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CN-122006010-A - Drug delivery system, delivery device and notification device for communicating the status of a medical device

CN122006010ACN 122006010 ACN122006010 ACN 122006010ACN-122006010-A

Abstract

The present disclosure relates to drug delivery systems, delivery devices, and notification devices 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 regarding a status of at least one characteristic of the delivery device. The delivery device is a wearable automatic injector 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 delivery apparatus of the present disclosure provides a simple and effective visual means of displaying the fill confirmation and the delivery confirmation.

Inventors

  • N. you Dian
  • R.ZHANG
  • DESPA MIRCEA
  • R. Dushpusel
  • J.R. Gehry
  • Kume Gustavo R.
  • A. Richards
  • M. MONI
  • ABRY HERVE
  • M. BOWEN

Assignees

  • 贝克顿·迪金森公司

Dates

Publication Date
20260512
Application Date
20180718
Priority Date
20170718

Claims (14)

  1. 1. A delivery device configured to deliver a dose of a drug to a patient, the delivery device comprising: a conveying apparatus comprising: a housing including a viewing window is provided, A flexible container disposed within the housing and for storing a medicament therein, A needle movable between a retracted position in which the needle does not protrude outside the housing and an extended position in which the needle protrudes outside the housing, the delivery device being configured to move the needle between the retracted position and the extended position, the delivery device retracting the needle to the retracted position after the dose of medicament has been delivered to a patient, and A visual identifier aligned with a portion of the viewing window, wherein a position of the visual identifier relative to the viewing window is dependent on a volume of medicament within the container; wherein the visual identifier is movable relative to the viewing window between an empty position in which the container is free of medicament and a full position in which the container is at least partially filled with medicament, and A notification device in communication with the delivery device, the notification device configured to communicate information regarding a status of at least one characteristic of the delivery device; Wherein the visual identifier comprises a cantilever deflectable member, and wherein when the container is filled with a medicament, the container expands to deflect an end of the cantilever deflectable member, the position of the end being visible through the viewing window.
  2. 2. The delivery device of claim 1, wherein the visual identifier comprises a connector attachable to a portion of the container.
  3. 3. The delivery device of claim 2, wherein the connector is attachable to a sealed edge of the container.
  4. 4. The delivery device of claim 2, wherein the connector comprises an indicator clip.
  5. 5. The delivery device of claim 1, wherein when the container delivers a drug, the container collapses and the one end of the cantilevered deflectable member returns to its original position.
  6. 6. The delivery device of claim 1, wherein the housing includes a fill indicator display proximate the viewing window.
  7. 7. The delivery device of claim 6, wherein the visual identifier is aligned with a portion of the fill indicator display to identify an amount of medicament within the container.
  8. 8. The delivery device of claim 1, wherein the viewing window is located in a side wall of the housing.
  9. 9. The delivery device of claim 1, wherein the delivery apparatus is a wearable automatic injector removably attachable to a skin surface of a patient.
  10. 10. The delivery device of claim 9, wherein the delivery apparatus comprises at least one indicator for communicating a condition of the delivery apparatus to a patient.
  11. 11. The delivery device of claim 1, wherein the notification apparatus is a wristband.
  12. 12. The delivery device of claim 1, wherein the notification apparatus is in passive unidirectional communication with the delivery apparatus, and wherein the notification apparatus displays a status of at least one characteristic of the delivery apparatus.
  13. 13. The delivery device of claim 1, wherein the notification apparatus is further configured to: Receiving information from the conveying device about the status of at least one characteristic of the conveying device, and Based on the received information, a first indication is provided when the delivery device is paired with the notification device, a second indication is provided when the delivery device is delivering a pharmaceutical composition to the patient, and a third indication is provided when the delivery device of the medicament to the patient is completed.
  14. 14. The delivery device of claim 13, wherein the at least one characteristic of the delivery apparatus comprises a delivery status of the delivery apparatus.

Description

Drug delivery system, delivery device and notification device for communicating the status of a medical device The present application is a divisional application of application number 201880055666.3, entitled "drug delivery System, delivery device, and notification device for communicating status of medical device", having application date of 2018, 7, 18. Cross Reference to Related Applications The present application claims priority to U.S. provisional application sequence No.62/533,954 entitled "Notification Device for Communicating Status of A MEDICAL DEVICE" filed on day 7, month 18, and U.S. provisional application sequence No.62/559,051 entitled "Notification Device for Communicating Status of A MEDICAL DEVICE" filed on day 9, month 15, and U.S. provisional application sequence No.62/626,935 filed on day 2, month 6, and "Administration System, Delivery Device, and Notification Device for Communicating Status of a Medical Device", the entire disclosure of each of which are incorporated herein by reference. Technical Field The present disclosure relates generally to devices, systems, and methods for delivering pharmaceutical compositions to a patient. More particularly, the present disclosure relates to devices, systems, and methods for delivering a pharmaceutical composition to a patient using an auto-injector, and to notification devices for communicating at least one characteristic of the auto-injector, and to devices that allow a patient to view the status of a container, such as visual means to display a fill confirmation and/or a delivery confirmation. Background A benefit of a wearable medical device, such as an auto-injector, is that treatment may be provided to a patient at a location remote from a clinical facility and/or when separately worn under the patient's clothing. In accordance with a physician's determination, the wearable medical device is applicable to the skin of the patient and is configured to automatically deliver a dose of the pharmaceutical composition within a predetermined period of time after the wearable medical device is applied to the skin of the patient (such as after a delay of 27 hours). After the device delivers the pharmaceutical composition to the patient, the patient may then remove and discard the device. Some wearable medical devices have the ability to communicate at least one characteristic of the device to a patient. For example, some devices may provide direct on-device visual, audible, or tactile feedback to the patient to inform the patient of the status of the device, such as when the device is delivering the pharmaceutical composition to the patient or when the delivery process is complete. While existing devices provide detachability, one disadvantage is that any visual, audible, or tactile feedback of the device cannot be easily conveyed to the patient because the device is obscured by the patient's clothing or by the device being placed in a particular location on the patient's body. For example, when the device is placed on the back of a patient's arm, the notification emitted by the device is limited in visibility, often requiring a caregiver to observe the notification. Furthermore, when the device is worn on the abdomen of a patient, the device may be hidden by the patient's clothing and the device may not be easily inspected without the patient taking off the clothing. Accordingly, there is a need in the art for a notification device for delivering a pharmaceutical composition to a patient using an auto-injector and for communicating at least one characteristic of the auto-injector. Disclosure of Invention The present disclosure provides a device for delivering a pharmaceutical composition to a patient using an auto-injector and a notification device for communicating at least one characteristic of the auto-injector. In some examples, a drug delivery system for delivering a pharmaceutical composition to a patient may have 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 may be configured to communicate information regarding a status of at least one characteristic of the delivery device. The delivery device may be a wearable automatic injector configured to be worn on the skin of a patient. The notification device may have at least one indicator. The at least one indicator may be a visual indicator, an audible indicator, a tactile indicator, or a combination thereof. The notification device may be a wristband. The at least one characteristic of the delivery device may include a delivery status of the delivery device. According to an embodiment of the invention, a delivery device is configured to deliver a dose of a drug to a patient. The delivery system includes a delivery device having a housing including a viewing window, a flexible container disposed within the housing and configured to store a medicament