WO2021037816A1 - Mikroarray applikator sowie verfahren zum verschieben eines auf mikroarray einwirkenden stempels - Google Patents
Mikroarray applikator sowie verfahren zum verschieben eines auf mikroarray einwirkenden stempels Download PDFInfo
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- WO2021037816A1 WO2021037816A1 PCT/EP2020/073670 EP2020073670W WO2021037816A1 WO 2021037816 A1 WO2021037816 A1 WO 2021037816A1 EP 2020073670 W EP2020073670 W EP 2020073670W WO 2021037816 A1 WO2021037816 A1 WO 2021037816A1
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- Prior art keywords
- applicator
- microarray
- stamp
- carrier
- force
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0061—Methods for using microneedles
Definitions
- the invention relates to an applicator for applying a microarray.
- the invention also relates to an application system for applying a microarray.
- the invention further relates to a method for moving a stamp.
- 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 large number of microneedles.
- the needles are short so that when the microneedles are pressed into the skin of a patient, the needles only penetrate the skin to such an extent that the needle tips do not touch nerves and blood vessels as far as possible.
- the microneedles have an active ingredient or a drug.
- the corresponding active ingredient can be applied to a surface of the needle or arranged in the needles. It is preferred that the needles are made of a material that dissolves in the patient's skin.
- the introduction of the microneedles into the skin must be reproducible, in particular to ensure reliable drug delivery.
- the introduction of the microneedles must also be independent of the user or patient, since otherwise reproducibility would not be guaranteed.
- the introduction of the microneedles should also be independent of the The texture of the skin so that a certain depth of penetration is always ensured.
- microarrays are generally stored in packaging and / or carrier devices.
- a carrier concept for microarrays is shown in DE 10 2019 200 561 A, for example.
- the object of the invention is to create an applicator for applying a microarray, with which the handleability of the microarray is improved.
- Another independent object of the invention is to provide an application system for applying a microarray that improves the ease of handling for users.
- Furthermore, there is an additional, independent task of the invention is to create a method for moving a stamp that enables a reliable stamp action.
- the object is achieved according to the invention by an applicator with the features of claim 1, an application system with the features of claim 14 and a method for moving a stamp with the features of claim 15.
- the applicator according to the invention for applying a microarray has a housing in which a stamp is arranged so as to be linearly movable. It is preferred that the applicator has plastic, in particular consists of it.
- the applicator preferably has, in particular in addition to plastic, metal, for example metallic reinforcing elements such as struts.
- the applicator, in particular all elements of the applicator, is particularly preferably injection molded components.
- the housing preferably has a cylinder shape. It is particularly preferably a hollow cylindrical shape. It is in particular a circular cylinder or a rectangular, in particular square, cylinder.
- a holding device for receiving a microarray in particular connected to the housing or arranged on it.
- the microarray device is preferably a microarray carrier device.
- the microarray device is particularly preferably a carrier as defined in DE 10 2019 200 561 A, preferably in one of the embodiments listed there and / or the claims there, in particular claim 1.
- the microarray device is a microarray carrier disc.
- the applicator has a pressure element for moving the stamp.
- the pressure element is in particular an element which is under pressure or tension. It is particularly preferably a pretensioning device, such as a spring, particularly preferably a helical spring. It is preferred that the stamp is displaced by means of a pressure element in order to act on a microarray device received by the holding device.
- the applicator has an actuating device which holds the stamp in a first posi tion and, by actuating the actuating device, releases the stamp for displacement by means of the pressure element.
- the first position is in particular a starting position, it being preferred that it this is an inner position within the housing in which the stamp is accordingly located.
- the stamp After the stamp has been moved, in particular into the maximum deflected position, the stamp is preferably in a second position, also referred to as the deflected position. It is preferred that the stamp has a conical or pyramidal or part-spherical shape, so that the stamp can act in particular on a negative-opposite surface of action of a microarray receptacle, preferably a microarray carrier stamp, in order to enable an optimal application of force.
- the shape of the stamp is preferably selected such that it can penetrate or bend a film, in particular a sealing film, of a microarray device.
- the actuating device has at least two separate actuators.
- the actuators are in particular mechanical actuators, that is to say elements that are actuated by means of mechanical action.
- an electrical actuator version is also possible.
- the design of the applicator, in particular the design of the actuating device is such that the stamp is only released by the actuating device when the at least two actuators are actuated. It is particularly preferred here that the release only takes place if there is cumulative actuation of the at least two actuators. Cumulative is to be equated with simultaneous. Simultaneously / cumulatively then means, in particular, a joint actuation, this particularly meaning a simultaneous and / or successive actuation. Simultaneously means in particular that an actuation takes place essentially at the same moment.
- one of the actuators is actuated first, for example a lever or slide is brought into an actuation position and thus, for example, an unlocking takes place.
- the further actuator is then actuated, in particular an actuator button is pressed, so that it is triggered, for example.
- a release only takes place when an unlocking and a triggering are present.
- the execution by means of a pressure element allows in particular advantageously that a definition of the application force can be made beforehand and thus a reproducible application is possible.
- the pressure element is selected and / or adjusted and / or designed in such a way that an optimal application force is triggered as a result.
- the pressure element is designed in such a way that after displacement of the stamp by the pressure element, a, in particular, renewed clamping is not possible manually by a user, but preferably only by means of aids such as a tool, e.g. a clamping tool is. It is preferred here that the pressure element has such a large spring force and / or spring constant that manual tensioning is not possible.
- the applicator is preferably designed in such a way that reuse, preferably by hand, in particular due to the spring force and / or spring constant of the pressure element, is prevented.
- the actuating device has a force trigger. The force release is in particular a first actuator of the actuating device.
- the force release is designed in such a way that actuation takes place when a defined force is applied, in particular in the direction of the application point.
- the application of a defined force means that either exactly the predefined force and / or a greater force than the predefined force must be applied in order to trigger an actuation.
- the force trigger is preferably a trigger with a force threshold, actuation taking place when a force is applied that exceeds the force threshold.
- the force release has a predetermined breaking device and / or flexibly yielding elements and / or a pretensioning device to implement the force definition.
- the actuating device to have several force triggers. For example, it is possible that the first and the second actuator are each a force trigger.
- the defined force, in particular the force threshold is preferably approx. 2 kg, preferably 2.5 kg, particularly preferably 3 kg.
- the defined force, in particular the force threshold is preferably approx. 20 N, preferably approx. 25 N, particularly preferably approx. 30 N.
- the actuating device has at least one operating element, which is actuated when it is acted upon. It is particularly preferred that a second actuator is the control element. On the other hand, it is also possible, for example, for the first and second actuators to be operating elements.
- the at least one operating element is in particular a, preferably technical, command transmitter on which a user can influence and which triggers an actuation in this way.
- the force release and the operating element are connected to one another. It is particularly preferred that it is a one-piece connection, which can also be referred to as integral.
- the force release and operating element can be designed together as a rotary push button.
- Such a turn-push button can thus preferably be pressed in on the one hand and thus take over the function of the force trigger and, on the other hand, be rotated and thus take over the function of the operating element.
- Other combinations of this type or similar are preferably also possible, such as a push-slide button, for example, such a button first having to be pushed into a position and being pressed in in this position.
- the actuating device has a coupling mechanism. It is particularly preferred that it is a form-fitting and / or force-fitting coupling mechanism.
- the coupling mechanism is designed in such a way that it couples the stamp to the housing in a first state and decouples it from the housing in a second state in order to enable the stamp to be displaced. Accordingly, it is preferred that the stamp is initially coupled, preferably held within the housing, by the coupling mechanism.
- the coupling mechanism is actuated or activated, in particular when the decoupling function of the coupling mechanism is released, a decoupling or release then takes place so that the stamp can be moved.
- the actuating device has a safety mechanism.
- the safety mechanism is designed in such a way that it locks the coupling mechanism in a first, preferably deactivated, state and unlocks it in a second, preferably activated, state, so that the coupling mechanism can enable the stamp to be displaced.
- the safety mechanism moves the applicator, particularly preferably the coupling mechanism, from a stable to an unstable state.
- the securing mechanism is designed in particular in such a way that it initially prevents the activation of the coupling mechanism, that is to say the decoupling, and only releases it when the securing mechanism is activated, that is to say when it is unlocked.
- the coupling mechanism rests on the stamp, preferably in a pressing manner, and thus prevents a movement of the stamp in the first state via friction. In this case, it is then preferred that the contact of the coupling mechanism or the pressing of the coupling mechanism on the punch is canceled when decoupling.
- the coupling mechanism has a hook device and / or a pawl device and / or a template device, in particular consists of it. It is particularly preferred here that these devices couple or lock the stamp with the housing in the first state.
- the securing mechanism has, for example, a hook, in particular it is evident from this, it is preferred that the hook locks the coupling mechanism in the secured state, that is to say in particular is connected to it by a hook. In the unlocked state, it is then preferred that the hook is unhooked from the coupling mechanism so that the coupling mechanism can be decoupled accordingly.
- the force release actuates the decoupling mechanism or the safety mechanism.
- the operating element actuates the safety mechanism; or the other way around.
- the holding device can be connected to the microarray device in a reversibly detachable manner or that the holding device can be irreversibly connected to the microarray device.
- a reversibly detachable holding device it is possible for the applicator to be reusable.
- the holding device has at least one flexible holding arm and / or a latching device and / or at least one snap hook, particularly preferably consists of it.
- the holding device can be irreversibly connected, it is in particular a disposable applicator, wherein it is particularly preferred that the holding device has a bayonet device, in particular consists of it. It is preferred that the holding device has a holding device operator for reversibly releasing the microarray device.
- the applicator has a protective device which shields at least part of the microarray device from the environment in a first position and releases it for application in a second position. It is particularly preferred that the protective device is movable relative to the holding device.
- the protective device preferably shields at least one microarray of the microarray device and / or an adhesive layer of the microarray device for adhesive connection to the skin.
- the protective device is preferably a type of shield which can preferably be folded in and / or retracted.
- the protective device has a protective collar, preferably consists of it.
- the protective collar is held in the first position by means of a pretensioning device. It is therefore preferred that the pretensioning device holds the protective collar in the first position against movement into the second position. For example, by acting against the pretensioning direction, it is then possible to transfer the protective collar from the first position to a second position, in particular to retract it, with at least part of the microarray device then being released for application.
- the applicator has a reversible or irreversible locking device.
- the locking device is preferably designed in such a way that it prevents reuse of the applicator. It is particularly preferred here that the locking device fixes the stamp in the displaced position, in particular in the deflected position, and / or blocks the actuating device. For this purpose, it is preferred that the locking device For example, a latching device and / or snap hook or the like has surfaces.
- the application system according to the invention is an application system for applying a microarray.
- the application system has an applicator according to one or more of the above definitions.
- the application system has a microarray device with at least one microarray.
- the microarray device is preferably designed as a microarray carrier disc, in particular in accordance with the statements from DE 10 2019 200 561 A, particularly preferably in accordance with the embodiments and / or claims described there, in particular claim 1.
- the holding device receives the microarray device, in particular in a latching manner.
- the recording is particularly preferably carried out via a reversible or irreversible connection between the holding device and the microarray device.
- the holding device has at least one flexible holding arm and / or a latching device and / or a snap hook device and / or a bayonet device, in particular consists of it.
- the method by means of an applicator with one or more features of the applicator or defined above Application system is executed. Furthermore, it is preferably possible for the method to be supplemented by one or more of the features defined above, preferably before method features. It is preferred to place the application system on an application site before or after the unlocking step or the actuation of the first actuator.
- Fig. 1 is a schematic perspective view of an embodiment of a carrier
- FIG. 2b shows the carrier from FIG. 2a in the application position
- Fig. 3 is a schematic sectional view of a further embodiment of a carrier
- Fig. 5a is a schematic sectional view of a further embodiment of a carrier
- FIG. 5b shows the carrier from FIG. 5b in the application position
- 6 is a schematic sectional view of a further embodiment of a carrier
- FIG. 7 shows a perspective view of an embodiment according to the invention of an application system with an embodiment of an applicator according to the invention
- FIG. 9 shows schematic sectional views of a further embodiment of an application system according to the invention with a further embodiment of an applicator according to the invention based on the respective embodiment from FIG. 7 in different states,
- FIG. 10 shows a perspective view of a further embodiment of an application system according to the invention with a further embodiment of an applicator according to the invention
- FIGs. 11a and 11b are perspective sectional views of the application system from FIG. 10 in two states
- FIG. 12 schematic sectional views of a further embodiment of an application system according to the invention with a further embodiment of an applicator according to the invention based on the respective embodiment from FIG. 10 in different states
- 13 shows a perspective view of a further embodiment according to the invention of an application system with a further embodiment according to the invention of an applicator
- Figs. 14a-14c are perspective sectional views of the application system from FIG. 13 in three states
- 16 shows a perspective view of a further embodiment according to the invention of an application system with a further embodiment according to the invention of an applicator
- 17a and 17b are perspective sectional views of the application system from FIG. 16 in two states
- FIG. 19 shows schematic sectional views of a further embodiment of an application system according to the invention with a further embodiment of an applicator 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 preferably already been identified are not provided with reference symbols in all figures.
- FIG. 1 shows a microarray device designed as a microarray carrier device 10, hereinafter referred to as carrier 10.
- carrier 10 from FIG. 1 has a carrier housing 14.
- the carrier housing 14 On the outside, the carrier housing 14 has a circumferential groove 22 which serves as a connecting device for an applicator 200 (see, for example, FIG. 7).
- the carrier housing 14 has an access opening 28 (see FIG. 2a) through which, for example, the plunger 204, also referred to as a piston, of an applicator 200 (see e.g. FIG. 7) onto the carrier housing interior 38 (see FIG. 2a ) can access or act.
- the plunger 204 also referred to as a piston
- an applicator 200 see e.g. FIG. 7
- the access opening 28 is closed off from the environment by a film 40 which is part of a sterile barrier 36.
- the film 40 is preferably connected to the carrier housing 14 by means of an adhesive and / or welded connection 41.
- the film 40 has a flexible region 46, so that, for example, the stamp 204 of an applicator 200 (see, for example, FIG. 7) can distally press the film interior 48 into the carrier housing interior 38 while the stamp 204 is accessing it.
- an applicator 200 can preferably move the support stamp 16, but in the non-triggered state there is still sterile isolation from the environment in relation to the upper side shown.
- the film 40 in particular at the area 46, to be of fragile design so that, for example, an applicator 200 can cause the film 40 to tear when the carrier stamp 16 is moved.
- the action of a stamp 204 of an applicator (see, for example, FIG. 7), which in particular leads to the movement and / or displacement of the carrier stamp 16, preferably takes place on the Carrier stamp active surface 60 at the proximal end of the carrier stamp 16.
- the carrier stamp active surface 60 is shown flat.
- other designs of the carrier die impact surface 60 for example a negatively conical design (see Figure 6), or a positive conical design, or a negative or positive pyramidal design, or a design with a smooth, sharp or jagged edge or with a point are possible.
- a blister 42 is connected to the carrier housing 14.
- a recess 15 can be provided in the carrier housing 14 for this purpose, which accommodates the blister 42.
- the connection between the blister 42 and the carrier housing 14 at the connection point 41 can be implemented, in particular by means of a releasable adhesive connection.
- FIG. 2a shows the carrier stamp 16 in the starting position.
- the Trä gerstempel 16 is fixed in a proximal position by means of a release device 30 rela tively to the carrier housing. This fixation takes place via an interlocking of the bead 31 of the support stamp 16 in the groove 29 of the support housing 14.
- Bead 31 and / or groove 29 are preferably designed to be flexible, with support housing 14 and / or support stamp 16 in particular, at least essentially, dimensionally stable are.
- a microarray 12 is connected to the carrier stamp 16 at the distal end.
- the patch 13 of the microarray 12 is connected, in particular adhesively, to the carrier stamp.
- the patch 13 of the microarray 12 has distally extending microneedles 11.
- the microarray is located within the carrier housing 14.
- a sterile barrier 36 for isolating the microarray 12 from the environment is created by means of blister 42 and film 40.
- the carrier housing interior 38 and / or the blister interior 43 can preferably have desiccant and / or protective gas. This has a particularly positive effect on the sterility and / or durability of the microarray.
- FIG. 2b shows the carrier 10 from FIG. 2a applied.
- the blister 42 was removed or removed, for example by a user.
- the carrier 10 was then connected to an application site 100, in particular the skin of a user, by means of an adhesive layer 34 at the proximal end 17 of the carrier housing 14.
- the carrier stamp 16 is in the application position. Here, the carrier stamp 16 has moved distally within the carrier housing 14 and in this way has guided the microarray 12 out of the carrier housing 14 through the application opening 18. The microneedles 11 of the microarray 12 are injected into the application site 100.
- the carrier stamp 16 is held or fixed in a distal application position by means of a holding device 32.
- the holding device 32 has a groove 33 into which the bead 31 of the carrier stamp 16 engages. In this way, the carrier stamp 16 is pushed back and thus a longer-lasting application of the microarray 12 is ensured.
- the movement or deflection of the support stamp 16 took place via an access or action through the access opening 28 on the proximal end of the support stamp 16.
- This action took place, for example, through a stamp 204 of an applicator 200 (see, for example, FIG. 7), which in particular was connected to the carrier 10 via the connecting device 20.
- a stamp 204 of the applicator 200 was accelerated, which first hit the film 40 and this due to the flexible design, deflected distally.
- the punch 204 indirectly also hit the proximal end of the carrier punch 16, as a result of which the release device 30 released the carrier punch 16 for movement.
- the carrier stamp 16 then moved into the distal position shown in FIG. 2b and is fixed by the holding device 32.
- deflecting the support stamp 16 by means of the applicator 200 for example, a deflection or action via the finger of a user who presses on the proximal end of the support stamp 16, preferably via the film 40, is possible.
- the release device 30 is preferably designed as a target force trigger.
- the carrier stamp is thus released only when at least one target force is applied, preferably when at least one target force is applied to the carrier stamp.
- the target force trigger can preferably be designed in such a way that the minimum required target force corresponds to an, in particular optimal, application force for puncturing and applying the microarray 12.
- the setpoint force release is achieved in particular via the releasable form fit between the groove 29 and the bead 31.
- FIG. 3 shows a further embodiment of a carrier 10. The embodiment shown is essentially similar to the embodiment from FIG. 2a.
- the release device 30 of the embodiment from FIG. 3 is a fit, in particular a special interference fit, between the carrier die 16 and the carrier housing 14. Due to the fit, the carrier die is initially held in the starting position. After the deflection of the carrier punch 16, the fit also brings about the function of the holding device 32 and thus ensures that the carrier punch is fixed in the application position.
- the connecting device 20 has a thread 24, with which, for example, a correspondingly opposite thread of an applicator 200 can be connected.
- the embodiment from FIG. 3 does not have a blister, but a film 44.
- the film 44 is connected at the distal end 17 to the carrier housing 14, in particular via an adhesive layer 41.
- the film 44 can be pulled off by a user via the illustrated film flap 47 and removed in this way.
- the adhesive layer 41 also serves as a fixing device 34 so that the carrier 10 can be connected to an application site.
- FIG. 4 shows a further embodiment of a carrier 10.
- the embodiment is similar to the embodiment from FIG. 3, although it has the differences described below.
- the embodiment has a blister 42 which completely radially surrounds the carrier housing 14. At the proximal end 17, the carrier housing 14 rests against a projection 45 extending radially inward from the blister 42. Seen from the front of the jump 45, the carrier housing 14 at the distal end 17 has an adhesive layer 34 lying radially on the inside, which represents a fixing device for fixing the carrier 10 at an application site. In contrast to other embodiments, for example the embodiment from FIG. 3, the adhesive layer 34 does not come into contact with the blister 42, but is spaced from it.
- the blister 42 forms a type of guide shape at the proximal end, for example for an applicator 200.
- An applicator 200 can thus be everted into the blister, for example, and then connected to the connection device 20, which is shown as a plug connection. Subsequently, it is possible that the blister 42, which is preferably only on the carrier housing 14 is attached, is removed. An application can then be carried out based on the execution forms described above.
- Figures 5a and 5b show a further embodiment of a carrier 10.
- the embodiment has no holding device.
- the carrier stamp 16 and the carrier housing 14 are therefore no longer connected to one another or loosely to one another.
- carrier stamp 16 and carrier housing 14 can be moved relative to one another.
- FIG. 5b accordingly shows a removal of the carrier housing 14 from the application site 100, the carrier stamp 16 with the applied microarray remaining on the application site 100.
- the illustrated sterile barrier 36 has the film 40.
- the film 40 arches from the distal end 17 of the carrier housing 14 through the application opening 18 and encloses the carrier stamp 16 towards the access opening 28.
- the carrier housing interior 38 or the microarray 12 is sterile, at least proximally.
- the film 40 preferably has an adhesive layer 39 distally so that, as shown in FIG. 5b, the film 40 can be connected to the application site 100.
- the, in particular elastic, film 40 can be used, on the one hand, for pressing the microarray 12 into the application site 100 and / or for sterility with respect to the environment.
- the illustrated embodiments of the carrier 10 are designed to be rotationally symmetrical about the axis of rotation 50.
- another design for example cuboid, is also possible.
- FIG. 6 shows a further embodiment of a carrier 10. The embodiment shown corresponds essentially to the embodiment from FIG. 2a.
- the conical indentation of the carrier stamp active surface 60 from FIG. 6 has an advantageous effect that, for example, an applicator stamp with a correspondingly positive conical shape can strike the carrier stamp active surface 60 and thus optimum force transmission is provided.
- Fig. 7 shows an embodiment of an application system 300 according to the invention for applying a microarray with an inventive embodiment of an applicator 200 for applying a microarray and with a microarray device 10, which is designed here as a microarray carrier disc.
- the microarray carrier disc 10 is designed in particular with one, several or all of the features of the carrier design from FIG. 6.
- the applicator 200 has an applicator housing 202 which, as shown, has in particular a base body 203 (see FIG. 8a). It is possible to see the actuating device 212 and / or the holding device 208 as part of the housing 202 or to identify them as independent components.
- the actuation device 212 has two actuators 214, 216.
- the applicator 200 is reversibly connected to a microarray carrier disc 10 via the holding device 208, so that the microarray carrier disc 10 can optionally be picked up or detached from the applicator 200 via the holding device operator 230, designed as flexible lever arms.
- FIG. 8a shows a sectional view of a first state of the application system 300 from FIG. 7, FIG. 8b showing a second state.
- the microarray carrier disc 10 is connected to the applicator 200 via a holding device 208 of the applicator 200.
- the holding device 208 has at least two flexible arms, which can also be referred to as snap hooks 230 who can.
- the snap hooks 230 have inwardly pointing projections 232. These projections 232 are inserted into indentations 22 for connection to the microarray carrier disc 10 and thereby establish a connection.
- the connection between the holding device 208 and the microarray carrier disc 10 can also be referred to as a tongue and groove connection, the holding device 208 having at least one tongue 232 which engages in the groove 22 of the micro array carrier disc 10.
- the flexible arms 230 can be deflected or flexibly bent inward, for example by a user, as a result of which the tongue 232 emerges from the groove 22 and thus an optional detachment of the microarray carrier device 10 from the applicator is possible.
- 8a shows an initial state of the applicator 200.
- the actuating device 212 has two separate mechanical actuators 214, 216.
- the mechanical actuator 214 is designed as a type of push button that can be displaced against the base body 203 of the housing 202.
- the embodiment from FIG. 8a also has a pressure lever 216 as a white direct actuator 216.
- the pressure lever 216 is rotatably mounted and has a coupling element 242 at an inner end, which is coupled in a form-fitting manner to a coupling element 240 of the stamp 204.
- the coupling elements 240, 242 are together part of a coupling mechanism 218, in particular form this.
- the punch 204 is held in a first position via this coupling mechanism.
- the stamp 204 has a conical stamp surface for acting on a carrier stamp influence surface 60 of a microarray device 10.
- FIG. 8b shows a second state of the applicator 200 from FIG. 8a, the push-button 214 and the base body 203 being moved relative to one another.
- rotation of the pressure lever 216 is released.
- the pressure lever 216 is rotated and thus the coupling element 242 of the pressure lever 216 is decoupled from the coupling element 240 of the Stem pels 204, whereby the punch 204 is released for movement.
- FIGS. 9 shows various states of an application system 300 with applicator 200, the application system 300 or the applicator essentially corresponding to the explanations from FIGS. 7-8.
- the application system 300 is placed on an application site 100, such as the skin of a user, shown by movement arrow 1. It is preferred here that the microarray carrier disc 10 is adhesively connected to the application site 100 via an adhesive layer 41 is.
- the microarray 12 of the microarray carrier device 10 is in the initial state I from the skin 100 spaced.
- the actuator 216 designed as a push lever 216, is blocked in the initial state I by a locking element 244 of the other actuator 214, designed as a push button 214.
- the blocking element 244 rests against a blocking element 246, designed as a rear surface of the actuator 216, and thus prevents rotation of the actuator 216.
- the actuator 214 is held in a first position via a force definition device 234.
- the force definition device 234 corresponds to a pretensioning element, in particular a spring 234.
- the spring 234 is designed in such a way that it only applies when at least one predefined force is applied, which in particular corresponds to the optimal contact pressure of the application system 300 on the skin 100, a movement of the actuator 214, in particular into the end position, allows.
- the actuator 214 accordingly corresponds to a force release which enables the securing mechanism 220 to be actuated, that is to say an unlocking, only when the previously defined force or a greater (greater than or equal) force than the predefined force is applied.
- the third state III shows such an operation of the operating element 216, with the pressure lever 216 being pressed, represented by movement arrow 3.
- the coupling element 242 of the actuator 216 from the Brought engagement with the coupling element 240 of the punch 204 and then an actuation of the coupling mechanism 238, that is, a decoupling, performed.
- the stamp 204 is thus released for displacement.
- the pressure element 210 designed as a pretensioning device, in particular as a spring, shifts the stamp 204, represented by movement arrow 4.
- the stamp 204 hits, in particular with the conical stamp surface 206, on the carrier stamp 12, in particular on the carrier stamp impact surface 60, on. This results in a displacement of the carrier die 12 and consequently an application of the microarray 12.
- the application by means of the illustrated applicator 200 takes place preferably only when the actuating device 212 is actuated cumulatively, that is to say when the actuator 214 is pressed and the operating element 216 is operated.
- FIG. 10 shows a further embodiment of an applicator 200 according to the invention.
- the microarray carrier disc 10 is received by means of the holding device 208 in a manner similar to that in the embodiment from FIG. 7.
- the snap hooks 230 are designed in such a way that they do not protrude beyond the outer contour of the applicator 200.
- the actuating device 212 has two actuators 214, 216, which Darge represents in one piece, in particular as a rotary push button, are formed.
- FIGS. 11a and 11b show two states of the embodiment from FIG. 10.
- FIG. 12 shows an embodiment of an application system 300 according to the invention with an embodiment of an applicator 200 according to the invention, the embodiments essentially corresponding to the embodiments from FIG. 11a.
- the applicator 200 has a securing mechanism 220 with at least one locking element 244 (see FIG. 11 a), preferably with two locking elements 244 (see FIG. 12).
- the safety mechanism 220 prevents the rotary pushbutton 212 from being pressed via the at least one locking element 244, since the at least one locking element 244 presses radially on the axis of the locking pawls 246 that hold the plunger 204.
- the at least one locking element 244 is only disengaged after a rotation, preferably 90 °, of the rotary pushbutton 212 (see movement arrow 2 in II) and the applicator 200 is then unlocked.
- the action of the locking element 244 causes the coupling elements 242 to rotate, in particular designed as locking pawls, so that a decoupling with the coupling elements 240 of the Stamp 204 takes place.
- the coupling mechanism 218 is activated, that is, a decoupling, so that a displacement of the stamp 204 (see IV) is possible.
- the operating element 216 which is implemented by the rotary function of the rotary pushbutton 212, actuates the safety mechanism 220.
- the force release 214 which is formed by the push function of the rotary pushbutton 212, however, activates the decoupling mechanism 218.
- FIG. 13 shows a further embodiment according to the invention of an application system 300 with an embodiment according to the invention Applicator 200, FIGS. 14a-14c showing sectional views in different states of the embodiments from FIG.
- the micro-array carrier disc 10 is not reversible, but irreversible, and is held by the applicator 200 via a holding device 208 designed as a type of bayonet lock.
- a protective device 222 Arranged in a ring around the microarray carrier disc 10 is a protective device 222, preferably spring-loaded, which has a protective collar 224, or consists of it.
- the protective collar 224 In the initial state (see Fig. 14a), the protective collar 224 is movably deflected, in particular by pretensioning by means of a pretensioning device (not shown), in such a way that contact of the adhesive layer 41 and / or a microarray 12 of the microarray carrier device 10 is shielded from the environment .
- the protective collar 224 By applying vertical force to the applicator 200, for example to the skin of a user, the protective collar 224 is moved into the interior of the applicator, preferably against a bias voltage. It is particularly preferred that the protective collar is then held, in particular irreversibly, for example latches and / or hooks. The adhesive surface 41 is thus released (see FIG. 14b).
- the securing mechanism 220 of the embodiment 13-15 has a locking slide 216 as an operating element.
- the operating element 216 see movement arrow 2 under II in Fig. 15
- a locking element 252 of the base body 203 is released for movement by moving the locking element 246.
- the coupling element 240 of the plunger 204 is compressed via at least one inclined edge 256 of the force release 214 and thus the coupling mechanism 218 is decoupled the punch 204 is released for movement by means of the pressure element 210 (see movement arrow 4 under IV from FIG. 15).
- FIGS. 17a and 17b show sectional views of different states of the embodiment from FIG. 16.
- FIG. 18 shows a further embodiment of an application system 300 with a further embodiment according to the invention of an applicator 200 based on the embodiment from FIG. 16.
- the microarray device 10 is received by means of a bayonet lock as a holding device 208.
- the safety mechanism 208 is activated by a toggle switch 216.
- the toggle switch 216 In the first state (see, for example, FIGS. 17a and I from FIG. 18), the toggle switch 216 prevents movement of the pushbutton 214, which corresponds to the force trigger, via a form fit with a locking element 252, i.e. in particular a missing distance 254.
- the toggle switch 216 By flipping the toggle switch 216, the form fit is released and a gap 254 is created (see II from FIG. 18).
- the locking element 252 is displaced by means of the inclined edge 256 of the force trigger 214 and thus a release for moving the stamp 204 (see movement arrow 3 from III in FIG. 18).
- the locking element 252 here corresponds in particular to a template device through which the stamp 204 only fits when the arrangement is appropriate, preferably due to the displacement of the locking element 252.
- the various holding devices for example bayonet lock or snap connection
- the different versions of the actuators 214, 216 or the versions of the force release and / or operating elements can also be used variably in all embodiments.
- the protective device 222 in particular in the embodiment from FIG. 14a, can also be implemented in all embodiments.
- the coupling mechanism and / or securing mechanism in particular according to the various concepts of the embodiments from FIGS. 7-18, can be implemented variably in all embodiments.
- 19 shows a further embodiment of an application system 300 with applicator 200.
- the application system 300 in the starting position I, is placed on an application site 100, ie in particular the skin. Similar to the other embodiments, the carrier 10 is held with the lugs 22 via a latching system. The microarray held by the carrier 10 is spaced apart from the skin 100 in the initial state I.
- the actuator 214 which is a large push head in the embodiment shown, is through in the initial state I. a locking element 216 locked.
- the locking element 216 is designed in the form of a pivot lever 217. Since the pivot lever 217 rests against the housing element 203, the actuator 214 can not be actuated in the starting position I, ie not be pressed down. Only when the pivot lever 217 has been turned over can the push button be moved downwards.
- the pivot lever 216 can be pivoted into state II. Since in state II a shoulder 219 of the actuator 216 no longer rests on an upper side 203 of a guide element 209, the two actuators 214 can be pressed down together with the pivot lever 216 as shown by a movement arrow 3. On the one hand, this leads to holding lugs 205 of actuator 214 reaching behind holding lugs 207 of guide element 209.
- the holding lugs 205 fulfill the function that the triggered state is retained and no renewed triggering is possible. It is thus clearly evident that a triggering has occurred.
- the plunger 204 is also released. This takes place by tilting the form-locking coupling mechanism 218 from position II to position III.
- the individual levers of the coupling mechanism 218 have spherical, in particular special hemispherical lugs 223, which serve as pivot bearings. By rotating the actuating element 221 and the cooperating inclined planes, the individual coupling elements 218 are tilted or pivoted.
- first a placement on the application site (arrow 1) and then actuation of the first actuator (arrow 2) is shown.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Automatic Analysis And Handling Materials Therefor (AREA)
- Coating Apparatus (AREA)
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202080059742.5A CN114340716A (zh) | 2019-08-27 | 2020-08-25 | 微阵列施用器和用于移动作用于微阵列的柱塞的方法 |
US17/638,119 US20220288371A1 (en) | 2019-08-27 | 2020-08-25 | Microarray Applicator and Method for Displacing a Plunger Acting Upon the Microarray |
CA3150595A CA3150595A1 (en) | 2019-08-27 | 2020-08-25 | Microarray applicator and method for displacing a plunger acting upon the microarray |
BR112022002908A BR112022002908A2 (pt) | 2019-08-27 | 2020-08-25 | Aplicador de microarranjo e método para deslocamento de um êmbolo que atua sobre o microarranjo |
EP20765219.9A EP4021553A1 (de) | 2019-08-27 | 2020-08-25 | Mikroarray applikator sowie verfahren zum verschieben eines auf mikroarray einwirkenden stempels |
JP2022513386A JP2022546459A (ja) | 2019-08-27 | 2020-08-25 | マイクロアレイアプリケータ、及び、マイクロアレイに作用するプランジャを移動させるための方法 |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102019122948.0A DE102019122948A1 (de) | 2019-08-27 | 2019-08-27 | Applikator, Applikationssystem sowie Verfahren zum Verschieben eines Stempels |
DE102019122948.0 | 2019-08-27 | ||
DE102020109563.5 | 2020-04-06 | ||
DE102020109563.5A DE102020109563A1 (de) | 2020-04-06 | 2020-04-06 | Applikator, Applikationssystem sowie Verfahren zum Verschieben eines Stempels |
Publications (1)
Publication Number | Publication Date |
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WO2021037816A1 true WO2021037816A1 (de) | 2021-03-04 |
Family
ID=72340321
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2020/073670 WO2021037816A1 (de) | 2019-08-27 | 2020-08-25 | Mikroarray applikator sowie verfahren zum verschieben eines auf mikroarray einwirkenden stempels |
Country Status (7)
Country | Link |
---|---|
US (1) | US20220288371A1 (de) |
EP (1) | EP4021553A1 (de) |
JP (1) | JP2022546459A (de) |
CN (1) | CN114340716A (de) |
BR (1) | BR112022002908A2 (de) |
CA (1) | CA3150595A1 (de) |
WO (1) | WO2021037816A1 (de) |
Families Citing this family (1)
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KR102639625B1 (ko) | 2023-03-13 | 2024-02-23 | (주)시지바이오 | 마이크로니들 패키지 및 상기 마이크로니들 패키지를 포함하는 어플리케이터 패키지 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014110016A1 (en) * | 2013-01-08 | 2014-07-17 | 3M Innovative Properties Company | Applicator for applying a microneedle device to skin |
EP2937111A1 (de) * | 2012-12-21 | 2015-10-28 | Hisamitsu Pharmaceutical Co., Inc. | Applikator |
WO2018111607A1 (en) * | 2016-12-16 | 2018-06-21 | Kimberly-Clark Worldwide, Inc. | Fluid delivery apparatus having a gas extraction device and method of use |
DE102019200561A1 (de) | 2019-01-17 | 2020-07-23 | Lts Lohmann Therapie-Systeme Ag | Träger |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MX2015012155A (es) * | 2013-03-12 | 2015-11-30 | Corium Int Inc | Aplicadores de microproyeccion. |
EP3037124A1 (de) * | 2014-12-22 | 2016-06-29 | Universite Libre De Bruxelles | Arzneimittelabgabevorrichtung mit Mikronadeln |
-
2020
- 2020-08-25 WO PCT/EP2020/073670 patent/WO2021037816A1/de unknown
- 2020-08-25 EP EP20765219.9A patent/EP4021553A1/de active Pending
- 2020-08-25 CN CN202080059742.5A patent/CN114340716A/zh active Pending
- 2020-08-25 CA CA3150595A patent/CA3150595A1/en active Pending
- 2020-08-25 JP JP2022513386A patent/JP2022546459A/ja active Pending
- 2020-08-25 US US17/638,119 patent/US20220288371A1/en active Pending
- 2020-08-25 BR BR112022002908A patent/BR112022002908A2/pt unknown
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2937111A1 (de) * | 2012-12-21 | 2015-10-28 | Hisamitsu Pharmaceutical Co., Inc. | Applikator |
WO2014110016A1 (en) * | 2013-01-08 | 2014-07-17 | 3M Innovative Properties Company | Applicator for applying a microneedle device to skin |
WO2018111607A1 (en) * | 2016-12-16 | 2018-06-21 | Kimberly-Clark Worldwide, Inc. | Fluid delivery apparatus having a gas extraction device and method of use |
DE102019200561A1 (de) | 2019-01-17 | 2020-07-23 | Lts Lohmann Therapie-Systeme Ag | Träger |
Also Published As
Publication number | Publication date |
---|---|
BR112022002908A2 (pt) | 2022-05-10 |
JP2022546459A (ja) | 2022-11-04 |
EP4021553A1 (de) | 2022-07-06 |
CA3150595A1 (en) | 2021-03-04 |
US20220288371A1 (en) | 2022-09-15 |
CN114340716A (zh) | 2022-04-12 |
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