Intradermal active ingredient delivery system

Abstract

An intradermal active ingredient delivery system comprising an extraction device (10) having, inter alia, several hollow needles (30) for extracting interstitial fluid. A delivery device (14) is in fluid connection with the extraction device (10). The delivery device (14) is also in fluid connection with an active ingredient reservoir (16). The delivery device (14) is in fluid connection with a delivery device (26) for delivering interstitial fluid comprising the active ingredient. The delivery device (26) preferably has hollow needles (30) to enable intradermal delivery of the liquid mixture.

Description

[Technical Field]

[0001] This invention relates to an intradermal active ingredient delivery system, through which active ingredients, especially pharmaceutical active ingredients, can be delivered intradermally to a patient. [Background Technology]

[0002] Transdermal therapy systems (TTS) are known for delivering active ingredients. For example, a transdermal patch can be applied to a patient's skin. The stored active ingredient is continuously reabsorbed through the skin. The advantages of this form of administration are that, unlike injections, it is painless for the patient and allows for drug administration over a longer period. However, the disadvantages are that drug administration can only be adjusted by removing or replacing the TTS. In particular, it is difficult to accurately determine the amount of drug delivered to the patient.

[0003] Furthermore, it is known that active ingredients can be administered via microneedles. Here, the active ingredient is delivered to the dermis of the skin via multiple microneedles. Therefore, delivery occurs in the nerveless outer layer of the skin, making this delivery of the active ingredient painless for the patient. In this case, the microneedles are known to be hollow needles, with the active ingredient contained within and delivered through the needle tip. Furthermore, it is known that microneedles are composed of materials that are soluble in the skin. Here, the active ingredient is incorporated into the microneedle material. However, there is also the problem of accurately determining the amount of active ingredient delivered to the patient, because, for example, the microneedles may not completely dissolve or may break. [Summary of the Invention]

[0004] The purpose of this invention is to provide an intradermal active ingredient delivery system that makes it easier to determine the amount of active ingredient delivered to the patient.

[0005] According to the present invention, this objective is achieved by an intradermal active ingredient delivery system having the features described in claim 1.

[0006] The intradermal active ingredient delivery system according to the invention includes an extraction device for extracting interstitial fluid. Preferably, the extraction device particularly has several microneedles designed as hollow needles. A delivery device is fluidly connected to the extraction device. In particular, the delivery device is used to extract interstitial fluid from patient tissue. Furthermore, the intradermal active ingredient delivery system includes an active ingredient reservoir. The active ingredient reservoir is fluidly connected to the delivery device. In the active ingredient reservoir, the active ingredient to be administered to the patient is provided in solid and / or powder and / or liquid form. According to the invention, the delivery device is also fluidly connected to the delivery device. The delivery device is used for intradermal delivery of a mixture of the active ingredient and the extracted interstitial fluid, or for delivery of interstitial fluid rich in the active ingredient to the patient. The delivery device preferably includes microneedles, particularly designed as hollow needles.

[0007] Therefore, the intradermal drug delivery system according to the invention can administer a defined amount of active ingredient to a patient. Preferably, the active ingredient is in a concentrated form in the active ingredient reservoir and is either diluted or dissolved by interstitial fluid.

[0008] In another particularly preferred embodiment of the invention, the extraction device particularly has a plurality of microneedles. Preferably, one or more microneedle arrays are provided, and in a preferred embodiment, each microneedle array has at least 4 needles / cm. 2 Preferably, there are at least 50 needles / cm. 2 Especially preferred is at least 100 needles / cm 2 .

[0009] In particular, if the extraction device has several microneedle arrays, it is preferable that these microneedle arrays are arranged parallel to each other and each is connected to the delivery device via a separate channel. Furthermore, several extraction devices can be arranged in a circle around the delivery device at the same distance from the delivery device. In particular, the advantage of arranging several microneedle arrays is that each microneedle array can be connected to a channel with a smaller cross-section, and in this respect, a very small intradermal active ingredient delivery system can be achieved. Arranging several microneedle arrays also has the advantage of always ensuring an adequate supply of liquid. A suitable liquid for extraction can be achieved, in particular, by combining a liquid delivery device with a pump having a longer stroke and / or more strokes.

[0010] Preferably, the delivery device has at least one pump. This pump can be a diaphragm pump, etc., particularly having multiple valves designed to allow liquid to be delivered only in one direction. Specifically, diaphragms are respectively positioned at the pump's inlet and outlet. This ensures, in particular, that mixing with the active ingredient preferably takes place only within the pump or in a space provided within the pump. Specifically, it prevents the active ingredient from remaining undiluted without active pumping or dosage administration. Furthermore, the advantage of positioning diaphragms on the microneedle array is that the channels are always continuously filled with liquid or the active ingredient solution, and backflow into the skin or into the chambers within the pump is avoided. For example, the pump can be controlled by a piezoelectric trigger that can create a pressure change in the pump chamber to trigger the pumping process. It is also conceivable that pumping can be accomplished by manually generating pressure in the respective chambers.

[0011] In a particularly preferred embodiment of the invention, an active ingredient reservoir containing the liquid active ingredient is connected to the inlet of the delivery device. Preferably, the extraction device is also connected to the inlet of the delivery device. In particular, it is connected to the inlet of the liquid pump. Although a single inlet is preferred for miniaturizing the active ingredient delivery system, the liquid pump may have one or more inlets.

[0012] In this preferred embodiment of the invention, the delivery device is capable of simultaneously drawing in the liquid active ingredient and the interstitial fluid. Here, it is preferable to mix the two liquids. Optionally, a mixing chamber may be provided, particularly within the delivery device, in which the two liquids are mixed. This chamber may be, in particular, the chamber of a liquid pump, especially a diaphragm pump. The two mixed liquids are then preferably delivered to the dermis of the skin via a delivery device connected to the delivery device.

[0013] In another preferred embodiment, the active ingredient storage tank is connected to the outlet of the delivery device, particularly the outlet of the pump of the delivery device. Here, the active ingredient can be in liquid, solid, or powder form in the active ingredient storage tank. In this preferred embodiment, the interstitial fluid is preferably drawn in via an extraction device using the delivery device and then delivered to the active ingredient storage tank. In this embodiment, the active ingredient storage tank can also serve as a mixing chamber, or the mixing or dissolution of the active ingredient can be carried out separately in the active ingredient storage tank.

[0014] In a preferred embodiment, the delivery device may have several pumps, particularly two pumps. In this embodiment, an active ingredient reservoir may be positioned between the two pumps. Accordingly, a pump positioned upstream of the active ingredient reservoir along the flow direction is used to draw in interstitial fluid, which is then pumped into the active ingredient reservoir. A pump positioned downstream of the reservoir along the flow direction draws in interstitial fluid rich in active ingredients and delivers it to the delivery device.

[0015] In a preferred embodiment, a delivery device having a plurality of hollow needles is connected directly or indirectly to a delivery device via one or more channels.

[0016] In another preferred embodiment, the delivery device may be directly or indirectly connected to the active ingredient chamber or mixing chamber, particularly via multiple channels. In this embodiment, it is preferred that a pump delivers the pumped interstitial fluid through the active ingredient reservoir and the mixing chamber. Here, the interstitial fluid absorbs the active ingredient, resulting in an active ingredient-rich interstitial fluid that reaches the delivery device.

[0017] In another preferred embodiment of the intradermal active ingredient delivery system according to the invention, an active ingredient reservoir or additional active ingredient reservoir is integrated into the delivery device. Therefore, the interstitial fluid is mixed with the active ingredient placed in such an active ingredient reservoir just before delivery to the patient. In particular, the active ingredient can be placed directly into the hollow needle.

[0018] Optionally, the active ingredient delivery system may include a mixing chamber. Here, a mixing element, such as a piezoelectric actuator, can act on the mixing chamber to ensure good mixing of the active agent with the interstitial fluid. This also ensures reliable dissolution of the active ingredient, whether in solid or powder form. According to this embodiment, the mixing chamber may be omitted or integrated, for example, into the delivery device, active ingredient reservoir, and / or delivery device.

[0019] The size of the active ingredient delivery system according to the invention allows the entire system to be reliably applied to the patient's skin in a simple manner. In addition to its small design with only a few square centimeters of skin contact surface, the active ingredient delivery system can also be implemented, for example, as a wristband encircling the arm. Particularly important for realizing the active ingredient delivery system according to the invention are the system's flexibility and the needle's penetration depth. To achieve the required flexibility, the system is always thin enough that it remains in contact with the entire surface of the skin even during movement, while on the other hand, the patient's freedom of movement is only slightly restricted. The needle's length allows it to penetrate only into the dermis of the skin, thus avoiding potentially painful nerve contact. [Attached Image Description]

[0020] The present invention will now be described in more detail with reference to the accompanying drawings and preferred embodiments.

[0021] In the attached diagram:

[0022] Figures 1 to 4 Different preferred embodiments of the intradermal active ingredient delivery system according to the present invention are shown;

[0023] Figure 5 A highly simplified cross-sectional schematic diagram of the extraction or delivery device is shown; and

[0024] Figure 6 A highly simplified schematic diagram of a delivery device in the form of a diaphragm pump is shown.

Detailed Implementation Methods

[0025] exist Figures 1 to 4 In various embodiments of the intradermal active ingredient delivery system according to the present invention, the same and similar components are labeled with the same reference numerals.

[0026] Figure 1 The illustrated embodiment includes an extraction device 10 having two microarrays with multiple hollow needles. Each of the two microarrays 10 is connected to a pump or delivery device 14 via a channel 12. An active ingredient reservoir 16 storing the liquid active ingredient is also connected to the pump 14 via a channel 18. In the illustrated exemplary embodiment, all three channels 12, 18 converge upstream of the pump 14 and connect to a single pump inlet 20.

[0027] In the illustrated exemplary embodiment, pump 14 includes two pump outlets 22, each pump outlet connected to a channel 24. Alternatively, pump 14 may also have an outlet, which is also connected to both channels 24. Channels 24 are connected to a delivery device 26. Delivery device 26 is a microarray having a plurality of hollow needles.

[0028] Figure 5 A portion of a microarray is schematically shown, which may be a microarray 10 for an extraction device or a microarray 26 for a delivery device. Microarrays 10 and 26 include a plurality of hollow needles 28 with openings 30 at their tips. If the microarray is an extraction device, interstitial fluid can be aspirated through the openings 30. If the microarray is a delivery device, interstitial fluid rich in active ingredients is delivered to the patient through the openings 30. The hollow needles 28 are connected to channels 32 on the side opposite to the openings 30. Channels 32 preferably extend over the entire surface of the microarray and are connected to channels 12 or 24.

[0029] Figure 1 The illustrated intradermal active ingredient delivery system allows interstitial fluid to be drawn in via a pump through a hollow needle in the microarray 10 and channel 12. Simultaneously, the liquid active ingredient is drawn in from the active ingredient reservoir 16. The two fluids are mixed within the pump 14 or in the area where channels 12 and 18 converge. After the pump inlet 20 is closed, the pump 14 can be used to deliver the fluid mixture through two outlets 22 and channel 24 to the microneedles 30 of the delivery system 26 for injection into the patient.

[0030] For example, pump 14 could be Figure 6 A diaphragm pump is schematically shown in the diagram. Figure 6 In the state shown for pump 14, both outlet 22 and inlet 20 are closed. Pump 14 is in an unloaded state. For example, force can be applied to pump chamber 34 via a piezoelectric element (not shown). When a negative pressure or vacuum is generated in pump chamber 34, inlet 20 opens to allow liquid to flow into pump chamber 34 in the direction of arrow 36. To deliver liquid out of pump chamber 34, pressure is applied to pump chamber 34 again, for example, via a piezoelectric element. Figure 6 As shown in the diagram below, this closes inlet 20. Simultaneously, outlet 22 opens, allowing the liquid to flow in the direction of arrow 38.

[0031] according to Figure 2 In another embodiment shown, the two microarrays 10 of the extraction device are again connected to the first pump 14 via channel 12. In this exemplary embodiment, the outlet 22 of the first pump 14 is connected to the active ingredient reservoir 16. Then, the active ingredient reservoir 16 flows along the flow direction, i.e. Figure 2 The right side of the pump is connected to the second pump 40 via its inlet 42. The outlet 44 of the second pump 40 is connected to the delivery device 26 via channel 24.

[0032] exist Figure 2 In the exemplary embodiment shown, the first pump 14 therefore draws in the interstitial fluid via the extraction device 10 and delivers it to the active ingredient reservoir 16. The active ingredient reservoir 16 contains liquid, solid, or powdered active ingredients. Therefore, in Figure 2 In the exemplary embodiment shown, the active ingredient reservoir 16 also serves as a mixing chamber. The second pump 40 draws the liquid mixture from the active ingredient reservoir 16 and delivers it to the delivery device 26 via the channel 24.

[0033] Figure 3 The exemplary embodiments shown are substantially corresponding to Figure 2 The exemplary embodiment shown differs in that a second pump is not provided. Therefore, pump 14 pumps the interstitial fluid drawn in by pump 14 through the active ingredient reservoir 16, where the interstitial fluid absorbs the active ingredient. Pump 14 then continues to deliver the liquid mixture directly through channel 24 to delivery device 26.

[0034] Figure 4 The illustrated embodiments are basically corresponding to Figure 1 In the illustrated embodiment, no active ingredient reservoir 16 is connected to the liquid pump inlet 20. Instead, in this exemplary embodiment, the active ingredient reservoir is integrated into the extraction device 26. For example, the active ingredient is disposed in the hollow needle 30 and / or channel region 32. Figure 5 It is absorbed by the interstitial fluid immediately before injection.

Claims

1. An intradermal active ingredient delivery system, comprising: Extraction device (10) is used for intradermal extraction of interstitial fluid and for diluting or dissolving concentrated active ingredients; A delivery device (14) is fluidly connected to the extraction device (10) to deliver liquid; An active ingredient storage tank (16) stores the concentrated active ingredient and is fluidly connected to the delivery device; A mixing chamber for mixing the interstitial fluid and the concentrated active ingredient to dilute or dissolve the concentrated active ingredient; as well as Delivery device (26), fluidly connected to the delivery device (14), for intradermal delivery of the active ingredient diluted or dissolved by the interstitial fluid.

2. The intradermal active ingredient delivery system according to claim 1, characterized in that, The extraction device (10) includes microneedles (30).

3. The intradermal active ingredient delivery system according to claim 2, characterized in that, The extraction device (10) includes a microarray having at least 4 needles / cm².

4. The intradermal active ingredient delivery system according to claim 3, characterized in that, The microarray has at least 50 needles / cm².

5. The intradermal active ingredient delivery system according to claim 4, characterized in that, The microarray has at least 100 needles / cm².

6. The intradermal active ingredient delivery system according to claim 3, characterized in that, The extraction device (10) includes two microarrays, each microarray having at least 4 needles / cm².

7. The intradermal active ingredient delivery system according to claim 6, characterized in that, Each microarray has at least 50 needles / cm².

8. The intradermal active ingredient delivery system according to claim 7, characterized in that, Each microarray has at least 100 needles / cm².

9. The intradermal active ingredient delivery system according to any one of claims 1 to 8, characterized in that, The conveying device (14) includes at least one pump.

10. The intradermal active ingredient delivery system according to any one of claims 1 to 8, characterized in that, The active ingredient, in solid, liquid or powder form, is stored in the active ingredient reservoir (16).

11. The intradermal active ingredient delivery system according to any one of claims 1 to 8, characterized in that, An active ingredient storage tank (16) containing liquid active ingredients and an extraction device (10) are connected to the inlet (20) of a conveying device (14).

12. The intradermal active ingredient delivery system according to claim 11, characterized in that, The active ingredient storage tank (16) and the extraction device (10) are connected to the inlet of the delivery device (14), so that the active ingredient and the interstitial fluid are simultaneously drawn in.

13. The intradermal active ingredient delivery system according to any one of claims 1 to 8, characterized in that, The active ingredient storage tank (16) is connected to the outlet (22) of the conveying device.

14. The intradermal active ingredient delivery system according to any one of claims 1 to 8, characterized in that, The delivery device includes two pumps (14, 40), and the active ingredient storage tank (16) is disposed between the two pumps (14, 40).

15. The intradermal active ingredient delivery system according to any one of claims 1 to 8, characterized in that, The delivery device (26) includes a microarray having at least 4 needles / cm².

16. The intradermal active ingredient delivery system according to claim 15, characterized in that, The microarray has at least 50 needles / cm².

17. The intradermal active ingredient delivery system according to claim 16, characterized in that, The microarray has at least 100 needles / cm².

18. The intradermal active ingredient delivery system according to any one of claims 1 to 8, characterized in that, The delivery device is connected to the outlet (22, 24) of the conveying device (14).

19. The intradermal active ingredient delivery system according to any one of claims 1 to 8, characterized in that, The active ingredient reservoir (16) is integrated into the delivery device (26), wherein the active ingredient is disposed in the needle (30) of the delivery device (26).

20. The intradermal active ingredient delivery system according to claim 1, characterized in that, The active ingredient storage tank (16) forms the mixing chamber.

21. The intradermal active ingredient delivery system according to claim 1 or 20, characterized in that, The mixing chamber is integrated into the conveying device (14).

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