SK8416Y1 - Kit for administration of medicaments - Google Patents

Abstract

The kit comprises a box (1) that contains at least one medicament delivery device (4, 4a) and a video device (3). The video device (3) may be configured to provide visual or audio-visual instructions for using the medicament delivery device (4, 4a). Both the at least one medicament delivery device (4, 4a) and the video device (3) are removably attached to the box (1). Removal of the at least one medicament delivery device (4, 4a) and the video device (3) from the box (1) allows carrying the at least one medicament delivery device (4, 4a) and the video device (3) without the need to carry the entire box (1). As carrying the at least one medicament delivery device (4, 4a) and the video device (3) without the box (1) is much more comfortable as compared to carrying the entire bulky box (1) it is more likely as compared to the prior art that the patient will indeed carry the medicament delivery device (4, 4a) at all times so that the medicament delivery device (4, 4a) is available when needed. Moreover, as the video device can be removed from the bulky box (1) it is more likely as compared to the prior art that the patient will also carry the video device (3).

Description

S K 8416

Technical field

Technical solution of the skeleton co-administration of drugs.

BACKGROUND OF THE INVENTION

Drug delivery devices, such as pre-filled pen pens (injectors), inhalers, transdermal delivery devices, and the like are often used as part of a patient's medication regimen. For example, known drug delivery devices may be used as part of an emergency patient care regime. Emergency care regimens may include, for example, the use of an auto-injector (pen) for rapid self-administration of the drug in response to an allergic reaction such as epinephrine, or to treat other emergencies such as poisoning. Known drug delivery devices may also be used as part of a chronic patient care regime. Chronic care regimens may include, for example, the use of a pen to self-administer the medicine as prescribed. Examples of chronic care regimens may include, for example, insulin injection, injection of human growth hormone (HGH), erythropoiesis-stimulating agent (ESA), interferons, and other chronic therapies or the like. Further, drug delivery devices can also be used for preventive and prophylactic therapies. Examples of preventive and prophylactic therapies include certain vaccines such as influenza vaccine.

A number of operations may be required of the user to activate some known drug delivery devices. For example, to activate some known autoinjectors (drug pens), the user must remove the protective cap, remove the locking device, insert the pen in the correct position against the body, and then press the button to activate the pen. Failure to perform these operations correctly may result in incomplete injection and / or injection into the undesirable area of the body.

The likelihood of misuse of known drug delivery devices may consist of the nature of the user and / or the circumstances in which such devices are used. For example, many users are untrained healthcare professionals and may never be trained to operate such devices. In addition, in certain situations, the user may not be a patient and therefore may not have experience with the drug delivery device. Similarly, since some known drug delivery devices are adapted to be used relatively infrequently in response to an allergic reaction or the like, even those familiar with the device. and / or who are trained may not operate the equipment well in practice. Finally, such devices must often be used during an emergency situation, during which experienced and / or trained users may also be subject to confusion, panic and / or the physiological effects of a condition requiring treatment. It is important that the person in need of treatment can be satisfied and not panic by quickly and safely administering the desired medicine. It should also be possible for people who are aware of an emergency situation to be able to help the patient. At best, elderly people and children should be in a state of patient support.

US 9,278,177 B2 suggests that the likelihood of misuse of known drug delivery devices can be substantially reduced if the drug delivery device is equipped with an output device that provides audio-visual output through a loudspeaker and a liquid crystal display (LCD) displaying step-by-step instructions for use. drug delivery device.

US 9,278,177 B2 proposes that a drug delivery device and an outlet device be provided together as a medical system in the form of a box that includes both a drug delivery device and an outlet device. However, according to the system proposed in US 9,278,177 B2, the patient must wear the entire box in order to be able to receive audiovisual instructions for use of the drug delivery device.

But this is disadvantageous because such a box is bulky and its wearing is inconvenient and undesirable. Similarly, a patient does not need to carry the drug delivery device with him and so the drug delivery device may not be available when needed. Further, the patient may remove the drug delivery device from the box and wear only the drug delivery device to avoid carrying a bulky box. However, in such a case, the audiovisual instructions for using the drug delivery device may not be available when needed and thus the likelihood of misuse of the drug delivery device will be increased.

The essence of the technical solution

The subject-matter of the protection claims has solved the problems of the prior art. In particular, problems are solved by a kit comprising a box comprising at least one drug delivery device and a video device, wherein at least one drug delivery device as a video device is removably attached to the box.

N E 8416 Υ1

A video device is a device for playing "video". As used herein, the term "video" refers to a series of images that are presented sequentially to provide visual instructions for use of the drug delivery device. The speed at which images are gradually presented is not particularly limited. The images may be presented sequentially at a rate that causes the viewer to perceive the visual instructions for using the drug delivery device as a film, so the rate at which the images are presented may be the rate that causes the viewer to perceive the visual instructions for using the drug delivery device as a continuous film. Alternatively, the rate may be such that visual instructions for use of the drug delivery device are perceived as demonstrating slides. Thus, the speed at which images are presented may be such that the viewer perceives the moment at which the image is replaced by the next image in a row. In examples where a series such as a slide show is presented, the sequence presentation may be automatic and / or include user input to and replace the image with the next or previous image in the series.

The kit according to the present invention comprises a box. The box is useful for compactly combining at least one drug delivery device and video device. In principle, any type of box that is large enough to contain at least one drug delivery device and video device is suitable. The box is preferably made of a durable material to prevent damage to at least one drug delivery device and / or video device by external forces. Preferred materials are selected from the group consisting of cardboard, plastic and metal.

Preferably, the kit comprises a video accessing means for a video device. The video accessing means may be used to access a training video containing visual instructions (video instructions) for using the drug delivery device. As discussed, the training video may include a movie or slide show. Preferably, the training video comprises a film. The video instructions are preferably step-by-step instructions for using the drug delivery device.

The video device may be for displaying a different video than the training video. For example, the video device may be for displaying a video at which the speed at which the images are presented is such that the viewer perceives the moment at which the image is replaced by the next image in a row and the training video may be displayed at a speed that causes the viewer to perceive visual instructions for use of the drug delivery device as a film.

In embodiments comprising a video accessing means, the box is large enough to contain at least one drug delivery device, video device, and video accessing means.

In some embodiments, the video access means comprises a graphical representation containing information regarding the video instructions for using the drug delivery device. Preferably, the graphical representation is data that describes a reference to the location where the training video can be used. In some embodiments, the reference to the site is a Uniform Resource Identifier (URI). For example, a uniform resource identifier may be a uniform object identifier (URL) that identifies a web page (a "URL").

In some embodiments, the graphical representation comprises a bar code. The barcode can be a two-dimensional (2D) barcode. Thus, the bar code may be a matrix bar code. Preferably, the bar code is a Quick Response (QR) code. In these embodiments, the barcode represents data that describes a reference to a location where video instructions can be viewed. Preferably, the reference is a URI. Preferably, the URI is a web page URL where a training video (i.e., a URI is a web page address) can be viewed.

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

In some embodiments, the video accessing means comprises a data storage device that includes a video containing video instructions for using the drug delivery device. The data storage device may be of any type of data storage device. It may include electronic, magnetic, optical and / or other types of storage media. For example, in some embodiments, the data storage device is an optical disc. In some other embodiments, the data storage device is a semiconductor storage device, such as a memory card. Preferably, the data storage device is a USB memory. In these embodiments, the data storage device comprises video data.

In some embodiments, the data storage device (e.g., USB memory) includes only training video containing video instructions for using the drug delivery device.

Alternatively, the data storage device may further comprise a player for playing a training video containing video instructions for using the drug delivery device. The player may be a hardware or software program for playing video data. In these embodiments, the data storage device may be encoded by one or more programs which, when executed on one or more processors, cause it to display a training video containing video instructions.

The data storage device may include an integrated physical interface for communicating data to the computer.

S K 8416 Υί

By providing a video accessing means in addition to the video device, the kit can provide the user with even more options than to watch the video instructions. In this way, the kit can provide improved user comfort. In addition, the video accessing means may provide failover protection in the event of video equipment malfunctions. This may reduce the risk of improper use of the dispensing device.

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

Preferably, the box according to this technical solution is closable. Therefore, the box is preferably reversibly hinged from the open state to the closed state and from the closed state to the open state. Preferably, the box comprises a lid adapted to close the box. Preferably, the lid is movable between an open position in which access to at least one drug delivery device and the video device in the box is possible and a closed position in which the lid prevents access to the at least one drug delivery device and the video device in the box. Optionally, in the closed position, the lid also prevents access to the video accessing means in the box. Preferably, the lid is movable between an open position and a closed position by means of a hinge that connects the lid to the body of the box. Preferably, the lid comprises closing means for fixing the lid in the closed position by detachably attaching the lid to the box body. Preferably, the closure means is located on the opposite side opposite the hinge. Preferably, the closure means is adapted to interact with a corresponding closure means on the body of the box so that the lid closure means and the corresponding closure means on the box body form a closure mechanism. Preferred closing mechanisms are selected from the group consisting of magnetic locks, zippers and Velcro.

The carton comprises at least one drug delivery device. Preferably, the box comprises exactly two drug delivery devices, preferably a first drug delivery device and a second drug delivery device. Preferably, the first medicament delivery device and the second medicament delivery device are interchangeable. Preferably, the drug delivery devices of the invention are adapted for self-administration of drugs. Preferred drug delivery devices are selected from the group consisting of pre-filled medical injectors (drug pens), auto-injectors, inhalers, and transdermal delivery devices.

Preferably, the drug delivery device comprises at least one active ingredient. Preferred active ingredients are selected from the group consisting of epinephrine, insulin, human growth hormone (HGH), erythropoiesis stimulating agents (ESA), interferons and vaccines such as influenza vaccine. More preferably, the active agent is selected from the group consisting of epinephrine, insulin, human growth hormone (HGH) and erythropoiesis stimulating agents (ESA).

The box also includes a video device. The video device is preferably adapted (configured) to provide visual or audiovisual instructions for use of the drug delivery device. Audiovisual instructions are preferred. The instructions are preferably step-by-step instructions for using the drug delivery device. Instructions for using the drug delivery device are useful to reduce the likelihood of legal use of the drug delivery device.

The kit may include means for initiating playback of instructions for use of the drug delivery device by the video device when the box is open. Preferably, the kit comprises means for automatically initiating playback of instructions for use of the drug delivery device by the video device when the box is open. For example, the kit may include a sensor configured to detect the opening of the box and a control unit adapted to control video devices to play visual or audiovisual instructions in response to a signal from the sensor indicating that the shell has opened.

Preferably, the video device is comparatively small. A comparatively small video device can be carried comfortably. Preferably, the size of the video device is comparable to the size of the drug delivery device. This allows the video device and the drug delivery device to be conveniently worn together. Preferably, the length of the video device is at most 200%, more preferably at most 150%, more preferably at most 125%, more preferably at most 110% of the length of the drug delivery device. Preferably, the width of the video device is at most 200%, more preferably at most 150%, more preferably at most 125%, more preferably at most 110% of the width of the drug delivery device. Preferably, the thickness of the video device is at most 200%, more preferably at most 150%, more preferably at most 125%, more preferably at most 110% of the thickness of the drug delivery device. Preferably, the length of the video device is at most 20 cm, more preferably at most 15 cm, more preferably at most 12 cm, more preferably at most 10%. Preferably the width of the video device 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 is at most 2 cm, more preferably at most 1.5 cm, more preferably at most 1.2 cm at most 0.8 cm, more preferably at most 0.5 cm, more preferably at most 0.2 cm Preferably, the dimensions of the video device are at most 20 x 10 x 2 cm, more preferably at most 15 x 8 x 1.5 cm, more preferably at most 12 x 6 x 1 cm , preferably at most 10 x 5 x 0.5 cm For example, dimensions of at most 20 x 1 x 2 cm mean that the video device has a length of at most 20 cm, a width of at most 10 cm, and a thickness of at most 2 cm

Thus, the at least one drug delivery device such as a video device is removably affixed to a box. Removing the at least one drug delivery device and video device from the box allows for carrying it

S K 8416 ΥΙ less one drug delivery device and video device without the need to carry the entire box. Since carrying at least one drug delivery device and a video device without a box is much more convenient compared to carrying a whole bulky box, it is more likely that the patient will actually carry the drug delivery device at all times so that the drug delivery device is available, when needed. In addition, since the video device can be removed from the bulky box, it is more likely than the prior art that the patient will also wear the video device so that instructions for using the drug delivery device are available when needed. Therefore, the likelihood of misuse of the drug delivery device is lower than that of the prior art.

In embodiments where the kit comprises a video accessing means, the video accessing means is preferably removably attached to the box. This allows the wearing of the video accessing means independently of the box, which may be more convenient than wearing the entire box.

Preferably, the at least one drug delivery device and the video device are secured to the box by a retaining means. Preferably, the retaining means is part of the box. The video device retaining means is preferably located on the inner surface of the lid.

Optionally, the video accessing means is also secured to the box by the holding means. Preferably, the video accessing means is removably attached to the box independently of the at least one drug delivery device and the video device such that the video accessing means can be removed from the box independently of the at least one drug delivery device and the video device.

Preferably, the at least one drug delivery device and the video device are secured to the box in such a way that access to the at least one drug delivery device and the video device is prevented when the lid is in the closed position. In this way, the at least one drug delivery device and the video device are protected from external forces when the lid is in the closed position.

Preferably, the at least one drug delivery device and the video device are removably attached to the box in such a way that the at least one drug delivery device and the video device can be removed from the box independently of each other. In this way, the patient may decide to wear at least one drug delivery device or video device, or so at least one drug delivery device as a video device. For example, there is no need to wear a video device for patients who are very experienced in self-administration. On the other hand, it may be advantageous if the video device can be worn separately since it can then be used for training purposes without the need to wear expensive and potentially sensitive drug delivery device. Further, it may be disadvantageous both to retain instructions provided by the video device as well as to administer the drug using the drug delivery device if the video device and the drug delivery device are inseparably connected to each other.

Preferably, the box further comprises a dummy drug delivery device. Such a dummy may be useful for testing the use of the drug delivery device. Preferably, the dummy drug delivery device is constructed analogously to the drug delivery device. However, the mock-up of the drug delivery device contains no drug in contrast to the drug delivery device. Therefore, the patient may use a dummy drug delivery device according to the instructions provided by the video device to effect self-administration of the drug.

Preferably, the box further comprises a removable housing for the at least one drug delivery device and / or video device. Preferably, the housing is a pouch. Preferably, the housing comprises a first compartment for storing the at least one drug delivery device and a second compartment for storing the video device. This allows the video device and the drug delivery device to be conveniently worn together. In some embodiments, the box further comprises a third compartment for storing the data storage device.

Preferably, the first compartment is closable. Therefore, the first compartment is preferably reversibly pivotable from the open state to the closed state and from the closed state to the open state. Preferably, the first compartment comprises a lid adapted to close the first compartment. Preferably, the lid is movable between an open position in which at least one drug delivery device in the first compartment is accessible and a closed position in which the lid prevents access to the at least one drug delivery device in the first compartment. Preferably, the lid is movable between an open position and a closed position by means of a hinge that attaches the lid to the housing body. Preferably, the housing comprises closing means for reserve fixing of the lid in the closed position such that the first compartment is in the closed state. The preferred closure means is selected from the group consisting of magnetic locks, zippers and Velcro. A particularly preferred closure means is a zipper.

Preferably, the second compartment is closable. Accordingly, the second compartment is preferably reversibly pivotable from the open state to the closed state and from the closed state to the open state. Advantageously, the housing comprises a closing means adapted for reversibly closing the second compartment, i.e. for reversibly fixing the second compartment in the closed state. Preferably, the closure means is movable between an open position in which access to the video device in the second compartment is possible and a closed position in which it prevents access to the video device in the second compartment. The preferred closure means is selected from the group consisting of elastic bands, magnetic locks, zippers and Velcro. separately

With K 8416 Υί the preferred closing means are elastic bands and magnetic locks. Even more preferred closure means are flexible bands.

In preferred embodiments, both the first compartment and the second compartment are closable.

The box of the present invention may also comprise both a dummy drug delivery device as a removable housing for at least one drug delivery device and / or video device.

This technical solution will be further explained with respect to the preferred embodiments shown in Figs.

5. The technical solution is not limited to the embodiments shown in the figures. Rather, these embodiments are preferred and representative embodiments that illustrate the inventive concept of the invention by way of example.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows a perspective diagram of a box according to the present invention. Figure 2 shows a perspective diagram of a box according to the present invention. Figure 3 shows a diagram of a box according to the present invention.

Figure 4 shows a perspective diagram of a box according to the present invention. Figure 5 shows a perspective diagram of a removable housing for at least one drug delivery device and a video device.

EXAMPLES

In Figure 1, the box 1 is in a closed state that does not allow direct access to at least one drug delivery device 4, 4a and to the video device 3 contained in the box 1. The box 1 must be opened to gain access to at least one drug delivery device 4, 4a. and video equipment 3.

Figure 2 shows a suitable embodiment of this technical solution in a schematic illustration. Figure 2 shows the box 1 in the open state. Therefore, the lid 2 is in the open position so that access to the drug delivery devices 4, 4a and the video device 3 in the box 1 is possible. According to the embodiment shown in Figure 2, the box 1 contains exactly two drug delivery devices 4, 4a. The video device 3 is attached to the box 1 by the holding means 2b. The retaining means 2b of the video device 3 is located on the inner surface of the lid 2. The lid 2 is movable between an open position and a closed position by means of a hinge connecting the lid 2 to the box body. The lid 2 comprises a closing means 2a for fixing the lid 2 in the closed position by detachably attaching the lid 2 to the body of the box 1. The closing means 2a is located opposite the hinge. The box 1 further comprises a removable housing 5 for the drug delivery device 4, 4a and the video device 3. The box 1 also comprises a video accessing means 11 which is mounted on the box. In this embodiment, the video accessing means 11 is a matrix bar code such as a QR code. When the matrix barcode is scanned using a mobile device, the mobile device is adapted to open a web page at a URL stored by the matrix barcode. The website displays a training video that provides video instructions for using the drug delivery devices 4, 4a. In this way, video instructions for using the drug delivery device using a mobile device can be accessed quickly.

Figure 3 shows the box 1 in the open state. Figure 3 shows a preferred embodiment of the present invention. Figure 3 shows an alternative embodiment compared to the embodiment shown in Figure 2. The box 1 shown in Figure 3 comprises a dummy 6 of a drug delivery device. In addition, box 1 contains a USB device (not shown). A training video is stored in the VUSB device that provides video instructions for using the drug delivery device.

Figure 4 shows the box 1 in the open state. Figure 4 shows a preferred embodiment of the present invention. Figure 4 shows an alternative embodiment compared to the embodiments shown in Figures 2 and 3. The box 1 shown in Figure 4 does not contain either a dummy 6 of a drug delivery device nor a removable housing 5 for a drug delivery device 4, 4a and a video device 3. In addition, the box 1 contains a USB device (not shown). A training video is stored on the USB device and provides video instructions for using the drug delivery device.

The housing 5 comprises a first compartment 9 for storing the at least one medicament dispensing device 4,4a and a second compartment 10 for storing the video device 3. The housing 5 comprises a closure means 7 for closing the first compartment 9 again. 10th

S K 8416

List of box lid reference numbers

2a a video device closing device

4, 4a a drug delivery device housing a dummy drug delivery device

7 closure means closure means first compartment second compartment video accessing means

Claims (19)

S K 8416 Υί PROTECTION REQUIREMENTS A kit comprising a box (1) comprising at least one drug delivery device (4, 4a) and a video device (3), characterized in that at least one drug delivery device (4, 4a) as a video device (3) is removably attached box (1). Kit according to claim 1, characterized in that it comprises a video accessing means in addition to the video device. The kit of claim 2, wherein the video access means comprises one or both of: (a) a graphical representation containing information regarding the video instructions for using the drug delivery device; and (b) a data storage device containing the video instructions for using the drug. of the feeding device. Kit according to claim 2, characterized in that the graphical representation comprises a bar code representing data describing a uniform resource identifier - URI, preferably the bar code is a two-dimensional bar code, more preferably the bar code is a QR code. Kit according to claim 3, characterized in that the data storage device comprises an integrated interface for communication with a personal computer, preferably the data storage device being a universal serial bus memory device - USB. Kit according to any one of the preceding claims, characterized in that the box (1) is closable by a lid (2) which is adapted to move between an open position and a closed position. Kit according to claim 6, characterized in that the lid (2) comprises closing means (2a) for fixing the lid (2) in the closed position by detachably attaching the lid (2) to the box body (1). Kit according to claim 7, characterized in that the closure means (2a) is adapted to interact with a corresponding closure means on the body of the box (1) such that the closure means (2a) on the lid (2) and the corresponding closure means on the body the boxes (1) form a closing mechanism selected from the group consisting of magnetic locks, zippers and Velcro. Kit according to at least one of the preceding claims, characterized in that the at least one medicament delivery device (4, 4a) and the video device (3) are removably attached to the box (1) in such a way that access to at least one medicament delivery device is prevented. the device (4, 4a) and the video device (3) when the lid (2) is in the closed position. Kit according to at least one of the preceding claims, characterized in that the at least one medicament delivery device (4, 4a) and the video device (3) are removably affixed to the box (1) in such a way that the at least one medicament delivery device (4), 4a) 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, characterized in that the box (1) comprises a first medicament delivery device (4) and a second medicament delivery device (4a). Kit according to at least one of the preceding claims, characterized in that the at least one medicament delivery device (4, 4a) is selected from the group consisting of pre-filled medical injectors, auto-injectors, inhalers and transdermal delivery devices. Kit according to at least one of the preceding claims, characterized in that the at least one medicament delivery device (4, 4a) comprises at least one active substance. Kit according to at least one of the preceding claims, characterized in that the active substance 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, characterized in that the dimensions of the video device (3) are at most 20 x 10 x 2 cm, preferably 15 x 8 x 1.5 cm and more preferably 12 x 6 x 1.2 cm Kit according to at least one of the preceding claims, characterized in that the video device (3) is adapted to provide visual or audiovisual instructions for using the drug delivery device (4, 4a). Kit according to at least one of the preceding claims, characterized in that the box (1) further comprises a dummy drug delivery device (6). Kit according to at least one of the preceding claims, characterized in that the box (1) further comprises a removable housing (5) for at least one medicament delivery device (4, 4a) and / or video device (3). Kit according to claim 18, characterized in that the housing (5) comprises a first compartment (9) for storing at least one drug delivery device (4, 4a) and a second compartment (10) for storing the video device (3).