Drug delivery system, delivery device and notification device for communicating status of medical device

Abstract

The disclosure relates to a drug delivery system, a delivery device, and a notification device for communicating a status of a medical device. A drug delivery system for delivering a pharmaceutical composition to a patient has a delivery device configured to deliver a dose of the pharmaceutical composition to the patient and a notification device in communication with the delivery device. The notification device is configured to communicate information about a state of at least one characteristic of the conveying device. The delivery device is a wearable autoinjector configured to be worn on the skin of a patient. The delivery device of the present disclosure allows a user or patient to view the status of the container. For example, the conveying device of the present disclosure provides a simple and effective visual means to display filling confirmation and conveying confirmation.

Description

[0001] This application is a divisional application of the application filed on July 18, 2018, with application number 201880055666.3 and entitled "Drug Delivery System, Delivery Device and Notification Device for Communicating the Status of a Medical Device".

[0002] Cross-references to related applications

[0003] This application claims priority to U.S. Provisional Application Serial No. 62 / 533,954, filed July 18, 2017, entitled “Notification Device for Communicating Status of a Medical Device”; U.S. Provisional Application Serial No. 62 / 559,051, filed September 15, 2017, entitled “Notification Device for Communicating Status of a Medical Device”; and U.S. Provisional Application Serial No. 62 / 626,935, filed February 6, 2018, entitled “Administration System, Delivery Device, and Notification Device for Communicating Status of a Medical Device”, the entire disclosure of each of these applications is incorporated herein by reference. Technical Field

[0004] This disclosure generally relates to devices, systems, and methods for delivering pharmaceutical compositions to a patient. More particularly, this disclosure relates to devices, systems, and methods for delivering pharmaceutical compositions to a patient using an autoinjector, and to a notification device for communicating at least one characteristic of the autoinjector, and to a device that allows the patient to view the status of the container, such as a visual means of displaying filling confirmation and / or delivery confirmation. Background Technology

[0005] The advantage of wearable medical devices, such as autoinjectors, is that they can deliver treatment to patients in locations remote from clinical facilities and / or separately when worn under the patient's clothing. As determined by a physician, the wearable medical device can be applied to the patient's skin and is configured to automatically deliver a dose of a drug composition within a predetermined time period after application (such as after a 27-hour delay). After the device has delivered the drug composition to the patient, the patient can subsequently remove and discard the device.

[0006] Some wearable medical devices have the ability to communicate at least one feature of the device to the patient. For example, some devices can provide direct visual, auditory, or tactile feedback to the patient to inform them of the device's status, such as when the device is delivering a drug composition to the patient or when the delivery process is complete. While existing devices offer isolation, one drawback is that any visual, auditory, or tactile feedback from the device cannot be easily communicated to the patient because the device is obscured by the patient's clothing or by the specific location on the patient's body. For example, when the device is placed on the back of the patient's arm, the visibility of the notifications emitted by the device is limited, and a caregiver usually needs to observe the notifications. Furthermore, when the device is worn on the patient's abdomen, the device is obscured by the patient's clothing, and the device cannot be easily examined without the patient removing their clothing.

[0007] Therefore, there is a need in the art for the use of an autoinjector to deliver a pharmaceutical composition to a patient, as well as a notification device for communicating at least one characteristic of the autoinjector. Summary of the Invention

[0008] This disclosure provides an apparatus for delivering a drug composition to a patient using an autoinjector and a notification device for communicating at least one characteristic of the autoinjector.

[0009] In some examples, a drug delivery system for delivering a drug composition to a patient may have a delivery device configured to deliver a dose of the drug composition to the patient and a notification device communicating with the delivery device. The notification device may be configured to convey information about the status of at least one characteristic of the delivery device. The delivery device may be a wearable autoinjector 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 auditory indicator, a tactile indicator, or a combination thereof. The notification device may be a wristband. At least one characteristic of the delivery device may include the delivery status of the delivery device.

[0010] According to an embodiment of the present invention, a delivery device is configured to deliver a dose of medication to a patient. The delivery system includes: a delivery apparatus having a housing including a viewing window; a flexible container disposed within the housing and for storing medication therein; and a visual identifier aligned with a portion of the viewing window, wherein the position of the visual identifier relative to the viewing window depends on the volume of medication within the container. The delivery device also includes a notification device in communication with the delivery apparatus, the notification device being configured to convey information regarding the status of at least one characteristic of the delivery apparatus.

[0011] In another configuration, the visual identifier can move relative to the viewing window between an empty position where the container is empty and a full position where the container is full. The visual identifier may include a connector that can be attached to a portion of the container. The connector may be attachable to a sealed edge of the container, and the connector may include an indicator clip.

[0012] A visual identifier can be disposed within the housing between the container and the deformable material. When the container is filled with medication, the container expands and moves the visual identifier downward, thereby compressing the deformable material. When the container delivers medication, the container contracts and the deformable material expands, thereby moving the visual identifier upward. Optionally, the deformable material includes foam.

[0013] In some configurations, the visual recognizer includes a deflectable member. When the container is filled with medication, the container expands and deflects one end of the deflectable member downwards. When the container delivers medication, the container contracts and the deflectable member returns to its original position. The housing may include a fill indicator display adjacent to a viewing window. The visual recognizer may be aligned with a portion of the fill indicator display to identify the amount of medication within the container. The container may be a storage bag, and the visual recognizer may be part of the storage bag.

[0014] In some configurations, the viewing window is located in the side wall of the housing. The delivery device may be a wearable autoinjector capable of being removably attached to the patient's skin surface. Optionally, the delivery device includes at least one indicator for communicating the status of the delivery device to the patient. The notification device may be a wristband and may passively communicate one-way with the delivery device, wherein the notification device displays the status of at least one characteristic of the delivery device.

[0015] According to another embodiment of the present invention, a drug delivery system for delivering a pharmaceutical composition to a patient includes a delivery device configured to deliver a dose of the pharmaceutical composition to the patient, and a notification device communicating with the delivery device, the notification device being configured to convey information regarding the status of at least one characteristic of the delivery device. The notification device engages in passive, one-way communication with the delivery device, and displays the status of at least one characteristic of the delivery device.

[0016] In some configurations, the delivery device is a wearable autoinjector configured to be worn on a patient's skin. The notification device may include at least one indicator. This indicator may be a visual indicator, an auditory indicator, a tactile indicator, or a combination thereof. Optionally, the notification device is a wristband, and at least one feature of the delivery device includes the delivery status of the delivery device. The delivery device may include a storage pouch configured to contain medication, and the storage pouch may include a visual identifier. The delivery device may also include a fill indicator display, and the visual identifier of the storage pouch is configured to align with a portion of the fill indicator display depending on the volume of medication disposed within the storage pouch. Optionally, the delivery device may also include at least one indicator capable of communicating the status of the delivery device to a user, wherein the indicator may be an LED.

[0017] These and other features and characteristics of the drug delivery system, as well as the method of using the system, will become clearer upon consideration of the following description and appended claims, and with reference to the accompanying drawings, which form part of this specification, wherein like reference numerals denote corresponding parts in the various drawings. However, it should be clearly understood that the drawings are for illustrative and descriptive purposes only. Attached Figure Description

[0018] The above and other features and advantages of this disclosure, as well as the ways in which they are implemented, will become clearer and the disclosure itself will be better understood through the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings, wherein:

[0019] Figure 1 This is a perspective view of a wearable autoinjector and a notification device paired with the wearable autoinjector according to an embodiment of the present invention;

[0020] Figure 2 This is a perspective top view of a wearable autoinjector according to an embodiment of the present invention;

[0021] Figure 3 This is a top view of a wearable autoinjector according to an embodiment of the present invention;

[0022] Figure 4 This is a perspective view of a notification device used with a wearable autoinjector according to an embodiment of the present invention;

[0023] Figure 5A This is a top view of the display of a notification device used with a wearable autoinjector according to an embodiment of the present invention, showing the state before initial use;

[0024] Figure 5BThis is a top view of the display of a notification device used with a wearable autoinjector according to an embodiment of the present invention, showing the status indicated after a first time period following activation;

[0025] Figure 5C This is a top view of the display of a notification device used with a wearable autoinjector according to an embodiment of the present invention, showing the status indicated after a second time period following activation;

[0026] Figure 5D This is a top view of the display of a notification device used with a wearable autoinjector according to an embodiment of the present invention, showing the status indicated after a third time period following activation;

[0027] Figure 6A This is a perspective view of a user preparing a wearable autoinjector to attach to a patient's skin according to an embodiment of the present invention;

[0028] Figure 6B This is a perspective view of a user preparing a wearable autoinjector to attach to a patient's skin according to an embodiment of the present invention;

[0029] Figure 6C This is a top view of a wearable autoinjector activated by a skin-concurrent signaling device for a patient, according to an embodiment of the present invention.

[0030] Figure 6D This is a top view of a wearable autoinjector in an activated state according to an embodiment of the present invention;

[0031] Figures 7A-7B This is a schematic diagram illustrating the lifecycle of a wearable autoinjector and notification device according to an embodiment of the present invention;

[0032] Figures 8A-8B This is a schematic diagram of the workflow using a wearable autoinjector and notification device according to an embodiment of the present invention;

[0033] Figure 9 This is a schematic diagram of the communication link between a wearable autoinjector and a notification device according to an embodiment of the present invention;

[0034] Figure 10A This is a schematic side view of a wearable autoinjector with a filling indicator display in an empty / pre-filling state according to an embodiment of the invention. The delivery needle is shown in an extended position to indicate the device only, and it is anticipated that the device may not include the extended delivery needle during the filling process.

[0035] Figure 10BThis is a schematic side view of a wearable autoinjector with a fill indicator display in a partially filled / delivery state according to an embodiment of the present invention. The delivery needle is shown in an extended position for device representation only, and it is anticipated that the device may not include the extended delivery needle during the filling process.

[0036] Figure 10C This is a schematic side view of a wearable autoinjector with a filling indicator display in a filling state according to an embodiment of the present invention. The delivery needle is shown in an extended position for device representation only, and it is anticipated that the device may not include the extended delivery needle during the filling process.

[0037] Figures 11 to 12 This is a perspective view of a wearable autoinjector with a fill indicator display and a separate LED indicator according to an embodiment of the present invention;

[0038] Figure 13 This is a side view of a wearable autoinjector with a viewing window according to an embodiment of the present invention, wherein a visual recognizer aligned within the viewing window is in the full position.

[0039] Figure 14 This is a side view of a wearable autoinjector with a viewing window according to an embodiment of the present invention, wherein a visual recognizer aligned within the viewing window is in an empty position.

[0040] Figure 15 This is a cross-sectional front view of a wearable autoinjector housing with a vision recognizer connector according to an embodiment of the present invention, the vision recognizer connector being attachable to a portion of a drug container, wherein the vision recognizer is in an empty position and aligned within a viewing window;

[0041] Figure 16 This is a perspective view of a drug container for inclusion in a wearable autoinjector according to an embodiment of the present invention, the drug container having a visual identifier that can be attached thereto.

[0042] Figure 17 This is a cross-sectional front view of a wearable autoinjector housing with a vision recognizer connector according to an embodiment of the present invention, the vision recognizer connector being attachable to a portion of a drug container, wherein the vision recognizer is in the filling position and aligned within a viewing window;

[0043] Figure 18 This is a cross-sectional front view of a wearable autoinjector housing having a visual recognizer and deformable material according to an embodiment of the present invention, wherein the visual recognizer is in an empty position;

[0044] Figure 19This is a cross-sectional front view of a wearable autoinjector housing having a visual identifier and a deformable material according to an embodiment of the present invention, wherein the visual identifier is in the filled position and the deformable material is in the compressed position;

[0045] Figure 20 This is a cross-sectional front view of a wearable autoinjector housing having a vision recognizer including a deflectable member according to an embodiment of the present invention, wherein the vision recognizer is in an empty position;

[0046] Figure 21 This is a cross-sectional front view of a wearable autoinjector housing having a vision recognizer including a deflectable member according to an embodiment of the present invention, wherein the vision recognizer is in the filled position;

[0047] Figure 22 This is an exploded perspective view of a drug container and a deflectable component according to an embodiment of the present invention; and

[0048] Figure 23 This is an assembly perspective view of the drug container and deflectable component according to an embodiment of the present invention.

[0049] Throughout the views, corresponding reference numerals indicate the corresponding parts. The examples illustrated herein illustrate exemplary embodiments of this disclosure, and these examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0050] Spatial or directional terms such as “left,” “right,” “inside,” “outside,” “above,” and “below” should not be considered limiting, as the invention may assume various alternative orientations.

[0051] All figures used in the specification and claims should be understood to be modified by the term "about" in all cases. "About" means a range of values ​​plus or minus ten percent. As used in the specification and claims, the singular forms "a" and "the" include plural indicators unless the context clearly indicates otherwise.

[0052] The terms "first," "second," etc., are not intended to indicate any specific order or chronological sequence, but rather to indicate different conditions, characteristics, or elements. "At least" means "greater than or equal to." "Not greater than" means "less than or equal to."

[0053] Drug delivery system

[0054] refer to Figure 1A drug delivery system 10 for delivering a pharmaceutical composition (e.g., any desired drug or therapeutic agent) to a patient may have a delivery device 20, such as a wearable autoinjector, configured to deliver a dose of the pharmaceutical composition to the patient, and a notification device 30 communicating with the delivery device 20. The notification device 30 may be configured to convey information about the status of at least one characteristic of the delivery device 20.

[0055] In some examples, the notification device 30 can communicate wirelessly with the conveying device 20. In other examples, the notification device 30 can communicate wired electronically with the conveying device 20. In some examples where the notification device 30 and the conveying device 20 are wirelessly connected, the notification device 30 can be configured to communicate passively and unidirectionally with the conveying device 20, wherein the notification device 30 is configured to convey information about the status of at least one characteristic of the conveying device 20 without controlling any aspect of the conveying device 20. In other examples where the notification device 30 and the conveying device 20 are wirelessly connected, the notification device 30 can be configured to communicate bidirectionally with the conveying device 20, wherein the notification device 30 is configured to convey information about the status of at least one characteristic of the conveying device 20 and control at least one aspect of the conveying device 20, such as activation, reset functions, etc.

[0056] The notification device 30 may have at least one indicator. This indicator may be a visual indicator, an auditory indicator, a tactile indicator, or a combination thereof. After a dose of the drug composition has been delivered to the patient, the delivery device 20 and / or the notification device 30 may be discarded. In some examples, after a dose of the drug composition has been delivered to the patient, the delivery device 20 may be discarded, while the notification device 30 may be reused together with another delivery device 20.

[0057] Conveying equipment

[0058] refer to Figure 2-3 In some examples, delivery device 20 may be a wearable autoinjector, such as an insulin or bone marrow stimulant delivery device. In use, delivery device 20, containing a drug composition (e.g., any desired drug), is attached to the patient's skin and triggered to inject the drug composition into the patient. Delivery device 20 may be pre-filled with the drug composition, or it may be filled with the drug composition by the patient or a healthcare professional prior to use.

[0059] Delivery device 20 is configured to deliver a dose of a pharmaceutical composition (e.g., any desired drug) to a patient via subcutaneous injection at a slow, controlled injection rate. Exemplary duration of delivery achieved by delivery device 20 may range from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. Exemplary volume of the pharmaceutical composition delivered by delivery device 20 may range from about 0.1 ml to about 10 ml, but is not limited to this exemplary range. The volume of the pharmaceutical composition delivered to the patient can be adjusted.

[0060] Continue to refer to Figure 2-3 The delivery device 20 has a housing 40, which includes a skin pad 50 that can be secured to a patient's skin. The skin pad 50 may have an adhesive for adhesively attaching the delivery device 20 to the patient's skin. The housing 40 has an injection assembly (not shown) movably disposed within the housing 40. The injection assembly has a hypodermal injection needle 60 for insertion into the patient's body. Figure 6B (As shown in the diagram). The injection assembly is configured to move the injection needle 60 between a retracted position and an extended position, in which the injection needle 60 does not protrude outside the housing 40, and in the extended position, the injection needle 60 protrudes outside the housing 40 and passes through the skin pad 50, allowing the injection needle 60 to be inserted into the patient. After the drug composition has been delivered to the patient and before the delivery device 20 has been removed from the patient, the injection needle 60 can be retracted from the extended position to the retracted position. A window 65 or other indicators may be provided on the housing 40 for visualization of the injection needle 60.

[0061] Continue to refer to Figure 2-3 The delivery device 20 has an internal drug container, such as a storage bag 306 disposed in the housing 40 for holding a volume of drug or therapeutic agent. Figure 15 (As shown in the diagram). The drug or therapeutic agent can be delivered from the container through the injection needle 60 via the delivery mechanism of the injection component.

[0062] The delivery device 20 of this disclosure allows a user or patient to view the status of the internal drug container 306. For example, the delivery device of this disclosure provides a simple and effective visual means of displaying filling confirmation and / or delivery confirmation. Reference Figures 13 to 23 In an exemplary embodiment, the delivery device 300 of this disclosure is configured to deliver a dose of medication to a patient or user. The delivery device 300 typically includes: a housing 302 including a viewing window 304; a medication container 306, such as a storage bag, disposed within the housing 302 and used to store medication or therapeutic agents therein; and a visual identifier 308 aligned with a portion of the viewing window 304, wherein the position of the visual identifier 308 relative to the viewing window 304 depends on the volume of medication within the container 306.

[0063] In this way, users of the delivery equipment can easily check the status of container 306. For example, technicians can easily determine whether any medication is stored in container 306, how much medication is stored in container 306, whether container 306 is empty and needs to be filled with medication, and / or whether container 306 is full of medication and ready for patient use, or whether the medication has been completely delivered from container 306 to the patient.

[0064] refer to Figures 10A-10C and Figure 15-21 In one embodiment, container 306 includes at least one expandable portion 290, which is at least partially visible through a viewing window 280 disposed in at least a portion of the housing of delivery device 20. In some configurations, the entire container 306 may be expandable. For example, container 306 may be made of a flexible material that expands in size when a fluid drug is filled into container 306. Optionally, container 306 may have a visual indicator integrally formed therewith. In one embodiment, container 306 may be made of a material with a visually distinct color, such as fluorescent green, making it easy to identify the location of container 306 within viewing window 280. In this way, when container 306 is empty, the band of color of storage bag 290 shown through viewing window 280 appears to be a straight line or near a straight line located near the empty indicator line. Similarly, when container 306 is filled and expands, the width of container 306 increases, so that the band of color of container 306 shown through viewing window 280 appears to be a wide band expanding to a point near the full indicator line. In other configurations, the ribbon of the storage bag 290 can be set in a first position within the viewing window 280 when empty, and in a second position within the viewing window 280 when full.

[0065] In other configurations, the visual identifier may be embossed or applied to at least a portion of container 306. The visual identifier may be in the form of lines or other different patterns; alternatively, the entire container 306 may include the visual identifier, such as the overall color of container 306.

[0066] In one embodiment, a ribbon can be added to container 306 by pad printing, roller printing, adhesive application, or other similar processes. In one embodiment, a window can be added to the top cover of conveyor 20 to allow the colored edge of container 306 to be visible. In one embodiment, this is accomplished by: overprinting or labeling a transparent top cover to conceal some areas of the top cover and allow the window to be seen through in other areas of the cover; molding multiple times to create transparent and opaque areas on the top cover; molding an opaque cover with a hole where the window is needed; and adding the transparent window portion as a post-processing step. It is also conceivable to create an opaque top cover without a window, cut a hole where the window is needed via a post-processing step, and then add the window in that location.

[0067] In one embodiment, container 306 may be made of a material with a visually distinct color. For example, a particular color may be more advantageous and increase the visibility of the state and / or condition of container 306. Similarly, lighting may be added internally or externally to improve visibility. The window area may be mesh-like to help distinguish between the filled and unfilled states of container 306.

[0068] In one embodiment, the entire container 306, or a significant portion thereof, may be made of a material with a visually distinct color, such as fluorescent green, to facilitate easy identification of the location of the contents of the viewing window 280, such as a storage pouch. In other configurations, a visual identifier 308 may be embossed or coated onto at least a portion of the container 306. The visual identifier 308 may be in the form of lines or other different patterns; alternatively, the entire container 306 may include the visual identifier 308, such as the overall color of the container 306. Depending on the specific nature of the medication to be delivered into the container 306, it may be desirable to provide an opaque container 306.

[0069] refer to Figure 13 and Figure 14 The separate visual identifier 308 of this disclosure can be positioned relative to the viewing window 304 of the housing 302 of the conveying device 300 in an empty location where the container 306 is empty. Figure 14 ) and the full position of container 306 ( ) Figure 13 Move between ( ). Reference Figure 13 and Figure 14 In one embodiment, container 306 expands when it is filled. In one embodiment, the top of container 306 is constrained by the top of housing 302, for example, as... Figure 15 and 17As shown, when container 306 is filled, it is forced to expand downwards. When container 306 is compressed in the downward direction, the individual visual identifier 308 can also be compressed in the downward direction due to the weight of container 306, causing the visual identifier 308 to shift from a first position to a second position, thereby indicating the amount of medication within container 306. It should be noted here that the positioning of the visual identifier 308 can be switched both during filling and during medication delivery. In this configuration, as the weight of container 306 is reduced as the contents of container 306 are delivered to the patient, the visual identifier 308 can shift from a first position to a second position in an upward direction.

[0070] refer to Figure 13 and Figure 14 In one embodiment, the viewing window 304 is located in the sidewall of the housing 302. (See reference...) Figure 3 In other embodiments, the viewing window 200 may be located in the top wall of the housing 40 of the delivery device 20. In other alternative embodiments, the viewing window of this disclosure may be configured to other orientations to allow a user or patient to view the status of the container. The fill indicator 70 may have accompanying markings indicating the volume of the pharmaceutical composition in the container. In some examples, the delivery device 20 may have multiple containers, each containing the same or different pharmaceutical compositions.

[0071] refer to Figure 10A-11 In another exemplary embodiment, the delivery device 20 may have a viewing window or fill indicator display 270, which includes a fill line display indicating pre-fill / empty status, partially filled / delivered status, and full status. In this way, a technician can easily identify how much medication (if any) has been delivered into the container 306. In this configuration, markings on the housing of the delivery device 20 can be aligned with a visual identifier on the container to indicate the amount of medication in the container 306 to the user and / or patient at a given time.

[0072] refer to Figure 15-17 In another exemplary embodiment, connector 312 includes a vision identifier 308, wherein connector 312 is attachable to a portion of container 306. In one embodiment, connector 312 is attachable to a sealed edge of container 306. Connector 312 may include an indicator clip, which may be secured to a portion of container 306, such as along a container seam. Connector 312 may be positioned relative to an empty location relative to a viewing window 304 of housing 302 of delivery device 300 where container 306 is empty. Figure 15 ) and the full position of container 306 ( ) Figure 17 Move between () . View movement within window 304 to indicate the amount of contents in container 306 to the user.

[0073] Refer again Figure 15 and Figure 17 In one embodiment, the container 306 expands when it is filled. In one embodiment, the container 306 is forced to expand downwards when it is filled because the top of the container 306 is constrained by the top of the housing 302. When the container 306 is filled, the connector 312 moves downwards, and its movement is visible in the viewing window 304 of the housing 302.

[0074] refer to Figure 18-19 In another exemplary embodiment, the visual recognizer 308 is disposed within the housing 302 between the container 306 and the deformable material 320. The deformable material 320 serves to support the container 306 and provide the visual recognizer 308 with a consistent initial position, pristine state, or empty position, such as... Figure 18 As shown.

[0075] In one embodiment, the deformable material is foam, such as low-density foam. When container 306 is filled with medication, the weight of container 306 compresses the deformable material 320. A visual identifier 308, in the form of a rigid member 322 (such as a plastic reinforcement), may be arranged within housing 302 between container 306 and deformable material 320, such that the visual identifier 308 is visible through a portion of viewing window 304, such as during filling of container 306, to allow visualization of the volume of contents within container 306 through viewing window 304. The rigid member 322 may be positioned relative to an empty location of viewing window 304 of housing 302 of delivery device 300 where container 306 is empty. Figure 18 ) and the full position of container 306 ( ) Figure 19 It moves between [the two containers]. When container 306 is filled, container 306 expands. In one embodiment, because the top of container 306 is constrained by the top of housing 302, for example, as... Figure 18 and Figure 19 As shown, when container 306 is filled, it is forced to expand downwards. When container 306 is filled, rigid member 322 moves downwards, and its movement is visible in viewing window 304 of housing 302. When container 306 delivers medication, container 306 contracts and deformable material 320 expands, causing rigid member 322 to move upwards. When rigid member 322 is in an empty position ( Figure 18 In the case of ), the deformable material 320 is in its original state, and the rigid component 322 is in its full position ( Figure 19 In the case of ), the deformable material 320 is compressed.

[0076] refer to Figure 20-23In another exemplary embodiment, the vision recognizer 308 includes a deflectable member 330. In one embodiment, the vision recognizer 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 vision recognizer 308 relative to the viewing window 304 of the housing 302 of the conveying device 300. (Reference) Figure 20 and Figure 21 The deflectable member 330 of this disclosure can be positioned relative to the viewing window 304 of the housing 302 of the conveying device 300 in an empty position where the container 306 is empty. Figure 20 ) and the full position of container 306 ( ) Figure 21 It moves between [the two containers]. When container 306 is filled, container 306 expands. In one embodiment, because the top of container 306 is constrained by the top of housing 302, for example, as... Figure 20 and Figure 21 As shown, when container 306 is filled, it is forced to expand downwards. When container 306 is filled, the deflectable member 330 moves downwards, and its movement is visible in the viewing window 304 of housing 302. When container 306 is filled with medication, container 306 expands and deflects one end of the deflectable member 330 (e.g., the first end 332) downwards. In one embodiment, when container 306 delivers medication, container 306 contracts, and one end of the deflectable member 330 (e.g., the first end 332) returns to its original position. Figure 20-21 As shown, the first end 332 of the deflectable member 330 can be seen through the viewing window 304 to indicate to the user the volume of the contents within the container 306.

[0077] refer to Figure 22 and Figure 23 In one embodiment, the deflectable member 330 may be secured to the container 306 via an adhesive 334, such as at one end of the deflectable member 330. In other embodiments, similar fastening mechanisms may be used to secure the deflectable member 330 to the container 306.

[0078] In other configurations, the visual recognizer is expected to be in the form of a viewable pattern. Optionally, a magnifying glass may be placed above the visual recognizer and / or the visualization window to provide enhanced visibility of the visual recognizer.

[0079] refer to Figure 2-3The conveying device 20 may also have at least one indicator 90. The at least one indicator 90 may be a visual indicator, an auditory indicator, a tactile indicator, or a combination thereof. For example, the at least one indicator 90 may be a speaker, such as, but not limited to, a piezoelectric buzzer, and / or a lamp, such as a light-emitting diode (LED) lamp. The LED may be a multi-color LED. In some examples, multiple LEDs of the same or different colors may be provided. (Reference) Figure 12 LEDs can be positioned on the top surface of the delivery device 20 for easy viewing by the patient. LEDs can be configured to demonstrate (walk through) certain medication delivery steps and / or error messages to the patient by changing the LED's color, the speed of its flashing, or by transitions between flashing and constant LED signals. LEDs can be configured to indicate device errors, such as improper attachment to the patient, blockages in the medication dispensing mechanism, low battery warnings, etc. LEDs can also be configured to indicate dosing end to the patient. Optionally, multiple indicators 90, such as multiple LEDs, can be provided on opposite sides of the delivery device 20 to optimize viewing from multiple directions.

[0080] In other examples, at least one indicator 90 is a display screen. At least one indicator 90 can provide information about the status of the delivery device 20, such as, but not limited to, when the delivery device 20 delivers the drug composition to the patient, when the delivery of the drug is complete, and / or whether the delivery device 20 is paired with the notification device 30. At least one indicator 90 can provide various other information about the status of the delivery device 20. At least one indicator 90 can be powered by a power source (not shown), such as a battery.

[0081] In other configurations, it is anticipated that LEDs may also be set in the viewing window 200 to enhance the visibility of the visual indicators and / or provide information on the status of the conveying device 20 itself.

[0082] The delivery device 20 may have one or more user input devices 100, such as one or more buttons. The one or more user input devices 100 may be used to configure the delivery device 20, such as, but not limited to, wirelessly connecting the delivery device 20 to the notification device 30 and / or activating the delivery device 20. In some configurations, the delivery device 20 may include one or more input devices 100, such as one or more translucent or at least partially translucent buttons, such that an indicator 90 (such as an LED) can be seen through the translucent or partially translucent buttons.

[0083] The conveying device 20 has a wireless communication circuit system 110, such as, but not limited to, a Wi-Fi module and Bluetooth. TM Modules, Near Field Communication (NFC) modules or other wireless communication circuit systems, such as reference Figure 9 The wireless communication circuitry system 110 is configured to allow the delivery device 20 to communicate with one or more other electronic devices (such as a notification device 30 or other devices) via a wireless connection. The wireless connection can be any Wi-Fi connection, Bluetooth, etc. TM Connection, NFC connection, or other wireless connection. The wireless communication circuitry system 110 can be configured to automatically pair with one or more other electronic devices within range of the wireless signals transmitted by the delivery device 20.

[0084] In some examples, the wireless communication circuitry 110 is configured to provide one-way communication with one or more other electronic devices, such as notification device 30 or other devices. One-way communication with one or more electronic devices may include conveying information about at least one characteristic of the delivery device 20, such as, but not limited to, the delivery status of the delivery device 20, the fill level of the delivery device 20, whether the delivery device 20 is paired with one or more other electronic devices, and / or the type of pharmaceutical composition delivered to the patient.

[0085] In other examples, the wireless communication circuitry 110 is configured to provide bidirectional communication with one or more other electronic devices (e.g., notification device 30 or other devices). This bidirectional communication with the one or more electronic devices may include, but is not limited to, conveying information about at least one characteristic of the delivery device 20 (such as, but not limited to, the delivery status of the delivery device 20, the fill level of the delivery device 20, whether the delivery device 20 is paired with one or more other electronic devices, and / or the type of pharmaceutical composition delivered to the patient) and receiving information from the one or more electronic devices. In some examples, receiving information from the one or more electronic devices may include receiving control signals for controlling at least one aspect of the delivery device 20 (such as the delivery status of the delivery device 20).

[0086] Notification device

[0087] refer to Figure 4 This illustrates an exemplary and non-limiting embodiment of the notification device 30. Figure 4 In the example shown, the notification device 30 is implemented as a wristband having a band portion 120 and a display portion 130. The band portion 120 is configured to secure around the user's wrist. In other examples, the notification device 30 may be a keychain, pendant, patch, ring, necklace, or any other wearable or non-wearable device configured to wirelessly communicate with the delivery device 20 to convey information about at least one characteristic of the delivery device 20, such as, but not limited to, the delivery status of the delivery device 20, the fill level of the delivery device 20, whether the delivery device 20 is paired with the notification device 30, and / or the type of drug composition delivered to the patient.

[0088] refer to Figures 5A-5D The display portion 130 of the notification device 30 has at least one indicator 140. The at least one indicator 140 can be a visual indicator, an auditory indicator, a tactile indicator, or a combination thereof. For example, the at least one indicator 140 can be a speaker, such as, but not limited to, a piezoelectric buzzer, and / or a lamp, such as a light-emitting diode (LED) lamp. The LED can be a multi-color LED. In some examples, multiple LEDs of the same or different colors can be provided. For example, in... Figure 5A The notification device 30 is shown in its initial configuration before use. Figure 5B In this process, the notification device 30 is activated, and the first LED becomes visible and illuminated, extending around the first portion of the display to indicate a first period of activation of the delivery device 20, such as the delivery of a first predetermined amount of medication. Figure 5C In this display, a second LED is visible and illuminated, extending around the second portion of the display to indicate the activation of the second portion of the delivery device 20, such as for delivering a second predetermined amount of medication. Figure 5D In the middle, the third LED is visible and lit, and extends around the third part of the display, thereby indicating the activation of the third part of the delivery device 20, such as delivering a third predetermined amount of medicine.

[0089] In other examples, at least one indicator 140 is a display screen. At least one indicator 140 can provide information about the status of the delivery device 20 and / or the notification device 30, such as, but not limited to, when the delivery device 20 delivers the drug composition to the patient, when the delivery of the drug is complete, whether the delivery device 20 is paired with the notification device 30, and / or the type of drug composition delivered to the patient. At least one indicator 140 can provide various other information about the status of the notification device 30 and / or the delivery device 20. At least one indicator 140 can be powered by a power source (not shown), such as a battery.

[0090] The notification device 30 may have one or more user input devices 150, such as one or more buttons. The one or more user input devices 150 may be used to configure the notification device 30, such as, but not limited to, wirelessly connecting the notification device 30 to the delivery device 20 and / or activating the notification device 30.

[0091] The notification device 30 has a wireless communication circuitry system 160, such as a Wi-Fi module or Bluetooth. TMThe module, near field communication (NFC) module, or other wireless communication circuit system. The wireless communication circuit system 160 is configured to allow the notification device 30 to communicate with one or more other electronic devices (such as the delivery device 20 or other devices) via a wireless connection. The wireless connection can be any Wi-Fi connection, Bluetooth, etc. TM Connection, NFC connection, or other wireless connection. The wireless communication circuitry system 160 can be configured to automatically pair with one or more other electronic devices within range of the wireless signals transmitted by the notification device 30.

[0092] In some examples, the wireless communication circuitry 160 is configured to provide unidirectional communication with one or more other electronic devices, such as conveyor 20 or other devices. Unidirectional communication with one or more electronic devices may include receiving information about at least one characteristic of conveyor 20, such as, but not limited to, the conveying status of conveyor 20, the fill level of conveyor 20, whether notification device 30 is paired with conveyor 20, etc. In other examples, the wireless communication circuitry 160 is configured to provide bidirectional communication with one or more other electronic devices, such as conveyor 20 or other devices. Bidirectional communication with one or more electronic devices may include receiving information about at least one characteristic of conveyor 20 and sending information to conveyor 20. In some examples, sending information to conveyor 20 may include sending control signals for controlling at least one aspect of conveyor 20, such as the conveying status of conveyor 20.

[0093] In one or more examples, the notification device 30 can be wirelessly connected to another electronic device (e.g., a telephone, laptop computer, tablet computer, etc.) to control the notification device 30 and / or send status information about the notification device 30 and / or the delivery device 20.

[0094] In some examples, the notification device 30 can be mechanically and / or electrically connected to the conveying device 20 via a wired connection.

[0095] Methods using drug delivery systems

[0096] The structure of the drug delivery system 10 has been described, and reference will now be made to... Figure 6A-9 A method for delivering a dose of a pharmaceutical composition to a patient using a drug delivery system 10 is described.

[0097] set up

[0098] The patient or healthcare worker removes the delivery device 20 from the package 170. In some examples, removing the delivery device 20 from the package can automatically activate it to a ready state. In other examples, after removal from the package, the delivery device 20 can be activated by pressing one or more user input devices 100, 150. In some instances, the patient or healthcare worker can set a target dose of the drug composition to be delivered to the patient.

[0099] Delivery device 20 and notification device 30 are initially in an "off" state. A patient or healthcare worker activates delivery device 20 and notification device 30 by actuating one or more user input devices 100, 150, respectively, for a predetermined amount of time (e.g., approximately 1 second). At least one indicator 90 on delivery device 20 can indicate that delivery device 20 has been turned on. For example, an LED on delivery device 20 can flash yellow at predetermined intervals (e.g., every 1 second), and a speaker can play an activation tone. Similarly, at least one indicator 140 on notification device 30 can indicate that notification device 30 has been turned on. For example, an LED on notification device 30 can flash green at predetermined intervals (e.g., every 0.5 seconds), and a speaker can play an activation tone.

[0100] pair

[0101] Upon activation, the delivery device 20 and the notification device 30 can activate their respective wireless communication circuit systems 110 and 160 to automatically pair the delivery device 20 with the notification device 30. The wireless communication circuit systems 110 and 160 can be active for a predetermined time period (e.g., approximately 75 seconds), during which the notification device 30, located within range of the delivery device 20, will pair with the delivery device 20. In some examples, the notification device 30 may use an out-of-band (OOB) pairing method. Upon pairing, at least one indicator 90 on the delivery device 20 and at least one indicator 140 on the notification device 30 can indicate successful pairing between the notification device 30 and the delivery device 20. For example, an LED on the delivery device 20 can be turned off, while an LED on the notification device 30 can flash green at predetermined intervals (e.g., every 0.5 seconds). If the notification device 30 and the delivery device 20 do not pair within the predetermined time period, both devices enter a standby mode.

[0102] Filling and Injection

[0103] Delivery device 20 can be filled and perfused with a pharmaceutical composition. Once the desired dose of pharmaceutical composition has been filled and delivery device 20 has been perfused, at least one indicator 90 on delivery device 20 and at least one indicator 140 on notification device 30 can indicate that delivery device 20 is ready. In some embodiments, and specifically referred to... Figures 10A-10C The container for the pharmaceutical composition 306 may be a storage bag, at least partially visible through a viewing window 280 disposed in at least a portion of the housing of the delivery device 20. For example, the container 306 may be made of a flexible material that expands in size when a fluid drug is filled into it. Optionally, the container 306 may have a visual indicator integrally formed therewith. In one embodiment, the container 306 may be made of a material with a visually distinct color, such as a fluorescent green material, making it easy to identify the location of the container 306 within the viewing window 280. In other configurations, the visual indicator may be embossed or coated onto at least a portion of the container 306. The visual indicator may be in the form of lines or other different patterns, or alternatively, the entire container 306 may include a visual indicator, such as the overall color of the container 306. Depending on the specific properties of the drug to be delivered into the container 306, it may be desirable to provide an opaque container 306.

[0104] For example in Figures 10A-10C As shown, the delivery device 20 may have a fill indicator display 270, which includes a fill line display indicating the pre-fill / empty status, partially filled / delivered status, and full status of the container 306 disposed within the delivery device 20. In this configuration, the positioning of the storage bag 290 within the viewing window 280 may coincide with at least one indicator of the fill indicator display 270 to indicate the fill status of the device during drug filling and delivery. Because the container 306 includes easily identifiable visual indicators, such as a horizontal line, the position of the container (such as the storage bag) can be aligned with the indicator of the fill indicator display 270 to communicate the amount of drug disposed within the container 306 to the user during filling or emptying processes.

[0105] like Figure 10A As shown in the first step, in the pre-filling (or completely empty) state, the visual identifier of container 306 aligns with the "empty" indicator of the fill indicator display 270, thereby conveying to the user that there is no perceptible medication inside container 306. Figure 10B As shown in the second step, in a partially filled (or partially delivered) state, the visual identifier of container 306 aligns with the intermediate indicator of the fill indicator display 270, thereby conveying information to the user about the amount of identified medication present in container 306. Figure 10CAs shown in the third step, when the container 306 (such as a storage bag) is full, the visual identifier aligns with the "full" indicator of the fill indicator display 270, thereby conveying to the user that the device contains a full dose of medication within the container 306. It will also be appreciated herein that if the entire container 306 is used as the visual identifier, such as when the container 306 has an overall contrasting color, then the positioning of the container 306 itself relative to the individual indicators of the fill indicator display 270 will convey to the user the amount of medication within the container 306.

[0106] In some instances, it may be desirable to delay the delivery of the drug composition dose for a predetermined period of time, such as, for example, about 27 hours. In some examples, the filling volume of the drug composition and the preset delay may be configurable. At least one indicator 90 on the delivery device 20 and at least one indicator 140 on the notification device 30 may indicate the start of the delay period. For example, an LED on the notification device 30 may flash green every second.

[0107] refer to Figures 6B-6C The filled and infused delivery 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 healthcare worker can activate the injection assembly to deploy the injection needle 60. At least one indicator 90 on the delivery device 20 and at least one indicator 140 on the notification device 30 can indicate when the injection needle 60 has been inserted into the patient's body.

[0108] delivery

[0109] After the delivery device 20 is infused and filled and attached to the patient's body, the delivery device 20 will begin delivering the drug composition after a delay time has elapsed. Once delivery has begun, at least one indicator 90 on the delivery device 20 and at least one indicator 140 on the notification device 30 can indicate that delivery is in progress. For example, an LED on the notification device 30 can flash green every 0.5 seconds. A buzzer on the notification device 30 can indicate the start of the delivery process by emitting a delivery tone. The delivery process can be paused when one or more user input devices 100 on the delivery device 20 are actuated. In some examples, the delivery process can be paused when one or more user input devices 150 on the notification device 30 are actuated. The delivery process can be resumed by actuating one or more user input devices 100 on the delivery device 20 and / or one or more user input devices 150 on the notification device 30. At least one indicator 90 on the delivery device 20 and at least one indicator 140 on the notification device 30 can indicate that delivery is complete. For example, an LED on the notification device 30 can be solid green. After delivery is complete, delivery device 20 and notification device 30 can be automatically deactivated. When delivery is complete, delivery device 20 can be removed from the patient's body and discarded. Notification device 30 can be reused with another delivery device 20, or it can be discarded after a single use.

[0110] In some examples, during administration of the pharmaceutical composition, at least one indicator 90 on delivery device 20 and at least one indicator 140 on notification device 30 may be used to indicate error messages. In some examples, LEDs on delivery device 20 and / or notification device 30 may flash red, and / or speakers / buzzers on delivery device 20 and / or notification device 30 may emit warning sounds to instruct the patient to contact healthcare professionals.

[0111] In some examples, the notification device 30 may use wireless communication to communicate the status of the notification device 30 and / or the delivery device 20 to remote devices, such as, but not limited to, computers, laptops, or smartphones (relay mode). In other examples, the notification device 30 may use wireless communication to communicate the status of the notification device 30 and / or the delivery device 20 to the cloud (cellular mode).

[0112] While the invention has been described in detail for illustrative purposes based on embodiments currently considered to be the most practical and preferred, it should be understood that such detail is for that purpose only, and the invention is not limited to the disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the invention contemplates that, where possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A delivery device configured to deliver a dose of medication to a patient, the delivery device comprising: Conveying equipment, including: Including the shell of the viewing window, A flexible container arranged within the housing and used to store drugs therein. A needle capable of moving between a retracted position and an extended position, wherein the needle is not protruding outside the housing in the retracted position and the needle protrudes outside the housing in the extended position, the delivery device is configured to move the needle between the retracted position and the extended position, and after a dose of medication has been delivered to the patient, the delivery device retracts the needle back to the retracted position. A visual identifier aligned with a portion of the viewing window, wherein the position of the visual identifier relative to the viewing window depends on the volume of the drug within the container; The visual recognizer is movable relative to the viewing window between an empty position and a full position, in which the container is empty of drug and in the full position the container is at least partially filled with drug; and A notification device that communicates with the conveying equipment, the notification device being configured to convey information about the status of at least one characteristic of the conveying equipment; The visual recognizer includes a cantilever deflectable member, and wherein when the container is filled with medication, the container expands to deflect one end of the cantilever deflectable member, the position of which is visible through the viewing window.

2. The conveying device of claim 1, wherein the visual identifier includes a connector capable of being attached to a portion of the container.

3. The conveying device of claim 2, wherein the connector is capable of being attached to the sealing edge of the container.

4. The conveying device of claim 2, wherein the connector includes an indicator clip.

5. The delivery device of claim 1, wherein when the container delivers the drug, the container contracts and one end of the cantilever deflectable member returns to its original position.

6. The delivery device of claim 1, wherein the housing includes a fill indicator display near the viewing window.

7. The delivery device of claim 6, wherein the visual recognizer is aligned with a portion of the filling indicator display to identify the amount of drug in the container.

8. The conveying device of claim 1, wherein the viewing window is located in the side wall of the housing.

9. The delivery device of claim 1, wherein the delivery device is a wearable autoinjector capable of being removably attached to the surface of a patient's skin.

10. The delivery device of claim 9, wherein the delivery device includes at least one indicator for communicating the status of the delivery device to the patient.

11. The delivery device of claim 1, wherein the notification device is a wristband.

12. The conveying device of claim 1, wherein the notification device communicates passively and unidirectionally with the conveying device, and wherein the notification device displays the status of at least one characteristic of the conveying device.

13. The conveying device of claim 1, wherein the notification device is further configured to: Receive information about the status of at least one characteristic of the conveying equipment from the conveying equipment; and Based on the received information, a first instruction is provided when the delivery device is paired with the notification device, a second instruction is provided when the delivery device is delivering the drug composition to the patient, and a third instruction is provided when the delivery of the drug to the patient is completed.

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

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