Active ingredient delivery system

Abstract

An active ingredient delivery system for delivering an active ingredient, in particular a pharmaceutical active ingredient, comprises an active ingredient means 10 and an electronic means 12 cooperating with the active ingredient means. The active ingredient means 10 has an active ingredient reservoir 16 fluidly connected to a delivery means 30. The electronic means 12, in particular manufactured as a separate component, has a control means 36 and a pump means 34 electrically connected to the control means. The pump means 34 transfers the active ingredient from the active ingredient reservoir 16 to the delivery means 30.

Description

[Technical Field]

[0001] The present invention relates to an active ingredient delivery system for delivering active ingredients, particularly pharmaceutical active ingredients. [Background technology]

[0002] For example, transdermal therapeutic systems (TTS) are known for delivering active ingredients. A transdermal patch that adheres to the patient's skin allows the stored active ingredient to be continuously absorbed through the skin. Unlike injections, such systems have the advantage that the delivery of the active ingredient is painless for the patient.

[0003] Furthermore, delivery of active ingredients via microneedles is known. In this case, the active ingredient is delivered to the dermis of the skin through multiple needles so that the active ingredient is delivered to the outer layer of the skin. Because there are no nerves in the outer layer of the skin, such delivery of the active ingredient is also painless to the patient. The microneedles may be configured as hollow needles that contain the active ingredient and deliver the active ingredient from the needle tip through the needle opening. Furthermore, it is known that microneedles are made of a material that dissolves in the skin, so that the active ingredient stored in the microneedles is delivered to the patient by dissolving the microneedles. Summary of the Invention [Problem to be solved by the invention]

[0004] Although the above systems have been developed specifically for the continuous delivery of active ingredients over long periods of time, they have the disadvantage that they do not allow for periodic delivery of active ingredients, which necessitates the need to remove such active ingredient delivery systems from the skin and then fix a new active ingredient delivery system to the skin for the next administration of the active ingredient.

[0005] An active ingredient delivery system is known from EP 0 840 634 A1, which allows delivery of the active ingredient even at time intervals. This active ingredient delivery system comprises a device in which microneedles are fluidly connected to an active ingredient reservoir. A pump integrated into the system and connected to control means can be used to deliver the active ingredient, for example, at predetermined times or at predetermined intervals. However, the system described in EP 0 840 634 A1 is a very complex system.

[0006] The object of the present invention is to provide an active ingredient delivery system for delivering active ingredients, in particular active pharmaceutical ingredients, which can be delivered simply and reliably, in particular over a long period of time or at time intervals. [Means for solving the problem]

[0007] According to the invention, this object is achieved by an active ingredient delivery system having the features of claim 1.

[0008] The active ingredient delivery system according to the present invention is used in particular for delivering active ingredients of pharmaceuticals, and is particularly capable of delivering the active ingredient over a long period of time, whereby time intervals, timing points, delivery amounts, etc. can be defined.

[0009] The active ingredient delivery system comprises an active ingredient means and an electronic means cooperating with the active ingredient means. The active ingredient means has an active ingredient reservoir in which an active ingredient, in particular a pharmaceutical active ingredient, is stored. The active ingredient reservoir is fluidly connected to a delivery means. The delivery means is used to deliver the active ingredient to a patient. In particular, the active ingredient is delivered to the dermis of the patient's skin.

[0010] The electronic means comprises at least a control means and a pump means electrically connected to the control means. The control means can control the pump means so that the active ingredient is delivered at a predetermined time for a predetermined duration. The pump means is used to deliver the active ingredient from the active ingredient reservoir to the delivery means. Here, the pump means can act directly or indirectly on the active ingredient reservoir. Furthermore, a pump chamber can be arranged between the active ingredient reservoir and the delivery means on which the pump means acts.

[0011] In a particularly preferred further development of the invention, the active ingredient means and the electronic means are separately formed components. In particular, the active ingredient means is manufactured independently from the electronic means. This has the particular advantage that the active ingredient means can be easily sterilized without the electronic components of the electronic means being damaged by sterilization. In this respect, it is particularly possible to sterilize the active ingredient means by irradiation. A further advantage is that the separation of the two means allows the active ingredient means to be manufactured, in particular as a foil formed from multiple layers. This allows for production in a continuous process, in particular a rolling process. This greatly simplifies the manufacture of the active ingredient means.

[0012] In particular, compared to the prior art in the form described in EP-A-0 840 634, the separation of the active ingredient means from the electronic means into two separate components is a significant advantage, in particular as it allows for a significantly reduced complexity and therefore more cost-effective production.

[0013] Furthermore, by separating the two means into different components, it has the advantage that for example different electronic means can be connected to the same active ingredient means. In particular, a modular system with different active ingredient means and electronic means can be provided, so that for example different active ingredient delivery systems for different application areas can be easily implemented.

[0014] Preferably, the active ingredient means has a skin-contacting surface for applying the active ingredient delivery system to the patient's skin. In particular, the skin-contacting surface extends over the entire outer side of the active ingredient means facing the patient and has a flat, substantially planar shape to ensure good skin contact. In particular, an adhesive layer may be applied to the skin-contacting surface so that the active ingredient delivery system can be easily applied to the patient's skin.

[0015] Furthermore, it is preferred that the active ingredient means has a connecting surface opposite the skin-contacting surface. The connecting surface is used to connect the active ingredient means to the electronic means. It is preferred that the connecting surface also has a planar shape. Where applicable, the connecting surface does not extend over the entire surface, so that, for example, part of the electronic means may protrude into a recess in the active ingredient means.

[0016] Preferably, both the active ingredient means and the electronic means are made of plastic material, in particular plastic foil, with the exception of electronic components etc. Thus, the connection between the active ingredient means and the electronic means may be effected, for example, by lamination.

[0017] In a preferred further development of the invention, the active ingredient means has a receiving area for receiving an active ingredient reservoir, in particular a replaceable active ingredient reservoir. This has the particular advantage that the active ingredient means can be manufactured independently from the reservoir containing the active ingredient, so that, for example, an active ingredient reservoir containing a different active ingredient can be inserted into the receiving area later. This also makes it easier to replace the active ingredient reservoir. For example, such a replacement can be performed by replacing an empty active ingredient reservoir with a full active ingredient reservoir while the active ingredient delivery system is placed on the patient's skin.

[0018] The receiving area is preferably configured with an opening that is fluidly connected to the delivery means, and a check valve may be arranged in said opening so that when the active ingredient reservoir is replaced, the active ingredient cannot leak from the fluid connection, i.e. the connecting channel, into the receiving area.

[0019] Regardless of whether the active ingredient reservoir is provided directly on the active ingredient means or whether a receiving area for the active ingredient reservoir is provided, a pump chamber is preferably provided between the active ingredient reservoir and the delivery means. The pump chamber is thus fluidly connected to the active ingredient reservoir and the delivery means. The pump means acts on this pump chamber to transport the active ingredient towards the delivery means. Preferably, a check valve may be provided at the inlet and / or outlet of the pump chamber. The check valve provided at the inlet of the pump chamber may be the same as the check valve located at the opening of the receiving area.

[0020] In a particularly preferred further development of the invention, the delivery means comprises a hollow needle. Preferably, the delivery means comprises a plurality of microneedles formed as hollow needles. In particular, for this purpose, at least 4 needles / cm 2 , preferably at least 50 stitches / cm 2 , particularly preferably at least 100 stitches / cm 2 wherein the needle penetration depth is preferably such that the needles penetrate into the dermis of the skin but not deeper so as to avoid penetrating into the layer of the skin where nerves are located.

[0021] The pump means is preferably constructed and arranged to act directly on the active ingredient reservoir and / or pump chamber. The pumping effect may be produced by a stroke-generating element. The pump means may comprise a piezoelectric element, an eccentric, etc.

[0022] Furthermore, it is preferred that the electronic means comprise sensor means for obtaining patient data. The sensor means may comprise one or more sensors. The patient data obtained by the sensor means may be transmitted directly to the control means. It is preferred that the measured patient data is taken directly into account in the control of the pump means.

[0023] For placement of the sensor means, the active ingredient means preferably has a recess into which the sensor means protrudes. If desired, multiple recesses may be provided in which one or more sensors may be placed. The provision of at least one recess in the active ingredient means has the advantage that the sensor is positioned close to the skin. If desired, the active ingredient means may have an opening in the recess to allow the sensor to come into direct contact with the skin.

[0024] Furthermore, the electronic means may comprise storage means for storing patient data, calculating control signals, etc. Furthermore, transmitting and / or receiving means may be provided for data transmission.

[0025] It is further preferred that the electronic means comprise an energy storage such as a battery or a capacitor. Where applicable, the battery may be a rechargeable battery. A combination of electrical and mechanical energy storage systems may also be advantageous.

[0026] The invention will now be described in more detail by way of preferred embodiments with reference to the accompanying drawings. [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a schematic plan view of an active ingredient delivery system according to the present invention. [Figure 2] 2 is a schematic cross-sectional side view of the active ingredient delivery system of the present invention taken along line II-II. [Figure 3] 1A-1C are schematic diagrams showing the pump chamber in various states. [Figure 4] FIG. 2 is a schematic diagram showing a pump means. DETAILED DESCRIPTION OF THE INVENTION

[0028] The active ingredient delivery system according to the present invention comprises an active ingredient means 10 and an electronic means 12. The active ingredient means and the electronic means are separately manufactured flat, in particular foil-like components.

[0029] The active ingredient means 10 has a receiving area 14 in which a reservoir 16 can be replaceably disposed. In Figure 1, the reservoir 16 can be inserted into the receiving area 14 from the right side. In the inserted state, the outlet 18 of the reservoir 16 protrudes into the channel 20. The channel 20 is initially fluidly connected to the pump chamber 22, with check valves 24, 26 disposed at the inlet and outlet of the pump chamber 22. The pump chamber 22 is then fluidly connected to the delivery means 30 via the channel 28 for delivery of the active ingredient.

[0030] The delivery means 30 has a plurality of hollow needles 32 through which the active ingredient in the reservoir 16 can be delivered to the patient's skin.

[0031] A pump means 34 is disposed on the electronic means 12 for transporting the active ingredient from the reservoir 16 inserted in the receiving area 14 to the delivery means 30. When the active ingredient means 10 is connected to the electronic means 12, the pump means 34 is disposed above the pump chamber 22 and acts on the pump chamber 22 to transport the active ingredient from the reservoir 16 towards the delivery means 30. The pump means 34 is electrically connected to a control means 36. The control means 36, which may further have a memory element, is connected to a battery 38. Furthermore, the control means 36 is connected to a sensor means 40. These electronic components are disposed on the electronic means 12 (Fig. 2).

[0032] The sensor means 40, which may have multiple sensors, protrudes into a recess 42 provided in the active ingredient means 10. The bottom 44 of the sensor means 40 may therefore be in direct contact with the skin, and the recess 42 may have an opening at the bottom 46 for direct contact with the skin if desired.

[0033] 2 shows the active ingredient means 10 and the electronic means 12 before assembly. Furthermore, a cover foil such as a blister 48 is shown. The blister 48 is arranged on the bottom 50 of the active ingredient means 10 and is removed just before the active ingredient delivery system is placed on the patient's skin. The bottom 50 therefore forms a skin-contacting surface which, in particular, comprises an adhesive. Opposite the skin-contacting surface 50, the active ingredient means 10 is provided with a connecting surface 52. The connecting surface 52 is used to connect the active ingredient means 10 to the bottom 54 of the electronic means 12. The bottom 54 of the electronic means 12 therefore also functions as a connecting surface. The connection can be made by gluing, lamination, etc.

[0034] The pump chamber 22 may be configured as shown in Figure 3 with a check valve 24 at the inlet and a check valve 26 at the outlet. When the pump compresses the pump chamber 22, the outlet check valve 26 opens to allow the active ingredient to flow out of the pump chamber in the direction of arrow 56 towards the delivery means 30.

[0035] When pump chamber 22 is to be filled, check valve 26 is closed and check valve 24 is opened, allowing fluid to flow from the reservoir in the direction of arrow 58 into pump chamber 22 .

[0036] The fluid may be delivered by pump means 34, shown diagrammatically in Figure 4. The pump means 34 comprises an electric motor 60 connected via a shaft 62 to an eccentric 64. The eccentric 64 acts on the top of the pump chamber 22 to deliver the active ingredient as described above with reference to Figure 3.

Claims

1. 1. An active ingredient delivery system for delivering an active ingredient over an extended period of time and / or at intervals, comprising: an active ingredient means and electronic means cooperating with said active ingredient means; the active ingredient means having an active ingredient reservoir fluidly connected to a delivery means; the electronic means includes at least one control means and a pump means electrically coupled to the control means, the pump means causing the active ingredient to be transferred from the active ingredient reservoir to the delivery means; An active ingredient delivery system wherein said active ingredient means and said electronic means are formed as separate films.

2. An active ingredient delivery system as described in claim 1, wherein the separate films can be manufactured independently of each other.

3. 3. An active ingredient delivery system according to claim 1 or 2, wherein the active ingredient means has a skin contact surface for applying the active ingredient delivery system to the skin of a patient.

4. 4. The active ingredient delivery system of claim 3, wherein said active ingredient means has a coupling surface opposite said skin contact surface for coupling to said electronic means.

5. 5. An active ingredient delivery system according to any one of claims 1 to 4, wherein the active ingredient means has a receiving area for receiving the active ingredient reservoir.

6. An active ingredient delivery system as described in claim 5, wherein the active ingredient reservoir is replaceable.

7. 7. An active ingredient delivery system according to any one of claims 1 to 6, wherein a pump chamber is provided between the active ingredient reservoir and the delivery means.

8. 8. The active ingredient delivery system according to claim 7, wherein the pump chamber has a check valve at the inlet and / or outlet.

9. The active ingredient delivery system according to any one of claims 1 to 6, wherein the delivery means comprises a hollow needle.

10. An active ingredient delivery system as described in claim 7 or 8, wherein the delivery means has a hollow needle.

11. 11. An active ingredient delivery system according to any one of claims 7, 8 and 10, wherein the pump means acts on the active ingredient reservoir and / or on the pump chamber.

12. An active ingredient delivery system according to any one of claims 1 to 11, wherein said electronic means comprises sensor means for obtaining patient data.

13. 13. The active ingredient delivery system according to claim 12, wherein patient data is transmitted to said control means.

14. An active ingredient delivery system as described in claim 13, wherein patient data is taken into account when controlling the pump means.

15. An active ingredient delivery system according to any one of claims 12 to 14, wherein the active ingredient means has a recess through which the sensor means protrudes.

16. An active ingredient delivery system according to any one of claims 1 to 15, wherein said electronic means comprises an energy store.

17. An active ingredient delivery system described in any one of claims 1 to 16, wherein the active ingredient is an active ingredient of a pharmaceutical.

18. An active ingredient delivery system described in any one of claims 1 to 17, wherein the electronic means is formed from a plastic film.

Images