DE10015928B4 - Carrier for a medicament and method for checking the integrity of this carrier - Google Patents

Abstract

Carrier (1) for one over the Skin of a recipient on this drug or on the skin of the recipient chemical other active ingredient, with a carrier element that is at least one side carries a drug or active substance (3), wherein the substance (3) before the application of the carrier element (2) to the skin of a drug recipient is covered with a protective layer (4), characterized in that that this support element (2) is provided with at least one conductor track (5) which has a severable section (6) of the protective layer (4).

Description

The Invention relates to a carrier for a drug with a support element, that carries an active substance on at least one side, whereby the active substance before the application of the carrier element to the skin of a receiver is covered with a protective layer.

On such carrier is usually referred to as a plaster. Patches are used in medical-pharmaceutical Area used on the one hand to cover wounds superficially and protect about that in addition, it is already known to use medicinal products on such patches or apply active ingredients that are applied to the skin surface receiver can act what the carrier with its support element on the skin of the drug recipient to stick on. As a rule, the substance is before application of the carrier element on the skin of the recipient covered with a protective layer to protect the substance from application free of external, if necessary negative influences to keep.

Drug- or active substances that come into contact with the skin surface of a Are recipient, only act as a medication on the recipient for a certain time, the effect wears off after a certain application time, so that a plaster support element must be replaced after a certain time.

Drug- or drug recipient can but often no longer sufficiently precise at the time remember which one the carrier have created, there is a permanent in not a few patients Uncertainty about that, whether the duration of application of the active substance patch is still correct or already exceeded is.

The Invention / innovation is based on the task of a carrier for a drug or another active substance with the features of the generic term of claim 1 so that the carrier in particular with regard its time of application with electronic additives can be queried. This task is characterized by the characteristics of claim 1 solved, advantageous further developments or parallel solutions result from the Sub or subclaims.

As It will be the essence of the invention first viewed that support member to be provided with at least one conductor track, which has a severable section of the protective layer. This means that the carrier element It can be electronically queried when the protective layer has been opened for the first time and whether the protective layer was intact before it was applied. To the ends of the conductor track are advantageously electronic Evaluation and display circuit to connect the different conditions can display or save times, so that the user of the wearer in is able to query when he is the drug carrier or put the patch on. It is also possible to use an alarm device Inform users when the exposure time of the substance to the Skin of the drug recipient has expired.

The carrier can be in a housing be inserted, which contains the evaluation and display device. If in claim 3 of housing is spoken, so different types of housing are included. A Kind of this housing can according to claim 4 placed on the skin of the drug recipient and attached be, the housing provided with the evaluation and display device z. B. in the manner of a watch case be trained or integrated into a watch worn on the body his. The electronic device can be designed so that it in Connection with the carrier emits a signal after the predefinable period of time, the desired wearing time can about Input elements entered in the evaluation and display device become.

alternative or additionally is it also possible that the carrier can be cut or individually in a row in a separate storage case is arranged that at least a conductor track or contact arrangement cooperates with mating contacts of the housing and when the carrier is removed out of the housing the interaction of the contacts is either interrupted or the conductor track is severed. So this storage case serves to keep the carrier in front the application on the skin of the recipient of the medicinal product. In this case, the evaluation unit is not worn on the body, but remains stationary in the storage case and reminds the user of the vehicle from there that the Wearing time has expired or a new dose of medicine in patch form is to be applied. additionally is it also possible enter the expiry date in the evaluation and display device. This ensures that it is not out of date Medicines are brought into contact with the skin.

Claim 11 relates to a carrier for a medicament, having a carrier element which can be placed on a skin section of a medicament receiver and which carries a medicinal substance on at least one side. According to the identification, the carrier or a housing accommodating the carrier is provided with a plurality of sensors which are connected via contacts to the evaluation circuit. This claim, separately or in conjunction with the feature according to claim 1, can also solve the task of presenting information to the user of the carrier to convey in what condition the wearer is and / or whether he should be replaced, discontinued or renewed if necessary.

The Sensors according to claim 11 can be different Sensors that are either temperature, moisture, chemical within the carrier conditions or the like or detect such conditions from the skin of the user scan. Details result from claims 12-14.

The Active ingredient according to claim 14 can either be a separate active ingredient that is only additional the carrier is placed to cause a detectable response, it but it is also possible that the active ingredient the drug itself or one contained in the drug substance Active ingredient is. Non-medical active ingredients are also addressed, z. B. chemical or cosmetic active ingredients.

Around the for the evaluation and display device and associated processors to protect the necessary voltage sources, it is useful to use the Sensors or cutting the conductor tracks the evaluation and Display device, d. H. activate processor activity for the first time.

In Further development of the invention, it is also possible in the carrier to integrate further sensors, for example the pulse frequency, Heart rate, blood sugar, blood pressure, and the like, and either display or transmitted to a separate evaluation circuit by radio. This gives you the opportunity a recipient, the plaster according to the invention wearing, regarding his physical reaction to monitor and in case of intolerance to issue warning signals to the active substance, for example in that the pavement is to be removed immediately.

According to claim 23 there are activation elements in the area of the substance via which the Substance delivery to the skin accelerated or delayed can. The possible Activation elements are, for example, heating elements, capacitive Elements, chemical activators, moisturizing elements and the same. Controlling the rate of delivery of the substance can from the outside can be controlled, for example, by a doctor who gives the opportunity has on one with the carrier to access the connected receiving device by radio.

In the housing can also be arranged a transmission device with which information stored in the evaluation circuit to a separate evaluation computer are transferred can. This makes it possible that separately for the purpose of a clinical evaluation, the physical reactions to a Substance can be recorded immediately.

According to claim 27 should the carrier with other same or similar ones carriers be arranged in a common receiving box with each removal of a carrier an electronic start pulse is generated in the recording device, which is a time reminder function regarding the maximum wearing time triggers. This electronic start impulse can be generated by different sensors triggered be, for example by a light barrier or the like.

If the evaluation and ad placement is integrated in the carrier, this can be formed from flexible film material. The carrier element can have a dome-like shape, it is possible to face away from the skin Side of the carrier one Arrange solar cell to support a voltage supply unit or to build. It is also possible the carrier to be made of soft, cushion-like material, which makes it more comfortable to wear is achieved. In the same sense, it is also possible to make the housing like a pillow train in which the carrier is to be integrated.

According to claim 32 should the carrier in the manner of a module carrier be trained and medicinal products different in intended subjects Type or number can be introduced. They are also different Sensors provided, if necessary with electronic Evaluation and display circuits can be connected.

In Further development of the invention, it is also possible to protect the protective film Patch between a battery contact and a contact of the evaluation and display circuit to run, so that at Removing the protective film of the battery contact contacts the mating contact and so the device is turned on.

The Invention is based on exemplary embodiments closer in the drawing figures explained. This demonstrate:

1 A schematic sectional view through a plaster-like carrier with a substance that is covered by a protective layer over which a conductor runs;

2 A top view of the beam according to 1 :

3 A carrier, which is inserted into a storage case with an electronic evaluation and display circuit;

4 A schematic sectional view of a carrier inserted into a housing before being placed on the skin surface;

5 A schematic representation of a housing in which a carrier is inserted;

6 A schematic sectional view through a housing with an inserted carrier;

7 A schematic representation of a carrier with integrated evaluation and display circuit;

8th A schematic representation of a storage case with several inserted carriers;

9 A carrier with different active ingredients, sensors, evaluation elements and transmitting / receiving devices in a schematic representation.

The carrier 1 is intended to take up a drug or other active substance acting on the skin of a recipient. The carrier 1 has a carrier element 2 on which carries a drug or active substance on at least one side, the following as a substance 3 referred to as. The substance 3 is before the application of the carrier element 2 on the skin of the drug recipient with a protective layer 4 covered. The carrier element 2 is with a trace 5 provided that over a severable or openable section 6 the protective layer 4 runs.

The ends 7 the conductor track 5 are with an electronic evaluation and display circuit 8th connected, on the one hand, the integrity of the protective layer 4 can be displayed or at a time of removal of the carrier element 2 from a storage unit 9 can be saved.

The carrier 1 can be in a housing 10 be inserted, the evaluation and display device 8th contains. It can be the case 10 the storage unit 9 act. However, a housing is also conceivable 11 to provide that to the skin 16 of the drug recipient can be placed and fastened there. That with the evaluation and display device 8th provided housing 11 can be designed according to the type of a watch case or integrated into a watch that can be worn on the body, for example a wristwatch.

Through the conductor track 5 an electronic start pulse can be generated by the evaluation and display device 8th is processed and emits a warning signal after a predeterminable time period after the start pulse. This can be the wearer's target wearing time 1 in the evaluation and display device 8th can be entered, for which input elements 12 in the form of buttons, adjustment crowns and the like are provided.

In the 3 and 8th can be seen like the carrier 1 in the form of individual applications in the housing 10 the storage unit 9 is arranged that the at least one conductor track 5 when the carrier or the carrier application is removed from the housing 10 the conductor track is cut or the contacts 13 to be interrupted.

7 shows an integrated form of the carrier 1 at which the carrier 1 even with the evaluation and display device 8th is connected or comprises these inseparably. The evaluation and display unit 8th is over a holding layer 14 with the support element 2 connected. On the top 15 is the layer 14 transparent or translucent, so that an optical display through the layer 14 can shine through.

Below is on 9 Referred. There is a carrier with a carrier element 2 shown on which a plurality of sensors 20 . 21 that has contacts 22 with an evaluation circuit 23 are connected. The sensors 20 . 21 can be temperature or humidity sensors. The sensors 20 . 21 can also on an active ingredient 24 be responsive to the progressive wear time of the wearer 1 is broken down on the skin of the drug recipient. The active substance 24 can either be the medicinal product or an active substance contained in the medicinal substance. But it is also possible to provide a separate active ingredient, in addition to the substance 3 of the drug separately on the carrier element 2 is attached and has no other medical effects on the receiver, but only has the task of reacting with appropriate sensors.

It is intended that the sensors 20 . 21 and / or cutting the conductor track 5 the evaluation and display device 8th and / or the evaluation circuit 23 is activated for the first time.

About the sensors 20 . 21 and the evaluation circuit 23 a signal can be generated when a predetermined wearing or exposure time has been reached, when the medicinal substance or the active substance has been consumed without a medical effect and / or an incompatibility of the medicament or the carrier element is registered on the skin section of the carrier.

The sensors 20 . 21 can also be used for pulse rate, heart rhythm, To measure blood pressure and blood sugar and the like. In principle, all types of sensors that can be applied to a plaster are conceivable, which can interact in some way with the patient, his skin or the active substance.

The outputs of the sensors can be sent to the separate evaluation circuit via separate data transfer contacts 23 are transmitted and via a transmitter 25 ,

Out 9 still shows that in the field of drug substance 3 or in the area of the separate active ingredient 24 activation elements 30 in the form of heating elements, capacitive elements, chemical activators and the like. are arranged, via the evaluation circuit 23 to accelerate or delay the delivery of drug substances to the skin 16 are controllable. The control of the activation elements 30 is carried out via signals via a with the carrier 1 connected transmitting and receiving device 25 can be controlled.

In the evaluation circuit 23 Stored information can via the transceiver 25 to a separate evaluation computer 40 transmitted, which is for example with a doctor or at a research institution that carries out "clinical research".

The carrier can have a dome-like shape and can be designed like a pillow. About a solar cell 50 that in drawing figure 9 is indicated, a battery can be supported.

The carrier can be modular and have subjects that are in the support elements introduced with drugs of different types or numbers can be. The insertion of different sensors after module inserts is also required conceivable.

Concerning the housings, that can be placed on the skin are very different housing forms conceivable about Go out of wristwatches or pillow-like cases. For example, the carrier Arrange with a chest band on the chest of the recipient or the carrier in one integrate stocking-like element so that the drug substance or an active ingredient on the ankle or calf area of the recipient.

1

carrier

2

support element

3

substance

4

protective layer

5

conductor path

6

section

7

end up

8th

evaluation and display device

9

Storage unit

10

casing

11

casing

12

input elements

13

contacts

14

layer

15

top

16

skin of the patient

20

sensor

21

sensor

22

contacts

23

evaluation

24

active substance

25

Transmitter-receiver

30

energizer

31

receiving device

40

evaluation computer

50

solar cell

Claims (35)

Carrier ( 1 ) for a medicament acting on the skin of a recipient or a chemical other active substance acting on the skin of the recipient, with a carrier element which has a drug or active substance on at least one side ( 3 ), whereby the substance ( 3 ) before application of the carrier element ( 2 ) on the skin of a drug recipient with a protective layer ( 4 ) is covered, characterized in that the carrier element ( 2 ) with at least one conductor track ( 5 ) which is provided over a severable section ( 6 ) the protective layer ( 4 ) runs. Carrier according to claim 1, characterized in that the ends ( 7 ) the conductor track ( 5 ) with an electronic evaluation and display circuit ( 8th ) are connected via which the integrity of the protective layer ( 4 ) can be displayed and / or in which a time of removal of the carrier element ( 2 ) from a storage unit ( 9 ) can be saved. Carrier according to claim 1 or 2, characterized in that the carrier ( 1 ) in a housing ( 10 . 11 ) that the evaluation and display device ( 8th ) contains. Carrier according to one of the preceding claims, characterized in that the housing ( 11 ) onto the skin ( 16 ) the recipient of the drug can be placed and fastened there. Carrier according to one of the preceding claims, characterized in that the housing ( 11 ) the carrier ( 1 ) only partially overlaps. Carrier according to one of the preceding claims, characterized in that the with the evaluation and display device ( 8th ) provided housing ( 11 ) is designed like a watch case or is integrated into a watch that can be worn on the body. Carrier according to one of the preceding claims, characterized in that the conductor track ( 5 ) an electronic start pulse can be generated, which is evaluated by the evaluation and display device ( 8th ) can be processed and a warning signal can be generated after a predefinable timeout after the start pulse. Carrier according to one of the preceding claims, characterized in that the desired wearing time of the carrier ( 1 ) in the evaluation and display device ( 8th ) can be entered. Carrier according to one of the preceding claims, characterized in that the carrier ( 1 ) in the form of individual applications in the separate housing ( 10 ) the storage unit ( 9 ) is arranged that at least one conductor track ( 5 ) or a contact arrangement with mating contacts of the housing ( 10 ) interacts and when the carrier is removed ( 1 ) from the housing ( 10 ) the interaction of the contacts is interrupted and / or the conductor track ( 5 ) is severed. Carrier according to one of the preceding claims, characterized in that the carrier ( 1 ) even with the evaluation and display device ( 8th ) is connected or includes them. Carrier according to one of the preceding claims, characterized in that the expiry date assigned to it in the evaluation and display device ( 8th ) can be entered. Carrier ( 1 ) according to claim 1, characterized in that the carrier ( 1 ) and / or a housing accommodating the carrier ( 11 ) a plurality of sensors ( 20 . 21 ) that has contacts ( 22 ) with an evaluation circuit ( 8th ) are connected. Carrier according to claim 12, characterized in that the sensors ( 20 . 21 ) Temperature sensors are or include. Carrier according to one of the preceding claims 12 or 13, characterized in that the sensors ( 20 . 21 ) are designed as moisture sensors or include them. Carrier according to one of the preceding claims, characterized in that the sensors ( 20 . 21 ) with the wearer's wear time ( 1 ) degradable active ingredient ( 24 ) are responsive. Carrier according to one of the preceding claims, characterized in that the active ingredient ( 24 ) a medicinal product, an active substance contained in the medicinal substance or a separate chemical or cosmetic active substance. Carrier according to one of the preceding claims, characterized in that the active ingredient ( 24 ) a separate one, next to the drug on the carrier element ( 2 ) is the intended active ingredient that has no medical effect on the recipient. Carrier according to one of the preceding claims, characterized in that the sensors ( 20 . 21 ) Include skin contact sensors or pressure sensors. Carrier according to claim 18, characterized in that the sensors ( 20 . 21 ) and / or cutting the conductor track ( 5 ) the evaluation and display device ( 8th ) and / or the evaluation circuit ( 23 ) can be activated for the first time. Carrier according to one of the preceding claims, characterized in that the sensors ( 20 . 21 ) and the evaluation circuit ( 23 ) a signal can be generated when a predetermined wearing or exposure time has been reached and / or the drug substance the active ingredient has been used up and / or an intolerance of the drug or the carrier element on the skin ( 16 ) is registered. Carrier according to one of the preceding claims, characterized in that on the top of the housing ( 11 ) manually operated input elements ( 12 ) are arranged. Carrier according to one of the preceding claims, characterized in that further sensors ( 20 . 21 ) are integrated, which are connected to the evaluation circuit via data transfer contacts (interface) 8th ) are transferable or via a carrier ( 1 ) or the housing ( 10 . 11 ) integrated transmitter ( 25 ) to a separate evaluation computer ( 40 ) are transferable. Carrier according to one of the preceding claims, characterized in that in the area of the pharmaceutical substance ( 3 ) and / or the active ingredient ( 24 ) Activation elements ( 30 ) are arranged, which via the evaluation circuit ( 23 ) to accelerate or delay the delivery of substance to the skin ( 16 ) are controllable. Carrier according to one of the preceding claims, characterized in that the control of the activation elements ( 30 ) is carried out via signals which are connected to the carrier ( 1 ) connected receiving device ( 31 ) are controllable by third parties. Carrier according to one of the preceding claims, characterized in that a combined transmitting / receiving device ( 25 ) is arranged. Carrier according to one of the preceding claims, characterized in that in the evaluation circuit ( 23 ) stored information to a separate evaluation computer ( 40 ) are transferable. Carrier according to one of the preceding claims, characterized in that it is combined with further carriers ( 1 ) in a common storage unit ( 9 ) is arranged and each time a carrier element is removed ( 2 ) an electronic start pulse can be generated, which has a temporal reminder function regarding the maximum wearing time of the wearer ( 1 ) triggers. Carrier according to one of the preceding claims, characterized in that the evaluation and display circuit ( 8th ) comprehensive carrier ( 1 ) is formed from a flexible film material. Carrier according to one of the preceding claims, characterized in that the carrier element ( 2 ) has a dome-like shape. carrier according to one of the preceding claims, characterized in that the Carrier and / or the housing are pillow-like. Carrier according to one of the preceding claims, characterized in that the carrier ( 1 ) on his skin ( 16 ) opposite side with a solar cell ( 50 ) is connected or contains one. Carrier according to one of the preceding claims, characterized in that the carrier ( 1 ) is designed in the manner of a module carrier and medicinal products of different types or numbers and / or different sensors are provided in the compartments provided ( 20 . 21 ) can be inserted and with the electronic evaluation and display circuit ( 8th ) are connectable. Carrier according to one of the preceding claims, characterized in that the protective film ( 4 ) between a battery contact and a contact of the evaluation and display circuit ( 8th ) runs and when removing the protective film ( 4 ) the battery contact contacts the counter contact. Procedure for checking the Integrity / originality a drug carrier provided with an active ingredient, in particular Medicinal patch, with the following procedural steps: - Provide at least one protective layer on the plaster that the drug assembly on the pavement / support closes; - Provide an electrical contact arrangement on the pavement that is intact Protective layer is bridged; - Provide an electronic evaluation arrangement with the contact arrangement is electrically connectable; - Carrying out an electrical continuity test the contact arrangement; - Pull it off or opening the protective layer, thereby interrupting the electrical conductor track between contacts. A method according to claim 34, characterized in that at the interruption of electrical continuity generates a start pulse becomes, which can be evaluated by an evaluation and display device is.