Applicator

Abstract

The invention relates to an applicator for applying a microarray, comprising a housing (10) in which a plunger (20) is arranged such that the plunger is linearly movable. A retaining element (38) for receiving the microarray (28) is also provided. The pressure element (34) makes the plunger (20) displaceable so as to act on the microarray (28) housed by the retaining element (38). The actuating element (44) allows the plunger (20) to be held in the internal position, and this can be released by actuating the actuating element (44).

Description

[0001] This application is a divisional application of patent application 201980089154.3, which is a PCT application with international application number PCT / EP2019 / 082699 and international application date November 27, 2019, and has entered the Chinese national phase. Technical Field

[0002] The present invention relates to an applicator for administering a microarray. Background Art

[0003] The microarray includes a plurality of microneedles, which are usually arranged on or attached to a carrier element such as a patch, a film, etc. Such a microarray includes a large number of microneedles, for example 500-600 needles per cm 2 The needles are short in length so that when the microneedles are pushed into the patient's skin, the needles will penetrate the patient's skin only to the extent that nerves and blood vessels preferably do not come into contact with any needle tip. The microneedles include an active substance or a drug. The corresponding active substance can be applied to the surface of the needles or disposed in the needles. Preferably, the needles are made of a material that dissolves in the patient's skin.

[0004] When applying the microarray into human skin, there is the problem that the insertion of the microneedles into the skin must be reproducible in order to ensure, in particular, reliable drug delivery. Furthermore, the insertion of the microneedles must be independent of the user or patient, since otherwise reproducibility would not be guaranteed. In particular, the insertion of the microneedles should also be independent of the skin texture, so that a certain penetration depth is always ensured. Summary of the invention

[0005] It is an object of the present invention to provide an applicator for applying a microarray which improves the reproducibility of inserting the microarray.

[0006] According to the invention, this object is achieved by an applicator having the features of claim 1 .

[0007] The applicator for applying a microarray according to the present invention comprises a housing in which a plunger is arranged for linear movement. Further, a holding element for accommodating the microarray is provided, the holding element being particularly connected to or arranged on the housing. Here, the microarray can be accommodated by the holding element indirectly or directly. In particular, the holding element can accommodate a carrier element, such as a patch, connected to or carrying the microarray. The applicator according to the present invention also comprises a pressure element for the displacement of the plunger.

[0008] By the corresponding displacement of the plunger, the microarray held by the holding element can be acted on. Preferably, the pressure element applies a short-term force, in particular, on the microarray so that the needle is pressed into the patient's skin. The applicator according to the present invention also includes an actuating element for actuating the plunger. The actuating element indirectly or directly maintains the plunger in an internal or retracted position, i.e., a position before the microarray is inserted into the patient's skin. Here, the actuating element can act directly on the plunger, be connected to the plunger, for example, in a form-fitting manner, or also act on the pressure element. By manual actuation, in particular of the actuating element, release is achieved so that the plunger is released for displacement. By a particularly sudden or impact movement of the plunger, the plunger presses the microarray into the skin at a corresponding speed. Thereby, a particularly well-defined force acts on the microarray so that good reproducibility of the insertion of the microarray into the patient's skin is achieved.

[0009] In a preferred development, the holding element has a receiving surface for arranging a carrier element connected to the microarray, such as a patch, a film, etc. The carrier element can be arranged, for example, by bonding it to the receiving surface. Preferably, the particularly planar receiving surface has at least the shape of a partial ring, and as particularly preferred, has the shape of a complete ring.

[0010] The housing of the applicator preferably comprises an outlet through which the plunger can exit. In a preferred embodiment, the plunger is pushed out by the pressure element through the outlet or acts on the microarray in the outlet region. In addition, it is particularly preferred that the plunger and / or the outlet of the plunger are at least partially, in particular completely, surrounded by the receiving surface. Here, the plunger is surrounded by the receiving surface, in particular in its outer position, i.e., in the position in which the microarray is pressed or has been pressed into the skin by the plunger.

[0011] Preferably, the pressure element is prestressed and / or compressed in the internal position of the plunger. Particularly preferably, the pressure element is a spring, such as a helical spring, a pneumatic or hydraulic chamber or a combination thereof. The pressure element may also include, for example, an elastic element acting on the plunger, such as a compressible plastic material.

[0012] The pressure element is preferably arranged on the rear side of the plunger opposite to the outlet. The pressure element can also be, for example, lateral and in other positions, and the microarray cooperates with the plunger so that upon actuation or triggering of the plunger, the plunger moves linearly toward the microarray in order to push the microarray into the patient's skin. In order to achieve a structure that is as simple as possible and good force transmission, it is preferred that the pressure element is arranged on the rear side of the plunger.

[0013] In another particularly preferred embodiment, the actuating element cooperates directly with the plunger. Here, an actuating element is particularly preferred, which can be manually operated by the patient, the doctor, etc. It is further preferred that the actuating element for holding the plunger in the internal position is connected to the plunger in a form-fitting manner, thereby holding the plunger in its internal position. As an alternative or in addition, the actuating element can also be connected to a pressure element, whereby actuation of the actuating element causes the pressure element to expand or relax, because it causes an actuation or linear displacement of the plunger. Here, the plunger does not necessarily have to be held in the internal position by the actuating element. This is preferably done essentially when the pressure element is held in a controlled position by the plunger itself and no separate triggering of the pressure element is implemented.

[0014] Preferably, the plunger has a recess or a protrusion cooperating with the actuating element. In particular, the actuating element or a protrusion on the actuating element may extend into the recess. By actuation, in particular by displacing the actuating element, the actuating element moves out of the recess so that the plunger is released and can be moved linearly by the pressure element. Here, preferably, the actuating element is displaced and / or twisted to release the plunger. Preferably, the actuating element is arranged in a housing of the housing. The housing may be a recess, a slot-shaped opening, etc.

[0015] In a particularly preferred development of the present invention, the housing comprises and / or is connected to a fixing element. The fixing element is used to fix the applicator on the patient's skin. This has the advantage that after the actuation of the actuator element, and thus after the displacement of the plunger to press the microarray, the microarray can be maintained in an insertion position in a simple manner. For example, a vacuum element can be provided as a fixing element. Similar to a suction cup, the vacuum element will be used to create a vacuum so that the applicator sucks itself to the patient's skin. The vacuum can be created by pressing the applicator onto the patient's skin. In addition, or instead of creating a vacuum by pressing, the creation of the vacuum can also be achieved by a pressure element. The pressure element can be configured so that when the plunger is actuated and the microarray is inserted into the skin, a vacuum is created simultaneously, thereby sucking the applicator to the patient's skin.

[0016] Preferably, the fixing element comprises a contact surface, in particular a plane. The contact surface at least partially surrounds a receiving surface, which is used to arrange a carrier element for the microarray thereon. Preferably, the contact surface is shaped as a partial ring, and in particular as a complete ring, in particular corresponding to the contact shape. It is further particularly preferred that the contact surface is provided with an adhesive layer to fix the applicator or the fixing element on the patient's skin. The contact surface provided with the adhesive layer is preferably provided with a peelable or removable protective film or the like.

[0017] After the microarray is applied into the patient's skin by the plunger, according to a preferred embodiment, the microarray can be maintained in the insertion position by the pressure element. This can be achieved, for example, by applying a residual force by the pressure element. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Hereinafter, the present invention will be described in more detail with reference to preferred embodiments and the accompanying drawings.

[0019] In the attached picture:

[0020] Figure 1 is a schematic perspective top plan view of an embodiment of an applicator according to the present invention; and

[0021] Figure 2 It is an example Figure 1 Schematic cross-sectional view of an applicator. DETAILED DESCRIPTION

[0022] The applicator comprises a housing 10. In the illustrated embodiment, the housing is composed of a cover element 12, an intermediate element 14 and a base element 16, wherein the intermediate element 14 and the base element 16 can be formed integrally. In the illustrated embodiment, the cover element 12 is fixed by a pin or a screw 18, but can also be fixed by gluing, snap connection, screw connection, etc. A plunger 20 is arranged in the housing 10. In the illustrated embodiment, the plunger 20 is designed to be rotationally symmetrical with respect to the central axis 22. The plunger 20 includes a plunger element 26 on the front side 24, which faces the patient's skin when the applicator is used. The plunger element 26 has a cross-section corresponding to the size of the microarray 28. The microarray 28 can be, for example, circular or square, or can also be other geometric shapes.

[0023] The pressure element 34 is arranged on the rear side 32 of the plunger 20 opposite the front side 24 or the outlet 30. In the illustrated embodiment, the pressure element 34 is a helical spring. Figure 2 In the illustrated inner position of the plunger 20 , the compression spring 34 is compressed, which is supported on the inner side of the housing cover 12 .

[0024] In the illustrated embodiment, the base element also rotationally symmetrical about the central axis 22 has a planar underside 36, which has an inner annular area 38, which is used as a retaining element and as a receiving surface for a patch 40, which carries or is connected to the patch microarray 28. Here, the patch 40 can be arranged on the receiving surface 38 by bonding in particular. The annular receiving surface 38 is surrounded by the same annular contact surface 42. The contact surface 42 is used to contact the patient's skin. Preferably, the contact surface 42 is also provided with an adhesive layer, which can be covered by a removable film. Here, the underside 36 can also be formed as a step, so that in particular the receiving surface 38 is formed as a recess relative to the contact surface 40, so that the patch 40 does not protrude particularly beyond the contact surface 42 together with the microarray 28.

[0025] Furthermore, the applicator has an actuating element 44. In the illustrated embodiment, the actuating element 44 is substantially L-shaped and has a protrusion 46, by which the actuating element can be manually operated. In particular, the actuating element can be moved from Figure 2 The illustrated position is displaced inwardly in the direction of arrow 48. By displacing the actuating element inwardly, the opening or recess 50 of the actuating element is displaced from the recess 54 provided in the plunger 20 to the Figure 2 The plunger 20 is thus released and can then be displaced linearly downward through Figure 2 As soon as the actuating element 44 is pushed inwardly in the direction of the arrow 48 and the plunger is released, the latter immediately moves in the Figure 2 The microarray 28 is moved downwardly toward the microarray 28 in the patient's skin. This is achieved by compressing the spring 34. The linear displacement of the plunger 20 causes the microarray 28 to be inserted into the patient's skin, not illustrated, in particular suddenly. The microarray 28 is maintained in the inserted position in the skin by the residual force exerted by the spring 34. Since in the illustrated embodiment, the applicator is configured as an adhesive surface and includes a fixing element 42, the applicator is also kept on the patient's skin. By providing a fixing element, as provided according to the present invention in a preferred embodiment, the microarray can be maintained in a position inserted into the patient's skin and is prevented from being pushed out, in particular due to the elasticity of the skin.

Claims

1. An applicator for applying a microarray (28), the applicator comprising: a housing (10) in which a plunger (20) is arranged so as to be linearly displaced in the housing; a holding element (38) for holding the microarray (28); a pressure element (34) for displacing the plunger (20) so as to act on the microarray held by the holding element (38); as well as an actuating element (44) which holds the plunger (20) before application of the microarray and releases the plunger for displacement by actuation of the actuating element (44), wherein the microarray (28) comprises needles made of a material that dissolves in the patient's skin, wherein the plunger (20) includes a recess (54) cooperating with the actuating element (44), and the actuating element includes a protrusion cooperating with the plunger; Prior to applying the microarray, the recess of the plunger engages with the protrusion of the actuating element to maintain the plunger, and When the actuating element is manually moved in a direction perpendicular to the moving direction of the plunger, the protrusion of the actuating element comes out of the recess of the plunger to release the plunger, and the plunger is moved by the pressure element; wherein the plunger (20) comprises a front side (24) facing the patient's skin when the applicator is in use and a rear side (32) opposite the front side; wherein the pressure element (34) is arranged on the rear side (32) of the plunger (20); and The recess (54) of the plunger (20) is located between the front side (24) and the rear side (32).

2. The applicator according to claim 1, characterized in that The holding element (38) comprises a receiving surface (38) for arranging thereon a carrier element (40), in particular a patch, connected to the microarray, the receiving surface being shaped at least as a partial ring, in particular as a complete ring.

3. The applicator according to claim 1 or 2, characterized in that The housing (10) has an outlet (30) for the plunger (20).

4. Applicator according to claim 2 or 3, characterized in that The receiving surface (38) in particular completely surrounds the plunger (20) and / or the outlet (30).

5. Applicator according to any one of claims 1 to 4, characterized in that The pressure element (34) is prestressed and / or compressed in the inner position of the plunger (20).

6. Applicator according to any one of claims 1 to 5, characterized in that The pressure element (34) comprises a spring element.

7. Applicator according to any one of claims 3 to 6, characterized in that The rear side (32) of the plunger (20) is opposite to the outlet (30).

8. Applicator according to any one of claims 1 to 7, characterized in that The actuating element (44) is arranged in a recess of the housing (10).

9. Applicator according to any one of claims 1 to 8, characterized in that The housing (10) comprises a fixing element (42) for fixing the applicator to the skin of a patient.

10. The applicator according to claim 9, characterized in that The fixing element comprises a contact surface (42) which preferably surrounds the receiving surface (38) in an at least partial or complete annular shape.

11. The applicator according to claim 10, characterized in that The contact surface (42) comprises an adhesive layer which is preferably provided with a removable protective film.

12. The applicator according to any one of claims 1 to 11, characterized in that The actuating element (44) includes an opening (50).

13. The applicator of claim 12, wherein: Upon release of the plunger (20), the plunger (20) is displaced linearly downward through the opening (50).

14. An applicator according to claim 12 or 13, wherein When the actuating element is displaced, the projection of the braking element formed by the opening comes out of the recess of the plunger to release the plunger (20).

15. The applicator according to any one of claims 1 to 14, wherein: After releasing the plunger (20), the plunger (20) is displaced toward the microarray (28).

16. The applicator according to any one of claims 1 to 15, characterized in that The actuating element (44) is substantially L-shaped.

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