microarray recording solid joint. The two microarray receptacle solid joints are in particular designed or arranged such that the microarray and / or the support surface can only experience a one-dimensional, preferably linear, deflection. This deflection is preferably a deflection along the extent of the microstructures of the microarray.

In a preferred embodiment, the microarray receptacle has a blocking device for fixing the first microarray receptacle solid joint and the second microarray receptacle solid joint relative to one another. In particular, the blocking device is a snap-in device that prevents a relative movement of the first microarray receptacle solid joint to the second microarray receptacle solid joint when it engages. The snap-in device is preferably a snap-in pin between the first microarray receptacle solid joint and the second microarray receptacle solid joint. The latching pin can be designed such that it is already connected to the first or the second microarray receptacle solid joint in the initial state and engages with the other microarray receptacle solid joint when it is latched in and thus prevents a relative movement of the two microarray receptacle solid joints. On the other hand, it is also possible that the Snap pin snaps into place with both microarray receptacle solid joints.

The first microarray recording solid joint and / or the second microarray recording solid joint is, in particular, a linear microarray recording solid joint. It is particularly preferably a linear plate solid joint. A linear plate solid body joint is a rigid plate with at least two areas movably connected to one another via webs. The mobility of the areas relative to one another is particularly limited to parallel and / or right-angled movements. The webs and / or the areas are produced in particular by means of tongues and / or laser cuts of a rigid plate. A linear plate solid-state joint is also referred to as a diaphragm microarray receptacle solid joint (English: "diaphragm flexure"). It is preferred that the carrier surface is configured in one piece with the microarray receiving joint device and / or with the microarray. It is also possible for the support surface to be connected in one piece to the support structure.

In a preferred embodiment, the microarray receiving joint device has a degree of freedom of 1. The microarray receptacle joint device therefore preferably only permits linear deflections, in particular along the extent of the microstructures of the microarray. In other words, the microarray receiving joint device is preferably designed in such a way that it only enables movements along the Z direction. It is particularly preferred that the microarray receiving joint device only allows movements in one direction, preferably in the needle tip direction of the microneedles.

On the one hand, it is possible for the microarray receiving joint device to be designed such that it automatically moves the carrier surface back into the starting position after a deflection. On the other hand, it is possible that the microarray receiving joint device holds the support surface in a deflected position. According to this first possible embodiment, when the microneedles penetrate the skin in particular, the microneedles are subsequently pulled out of the skin as soon as the microarray receiving joint device is no longer deflected, in particular from the outside. According to the possible second embodiment, it is possible, in particular, for the micro needles to penetrate into the skin after a first deflection of the microarray receptacle joint device and preferably deflected by the microarray receptacle joint device and thus to be kept penetrated into the skin. For this purpose, it is preferred that the microarray receptacle has a fixing device, in particular a snap-in fixing device, where, in the fixing device, the microarray receptacle joint device and / or the support surface blocks or fixes in the deflected position and, in this way, at least temporarily, prevents the microarray from moving back into the starting position different. In particular, the snap-in fixing device is a snap-in hinge having the microarray receiving joint device and / or the one snap lock, which acts in particular between the support surface and the support structure. It is preferred that the microarray receptacle, in particular the microarray receptacle joint device, has a pretensioning device, such as a spring. The pretensioning device is in particular designed such that it triggers an acceleration of the support surface during the deflection and / or a holding of the support surface in the deflected position.

It is preferred that the microarray receptacle has a force introduction structure connected to the back of the microarray. In particular, the force introduction structure can be connected to the carrier surface opposite the microarray. It is preferred that the force introduction structure is designed to be convex. It is preferred that the microarray holder and the applicator are arranged and / or connected to one another in such a way that the stamp of the applicator acts directly or indirectly on the microarray of the microarray holder. When the stamp acts on the microarray of the micro array recording, there is in particular an indirect or direct connection and / or an indirect or direct impact of the stamp and the microarray, preferably during the movement of the stamp. When the stamp acts indirectly on the microarray, the arrangement and / or connection of the microarray holder and the applicator is preferably such that the stamp acts directly on the force introduction structure or the support surface or the first microarray holder solid joint or the second microarray holder solid joint, in particular hitting it.

The microarray holder has, in particular, a bottom film. The bottom film is preferably arranged on the second side of the microarray holder. In a preferred embodiment, the base film represents a sterile barrier of the microarray on the second side to the surroundings. It is possible that the base film is designed in such a way that the microarray can penetrate it. In particular, microneedles of the microarray can thus pierce the bottom film.

It is preferred that the base film is connected to the support structure. It is particularly preferred here that the base film is detachably or removably connected to the support structure. This peelable connection is made in particular by gluing the base film to the support structure. It is thus possible for a user to detach the base film from the carrier structure, in particular before use, and thus release the microarray. It is possible that the bottom film has an adhesive layer. In this way it is possible in particular to attach the microarray holder to an application site.

The microarray holder preferably has a cover film. The lid film is in particular connected to the support structure. A firm, non-releasable connection is preferred. In particular, the cover film can be welded to the carrier structure, in particular by ultrasound welding, or glued. The cover film preferably forms a sterile barrier on the first side of the microarray holder towards the surroundings.

The cover film is particularly flexible and / or fragile. In the case of a flexible configuration, in particular an action can take place on the cover film from the outside, so that the cover film yields flexibly. In the case of a fragile, preferably perforated, configuration, the cover film can tear when subjected to external influences and thus allow external influences on the microarray receptacle.

In a preferred embodiment, the microarray receptacle has a connection device, referred to as a microarray receptacle connection device. The microarray receptacle connection device is particularly provided on the first side of the microarray receptacle. It is particularly preferred that the microarray receptacle connection device is connected to the support structure, preferably in one piece. The microarray receptacle connection device is, in particular, a microarray receptacle connection device for connection to the applicator for application of a microarray. The microarray receptacle connection device preferably has a thread and / or a connector and / or a form-locking connector and / or an adhesive point and / or a flange. The microarray receptacle connection device preferably has one of these Like the connecting element described above, which corresponds to a counterpart of the connecting device of the applicator. The applicator can preferably be connected to the microarray holder by means of a microarray connection device.

The microarray recording cluster preferably has a plurality of microarray recordings according to the definition above. The multiple microarray receptacles can have identical or different microarrays, so that in particular different microarrays with different active substances and / or different numbers of needles, etc. can be present. The carrier surfaces and / or the floor foils and / or the ceiling foils and / or the carrier structures of the plurality of microarray receptacles are preferably connected to one another, with a one-piece connection being preferred in particular. Several microarray recordings can be connected in this way. In particular, several microarray recordings can be produced together, preferably continuously. It is also advantageously possible in this way to apply several interconnected microarray recordings together to a body part to be applied, in particular a curved area of skin. These multiple microarray recordings can then be applied at the same time or with a time delay. The applicator can preferably be used to apply the microarray receptacles of the microarray receptacle cluster, a single application of the microarray receptacles in particular being preferred in succession.

The invention is explained in more detail below with reference to a preferred embodiment with reference to the drawing.

Show it : La is a schematic sectional view of an embodiment of an application system according to the invention with an embodiment of an applicator according to the invention and an embodiment of a microarray receptacle in the starting position,

Fig. Lb is a schematic sectional view of the application system

Figure la in the application position,

2a is a schematic sectional view of a further embodiment of an application system according to the invention with a further embodiment of an applicator according to the invention and a further embodiment of a microarray recording in the starting position,

2b shows a schematic sectional view of the application system

FIG. 2a in the application position,

Fig. 3 is a schematic plan view of an embodiment of a

Microarray recording clusters,

4 shows a detailed view of area IV from FIG. 3, which shows an embodiment of a microarray recording,

Fig. 5 is a schematic sectional view of an embodiment of a

Microarray recording, the microarray recording essentially being the microarray recording from FIG. 4

Cutting plane V corresponds to

6 shows a schematic sectional view of a further embodiment of a microarray holder, 7 is a schematic sectional view of a further embodiment of a microarray holder,

8a is a schematic sectional view of a further embodiment of a microarray recording according to the invention,

8b shows a schematic sectional view of the microarray image from

Figure 8a in an applied position, and

Fig. 9 is a schematic sectional view of another embodiment form of a microarray recording according to the invention.

Similar or identical components or elements are identified in the figures with the same reference symbols. In particular for improved clarity, elements that have already been identified are preferably not provided with reference numerals in all the figures.

FIG. 1 a shows a sectional view of an embodiment of an application system 1000 according to the invention with an embodiment of an applicator 100 according to the invention, the applicator 100 being connected to an embodiment of a microarray receptacle 10. The microarray holder 10 corresponds to the microarray holder 10 from FIG. 5, which is described in more detail below.

The microarray receptacle 10 is arranged on an application site 18, the application site 18 in particular being the skin of a user or patient. For application, a base film 36 (see FIG. 5 and the corresponding description) was removed or removed from the microarray receptacle 10. The essentially cuboidal applicator 100 is placed on the microarray receptacle 10 or connected to the microarray receptacle 10. In addition to the cuboid shape, which can be square or rectangular, for example, other shapes, such as. B. a circular cylindrical shape, etc. possible. The applicator 100 is connected to the microarray receptacle 10 in particular by means of a connecting device 136 of the applicator 100 and a microarray receptacle connecting device 40 of the microarray receptacle 10. On the one hand, this connection can be made by placing the applicator 100 onto the microarray receptacle 10, preferably loosely. On the other hand, the connection between the connecting device 136 of the applicator 100 and the microarray receptacle connecting device 40 can take place via a constructive connection. In the context of the constructive connection, it is preferred that the connecting device 136 of the applicator 100 has a thread and / or a plug connection and / or a form-fitting connection piece and / or a flange and / or an adhesive connection device. Accordingly, the microarray receptacle connection device 40 preferably has a corresponding counterpart. Furthermore, it is alternatively or additionally possible that the connecting device 136 of the applicator 100 has a connecting element, such as in particular a strap and / or a loop, the applicator 100 being connected, for example, to a body part, such as an arm. In particular, it is possible for a loop of the connecting device 136 of the applicator 100, preferably under tension, to be wrapped around an arm and in this way the applicator, preferably with the microarray receptacle 10 located underneath, to be attached to the skin of a user.

The applicator 100 has a, preferably cuboid, housing 104. The outer wall 106 and the outer wall 108 of the housing are shown. Preferably, the housing also has two further side walls, which correspond to the front and the back. The housing 104 terminates on one side (in the illustration above) with an actuating surface 114 of a stamp 102. The stamp 102 is by means of a joint device 124 connected to the side wall 108. In the illustrated embodiment, the joint device 124 has a swivel joint 128, which is preferably a solid-state joint. On the opposite side, the stamp 102 is connected to the outer wall 106 via a predetermined force trigger, which has a predetermined breaking point 112.

The actuating surface 114 can be actuated from the outside, so that, for example, a user can press the actuating surface 114 with a finger.

Opposite the actuating surface 114, the stamp 102 has a convex structure 116. This convex structure 116 is opposite the convex force in line structure 34 of the microarray receptacle 10.

In Figure lb the applicator is shown in the triggered or applied position.

For example, due to the pressure of a user with a finger on the actuating surface 114, the predetermined breaking point 112 was broken, the stamp 102 being deflected around the joint device 124.

Due to the deflection of the stamp 102, there is an action, for example a force transmission from the convex structure 116 of the stamp 102 to the convex force introduction structure 34 of the microarray receptacle 10. Because of the two contacting convex structures 116, 34, the force transmission takes place as a point force, whereby it is thereby there is a deflection of the microarray 22 perpendicularly or in the normal vector to the application site 18. The microarray 22 is deflected along the microarray receiving joint device 26.

Due to the deflection of the microarray 22, the microneedles 24 are inserted into the application point 18. It is preferred that the target force trigger 110, ie the target breaking point 112, is designed such that the target force, which leads to a triggering of the target force trigger 110, corresponds to a necessary, in particular special, optimal application force of the microarray 22. Accordingly, as soon as a desired force is applied to the desired force trigger 110 via the actuating surface 114, the microarray 22 is optimally applied.

In the deflected position, the stamp 102 is held or fixed by the holding device 130, so that the stamp 102 is pressed onto the microarray 22. In this way, an application of the microneedles 24 of the micro array 22 is accomplished over a longer period of time. The holding device 130 has, in the form shown, a type of inner wall which is designed to be flexible and is pretensioned towards the center of the housing. In a vertical Pas sieren the stamp 102 of the inner wall 132 there is a deflection of the inner wall 132 towards the center of the housing and thereby to a kind of tilting of the stamp 102 and the inner wall 132, resulting in a fixation of the stamp in a deflected position.

FIG. 2a shows a further embodiment of an application system 1000 according to the invention with a further embodiment of an applicator 100 according to the invention and a microarray holder 10, the microarray holder 10 essentially corresponding to the microarray holder 10 from FIG.

The applicator 100 is connected to the microarray receptacle 10 via the connection device 136 and the microarray receptacle connection device 40, based on the embodiment from FIG.

In the embodiment shown, the target force release 110 is designed as a fit 118 between the punch 102 and the housing 104. For this purpose, the stamp 102 has at least one flexible bead 120. This bead 120 is located in a groove 122 in the starting position shown in FIG. 2b. Bead 120 and / or groove 122 are preferably designed to be flexible. This flexible configuration is in particular designed such that a fit force to be overcome is defined thereby. This fit corresponds to the target force of the target force trigger 110.

For example, when a user presses the actuating surface 114 with the desired force, the bead 120 and / or the projection 119 of the groove 122 are displaced, so that the punch 102 moves vertically (downward) (see FIG. 2b) ). The movement of the stem 102 relative to the housing 104 takes place along the joint device 124, which is shown as a sliding joint 126. The thrust joint 126 is defined by the inner hollow shape of the housing 104, so that the punch 102 can move vertically, preferably with degree of freedom 1, inside the housing, the thrust joint 126.

The applicator 100 has a holding device 130 designed as a further groove 134. After the stamp 102 has been moved vertically (see FIG. 2b), the stamp 102 remains in the holding device 130, preferably in accordance with a type of latching or snapping. This causes the stamp 102 to be pressed onto the microarray 22 of the microarray receptacle 10 (see FIG. 1) 2 B).

In the illustrated embodiment, it is a cuboid Ge 104, but a circular cylindrical configuration is also possible. In addition, instead of the illustrated combinations of bead 120 and groove 122 of the desired force release 110, only the provision of a bead 120 or a groove 122 is possible. Furthermore, it is possible that only the punch 102 has a bead or a groove or, on the other hand, only the housing has a bead or a groove. The same applies to the holding device 130.

3 shows a top view of the underside of an embodiment of a microarray recording cluster 60 (with the base film 36 hidden). The microarray recording cluster 60 shows several embodiments of microarray recordings 10, 10 ', 10 ", 10"', which are connected to one another via a cover film 38. For application of the microarray recording cluster 60, this is in particular applied to human skin, so that the illustrated side 62 of the microarray recording cluster 60 rests on the skin and is thus shielded from the cover film 38 from the surroundings. The cover film 38 and / or the microarray receptacles 10, 10 ', 10 ", 10'" are preferably designed to be flexible, so that the microarray receptacle cluster 60 clings in particular to a curved skin section. After placing the microarray recording cluster 60 on the skin, in particular individual microarray recordings 10 can be applied independently of one another, or it is possible to apply all microarray recordings together.

Instead of the embodiment shown, it is possible for the support structures 16, 16 ', 16 ", 16'" to be connected to one another, in particular in one piece.

FIG. 4 shows a detailed view of the microarray receptacle 10 from FIG. 3. FIG. 4 shows the underside 14 of the microarray receptacle 10, which lies opposite the top 12 that cannot be seen in the view.

The microarray receptacle 10 has a circumferential support structure 16 which partially projects beyond a support surface 20, the support structure 16 being connected to the support surface 20 by the area overlapping with the support surface 20 (see FIG. 5). The protruding area of the carrier structure 16 is preferably connected to the cover film 38 (not shown in FIG. 4) (see FIGS. 3 and 5). The connection between cover film 38 and carrier structure 16 is preferably carried out by means of welding and / or gluing, but an integral or other configuration is also possible. The connection between support structure 16 and support surface 20 can in particular which take place by means of gluing and / or welding, but can also be made in one piece. The carrier surface 20 is connected to a microarray 22 with a plurality of microneedles 24. The microarray 22 is shown as a patch with micro needles 24 arranged thereon, in particular in one piece with it. The micro needles 24 preferably run out of the image plane in a conical shape (in the Z direction). Instead of the embodiment shown, it is also possible to connect the microarray 22 directly to the carrier surface 20, wherein an integral connection is also possible. Accordingly, it is possible to design the carrier surface 20 in one piece with the microarray 22 and / or the microneedles. The support structure 16 preferably has a height (protruding from the image plane in the illustration), which in particular ensures that the support surface 20 is spaced apart from an application point.

The microarray holder 10 from FIG. 4 also has a microarray holder joint device 26. The microarray receptacle joint device 26 is embodied here as a microarray receptacle solid joint, in particular as a linear plate solid joint. For this purpose, the carrier structure 16 has slots 42, 44, which are produced in particular by stamping a plate which preferably essentially corresponds to the carrier surface 20. Between these slots 42, 44 there are webs 48. These, preferably flexible webs 48 allow the inner region of the support surface 20 to be movable with respect to the outer region. The microarray receiving joint device 26 in particular enables the microarray to move in the Z direction. Due to the embodiment in the illustrated embodiment of the microarray receptacle solid-state joint device 26, however, tilting of the microarray 22 is also possible, so that movement about the X and / or Y axis is also possible. It is possible for the microarray recordings 10 to be formed independently of the microarray recording cluster 60. Accordingly, the microarray receptacles 10 according to the embodiment from FIG. 4 would in particular have a separate cover film 38.

FIG. 5 shows a sectional view of an embodiment of a microarray holder 10, the microarray holder 10 essentially corresponding to the microarray holder from FIG. 4 (independent of the microarray holder cluster 60) along the sectional plane V.

In contrast to the embodiment from FIG. 4, a bottom film 36 is shown in FIG. This bottom film 36 is connected to the support structure 16. This connection between the base sheet 36 and the support structure 16 is preferably made adhesive. It is particularly preferred that the base film 36 is designed to be removable or removable, so that, in particular, a user can remove the base film 36 from the microarray receptacle 10 before application. As an alternative or in addition, it is possible for the base film 36 to be designed such that it can be pierced by the microarray 22, that is to say in particular the microneedles 24. In particular, the base film 36 can have an adhesive layer, preferably on the underside shown, so that the microarray receptacle 10 can be adhesively connected to an application site via the adhesive layer of the base film 36.

In the form shown, the microarray receptacle 10 is in a non-deflected or non-applied position. The microarray receptacle solid joint 26, which is in particular a linear plate solid joint, is therefore not deflected. On the back of the microarray 22 or the back of the support surface 20, a convex force transmission structure 34 is connected. This convex force introduction structure 34 makes it possible, in particular in the case of force introduction by means of an oppositely convex applicator, for the application of the microarray 22 in the normal vector Application site, in particular to the skin. This results in a deflection along the Z axis and it is possible to optimally puncture and apply the microneedles into the skin.

The microarray 22 is protected from the environment via the base film 36 and the cover film 38 and / or the carrier surface 20. In particular, sterile protection from the environment is possible.

FIG. 6 shows a further embodiment of a microarray receptacle 10. The embodiment from FIG. 6 largely corresponds to the embodiment from FIG. 5. In contrast to the embodiment from FIG. 5, the microarray receptacle from FIG. 6 has no force introduction structure 34. Likewise, no cover film 38 is shown in the embodiment from FIG. However, it is also possible to provide a cover film 38 in the embodiment from FIG.

In addition, the design of the microarray recording joint device 26 from FIG. 6 differs from the embodiment from FIG. 5. The microarray recording joint device 26 here has a first microarray recording fixed body joint 28, this microarray recording fixed body joint 28 essentially corresponding to the design from FIG is designed in particular as a linear plate solid joint. In addition, the microarray receptacle has a second microarray receptacle solid joint 30 above the first microarray receptacle solid joint 28. The second microarray receptacle solid joint 30 is preferably a plate, in particular made of spring steel, which is bent upwards and is in the prestressed state in this way. In other words, the design of the second microarray recording solid-state joint 30 corresponds to a design according to a "pop frog". When pressure is applied to the second microarray recording solid body joint 30 from above, the latter is deformed and jumps to the opposite side, whereupon the second microarray recording solid articulation 30 bends downward and remains in this position. Because of this jump in deformation, the second microarray recording solid body joint 30 acts on and deflects the first microarray recording solid body joint 28 as well. This results in a deflection or application of the microarrays 22 connected to the first microarray receptacle solid joint.

In the illustrated embodiment, the microarray receptacle 10 has a blocking device designed as a latching device 60. The latching device 60 has a pin 32 and an opening 31 of the second solid body joint 30. The pin 32 is connected to the first microarray receptacle solid joint 28, in particular is formed in one piece with it. The pin 32 preferably has about half a bone structure, so that a type of hemisphere or thickening 33 is provided at one end. The pin 32 tapers to the other side, which is connected to the first microarray receptacle solid joint 28. When the second microarray receptacle solid joint 30 is deflected, the second microarray receptacle solid body joint 30 slips over the thickening 33 of the, in particular flexibly designed, pin by means of an opening 31 provided 32. This causes the second microarray receptacle solid joint 30 to engage with the first microarray receptacle solid joint 28, so that subsequent relative movement between the microarray receptacle solid joints 28, 30 is prevented. In other words, the second microarray receptacle solid joint 30 is latched to the first microarray receptacle solid joint 28. Due to the pretensioning of the second microarray recording solid body joint 30, the first microarray recording solid body joint 28 and the second microarray recording solid body joint 30 remain in a deflected position, so that the microarray 22 is deflected and thus kept applied. Instead of the embodiment shown here with snap-in device 60, it is also possible to design microarray receptacle 10 without snap-in device and therefore preferably also without opening 31 of second microarray receptacle solid joint 30.

Due to the provision of the two, preferably parallel to one another, microarray receptacle solid joints 28, 30, in particular in contrast to the embodiment from FIG. 5, no tilting, that is to say no movement of the microarray 22 about the X and / or Y axis is possible . The two microarray receptacle solid joints 28, 30 arranged in relation to one another ensure that only a deflection along the Z axis is possible.

FIG. 7 shows a further embodiment of a microarray holder 10. The microarray holder 10 has two microarray holder solid joints 28, 30. The two microarray receptacle solid joints 28, 30 are in this case based on the microarray receptacle solid body joint 28 from FIG. 5, that is to say in particular as linear plate solid body joints. Once again, the composition of the two microarray recording solid joints 28, 30 ensure that only a deflection along the Z axis is possible. The first microarray recording solid body joint 28 has an opening 29 and the second microarray recording solid body joint 30 has an opening 31. Between the openings, a snap-in device 60 is provided, which in the illustrated embodiment is designed as a snap-in pin 32. The latching pin 32 essentially has a bone shape, so that there are thickenings 33 ', 33 "at the two ends of the latching pin. If the second microarray recording solid body joint 30 is deflected in the positive Z direction, the second microarray recording solid body joint 30 acts on the basis of the action a deflection of the first microarray recording solid joint 28 and thus an application of the microarray 22 in the Z direction to the first microarray recording solid joint 28. In addition, this deflection ensures that the first microarray recording solid joint 28 and slip the second microarray receptacle solid joint 30 with the openings 29, 31 over the latching pin 32 and remain latched in the central region of the latching pin 32. The first microarray receptacle solid joint 28 snaps into place in relation to the second microarray receptacle solid body joint 30.

Between the first microarray recording solid body joint 28 and the two th microarray recording solid body joint 30, a support structure 16 is provided. Based on the embodiment from FIG. 5, this carrier structure 16 can also extend below the first microarray receptacle solid joint 28 and in this way in particular produce a spacing from the application site. In addition, in the embodiment from FIG. 7, based on the embodiment from FIG. 5, the provision of a base film 36 and / or cover film 38 and / or a force introduction structure 34 can also be implemented.

FIG. 8a shows a further embodiment of a microarray recording 10 according to the invention. The embodiment is based on the embodiment from FIG. 7.

In contrast to the embodiment from FIG. 7, the pin 32 is already inserted into the openings 29, 31 in the initial state. The pin 32 corresponds approximately to the design of a shaft with two shaft shoulders 72, 74, where various shapes of the pin 32, for example round, rectangular, square, etc., are possible. Shaft shoulder 72 is inserted into opening 31, shaft shoulder 74 in opening 29. The pin 32 functions on the one hand as a spacer between the first solid body joint 28 and the second solid body joint 30. Furthermore, the embodiment has a guide device 70 which comprises the shaft shoulders 72, 74 of the pin 32 and the openings 29, 31. The pin 32, as a kind of guide rod, ensures linear guidance of the first solid-state joint 28 and the second solid-state joint 30, so that only a deflection along the z direction is possible. Accordingly, if the first solid-state joint 28 acts in such a way that it would experience a tipping or a moment, the pin 32 picks up this moment and prevents the tipping. As a result, there is only a linear deflection of the microarray 22 along the z direction.

The embodiment also has a latching device 60. The snap-in device 60 comprises the projection 33 of the pin 32 and the snap-in plate 62. The snap-in plate 62 is shown immovably connected to the support structure 16, in particular designed in one piece, and has an opening 64 provided with a chamfer. In the starting position (FIG. 8a), the projection 33, which can also be designed as a bead, bears against the opening 64 of the latching plate 62. When the second solid-state joint 30 is deflected (FIG. 8b), for example due to pressure on it by a user, along the z-direction, a force is transmitted to the first solid-state joint 28 via pin 32 and thus also a deflection of the pin 32 and the first solid-state joint 28 in the z direction. In this case, the projection 33 overcomes the opening 64 of the snap-in plate 62. As a result, the pin 32 snaps in below (in the z-direction) of the snap-in plate 62. This results in the first solid body 28 being fixed in the deflected position, as a result of which the microarray 22 connected to the first solid body 28 is pressed up. It is thus possible to keep the microarray 22 applied.

It is possible that the second solid 30 moves back to the starting position after an initial deflection. This can be accomplished in particular in that the plug connection between the shaft section 72 and the opening 31 is designed to be detachable. On the other hand, it is possible for shaft shoulder 72 with opening 31 and / or shaft shoulder 74 with opening 29 to be non-detachable, in particular in one piece. It is also possible that pin 32 has no shaft shoulders 72, 74 and / or the solid-state joints 28, 30 no openings 29, 31, but pin 32 directly on one side with the first Solid body joint 28 and on the other side with the second solid body joints 30, preferably inseparably, connected, in particular is designed in one piece.

The projection 33 can be designed to be flexible. Alternatively or additionally, the latch plate 62 or the region of the opening 62 of the latch plate 62 can be configured flexibly.

An embodiment based on the embodiment from FIG. 8a is also possible which has no latching device 60, that is to say in particular no latching plate 62 and / or no projection 33 on pin 32.

Claims

Expectations

1. Applicator (100) for applying a microarray (22) with

one, preferably cylindrical, housing (104), and

a plunger (102) movable within the housing (104) for accelerating the microarray (22),

marked by

a target force trigger (110), the target force trigger (110) fixing the plunger (102) relative to the housing (104) and releasing at least the target force for movement when applied.

2. Applicator (100) according to claim 1, characterized in that the target force corresponds to at least one application force of the microarray (22).

3. Applicator (100) according to claim 1 or 2, characterized by a, in particular from the outside of the applicator (100) accessible, actuation supply surface (114) for the purpose of the target force, preferably the actuation surface (114) preferably with the stamp ( 102), in particular in one piece, is connected.

4. Applicator (100) according to any one of claims 1 to 3, characterized in that the plunger (102) is directly or indirectly applied to a pre-tension, in particular by means of a spring plate and / or an inner material, the pre-tensioning the punch ( 102) moved after motion release.

5. Applicator (100) according to one of claims 1 to 4, characterized in that the stamp (102) is substantially rigid.

6. Applicator (100) according to one of claims 1 to 5, characterized by a with the stamp (102), in particular in one piece, connected convex structure (116).

7. Applicator (100) according to one of claims 1 to 6, characterized in that the target force trigger (110), preferably between Ge housing (104) and stamp (102), a predetermined breaking point (112) and / or one, in particular one Has bead (120) and / or groove (122), fit (118).

8. Applicator (100) according to any one of claims 1 to 7, characterized by an articulation device (124), in particular a solid body device, for defined movement of the plunger (102) relative to the housing (104).

9. Applicator (100) according to claim 8, characterized in that the Ge steering device (124) has a thrust joint (126) or a screw joint or a swivel joint (128) or a ball joint.

10. Applicator (100) according to one of claims 1 to 9, characterized by a holding device (130), in particular a latching device, for fixing the stamp (102) after the movement has been released.

11. Applicator (100) according to one of claims 1 to 10, characterized in that the microarray (22) is connected directly or indirectly to the stamp (102).

12. Applicator (100) according to one of claims 1 to 11, characterized by a connecting device (136) for connecting the applicator (100) with a microarray holder (10) and / or an application point (18).

13. Applicator (100) according to claim 12, characterized in that the connecting device (136) has a thread and / or a plug-in connector and / or a form-locking connector and / or a flange and / or an adhesive connecting device and / or a tab and / or which has a loop.

14. Application system (1000) for applying a microarray (22), with an applicator (100) according to one of claims 1 to 13, and a microarray (22) or, preferably with a microarray recording cluster (60) connected, microarray recording ( 10) with a microarray (22),

wherein the microarray (22) or the microarray receptacle (10) is arranged to the applicator (100) and / or connected to the applicator (100) in such a way that the stamp (102) can apply the microarray (22).

15. Application system (1000) according to claim 14, characterized in that

the microarray holder (10) has:

a first side (12), preferably an upper side,

a second side (14), preferably an underside,

a support structure (16) for connecting the microarray holder (10) to an application site (18),

one with the support structure (16) connected to the support surface (20), one with the support surface (20), in particular in one piece

Microarray (22), and

a microarray receiving joint device (26) between the support surface (20) and the support structure (16),

wherein the microarray receptacle hinge device (26) moves the microarray (22) connected to the support surface (20) relative to the Support structure (16) along the extent of the microarray (22) enables light.

16. Application system according to claim 14 or 15, characterized by a force introduction structure (34) connected to the back of the support surface (22), preferably convexly proceeding therefrom, the stamp of the applicator acting directly or indirectly on the force introduction structure for application.