Microneedle device and method of detecting at least one force acting on a microneedle array

Abstract

The invention relates to a microneedle device (10), in particular a manually applied microneedle device (10). The microneedle device (10) has a microneedle array (12) and a sensor device (14) connected to the microneedle array (12). The sensor device (14) is designed to detect at least one force acting on the microneedle array (12). The invention also relates to a method for detecting at least one force acting on a microneedle array (12) by means of a sensor device (14) connected to the microneedle array (12). The invention also relates to a method for applying a microneedle array (12).

Description

Technical Field

[0001] The present invention relates to a microneedle device and a method for detecting at least one force acting on a microneedle array. Background Technology

[0002] In addition to typical forms of active ingredient administration such as swallowing or injecting medications, there is also the concept of administering active ingredients through the skin. In this case, the use of microneedling is of particular interest.

[0003] Also known as a microarray, a microneedle array has multiple microneedles that are typically arranged on or attached to a support element such as a patch or drug film. This type of microneedle array comprises a large number of microneedles, for example, per square centimeter (cm²). 2 100 to 600 needles. The needles are short in length, such that, if possible, when pressed into the patient's skin, the needle penetrates only to the point where nerves and blood vessels are not in contact with the needle tip. Microneedles contain active ingredients or drugs. The corresponding active ingredients can be provided on the surface of the needle or provided within the needle. Preferably, the needles are made of a material that dissolves in the skin.

[0004] For successful application of microneedle arrays, and especially for successful drug administration using microneedle arrays, it is crucial to correctly introduce the microneedle array into the desired skin layer. Of particular importance here is achieving sufficient insertion depth during application.

[0005] DE 10 2014 201 605 A1 describes a microneedle device having a container that bursts upon application of a certain contact pressure, releasing a colored liquid indicating successful application. Disadvantageously, due to its size and / or design, this indication of application is only visible after use.

[0006] Another factor for successful application of microneedle arrays is the application time. Therefore, a sufficiently long application period is necessary to release the active material. In particular, the combination of insertion depth and application time is critical; in other words, whether the application has been performed for a sufficient duration at a sufficient insertion depth.

[0007] Furthermore, skin-specific factors are related to application, particularly to optimal insertion depth and / or application time. Consequently, there are significant differences in individual user skin types, due to factors such as age, skin texture, medical conditions, and BMI. These factors, for example, influence the force required to achieve the desired insertion depth. Summary of the Invention

[0008] The object of the present invention is to provide a microneedle device and method that enables improved examination of the applied microneedle array.

[0009] The microneedle array according to the invention is particularly for manual application. Here, "manual" preferably means that the microneedle array of the microneedle device can be applied manually by a user, particularly using one or more fingers or the hand. The microneedle device is preferably designed for application by means of the user's thumb. Therefore, it is preferable that application does not require, in particular, a force-applying device. On the other hand, the microneedle device can alternatively be a microneedle device that is applied using, in particular, a force-applying device. The microneedle device comprises a microneedle array. The microneedle array comprises a plurality of microneedles. The microneedles are preferably conical, pyramidal, or obelisk-shaped. The microneedles are particularly integrally connected to a support element. The microneedle device also includes a sensor device, for example, adhesively connected to the microneedle array. The sensor device is connected indirectly or directly to the microneedle array. Preferably, the sensor device is connected to the side opposite to the tip of the microneedle, which may also be referred to as the rear side. Preferably, the sensor device is connected to the support element, particularly directly. The sensor device is configured to detect at least one force acting on the microneedle array. Preferably, the sensor device is configured to detect at least one force acting on the microneedle array in a direction substantially perpendicular to the microneedle array. As a substitute for or supplement to the force to be detected, the sensor device is configured to detect at least one pressure acting on the microneedle array. Preferably, the sensor device is configured to measure at least one force acting on the microneedle array, such that force measurements of different magnitudes are specifically performed. The sensor device measures at least one force, particularly as a value in N (Newtons) or Pa (Pascals). The sensor device and the microneedle array are preferably connected by force-fit and / or form-fit and / or adhesive. In the case of adhesive connection, it is preferred that the microneedle array and the sensor device are glued and / or brazed and / or welded to each other. The sensor device and the microneedle array are particularly inseparably connected, i.e., they are preferably inseparable by non-destructive methods. Thus, it is preferred that the sensor device and the microneedle array can only be separated by separation such as sawing, milling, and / or breaking. The sensor device and the microneedle array are particularly permanently connected. The sensor device and the microneedle array are preferably rigidly connected to each other.

[0010] Preferably, the sensor device is configured to detect applied force and / or reaction force. The applied force to be detected is particularly the force applied by the user, indirectly or directly, to the microneedle array, preferably the support element, to apply the microneedle array into the skin. The reaction force is particularly the force opposing the applied force. Preferably, the reaction force is the force acting from the skin on the microneedle array, preferably the microneedles. In particular, the reaction force depends on the corresponding skin type selected for application. Generally, it can be assumed that the reaction force increases during application until the microneedle array has penetrated the skin. Thereafter, the reaction force decreases until the microneedle array is, in particular, fully applied. Once the applied force is no longer applied, it can be assumed that the skin's reaction force pushes the microneedle array out of the skin. Thus, the microneedle device of the present invention advantageously enables the detection of skin-specific conditions by detecting the reaction force, and in particular enables the application, preferably the applied force, to be adapted to the microneedle device.

[0011] Preferably, the sensor device includes at least one force sensor or is preferably formed by at least one force sensor. Particularly preferred is that the at least one force sensor is a piezoelectric sensor. Specifically, the force sensor is a piezoelectric disc. The piezoelectric disc can be, for example, the EPZ-20MS64W type. The piezoelectric disc is preferably circular.

[0012] Preferably, the sensor device includes two force sensors, particularly two piezoelectric discs. More preferably, one force sensor is configured and / or arranged to detect the applied force, and the other force sensor is configured and / or arranged to detect the reaction force.

[0013] Preferably, the sensor device includes a support structure. The support structure is particularly cylindrical in design. The cylindrical shape of the support structure can be described as circular, elliptical, square, rectangular, or triangular. It can preferably be a hollow cylinder. The support structure is specifically configured for force transmission and / or housing at least one force sensor. Preferably, at least two, preferably all, of the following conditions are met: the cylindrical base of the support structure substantially corresponds to the area of ​​the support element; the cylindrical base of the support structure substantially corresponds to the area of ​​at least one force sensor; and the area of ​​the support element substantially corresponds to the area of ​​at least one force sensor. Preferably, the force sensor is particularly directly connected to the base of the support structure. Preferably, particularly, another base of the support structure is directly or indirectly connected to the support element of the microneedle array. The support structure and / or sensor device is particularly generally rotationally symmetric in design.

[0014] Preferably, the two force sensors are connected to the support structure opposite to each other. Here, the two force sensors are specifically separated by the support structure. Preferably, one force sensor is specifically directly connected to the base of the support structure, while the other force sensor is specifically directly connected to another base of the support structure. Preferably, one force sensor is connected to the support structure via one side and to the microneedle array, particularly the carrier element, via the other side.

[0015] Preferably, the sensor device is specifically connected to the rear side of the microneedle array in a two-dimensional manner. In particular, the rear side is the surface of the support element. Preferably, a force sensor or support structure is connected to the support element.

[0016] Preferably, the microneedle device includes a processing means for evaluating at least one detected force. Specifically, the processing means includes a processor. Preferably, the processing means is connected to the sensor device, particularly in a manner that transmits information. The connection between the processing means and the sensor device is preferably wired and / or wireless, such as via Bluetooth or Wi-Fi. It is also possible that the processing means is part of a mobile device such as a smartphone.

[0017] Preferably, the processing device is configured to compare at least one detected force with a target force. The target force is particularly 10 N to 100 N. Specifically, the target force is the force required for application, preferably predetermined. Preferably, the target force is the minimum force required for application. Alternatively or additionally, it is preferred that the processing device is configured to record the time for force to be applied to the microneedle device, particularly the microneedle array. The processing device is preferably configured to compare the time of force application with a target time, particularly a predetermined target time for application. Specifically, the target time is 3 s to 300 s. Particularly preferred is that the processing device is configured to record the force applied over time and preferably compare it with a target value. Specifically, the processing device is configured to detect when the detected force reaches the target force and / or when the application time reaches the target time, wherein, preferably, the target force is detected within a target time period. If the detected force corresponds at least to the target force within a time period up to the target time, particularly up to at least the target time, then the target force has been reached within the target time period. Preferably, the target force is reached within the target time period if the force detected within a single time interval (i.e., continuously) or overall (i.e., within a cumulative period) corresponds to the target force until at least the target time is reached. Preferably, the processing device is configured to record the detected force and / or time. Preferably, the processing device is configured to compare the applied force with the reaction force. This allows, for example, skin-specific characteristics to be incorporated. Preferably, the processing device is configured to determine the target force for the applied force based on the reaction force.

[0018] Preferably, the processing device is configured to send feedback to the user regarding the application of the microneedle array using the microneedle device. Specifically, the roller is a pressure roller. Preferably, the processing device is configured to send feedback when the detected force reaches a target force and / or when the application time reaches a target time. Particularly preferably, the processing device is configured to send feedback when the target force is reached within a target time. Preferably, a single signal, particularly an acoustic and / or optical and / or tactile signal, is output upon reaching the target time and / or the application time and / or the target force within a target time period.

[0019] Preferably, the microneedle device includes a feedback device, particularly an acoustic and / or optical and / or tactile feedback device for transmitting, preferably outputting, feedback. The feedback device may include, for example, a light device such as an LED and / or a speaker. The feedback device may also include, for example, an actuator, such as a vibrating element. Preferably, the feedback device is configured to output feedback upon successful and / or unsuccessful application. Specifically, the feedback output upon successful application differs from the feedback output upon unsuccessful application. Preferably, the feedback device is connected to a processing device, particularly in a manner that transmits information. The connection between the processing device and the feedback device is preferably wired and / or wireless, for example, via Bluetooth or Wi-Fi. The feedback device may be part of a mobile device such as a smartphone.

[0020] Preferably, the microneedle device includes a finger application surface for manually applying the microneedle array using at least one of the user's fingers. The finger application surface is preferably a thumb application surface for applying the microneedle array by means of the thumb. Specifically, the finger application surface is approximately the size of a human finger, preferably a thumb. Preferably, the finger application surface is connected to, particularly integrally connected to, the exposed surface of the force sensor of the microneedle device, and preferably corresponds to it. The finger application surface is preferably planar.

[0021] Preferably, the microneedle device, particularly the sensor device, is configured such that the applied force, such as the applied force applied to the application surface of the finger, is uniformly transmitted to the microneedle array.

[0022] Furthermore, this disclosure also relates to a method for detecting at least one force acting on a microneedle array by means of a sensor device connected to the microneedle array. The detected force is particularly an applied force, preferably a manually applied force by a user, and / or a reaction force on the microneedle array.

[0023] Preferably, the method for detecting at least one force acting on the microneedle array is performed using a microneedle device having one or more of the features of the microneedle device described above.

[0024] This disclosure also relates to a method for applying a microneedle array. The method includes the step of applying the microneedle array to a patient's skin. This application is particularly performed manually or by means of an application device. Further, the method includes the step of detecting, in particular measuring, at least one force acting on the microneedle array by means of the aforementioned method for detecting at least one force acting on the microneedle array. The detected force is particularly an application force, preferably a manual application force by the user and / or a reaction force on the microneedle array. Optionally, the method includes an additional step of evaluating at least one detected force. This evaluation specifically includes comparing the detected force with a preferably predetermined target force for application. Another optional step of the method is a feedback output regarding at least one detected force. Preferably, the feedback output occurs once the detected force reaches the target force, particularly during the period until the target force is reached. The feedback output is preferably tactile and / or optical and / or acoustic.

[0025] Preferably, the method for applying the microneedle array is performed using a microneedle device having one or more of the features of the microneedle device described above. Attached Figure Description

[0026] The invention will now be described in more detail with reference to the accompanying drawings and preferred embodiments.

[0027] In the attached diagram:

[0028] Figure 1 This is a schematic cross-sectional side view of an embodiment of the microneedle device according to the present invention during application;

[0029] Figure 2 This is a schematic cross-sectional side view of another embodiment of the microneedle device according to the present invention;

[0030] Figure 3 This is a schematic cross-sectional side view of another embodiment of the microneedle device according to the present invention; and

[0031] Figure 4 This is a schematic cross-sectional side view of another embodiment of the microneedle device according to the present invention. Detailed Implementation

[0032] In the accompanying drawings, similar or identical parts or elements are identified by the same reference numerals or variations thereof (e.g., 16 and 16', 16"). In particular, for clarity, it is preferable that elements already identified are not provided with reference numerals in all the drawings.

[0033] Figure 1 This is a schematic cross-sectional side view of the microneedle device 10 during application.

[0034] The microneedle device 10 includes a microneedle array 12 having a support element 20, such as a patch, to which a plurality of microneedles 22 are connected, particularly integrally connected, to the support element.

[0035] The sensor device 14 is, for example, adhesively attached to the rear side 40 of the microneedle array 12, in which case the rear side corresponds to the surface of the support element 20. The sensor device 14 is shown as comprising a single force sensor 16, particularly consisting of a single force sensor. In particular, the force sensor is a piezoelectric sensor 16. Preferably, the piezoelectric sensor 16 is a piezoelectric disk, particularly a disc.

[0036] The microneedle device 10 is shown to be applied to, for example, the skin 104 of a patient by the thumb 102 of a user's hand 100, such as a patient or medical professional. Here, by means of the thumb 102, an application force (indicated by arrow 24) is applied to the application surface 38 of the microneedle device 10, thereby inserting the microneedles 22 into the skin 104. For example, the application force 24 may be applied for a period of time, causing further pressure on the microneedle array 12.

[0037] The applied force 24 can be detected, and in particular measured, by the force sensor 16.

[0038] Skin 104 resists insertion by the reaction force acting on the microneedle array 12 (shown by arrow 26).

[0039] The microneedle array 12 and / or sensor device 14 particularly have a circular, elliptical, rectangular, or square base. Preferably, the microneedle array 12 and / or sensor device 14, and especially preferably the microneedle device 10, are symmetrical, particularly rotationally symmetrical.

[0040] Figure 2 Another embodiment of the microneedle device 10 according to the present invention is shown.

[0041] The sensor device 14 is shown as comprising two force sensors 16', 16'', which are particularly piezoelectric, and they are separated by a hollow cylindrical support structure 18. In particular, the support structure 18 has a circular base.

[0042] The reaction force 26 can be detected via a force sensor 16” directly connected to the microneedle array 12, while the applied force 24 can be detected via a force sensor 16' specifically integrally connected to the application surface 38.

[0043] During application, an application force 24, for example from the thumb 102, acts on the microneedle array 12. This application force 24 is specifically increased to the target force by which the microneedle array 12 penetrates the skin 104. This force, i.e., the application force 24, which is specifically ≥ the target force, is then maintained for a period of time (holding time), for example by the thumb 102. The skin 104 continues to exert a reaction force 26 on the microneedle array 12, thereby also exerting a reaction force on the thumb 102, for example. This reaction force 26 increases until the microneedle array 12 penetrates the skin 104. Then, as the microneedle array 12 penetrates further, the reaction force 26 decreases. When the application ends or is canceled, for example when the thumb 102 is removed, the reaction force 26 eventually becomes dominant. In particular, the reaction force 26 is particularly dependent on the corresponding skin 104 selected for application. A sensor device 14 having two force sensors 16', 16" is preferably capable of detecting the application force 24 and the reaction force 26. This enables optimal assessment and / or adaptation of the application.

[0044] Figure 3 Another embodiment of the microneedle device 10 is shown, which is generally based on Figure 2 Examples of implementations.

[0045] exist Figure 3 In the process, force sensor 16' is connected to processing device 28 via cable 32, and force sensor 16" is connected to processing device 28 via cable 34, particularly in the form of information transmission.

[0046] The processing device 28 is specifically configured to evaluate the detection values ​​of the force sensors 16' and 16" .

[0047] Feedback (indicated by dashed line 36) can be provided to the user via feedback device 30 connected to processing device 28. For example, feedback can be provided once sufficient application force 24 has been applied, particularly once sufficient application force 24 has been applied within a preferred predetermined time period.

[0048] The feedback device 30 may have, for example, a light such as an LED and / or a speaker and / or an actuator such as a vibrating element.

[0049] Instead of a wired connection between the sensor device 14 and the processing device 28, a wireless connection, such as Wi-Fi and / or Bluetooth, is also possible.

[0050] Figure 4 Another embodiment of the microneedle device 10 according to the present invention is shown, which is generally based on Figure 2 and Figure 3 Examples of implementations.

[0051] and Figure 3 Compared to the embodiment shown, which includes an external processing device 28 and a feedback device 30, in Figure 4 In the embodiment shown, the processing device 28 and the feedback device 30 are integrated into the sensor device 14.

Claims

1. A microneedle device (10), comprising: Microneedle array (12); as well as A sensor device (14) is connected to the microneedle array (12). The sensor device (14) is configured to detect at least one force acting on the microneedle array (12). The sensor device (14) includes two force sensors (16), one of which is configured to detect applied force (24), and the other of which is configured to detect reaction force (26) acting on the microneedle array (12).

2. The microneedle device (10) according to claim 1, characterized in that, The force sensor is a piezoelectric sensor.

3. The microneedle device (10) according to claim 1, characterized in that, The sensor device (14) includes a support structure (18).

4. The microneedle device (10) according to claim 3, characterized in that, The supporting structure is cylindrical.

5. The microneedle device (10) according to claim 3, characterized in that, Two opposing force sensors (16) are connected to the support structure (18).

6. The microneedle device (10) according to claim 5, characterized in that, The two force sensors are separated by the support structure.

7. The microneedle device (10) according to any one of claims 1 to 6, characterized in that, The sensor device (14) is connected in two dimensions to the rear side of the microneedle array (12).

8. The microneedle device (10) according to any one of claims 1 to 6, characterized in that, It also includes a processing device (28) for evaluating at least one of the detected forces.

9. The microneedle device (10) according to claim 8, characterized in that, The processing device (28) is configured to compare at least one detected force with a target force and / or detect the time period during which the force is applied.

10. The microneedle device (10) according to claim 9, characterized in that, The processing device (28) is configured to detect the force progression over time.

11. The microneedle device (10) according to claim 8, characterized in that, The processing device (28) is configured to provide feedback to a person regarding the application of the microneedle array (12) performed using the microneedle device (10).

12. The microneedle device (10) according to any one of claims 1 to 6, characterized in that, It also includes acoustic and / or optical and / or tactile feedback devices (30).

13. The microneedle device (10) according to any one of claims 1 to 6, characterized in that, It also includes a finger application surface (38) for manually applying the microneedle array (12) by at least one finger (102) of a user.

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