Patent Application
20250213783
The present invention relates to a drug delivery device, and more particularly, to a drug delivery device capable of automatically controlling the delivery of a therapeutic substance and providing alarm signals to inform users by detecting the orientation of a drug container.
A glass vial sealed by a rubber stopper is the most widely used drug container for filling pharmaceutical therapeutic substances. To access the therapeutic substance inside a vial, a needle is pierced through the rubber stopper and draws the therapeutic substance from the vial. The drawn therapeutic substance is then injected into human body either manually or by using a device with automated functions. . . . In the case of using a drug delivery device that is based on a vial as the source of a therapeutic substance, air can be inadvertently drawn into the fluid path of a device and then get injected into the body of a human subject. Such inadvertent drawing of air can be caused by over-tilting of a vial as a result of undesired device positioning or human posture, especially when the device containing a vial is worn on the body as a wearable injector. Consequently, injecting excessive air into the body may cause harm to heath. Therefore, a drug delivery device capable of automatically controlling the delivery of therapeutic substance by detecting the orientation of a drug container is an important design consideration for a safe and reliable delivery of a therapeutic substance from a non-collapsible container such as a vial . . . .
The present invention provides a drug delivery device capable of automatically controlling the delivery of a therapeutic substance and providing alarm signals to inform users by detecting the orientation of a drug container for solving the above drawbacks.
According to the claimed invention, a drug delivery device includes a drug container, a peristaltic pump, a drive system, an orientation sensor and an operation processor. The peristaltic pump is engaged with the drug container and adapted to deliver a therapeutic substance from the drug container to a subject. The drive system is adapted to drive the peristaltic pump to move the therapeutic substance from the drug container. The orientation sensor is adapted to detect an orientation of the drug container relative to gravity. The operation processor acquires a pre-set program, in response to delivered volumes of the therapeutic substance and the orientation of the drug container, and is adapted to provide an output signal to control delivery of the therapeutic substance.
According to the claimed invention, the drug container is a vial made by hard materials, and the peristaltic pump takes out the therapeutic substance from the vial by suction.
According to the claimed invention, the orientation sensor acquires the orientation of the drug container by detecting an angle difference between a longitudinal direction of the drug container and a direction of the gravity.
According to the claimed invention, the operation processor acquires the pre-set program containing specific parameters, and includes the delivered volumes and/or time progression of the delivery of the therapeutic substance.
According to the claimed invention, the operation processor defines a first angle boundary and a second angle boundary in accordance with the specific parameters.
According to the claimed invention, the operation processor acquires the pre-set program containing the specific parameters, the operation processor pauses the delivery of the therapeutic substance when the orientation of the drug container is greater than the second angle boundary.
According to the claimed invention, the operation processor acquires the pre-set program containing the specific parameters, the operation processor maintains the delivery of the therapeutic substance when the orientation of the drug container is smaller than or equal to the second angle boundary.
According to the claimed invention, the operation processor acquires the pre-set program containing the specific parameters, the operation processor maintains the delivery of the therapeutic substance when the orientation of the drug container is smaller than or equal to the first angle boundary.
According to the claimed invention, the drug delivery device further includes a memory unit electrically connected to the operation processor, and the operation processor acquires the specific parameters for searching the first angle boundary and the second angle boundary in accordance with the specific parameters from the memory unit.
According to the claimed invention, the drug delivery device further includes a case or multiple cases assembled together as a single structure adapted to accommodate the drug container, the peristaltic pump, the orientation sensor, the drive system, and the operation processor.
According to the claimed invention, a drug delivery device includes a drug container, a peristaltic pump, a drive system, an orientation sensor, an operation processor and an alarm system. The peristaltic pump is engaged with the drug container and adapted to deliver a therapeutic substance from the drug container to a subject. The drive system is adapted to drive the peristaltic pump to move the therapeutic substance from the drug container. The orientation sensor is adapted to detect an orientation of the drug container relative to gravity. The operation processor acquires a pre-set program, in response to delivered volumes of the therapeutic substance and the orientation of the drug container, and is adapted to provide an output signal to control delivery of the therapeutic substance. The alarm system is based on the output signal from the operation processor, and adapted to provide an interface output to inform users a delivery status of the therapeutic substance.
According to the claimed invention, the alarm system includes a single or a plurality of alarm units, the operation processor activates the alarm units to output an alarm signal or a combined alarm signal in response to the orientation greater than the second angle boundary, and the operation processor pauses the delivery of the therapeutic substance.
According to the claimed invention, the alarm system includes a single or a plurality of alarm units, the operation processor activates the alarm units to output an alarm signal or a combined alarm signal in response to the orientation greater than the first angle boundary but smaller than or equal to the second angle boundary, and the operation processor maintains the delivery of the therapeutic substance.
According to the claimed invention, the operation processor is further adapted to maintain the delivery of the therapeutic substance and not actuate the alarm system in response to the orientation smaller than or equal to the first angle boundary.
The drug delivery device of the present invention can be hung around the user's neck, tied to the arm or the chest, or placed in the backpack or the waist bag; placement of the drug delivery device is not limited to the foresaid position or any specific position, and can be applied for a wide range of application. The drug delivery device can utilize the orientation sensor to sense the orientation of the drug container relative to the gravity, and the peristaltic pump and the alarm unit can be immediately respond to the variation of the orientation to ensure the therapeutic substance can be injected into the user accurately and safely within the predefined angle boundary, for enhancing operation safety and providing enhanced user experience.
These and other objectives of the present invention will no doubt become obvious to those of ordinary skill in the art after reading the following detailed description of the preferred embodiment that is illustrated in the various figures and drawings.
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The drive system 15 can be a motor, a micro electromechanical structure or any component that can provide rotational motion, and can be used to drive the peristaltic pump 14 to move the therapeutic substance from the drug container 12. The orientation sensor 16 can be used to detect orientation V of the drug container 12 relative to the gravity G. Generally, the orientation sensor 16 can acquire an angle difference between a longitudinal direction D of the drug container 12 and a direction of the gravity G for setting as the orientation V; however, the present invention may utilize other reference line of the drug container 12 to define the orientation V relative to the gravity G. The alarm system 18 can output a tactile reminder, a visual reminder and/or an audible reminder, which depends on a design demand. The alarm system 18 may include a single or a plurality of alarm units, which are adapted to provide an interface output to output an alarm signal or a combined alarm signal, for informing users the delivery status of the therapeutic substance. A property of the alarm unit is designed in accordance with the tactile reminder, the visual reminder and/or the audible reminder that are output by the alarm system 18, and a detailed description is illustrated later.
The memory unit 20 can store the first angle boundary IAB and the second angle boundary OAB relevant to a specific parameter of the drug container 12. Storage information of the memory unit 20 is not limited to the foresaid embodiment, and depends on the design demand. The specific parameter can be delivered volumes of the therapeutic substance inside the drug container 12 and/or time progression of the delivery of the therapeutic substance. The drug delivery device 10 can analyze an operation parameter of the drive system 15 (such as a number of turns that an element of the drive system 15 is rotated) or any available parameter of other elements to decide the delivered volumes of the therapeutic substance inside the drug container 12; variation of deciding the delivered volumes can depend on the design demand. In addition, the residual volumes in the drug container 12 can be equal to a difference between the total initial volumes of the therapeutic substance inside the drug container 12 and the delivered volumes of the therapeutic substance, so that the specific parameter may be expressed in various ways as the delivered volumes of therapeutic substance or the residual volumes in the drug container 12. The drug delivery device 10 may optionally include a timer used to count the time progression of the delivery of the therapeutic substance. The foresaid specific parameter can be a vial feature or a preset barcode of the drug container 12. The drug delivery device 10 can read and identify the specific parameter of the drug container 12, and search the corresponding first angle boundary IAB and the corresponding second angle boundary OAB from a database of the memory unit 20.
The operation processor 22 can be electrically connected to the peristaltic pump 14, the orientation sensor 16, the alarm system 18 and the memory unit 20. The operation processor 22 may acquire a pre-set program from the memory unit 20 that includes the specific parameter, and the specific parameter includes, but is not limited to, the delivered volumes of the therapeutic substance inside the drug container 12 and/or the time progression of the delivery of the therapeutic substance. The operation processor 22 can acquire the first angle boundary IAB and the second angle boundary OAB relevant to the drug container 12 from the memory unit 20, and decide whether to actuate the peristaltic pump 14 and/or the alarm system 18 in accordance with a comparison result of the orientation V to the first angle boundary IAB and the second angle boundary OAB. The drug delivery device 10 can further include a protective case 24 used to accommodate the drug container 12, the peristaltic pump 14, the orientation sensor 16, the memory unit 20 and the operation processor 22 for protection. The protective case 24 can be designed as one case, or multiple cases assembled together as a single structure. Variation of the protective case 24 can depend on a design demand.
As mentioned above, the alarm system 18 can provide the tactile reminder, the visual reminder and/or the audible reminder, and may be disposed inside the protective case 24 or on an outer surface of the protective case 24 in accordance with an actual application. For example, the alarm system 18 which outputs the visual reminder can be disposed on the outer surface of the protective case 24, so the user can directly see the visual reminder displayed by or on the visual reminder. The alarm system 18 which outputs the audible reminder and/or the tactile reminder can be optionally disposed inside or on the outer surface of the protective case 24; the alarm system 18 can be set on any position that the user can clearly hear voice or hear vibration.
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In the preferred embodiment, the delivery initiation angle of each boundary of the first angle boundary IAB and the second angle boundary OAB can be smaller than the delivery ending angle of the same boundary of the first angle boundary IAB and the second angle boundary OAB, which depends on the design demand.
In the operation process, the operation processor 22 can set the corresponding first angle boundary IAB and the corresponding second angle boundary OAB in accordance with the specific parameter of the drug container 12. For example, the protective case 24 may be designed to accommodate the drug container 12 with the specific vial feature, and the operation processor 22 can read the first angle boundary IAB and the second angle boundary OAB that are relevant to the specific vial feature directly from the memory unit 20; besides, the protective case 24 may be designed to accommodate the drug container 12 with various types, and the operation processor 22 can identify the preset barcode printed on the drug container 12, or the user can manually input the vial feature of the drug container 12 via an operation interface, so the operation processor 22 can search the suitable first angle boundary IAB and the suitable second angle boundary OAB within the database of the memory unit 20.
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The orientation V can be interpreted as staying in the safe zone when the orientation Vis smaller than or equal to the first angle boundary IAB, and delivery of the peristaltic pump 14 can be maintained and the alarm system 18 is not actuated; the orientation V can be interpreted as staying in the danger zone when the orientation V is greater than the first angle boundary IAB but smaller than or equal to the second angle boundary OAB, and the delivery of the peristaltic pump 14 can be maintained and the alarm system 18 is actuated; the orientation V can be interpreted as staying in the pause zone when the orientation Vis greater than the second angle boundary OAB, and the delivery of the peristaltic pump 14 can be paused and the alarm system 18 can be optionally shut down or actuated. It should be mentioned that the alarm system 18 is an optional element, which means the drug delivery device 10 may exclude the alarm system 18, and the operation processor 22 can only maintain or pause the delivery of the peristaltic pump 14 in accordance with a comparison result of the orientation V to the first angle boundary IAB and/or the second angle boundary OAB; the alarm system 18 is removed or shut down.
Therefore, the orientation V being smaller than or equal to the first angle boundary IAB can indicate that the drug delivery device 10 is set in an upright position, so the delivery of the peristaltic pump 14 can be maintained. The orientation V being greater than the first angle boundary IAB but smaller than or equal to the second angle boundary OAB can indicate that the drug delivery device 10 is slightly tilted within the allowable error, so the delivery of the peristaltic pump 14 can be maintained, and the alarm system 18 can be actuated to remind the user to not further tilt the drug delivery device 10 or to calibrate the drug delivery device 10 back to the upright position. The orientation V being greater than the second angle boundary OAB can indicate that the drug delivery device 10 is excessively tilted and the peristaltic pump 14 may inject gaseous matter from the drug container 12 into the subject, so the delivery of the peristaltic pump 14 is immediately paused.
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In another possible variation, the base 32 can be the display panel, and the movable element 34 can be a specific pattern displayed on the display panel. When the orientation V is smaller than or equal to the first angle boundary IAB, the movable element 34 can be located at the central region R1 of the base 32 and display as the specific green pattern. When the orientation Vis greater than the first angle boundary IAB but smaller than or equal to the second angle boundary OAB, the movable element 34 can be located at the side region R2 of the base 32 and display as the specific green pattern or the specific yellow pattern. When the orientation V is greater than the second angle boundary OAB, the movable element 34 can be stayed at the side region R2 of the base 32 and display as the specific red pattern.
Moreover, the alarm system 18 can further include a speaker and/or a piezoelectric element, which is electrically connected to the operation processor 22 and not shown in the figures. The operation processor 22 can drive the speaker to output an audio signal, or drive the piezoelectric element to generate a vibration amplitude in accordance with the orientation V varied relative to the first angle boundary IAB and/or the second angle boundary OAB. For example, when the orientation Vis smaller than or equal to the first angle boundary IAB, the speaker may not output the audio signal or output the week beep, and the piezoelectric element may be not vibrated or generate the weak vibration amplitude. When the orientation V is greater than the first angle boundary IAB but greater than or smaller than or equal to the second angle boundary OAB, the speaker may not output the audio signal or output the medium volume beep, and the piezoelectric element may be not vibrated or generate the medium intensity vibration amplitude. When the orientation Vis greater than the second angle boundary OAB, the speaker can output the harsh beep and the piezoelectric element can generate the high intensity vibration amplitude.
In other possible embodiment, the alarm system 18 may integrate the above-mentioned types to simultaneously provide two or three types of the tactile reminder, the visual reminder and the audible reminder. In addition, the drug delivery device 10 can further include the operation interface, and the user can utilize the operation interface to manually select or switch the alarm system 18 to output the tactile reminder, the visual reminder and/or the audible reminder. Application of the alarm system 18 and the operation interface can depend on the actual demand.
In conclusion, the drug delivery device of the present invention can be hung around the user's neck, tied to the arm or the chest, or placed in the backpack or the waist bag; placement of the drug delivery device is not limited to the foresaid position or any specific position, and can be applied for a wide range of application. The drug delivery device can utilize the orientation sensor to sense the orientation of the drug container relative to the gravity, and the peristaltic pump and the alarm system can be immediately respond to the variation of the orientation to ensure the therapeutic substance can be injected into the user accurately and safely within the predefined angle boundary, for enhancing operation safety and providing enhanced user experience.
Those skilled in the art will readily observe that numerous modifications and alterations of the device and method may be made while retaining the teachings of the invention. Accordingly, the above disclosure should be construed as limited only by the metes and bounds of the appended claims.
