Microarray applicator and method for moving a plunger that acts on a microarray

Abstract

The present invention relates to an applicator (200) for the application of a microarray. The applicator comprises a housing (202), a plunger (204) linearly movable within the housing (202), a holding device (208) for receiving a microarray device (10), a pressing element (210) for moving the plunger (204) to act on the microarray device (10) received by the holding device (208), and an actuator (212) that holds the plunger (204) in a first position and releases the plunger (204) for movement by the actuation of an actuator (212). The actuator (212) has at least two separate actuators (214, 216), in particular mechanical actuators. The plunger (204) is released by the actuator (212) only when at least two actuators (214, 216) are actuated. The present invention further relates to an application system (300) comprising such an applicator (200) and a microarray device (10), and a method for moving a plunger. According to this method, the plunger (204) is held in a first position against a pre-tension, and the plunger (204) is released by the pre-tension for movement during at least two distinct acts. At least two acts are required for release.

Description

Technical Field

[0001] The present invention relates to an applicator for applying a microarray. Further, the present invention relates to an application system for applying a microarray. Further, the present invention relates to a method for moving a plunger.

Background Art

[0002] A microarray comprises a plurality of microneedles, which are usually arranged on or connected to a support element such as a patch, a band-aid, etc. Such a microarray comprises a large number of microneedles. If possible, the length of the needles is short so that when the microneedles are pushed into the patient's skin, the needles do not penetrate the skin further than to such an extent that the tip of the needle does not contact nerves and blood vessels. The microneedles contain an active ingredient or a drug. It is possible to apply the corresponding active ingredient to the surface of the needle or to include it within the needle. The needle is preferably formed of a substance that dissolves in the patient's skin.

Summary of the Invention

Problems to be Solved by the Invention

[0003] When applying a microarray to human skin, there arises the problem that the insertion of the microneedles into the skin must be reproducible, especially to ensure reliable administration of a drug. Further, the insertion of the microneedles must be independent of the user or patient, since reproducibility cannot be guaranteed. In particular, the insertion of the microneedles should be further independent of the type of skin so that a specific penetration depth is always guaranteed.

[0004] Microarrays are generally stored in a package and / or a support device for protecting the microarray against environmental influences such as physical influences and / or contamination and for transport purposes.

[0005] Concepts for support structures for microarrays are illustrated, for example, in German Patent Application Publication No. 102019200561.

[0006] Another problem that arises in relation to microarrays is that when users apply microarrays to microarray-supporting devices, they first encounter a problem, particularly not knowing how to apply such microarrays. This is because the interface and / or the required type of action, especially the force of action, for acting on various microarray-supporting devices is ambiguous.

[0007] An object of the present invention is to provide an applicator for applying microarrays that improves the handling of microarrays. Another independent object of the present invention is to provide an application system for applying microarrays that improves user handling. Furthermore, a further independent object of the present invention is to provide a method for moving a plunger that enables reliable operation of the plunger. [Means for solving the problem]

[0008] According to the present invention, these objectives are achieved by an applicator having the features of claim 1, an application system having the features of claim 14, and a method for moving a plunger having the features of claim 15.

[0009] An applicator according to the present invention for the application of microarrays comprises a housing in which a plunger is linearly movable. The applicator contains, and is more preferably formed of, a plastic material. The applicator is more preferably, in addition to the plastic material, to have metal reinforcing elements, such as a rod. It is more preferably that the applicator, and especially all elements of the applicator, are injection-molded parts. The housing is more preferably cylindrical. It is more preferably hollow cylindrical. In particular, the housing is a circular cylinder or rectangular, and especially a square cylinder. Furthermore, a holding element for receiving the microarray is particularly connected to or disposed in the housing.

[0010] The microarray device is preferably a microarray support device. The microarray device is preferably a support as defined in German Patent Application Publication No. 102019200561, preferably an embodiment and / or one of the claims, particularly claim 1. In particular, the microarray device is a microarray support disk.

[0011] Furthermore, the applicator includes a pressing element for moving the plunger. In particular, the pressing element is an element that is subjected to pressure or tension. The pressing element is preferably a pre-tensioning device, such as a spring, and especially preferably a coil spring. It is preferable that the plunger is moved by the pressing element to act on the microarray device that the holding device receives. Furthermore, the applicator includes an actuation device, which holds the plunger in a first position and, by actuation of the actuation device, releases the plunger by the pressing element for movement. The first position is particularly the initial position, and it is preferable that the first position is an internal position inside the housing where the plunger is located. When the plunger has moved to a particularly maximum displacement position, it is preferable that the plunger is in a second position, also referred to as the displacement position. To enable optimal force application, the plunger is preferably conical, pyramidal, or partially spherical so that the plunger can act particularly on the negative opposing surface of the microarray receiving portion, preferably the microarray supporting plunger. The shape of the plunger is preferably selected so that it can penetrate or bend the film of the microarray device, particularly the sealing film. The actuation device has at least two separate actuators. The actuators are, in particular, mechanical actuators, that is, elements that are actuated by a mechanical action. A configuration as an electric actuator is further possible instead of or in addition to the configuration as a mechanical actuator. The configuration of the applicator, in particular the configuration of the actuation device, is such that the plunger is released by the actuation device only when at least two actuators are actuated. Here, it is particularly preferable that the release occurs only when cumulative actuation of at least two actuators occurs. Here, cumulative means simultaneous. Simultaneous / cumulative means joint actuation in particular, which in particular means simultaneous and / or sequential actuation in particular. Simultaneous means that the actuation is essentially simultaneous. For example, sequential means that the first actuator among the actuators is actuated, for example, a lever or slider moves to the actuation position, and as a result, for example, a release occurs.Next, another actuator is activated, for example, to trigger a mechanism, and in particular, an actuator knob is pressed. In other words, it is preferable that release occurs only when the locking release and triggering are performed.

[0012] Here, a configuration including a pressing element allows for a particularly advantageous pre-defined application force, and consequently, enables reproducible application. For this reason, it is preferable that the pressing element is selected and / or adjusted and / or configured so that the optimal application force is triggered. Two separate actuators particularly allow for the implementation of a kind of protective function and a kind of trigger function in an advantageous manner. In other words, a kind of release in the form of a gun can be implemented such that the trigger function is only possible after the release.

[0013] The applicator according to the present invention offers the particular advantage of improved reproducibility of microarray insertion. Another advantage is that the specific operation of at least two actuators, particularly the release and triggering, improves transport safety and / or prevents unintended activation. Furthermore, it is particularly advantageous that an optimal, and especially minimal, pressing force is preferably ensured in the direction of application to ensure bonding and sufficient holding force during the trigger pulse.

[0014] The pressing element is preferably configured such that, after the plunger has moved due to the pressing element, further tensioning cannot be performed manually by the user, and can only be done by means of a tool, preferably such as a tensioning tool. Here, the pressing element preferably has a large spring force and / or spring constant such that it is impossible to apply tension manually. It is particularly preferable that the applicator is advantageously configured such that manual reuse is prevented, in particular by the spring force and / or spring constant of the pressing element.

[0015] According to a preferred embodiment, the actuation device has a force trigger element. The force trigger element is particularly the first actuator of the actuation device. The force trigger element is configured to act when a defined force is applied, particularly in the direction of the application point. Here, the application of a defined force means that exactly a predetermined force and / or a force greater than the predetermined force must be applied to trigger the actuation. In other words, the force trigger element is preferably a trigger element having a force threshold, and when a force exceeding the force threshold is applied, the actuation occurs. The force trigger element particularly preferably has a rated breaking point device for determining the force, and / or a flexible elastic element, and / or a pre-tensioning device. Furthermore, the actuation device may have multiple force trigger elements. For example, the first actuator and the second actuator may each be force trigger elements. The defined force, particularly the force threshold, preferably reaches about 2 kg, preferably 2.5 kg, and particularly preferably 3 kg. The defined force, particularly the force threshold, preferably reaches about 20 N, preferably about 25 N, and particularly preferably about 30 N.

[0016] The actuation device preferably has at least one actuation element that acts when acted upon. It is particularly preferable that the second actuator is the actuation element. On the other hand, it is even more possible that the first actuator and the second actuator are, for example, actuation elements. The at least one actuation element is preferably a technical command controller that can be operated by a user in particular to trigger the actuation.

[0017] The force trigger element and / or actuation element particularly has at least one of the following devices, preferably the force trigger element and / or actuation element is comprised of one of a press and / or rotate knob, lever, slider, or switch. Here, a press knob means a tactilely movable element which is preferably designed to be pressed in and / or pulled out.

[0018] In a preferred embodiment, the force trigger element and the operating element are connected to each other. This connection is particularly preferably a single, integrated connection, also known as a joint connection. For example, the force trigger element and the operating element can preferably be configured together as a rotary / pressure knob. Thus, such a rotary / pressure knob can preferably be pressed in on the one hand to function as a force trigger element, and rotate on the other hand to function as an operating element. Preferably, other or similar combinations are possible, such as a pressure / sliding knob, which, for example, must first slide into a predetermined position and then be pressed in that position.

[0019] According to a preferred embodiment, the actuating device has a coupling mechanism. The coupling mechanism is particularly preferably a shape-locking and / or force-locking coupling mechanism. The coupling mechanism is configured to connect the plunger to the housing in a first state and to separate the plunger from the housing in a second state so that the plunger can be moved. Therefore, it is preferable that the plunger, which is preferably connected inside the housing, is first held by the coupling mechanism. When the coupling mechanism is actuated or activated, in particular when the separation function of the coupling mechanism is triggered, separation or release occurs so that the plunger can be moved.

[0020] The operating device preferably has a locking mechanism. The locking mechanism is configured to first, preferably in a non-operating state, prevent the coupling mechanism from moving, and second, preferably in an operating state, release the coupling mechanism so that the coupling mechanism can move the plunger. In other words, it is preferable that the locking mechanism moves the applicator, particularly preferably the coupling mechanism, from a stable state to an unstable state. For this reason, the locking mechanism is particularly configured to first prevent the activation, i.e., separation, of the coupling mechanism, and to release the coupling mechanism only when the locking mechanism is activated, i.e., when it is released.

[0021] In the force-locking configuration of the coupling mechanism, it is preferable that the coupling mechanism presses against the plunger, thereby preventing the plunger from moving to the first state by friction. Here, it is preferable that the contact with the coupling mechanism or the pressure of the coupling mechanism on the plunger is released upon separation. In the force-locking configuration of the coupling mechanism, the coupling mechanism has a hook device and / or a retaining claw device and / or a template device, and is particularly preferably configured with a hook device and / or a retaining claw device and / or a template device. Here, it is particularly preferable that these devices connect the plunger to the housing or block the plunger in the first state. Therefore, the hook device and / or retaining claw device can selectively connect the plunger to the housing, for example. In the configuration as a template device, it is preferable that the coupling mechanism has a template, and the corresponding equivalent of the plunger cannot be fitted through the template in the first state, but can pass through it when separating, for example when moving the template device.

[0022] In the shape locking configuration and / or force locking configuration of the locking mechanism, it is preferable that the configuration is based on the shape locking configuration and / or force locking configuration of the coupling mechanism. However, in contrast to the configuration of the coupling mechanism, it is preferable that the locking mechanism does not act on the plunger but acts on the coupling mechanism, and in particular to prevent the coupling mechanism from moving. If the locking mechanism has, for example, a hook or is composed of a hook, it is preferable that the hook prevents the coupling mechanism from moving when locked, that is, is particularly hooked onto and connected to the coupling mechanism. In the released state, it is preferable that the hook is detached from the coupling mechanism so that the coupling mechanism can be separated.

[0023] It is preferable that the force trigger element activates the separation mechanism or the locking mechanism.

[0024] In a preferred configuration, the operating element activates a separation mechanism or a locking mechanism.

[0025] When the force trigger element activates the separation mechanism, it is particularly preferred that the operating element activates the locking mechanism or vice versa.

[0026] Preferably, the holding device is reversibly removably connectable to the microarray device, or the holding device is irreversibly connectable to the microarray device. A reversibly removable holding device allows for reuse of the applicator. In the case of a reversibly removable holding device, the holding device preferably has at least one flexible holding arm and / or engagement device and / or at least one snap-in hook, and particularly preferably is constituted by at least one flexible holding arm and / or engagement device and / or at least one snap-in hook. When the holding device is irreversibly connectable, the holding device is particularly a disposable applicator, and the holding device preferably has a bayonet device, and is particularly preferably constituted by the bayonet device. The holding device preferably has a holding device operating member for reversibly separating the microarray device.

[0027] According to a preferred embodiment, the applicator comprises a protection device, which protects at least a part of the microarray device from the environment in the first position and releases at least a part of the microarray device for application in the second position. It is particularly preferred that the protection device is movable relative to the holding device. The protection device preferably protects at least one microarray of the microarray device and / or the adhesive layer of the microarray device provided for adhesive connection to the skin. In other words, the protection device is preferably a kind of shield that is preferably foldable and / or retractable.

[0028] In particular, the protection device has a protection color, and preferably consists of the protection color. In a preferred configuration, the protection color is held by a pre-tensioning device in a first position. Accordingly, it is preferred that the pre-tensioning device prevents the movement of the protection color to a second position in the first position. For example, by applying a force in a direction opposite to the pre-tensioning direction, the protection color can move from the first position to the second position, and in particular can be retracted, and at least a part of the microarray device is released for application.

[0029] The applicator preferably has a reversible or irreversible blocking device. The blocking device is preferably configured to prevent the reuse of the applicator. Here, it is particularly preferred that the blocking device fixes the plunger in a moving position, in particular a displaced position, and / or blocks the actuating device. For this purpose, it is preferred that the blocking device has, for example, an engagement device and / or a snap-in hook.

[0030] The application system according to the present invention is an application system for applying a microarray. The application system comprises an applicator according to one or more of the definitions described above. Furthermore, the application system comprises a microarray device having at least one microarray. The microarray device is preferably configured as a microarray support disk, and is particularly configured as described in German Patent Application Publication No. 102019200561, and is particularly preferably configured as in the embodiments and / or claims described in German Patent Application Publication No. 102019200561, particularly claim 1. The retaining device particularly engages with and receives the microarray device. It is particularly preferable that the retaining device is received by a reversible or irreversible connection of the retaining device to the microarray device. With respect to the connection, it is particularly preferable that the retaining device has at least one flexible retaining arm and / or engaging device and / or snap-in hook device and / or bayonet device, and is particularly preferably configured by at least one flexible retaining arm and / or engaging device and / or snap-in hook device and / or bayonet device.

[0031] The method according to the present invention is a method for moving a plunger, in particular an applicator plunger. The method includes a step of holding the plunger in a first position against a pre-tension. In at least two separate, in particular mechanical, acting steps, the plunger is released so that the plunger moves due to the pre-tension. At least two acting steps for release must preferably be performed cumulatively, and especially simultaneously or sequentially. In other words, preferably, according to another definition, the plunger is released only after a release step, followed by a trigger step.

[0032] It is particularly preferable to carry out this method using an applicator or application system having one or more of the features of the applicator defined above. Furthermore, it is preferable to supplement this method with one or more of the features, preferably method features, defined above. It is preferable to place the application system at the application site before or after the step of releasing the first actuator or operating the first actuator.

[0033] The present invention will be described in detail below based on preferred embodiments with reference to the accompanying drawings. [Brief explanation of the drawing]

[0034] [Figure 1] This is a schematic perspective view showing an embodiment of the support. [Figure 2a] This is a schematic cross-sectional view showing the support along section II of Figure 1 at the initial position. [Figure 2b] This figure shows the support of Figure 2a at the application location. [Figure 3] This is a schematic cross-sectional view showing another embodiment of the support. [Figure 4] This is a schematic cross-sectional view showing another embodiment of the support. [Figure 5a] This is a schematic cross-sectional view showing another embodiment of the support. [Figure 5b] This figure shows the support of Figure 5a at the application location. [Figure 6] This is a schematic cross-sectional view showing another embodiment of the support. [Figure 7] This is a perspective view showing an embodiment of an application system according to the present invention, which includes an embodiment of the applicator according to the present invention. [Figure 8a] Figure 7 is a perspective cross-sectional view showing one state of the applied system. [Figure 8b] Figure 7 is a perspective cross-sectional view showing one state of the applied system. [Figure 9] This is a schematic cross-sectional view showing in various states another embodiment of the application system according to the present invention, which includes another embodiment of the applicator according to the present invention, based on the embodiment of Figure 7. [Figure 10] This is a perspective view showing another embodiment of the application system according to the present invention, which includes another embodiment of the applicator according to the present invention. [Figure 11a] Figure 10 is a perspective cross-sectional view showing one state of the applied system. [Figure 11b] Figure 10 is a perspective cross-sectional view showing one state of the applied system. [Figure 12] This is a schematic cross-sectional view showing in various states another embodiment of the application system according to the present invention, which includes another embodiment of the applicator according to the present invention, based on the embodiment of Figure 10. [Figure 13] This is a perspective view showing another embodiment of the application system according to the present invention, which includes another embodiment of the applicator according to the present invention. [Figure 14a] Figure 13 is a perspective cross-sectional view showing one state of the applied system. [Figure 14b] Figure 13 is a perspective cross-sectional view showing one state of the applied system. [Figure 14c] Figure 13 is a perspective cross-sectional view showing one state of the applied system. [Figure 15] This is a schematic cross-sectional view showing in various states another embodiment of the application system according to the present invention, which includes another embodiment of the applicator according to the present invention, based on the embodiment of Figure 13. [Figure 16] This is a perspective view showing another embodiment of the application system according to the present invention, which includes another embodiment of the applicator according to the present invention. [Figure 17a] Figure 16 is a perspective cross-sectional view showing one state of the applied system. [Figure 17b] Figure 16 is a perspective cross-sectional view showing one state of the applied system. [Figure 18] This is a schematic cross-sectional view showing in various states another embodiment of the application system according to the present invention, which includes another embodiment of the applicator according to the present invention, based on the embodiment of Figure 16. [Figure 19] This is a schematic cross-sectional view showing another embodiment of the application system according to the present invention, which includes another embodiment of the applicator according to the present invention. [Modes for carrying out the invention]

[0035] In the drawings, similar or identical parts or elements are shown with the same reference number. For clarity in particular, elements that have already been identified are preferably not given a reference number in all drawings.

[0036] Figure 1 shows a microarray device configured as a microarray support device 10, which is hereafter referred to as the support 10. The support 10 in Figure 1 comprises a support housing 14. The support housing 14 has circumferential grooves 22 on its exterior that function as connecting means for an applicator 200 (see, for example, Figure 7).

[0037] At the proximal end 19, the support housing 14 has an access opening 28 (see Figure 2a), through which a plunger 204, also called a piston of, for example, an applicator 200 (see, for example, Figure 7), accesses or acts upon the inside 38 (see Figure 2a) of the support housing through the access opening.

[0038] The access opening 28 is closed to the environment by a film 40 that forms part of the sterile barrier 36. The film 40 is preferably connected to the support housing 14 by adhesive joints and / or welded joints 41. For example, when the plunger 204 of the applicator 200 (see, e.g., Figure 7) accesses the inside 38 of the support housing, the film 40 has a flexible region 46 so that the plunger 204 can push distally into the inside of the film 48. However, it is preferable that the applicator 200 can move the support plunger 16 in a non-triggered state and that sterile isolation to the environment with respect to the illustrated upper side is still maintained. Instead of a flexible configuration, it is further possible that the film 40, particularly the flexible region 46, is fragile so that, for example, when the support plunger 16 moves, the applicator 200 can cause the film 40 to tear. In particular, the operation of the plunger 204 of the applicator (see, for example, Figure 7) that causes the movement and / or displacement of the support plunger 16 is preferably performed in the support plunger operating region 60 at the proximal end of the support plunger 16. The support plunger operating region 60 is shown as a planar configuration. However, other configurations of the support plunger operating region 60 are further possible, for example, a negatively conical configuration (see Figure 6), or a positively conical configuration, or a negative or positively pyramidal configuration, or a configuration having a smooth edge, a sharp edge, or a serrated edge or tip.

[0039] At the distal end 17, the blister 42 is connected to the support housing 14. As shown in Figure 2a, a recess 15 for receiving the blister 42 may be provided in the support housing 14. In addition, or alternatively, the connection between the blister 42 and the support housing 14 may be provided at the connection point 41 by a particularly releasable adhesive connection portion.

[0040] Figure 2a shows the support plunger 16 in its initial position, where it is fixed proximal to the support housing by a release device 30. This fixation is achieved by the engagement of the bead 31 of the support plunger 16 with the groove 29 of the support housing 14. Here, the bead 31 and / or groove 29 are preferably flexible, and the support housing 14 and / or support plunger 16 are stable, at least essentially.

[0041] The support plunger 16 is connected to the microarray 12 at its distal end. Therefore, the patches 13 of the microarray 12 are specifically bonded to the support plunger. Each patch 13 of the microarray 12 has a microneedle 11 extending distally. In the initial position shown in Figure 2a, the microarray is located within the support housing 14. The blister 42 and film 40 form a sterile barrier 36 to isolate the microarray 12 from the environment.

[0042] The inner space 38 of the support housing and / or the internal space 43 of the blister may preferably contain a desiccant and / or protective gas. This has a positive effect, in particular on the sterility and / or durability of the microarray.

[0043] Figure 2b shows the support 10 of Figure 2a in the applied state.

[0044] For application, the blister 42 is separated or removed, for example, by the user. The support 10 is then connected to the application site 100 via the adhesive layer 34 at the distal end 17 of the support housing 14. The application site is, in particular, the user's skin.

[0045] The support plunger 16 is in the application position. Here, the support plunger 16 moves distally inside the support housing 14, thereby moving the microarray 12 away from the support housing 14 through the application opening 18. The microneedles 11 of the microarray 12 are inserted into the application site 100.

[0046] The support plunger 16 is held or fixed in the distal application position by the retaining device 32. In the illustrated embodiment, the retaining device 32 has a groove 33 that engages with the bead 31 of the support plunger 16. Thus, the support plunger 16 is further pressed, thereby ensuring that the microarray 12 is applied over a long period of time.

[0047] The support plunger 16 is moved or displaced by accessing or acting upon its proximal end through the access opening 28. This action is performed, for example, by the plunger 204 of the applicator 200 (see, e.g., Figure 7), which is connected to the support 10 via the coupling device 20. The plunger 204 of the applicator 200 is then accelerated, for example, to first collide with the film 40, thereby displacing the film 40 distally for its flexible configuration. In particular, the release device 30 releases the support plunger 16 for movement by further indirect collision of the plunger 204 with the proximal end of the support plunger 16. The support plunger 16 then moves to the distal position shown in Figure 2b and is fixed in the distal position by the holding device 32.

[0048] Instead of displacing the support plunger 16 with the applicator 200, it is possible to displace or act on the support plunger 16 by the user's finger pressing on the proximal end of the support plunger 16, preferably indirectly via the film 40.

[0049] The release device 30 is preferably configured as a target force trigger element. Thus, the support plunger is released only when a target force is applied, preferably when a target force is applied to the support plunger. Here, the target force trigger element may preferably be configured such that at least the required target force corresponds to a particularly optimal applied force for puncturing and applying the microarray 12. In the illustrated configuration, the target force trigger element acts particularly by a removable connection between the groove 29 and the bead 31.

[0050] Figure 3 shows another embodiment of the support 10. The illustrated embodiment is essentially similar to the embodiment in Figure 2a.

[0051] In contrast to the embodiment in Figure 2a, the release device 30 in the embodiment in Figure 3 is configured as a mating portion, particularly a tightening portion, between the support plunger 16 and the support housing 14. The mating portion initially holds the support plunger in its initial position. After displacement of the support plunger 16, the mating portion functions as a holding device 32, thereby ensuring that the support plunger is fixed in the application position.

[0052] The connecting device 20 has a screw 24, which can be connected to a corresponding engaging screw on the applicator 200.

[0053] In contrast to the embodiment in Figure 2a, the embodiment in Figure 3 does not have a blister, but it does have a film 44. The film 44 is connected to the support housing 14 at its distal end 17, particularly by an adhesive layer 41. The film 44 can be peeled off and subsequently removed, for example, by the user using the illustrated film tab 47. The adhesive layer 41 further functions as a fastening means 34 so that the support 10 can be connected to the application site.

[0054] Figure 4 shows another embodiment of the support 10. This embodiment is the same as the embodiment in Figure 3, except for the differences described below.

[0055] In this embodiment, a blister 42 is provided that completely encloses the support housing 14 in the radial direction. The support housing 14 is in contact with a protruding portion 45 that extends radially inward from the blister 42 at its distal end 17. Viewed from the protruding portion 45, the support housing 14 has an adhesive layer 34 at its distal end 17 that is positioned further inward radially and functions as a fixing means for fixing the support 10 to the application site. In contrast to other embodiments, such as the embodiment in Figure 3, the adhesive layer 34 does not contact the blister 42 and is positioned at a distance from the blister 42.

[0056] The blister 42 constitutes a kind of guide at its proximal end, for example, for the applicator 200. Thus, the applicator 200 can be pushed into the blister and then connected to the coupling device 20, which is configured as a plug coupling as shown in the figure. Subsequently, the blister 42, which preferably simply slides on the support housing 14, can be removed. Then, applications according to the embodiments described above can be carried out.

[0057] Figures 5a and 5b show another embodiment of the support 10. This embodiment does not have a holding device. After moving the support plunger 16, and preferably as a result applying the microarray 12 to the application location 100, the support plunger 16 and the support housing 14 are no longer connected to each other and separate from each other. As a result, the support plunger 16 and the support housing 14 can move relative to each other.

[0058] Figure 5b shows the state in which the support housing 14 has been removed from the application location 100, and the support plunger 16 remains in the application location 100 together with the applied microarray.

[0059] The illustrated sterilization barrier 36 has a film 40. In the initial position, as shown in Figure 5a, the film 40 expands from the distal end 17 of the support housing 14 through the application opening 18, surrounding the support plunger 16 toward the access opening 28. Thus, sterility of the inside 38 of the support housing or the microarray 12 is ensured at least proximal to the support housing. Preferably, the film 40 has an adhesive layer 39 distal to it so that the film 40 can be bonded to the application site 100, as shown in Figure 5b. After or during application (Figure 5b), the elastic film 40 can perform the function of further pressing the microarray 12 against the application site 100 and / or ensuring sterility to the environment.

[0060] In the embodiments shown in Figures 5a and 5b, it is further possible to provide a blister or another film, particularly removable, at the distal end to close the application opening 18, preferably to ensure sterility.

[0061] In the illustrated embodiment of the support 10, the support is configured to be rotationally symmetric about the axis of rotation 50. However, other configurations, such as a cube, are possible.

[0062] Figure 6 shows another embodiment of the support 10. The illustrated embodiment essentially corresponds to the embodiment in Figure 2a.

[0063] In contrast to the embodiment in Figure 2a, the support plunger action area 60 of the support plunger 16 in Figure 6 is not flat, but is configured as a conical depression, also referred to as a negative cone shape. For example, instead of a conical depression, a pyramidal or partially spherical depression is possible. Other embodiments of the support body 10, such as those in Figures 3 and 4, can further be configured using the support plunger action area 60 as defined above.

[0064] In the conical recess of the support plunger action region 60 shown in Figure 6, it is advantageous for an applicator plunger having a corresponding positive conical structure to collide with the support plunger action region 60, for example, so that optimal force transmission can be achieved.

[0065] Figure 7 shows an embodiment of an application system 300 according to the present invention for applying a microarray, comprising an applicator 200 according to the present invention for applying a microarray and a microarray device 10 configured as a microarray disk. Here, the microarray support disk 10 is configured having one, more, or all of the features of the support configuration in Figure 6.

[0066] The applicator 200 comprises an applicator housing 202, which in particular has a base body 203 (see Figure 8a), as shown in the illustration. The actuation device 212 and / or retaining device 208 may be considered part of the applicator housing 202 or may be identified as separate components.

[0067] The operating device 212 has two actuators 214 and 216.

[0068] The applicator 200 is reversibly connected to the microarray support disk 10 via a retaining device 208 so that the microarray support disk 10 can be arbitrarily received by the applicator 200 or detached from the applicator via a retaining device operating member 230 configured as a flexible lever arm.

[0069] Figure 8a shows a cross-sectional view of the first state of the application system 300 in Figure 7, while Figure 8b shows the second state.

[0070] The microarray support disk 10 is connected to the applicator 200 via a retaining device 208 of the applicator 200. The retaining device 208 has at least two flexible arms, which may also be referred to as snap-in hooks 230. The snap-in hooks 230 have inwardly facing projections 232. These projections 232 are inserted into recesses 22 to connect to the microarray support disk 10, thereby establishing the connection. The connection between the retaining device 208 and the microarray support disk 10 may also be referred to as a tongue-and-groove joint, and the retaining device 208 has at least one tongue 232 that engages with a groove 22 of the microarray support disk 10. The flexible arms 230 can be deflected inward or bent by, for example, a user, so that the tongue 232 can exit the groove 22, thereby allowing the microarray support device 10 to be arbitrarily removed from the applicator.

[0071] Figure 8a shows the initial state of the applicator 200. The operating device 212 has two separate mechanical actuators 214 and 216. The mechanical actuator 214 is configured as a kind of pressing knob that is movable toward the base body 203 of the applicator housing 202.

[0072] Furthermore, the embodiment in Figure 8a includes a pressing lever 216 as another actuator 216. The pressing lever 216 is rotatably supported and has a connecting element 242 at its inner end, which is connected to the connecting element 240 of the plunger 204 in a shape-locking manner. The connecting elements 240 and 242 together form part of a connecting mechanism 218, and specifically constitute the connecting mechanism. In the initial position, the plunger 204 is held in a first position by this connecting mechanism. The plunger 204 has a conical plunger region for acting on the support plunger operating region 60 of the microarray device 10.

[0073] Figure 8b shows the second state of the applicator 200 in Figure 8a, where the pressing knob 214 and the base body 203 move relative to each other. This relative movement allows the pressing lever 216 to rotate. Consequently, the pressing lever 216 rotates, and the connecting element 242 of the pressing lever 216 is detached from the connecting element 240 of the plunger 204, thereby freeing the plunger 204 for movement.

[0074] Figure 9 shows various states of the application system 300 equipped with the applicator 200, where the application system 300 and the applicator essentially correspond to the configurations in Figures 7 and 8, respectively.

[0075] In the initial position I, the application system 300 is placed on the application site 100, such as the user's skin, as indicated by the movement arrow 1. Here, it is preferable that the microarray support disk 10 is bonded to the application site 100 via the adhesive layer 41. In the initial state I, the microarray 12 of the microarray support device 10 is positioned at a distance from the skin 100.

[0076] In the initial state I, the actuator 216 configured as a pressing lever 216 is blocked by the blocking element 244 of another actuator 214 configured as a pressing knob 214. As a result, the blocking element 244 contacts the blocking element 246 configured as the rear surface of the actuator 216, thereby preventing the actuator 216 from rotating.

[0077] The actuator 214 is held in a first position by a force-regulating device 234. In the illustrated embodiment, the force-regulating device 234 corresponds to a pre-tensioning element, in particular a spring 234. Here, the spring 234 is configured to allow movement of the actuator 214, in particular to the end position, only when a predetermined force is applied that is in particular equivalent to the optimal pressing force applied to the skin 100 by the application system 300. Thus, the actuator 214 corresponds to a force trigger element that allows the locking mechanism 220 to be activated, i.e., released, only when a predetermined force or a force greater than (greater than / equal to) the predetermined force is applied.

[0078] In state II, actuator 214 is pressed as indicated by the movement arrow 2. Consequently, the blocking element 244 of actuator 214 detaches from the other actuator 216, particularly the blocking element 246 which is configured as a contact area 246. This activates the locking mechanism 220, and as a result, the locking of the applicator 200 is released. Consequently, the other actuator 216 which is configured as an operating element can rotate.

[0079] The third state III describes this operation of the operating element 216, where pressure is applied to the pressing lever 216 as indicated by the movement arrow 3. As a result, the coupling element 242 of the actuator 216 detaches from the coupling element 240 of the plunger 204, and consequently the coupling mechanism 238 is activated, i.e., separated. Therefore, the plunger 204 is released for movement.

[0080] In the final state IV, the plunger 204 moves via a pre-tensioning device, specifically a pressing element 210 configured as a spring, as indicated by the movement arrow 4. In particular, the conical plunger region 206 of the plunger 204 collides with the support plunger 16, specifically the support plunger action region 60. This causes the support plunger 16 to move, thereby applying the microarray 12.

[0081] The application by the illustrated applicator 200 is preferably performed only when the actuator device 212 is cumulatively activated, i.e., when the actuator 214 is pressed to operate the operating element 216.

[0082] Figure 10 shows another embodiment of the applicator 200 according to the present invention.

[0083] The microarray support disk 10 is received by the holding device 208 in a manner similar to that of the embodiment in Figure 7. In contrast to the embodiment in Figure 7, the snap-in hook 230 is configured not to extend beyond the outer contour of the applicator 200.

[0084] The operating device 212 has two actuators 214 and 216 that are integrally formed with each other, in particular as a rotary / pressing knob, as shown in the figure.

[0085] Figures 11a and 11b show two states of the embodiment shown in Figure 10.

[0086] Figure 12 shows an embodiment of the application system 300 according to the present invention, which includes an embodiment of the applicator 200 according to the present invention, and the embodiment essentially corresponds to the embodiment in Figure 11a.

[0087] The applicator 200 includes a locking mechanism 220 having at least one blocking element 244 (see Figure 11a), preferably two blocking elements 244 (see Figure 12). In the initial state, at least one blocking element 244 presses radially against the axis of the retaining claw 246 that holds the plunger 204, so that the locking mechanism 220 prevents the rotation / press knob from being pressed by at least one blocking element 244. Only after the rotation / press knob 212 has preferably rotated 90° (see movement arrow 2 in II) does at least one blocking element 244 disengage, thus releasing the lock of the applicator 200.

[0088] By pressing the rotation / pressing knob 212 against the force-defining device 234 (see movement arrow 3 in III), rotation of the connecting element 242, which is configured in particular as a retaining claw, occurs due to the action of the blocking element 244, so that the plunger 204 is separated from the connecting element 240. Thus, in III, the connecting mechanism 218 is activated, i.e., separated, so that the plunger 204 can be moved (see IV).

[0089] In the embodiments shown in Figures 10 to 12, the rotation function of the rotation / pressure knob 212 activates the locking mechanism 220 via the operating element 216. The pressing function of the rotation / pressure knob 212 activates the separation mechanism 218 via the force trigger element 214.

[0090] Figure 13 shows another embodiment of the application system 300 according to the present invention, which includes an embodiment of the applicator 200 according to the present invention, and Figures 14a to 14c are cross-sectional views showing various states of the embodiment of Figure 13.

[0091] In contrast to the embodiments shown in Figures 7 to 12, the microarray support disk 10 is received irreversibly, rather than reversibly, by the applicator 200 via a retaining device 208 configured as a kind of bayonet closure.

[0092] Preferably, a spring-supported protective device 222 is arranged annularly around the microarray support disk 10, and this protective device has or is composed of a protective collar 224. In the initial state (see Figure 14a), the protective collar 224 is movably displaced by a pre-tension generated by a pre-tensioning device (not shown), so that contact between the adhesive layer 41 of the microarray support device 10 and / or the microarray 12 is isolated from the environment. This advantageously prevents unintended adhesion of the microarray support device 10 to an object, and / or contamination of the microarray 12, and / or physical action on the microarray 12. As a force perpendicular to the applicator 200, for example, the user's skin, the protective collar 224 preferably moves inward against the pre-tension of the applicator 200. Therefore, it is particularly preferable that the protective collar is held irreversibly, for example, by fitting and / or hooking. Therefore, the adhesive layer 41 is removed (see Figure 14b).

[0093] The locking mechanism 220 in the embodiments shown in Figures 13 to 15 has a gate valve 216 as an operating element. When the operating element 216 is moved, for example by the user (see movement arrow 2 in II of Figure 15), the locking is released, and by moving the locking element 246, the blocking element 252 of the base body 203 is released for movement.

[0094] Subsequently, by pressing the force trigger element 214 against the force setting device 234 (see movement arrow 3 in III of Figure 15), the connecting element 240 of the plunger 204 is compressed via at least one inclined edge 256 of the force trigger element 214, thereby separating the connecting mechanism 218. As a result, the plunger 204 is released for movement by the pressing element 210 (see movement arrow 4 in IV of Figure 15).

[0095] Figure 16 shows another embodiment of the application system 300 according to the present invention, which includes another embodiment of the applicator 200 according to the present invention.

[0096] Figures 17a and 17b are cross-sectional views showing various states of the embodiment shown in Figure 16.

[0097] Figure 18 shows another embodiment of the application system 300, which includes another embodiment of the applicator 200 according to the present invention based on the embodiment of Figure 16.

[0098] The microarray device 10 is received via a bayonet closure that functions as a holding device 208. The locking mechanism 220 is activated by a toggle switch 216. In the first state (see, for example, Figures 17a and 18I), the toggle switch 216 prevents the movement of the pressing knob 214, which corresponds to the force trigger element, by its connection with the blocking element 252, i.e., because there is no distance 254. By flipping the toggle switch 216, the connection is released, and distance 254 is created (see Figure 18II). For example, when a user presses the force trigger device 214 against the force specifying device 234, the blocking element 252 moves due to the inclined edge 256 of the force trigger device 214, thereby creating a release that allows the plunger 204 to move (see movement arrow 3 in Figure 18III). This activates, i.e., separates, the coupling mechanism 218. Here, the blocking element 252 corresponds in particular to a template device, and preferably, by moving the blocking element 252, the plunger 204 is mated via the template device only in the mating configuration.

[0099] Therefore, the pressing element 210 moves the plunger 204 for application (see movement arrow 4 in IV of Figure 18).

[0100] Various solutions, particularly the embodiments shown in Figures 7 to 18, can be combined with and / or interchangeable with each other. In particular, various retaining devices (e.g., bayonet closures or snap-in connectors) can be used in all embodiments. Furthermore, various configurations of actuators 214, 216, or configurations of force trigger elements and / or operating elements can be variably used in all embodiments. In particular, the protective device 222 in the configuration of Figure 14a can be implemented in all embodiments. Moreover, preferred coupling mechanisms and / or locking mechanisms, particularly those relating to various concepts in the embodiments shown in Figures 7 to 18, can be variably implemented in all embodiments.

[0101] Figure 19 shows another embodiment of the application system 300 equipped with the applicator 200.

[0102] According to the embodiments described above, in the initial state I, the application system 300 is placed on the application site 100, in particular on the skin. As in other embodiments, the support 10 is held via an engagement system having projections 22. In the initial state I, the microarray held by the support 10 is positioned at a distance from the skin 100. In the initial state I, the actuator 214, which is a large pressing knob in the illustrated exemplary embodiment, is blocked by a blocking element 216. The blocking element 216 is configured as a pivot lever 217. Because the pivot lever 217 is in contact with the housing element 203, the actuator 214 is not operable in the initial position I, i.e., it cannot be pressed down. The pressing knob can only be pressed down by reversing the pivot lever 217.

[0103] After release, the pivot lever 216 can rotate to state II. In state II, the projection 219 of actuator 216 no longer contacts the upper side 203 of guide element 209, so the two actuators 214 can be pushed down together with the pivot lever 216 as indicated by the movement arrow 3. On the one hand, this causes the retaining projection 205 of actuator 214 to engage behind the retaining projection 207 of guide element 209. The retaining projection 205 serves to maintain the triggered state and prevent another trigger. Thus, it is clear that a trigger has occurred.

[0104] Furthermore, the plunger 204 is released for operation in the direction indicated by the movement arrow 3. The release of the plunger 204 is achieved by tilting the shape-locking coupling mechanism 218 from position II to position III. For this purpose, each lever of the coupling mechanism 218 has a spherical, particularly hemispherical projection 223 that functions as a pivot bearing. By rotating the actuating element 218 and the cooperating inclined surface, the individual coupling elements 218 tilt or rotate.

[0105] Therefore, as the spring 210 is released, the plunger 204 moves toward the support element 10 that supports the microneedle array.

[0106] The drawings, particularly Figures 9, 12, 15, 18, and 19, first show placement at the application site (arrow 1), and then show operation of the first actuator (arrow 2). Generally, in the embodiments shown in particular, it is preferable, if possible, to perform the first operation of the first actuator, followed by placement at the application site. In other words, it is even possible to first release the lock and then place the actuator.

Claims

1. An applicator for the application of microarrays, The casing and A plunger is linearly movable within the housing, A holding device connected to the housing, the holding device for receiving a microarray device, A pressing element for moving the plunger so that the plunger acts on the microarray device that the holding device receives, The actuator holds the plunger in a first position, and the actuator releases the plunger for movement so that, by the operation of the actuator, the plunger moves toward the microarray device and strikes the microarray device to apply the microarray. It is equipped with, The actuation device comprises at least one force trigger element that is activated when a predetermined force is applied, and at least one actuation element that is activated when subjected to an action. The aforementioned operating element is blocked by the force trigger element before the force trigger element is activated, and the activation of the force trigger element releases the blockage of the operating element by the force trigger element, making the operating element operable, and when it is subjected to an external force while in an operable state, it operates. An applicator in which the release of the plunger by the actuation device occurs only when the force trigger element is activated, and when the actuation element is activated after the force trigger element has been activated.

2. The applicator according to claim 1, wherein the force trigger element and / or the operating element has at least one of a press knob, a rotary knob, a lever, a slider, and a switch.

3. The applicator according to claim 1 or 2, wherein the force trigger element and the operating element are connected to each other.

4. The applicator according to any one of claims 1 to 3, wherein the operating device has a shape-locking and / or force-locking coupling mechanism, the coupling mechanism connects the plunger to the housing in a first state and separates the plunger from the housing in a second state so that the plunger can be moved.

5. The applicator according to claim 4, wherein the operating device has a shape-locking and / or force-locking locking mechanism, the locking mechanism prevents the coupling mechanism in a first non-operating state and releases the coupling mechanism in a second operating state so that the coupling mechanism can move the plunger.

6. The applicator according to claim 5, wherein the force trigger element activates the coupling mechanism or the locking mechanism.

7. The applicator according to claim 5 or 6, wherein the operating element activates the coupling mechanism or the locking mechanism.

8. The applicator according to any one of claims 1 to 7, wherein the holding device is reversibly detachably connectable to or irreversibly connectable to the microarray device.

9. An applicator according to any one of claims 1 to 8, comprising a protective device, the protective device protecting at least a portion of the microarray device from the environment in a first position and releasing it for application in a second position.

10. The applicator according to claim 9, wherein the protective device has a protective color.

11. The applicator according to any one of claims 1 to 10, comprising a reversible or irreversible blocking device for preventing reuse of the applicator, wherein the blocking device fixes the plunger in a moving position and / or blocks the operating device.

12. The applicator according to any one of claims 1 to 11, wherein the force trigger element and the operating element are mechanical.

13. An application system for the application of microarrays, An applicator according to any one of claims 1 to 12, A microarray device having at least one microarray and It is equipped with, The holding device is an application system that receives the microarray device.

14. A method for moving a plunger by an applicator according to any one of claims 1 to 12, or by an application system according to claim 13, A method comprising the steps of releasing a plunger, which is held in a first position against a pre-tension, by the activation of the force trigger element and the subsequent activation of the operating element, thereby moving the plunger by the pre-tension.

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