IT201800002452U1 - Kit for the administration of medicines. - Google Patents

Description

<KIT FOR THE RELEASE OF MEDICINALS>

DESCRIPTION

Automatically administered drug delivery devices, such as, for example, preloaded drug injectors, inhalers, transdermal delivery devices and the like are often used as a part of a patient's drug regimen. For example, known devices for automatically administered drug delivery can be used as a part of a patient's emergency care regimen. Emergency care regimes may include, for example, the use of an auto injector to automatically administer a medicine, such as epinephrine, in response to an allergic reaction, or to treat other emergency conditions such as, for example, poisoning. Known devices for automatically administered drug delivery may also be used as a part of a chronic patient care regimen. Chronic care regimes may include, for example, the use of a pen injector to automatically administer a medicine according to a prescribed plan. Examples of chronic treatment regimens may include, for example, insulin injections, human growth hormone (HGH) injection, erythropoiesis stimulating agents (ESA), interferons and other chronic therapies, or the like. Additionally, automatically administered drug delivery devices may also be used for preventive / prophylactic therapies. Examples of prevention / prophylaxis therapies include certain vaccines, such as the flu vaccine.

To activate certain known devices for the delivery of medicines, the user can request to perform a series of operations. For example, to activate some well-known auto injectors, the user must remove a protective cap, remove a locking device, place the auto injector in a correct position against the body and then press a button to activate the auto injector. Failure to complete these steps correctly can result in an incomplete injection and / or injection into an unwanted body position.

The likelihood of incorrect use of known devices for delivering medicines may be aggravated by the nature of the user and / or the circumstances in which these devices are used. For example, many users are not trained medical professionals, and may never have been trained in the operation of such devices. Furthermore, in certain situations, the user may not be the patient and, therefore, may not have any experience with the device for delivering medicines. Similarly, since certain known drug delivery devices are configured to be used relatively infrequently in response to an allergic reaction or the like, even those users familiar with the device and / or who have been trained may not be well trained. be prepared for device operation. Finally, such devices often need to be used during an emergency situation, during which even experienced and / or trained users may be subject to confusion, panic and / or the physiological effects of the condition requiring treatment. It is essential that the person in need of treatment can calm down and stop panic by quickly and safely administering the required medicine. It would also be possible that people who become aware of the emergency situation can help the patient. In the best case scenario, older people and children should also be in a position to help the patient.

It has been suggested, in US 9,278, 177 B2, that the likelihood of misuse of known drug delivery devices could be substantially reduced if a drug delivery device were together equipped with an output device providing audiovisual output. , via a loudspeaker and an LCD screen showing step-by-step instructions for using the drug delivery device.

US 9,278,177 B2 suggests that a drug delivery device and an exit device are provided together as a medical system, in the form of a box containing both the drug delivery device and the exit device. However, according to the system suggested by US 9,278,177 B2, the patient must bring the entire box in order to be able to receive audiovisual instructions to use the device for the delivery of medicines.

However, this is disadvantageous since such a box is bulky and carrying it is inconvenient and undesirable. As a result, the patient may not always carry the drug delivery device, so the drug delivery device may be unavailable when needed. In addition, the patient can remove the drug delivery device from the box in order to carry only the drug delivery device and avoid carrying the bulky box. However, in such a case, audiovisual instructions for using the drug delivery device may not be available when needed, which increases the likelihood of misuse of the drug delivery device.

The problems of the prior art are solved by the argument of the patent claims. The problems are solved in particular by a kit comprising a box (1) containing at least one device (4, 4a) for delivering medicines, and a video device (3), in which both the device (4, 4a) for release of medicines which the video device (3) are detachably attached to the box (1).

The video device is a device for playing a video. The term “video”, as used herein, refers to a series of images that are presented sequentially to relay visual instructions for using the drug delivery device. The speed at which images are presented sequentially is not specially limited. The images can be presented sequentially at a speed that makes the observer perceive the visual instructions for using the drug delivery device as a moving image. That is, the speed at which the images are presented can be a speed that determines that the observer perceives the visual instructions for using the drug delivery device as a continuously moving image. Alternatively, the speed can be such that the visual instructions for using the drug delivery device are presented as a slide show. That is, the speed at which the images are presented can be such that the observer perceives the instant in which an image is replaced by the next image in the series. In examples where the series is presented as a slideshow, the presentation of the sequence may be automatic and / or involve user input to perform replacement of an image with the next or previous image in the series.

The kit of the present innovation comprises a box (1). The box (1) is useful for compactly combining the at least one device (4, 4a) for delivering medicines and the video device (3). In principle, any type of box (1) that is large enough to contain at least one device (4, 4a) for the release of medicines and the video device is suitable. The box (1) is preferably made of a robust material in order to prevent damage, from external forces, to at least one device (4, 4a) for the delivery of medicines and / or to the video device (3). Preferred materials are selected from the group consisting of cardboard, plastic and metal.

Preferably, the kit comprises video access means (11), in addition to the video device. The video access means can be used to access a training video comprising visual instructions (video instructions) for using the drug delivery device. As discussed above, the training video may include a moving image, or a slideshow. Preferably, the training video comprises a moving image. The video instructions are preferably step-by-step instructions for using the device (4, 4a) for delivering medicines.

The video device can be to display a different wine to the training video. For example, the video device may be for displaying a video, where the rate at which images are presented is such that the observer perceives the moment when one image is replaced by the next image in the series, and the training video can be viewed at a speed that causes the viewer to perceive the visual instructions for using the drug delivery device as a moving image.

In embodiments including the video access means (11), the box (1) large enough to contain the at least one drug delivery device (4, 4a), the video device (3) and the means ( 11) video access.

In certain embodiments, the video access means comprises a graphical representation containing information about the video instructions for using the device (4, 4a) for delivering drugs. Preferably, the graphical representation represents data describing a reference to a location where the training video can be used. In some embodiments, the reference to a position is a Uniform Resource Identifier. For example, the Uniform Resource Identifier can be a Uniform Resource Locator that refers to a web page (a "web address").

In some embodiments, the graphic representation comprises a barcode. The barcode can be a two-dimensional (2D) barcode. That is, the barcode can be a matrix barcode. Preferably, the barcode is a Quick Response code (QR code). In these embodiments, the barcode represents data describing a reference to a location where the video instructions can be viewed. Preferably, the reference is a URI. Preferably, the URI is a URL for a web page and where the training video can be viewed (that is, the URI is an address for a web page).

The graphic representation is machine readable. In some embodiments, the graphic representation can be read by a mobile device (e.g., a mobile phone). By scanning the graphical representation, the mobile device can obtain information about the video instructions for using the device for delivering medicines.

In certain embodiments, the video access means comprises a data storage device that contains a video comprising video instructions for using the drug delivery device. The data storage device can be any type of data storage device. It may incorporate electronic, magnetic, optical, and / or other types of storage media. For example, in certain embodiments, the data storage device is an optical disc. In some other embodiments, the data storage device is a solid state memory device, such as a memory card. Preferably, the data storage device is a USB drive. In these embodiments, the data storage device contains video data.

In some embodiments, the data storage device (for example, the USB drive) contains only a training video including video instructions for using the drug delivery device.

Alternatively, the data storage device may in addition comprise a player for playing the training video, including video instructions, for using the drug delivery device. The player can be a hardware element or a software program for playing video data. In these embodiments, the data storage device may be encoded with one or more programs which, when executed on one or more computers, cause the training video, including video instructions, to be displayed.

The data storage device (11) may comprise an integrated physical interface for communicating data to a computer.

By providing the means (11) of video access, in addition to the video device (3), the kit can provide a user with even more options on how to observe the video instructions. In this way, the kit can equip a user with even more options, regarding how to observe the video instructions. In this way, the kit can provide improved ease of use to a user. In addition, the video access means can provide a safety device in case of failure, in case the video device malfunctions. This may reduce the risk of misuse of the drug delivery device.

Preferably, the video instructions include audio-visual instructions for using the drug delivery device.

Preferably, the box (1) of the present invention is closable. Therefore, the box (1) is preferably reversibly switchable from an open state to a closed state, and from a closed state to an open state. Preferably, the box (1) comprises a lid (2) configured to close the box (1). Preferably, the lid (2) is movable between an open position, in which access to the at least one device (4, 4a) for delivering medicines and to the video device (3) in the box (1) is possible, and a closed position, in which access to the at least one device (4, 4a) for delivering medicines and to the video device (3) in the box (1) is prevented from the lid (2). Optionally, in the closed position, access to the video access means in the box (1) is also prevented by the cover (2). Preferably, the lid (2) is movable between the open position and the closed position by means of a hinge which connects the lid (2) to the body of the box. Preferably, the lid (2) comprises closing means (2a) for fixing the lid (2) in the closed position by removably joining the lid (2) to the body of the box (1). Preferably, the closing means (2a) are located on the opposite side of the hinge. Preferably, the closing means (2a) are configured for interaction with corresponding closing means on the body of the box (1), so that the closing means (2a), on the lid (2) and the corresponding closing means on the body of the box (1) form a locking mechanism. Preferred closure mechanisms are selected from the group consisting of magnetic locks, zip fasteners and hook and loop fasteners.

The box (1) contains at least one device (4, 4a) for delivering medicines. Preferably, the box (1) contains exactly two devices (4, 4a) for delivering drugs, preferably a first device (4) for delivering drugs and a second device (4a) for delivering drugs. Preferably, the first device (4) for delivering medicines and the second device (4a) for delivering medicines are interchangeable. Preferably, the devices (4, 4a) for delivering medicines of the invention are configured for automatic administration of medicines. Preferred drug delivery devices (4, 4a) are selected from the group consisting of preloaded drug injectors, auto injectors, inhalers and transdermal delivery devices.

Preferably, the device (4, 4a) for delivering medicines comprises at least one active ingredient. Preferred active ingredients are selected from the group consisting of epinephrine, insulin, human growth hormone (HGH), agents for the stimulation of erythropoiesis (ESA), interferons and vaccines, such as the flu vaccine. More preferably, the active ingredient is selected from the group consisting of epinephrine, insulin, human growth hormone (HGH), and agents for the stimulation of erythropoiesis (ESA).

The box (1) also contains a video device (3). The video device (3) is preferably configured to provide visual or audiovisual instructions for using the device (4, 4a) for delivering medicines. Audiovisual instructions are preferred. The instructions are preferably step-by-step instructions for using the device (4, 4a) for drug delivery. Instructions for using the drug delivery device (4, 4a) are helpful in reducing the likelihood of misuse of the drug delivery device (4, 4a).

The kit may include means for initiating playback of the instructions, with the video device, for using the drug delivery device when the box is open. Preferably, the kit comprises means for automatically starting playback of the instructions for using the drug delivery device with the video device when the box is open. For example, the kit may comprise a sensor arranged to detect the opening of the box and a control device configured to control the video device to reproduce the visual or audiovisual instructions in response to a signal from the sensor, indicating that the box has been opened. .

Preferably, the video device (3) is comparatively small. A comparatively small video device (3) can be carried comfortably. Preferably, the dimensions of the video device (3) are comparable to the dimensions of the device (4, 4a) for delivering medicines. This allows the video device (3) and the device (4, 4a) for delivering medicines to be comfortably transported together. Preferably, the length of the video device (3) is at most 200%, more preferably at most 150%, more preferably at most 125%, more preferably at most 110% of the length of the device (4, 4a) for the release of medicines. Preferably, the width of the video device (3) is at most 200%, more preferably at most 150%, more preferably at most 125%, more preferably at most 110% of the width of the device (4, 4a) for the release of medicines. Preferably, the thickness of the video device (3) is at most 200%, more preferably at most 150%, more preferably at most 125%, more preferably at most 110% of the thickness of the device (4, 4a) for the release of medicines. Preferably, the length of the video device (3) is at most 20 cm, more preferably at most 15 cm, more preferably at most 12 cm, more preferably at most 10 cm. Preferably, the width of the video device (3) is at most 10 cm, more preferably at most 8 cm, more preferably at most 6 cm, more preferably at most 5 cm. Preferably, the thickness of the video device (3) is at most 2 cm, more preferably at most 1.5 cm, more preferably at most 1.2 cm, more preferably at most 1, more preferably at most 0.8 cm, plus preferably at most 0.5 cm, more preferably at most 0.2 cm. Preferably, the dimensions of the video device (3) are at most 20 × 10 × 2 cm, more preferably at most 15 × 8 × 1.5 cm, more preferably at most 12 × 6 × 1 cm, more preferably at most 10 × 5 × 0.5 cm. For example, dimensions of at most 20 × 10 × 2 cm mean, according to this description, that the video device (3) has a length of at most 20 cm, a width of at most 10 cm and a thickness of at most 2 cm.

Both the at least one device (4, 4a) for delivering medicines and the video device (3) are removably joined to the box (1). Removing the at least one drug delivery device (4, 4a) and the video device (3) from the box (1) allows the transport of the at least one drug delivery device (4, 4a) and the device video (3) without the need to transport the entire box (1). Since the transport of the at least one device (4, 4a) for delivering medicines and the video device (3) without box (1) is much more convenient compared to the transport of the entire bulky box (1), it is more it can be assumed, compared to the prior art, that the patient actually always carries the drug delivery device (4, 4a), so that the drug delivery device (4, 4a) is available when needed. Furthermore, since the video device can be removed from the bulky box (1), it is more likely, compared to the prior art, that the patient also carries the video device (3), so that the instructions for using the device (4 , 4a) for the release of medicines are available when needed. Therefore, the likelihood of misuse of the device (4, 4a) for drug delivery is decreased compared with the prior art.

In embodiments where the kit comprises video access means (11), the video access means are preferably removably joined to the box (1). This allows the video access media to be transported independently of the box (1), which can be more convenient compared to transporting the entire box (1).

Preferably, the at least one device (4, 4a) for delivering medicines and the video device (3) are joined to the box (1) by means of sealing means. Preferably, the sealing means are part of the box (1). The sealing means (2b) for the video device (3) are preferably located on the inner surface of the cover (2).

Optionally, the video access means (11) are also joined to the box (1) by sealing means. Preferably, the video access means (11) are removably joined to the box (1) independently of the at least one device (4, 4a) for delivering medicines and the video device (3), so that the means of video access can be removed from the box (1) independently of the at least one device (4, 4a) for delivering medicines and the video device (3).

Preferably, the at least one device (4, 4a) for delivering medicines and the video device (3) are joined to the box (1) so that access to the at least one device (4, 4a) for drug delivery and to the video device (3) when the lid (2) is in the closed position. In this way, the at least one device (4, 4a) for delivering medicines and the video device (3) are protected from external forces if the lid (2) is in the closed position.

Preferably, the at least one device (4, 4a) for delivering medicines and the video device (3) are removably joined to the box (1) so that the at least one device (4, 4a) for delivering of medicines and the video device (3) can be removed from the box (1) independently of each other. In this way, the patient can decide whether the at least one device (4, 4a) for the delivery of medicines or the video device (3) or both, the at least one device (4, 4a) for the delivery of drugs should be transported. of medicines and the video device (3). For example, for patients who are highly skilled in automatic drug administration, there is no need to carry the video device (3). On the other hand, it may be advantageous if the video device (3) can be transported separately, since it can then be used for training purposes, without the need to transport the expensive drug delivery device (4, 4a) and potentially sensitive. Furthermore, it can be disadvantageous both for receiving the instructions provided by the video device (3) and for administering the medicine with the use of the device (4, 4a) for delivering medicines if the video device (3) and the device (4, 4a) for the release of medicinal products were inseparably connected to each other.

Preferably, the box (1) comprises a drug delivery device imprint (6). This imprint (6) can be useful for testing the way to apply the device (4, 4a) for the delivery of medicines. Preferably, the impression (6) of the device for the delivery of medicines is constructed in a similar way to the device (4, 4a) for the delivery of medicines. However, the imprint (6) of the device for the delivery of medicines does not contain any medicine, unlike the device (4, 4a) for the delivery of medicines. Therefore, the patient can use the impression (6) of the device for the delivery of medicines according to the instructions provided by the video device (3), in order to put into practice the automatic administration of the medicine.

Preferably, the box (1) also comprises a removable case (5) for the at least one device (4, 4a) for delivering medicines and / or the video device (3). Preferably, the case (5) is a pouch (5). Preferably, the case (5) comprises a first compartment (9) to receive the at least one device (4, 4a) for delivering medicines, and a second compartment (10) to receive the video device (3). This allows the video device (3) and the device (4, 4a) for delivering medicines to be comfortably transported together. In some embodiments, the box (1) further comprises a third compartment for receiving the data storage device (11).

Preferably, the first compartment (9) is closable. Therefore, the first compartment (9) is preferably reversibly switchable from an open state to a closed state and from a closed state to an open state. Preferably, the first compartment (9) comprises a lid configured to close the first compartment (9). Preferably, the lid is movable between an open position, in which it is possible to access the at least one device (4, 4a) for delivering medicines into the first compartment (9), and a closed position, in which access the at least one device (4, 4a) for delivering medicines, in the first compartment, is prevented by the lid. Preferably, the lid is movable between the open position and the closed position by means of a hinge which connects the lid to the housing body (5). Preferably, the case (5) comprises closing means (7) for reversibly fixing the lid in the closed position, so that the first compartment (9) is in the closed state. Preferred closure means (7) are selected from the group consisting of magnetic locks, zip fasteners and tear-off devices. Particularly preferred closure means (7) are zip fasteners.

Preferably, the second compartment (10) is closable. Therefore, the second compartment (10) is preferably reversibly switchable from an open state to a closed state and from a closed state to an open state. Preferably, the enclosure (5) comprises closing means (8) configured for reversibly closing the second compartment (10), therefore for reversibly fixing the second compartment (10) in the closed state. Preferably, the closing means (8) are movable between an open position, in which access to the video device (3) in the second compartment (10) is possible, and a closed position, in which access to the video device ( 3), in the second compartment (10), is prevented by the closing means (8). Preferred closure means (8) are selected from the group consisting of elastic bands, magnetic locks, zip fasteners and hook and loop fasteners. Particularly preferred closure means (8) are elastic bands and magnetic blocks. Even more preferred closure means (8) are elastic bands.

In preferred embodiments, both the first compartment (9) and the second compartment (10) are closable.

The box (1) of the present innovation can comprise both an imprint (6) of a device for the delivery of medicines and a removable case (5) for the at least one device (4, 4a) for the delivery of medicines and / or video device (3).

The present innovation will be further explained with respect to preferred embodiments shown in Figures 1 to 5. It is understood that the present innovation is not limited to the embodiments shown in the Figures. Rather, these embodiments are representative and preferred embodiments which illustrate by way of example the innovative concept of the present innovation.

Figure 1 shows a perspective diagram of a box (1) of the present invention. In figure 1, the box (1) is in a closed state that does not allow direct access to at least one device (4, 4a) for the delivery of medicines and to the video device (3) contained in the box (1). The box (1) must be opened in order to gain access to at least one device (4, 4a) for the delivery of medicines and to the video device (3).

Figure 2 shows a perspective diagram of a box (1) of the present invention. Figure 2 shows, in a schematic illustration, a preferred embodiment according to the present invention. Figure 2 shows the box (1) in an open state. Therefore, the lid (2) is in an open position, so that it is possible to access the devices (4, 4a) for delivering medicines and the video device (3) in the box (1). According to the embodiment shown in Figure 2, the box (1) comprises exactly two devices (4, 4a) for delivering medicines. The video device (3) is joined to the box (1) by means of sealing means (2b). The sealing means (2b) for the video device (3) are located on the inner surface of the cover (2). The lid (2) is movable between the open position and the closed position by means of a hinge that connects the lid (2) to the body of the box. The lid (2) comprises closing means (2a) for fixing the lid (2) in the closed position by removably joining the lid (2) to the body of the box (1). The closing means (2a) are located on the opposite side of the hinge. The box (1) also includes a removable case (5) for the devices (4, 4a) for delivering medicines and for the video device (3). The box (1) also comprises video access means (11), which are joined to the box. In this embodiment, the video access means (11) is a matrix barcode, such as a QR code. When the matrix barcode is scanned using a mobile device, the mobile device is configured to open a web page and at the URL address stored by the matrix barcode. The web page displays a training video that provides video instructions for using the devices (4, 4a) for delivering medicines. In this way, using a mobile device, you can quickly access video instructions for using the device for drug delivery. Figure 3 shows a perspective diagram of a box (1) of the present invention. Figure 3 shows the box (1) in an open state. Figure 3 shows a preferred embodiment according to the present invention. Figure 3 shows an alternative embodiment in comparison with the embodiment shown in Figure 2. The box (1), shown in Figure 3, comprises an imprint (6) of a drug delivery device. In addition, the box (1) includes a USB device (not shown). The USB device stores a training video that provides video instructions for using the drug delivery device.

Figure 4 shows a perspective diagram of a box (1) of the present invention. Figure 4 also shows the box (1) in an open state. Figure 4 shows a preferred embodiment according to the present invention. Figure 4 shows an alternative embodiment in comparison with the embodiments shown in the figures

Claims (19)

CLAIMS 1. Kit comprising a box (1) containing at least one drug delivery device (4, 4a) and a video device (3), in which the at least one drug delivery device (4, 4a) is the video device (3) are joined in a removable way to the box (1). The kit according to claim 1, further comprising video access means in addition to the video device. The kit according to claim 2, wherein the video access means comprises one or both of (a) a graphical representation containing information relating to video instructions, for using the drug delivery device and (b) a device for delivery data storage including video instructions for using the drug delivery device. The kit according to claim 2, wherein the graphical representation comprises a barcode representing data describing a Uniform Resource Identifier (URI) and, preferably, wherein the barcode is a two-dimensional barcode, more preferably where the barcode is a Quick Response code (QR code). Kit according to claim 3, wherein the data storage device comprises an integrated interface for communicating with a personal computer, preferably where the data storage device is a Universal Serial Bus (USB) memory device . Kit according to any preceding claim, wherein the box (1) is closable by a lid (2) which is movable between an open position and a closed position. Kit according to claim 6, wherein the lid (2) comprises closing means (2a) for fixing the lid (2) in the closed position by removably joining the lid (2) to the body of the box (1). Kit according to claim 7, wherein the closing means (2a) are configured for interaction with corresponding closing means on the body of the box (1), so that the closing means (2a) on the lid (2) and the corresponding closing means on the body of the box (1) form a closing mechanism selected from the group consisting of magnetic blocks, zip fasteners and tear-off devices. Kit according to at least one of the preceding claims, wherein the at least one device (4, 4a) for delivering medicines and the video device (3) are removably joined to the box (1), so that, when the lid (2) is in the closed position, it prevents access to the at least one device (4, 4a) for delivering medicines and to the video device (3). Kit according to at least one of the preceding claims, wherein the at least one device (4, 4a) for delivering medicines and the video device (3) are removably joined to the box (1) so that the at least a device (4, 4a) for delivering medicines and the video device (3) can be removed from the box (1) independently of each other. Kit according to at least one of the preceding claims, wherein the box (1) contains a first device (4) for delivering medicines and a second device (4a) for delivering medicines. 12. Kit according to at least one of the preceding claims, in which the at least one device (4, 4a) for delivering drugs is selected from the group consisting of preloaded drug injectors, self-injectors, inhalers and transdermal release devices. 13. Kit according to at least one of the preceding claims, in which the at least one device (4, 4a) for delivering medicines comprises at least one active ingredient. Kit according to at least one of the preceding claims, wherein the active ingredient is selected from the group consisting of epinephrine, insulin, human growth hormone (HGH) and erythropoiesis stimulating agents (ESA). Kit according to at least one of the preceding claims, wherein the dimensions of the video device (3) are at most 20 × 10 × 2 cm, preferably 15 × 8 × 1.5 cm and most preferably 12 × 6 × 1, 2 cm. Kit according to at least one of the preceding claims, wherein the video device (3) is configured to provide visual or audiovisual instructions for using the device (4, 4a) for delivering medicines. Kit according to at least one of the preceding claims, wherein the box (1) further comprises an imprint (6) of a drug delivery device. Kit according to at least one of the preceding claims, wherein the box (1) further comprises a removable case (5) for the at least one drug delivery device (4, 4a) and / or the video device (3) . Kit according to claim 9, wherein the case (5) comprises a first compartment (9) for receiving the at least one device (4, 4a) for delivering medicines and a second compartment (10) for receiving the device video (3). We declare that this translation conforms to the original foreign language text.