Administration device

Abstract

To provide equipment for administering drugs to patients. [Solution] The administration device comprises an administration device 300. The administration device 300 includes a housing 302 including a viewing window 304, and a visual identification unit 308 aligned with a portion of the viewing window 304, the visual identification unit 308 whose position relative to the viewing window 304 depends on the volume of the drug in the container 306. The visual identification unit 308 is movable relative to the viewing window 304 between an empty position where the container 306 is empty of drug and a full position where the container 306 is filled with drug. The visual identification unit 308 includes a cantilever deflectable member 330, and as the container 306 is filled with drug, the container 306 expands, deflecting one end 332 of the cantilever deflectable member 330, the position of which is visible through the viewing window 304.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 533,954, entitled "Notification Device for Informing the State of a Medical Device," filed on July 18, 2017, and also claims priority to U.S. Provisional Patent Application No. 62 / 559,051, entitled "Notification Device for Informing the State of a Medical Device," filed on September 15, 2017, and further claims priority to U.S. Provisional Patent Application No. 62 / 626,935, entitled "Administration System, Administration Device, and Notification Device for Informing the State of a Medical Device," filed on February 6, 2018. The entire disclosure of each of these is hereby incorporated by reference into this specification.

[0002] This application generally relates to devices, systems, and methods for the administration of pharmaceutical compositions to patients. More specifically, the present disclosure relates to devices, systems, and methods for the administration of pharmaceutical compositions to patients using an autoinjector, and to a notification device for informing at least one characteristic of the autoinjector, and to a device that enables a patient to view the state of a container, such as visual means for displaying a fill confirmation and / or an administration confirmation.

Background Art

[0003] Wearable medical devices, such as autoinjectors, have the advantage of treating patients at locations far from a medical facility and / or while individually worn under a patient's clothing. Based on a physician's determination, a wearable medical device can be applied to a patient's skin, and the medical device can be configured to automatically administer a single dose of a pharmaceutical composition, for example, after a delay time of 27 hours, within a predetermined period after applying the wearable medical device to the patient's skin. After the device has administered the pharmaceutical composition to the patient, the patient can then remove and discard the device.

[0004] Some wearable medical devices have the ability to inform patients of at least one characteristic of the device. For example, some devices can report to the patient about the status of the device by providing direct visual, audible, or tactile feedback on the device, for example, when the device is administering a pharmaceutical composition to the patient or when the administration process is complete. Existing devices offer discreteness, but one drawback of this is that any visual, audible, or tactile feedback from the device cannot be easily conveyed to the patient because it is obstructed by the patient's clothing or by the placement of the device on a specific part of the patient's body. For example, if the device is placed behind the patient's arm, the notifications emitted by the device may have limited visibility and may require a healthcare professional to monitor the notifications. Furthermore, if the device is worn on the patient's abdomen, it may be obstructed by the patient's clothing and cannot be easily inspected without removing the patient's clothing. [Overview of the project] [Problems that the invention aims to solve]

[0005] Therefore, in this art, there is a need for administering pharmaceutical compositions to patients using an automated injector, and a need for a notification device to inform the user of at least one characteristic of the automated injector.

[0006] This disclosure provides an apparatus for administering a pharmaceutical composition to a patient using an automated injector, and a notification device for informing the user of at least one characteristic of the automated injector. [Means for solving the problem]

[0007] In some embodiments, an administration system for administering a pharmaceutical composition to a patient may include an administration device configured to administer a single dose of the pharmaceutical composition to the patient, and a notification device that communicates with the administration device. The notification device may be configured to convey information regarding the status of at least one characteristic of the administration device. The administration device may be a wearable automatic injector configured to be worn on the patient's skin. The notification device may have at least one indicator. The at least one indicator may be a visual indicator, an audible indicator, a tactile indicator, or a combination thereof. The notification device may be a wristband. At least one characteristic of the administration device may include the administration status by the administration device.

[0008] According to embodiments of the present invention, the administration device is configured to administer a single dose of a drug to a patient. The administration system includes an administration device having a housing including a viewing window, a flexible container disposed within the housing for containing the drug, and a visual identification section aligned with a portion of the viewing window, wherein the position of the visual identification section relative to the viewing window depends on the volume of the drug in the container. The administration device also includes a notification device that communicates information with the administration device, the notification device being configured to convey information regarding the status of at least one characteristic of the administration device.

[0009] In another configuration, the visual identification unit is movable relative to the viewing window between an empty position, indicating the container is empty, and a full position, indicating the container is filled. The visual identification unit may include a connector that can be attached to a portion of the container. The connector can be attached to the sealed edge of the container, and the connector may include an indicator clip.

[0010] The visual identification section can be positioned within the housing, between the container and the deformable material. As the container is filled with the drug, the container expands, moving the visual identification section downwards and thereby compressing the deformable material. As the container dispenses the drug, the container contracts and the deformable material expands, thereby moving the visual identification section upwards. If necessary, the deformable material is made of a foamed material.

[0011] In some configurations, the visual identification section includes a deflectable member. As the container is filled with the drug, the container expands, deflecting one end of the deflectable member downwards. As the container dispenses the drug, it contracts, returning the other end of the deflectable member to its original position. The housing may include a filling indicator display adjacent to the viewing window. The visual identification section can be aligned with a portion of the filling indicator display to identify the amount of drug in the container. The container may be a storage bag, and the visual identification section may be part of the storage bag.

[0012] In some configurations, the viewing window is located within the side wall of the housing. The administration device may be a wearable automatic injector that is movably attached to the patient's skin surface. If necessary, the administration device includes at least one indicator for informing the patient of the status of the administration device. The notification device may be a wristband, or it may passively exchange information with the administration device in one direction, in which case the notification device displays the status of at least one characteristic of the administration device.

[0013] According to another embodiment of the present invention, a drug administration system for administering a pharmaceutical composition to a patient includes a drug administration device configured to administer a single dose of the pharmaceutical composition to the patient, and a notification device that exchanges information with the drug administration device, the notification device being configured to convey information regarding the status of at least one characteristic of the drug administration device. The notification device passively exchanges information with the drug administration device in a one-way manner, and the notification device also displays the status of at least one characteristic of the drug administration device.

[0014] In some configurations, the administration device is a wearable automatic injector configured to be worn on the patient's skin. The notification device may include at least one indicator. The at least one indicator may be a visual indicator, an audible indicator, a tactile indicator, or a combination thereof. Optionally, the notification device is a wristband, and at least one characteristic of the administration device includes the administration status of the administration device. The administration device may include a storage bag configured to contain a drug, and the storage bag may include a visual identification section. Furthermore, the administration device may include a filling indicator display, and the visual identification section of the storage bag is configured to align with a portion of the filling indicator display depending on the volume of drug placed in the storage bag. Optionally, the administration device further includes at least one indicator capable of informing the user of the status of the administration device, in which case the indicator may be an LED.

[0015] These and other geographical configurations and features of the administration system and the method of utilizing the administration system will become more apparent upon consideration of the following description and attached claims with reference to the attached drawings, all of which constitute part of this specification, and in this case, similar reference figures indicate corresponding members in various drawings. However, it should be clearly understood that these drawings are for illustrative and explanatory purposes only. [Brief explanation of the drawing]

[0016] Interpreting the accompanying drawings together with the following description of embodiments of the disclosure will make the other geometric configurations and advantages of this disclosure, and the methods for achieving them, more apparent, and the disclosure itself will be better understood.

[0017] [Figure 1]A perspective view of a wearable automatic injector according to an embodiment of the present invention and a notification device paired with the wearable automatic injector. [Figure 2] Upper perspective view of a wearable automatic injector according to an embodiment of the present invention [Figure 3] Plan view of a wearable automatic injector according to an embodiment of the present invention [Figure 4] Perspective view of a notification device used in a wearable automatic injector according to an embodiment of the present invention. [Figure 5A] Plan view of the display of a notification device used in a wearable automatic injector that shows the initial pre-use state, according to an embodiment of the present invention. [Figure 5B] A plan view of the display of a notification device used in a wearable automatic injector, showing the notification status after a first period has elapsed following initialization, according to an embodiment of the present invention. [Figure 5C] A plan view of the display of a notification device used in a wearable automatic injector, showing the notification status after a second period has elapsed following initialization, according to an embodiment of the present invention. [Figure 5D] A plan view of the display of a notification device used in a wearable automatic injector, showing the notification status after a third period has elapsed following initialization, according to an embodiment of the present invention. [Figure 6A] A perspective view of a user preparing a wearable automatic injector for attachment to a patient's skin, according to an embodiment of the present invention. [Figure 6B] A perspective view of a user preparing a wearable automatic injector for attachment to a patient's skin, according to an embodiment of the present invention. [Figure 6C] Plan view of an embodiment of the present invention when applied to a patient's skin and the device's signal transduction is activated. [Figure 6D] Plan view of a wearable automatic injector in operation according to an embodiment of the present invention. [Figure 7A] Schematic diagram of the lifecycle of a wearable automatic injector and notification device according to an embodiment of the present invention. [Figure 7B]Schematic diagram of the life cycle of a wearable automatic injector and notification device according to an embodiment of the present invention [Figure 8A] Schematic diagram of the workflow of a wearable automatic injector and notification device according to an embodiment of the present invention [Figure 8B] Schematic diagram of the workflow of a wearable automatic injector and notification device according to an embodiment of the present invention [Figure 9] Schematic diagram of the communication link between a wearable automatic injector and a notification device according to an embodiment of the present invention [Figure 10A] Schematic side view of a wearable automatic injector having a fill indicator display before the full / empty state (the dosing needle is shown in the extended position simply for illustration of the device, and it is intended that the device may not include an extended dosing needle during the filling process.) [Figure 10B] Schematic side view of a wearable automatic injector having a fill indicator display in a partially filled / administered state (the dosing needle is shown in the extended position simply for illustration of the device, and it is intended that the device may not include an extended dosing needle during the filling process.) [Figure 10C] Schematic side view of a wearable automatic injector having a fill indicator display in the filled state, (the dosing needle is shown in the extended position simply for illustration of the device, and it is intended that the device may not include an extended dosing needle during the filling process.) [Figure 11] Perspective view of a wearable automatic injector having a fill indicator display and an independent LED indicator according to an embodiment of the present invention [Figure 12] Perspective view of a wearable automatic injector having a fill indicator display and an independent LED indicator according to an embodiment of the present invention [Figure 13]Side view of a wearable automatic injector having a viewing window, according to an embodiment of the present invention, showing the visual identification unit aligned within the viewing window in the fully positioned state. [Figure 14] Side view of a wearable automatic injector having a viewing window in which the visual identification unit aligned within the viewing window is in an empty position, according to an embodiment of the present invention. [Figure 15] Front cross-sectional view of a wearable automatic injector housing equipped with a visual identification connector that can be attached to a part of a drug container, according to an embodiment of the present invention, in a state where the visual identification part is in an empty position and aligned within a viewing window. [Figure 16] A perspective view of a drug container for storage in a wearable automatic injector according to an embodiment of the present invention (the drug container has a visual identification part that can be attached thereto). [Figure 17] Front cross-sectional view of a wearable automatic injector housing equipped with a visual identification connector that can be attached to a part of a drug container, in a state in which the visual identification part is in the full position and aligned within the viewing window, according to an embodiment of the present invention. [Figure 18] Front cross-sectional view of a wearable automatic injector housing equipped with a visual identification section and a deformable material, with the visual identification section in an empty position, according to an embodiment of the present invention. [Figure 19] Front cross-sectional view of a wearable automatic injector housing equipped with a visual identification section and a deformable material, according to an embodiment of the present invention, in a state where the visual identification section is in the full position and the deformable material is in the compressed position. [Figure 20] Front cross-sectional view of a wearable automatic injector housing equipped with a visual identification section including a deflectable member, in a state where the visual identification section is in an empty position, according to an embodiment of the present invention. [Figure 21] Front cross-sectional view of a wearable automatic injector housing equipped with a visual identification section including a deflectable member, according to an embodiment of the present invention, with the visual identification section in the fully positioned position. [Figure 22] Exploded perspective view of a drug container and deflectable member according to an embodiment of the present invention. [Figure 23] A perspective view of the assembly of a drug container and a deflectable member according to an embodiment of the present invention.

[0018] Similar reference numerals indicate corresponding components in some figures. The examples described herein illustrate exemplary embodiments of the disclosure and should not be construed as limiting the scope of the disclosure in any way. [Modes for carrying out the invention]

[0019] Because the present invention can be adapted to various alternative applications, terms indicating space or direction, such as "left," "right," "inside," "outside," "upper," and "lower," should not be considered limiting to the invention.

[0020] All figures used in this specification and in the claims should be understood to be modified in any case by the term “approximately,” which means a range of plus or minus 10 percent of the stated value. The singular forms “a,” “an,” and “the” refer to multiple objects unless otherwise specified in the context.

[0021] Terms such as "first" and "second" are not intended to refer to any particular order or time sequence, but rather to different states, characteristics, or elements. "At least" means "greater than or equal to." "Not greater than" means "less than or equal to."

[0022] [Administration System] Referring to Figure 1, the administration system 10 for administering a pharmaceutical composition, such as some desired drug or therapeutic agent, to a patient may include an administration device 20, such as a wearable automatic injector, configured to administer a single dose of the pharmaceutical composition to the patient, and a notification device 30 that communicates with the administration device 20. The notification device 30 may be configured to convey information regarding the status of at least one characteristic of the administration device 20.

[0023] In some embodiments, the notification device 30 may communicate with the administration device 20 wirelessly and electronically. In other embodiments, the notification device 30 may communicate with the administration device 20 electronically via a wired connection. In some embodiments where the notification device 30 and the administration device 20 are wirelessly connected, the notification device 30 may be configured to communicate with the administration device 20 passively and unidirectionally, in which case the notification device 30 is configured to convey information regarding the state of at least one characteristic of the administration device 20 without controlling any characteristics of the administration device 20. In other embodiments where the notification device 30 and the administration device 20 are wirelessly connected, the notification device 30 may be configured to communicate with the administration device 20 bidirectionally, in which case the notification device 30 communicates information regarding the state of at least one characteristic of the administration device 20 and is configured to control at least one characteristic of the administration device 20, such as an activation function or a reset function.

[0024] The notification device 30 may have at least one indicator. The at least one indicator may be a visual indicator, an audible indicator, a tactile indicator, or a combination thereof. The administration device 20 and / or the notification device 30 may be discardable after a single dose of the pharmaceutical composition has been administered to the patient. In some embodiments, the administration device 20 may be discardable after a single dose of the pharmaceutical composition has been administered to the patient, while the notification device 30 may be reusable for another administration device 20.

[0025] [Administrative device] Referring to Figures 2 and 3, the administration device 20 may, in some embodiments, be a wearable automated injector, such as an insulin or bone marrow stimulant administration device. When in use, the administration device 20, which contains a pharmaceutical composition, such as some desired drug, is attached to the patient's skin and activated to inject the pharmaceutical composition into the patient. The administration device 20 may be pre-filled with the pharmaceutical composition, or the device may be filled with the pharmaceutical composition by the patient or a healthcare professional before use.

[0026] The administration device 20 is configured to administer a single dose of a pharmaceutical composition, such as any desired drug, into the patient's body by subcutaneous injection at a controlled, slow infusion rate. The exemplary duration of administration achieved by the administration device 20 can range from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. The exemplary volume of the pharmaceutical composition administered by the administration device 20 can range from about 0.1 milliliters to about 10 milliliters, but is not limited to this exemplary range. The volume of pharmaceutical composition administered to the patient is adjustable.

[0027] Continuing to refer to Figures 2 and 3, the administration device 20 has a housing 40 equipped with a skin pad 50 that can be fixed to the patient's skin. The skin pad 50 may have an adhesive for adhesively connecting the administration device 20 to the patient's skin. The housing 40 has an injection assembly (not shown) that is movably provided within the housing 40. The injection assembly has a subcutaneous injection needle 60 (Figure 6B) for insertion into the patient. The injection assembly is configured to move the injection needle 60 between a retracted position in which the injection needle 60 does not protrude outside the housing 40 and an extended position in which the injection needle 60 protrudes outside the housing 40 and penetrates the skin pad 50 so that the injection needle 60 can be inserted into the patient's body. The injection needle 60 can be retracted from the extended position to the retracted position after the pharmaceutical composition has been administered to the patient and before the administration device 20 is removed from the patient's body. A window 65 or other indicator may be provided in the housing 40 to visualize the injection needle 60.

[0028] Continuing to refer to Figures 2 and 3, the administration device 20 has an internal drug container, for example, a storage bag 306 (Figure 15) provided within the housing 40 to hold a certain amount of drug or therapeutic agent. The drug or therapeutic agent can be administered from the container via the injection needle 60 by the administration mechanism of the injection assembly.

[0029] The dispensing device 20 of the present disclosure allows a user or patient to observe the state of the internal drug container 306. For example, the dispensing device of the present disclosure has a simple and effective visual means for displaying filling confirmation and / or administration confirmation. Referring to Figures 13 to 23, in an exemplary embodiment, the dispensing device 300 of the present disclosure is configured to administer a single dose of drug to a patient or user. The dispensing device 300 generally includes a housing 302 which includes a viewing window 304, a drug container 306, such as a storage bag, disposed within the housing 302 for containing a drug or therapeutic agent, and a visual identification unit 308 aligned with a portion of the viewing window 304, in which case the position of the visual identification unit 308 relative to the viewing window 304 depends on the volume of drug in the container 306.

[0030] In this way, the user of the administration device can easily observe the state of container 306. For example, a specialist can easily determine whether or not any drug is contained in container 306, how much drug is contained in container 306, whether or not container 306 is empty and needs to be filled with drug, and / or whether or not container 306 is filled with drug and ready for patient use, or whether or not enough drug has already been administered to the patient from container 306.

[0031] Referring to Figures 10A to 10C and Figures 15 to 21, in one embodiment, the container 306 includes at least one expandable portion 290 that is at least partially visible through a viewing window 280 provided in at least a portion of the housing of the dispensing device 20. In some configurations, the entire container 306 may be inflatable. For example, the container 306 may be formed from a flexible material that expands in size as a fluid drug is filled into the container 306. If necessary, the container 306 may have a visual indicator integrally formed therewith. In one embodiment, the container 306 may be formed from a material having a visually distinct color, such as fluorescent green material, so that the position of the container 306 in the viewing window 280 can be easily identified. In this way, when the container 306 is empty, the colored band of the storage bag 290 visible through the viewing window 280 appears to be a straight or nearly straight line located adjacent to the empty indicator line. Furthermore, as container 306 is filled and expands, its width increases, causing the colored band of container 306 visible through the viewing window 280 to appear as a wider band extending to the area adjacent to the full indicator line. In other configurations, the colored band of the storage bag 290 can be positioned in a first location within the viewing window 280 when empty, and in a second location within the viewing window 280 when full.

[0032] In other configurations, the visually identifiable portion may be stamped or coated onto at least a portion of the container 306. The visually identifiable portion may be in the form of lines or other distinct patterns, or alternatively, the entire container 306 may include the visually identifiable portion, for example, the overall color of the container 306.

[0033] In one embodiment, the colored band may be added to the container 306 by pad printing, roll printing, adhesive patch attachment, or other similar processes. In one embodiment, a window may be added to the top cover of the dispensing device 20 to allow visibility of the colored edge of the container 306. In one embodiment, this is done by overprinting or overlabeling a transparent top cover, creating transparent and opaque areas in the top cover, or by forming an opaque cover with a window opening and then incorporating the transparent window portion as a post-processing step. Alternatively, an opaque top cover without a window may be formed, and a window opening may be cut out via a post-processing step, after which the window can be added.

[0034] In one embodiment, the container 306 can be formed from a material having a visually distinct color. For example, a particular color may be more advantageous and can improve the visibility of the state and / or condition of the container 306. Adding lighting to the inside or outside of the system can also be used to improve visibility. The window area may be meshed to help distinguish between the filled and unfilled states of the container 306.

[0035] In one embodiment, the entire container 306 or a substantial portion of the container 306 may be formed of a material having a visually distinct color, such as fluorescent green, so that the position of the container 306 within the viewing window 280 of the storage bag, for example, is easily identifiable. In other configurations, the visual identification portion 308 may be stamped or coated onto at least a portion of the container 306. The visual identification portion 308 may be in the form of lines or other distinct patterns, and alternatively, the entire container 306 may include the visual identification portion 308, for example, the overall color of the container 306. Depending on the specific properties of the drug supplied into the container 306, it may be desirable to provide a light-shielding container 306.

[0036] Referring to Figures 13 and 14, the independent visual identification unit 308 of this disclosure is movable relative to the viewing window 304 of the housing 302 of the dispensing device 300 between an empty position (Figure 14) when the container 306 is empty and a full position (Figure 13) when the container 306 is filled. Referring to Figures 13 and 14, in one embodiment, as the container 306 is filled, the container 306 expands. In one embodiment, the top of the container 306 is constrained by the top of the housing 302, for example as illustrated in Figures 15 and 17, so that the container 306 is forced to expand downward as it is filled. As the container 306 is pushed downward, the independent visual identification unit 308 is also pushed downward by the weight of the container 306, causing the visual identification unit 308 to move from a first position to a second position indicating the amount of drug in the container 306. In this specification, it should be noted that the position of the visual identification section 308 may change both during drug filling and administration. In this configuration, as the contents of the container 306 are administered to the patient, the visual identification section 308 can move upward from the first position to the second position as the weight of the container 306 decreases.

[0037] Referring to Figures 13 and 14, in one embodiment, the viewing window 304 is located on the side wall of the housing 302. In another embodiment, referring to Figure 3, the viewing window 200 may be located on the upper wall of the housing 40 of the administration device 20. In other alternative embodiments, the viewing windows of the present disclosure may be configured in other orientations to allow a user or patient to observe the state of the container. The filling indicator 70 may have an attached mark indicating the volume of the pharmaceutical composition in the container. In some embodiments, the administration device 20 may have a plurality of containers, each containing the same or different pharmaceutical composition.

[0038] Referring to Figures 10A and 11, in another exemplary embodiment, the dispensing device 20 may have a viewing window or filling indicator display 270 including a filling line display that shows the pre-full / empty state, the partially filled / dispensing state, and the filled state. In this way, a professional can easily identify how much drug, if any, has been dispensed into the container 306. In this configuration, a mark on the housing of the dispensing device 20 can be aligned with a visual identification mark on the container to show the amount of drug in the container 306 to the user and / or patient at a glance.

[0039] Referring to Figures 15 to 17, in another exemplary embodiment, the connector 312 includes a visual identification unit 308, and the connector 312 is attachable to a portion of the container 306. In one embodiment, the connector 312 is attachable to the sealing edge of the container 306. The connector 312 may include an indicator clip that can be fixed to a portion of the container 306, for example, along the bonding portion of the container. The connector 312 can be movable relative to the viewing window 304 of the housing 302 of the dispensing device 300 between an empty position (Figure 15) where the container 306 is empty and a full position (Figure 17) where the container 306 is filled. The movement within the viewing window 304 indicates to the user the volume of the contents of the container 306.

[0040] Referring to Figures 15 and 17, in one embodiment, the container 306 expands as it is filled. In one embodiment, the top of the container 306 is constrained by the top of the housing 302, so the container 306 is forced to expand downward as it is filled. As the container 306 is filled, the connector 312 moves downward, and this movement can be seen in the viewing window 304 of the housing 302.

[0041] Referring to Figures 18 and 19, in another exemplary embodiment, a visual identification unit 308 is provided within the housing 302, between the container 306 and the deformable material 320. The deformable material 320 supports the container 306 and acts to indicate a certain initial position, original state, or empty position of the visual identification unit 308, as illustrated in Figure 18.

[0042] In one embodiment, the deformable material is a foamed material, such as a low-density foamed material. As the drug is filled into the container 306, the weight of the container 306 compresses the deformable material 320. A rigid component 322, such as a plastic reinforcement, a visual identification section 308, can be provided in the housing 302 between the container 306 and the deformable material 320, so that the visual identification section 308 is visible through a portion of the viewing window 304, for example, during the filling of the container 306, to enable visualization of the volume of contents in the container 306 through the viewing window 304. The rigid component 322 is movable relative to the viewing window 304 of the housing 302 of the dispensing device 300 between an empty position (Figure 18) when the container 306 is empty and a full position (Figure 19) when the container 306 is filled. As the container 306 is filled, the container 306 expands. In one embodiment, the top of the container 306 is constrained by the top of the housing 302, as illustrated in Figures 18 and 19, for example, so that the container 306 is forced to expand downward as it is filled. As the container 306 is filled, the rigid component 322 moves downward, and this movement can be seen in the viewing window 304 of the housing 302. As the container 306 dispenses the drug, the container 306 contracts, causing the deformable material 320 to expand, thereby moving the rigid component 322 upward. When the rigid component 322 is empty (Figure 18), the deformable material 320 is in its original state, and when the rigid component 322 is full (Figure 19), the deformable material 320 is compressed.

[0043] Referring to Figures 20 to 23, in another exemplary embodiment, the visual identification section 308 includes a deflectable member 330. In one embodiment, the visual identification section 308 is a flexible cantilever, such as a long reinforcing member. In one embodiment, the deflectable member 330 allows for a greater range of movement of the visual identification section 308 relative to the viewing window 304 of the housing 302 of the dosing device 300. Referring to Figures 20 and 21, the deflectable member 330 of this disclosure is movable relative to the viewing window 304 of the housing 302 of the dosing device 300 between an empty position (Figure 20) where the container 306 is empty and a full position (Figure 21) where the container 306 is filled. As the container 306 is filled, the container 306 expands. In one embodiment, the top of the container 306 is constrained by the top of the housing 302, for example, as illustrated in Figures 20 and 21, so that the container 306 is forced to expand downward as it is filled. As container 306 is filled, the deflectable member 330 moves downward, and this movement can be seen in the viewing window 304 of the housing 302. As the drug fills container 306, container 306 expands, deflecting one end of the deflectable member 330, for example, the first end 332, downward. In one embodiment, as container 306 dispenses the drug, container 306 contracts, and one end of the deflectable member 330, for example, the first end 332, returns to its original position. As illustrated in Figures 20 and 21, the first end 332 of the deflectable member 330 may be made visible through the viewing window 304 to show the user the volume of contents in container 306.

[0044] Referring to Figures 22 and 23, the deflectable member 330 can be fixed to the container 306, for example, at one end of the deflectable member 330 via adhesive 334. In other embodiments, a similar fastening mechanism may be used to fix the deflectable member 330 to the container 306.

[0045] In other configurations, it is expected that the visually identifiable portion may be in the form of a visible pattern, as described in this specification. If necessary, a magnifying glass may be provided to cover the visually identifiable portion and / or the visualization window to enhance the visibility of the visually identifiable portion.

[0046] Referring to Figures 2 and 3, the administration device 20 may also have at least one indicator 90. The at least one indicator 90 may be a visual indicator, an audible indicator, a tactile indicator, or a combination thereof. For example, the at least one indicator 90 may be, for example, a speaker such as a piezoelectric buzzer and / or a light such as a light-emitting diode (LED) light. The LED may be a multi-color LED. In some embodiments, multiple LEDs of the same or different colors may be provided. Referring to Figure 12, the LED may be located on the top surface of the administration device 20 so that it is easily visible to the patient. For the benefit of the patient, the LED may be configured to go through several drug administration steps and / or error messages by changing the color of the LED, by changing the speed at which the LED flashes, or through a transition between flashing and continuous LED signals. The LED may be configured to indicate errors related to the device, such as improper attachment to the patient, blockage in the drug release mechanism, or low battery warning. The LED may also be configured to indicate to the patient that administration has ended. If necessary, multiple indicators 90, such as multiple LEDs, may be provided on both sides of the administration device 20 to optimize visibility from multiple directions.

[0047] In other embodiments, at least one indicator 90 is a display screen. At least one indicator 90 can provide information about the status of the administration device 20, for example, but not limited to, whether the administration device 20 is administering a pharmaceutical composition to a patient, whether drug administration is complete, and / or whether the administration device 20 is paired with the notification device 30. Various other information about the status of the administration device 20 may be provided by at least one indicator 90. At least one indicator 90 may be powered by a power source (not shown), such as a battery.

[0048] In other configurations, it is anticipated that LEDs may also be provided in the viewing window 200 in order to provide high visibility for the visual indicators and / or to indicate the status of the administration device 20 itself, as described in this specification.

[0049] The administration device 20 may have one or more user input devices 100, for example, one or more buttons. One or more user input devices 100 can be used to configure the administration device 20, for example, but not limited to, wirelessly connecting the administration device 20 to the notification device 30 and / or operating the administration device 20. In some configurations, the administration device 20 may include one or more input devices 100, for example, one or more buttons that are translucent or at least partially translucent, such that an indicator 90, such as an LED, is visible through the translucent or partially translucent buttons.

[0050] The administration device 20 has a wireless communication circuit 110, which may include, but is not limited to, a Wi-Fi® module, a Bluetooth® module, a Near Field Communication (NFC) module, or other wireless communication circuits shown, for example, in relation to Figure 9. The wireless communication circuit 110 is configured to enable the administration device 20 to exchange information wirelessly with one or more other electronic devices, such as a notification device 30 or other devices. The wireless connection may be any Wi-Fi connection, Bluetooth connection, NFC connection, or other wireless connection. The wireless communication circuit 110 may be configured to automatically pair with one or more other electronic devices within the range of the wireless signal transmitted by the administration device 20.

[0051] In some embodiments, the wireless communication circuit 110 is configured to exchange information in one direction with one or more other electronic devices, such as a notification device 30 or other devices. The one-way exchange of information with one or more electronic devices may include conveying information about at least one characteristic of the administration device 20, for example, but not limited to, the administration status of the administration device 20, the maximum capacity of the administration device 20, whether or not the administration device 20 is paired with one or more other electronic devices, and / or the type of pharmaceutical composition being administered to the patient.

[0052] In other embodiments, the wireless communication circuit 110 is configured to perform bidirectional communication with one or more other electronic devices, such as the notification device 30 or other devices. Bidirectional information exchange with one or more electronic devices may include, but are not limited to, exchanging information about at least one characteristic of the administration device 20, such as, but are not limited to, the administration status of the administration device 20, the maximum capacity of the administration device 20, whether or not the administration device 20 is paired with one or more other electronic devices, and / or the type of drug being administered to the patient, and receiving information from one or more electronic devices. In some embodiments, receiving information from one or more electronic devices may include receiving information about at least one feature of the administration device 20, such as a control signal for controlling the administration status of the administration device 20.

[0053] [Notification device] Referring to Figure 4, one exemplary and non-limiting embodiment of the notification device 30 is illustrated. In the embodiment shown in Figure 4, the notification device 30 is embodied as a wristband having a strap portion 120 and a display portion 130. The strap portion 120 is configured to be attached around the user's wrist W. In other embodiments, the notification device 30 may be a keychain, pendant, patch, ring, necklace, or any other wearable or non-wearable device configured to communicate wirelessly with the administration device 20 to exchange information regarding at least one characteristic of the administration device 20, such as, but not limited to, the administration status of the administration device 20, the filled capacity of the administration device 20, whether or not the administration device 20 is paired with the notification device 30, and / or the type of pharmaceutical composition being administered to the patient.

[0054] Referring to Figures 5A to 5D, the display unit 130 of the notification device 30 has at least one indicator 140. The at least one indicator 140 may be a visual indicator, an audible indicator, a tactile indicator, or a combination thereof. For example, the at least one indicator 140 may be, for example, a speaker such as a piezoelectric buzzer and / or a light such as a light-emitting diode (LED) light. The LED may be a multi-color LED. In some embodiments, multiple LEDs of the same or different colors may be provided. For example, in Figure 5A, the notification device 30 is shown in its initial configuration before use. In Figure 5B, the notification device 30 is activated, and the first LED is visible and illuminated around the first part of the display, indicating the activation of the first period of the administration device 20, for example, the administration of a first predetermined amount of drug. In Figure 5C, the second LED is visible and illuminated around the second part of the display, indicating the activation of the second part of the administration device 20, for example, the administration of a second predetermined amount of drug. In Figure 5D, the third LED is visible and illuminated around the third part of the display, indicating the activation of the third part of the administration device 20, for example, the administration of a third predetermined amount of drug.

[0055] In other embodiments, at least one indicator 140 is a display screen. At least one indicator 140 can provide information regarding the status of the administration device 20 and / or notification device 30, for example, but not limited to, that the administration device 20 is administering a pharmaceutical composition to a patient, that drug dispensing is complete, that the administration device 20 is paired with the notification device 30, and / or the type of pharmaceutical composition being administered to the patient. Various other information regarding the status of the administration device 20 and / or notification device 30 can be provided by at least one indicator 140. At least one indicator 140 may be powered by a power source (not shown), such as a battery.

[0056] The notification device 30 may have one or more user input devices 150, for example, one or more buttons. One or more user input devices 150 can be used to configure the notification device 30, for example, but not limited to, wirelessly connecting the notification device 30 to the administration device 20, and / or to activate the notification device 30.

[0057] The notification device 30 has a wireless communication circuit 160, such as a Wi-Fi module, a Bluetooth module, a near-field communication (NFC) module, or another wireless communication circuit. The wireless communication circuit 160 is configured so that the notification device 30 can exchange information with one or more other electronic devices, such as the administration device 20 or other devices, via a wireless connection. The wireless connection can be any Wi-Fi connection, Bluetooth connection, NFC connection, or other wireless connection. The wireless communication circuit 160 can be configured to automatically pair with one or more other electronic devices within the range of the wireless signal transmitted by the notification device 30.

[0058] In some embodiments, the wireless communication circuit 160 is configured to exchange information unidirectionally with one or more other electronic devices, such as the administration device 20 or other devices. The unidirectional exchange of information with one or more electronic devices may include information about at least one characteristic of the administration device 20, such as, but not limited to, the administration status of the administration device 20, the maximum capacity of the administration device 20, or whether the notification device 30 is paired with the administration device 20. In other embodiments, the wireless communication circuit 160 is configured to perform bidirectional communication with one or more other electronic devices, such as the administration device 20 or other devices. The bidirectional exchange of information with one or more electronic devices may include receiving at least one characteristic of the administration device 20 and transmitting information to the administration device 20. In some embodiments, transmitting information to the administration device 20 may include transmitting a control signal to control at least one feature of the administration device 20, such as the administration status of the administration device 20.

[0059] In one or more embodiments, the notification device 30 may be connected wirelessly to another electronic device (e.g., a telephone, laptop, tablet, etc.) in order to control the notification device 30 and / or to transmit status information relating to the notification device 30 and / or the administration device 20.

[0060] In some embodiments, the notification device 30 may be mechanically and / or electrically connected to the administration device 20 by a wired connection.

[0061] [How to use the administration system] Having described the structure of the administration system 10, we will now explain how to administer a single dose of the pharmaceutical composition to a patient using the administration system 10, with reference to Figures 6A to 9.

[0062] 〔setting〕 The patient or physician removes the administration device 20 from the package 170. In some embodiments, the administration device 20 can be automatically activated in a ready state after being removed from the package. In other embodiments, the administration device 20 can be activated by pressing one or more user input devices 100, 150 after being removed from the package. In some embodiments, the patient or physician can set the desired single dose of the pharmaceutical composition to be administered to the patient.

[0063] The administration device 20 and notification device 30 are initially in the "off" state. The patient or physician activates the administration device 20 and notification device 30 by operating one or more user input devices 100, 150, respectively, for example by pressing one or more buttons for a predetermined time, for example, about 1 second. At least one indicator 90 on the administration device 20 may indicate that the administration device 20 is already switched on. For example, an LED light on the administration device 20 may flash yellow at predetermined intervals, for example, every 1 second, or a speaker may emit an operating sound. Similarly, at least one indicator 140 on the notification device 30 may indicate that the notification device 30 is already switched on. For example, the LED light on the notification device 30 may flash green at predetermined intervals, for example, every 0.5 seconds, and the speaker may emit an operating sound.

[0064] [Pairing] The administration device 20 and the notification device 30 can automatically pair with each other by activating their respective wireless communication circuits 110 and 160 when in operation. The wireless communication circuits 110 and 160 may operate for a predetermined period of time, for example about 75 seconds, during which the notification device 30, which is within range of the administration device 20, will be paired with the administration device 20. In some embodiments, the notification device 30 may use an out-of-band (OOB) method for pairing. When paired, at least one indicator 90 on the administration device 20 and at least one indicator 140 on the notification device 30 can indicate good pairing between the notification device 30 and the administration device 20. For example, the LED on the administration device 20 may be turned off, while the LED light on the notification device 30 may blink green at predetermined intervals, for example every 0.5 seconds. If the notification device 30 and the administration device 20 are not paired within a predetermined period, the notification device 30 and the administration device 20 enter standby mode.

[0065] [Filling and Initialization] The administration device 20 can be initialized by filling it with a pharmaceutical composition. Once the desired single dose of pharmaceutical composition has been filled and the administration device 20 is ready, at least one indicator 90 on the administration device 20 and at least one indicator 140 on the notification device 30 can indicate that the administration device 20 is ready for use. In some embodiments, and specifically referring to Figures 10A to 10C, the container 306 of the pharmaceutical composition may be a storage bag that is at least partially visible through a viewing window 280 provided in at least a portion of the housing of the administration device 20. For example, the container 306 may be formed from a flexible material that expands in size when a fluid drug is filled into the container 306. If necessary, the container 306 may have a visual indicator formed integrally with it. In one embodiment, the container 306 may be formed from a material having a visually distinct color, such as fluorescent green material, so that the position of the container 306 in the viewing window 280 is easily identifiable. In other configurations, the visually identifiable portion may be stamped or coated onto at least a portion of the container 306. The visually identifiable portion may be in the form of lines or other distinct patterns, or alternatively, the entire container 306 may include the visually identifiable portion, for example, the overall color of the container 306. Depending on the specific properties of the drug supplied to the container 306, it may be desirable to provide a light-shielding container 306.

[0066] As specifically illustrated in Figures 10A to 10C, the dispensing device 20 may have a filling indicator display 270, which includes a filling line display that shows the pre-full / empty, partially filled / dispensing, and fully filled state of a container 306 provided within the dispensing device 20. In this configuration, the position of the storage bag 290 within the viewing window 280 can be aligned with at least one indicator on the filling indicator display 270 to indicate the filling state of the device both during drug filling and dispensing. Since the container 306 includes easily identifiable visual identification features such as horizontal lines, the position of a container such as a storage bag can be aligned with an indicator on the filling indicator display 270 to inform the user of the amount of drug provided in the container 306 during the filling or emptying process.

[0067] As illustrated in the first step of Figure 10A, in the pre-filled (or completely empty) state, the visual identification part of the container 306 is aligned with the "empty" indicator on the filling indicator display 270 to inform the user that there is no amount of medication to be found in the container 306. As illustrated in the second step of Figure 10B, in the partially filled (or partially administered) state, the visual identification part of the container 306 is aligned with the intermediate indicator on the filling indicator display 270 to inform the user that a certain amount of medication has been confirmed to be in the container 306. As illustrated in the third step of Figure 10C, in the filled state, the visual identification part of the container 306, for example, the storage bag, is aligned with the "full" indicator on the filling indicator display 270 to inform the user that the device has a total amount of medication for one dose in the container 306. In this specification, if the entire container 306 functions as a visual identification unit, for example, if the container 306 as a whole has contrasting colors, it will also be correctly recognized that the position of the container 306 itself relative to the individual indicators of the filling indicator display 270 will inform the user of the amount of drug in the container 306.

[0068] In some embodiments, it may be desirable to delay the administration of a single dose of the pharmaceutical composition for a predetermined period, for example, about 27 hours. In some embodiments, the filling volume of the pharmaceutical composition and the preset delay may be configurable. At least one indicator 90 on the administration device 20 and at least one indicator 140 on the notification device 30 can indicate the start of the delay period. For example, the LED on the notification device 30 may blink green at 1-second intervals.

[0069] Referring to Figures 6B and 6C, the filled and prepared administration device 20 is applied to the patient's body B by removing the protective cover 180 from the skin pad 50 to expose the injection needle 60 and applying the skin pad 50 to the patient's skin. The patient or physician can then activate the injection assembly to position the injection needle 60. At least one indicator 90 on the administration device 20 and at least one indicator 140 on the notification device 30 can indicate that the injection needle 60 has already been inserted into the patient's body.

[0070] [Administration] Once the administration device 20 is initialized and filled and attached to the patient's body, the administration device 20 will begin administering the pharmaceutical composition at the end of the delay period. Once the administration process has started, at least one indicator 90 on the administration device 20 and at least one indicator 140 on the notification device 30 may indicate that administration is in progress. For example, an LED on the notification device 30 may flash green at 0.5-second intervals. A buzzer on the notification device 30 may indicate the start of the administration process by emitting an administration sound. The administration process may be interrupted when one or more user input devices 100 on the administration device 20 are activated. In some embodiments, the administration process may be interrupted when one or more user input devices 150 on the notification device 30 are activated. The administration process can be restarted by activating one or more user input devices 100 on the administration device 20 and / or one or more user input devices 150 on the notification device 30. At least one indicator 90 on the administration device 20 and at least one indicator 140 on the notification device 30 can indicate that administration is complete. For example, the LED on the notification device 30 may light up green. The administration device 20 and the notification device 30 may automatically stop after administration is complete. Once administration is complete, the administration device 20 can be removed from the patient's body and discarded. The notification device 30 can be reused with another administration device 20, or the notification device may be discarded after a single use.

[0071] In some embodiments, at least one indicator 90 on the administration device 20 and at least one indicator 140 on the notification device 30 can be used to indicate error messages during administration of the pharmaceutical composition. In some embodiments, the LEDs on the administration device 20 and / or the notification device 30 may flash red, and / or the speaker / buzzer on the administration device 20 and / or the notification device 30 may emit a warning sound to instruct the patient to contact a doctor.

[0072] In some embodiments, the notification device 30 can use wireless communication to transmit the status of the notification device 30 and / or the administration device 20 to a remote device, for example, a computer, laptop, or smartphone (relay mode). In other embodiments, the notification device 30 can use wireless communication to transmit the status of the notification device 30 and / or the administration device 20 to the cloud (cell mode).

[0073] While the present invention has been described in detail for illustrative purposes based on what is considered to be the most practical and preferred embodiment at present, it should be understood that such details are for illustrative purposes only, and that the present invention is not limited to the disclosed embodiments, but rather intended to cover modifications and equivalent configurations within the spirit and scope of the appended claims. For example, it should be understood that, wherever possible, one or more of the embodiments of the present invention can be combined with one or more configurations of any other embodiments.

Claims

1. An administration device configured to administer a single dose of medication to a patient, The system comprises an administration device and a notification device configured to exchange information with the administration device and to convey information regarding the state of at least one characteristic of the administration device. The aforementioned administration device is Housing including a viewing window, A flexible container for housing the drug, which is placed inside the housing, A needle that is movable between a retracted position in which the needle does not protrude outside the housing and an extended position in which the needle protrudes outside the housing, wherein the administration device is configured to move the needle between the retracted position and the extended position, and after the administration of a single dose of the drug to the patient is completed, the administration device retracts the needle to the retracted position, A visual identification unit aligned with a portion of the viewing window, wherein the position of the visual identification unit relative to the viewing window depends on the volume of the drug in the container, The visual identification unit is movable relative to the viewing window between an empty position where the container is empty of the drug and a full position where the container is at least partially filled with the drug. An administration device wherein the visual identification section includes a cantilevered deflectable member, and as the container is filled with the drug, the container expands, deflecting one end of the cantilevered deflectable member, the position of which end is visible through the viewing window.

2. The administration device according to claim 1, wherein the visual identification unit has a connector that can be attached to a part of the container.

3. The dispensing device according to claim 2, wherein the connector is attachable to the sealed edge of the container.

4. The administration device according to claim 2, wherein the connector comprises an indicator clip.

5. The dispensing device according to claim 1, wherein as the container dispenses the drug, the container contracts and one end of the cantilevered deflectable member returns to its original position.

6. The dispensing device according to claim 1, wherein the housing comprises a filling indicator display adjacent to the viewing window.

7. The dispensing device according to claim 6, wherein the visual identification unit is aligned with a part of the filling indicator display to identify the amount of drug in the container.

8. The administration device according to claim 1, wherein the viewing window is disposed on the side wall of the housing.

9. The administration device according to claim 1, wherein the administration device is a wearable automatic injector that can be detachably attached to the surface of the patient's skin.

10. The administration device according to claim 9, wherein the administration device includes at least one indicator for informing the patient of the status of the administration device.

11. The administration device according to claim 1, wherein the notification device is a wristband.

12. The administration device according to claim 1, wherein the notification device passively exchanges information with the administration device in one direction, and the notification device displays the status of at least one characteristic of the administration device.

13. The notification device further, The administration device receives information regarding the state of at least one characteristic of the administration device, and Based on the information received, a first display is shown when the administration device is paired with the notification device, a second display is shown when the administration device is administering the drug to the patient, and a third display is shown when the administration of the drug to the patient is completed. The administration device according to claim 1, configured as follows.

14. The administration device according to claim 13, wherein the at least one characteristic of the administration device includes the administration state of the administration device.

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