WO2024251597A1 - Procédé permettant à un utilisateur de détecter l'état d'un dispositif d'administration de médicament - Google Patents

Procédé permettant à un utilisateur de détecter l'état d'un dispositif d'administration de médicament Download PDF

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Publication number
WO2024251597A1
WO2024251597A1 PCT/EP2024/064848 EP2024064848W WO2024251597A1 WO 2024251597 A1 WO2024251597 A1 WO 2024251597A1 EP 2024064848 W EP2024064848 W EP 2024064848W WO 2024251597 A1 WO2024251597 A1 WO 2024251597A1
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WO
WIPO (PCT)
Prior art keywords
medicament delivery
delivery device
user
signal
information
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2024/064848
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English (en)
Inventor
Matthew Conner D'AURIA
Demosthenis KATSAROS
Martin Michael COYNE III
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SHL Medical AG
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SHL Medical AG
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Filing date
Publication date
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Publication of WO2024251597A1 publication Critical patent/WO2024251597A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6072—Bar codes

Definitions

  • the present disclosure provides apparatuses and methods enabling a user to detect a status of a medicament delivery device, in particular, a method comprising a step of capturing at least one of a light signal, an image signal, and an audible signal generated by the medicament delivery device via at least one of a light sensor, an image sensor, and a sound sensor of an electronic device to detect a status of a medicament delivery device.
  • medicament delivery devices such as auto-injectors are generally known for the self-administration of medicament by patients without formal medical training. Most of the self-administration medicament delivery devices are arranged with indication functions to guide the patients to use the medicament delivery device correctly. However, to avoid the higher cost of the medicament delivery devices, medicament delivery devices do not usually have complex processor units. Some disposable medicament delivery devices might not have any electronics. As a result, the indication provided by medicament delivery devices are usually simple, e.g., color codes, click sounds, simple icons, or a combination thereof. Those simple indications might be difficult for the patients to interpret.
  • some large volume medicament delivery devices utilize a disposable or prefilled syringe as a primary drug container.
  • the syringe is loaded into a pre-determined position, such as a carrier, slot, or bracket.
  • Syringe geometry can include size-specific aspects, such as those differing between 10, 20, 30, or 50/60mL designs.
  • Syringe features can include size-specific aspects such as flange size, thickness, shape, barrel outer diameter, or contour of the distal syringe cone and luer connection.
  • SOD start of dose
  • EOD end of dose
  • IPF in process feedback
  • the user of the device can manually view and interpret progress by viewing a moving stopper through the device window. For instance, in some prior art devices, users may view relative stopper position and movement through a device window to estimate injection process.
  • the scale marking is visible during drug delivery, but this need not be the case.
  • a user may load the syringe rotated 180°, in which case, the stopper would be visible, while the syringe markings would not be visible through the window.
  • only relative measurement of progress could be estimated by a user.
  • improved approaches are needed to provide users with a more accurate estimation of progress and time remaining.
  • flow rates can be low. For instance, in a 30mL injection at ImL/min, movement of the stopper would be one minor syringe marking line per minute. Put another way, a user would have to maintain sight of the syringe for a full minute to verify medication administration, which is impractical. Similarly, shorter glances may not be practical to readily compare movement from a prior position.
  • injection progress e.g., the rate of injection
  • injection progress can be highly variable. This is especially the case for biologies, which are viscous and have strong temperature sensitivity, which affects overall injection time and rate, especially in systems that use hydraulic resistance to throttle flow.
  • a method for enabling a user to detect a status of a medicament delivery device comprising the following steps in the following order: capturing at least one of a light signal, an image signal and an audible signal generated by the medicament delivery device via at least one of a light sensor, an image sensor and a sound sensor of an electronic device; fetching information from a database with the captured signal; and providing an indication based on the fetched information to a user of the medicament delivery device via a user interface of the electronic device.
  • the method is configured to capture the indications provided by the medicament delivery device and interpret the captured indications for the user.
  • the user doesn't need to remember the meaning of all indications provided by different medicament delivery devices and the operation errors of the medicament delivery devices due to the misunderstanding of the meaning of the indication generated by the medicament delivery device can be reduced.
  • the method comprises a step of selecting a type of indication to be provided to the user based on inputted user information.
  • the indication provided by the method can be tailored-made to different patients, e.g., elders, children, patients with vision impairment, patients with color blindness, and/or patients with hearing impairment.
  • This customized indication can be done by simply programming the software or selecting from pre-programmed models instead of re-designs the medicament delivery devices.
  • patients who receive the same treatment usually are prescribed the same medication delivery device. Within the same patient group, some patients might have vision impairment and some patients might have a hearing impairment.
  • the same type of medicament delivery devices usually only has one set of indications, e.g., a combination of sounds and vision, and the sound indication might be loud enough for most patients but not loud enough for some other patients for example.
  • the method provides an easy way to customize the indication for different patients and thus can mitigate the potential operation errors of the self-administration medicament delivery devices.
  • the indication provided to the user is presented to the user with at least one of text message, voice message, animation, and a vibration indication.
  • the method is configured to be operated by a processor of an electronic device; wherein the electronic device comprises a memory coupled to the processor, at least one of a light sensor, an image sensor and a sound sensor, and a user interface.
  • the electronic device comprises a memory coupled to the processor, at least one of a light sensor, an image sensor and a sound sensor, and a user interface.
  • the electronic device is a mobile device, e.g., mobile phones, tablet computers, smart watches, and/or smart speaker.
  • a mobile device e.g., mobile phones, tablet computers, smart watches, and/or smart speaker.
  • a more complex indication can be provided.
  • the sound sensor can capture an end click of a medicament delivery device and the image sensor can capture an image that a plunger rod of the medicament delivery device is positioned within a medicament container.
  • the sound signal and the image signal can be interpreted as the status of the medicament delivery device that the medicament delivery operation is completed.
  • the indication provided by the method can be a human voice in a local language via a speaker of the mobile phone to the user.
  • the step of capturing at least one of a light signal, an image signal and an audible signal of the medicament delivery device comprises a step of capturing at least one of a subvisible light signal and a subaudible sound signal generated by the medicament delivery device.
  • the at least one of the subvisible light signal and the subaudible sound signal is configured to contain encoded information related to the medicament delivery device.
  • the visible light and/or image signal and/or the audible signal generated from the medicament delivery device can be used to serve its core functionality for medicament delivery device delivery, namely that people can observe the indications generated from the medicament delivery device to understand the status the medicament delivery device and provide help to the patient who is needed.
  • the at least one of a subvisible light signal and a subaudible sound signal can be used to carry more detailed information such as the information related to the dosage delivered, the ordinal number of a medication sequence, or the number of medicament containers administered in a dosing interval.
  • the method further comprises the following steps in the following order: repeating all operated steps in the same operated order.
  • the plunger rod will continue to move within the medicament container until the end of the medicament delivery operation, repeating the steps mentioned above results in providing the patients with real-time information about the medicament delivery device.
  • the patients can be indicated with the remaining medicament delivery time or delivery progress as what percentage has been completed in a more understandable way (as the indication can be customized for the patients or is closer to the human language).
  • the captured signal can also be video, e.g., captured by repeating the step of capturing images signal.
  • the indication provided to the user comprises content related to the medicament delivery device.
  • the content comprises at least one of instructional content, warning content, troubleshooting content, and informational content.
  • the instructional content can be used to instruct the patients about the operation steps that the patients need to perform in order to properly complete the medicament delivery operation.
  • the warning content can be used to warn the patients to avoid any action that might harm the patients, e.g., injury or incorrect dosage.
  • the troubleshooting content can be used to guide the patients to solve an issue of the medicament delivery device.
  • the medicament delivery device is a motor-driven device and comprises electronics
  • the troubleshooting content may be more intuitive for a patient since a complex user manual or an instruction for use (IFU) is not required.
  • the troubleshooting content could provide animations or step-by-step instructions to resolve the specific error. This is particularly useful when the manual or IFU is not available, or when users are easily overwhelmed by instructions or have low health literacy.
  • the informational content can be used to indicate to the user the current status of the medicament delivery device and/or any potential next status of the medicament delivery device.
  • the step of fetching information from a database with the captured signal comprises the following steps in the following order: searching for information from the database stored in a memory of the electronic device; matching the information with the captured signal; and retrieving the matched information.
  • the database is stored in the electronic device. Thus, an internet connection is not necessary.
  • the step of fetching information from a database with the captured signal comprises the following steps in the following order: searching information from the database stored in the memory of the electronic device; matching the information with the captured signal; and retrieving the matched information.
  • the patients can always get the latest information about the medicament delivery device.
  • the method before the step of capturing at least one of a light signal, an image signal and an audible signal of the medicament delivery device, comprises a step of receiving an activation signal from an action of a user on the user interface or a wirelessly transmitted activation signal.
  • the patients can start the steps of the method by for example opening an application on the mobile phone and scanning QR code or NFC on the device.
  • the method as mentioned above is a method of operating a computer system.
  • the computer system comprises memory storing instructions and one or more processors coupled to the memory to execute the instructions, wherein the instructions, when executed by the one or more processors, cause the system to implement the method as mentioned above.
  • companion software comprising instructions to carry out the method is provided.
  • the software is an application configured to be executed on a mobile device and when the software is executed on a mobile device by the processor of the mobile device, the processor causes the method disclosed herein to be implement by the mobile device.
  • Another aspect of the invention provides a system for guiding a user of a medicament delivery device to use the medicament delivery device, the system comprising an electronic device, the electronic device comprising: a processor configured to operate the method as mentioned in any embodiment above, a memory coupled to the processor; at least one of a light sensor, an image sensor and a sound sensor, and a user interface.
  • the database is stored in the memory of the electronic device.
  • the database is in a remote server; and wherein the processor is configured to establish a communication with the remote server before operating the method according to any one of the above-mentioned embodiment.
  • a user utilizes receives pre-processed medicament delivery device administration progress feedback by way of a smartphone camera and software, without a connected medicament delivery device.
  • the present disclosure further provides calibrating features on medicament delivery device that are positioned relative to a syringe loaded into fixed, predictable position relative to those features.
  • the present disclosure further provides calibrating visual features are fixed reference points on the device window that are machine-readable, and optionally human readable (if software component unused/unavailable).
  • the present disclosure further provides using machine vision to identify the syringe stopper position within a medicament delivery device and interpret medication administration progress.
  • the present disclosure provides an approach that relies only on underlying syringe geometry and movement of stopper within the syringe and does not rely on the printed or labeled syringe scale, making it insensitive to manufacturing limitations or variability (i.e., this ID is not machine vision reading of a pre-printed scale).
  • the present disclosure provides progress reported by software incorporates time-based variations in drug delivery rate, effectively compensating for variations in estimates provided to a user.
  • Figures 1-2 show simplified block diagrams of an electronic device configured to operate a method of the invention being used with different medicament delivery devices.
  • Figures 3-4 show the electronic device of Figures 1-2 being used with different medicament delivery devices.
  • Figure 5 shows a block diagram of the method of the invention.
  • Figure 6 illustrates a system for detecting a status of a medicament delivery device, according to an example embodiment.
  • Figure 7 illustrates a syringe installed in the representative medicament delivery device, according to an example embodiment.
  • Figure 8 illustrates an illustrative example of a complete delivery profile for a representative device, according to an example embodiment.
  • Figures 9A-9C illustrates an example elastomeric pump, according to an example embodiment.
  • Apparatuses and methods for enabling a user to detect a status of a medicament delivery device is provided.
  • the method is configured to assist users of the medicament delivery device to understand signals generated by the medicament delivery device.
  • the method can be used to assist the user to use a pure mechanical medicament delivery device, e.g., a syringe, an insulin pen, or a disposable autoinjector.
  • the method can be used to assist the user to use a medicament delivery device comprises electronics, e.g., an infusion pump or a reusable motor- driven injection device.
  • the user of the medicament delivery device can be a patient who will receive the medicament contained within the medicament delivery device or people who help the patient to receive the medicament contained within the medicament delivery device, e.g., caregivers.
  • the method is configured to be used with an electronic device comprising at least one of a light sensor, an image sensor and a sound sensor; and a user interface.
  • the user interface is an integral part of the electronic device.
  • the at least one of a light sensor, an image sensor and a sound sensor and the user interface can be an independent device that is electrically connected to the electronic device.
  • a user may connect a mobile phone to a smart TV via a cable or wirelessly, e.g., via Bluetooth connection, for example.
  • the mobile phone can be the electronic device; and the smart TV can be the user interface.
  • the electronic device comprises one or more processors.
  • the method is configured to be operated by the one or more processors of the electronic device.
  • companion software comprising instructions to carry out the method is provided.
  • the software is an application configured to be executed on a mobile device, e.g., a mobile phone, a tablet computer, a smart wearable device such as smart watches or smart rings, or a smart speaker.
  • the processor causes the method disclosed herein to be implement by the mobile device.
  • the medicament delivery device is configured to be used around the electronic device.
  • the method 400 comprises the following steps in the following order, as shown in Figure 5:
  • an indication generated by the medicament delivery device can be captured, interpreted, and provided to the user of the medicament delivery device.
  • the method 400 is configured to be operated by a processor 120 of an electronic device 100.
  • the medicament delivery device 200 is a pure mechanical medicament delivery device, in other words, the medicament delivery device does not comprise electronics, such as a disposable autoinjector.
  • the medicament delivery device 200 comprises a medicament container 220 containing medicament for being delivered to a user of the medicament delivery device 200.
  • the medicament delivery device 200 further comprises a delivery powerpack 230 configured to, upon the medicament delivery device being activated, output force on the contained medicament and thereby cause the contained medicament to be expelled from the medicament container 220.
  • the powerpack 230 comprises a plunger rod connected to a power source.
  • the power source can be a spring or a gas canister.
  • the delivery powerpack 230 is configured to provide a mechanical click indication.
  • the user of the medicament delivery device can get an audible signal that indicates the start of the medicament delivery operation.
  • the medicament container 220 can provide an image indication to the user of the medicament delivery device.
  • the user can see the plunger rod positioned within the medicament container 220 after medicament delivery operation or the user can see the decrease of the contained medicament.
  • the user can use a camera from the mobile phone to be the image sensor to take photos/video of the medicament delivery device 200, as shown in Figure 4.
  • the processor 120 of the mobile phone is configured to operate the method to capture the image signal generated by the medicament container 220 of the medicament delivery device 200 and the audible signal generated by the delivery powerpack 230 of the medicament delivery device 200 via the camera 112 and the microphone 113. Once the signals are captured, the processor 120 is configured to fetch information from a database with the capture signal.
  • the information that can be fetched with the captured audible signal can be the information of the start of the medicament delivery operation.
  • the processor 120 is configured to provide an indication of the fetched information to a user of the medicament delivery device via a user interface of the mobile device.
  • the indication that is provided to the user is presented to the user with at least one of text message, voice message, animation, and a vibration indication.
  • the indication may be presented with additional words, graphics, animation, sound, or notifications, all of which are not present on the medicament delivery device itself.
  • the indication can be presented in a local language.
  • the processor 120 can cause the speaker of the mobile device 100 to output an audible indication in human language and human voice. For example, the user might hear ‘Injection starts’ from the speaker of the mobile phone.
  • the step of fetching information from a database with the captured signal comprises the following steps in the following order:
  • the database is stored in the memory 130 of the electronic device 100.
  • the database is connected to a server 300, e.g., a cloud server, preferably, the database is stored in the server 300.
  • the step of fetching information from a database with the captured signal comprises the following steps in the following order:
  • the processor 120 is configured to send a request with the captured signal with the communication unit 150 of the electronic device 100 to the server 300.
  • the server 300 is configured to match the information with the received request, retrieve the matched information, and then send the retrieved information to the electronic device 100.
  • the mobile device can receive the information from the server via the communication unit 150.
  • the method comprises a step of: receiving an activation signal from an action of a user on the user interface or a wirelessly transmitted activation signal.
  • the processor 120 of the electronic device 100 is configured to operate the above- mentioned method, the processor 120 will start to cause the at least one sensor to capture the signal generated by the medicament delivery device only when the processor receives an activation signal from an action of the user.
  • the user can open an application on the mobile device, and/or scan QR code, and/or place the mobile device nearby an RFID/NFC tag on the medicament delivery device.
  • the medicament delivery device is arranged with an information tag 240, e.g., an RFID/NFC tag.
  • the communication unit 150 of the mobile device may comprise an RFID/NFC reader to receive a signal when the mobile device is placed nearby the medicament delivery device.
  • the processor 120 can receive the activation signal from the communication unit 150 to start the operation of the method as mentioned above.
  • the method further comprises the following steps in the following order: repeating all operated steps in the same operated order. In a preferred example, all operated steps will be repeated until an operation-completed signal is detected.
  • the operation completed signal can be designed dependent on the design.
  • the operation completed signal can be a signal that the user closes the application of the mobile device, or the user moves the mobile device away from the medicament delivery device (out of the communication range that the RFID/NFC tag can be read by the mobile device), or a detection of the end of the medicament delivery operation by the method mentioned above, or the absence of actions being taken by the at least one of a light sensor, an image sensor and a sound sensor of an electronic device in a period of time, e.g., 5 seconds or 10 seconds.
  • the user of the medicament delivery device can get real-time information about the status of the medicament delivery operation.
  • the user can get an indication about the progress of the medicament delivery operation, e.g., how many percentages of the medicament is delivered.
  • the method comprises a step of selecting a type of indications to be provided to the user based on inputted user information. For example, a caregiver can select a type of indications for individual patients, e.g., for patients with vision impairment, the indications can be selected to be audible indication.
  • the medicament delivery device may comprise electronics, e.g., an infusion pump or a reusable motor-driven injection device, as shown in Figure 2.
  • This type of medicament delivery device is commonly used for delivering high volume/high viscosity medicament and/or long period of the medicament delivery, e.g., long hours or couple days.
  • this type of the medicament delivery device usually is arranged with more complicated indications as there might be more actions that the user needs to carry out and/or there might be more events that the user needs to be aware of.
  • the medicament delivery device 200’ comprises a light emitter 213’, e.g., LED light, an image indicator 211, e.g., icons, a speaker 212’, and a processor 250’.
  • the medicament delivery device 200’ also comprises at least one medicament container 220’ and a delivery powerpack 230.
  • the medicament container 220’ can be packed in a cassette that is releasably attached to a reusable part of the medicament delivery device 200’, as shown in Figure 5.
  • the electronics and the delivery powerpack 230 are positioned within the reusable part of the medicament delivery device 200’.
  • the medicament container can be preassembled within the medicament delivery device.
  • the medicament delivery device may comprise multiple medicament containers containing with the same or different medicaments.
  • the medicament delivery device comprises multiple medicament containers containing with different medicaments respectively, the medicaments may be configured to be delivered to the patient in a predetermined sequence.
  • the delivery powerpack 230 can be a motor or an air pump.
  • the medicament delivery device 200’ comprises a battery 260’ and a communication unit 240’.
  • the signal captured, interpreted and indicated with the method mentioned above is shown in Table 1 below as an example.
  • the above-mentioned method is operated by the processor 120 of the mobile device 100.
  • I instructional content
  • W warning content
  • T troubleshooting content
  • N informational content
  • the indication that is provided to the user comprises content related to the medicament delivery device.
  • the content comprises at least one of instructional content, warning content, troubleshooting content, and informational content.
  • the Instructional content helps the user operate the medicament delivery device correctly, e.g., guiding the users to connect multiple cassettes to the medicament delivery device in a specific order, while informational content helps the user understand what is taking place with one or more aspects of the medicament delivery device (or medication delivery operation). Warning content may also be displayed for unsafe or undesired operating conditions and troubleshooting content may be displayed when an error occurs that can be corrected by user action.
  • the medicament delivery device 200’ comprises the information regarding the interpretation of the indications that the medicament delivery device 200’ can provide, the user operation manual of the medicament delivery device, and the information related to the medicament.
  • the communication unit 240' of the medicament delivery device 200' can send the information to the communication unit 150 of the mobile device 100 when the user establishes a communication between the medicament delivery device 200' and the mobile device 100.
  • the information can be stored in the database stored in the mobile device for being fetched with a specific captured signal of the medicament delivery device during use.
  • some of medicament delivery devices having electronics can output the indication, e.g., light, sound, or images, carrying encoded information.
  • some of medicament delivery devices having electronics can provide at least one of a subvisible light signal, e.g., infrared, or small color/luminance change by pulsing LEDs, and a subaudible sound signal, e.g., ultrasound or a barely audible tone.
  • a subvisible light signal e.g., infrared, or small color/luminance change by pulsing LEDs
  • a subaudible sound signal e.g., ultrasound or a barely audible tone.
  • the step of capturing at least one of a light signal, an image signal and an audible signal of the medicament delivery device comprises a step of: capturing at least one of a subvisible light signal and a subaudible sound signal generated by the medicament delivery device.
  • the encoded information can be interpreted by the processor 120 of the electronic device 100 when the indications are captured.
  • the medicament delivery device can provide at least one of the humaninvisible and the subaudible sound signal, it may be preferred to have the at least one of the subvisible light signal and the subaudible sound signal to carry the encoded information.
  • the medicament delivery device comprises LED indicators and can generate the subvisible light signal
  • the signal captured, interpretation and indicated with the method mentioned above is shown in Table 2 below.
  • the above-mentioned method is operated by the processor 120 of the mobile device 100.
  • the system comprises an electronic device.
  • the electronic device 100 comprises a processor 120 configured to operate the method as mentioned above; a memory 130 coupled to the processor 120; at least one of a light sensor 111, an image sensor 112 and a sound sensor 113, and a user interface 140.
  • the system further comprises a medicament delivery device 200’ comprises a light emitter 213’, e.g., LED light, an image indicator 211, e.g., icons, a speaker 212’, and a processor 250’.
  • the medicament delivery device 200’ comprises at least one medicament container 220’ and a delivery powerpack 230.
  • the medicament container 220’ is packed in a cassette that is releasably attached to a reusable part of the medicament delivery device 200’.
  • the electronics and the delivery powerpack 230 are positioned within the reusable part of the medicament delivery device 200’.
  • one cassette is capable of containing multiple medicament containers containing with the same or different medicaments.
  • the medicament delivery device is capable of being attached with one or more cassette.
  • the medicament delivery device comprises multiple medicament containers containing with different medicaments respectively, the medicaments may be configured to be delivered to the patient in a predetermined sequence.
  • the delivery powerpack is a motor, preferably, a stepper motor; or the powerpack is a pneumatic pump, e.g., an air pump.
  • the medicament delivery device 200’ comprises a battery 260’ and a communication unit 240’.
  • the medicament delivery device 200’ comprises the information regarding the interpretation of the indications that the medicament delivery device 200’ can provide, the user operation manual of the medicament delivery device, and the information related to the medicament.
  • the communication unit 240' of the medicament delivery device 200' can send the information to the communication unit 150 of the mobile device 100 when the user establishes a communication between the medicament delivery device 200' and the mobile device 100.
  • the medicament delivery device 200’ comprises electronics that can output the indication, e.g., light, sound, or images, carrying encoded information.
  • the medicament delivery device 200’ comprises electronics that can provide at least one of a subvisible light signal, and a subaudible sound signal.
  • Figure 6 illustrates a system for detecting a status of a medicament delivery device 500, according to an example embodiment.
  • the medicament delivery device 500 may include one or more of the features of the medicament delivery devices 200, 200’ as discussed above.
  • a medicament delivery device 500 is provided that accepts a syringe 502 filled with medication in a known orientation.
  • the known orientation is based on aspects of the syringe geometry or syringe features, such as the syringe flange, outer window, or luer connection.
  • the medicament delivery device 500 is provided with a window 504 to view an enclosed syringe 502 (and particularly, the syringe plunger 503), once installed in the medicament delivery device 500.
  • the window 504 provided in the housing 506 of the medicament delivery device 500 allows viewing the enclosed syringe 502 in the predetermined operational position. At least part of the syringe 502 remains visible while the medicament delivery device 500 operates such that a user can visually inspect the progress of the infusion.
  • the window 504 has one or more visual features 508 distinguishable by the electronic device 100, as described later. Importantly, visual features 508 are pre-determined dimension, shape, and placement relative to each other and the syringe 502 once placed in the medicament delivery device 500.
  • these cooperating components may provide a reference on progress of the syringe plunger 503 movement when viewed relative to each other.
  • This construct may be viewed by a field of view 510 of the electronic device 100 (e.g., a camera-enabled smartphone as a non-limiting example) and cooperating software on the electronic device 100.
  • software consists of a companion software application that are common for specialty pharmaceuticals, but the software may alternatively be another software application, web interface, or other suitable software.
  • the software is pre-provided with information about a syringe geometry used with the medicament delivery device 500 and characteristics of the window 504 size, shape, and visual features.
  • the pre-provided information includes characteristics of the syringe 502 and window 504 geometries relative to each other when the syringe 502 is installed and the window 504 covers the syringe during medication delivery. Additionally, the pre-provided information need not include the scale markings on the syringe itself, and instead may rely only on the structural features of the medicament delivery device 500.
  • the electronic device 100 captures photographic or videographic data of the syringe 502, syringe stopper 503, device window 504, and visual features 508 located on, in, and/or around the device window 504. Such capture may take place repeatedly at different times during medication delivery, and thus, preferably time-series metadata is captured along at each instance.
  • Captured data is collected by the software application for later analysis and presented to a user in a easily understood format as described below.
  • either or both of instantaneous or time-series comparisons may be used, each providing different types of useful information to a user of the medicament delivery device 500.
  • connectivity between the medicament delivery device 500 and the electronic device 100 is not required for the present method to function.
  • Connectivity may be provided for other functions, such as adherence monitoring, but a connected device is not required for the present invention. This greatly simplifies the medicament delivery device 500, and provides a pathway for connected-like functionality without device redesign or revalidation.
  • this functionality can be implemented in current medicament delivery devices with minimal modification, provided the medicament delivery device has a viewing window or similar visual or audible indicators from which the status of the medicament delivery device, e.g. ready for use, progress of delivery and/or end of delivery, can be derived.
  • the visual feautures 508 can be colored “inserts” that are molded, glued, or snapped into pre-molded areas of the device windows. Colors may obviously be varied, either for human user intuitiveness, or to improve the accuracy of a machine vision system. Shapes may similarly be selected to improve the accuracy of a software vision system.
  • Such a configuration takes advantage of the inherent accuracy of molded parts to locate each visual feauture 508, and allows customization of the design of the visual features 508 for a specific situation (brand colors for a drug or pharmaceutical company, drug dispensing characteristics, syringe fill, user population, etc.) without changing the underlying pump design, function, or molds.
  • the visual features 508 may be a shape (e.g., triangle as shown, or a square, circle, diamond, oval, or other shape) that have no inherent human- readable value. To improve intuitiveness, the visual features 508 may also be provided as “Harvey Balls” that are progressively filled towards the luer end of the syringe (e.g., 25/50/75/100%).
  • any of the visual features 508 may also have human-readable information, such as numeric percentage, mL volume, or other indicia.
  • the visual features 508 may be molded into the shape of a specific number or may be the same shape and then pad printed. This is particularly valuable for prefilled syringes used with the pump, since these presentations ordinarily do not have scale markings provided.
  • the visual features 508 may be molded, and the indicia (color, shape, numerals, etc.) as described previously may be provided on the device housing surface, as by pad printing, in mold decoration, or other techniques. In all these instances, provision of human-readable information may be used to show progression regardless of whether a companion software application is used.
  • Figure 7 shows a syringe 602 installed in the representative medicament delivery device 600.
  • the housing 606 of the the medicament delivery device 600 incldues a window 604, tapering down in width from left to right (i.e., in the direction of the movement of the stopper 603 during drug delivery).
  • This tapered window 604 provides an example of a readily identifiable shape for the electronic device 100, also allowing discernment of the device orientation.
  • the window need not be shaped as in Figure 7.
  • a symmetric window may be provided with indicators, as shown and described above in relation to Figure 6.
  • the companion software application may be configured to remind a user of the apparatus to capture visual information at one or more time points.
  • the first prompt is taken at the beginning of administration.
  • the prompts are made periodically, for instance, every 15 minutes in a one-hour period, or every 10 minutes in a half-hour period.
  • the camera captures photographic or videographic data of the syringe, syringe stopper, device window, and visual features located on, in, and/or around the device window. Such data is optionally tagged with timestamp metadata for later analysis as described in Scenario 1.
  • Device orientation determination One or more virtual features of the medicament delivery device or medicament delivery device window are used to determine known reference points and determine orientation of the device relative to the camera capturing the visual data, optionally also compensating for angulation, rotation, or optical artifacts such as parallax.
  • Syringe stopper identification Within the medicament delivery device window, the position of the syringe stopper is identified relative to the device window and any visual feature(s). This is easily performed with edge detection software, as the stopper is comparatively darker and opaquer compared to the syringe, which is light and translucent. 5. Stopper position in syringe is inferred. As described previously, the syringe and window positions are pre-determined relative to each other. Thus, identifying the stopper position within the window also allows inference of its instantaneous position within the syringe, and thus the current volume of medication administered or remaining.
  • the inferred syringe volume of Step 6 may be stored in the companion software application along with time metadata of Step 2 as a volume-time datapoint for subsequent use as described below in Scenario 2.
  • Step 7 Volume administered thus far.
  • the starting volume is compared to the instantaneous volume of Step 6.
  • the display of Step 7 is augmented with a display of the volume administered or as a percent complete.
  • Step 10 Volume remaining. The starting volume is compared to the instantaneous volume of Step 6.
  • the display of Step 7 is augmented with a display of the volume remaining (or percent remaining).
  • Time remaining If the average rate of the pump and fluidic system is known in advance, the comparison from Step 10 may be used (along with the average rate) to provide a time estimate to a user of the device. This estimate may be provided as a single point estimate (i.e., volume remaining average flow rate).
  • the companion software application may be configured to display the time estimate as a range, especially if the software application is pre-programmed with a tolerance on the average flow rate.
  • Certain readings may also be included or excluded; for instance, two nearby snapshots may be treated as a single reading, may be averaged, or one may be excluded, especially if flow rates (and thus stopper movement) are small.
  • each snapshot used is each at a different discrete position, as this maximizes the information that may be extracted, especially for longer injection times.
  • stopper movement relative to the visual features may be compared by the companion app, giving users “virtual” in process feedback in in various useful ways beyond Scenario 1.
  • relating displacement between two or more instantaneous snapshots in conjunction with time metadata yields an approximate average rate.
  • Calculation of a trailing average provides a forecast of approximate time remaining, or a trend/graph of rate versus time.
  • strings of multiple images in the form of videos or time-lapse sequences may be analyzed frame-by-frame or frames sampled for greater data collection frequency if desired. This is particularly advantageous if prompts are supplied to the user, as in Step 1 of Scenario 1.
  • the average rate is then communicated visually to a user of the companion software application or device, along with different inferences made from the data.
  • Calculation of these parameters also allows detection of undesired or unsafe conditions, especially that can be inferred from changes to flow rate.
  • a rapid decrease in average rate may prompt a warning on the companion software application to check for tubing set occlusion, as by inadvertent closure of the tubing set clamp or tangling of the tubing set.
  • a rapid increase in average rate could prompt a warning that there is a leak or disconnection in a fluidic connection, or removal of a needle from an injection site.
  • these situations are not easily detectible simply by a user visually observing stopper movement in a syringe at a single point in time but are easily discerned by software.
  • Figure 8 shows an illustrative example of a complete delivery profile for a representative device that may be used in early clinical trials or commercially approved molecules.
  • known devices may include a constant pressure pump with mechanical (spring drive) and has a delivery profile shown in Figure 8 when tested with 60mL of water.
  • the flow behavior may be different with non-Newtonian biologic medications.
  • the startup behavior is visible at the left side (e.g., 0-1 min), and steady state behavior is visible as time progresses (e.g., 2-28 min).
  • the fluidic path used in this example incorporates a reduced-diameter tubing segment that allows for approximately 120mL/h.
  • the device used to generate the graph shown in Figure 8 is a pressure- regulated device (as it is driven via spring).
  • the data would look different if the drug dispensed has a different viscosity than water, or if the needle were elevated relative to the device (increasing head pressure), as the resultant flow rate would change.
  • the device s driving pressure, however, would not be impacted by these variables, as the device is fundamentally pressure-regulated via its drive spring.
  • the companion software application may be pre-provisioned with one or more profiles, each corresponding to a specific pump and fluid (such as a biologic medication).
  • a specific pump and fluid such as a biologic medication
  • such information may also be provided versus temperature, either as discrete curves or a surface plot.
  • Calculations of instantaneous flow rate may be compared to a pump and drugspecific flow vs. time curve to confirm that the flow rate is “on track” or “as expected.” For instance, if an instantaneous flow rate measured at 20 minutes into infusion was approximately 125 ml/hr using the curve of Figure 8, and the total volume was 60mL at the outset, the system could provide a refined time remaining estimate to a user (in this case, about 10 minutes longer).
  • the companion software application could estimate a longer time (e.g., 15 minutes) based on a “search” through the temperature-flow-time curves to match the observed flow rates, thus inferring the medication temperature from the inferred flow rate.
  • the curve of Figure 8 will shift (i.e., vary) based on temperature.
  • the companion application by comparing observed time-series data to expected preconfigured room-temperature data, can develop a patient-specific calculation predicting behavior of the medicament delivery device, e.g., estimated infusion duration. This is useful for patients that live in different climes, or those that prefer not to warm medication prior to administration to reduce total duration of the process.
  • FIGS 9A-9C shows a simple elastomeric pump 700, where a central medication reservoir is inside an expandable elastomeric bladder 702. The elastomeric pump 700 takes on a distinctive shape at each stage of medication delivery as seen from Figures 9A-9C.
  • the medicament delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders.
  • exemplary disorders include but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies.
  • Exemplary types of drugs that could be included in the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies and/or protein derivatives.
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g.
  • evolocumab hypercholesterolaemia
  • exenatide type 2 diabetes
  • secukinumab psoriasis
  • erenumab mimerase
  • alirocumab rheumatoid arthritis
  • methotrexate amethopterin
  • tocilizumab rheumatoid arthritis
  • interferon beta- la multiple sclerosis
  • sumatriptan miraines
  • adalimumab rheumatoid arthritis
  • darbepoetin alfa anaemia
  • belimumab laupus
  • peginterferon beta- la' multiple sclerosis
  • sarilumab rheumatoid arthritis
  • semaglutide type 2 diabetes, obesity
  • dupilumab atopic dermatitis, asthma, nasal polyps, allergies
  • glucagon a
  • ipilimumab nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado- trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab
  • compositions including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier.
  • pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • an immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD- 1/PD-L1 inhibitors/modulators, B-lymphocyte antigen CD19 inhibitors, B- lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDwl37 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mF0LF0X7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R- EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP,
  • Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those used for chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • chemotherapy such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Public Health (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Procédé permettant à un utilisateur de détecter l'état d'un dispositif d'administration de médicament. La présente divulgation concerne un procédé permettant à un utilisateur de détecter l'état d'un dispositif d'administration de médicament (200), le procédé consistant à capturer un signal lumineux et/ou un signal d'image et/ou un signal sonore généré par le dispositif d'administration de médicament par l'intermédiaire d'un capteur de lumière (111) et/ou d'un capteur d'image (112) et/ou d'un capteur de son (113) d'un dispositif électronique (100). Le procédé consiste en outre à extraire des informations d'une base de données avec le signal capturé. Le procédé consiste en outre à fournir une indication sur la base des informations extraites à un utilisateur du dispositif d'administration de médicament (200) par l'intermédiaire d'une interface utilisateur (140) du dispositif électronique (100).
PCT/EP2024/064848 2023-06-06 2024-05-29 Procédé permettant à un utilisateur de détecter l'état d'un dispositif d'administration de médicament Ceased WO2024251597A1 (fr)

Applications Claiming Priority (6)

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US202363471341P 2023-06-06 2023-06-06
US63/471,341 2023-06-06
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EP23183760.0 2023-07-06
EP24386056.6 2024-05-20
EP24386056 2024-05-20

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9179260B2 (en) * 2012-12-03 2015-11-03 Mylan Inc. Medicament information system and method
US20180280624A1 (en) * 2014-11-05 2018-10-04 Insuline Medical Ltd. Drug tracking device
US20180336962A1 (en) * 2015-11-23 2018-11-22 Koninklijke Philips N.V. Pulse oximeter integration for evaluating and updating a drug administration schedule using effectiveness rating
CA3155914A1 (fr) * 2019-09-25 2021-04-01 Janssen Pharmaceuticals, Inc. Reglage d'administration de medicament
WO2022178447A1 (fr) * 2021-02-19 2022-08-25 Beta Bionics, Inc. Pompes à médicament dotées de systèmes et procédés pour améliorer l'expérience de l'utilisateur

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9179260B2 (en) * 2012-12-03 2015-11-03 Mylan Inc. Medicament information system and method
US20180280624A1 (en) * 2014-11-05 2018-10-04 Insuline Medical Ltd. Drug tracking device
US20180336962A1 (en) * 2015-11-23 2018-11-22 Koninklijke Philips N.V. Pulse oximeter integration for evaluating and updating a drug administration schedule using effectiveness rating
CA3155914A1 (fr) * 2019-09-25 2021-04-01 Janssen Pharmaceuticals, Inc. Reglage d'administration de medicament
WO2022178447A1 (fr) * 2021-02-19 2022-08-25 Beta Bionics, Inc. Pompes à médicament dotées de systèmes et procédés pour améliorer l'expérience de l'utilisateur

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