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WO2024179717A1 - Method for automatic priming a medicament container - Google Patents

Method for automatic priming a medicament container Download PDF

Info

Publication number
WO2024179717A1
WO2024179717A1 PCT/EP2023/087962 EP2023087962W WO2024179717A1 WO 2024179717 A1 WO2024179717 A1 WO 2024179717A1 EP 2023087962 W EP2023087962 W EP 2023087962W WO 2024179717 A1 WO2024179717 A1 WO 2024179717A1
Authority
WO
WIPO (PCT)
Prior art keywords
medicament delivery
priming
delivery device
medicament
disposable cassette
Prior art date
Application number
PCT/EP2023/087962
Other languages
French (fr)
Inventor
Daniel Carlsson
Daniel SÄLL
Original Assignee
Shl Medical Ag
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Shl Medical Ag filed Critical Shl Medical Ag
Publication of WO2024179717A1 publication Critical patent/WO2024179717A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3146Priming, e.g. purging, reducing backlash or clearance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403Ampoule inserted into the ampoule holder
    • A61M2005/2407Ampoule inserted into the ampoule holder from the rear
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2485Ampoule holder connected to rest of syringe
    • A61M2005/2492Ampoule holder connected to rest of syringe via snap connection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M2005/31588Constructional features or modes of drive mechanisms for piston rods electrically driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/21General characteristics of the apparatus insensitive to tilting or inclination, e.g. spill-over prevention
    • A61M2205/215Tilt detection, e.g. for warning or shut-off
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6036General characteristics of the apparatus with identification means characterised by physical shape, e.g. array of activating switches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/82Internal energy supply devices
    • A61M2205/8206Internal energy supply devices battery-operated

Definitions

  • the present disclosure generally relates to medical devices for medicament administration.
  • a number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and on-body devices. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations do still exist in the current technology.
  • the medicament container holding the medicament may comprise air or gas trapped inside the medicament container which may disturb, or complicate, the medicament administration.
  • a medicament container comprises several doses of medicament, and it is important to administer the correct amount of medicament in every dose. Air or gas trapped inside the medicament container may result in an inadequate amount of medicament in at least one dose. There are also other reasons why it is desirable to remove air or gas prior to a medicament delivery event.
  • the medicament container may be subject to priming, in which air or gas is removed prior to a medicament delivery event.
  • An object of the present disclosure is to provide a method for automatic priming a medicament container accommodated within a disposable cassette of a medicament delivery device which solves, or at least mitigates problems of the prior art.
  • a method for automatic priming a medicament container accommodated within a disposable cassette of a medicament delivery device having a proximal end and a distal end the medicament container comprising a medicament delivery member having a proximal end
  • the medicament delivery device comprising a power module having a plunger rod configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member, a drive unit configured to move the plunger rod in the proximal direction, and an accelerometer for determining orientation and acceleration of the medicament delivery device, the method comprising:
  • the first priming parameter being the orientation of the medicament delivery device determined by the accelerometer
  • the second priming parameter being related to a physical action of moving a part of the medicament delivery device
  • the priming of the medicament container can thus be achieved in an automatic and improved manner.
  • an automatic priming of the medicament container can be performed in an advantageous manner.
  • any trapped air or gas in the medicament container is likely to be migrated to a location near the medicament delivery member, typically at the top of the medicament container, and can thus be expelled upon movement of the plunger rod in the proximal direction.
  • the physical action of moving a part of the medicament delivery device associated with the second priming criterium results in an impact of the medicament container causing, or at least increasing the likelihood of, trapped air or gas to migrate towards the top of the medicament container.
  • variable medicament containers having different volumes are possible to use by the same power module.
  • the volume of the medicament container can range from smaller volumes of about 2 ml to larger volumes of about io ml or more depending on the size of the disposable cassette.
  • the engagement of the disposable cassette with the power module forming the medicament delivery device is the same.
  • the disposable cassette is sometimes simply referred to as “the cassette” throughout this application.
  • air is to be interpreted broadly, and may be referring to any type of gas containing oxygen and/or nitrogen, typically as air bubbles or gas bubbles. Priming may thus be referred to as the action of expelling air bubbles or gas bubbles from the medicament container.
  • distal direction refers to the direction pointing away from the dose delivery site during use of the medicament delivery device.
  • distal part/end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site.
  • proximal direction refers to the direction pointing towards the dose delivery site during use of the medicament delivery device.
  • proximal part/end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.
  • longitudinal refers to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and/or component.
  • transverse refers to a direction generally perpendicular to the longitudinal direction.
  • circumference refers to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component.
  • radial or radially refer to a direction extending radially relative to the axis
  • rotation refer to rotation relative to the axis
  • the automatic priming is performed in response to fulfilling the first priming criterium prior to fulfilling the second priming criterium.
  • the cassette is positioned, and identified as being positioned, such that the proximal end of the medicament delivery member points upwards, prior to the identification of the presence of the physical action of moving a part of the medicament delivery device, thereby improving the likelihood of trapped air or gas to migrate towards the top of the medicament container, prior to automatically moving the plunger rod in the proximally direction to act on the medicament container and release air or gas through the proximal end of the medicament delivery member.
  • the first criterium is fulfilled while, or during, fulfilment of the second criterium.
  • the automatic priming of the medicament container may be performed as a direct consequence of identifying that the first and second criteria are fulfilled, e.g. within 1 second or 2 seconds of identifying that the second criterium is fulfilled.
  • the automatic priming is performed by moving, by the drive unit, the plunger rod to a predefined priming position.
  • the priming of the medicament container may be performed in a predefined manner.
  • sufficient amount of air or gas, typically all of the entrapped air or gas, in the medicament container may be released from the medicament container via the medicament delivery member during the automatic priming, but only a small amount of medicament.
  • the amount of medicament expelled from the medicament container during the automatic priming may be controlled by the predefined priming position of the plunger rod.
  • the predefined priming position is corresponding to the volume of the medicament container. That is, a certain volume of the medicament container may correspond to an associated predefined priming position of the plunger rod.
  • the predefined priming position of the plunger rod can be adapted to the volume of the medicament container.
  • the method further comprising identifying the physical action of moving a part of the medicament delivery device by the accelerometer, wherein the second priming parameter is defined by such identification.
  • the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as a physical action of moving a part of the medicament delivery device which is detected by the accelerometer.
  • the physical action of moving a part of the medicament delivery device may be of such nature that the accelerometer can detect it.
  • the sensitivity of the accelerometer is adapted accordingly.
  • the sensitivity of the accelerometer is adapted such that the physical action of moving a part of the medicament delivery device that causes an impact of the medicament container resulting in, or at least increasing the likelihood of, trapped air or gas migrating towards the top of the medicament container, is detected.
  • the physical action of moving a part of the medicament delivery device identified by the accelerometer is a repetitive tapping of, or on, the medicament delivery device.
  • the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as a physical action of moving a part of the medicament delivery device which is detected by the accelerometer as a tapping of, or on, the medicament delivery device.
  • Such repetitive tapping is an example of a physical action of moving a part of the medicament delivery device that causes an impact of the medicament container resulting in, or at least increasing the likelihood of, trapped air or gas migrating towards the top of the medicament container.
  • the physical action of moving a part of the medicament delivery device may e.g. be the physical action of moving the medicament container itself, e.g. by tapping it against a hard surface, or by using a finger to tap on the medicament delivery device.
  • the repetitive tapping of, or on, the medicament delivery device comprises at least three successive tappings.
  • the plunger rod is typically moved, by the drive unit, subsequent to the last of the at least three successive tappings.
  • the disposable cassette comprises a cap protecting the medicament delivery member, wherein the physical action of moving a part of the medicament delivery device identified by the accelerometer is a cap removal action.
  • the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as a physical action of moving a part of the medicament delivery device which is detected by the accelerometer as a cap removal action.
  • the delivery member is made exposed and air or gas, and medicament, may be expelled via the delivery member upon movement of the plunger rod in the proximal direction.
  • the cap removal action is another example of a physical action of moving a part of the medicament delivery device that causes an impact of the medicament container resulting in, or at least increasing the likelihood of, trapped air or gas migrating towards the top of the medicament container.
  • the power module comprises a proximal receiving interface adapted to receive the disposable cassette
  • the method further comprises installing the disposable cassette into the power module via the proximal receiving interface, wherein the physical action of moving a part of the medicament delivery device is related to such disposable cassette installation action.
  • the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as movement related to installing the disposable cassette into the power module via the proximal receiving interface.
  • the power module comprises an activation interface and a first switch
  • the disposable cassette comprises a tubular main body and at least one distally extending protrusion that extend distally away from a distal end of the tubular main body
  • the method further comprises, upon the disposable cassette installation action, moving the distally extending protrusion to abut against and push the activation interface in a distal direction to actuate the first switch, wherein the physical action of moving a part of the medicament delivery device is the movement to cause the activation of the first switch.
  • the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as movement of the first switch.
  • the distally extending protrusion may comprise a distally facing surface that is configured to abut against and push the activation interface of the medicament delivery device in the distal direction to cause actuation of the first switch.
  • a medicament delivery device comprising a disposable cassette accommodating a medicament container, the medicament delivery device having a proximal end and a distal end and the medicament container comprising a medicament delivery member having a proximal end
  • the medicament delivery device comprising: a power module having a plunger rod configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member; a drive unit configured to move the plunger rod in the proximal direction; an accelerometer for determining orientation and acceleration of the medicament delivery device; and a control unit configured to: determine a first priming parameter, the first priming parameter being the orientation of the medicament delivery device determined by the accelerometer, determine a second priming parameter, the second priming parameter being related to a physical action of moving a part of the medicament delivery device, identify fulfilment of a first priming criterium of the first priming parameter as a position in which the medicament delivery device accommodating the cassette is arranged such that the proximal end of the
  • the accelerometer is configured to identify the physical action of moving a part of the medicament delivery device, wherein the control unit is configured to define the second priming parameter by such identification.
  • the control unit may be configured to define the second priming parameter as the physical action of moving a part of the medicament delivery device which is detected by the accelerometer.
  • the disposable cassette comprises a cap protecting the medicament delivery member, wherein the accelerometer is configured to identify a cap removal action as the physical action of moving a part of the medicament delivery device.
  • the control unit may be configured to define the second priming parameter as the physical action of moving a part of the medicament delivery device which is detected by the accelerometer as a cap removal action.
  • the power module comprises a proximal receiving interface adapted to receive the disposable cassette, the control unit being configured to identify installation of the disposable cassette into the power module via the proximal receiving interface and to define the second priming parameter based on such disposable cassette installation action.
  • the control unit may be configured to define the second priming parameter as the physical action of moving a part of the medicament delivery device as movement related to installing the disposable cassette into the power module via the proximal receiving interface.
  • the power module comprises an activation interface and a first switch
  • the disposable cassette comprises a tubular main body and at least one distally extending protrusion that extend distally away from a distal end of the tubular main body and is configured to, upon the disposable cassette installation action, move to abut against and push the activation interface in a distal direction to actuate the first switch
  • the control unit is configured to define the second priming parameter as the activation of the first switch
  • the control unit may be configured to define the second priming parameter as the physical action of moving a part of the medicament delivery device as movement of the first switch.
  • the power module comprises the drive unit. Additionally or alternatively, the power module comprises the accelerometer. Additionally or alternatively, the power module comprises the control unit.
  • the tubular main body of the disposable cassette comprises a radially extending protrusion on a radially outwards facing surface, the radially extending protrusion includes a proximally facing surface.
  • the disposable cassette is attachable to a proximal end of the power module by insertion of the disposable cassette in the previously mentioned proximal receiving interface, and a subsequent axial rotation of the disposable cassette, whereby the radially extending protrusion is configured to slide on a curved distally facing surface of the receiving interface of the power module until the proximally facing surface engages with a distally facing surface of the receiving interface to longitudinally lock the disposable cassette in an attached position in the receiving interface.
  • the disposable cassette comprises an electronic tag attached to a distal end of the tubular main body, the electronic tag having stored data that is related to the medicament contained within the tubular main body, wherein the data is readable by an electronic reader of the medicament delivery device when the disposable cassette is in the attached position.
  • the electronic tag advantageously enables for providing the data to the medicament delivery device to make corresponding settings.
  • the stored data may furthermore be related to the volume of the medicament container.
  • the previously mentioned actuation of the first switch activates the electronic reader.
  • the activation interface is advantageous pushed without any additional required action from the user, to activate the electronic reader.
  • the distally extending protrusion comprises a distally facing inclined surface inclined with respect to a longitudinal axis of the tubular main body, wherein the distally facing inclined surface is arranged to interact with a surface of the activation interface when the disposable cassette is rotated further.
  • the distally facing inclined surface facilitates for an axial motion of the activation interface caused by the interaction.
  • the interaction between the distally facing inclined surface and the surface of the activation interface cause the activation interface to move distally.
  • the activation interface activates a second switch when it is moved distally.
  • the disposable cassette may comprise a delivery member cover, which upon exertion of a force in the distal direction, e.g. by pushing the delivery member cover against a medicament delivery site, interacts with the activation interface causing the activation interface to move further distally to activate the second switch.
  • the activation of the second switch actuates further movement of the plunger rod in the proximal direction to act on the medicament container expel medicament through the proximal end of the medicament delivery member.
  • the plunger rod is typically moved by the drive unit.
  • the disposable cassette comprises a second set of radially extending protrusions on the radially outwards facing surface that are configured to engage in corresponding radially inner facing slots of the receiving interface to rotationally lock the disposable cassette in the receiving interface.
  • the second set of radially extending protrusions may be longitudinal ribs.
  • the disposable cassette comprises an activation ring removably attached to the tubular body, the activation ring comprises the at least one distally extending protrusion.
  • the previously mentioned electronic tag may be attached to the activation ring.
  • the activation ring may comprise two distally extending protrusion symmetrically arranged with respect to a longitudinal axis of the tubular main body.
  • the symmetric arrangement provides for an evenly distributed force on the activation surface when the disposable cassette is inserted in the receiving interface of the power module.
  • the disposable cassette comprises a plunger rod adapter fitted in the tubular main body and being configured to be pushed proximally by the plunger rod of the medicament delivery device during automatic priming or a medicament delivery event.
  • the disposable cassette comprises a further protrusion on the radially outwards facing surface of the tubular main body, the further protrusion being located proximally with respect to the radially extending protrusion, the further protrusion being configured to abut against the receiving interface to limit the insertion length of the disposable cassette in the receiving interface. In this way, the disposable cassette is not inserted too far in the receiving interface.
  • the attachment between the disposable cassette and the receiving interface is a bayonet coupling.
  • the activation interface comprises a first and second distally extending arms extending towards the respective first and second switches, wherein the first arm reaches and causes the activation of the first switch when the activation interface is moved distally.
  • the activation interface comprises an inclined surface adapted to receive the distally extending protrusion of the cassette when the cassette is further rotated in the receiving interface, whereby an interaction between the distally facing surface of the cassette and the inclined surface of the activation interface cause the activation interface to move distally.
  • the distal motion of the activation interface may cause the second arm to reach to and active the second switch.
  • the distal ends of the first arm and the second arm are asymmetric.
  • the subassembly advantageously comprises a spring arranged to spring load the activation interface away from the first switch and the second switch.
  • the medicament container is a syringe.
  • the medicament delivery member may thus be a needle.
  • the medicament delivery device comprises an infusion set including a flexible tube connected to a through hole of the disposable cassette at proximal end thereof. At the other end of the tube, a needle is typically attached via a pad at a medicament delivery site.
  • Fig. 1 is a perspective view of a medicament delivery device according to embodiments of the present disclosure
  • Fig. 2 is a perspective view of the medicament delivery device with housing removed according to embodiments of the present disclosure
  • Fig. 3 is a perspective view of a disposable cassette according to embodiments of the present disclosure.
  • Fig. 4 is a perspective view of a receiving interface according to embodiments of the present disclosure.
  • Fig. 5 is a perspective view of a receiving interface according to embodiments of the present disclosure.
  • Fig. 6 is a perspective view of an activation interface according to embodiments of the present disclosure
  • Fig. 7 is a close-up view of a distal end of the disposable cassette and the activation interface according to embodiments of the present disclosure
  • Fig. 8 is a close-up view of a distal end of the disposable cassette and the activation interface according to embodiments of the present disclosure
  • Fig. 9 is a flowchart illustrating the steps of a method in according to embodiments of the present disclosure.
  • Fig 1 shows an example of a medicament delivery device 1 such as an autoinjector of an injection device according to embodiments of the present disclosure.
  • the medicament delivery device 1 is configured to expel medicament from a medicament container 13 via a medicament delivery member 2, here embodied as needle, to a user at a dose delivery site.
  • the medicament delivery device 1 extends from a proximal end la to a distal end lb relative to the axis 112.
  • the axis 112 is in Fig. 1 a centre axis, from which a circumferential direction 131 relative to the centre axis 112 and a radial direction 132 extending radially relative to the centre axis 112, can be defined.
  • the medicament delivery device 1 comprises a power module 3 which is connectable to a disposable cassette 4 having a proximal end 4a and a distal end 4b.
  • the power module 3 has a corresponding proximal end 3a and distal end 3b, and comprises a housing 6.
  • the disposable cassette 4 comprises a tubular main body 11 accommodating the medicament container 13 and the thereto arranged medicament delivery member 2 having a proximal end 2a.
  • the proximal end 2a is the tip of the needle.
  • the disposable cassette 4 is typically adapted to accommodate medicament containers of different volumes, for example ranging from about 1 ml to about 10 ml.
  • the power module 3 comprises a receiving interface 10 configured to received and lock the disposable cassette 4 to the proximal end 3a of the power module 3.
  • the disposable cassette 4 comprises a cap 5 arranged to protect the medicament delivery member 2.
  • the cap 5 is shown proximally of the disposable cassette 4, as after the cap 5 has been removed from the medicament delivery member 2 during a cap removal action.
  • the disposable cassette 4 may comprise a delivery member cover 7 configured to cover the delivery member 2.
  • the delivery member cover 7 is configured to move axially relative to the tubular main body 11. For example, the delivery member cover 7 may be moved from a protracted position into a retracted position, shown in Fig. 1, in which the delivery member cover 7 is received further into the tubular main body 11 in order to expose the delivery member 2 of the medicament container 13.
  • Fig. 2 is a partly exploded view of the medicament delivery device 1 with the housing 6 removed from the power module 3 and the cap 5 has been removed from the disposable cassette 4.
  • the housing 6 may be divided in two parts, a first housing part 6a and a second housing part 6b, wherein the second housing part 6b is arranged distally of the first housing part 6a.
  • the power module 3 comprises a plunger rod 83 configured to move proximally to act on the medicament container 13 to expel air or gas, and medicament, via the proximal end 2a of the medicament delivery member 2.
  • the medicament delivery device 1 further comprises a drive unit 82 configured to move the plunger rod 83 in the proximal direction, and an accelerometer 84 configured to determine the orientation and acceleration of the medicament delivery device 1.
  • the drive unit 82 and the accelerometer 84 are comprised in the power module 3, and housed withing the housing 6.
  • the power unit 3 may optionally comprise an antenna 80 (or a set of antennas) and a power pack 86 with electronic circuitry and batteries.
  • Fig. 3 is a perspective view of a disposable cassette 4 according to embodiments of the present disclosure.
  • the disposable cassette 4 comprises a tubular main body 11 adapted to receive the medicament container 13 radially inside the tubular main body 11.
  • the tubular main body 11 extends from a proximal end 11a to a distal end 11b, wherein the proximal end 11a of the tubular main body 11 typically coincides with the proximal end 4a of the cassette 4.
  • the tubular main body 11 has a through hole 15 at its proximal end 11a through which the medicament delivery member 2 (not shown in Fig. 3) extends during a medicament delivery event.
  • the tubular main body 11 comprises a radially extending protrusion 19 on a radially outwards facing surface 21.
  • the radially extending protrusion 19 includes a proximally facing surface 23.
  • the disposable cassette 4 comprises an activation ring 27 removably attached to the distal end 11b of the tubular body 11.
  • the activation ring 27 may form at least a part of the distal end 4b of the disposable cassette 4.
  • the disposable cassette 4 may optionally comprise an electronic tag 25, here attached at a distal end portion of the cassette 4.
  • the electronic tag 25 may be attached to the tubular main body 11 or to the activation ring 27.
  • the electronic tag 25 is typically configured to store data that is related to the medicament contained within the medicament container 13, e.g. the medicament volume.
  • the electronic tag 25 and the data therein may be readable by an electronic reader of the medicament delivery device 1 when the disposable cassette 4 is in an attached position in the power module 3.
  • the electronic reader may e.g. comprise the previously mentioned antenna 80.
  • the disposable cassette 4 includes a distally extending protrusion 28 that extends distally away from a distal end 11b of the tubular main body 11, or as in Fig. 3 exemplified as two separate distally extending protrusions 28.
  • each one of the distally extending protrusions 28 is comprised in the activation ring 27.
  • Each one of the distally extending protrusions 28 comprises a distally facing surface 29 and a distally facing inclined surface 36 inclined with respect to the longitudinal axis 102 of the tubular main body 11.
  • the distally facing inclined surfaces 36 are connected with the distally facing surfaces 29 at a respective oblique angle.
  • the activation ring 27 comprises two distally extending protrusions 28 symmetrically arranged with respect to the longitudinal axis 102 of the tubular main body 11.
  • a further protrusion 33 may optionally be arranged on the radially outwards facing surface 21 of the tubular main body 11.
  • the further protrusion 33 is in Fig. 3 located proximally with respect to the radially extending protrusion 19.
  • the further protrusion 33 is an annular protrusion that extend around the circumference, preferably the entire circumference, of the tubular main body 11.
  • the further protrusion 33 is configured to abut against the proximal end 3a of the power module 3, or of the receiving interface 10, to limit the insertion length of the disposable cassette 4 in the receiving interface 10.
  • the further protrusion 33 may act like stop for preventing the cassette 4 to be inserted too deep into the power module 3 and the receiving interface 10.
  • Figs. 4 and 5 are different perspective views of a proximal receiving interface 10 of the medicament delivery device 1.
  • the proximal receiving interface 10 is adapted to receive the disposable cassette 4 as previously described.
  • the proximal receiving interface 10 comprising a curved distally facing surface 30 adapted to receive and slidably guide the radially extending protrusion 19 of the cassette 4 in a distal direction when the cassette 4 axially rotates relative to the receiving interface 10.
  • the disposable cassette 4 is first axially inserted into the receiving interface 10.
  • the radially extending protrusion 19 slides on the curved distally facing surface 30 of the receiving interface 10 of the power module 3.
  • the radially extending protrusion 19 slides on the curved distally facing surface 30 until the proximally facing surface 23 engages with a distally facing surface 32 of the receiving interface 10 to longitudinally lock the disposable cassette 4 in an attached position in the receiving interface 10.
  • the receiving interface 10 comprises radially inner facing slots 38 (only one is shown in Fig. 5).
  • the disposable cassette 4 shown in Fig. 3 comprises a second set of radially outwards extending protrusions 34 on the radially outwards facing surface 21 that are configured to engage with the corresponding radially inner facing slots 38 to rotationally lock the disposable cassette 4 in the receiving interface 10.
  • the second set of radially extending protrusions 34 are longitudinal ribs.
  • Fig. 6 is a perspective view of an activation interface 40 according to embodiments of the present disclosure.
  • the activation interface 40 comprises a proximal end 40a and a distal end 40b.
  • the proximal end 40a comprises protrusions 42 that extend in a proximal direction.
  • the protrusions 42 are configured to receive the distally extending protrusions 29 of the cassette 4 when the cassette 4 is rotated as will be discussed further herein.
  • Each one of the protrusions 42 comprises an inclined surface 45 adapted to receive the distally facing inclined surfaces 36 of the distally extending protrusions 28 of the disposable cassette 4 when the disposable cassette 4 is rotated axially from its attached position.
  • the activation interface 40 comprises a first distally extending arm 44 and second distally extending arm 54.
  • Each one of the first and second distally extending arms 44, 54 comprises a cut-out 46, 56 at the distal end 40b of the cassette, the cut-outs 46, 56 being arranged diagonally with respect to each other so that the first and second distally extending arm 44, 54 are asymmetric.
  • the activation interface 10 further comprises longitudinal ribs 48 on the respective first and second distally extending arm 44, 54 (only the rib 48 of the first distally extending arm 44 is shown in Fig. 6), that are configured to fit in and slide in corresponding slots or grooves 39 (shown in Fig. 5) on a radially inwards facing surface of the receiving interface 10.
  • Figs. 7 and 8 are close-up views of the distal end 4b of the disposable cassette 4 inserted in the receiving interface 10 but not yet mounted by rotating the disposable cassette 4 in the receiving surface 10 as previously described.
  • the first distally extending arm 44 of the activation interface 40 extends towards a first switch 90.
  • the second distally extending arm 54 extends towards a second switch 92.
  • a spring 95 is arranged to spring load the activation interface 40 away from the first switch 90 and the second switch 92.
  • the radially extending protrusion 19 slides on the curved distally facing surface 30 of the receiving interface 10.
  • This sliding motion on the curved surface 30 causes a distal axial motion of the disposable cassette 4 so that the distally facing surface 29 of the protrusions 28 abut against and push on a proximally facing surface 47 the activation interface 40 in a distal direction.
  • the distally facing inclined surfaces 36 interact with the inclined surfaces 45 of the protrusions 42 of the activation interface 40 when the disposable cassette 4 is rotated.
  • the axial rotation for locking of disposable cassette 4 may be about 60 degrees with respect to the receiving interface 10.
  • the spring 95 is compressed by the axial motion of the activation interface 40 caused by the force from the disposable cassette 4 moving distally when mounted in the receiving interface 10.
  • the first distally extending arm 44 of the activation interface 40 will activate the first switch 90.
  • the cut-out 46 of the first distally extending arm 44 is asymmetrically arranged with respect to the cut-out 56 of the second distally extending arm 54 (as shown by comparing Figs. 8 and 9)
  • the second distally extending arm 54 of the activation interface 40 does not reach to activate the second switch 92.
  • the second switch 92 is not activated by mounting the disposable cassette 4 in the receiving interface 10.
  • the second switch 92 may be activated by moving the delivery member cover 7.
  • a force of the delivery member cover 7 in the distal direction e.g. by pushing a proximal end 7a of the delivery member cover 7 against a medicament delivery site
  • the distal end 7b of the delivery member cover interacts with the activation interface 40 causing the activation interface 40 to move further distally such that the second distally extending arm 54 reach to activate the second switch 92.
  • a rotation of the disposable cassette 4 in the opposite direction causes the activation interface 40 to move proximally by the force applied by the spring 95. This may cause deactivation of the first switch 90 and/or the second switch 92 depending on degree of rotation of the disposable cassette 4 that allow the activation interface 40 to move variable distances in the proximal direction.
  • a further rotation in this opposite direction allows for dismounting the cassette 4 from the receiving interface 10 so that it can be disposed of. Subsequently, a new cassette 4 can be mounted to the receiving interface 10 as described herein.
  • Activation of the first switch 90 may e.g. cause activation of the electronic reader of the power module 3 to read the electronic tag 25.
  • Activation of the second switch may e.g. actuate movement of the plunger rod 83 in the proximal direction to act on the medicament container 13 to expel medicament through the proximal end 2a of the medicament delivery member 2.
  • the plunger rod 83 is typically moved by the drive unit 82.
  • the disposable cassette 4 may comprise a plunger rod adapter fitted in the tubular main body 11.
  • the plunger rod adapter is preferably cylindrical and is adapted to be pushed proximally by the plunger rod 83 during a medicament delivery event. The proximal motion of the plunger rod adapter cause expulsion of a medicament from the medicament container 13.
  • Fig. 9 is a flow-chart describing steps of a method for automatic priming the medicament container 13 accommodated within the disposable cassette 4 of the medicament delivery device 1, according to embodiments of the present disclosure. Priming is the action of expelling air bubbles or gas bubbles from the medicament container prior to the medicament delivery event.
  • a first priming parameter is determined, the first priming parameter being the orientation of the medicament delivery device 1 determined by the accelerometer 84.
  • the accelerometer 84 may determine the orientation of the medicament delivery device 1, such as e.g. that the medicament delivery device 1 is oriented with the medicament delivery member 2 pointing upwards or downwards.
  • a step S15 e.g. being a performed subsequent to step S10, the medicament delivery device 1 accommodating the cassette 4 is positioned such that the proximal end 2a of the medicament delivery member 2 points upwards.
  • upwards may here be defined as that the proximal end 2a of the medicament delivery member 2 points upwards along a vertical axis, or at least within 6o degrees of such vertical axis.
  • the medicament delivery device 1 may be positioned with its centre axis 112 coinciding with a vertical axis (the vertical axis coinciding with the gravitational axis) and the proximal end 2a of the medicament delivery member 2 pointing upwards, or the medicament delivery device 1 may be positioned with its centre axis 112 angled at most 60 degrees (in all directions) relative to the vertical axis and the proximal end 2a of the medicament delivery member 2 pointing upwards within those 60 degrees.
  • step S15 may be performed prior to step S10, i.e. the first priming parameter may be determined when the medicament delivery device 1 already is positioned such that the proximal end 2a of the medicament delivery member 2 points upwards.
  • a first priming criterium of the first priming parameter is fulfilled.
  • the first priming criterium is fulfilled by a sub-step 830a of identifying a position of the medicament delivery device 1 such that the proximal end 2a of the medicament delivery member 2 points upwards.
  • the fulfilment of the first priming criterium is achieved subsequent to steps S10 and S15.
  • a second priming parameter is determined, the second priming parameter being related to a physical action of moving a part of the medicament delivery device 1.
  • the determination of the second priming parameter in step S20 may include further defining which part of the medicament delivery device 1 that is moved, and need not to include identifying the actual presence of such movement.
  • a second priming criterium of the second priming parameter is fulfilled.
  • the second priming criterium is fulfilled after a step S40 of identifying a presence of the second priming parameter.
  • step S50 performed in response to fulfilling the first priming criterium in step S30 and fulfilling the second priming criterium in step S48, automatic priming of the medicament container 13 is performed by causing the drive unit 82 to automatically move the plunger rod 83 in the proximally direction to act on the medicament container 13 and release air or gas through the proximal end 2a of the medicament delivery member 2.
  • efficient automatic priming of the medicament container 13 is achieved.
  • step S30 As the first priming criterium is fulfilled by step S30 when the medicament delivery device 1 accommodating the cassette 4 is identified as being positioned such that the proximal end 2a of the medicament delivery member 2 points upwards, and as the second priming criterium is fulfilled by step S48 when a physical action of moving a part of the medicament delivery device 1 is identified as being present, any trapped air or gas in the medicament container 13 is likely to be migrated to a location near the medicament delivery member 2, typically at the top of the medicament container 13, and can thus be expelled upon movement of the plunger rod 83 in the proximal direction.
  • the step S50 of automatic priming is performed in response to the step S30 of fulfilling the first priming criterium prior to the step S48 of fulfilling the second priming criterium, thereby improving the likelihood of trapped air or gas to migrate towards the top of the medicament container 13, prior to automatically moving the plunger rod 83 in the proximally direction.
  • the disposable cassette 4 may comprise a plunger rod adapter adapted to be pushed proximally by the plunger rod 83.
  • the proximal motion of the plunger rod adapter cause expulsion of air or gas through proximal end 2a of the medicament delivery member 2.
  • the step S50 may comprise the sub-step S52 of moving, by the drive unit 82, the plunger rod 83 to a predefined priming position.
  • the priming of the medicament container 13 may be performed in a predefined manner.
  • step S20 The second priming parameter determined in step S20 will now be further exemplified.
  • the physical action of moving a part of the medicament delivery device 1 is identified by the accelerometer 83, wherein the second priming parameter is defined by such identification.
  • the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as a physical action of moving a part of the medicament delivery device 1 which is detected by the accelerometer 83.
  • the sub-step S42 may comprise a first further sub-step 842a of identifying, by the accelerometer 83, a repetitive tapping of, or on, the medicament delivery device 1.
  • a user may move the medicament delivery device 1 itself, e.g. by tapping it against a hard surface, or by using a finger to tap on the medicament delivery device 1.
  • the first sub-step 842a may comprise identifying at least three successive tappings.
  • the determination of the second priming parameter in step S20 may comprise defining the second priming parameter as a repetitive tapping of, or on, the medicament delivery device 1.
  • the sub-step S42 may comprise a second further sub-step 842b, typically instead of first sub-step 842a, of identifying a cap removal action.
  • a user may remove the cap 5 from the disposable cassette 4 and thereby perform the cap removal action.
  • the determination of the second priming parameter in step S20 may comprise defining the second priming parameter as a cap removal action.
  • the physical action of moving a part of the medicament delivery device 1 associated with the second priming parameter may be that of a installing the disposable cassette 4 into the receiving interface 10 described with reference to Figs. 8 and 9.
  • the disposable cassette 4 is installed into the power module 3 via the proximal receiving interface 10, and the physical action of moving a part of the medicament delivery device 1 is related to such disposable cassette installation action.
  • the determination of the second priming parameter in step S20 may comprise defining the second priming parameter as a disposable cassette installation action.
  • the physical action of moving a part of the medicament delivery device 1 associated with the second priming parameter may be related to a further sub-step 844a of sub-step S44, being movement to cause the activation of the first switch 90.
  • the second priming parameter is fulfilled S48.
  • the medicament delivery device 1 may comprise a control unit 85, the control unit 85 being configured to execute at least some of the steps descried with reference to Fig. 9.
  • the control unit may be configured to determine the first priming parameter, the first priming parameter being the orientation of the medicament delivery device 1 determined by the accelerometer 83, as described in step S10.
  • the control unit 85 may be further be configured to determine the second priming parameter, the second priming parameter being related to the physical action of moving a part of the medicament delivery device 1, as previously described.
  • the control unit 85 may be configured to identify fulfilment of the first priming criterium of the first priming parameter as a position in which the medicament delivery device 1 accommodating the cassette 4 is arranged such that the proximal end 2a of the medicament delivery member 2 points upwards, as described in step S30.
  • the control unit 85 may furthermore be configured to identify fulfilment of the second priming criterium by identifying a presence of the second priming parameter, as described in step S48.
  • the control unit 85 may be configured to perform automatic priming of the medicament container 13 in response to identifying fulfilment of the first and second priming criteria by causing the drive unit 82 to automatically move the plunger rod 83 in the proximally direction to act on the medicament container 13 and release air or gas through the proximal end 2a of the medicament delivery member 2.
  • the control unit 85 may be configured to define and identify the second priming parameter as the physical action of moving a part of the medicament delivery device which is detected by the accelerometer 83.
  • control unit 85 may be configured to define and identify the second priming parameter as the physical action of moving a part of the medicament delivery device 1 which is detected by the accelerometer 83 as a cap removal action. Additionally, or alternatively, the control unit 85 may be configured to define and identify the second priming parameter as the physical action of moving a part of the medicament delivery device as movement related to installing the disposable cassette 4 into the power module 3 via the proximal receiving interface 10. The control unit may be configured to define and identify the second priming parameter as the physical action of moving a part of the medicament delivery device 1 as movement of the first switch 90.
  • a medicament delivery device may generally include various other components.
  • a sensor unit which may recognize medicament delivery events, such as the medicament delivery member inserted into an attachment portion of e.g., a pad, injection started, and medicament delivery event ends
  • a memory unit which is configured to store the recorded data during the medicament delivery event
  • a connectivity unit configured to transmit the stored data to a smart device or the network directly
  • a processing unit e.g. the previously described control unit 85
  • user interface units that are configured to provide feedback to the patient, such as status LEDs, haptic, and/or audio feedback.
  • the sensors inside of the pad are configured to recognize the event and give feedback to the patient via haptic/visual or audio elements.
  • the sensors are configured to recognize the event and give feedback to the patient again. Further, the collected data is stored in the memory unit and may be transmitted to the smart device/network via the connectivity unit after the medicament delivery event finishes.
  • the sensor can be one of or the combination of the following: a mechanical switch, a Hall-effect sensor, an accelerometer.
  • the mechanical switch, hall-effect sensor, or accelerometer can be used for detection of the insertion of the medicament delivery member into an injection port.
  • the accelerometer can be used for detecting medicament delivery events.
  • Possible wireless communication methods include Bluetooth and Cellular Networks.
  • Bluetooth connectivity requires a smart device to transmit the stored data to the network and it requires a pairing action between the pad and the smart device before being able to use the supporting pad in case of 2-way connection. But it’s a cheaper alternative and it requires less space on PCB. A l-way connection does not require pairing.
  • the cellular network does not require any pairing process, it can be used as a plug-n-play device, no prior setup is needed, but it’s more expensive and it requires more space on PCB.
  • the processing units may comprise processing circuitry, logic circuit and/or further control units, including a microprocessor, microcontroller, programmable digital signal processor or another programmable device.
  • the processing circuitry may also, or instead, each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor.
  • the processing circuitry includes a programmable device such as the microprocessor, microcontroller or programmable digital signal processor mentioned above, the processor may further include computer executable code that controls operation of the programmable device.
  • 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
  • xemplary drugs that could be included in the injection assemblies 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-ia multiple sclerosis
  • sumatriptan miraines
  • adalimumab rheumatoid arthritis
  • darbepoetin alfa anaemia
  • belimumab lupus
  • peginterferon beta-ia' multiple sclerosis
  • sarilumab rheumatoid arthritis
  • semaglutide type 2 diabetes, obesity
  • dupilumab atopic dermatitis, asthma, nasal polyps, allergies
  • glucagon glucagon
  • immunoglobulins primary immune deficiencies
  • ipilimumab nivolumab
  • pembrolizumab 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 daratumumab
  • gemtuzumab ozogamicin 90-Yttrium- ibritumomab tiux
  • 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.
  • Pharmaceutical formulations may also include separately administered or co-formulated dispersion enhancers, such as hyaluronidase.
  • 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, CDygb 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, CDW137 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, mFOLFOXy, 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, DHAX
  • 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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Abstract

A method for automatic priming a medicament container (13) accommodated within a disposable cassette (4) of a medicament delivery device (1). The method comprises: determining (S10) a first priming parameter, the first priming parameter being the orientation of the medicament delivery device (1) determined by an accelerometer (84); determining (S20) a second priming parameter, the second priming parameter being related to a physical action of moving a part of the medicament delivery device (1), in response of fulfilling (S30) a first priming criterium of the first priming parameter by identifying (S30a) a position of the medicament delivery device (1) accommodating the cassette (4) such that the proximal end (2a) of the medicament delivery member (2) points upwards, and fulfilling (S48) a second priming criterium of identifying (S40) a presence of the second priming parameter, performing automatic priming (S50) of the medicament container (13).

Description

METHOD FOR AUTOMATIC PRIMING A MEDICAMENT CONTAINER
TECHNICAL FIELD
The present disclosure generally relates to medical devices for medicament administration.
BACKGROUND
A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and on-body devices. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations do still exist in the current technology.
For example, the medicament container holding the medicament may comprise air or gas trapped inside the medicament container which may disturb, or complicate, the medicament administration. For example, for certain medicament delivery devices, a medicament container comprises several doses of medicament, and it is important to administer the correct amount of medicament in every dose. Air or gas trapped inside the medicament container may result in an inadequate amount of medicament in at least one dose. There are also other reasons why it is desirable to remove air or gas prior to a medicament delivery event. The medicament container may be subject to priming, in which air or gas is removed prior to a medicament delivery event.
In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, which are set out in more detail below.
SUMMARY
An object of the present disclosure is to provide a method for automatic priming a medicament container accommodated within a disposable cassette of a medicament delivery device which solves, or at least mitigates problems of the prior art.
There is hence provided a method for automatic priming a medicament container accommodated within a disposable cassette of a medicament delivery device having a proximal end and a distal end, the medicament container comprising a medicament delivery member having a proximal end, and the medicament delivery device comprising a power module having a plunger rod configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member, a drive unit configured to move the plunger rod in the proximal direction, and an accelerometer for determining orientation and acceleration of the medicament delivery device, the method comprising:
- determining a first priming parameter, the first priming parameter being the orientation of the medicament delivery device determined by the accelerometer,
- determining a second priming parameter, the second priming parameter being related to a physical action of moving a part of the medicament delivery device,
- in response of fulfilling a first priming criterium of the first priming parameter by identifying a position of the medicament delivery device accommodating the cassette such that the proximal end of the medicament delivery member points upwards, and fulfilling a second priming criterium of identifying a presence of the second priming parameter, performing automatic priming of the medicament container by causing the drive unit to automatically move the plunger rod in the proximally direction to act on the medicament container and release air or gas through the proximal end of the medicament delivery member.
The priming of the medicament container can thus be achieved in an automatic and improved manner. By providing the first priming parameter and the second priming parameter, the second priming parameter being different to the first priming parameter, and the condition of fulfilling the first priming criterium associated with the first priming parameter and fulfilling the second priming criterium associated with the second priming parameter, an automatic priming of the medicament container can be performed in an advantageous manner. In more detail, as the first priming criterium is fulfilled when the medicament delivery device accommodating the cassette is identified as being positioned such that the proximal end of the medicament delivery member points upwards, and as the second priming criterium is fulfilled when a physical action of moving a part of the medicament delivery device is identified as being present, any trapped air or gas in the medicament container is likely to be migrated to a location near the medicament delivery member, typically at the top of the medicament container, and can thus be expelled upon movement of the plunger rod in the proximal direction. For example, the physical action of moving a part of the medicament delivery device associated with the second priming criterium, results in an impact of the medicament container causing, or at least increasing the likelihood of, trapped air or gas to migrate towards the top of the medicament container.
By means of the disposable cassette, variable medicament containers having different volumes are possible to use by the same power module. Thus, the volume of the medicament container can range from smaller volumes of about 2 ml to larger volumes of about io ml or more depending on the size of the disposable cassette. Regardless of medicament volume, the engagement of the disposable cassette with the power module forming the medicament delivery device is the same. The disposable cassette is sometimes simply referred to as “the cassette” throughout this application.
It should be noted that air is to be interpreted broadly, and may be referring to any type of gas containing oxygen and/or nitrogen, typically as air bubbles or gas bubbles. Priming may thus be referred to as the action of expelling air bubbles or gas bubbles from the medicament container. In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site.
Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device.
When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.
Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and/or component.
Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.
Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component.
Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.
According to one embodiment, the automatic priming is performed in response to fulfilling the first priming criterium prior to fulfilling the second priming criterium. Hereby, the cassette is positioned, and identified as being positioned, such that the proximal end of the medicament delivery member points upwards, prior to the identification of the presence of the physical action of moving a part of the medicament delivery device, thereby improving the likelihood of trapped air or gas to migrate towards the top of the medicament container, prior to automatically moving the plunger rod in the proximally direction to act on the medicament container and release air or gas through the proximal end of the medicament delivery member. Typically, the first criterium is fulfilled while, or during, fulfilment of the second criterium. The automatic priming of the medicament container may be performed as a direct consequence of identifying that the first and second criteria are fulfilled, e.g. within 1 second or 2 seconds of identifying that the second criterium is fulfilled.
According to one embodiment, the automatic priming is performed by moving, by the drive unit, the plunger rod to a predefined priming position. Thus, the priming of the medicament container may be performed in a predefined manner. For example, sufficient amount of air or gas, typically all of the entrapped air or gas, in the medicament container may be released from the medicament container via the medicament delivery member during the automatic priming, but only a small amount of medicament. Stated differently, the amount of medicament expelled from the medicament container during the automatic priming may be controlled by the predefined priming position of the plunger rod.
According to one embodiment, the predefined priming position is corresponding to the volume of the medicament container. That is, a certain volume of the medicament container may correspond to an associated predefined priming position of the plunger rod. Hereby, the predefined priming position of the plunger rod can be adapted to the volume of the medicament container.
According to one embodiment, the method further comprising identifying the physical action of moving a part of the medicament delivery device by the accelerometer, wherein the second priming parameter is defined by such identification. Thus, the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as a physical action of moving a part of the medicament delivery device which is detected by the accelerometer. In other words, the physical action of moving a part of the medicament delivery device may be of such nature that the accelerometer can detect it. For example, the sensitivity of the accelerometer is adapted accordingly. For example, the sensitivity of the accelerometer is adapted such that the physical action of moving a part of the medicament delivery device that causes an impact of the medicament container resulting in, or at least increasing the likelihood of, trapped air or gas migrating towards the top of the medicament container, is detected.
According to one embodiment, the physical action of moving a part of the medicament delivery device identified by the accelerometer is a repetitive tapping of, or on, the medicament delivery device. Thus, the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as a physical action of moving a part of the medicament delivery device which is detected by the accelerometer as a tapping of, or on, the medicament delivery device. Such repetitive tapping is an example of a physical action of moving a part of the medicament delivery device that causes an impact of the medicament container resulting in, or at least increasing the likelihood of, trapped air or gas migrating towards the top of the medicament container. The physical action of moving a part of the medicament delivery device, may e.g. be the physical action of moving the medicament container itself, e.g. by tapping it against a hard surface, or by using a finger to tap on the medicament delivery device.
According to one embodiment, the repetitive tapping of, or on, the medicament delivery device comprises at least three successive tappings. Thus, the likelihood of that the physical action causes trapped air or gas migrating towards the top of the medicament container is increased. According to such example, the plunger rod is typically moved, by the drive unit, subsequent to the last of the at least three successive tappings. According to one embodiment, the disposable cassette comprises a cap protecting the medicament delivery member, wherein the physical action of moving a part of the medicament delivery device identified by the accelerometer is a cap removal action. Thus, the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as a physical action of moving a part of the medicament delivery device which is detected by the accelerometer as a cap removal action. By the cap removal action, the delivery member is made exposed and air or gas, and medicament, may be expelled via the delivery member upon movement of the plunger rod in the proximal direction. The cap removal action is another example of a physical action of moving a part of the medicament delivery device that causes an impact of the medicament container resulting in, or at least increasing the likelihood of, trapped air or gas migrating towards the top of the medicament container.
According to one embodiment, the power module comprises a proximal receiving interface adapted to receive the disposable cassette, wherein the method further comprises installing the disposable cassette into the power module via the proximal receiving interface, wherein the physical action of moving a part of the medicament delivery device is related to such disposable cassette installation action. Thus, the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as movement related to installing the disposable cassette into the power module via the proximal receiving interface.
According to one embodiment, the power module comprises an activation interface and a first switch, and the disposable cassette comprises a tubular main body and at least one distally extending protrusion that extend distally away from a distal end of the tubular main body, wherein the method further comprises, upon the disposable cassette installation action, moving the distally extending protrusion to abut against and push the activation interface in a distal direction to actuate the first switch, wherein the physical action of moving a part of the medicament delivery device is the movement to cause the activation of the first switch. Thus, the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as movement of the first switch.
The distally extending protrusion may comprise a distally facing surface that is configured to abut against and push the activation interface of the medicament delivery device in the distal direction to cause actuation of the first switch.
According to a second aspect of the present disclosure, there is provided a medicament delivery device comprising a disposable cassette accommodating a medicament container, the medicament delivery device having a proximal end and a distal end and the medicament container comprising a medicament delivery member having a proximal end, the medicament delivery device comprising: a power module having a plunger rod configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member; a drive unit configured to move the plunger rod in the proximal direction; an accelerometer for determining orientation and acceleration of the medicament delivery device; and a control unit configured to: determine a first priming parameter, the first priming parameter being the orientation of the medicament delivery device determined by the accelerometer, determine a second priming parameter, the second priming parameter being related to a physical action of moving a part of the medicament delivery device, identify fulfilment of a first priming criterium of the first priming parameter as a position in which the medicament delivery device accommodating the cassette is arranged such that the proximal end of the medicament delivery member points upwards, and identify fulfilment of a second priming criterium by identifying a presence of the second priming parameter, and perform automatic priming of the medicament container in response to identifying fulfilment of the first and second priming criteria by causing the drive unit to automatically move the plunger rod in the proximally direction to act on the medicament container and release air or gas through the proximal end of the medicament delivery member. Effects and features of the second aspect are largely analogous to those described above in connection with the first aspect. Embodiments mentioned in relation to the first aspect are largely compatible with the second aspect, and vice versa, of which some are exemplified below.
According to one embodiment, the accelerometer is configured to identify the physical action of moving a part of the medicament delivery device, wherein the control unit is configured to define the second priming parameter by such identification. Thus, the control unit may be configured to define the second priming parameter as the physical action of moving a part of the medicament delivery device which is detected by the accelerometer.
According to one embodiment, the disposable cassette comprises a cap protecting the medicament delivery member, wherein the accelerometer is configured to identify a cap removal action as the physical action of moving a part of the medicament delivery device. Thus, the control unit may be configured to define the second priming parameter as the physical action of moving a part of the medicament delivery device which is detected by the accelerometer as a cap removal action.
According to one embodiment, the power module comprises a proximal receiving interface adapted to receive the disposable cassette, the control unit being configured to identify installation of the disposable cassette into the power module via the proximal receiving interface and to define the second priming parameter based on such disposable cassette installation action. Thus, the control unit may be configured to define the second priming parameter as the physical action of moving a part of the medicament delivery device as movement related to installing the disposable cassette into the power module via the proximal receiving interface.
According to one embodiment, the power module comprises an activation interface and a first switch, wherein the disposable cassette comprises a tubular main body and at least one distally extending protrusion that extend distally away from a distal end of the tubular main body and is configured to, upon the disposable cassette installation action, move to abut against and push the activation interface in a distal direction to actuate the first switch, wherein the control unit is configured to define the second priming parameter as the activation of the first switch, the control unit may be configured to define the second priming parameter as the physical action of moving a part of the medicament delivery device as movement of the first switch.
According to one embodiment, the power module comprises the drive unit. Additionally or alternatively, the power module comprises the accelerometer. Additionally or alternatively, the power module comprises the control unit.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the tubular main body of the disposable cassette comprises a radially extending protrusion on a radially outwards facing surface, the radially extending protrusion includes a proximally facing surface.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the disposable cassette is attachable to a proximal end of the power module by insertion of the disposable cassette in the previously mentioned proximal receiving interface, and a subsequent axial rotation of the disposable cassette, whereby the radially extending protrusion is configured to slide on a curved distally facing surface of the receiving interface of the power module until the proximally facing surface engages with a distally facing surface of the receiving interface to longitudinally lock the disposable cassette in an attached position in the receiving interface.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the disposable cassette comprises an electronic tag attached to a distal end of the tubular main body, the electronic tag having stored data that is related to the medicament contained within the tubular main body, wherein the data is readable by an electronic reader of the medicament delivery device when the disposable cassette is in the attached position. The electronic tag advantageously enables for providing the data to the medicament delivery device to make corresponding settings. The stored data may furthermore be related to the volume of the medicament container.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the previously mentioned actuation of the first switch activates the electronic reader. Thus, when the disposable cassette is fully inserted in the receiving interface, or at least sufficiently to reach the activation interface, the activation interface is advantageous pushed without any additional required action from the user, to activate the electronic reader.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the distally extending protrusion comprises a distally facing inclined surface inclined with respect to a longitudinal axis of the tubular main body, wherein the distally facing inclined surface is arranged to interact with a surface of the activation interface when the disposable cassette is rotated further. The distally facing inclined surface facilitates for an axial motion of the activation interface caused by the interaction. Thus, in one embodiment, the interaction between the distally facing inclined surface and the surface of the activation interface cause the activation interface to move distally.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the activation interface activates a second switch when it is moved distally. For example, the disposable cassette may comprise a delivery member cover, which upon exertion of a force in the distal direction, e.g. by pushing the delivery member cover against a medicament delivery site, interacts with the activation interface causing the activation interface to move further distally to activate the second switch. Advantageously, the activation of the second switch actuates further movement of the plunger rod in the proximal direction to act on the medicament container expel medicament through the proximal end of the medicament delivery member. As previously described, the plunger rod is typically moved by the drive unit. According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the disposable cassette comprises a second set of radially extending protrusions on the radially outwards facing surface that are configured to engage in corresponding radially inner facing slots of the receiving interface to rotationally lock the disposable cassette in the receiving interface. The second set of radially extending protrusions may be longitudinal ribs.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the disposable cassette comprises an activation ring removably attached to the tubular body, the activation ring comprises the at least one distally extending protrusion. The previously mentioned electronic tag may be attached to the activation ring.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the activation ring may comprise two distally extending protrusion symmetrically arranged with respect to a longitudinal axis of the tubular main body. The symmetric arrangement provides for an evenly distributed force on the activation surface when the disposable cassette is inserted in the receiving interface of the power module.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the disposable cassette comprises a plunger rod adapter fitted in the tubular main body and being configured to be pushed proximally by the plunger rod of the medicament delivery device during automatic priming or a medicament delivery event.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the disposable cassette comprises a further protrusion on the radially outwards facing surface of the tubular main body, the further protrusion being located proximally with respect to the radially extending protrusion, the further protrusion being configured to abut against the receiving interface to limit the insertion length of the disposable cassette in the receiving interface. In this way, the disposable cassette is not inserted too far in the receiving interface.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the attachment between the disposable cassette and the receiving interface is a bayonet coupling.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the activation interface comprises a first and second distally extending arms extending towards the respective first and second switches, wherein the first arm reaches and causes the activation of the first switch when the activation interface is moved distally.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the activation interface comprises an inclined surface adapted to receive the distally extending protrusion of the cassette when the cassette is further rotated in the receiving interface, whereby an interaction between the distally facing surface of the cassette and the inclined surface of the activation interface cause the activation interface to move distally.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the distal motion of the activation interface may cause the second arm to reach to and active the second switch.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the distal ends of the first arm and the second arm are asymmetric.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the subassembly advantageously comprises a spring arranged to spring load the activation interface away from the first switch and the second switch.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the medicament container is a syringe. The medicament delivery member may thus be a needle. According to one embodiment, the medicament delivery device comprises an infusion set including a flexible tube connected to a through hole of the disposable cassette at proximal end thereof. At the other end of the tube, a needle is typically attached via a pad at a medicament delivery site.
Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a/an/the element, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.
BRIEF DESCRIPTION OF THE DRAWINGS
The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:
Fig. 1 is a perspective view of a medicament delivery device according to embodiments of the present disclosure;
Fig. 2 is a perspective view of the medicament delivery device with housing removed according to embodiments of the present disclosure;
Fig. 3 is a perspective view of a disposable cassette according to embodiments of the present disclosure;
Fig. 4 is a perspective view of a receiving interface according to embodiments of the present disclosure;
Fig. 5 is a perspective view of a receiving interface according to embodiments of the present disclosure;
Fig. 6 is a perspective view of an activation interface according to embodiments of the present disclosure; Fig. 7 is a close-up view of a distal end of the disposable cassette and the activation interface according to embodiments of the present disclosure;
Fig. 8 is a close-up view of a distal end of the disposable cassette and the activation interface according to embodiments of the present disclosure;
Fig. 9 is a flowchart illustrating the steps of a method in according to embodiments of the present disclosure.
DETAILED DESCRIPTION
The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.
Fig 1 shows an example of a medicament delivery device 1 such as an autoinjector of an injection device according to embodiments of the present disclosure. The medicament delivery device 1 is configured to expel medicament from a medicament container 13 via a medicament delivery member 2, here embodied as needle, to a user at a dose delivery site. The medicament delivery device 1 extends from a proximal end la to a distal end lb relative to the axis 112.
The axis 112 is in Fig. 1 a centre axis, from which a circumferential direction 131 relative to the centre axis 112 and a radial direction 132 extending radially relative to the centre axis 112, can be defined.
The medicament delivery device 1 comprises a power module 3 which is connectable to a disposable cassette 4 having a proximal end 4a and a distal end 4b. The power module 3 has a corresponding proximal end 3a and distal end 3b, and comprises a housing 6. The disposable cassette 4 comprises a tubular main body 11 accommodating the medicament container 13 and the thereto arranged medicament delivery member 2 having a proximal end 2a. In the embodiment of Fig. 1, in which the medicament delivery member 2 is a needle, the proximal end 2a is the tip of the needle. The disposable cassette 4 is typically adapted to accommodate medicament containers of different volumes, for example ranging from about 1 ml to about 10 ml.
The power module 3 comprises a receiving interface 10 configured to received and lock the disposable cassette 4 to the proximal end 3a of the power module 3.
The disposable cassette 4 comprises a cap 5 arranged to protect the medicament delivery member 2. In Fig. 1, the cap 5 is shown proximally of the disposable cassette 4, as after the cap 5 has been removed from the medicament delivery member 2 during a cap removal action.
The disposable cassette 4 may comprise a delivery member cover 7 configured to cover the delivery member 2. The delivery member cover 7 is configured to move axially relative to the tubular main body 11. For example, the delivery member cover 7 may be moved from a protracted position into a retracted position, shown in Fig. 1, in which the delivery member cover 7 is received further into the tubular main body 11 in order to expose the delivery member 2 of the medicament container 13.
Fig. 2 is a partly exploded view of the medicament delivery device 1 with the housing 6 removed from the power module 3 and the cap 5 has been removed from the disposable cassette 4. As shown in Fig. 2, the housing 6 may be divided in two parts, a first housing part 6a and a second housing part 6b, wherein the second housing part 6b is arranged distally of the first housing part 6a.
The power module 3 comprises a plunger rod 83 configured to move proximally to act on the medicament container 13 to expel air or gas, and medicament, via the proximal end 2a of the medicament delivery member 2. The medicament delivery device 1 further comprises a drive unit 82 configured to move the plunger rod 83 in the proximal direction, and an accelerometer 84 configured to determine the orientation and acceleration of the medicament delivery device 1. In the embodiment of Fig. 2, the drive unit 82 and the accelerometer 84 are comprised in the power module 3, and housed withing the housing 6.
The power unit 3 may optionally comprise an antenna 80 (or a set of antennas) and a power pack 86 with electronic circuitry and batteries.
Fig. 3 is a perspective view of a disposable cassette 4 according to embodiments of the present disclosure. As previously described, the disposable cassette 4 comprises a tubular main body 11 adapted to receive the medicament container 13 radially inside the tubular main body 11. The tubular main body 11 extends from a proximal end 11a to a distal end 11b, wherein the proximal end 11a of the tubular main body 11 typically coincides with the proximal end 4a of the cassette 4. The tubular main body 11 has a through hole 15 at its proximal end 11a through which the medicament delivery member 2 (not shown in Fig. 3) extends during a medicament delivery event.
The tubular main body 11 comprises a radially extending protrusion 19 on a radially outwards facing surface 21. The radially extending protrusion 19 includes a proximally facing surface 23.
The radially extending protrusion 19, or as in Fig. 3 exemplified as two separate radially extending protrusions 19, extend along a circumference of the outer surface 21 so that the protrusions 19 are curved along the circumference. However, the protrusions 19 only extend along part of the circumference of the tubular body 11.
The disposable cassette 4 comprises an activation ring 27 removably attached to the distal end 11b of the tubular body 11. The activation ring 27 may form at least a part of the distal end 4b of the disposable cassette 4. The disposable cassette 4 may optionally comprise an electronic tag 25, here attached at a distal end portion of the cassette 4. The electronic tag 25 may be attached to the tubular main body 11 or to the activation ring 27. The electronic tag 25 is typically configured to store data that is related to the medicament contained within the medicament container 13, e.g. the medicament volume. The electronic tag 25 and the data therein may be readable by an electronic reader of the medicament delivery device 1 when the disposable cassette 4 is in an attached position in the power module 3. The electronic reader may e.g. comprise the previously mentioned antenna 80.
Further, the disposable cassette 4 includes a distally extending protrusion 28 that extends distally away from a distal end 11b of the tubular main body 11, or as in Fig. 3 exemplified as two separate distally extending protrusions 28. In the embodiment of Fig. 3, each one of the distally extending protrusions 28 is comprised in the activation ring 27. Each one of the distally extending protrusions 28 comprises a distally facing surface 29 and a distally facing inclined surface 36 inclined with respect to the longitudinal axis 102 of the tubular main body 11. The distally facing inclined surfaces 36 are connected with the distally facing surfaces 29 at a respective oblique angle.
Thus, in some possible embodiments, the activation ring 27 comprises two distally extending protrusions 28 symmetrically arranged with respect to the longitudinal axis 102 of the tubular main body 11.
A further protrusion 33 may optionally be arranged on the radially outwards facing surface 21 of the tubular main body 11. The further protrusion 33 is in Fig. 3 located proximally with respect to the radially extending protrusion 19. Here the further protrusion 33 is an annular protrusion that extend around the circumference, preferably the entire circumference, of the tubular main body 11. The further protrusion 33 is configured to abut against the proximal end 3a of the power module 3, or of the receiving interface 10, to limit the insertion length of the disposable cassette 4 in the receiving interface 10. In other words, the further protrusion 33 may act like stop for preventing the cassette 4 to be inserted too deep into the power module 3 and the receiving interface 10.
Figs. 4 and 5 are different perspective views of a proximal receiving interface 10 of the medicament delivery device 1. The proximal receiving interface 10 is adapted to receive the disposable cassette 4 as previously described.
The proximal receiving interface 10 comprising a curved distally facing surface 30 adapted to receive and slidably guide the radially extending protrusion 19 of the cassette 4 in a distal direction when the cassette 4 axially rotates relative to the receiving interface 10. In other words, the disposable cassette 4 is first axially inserted into the receiving interface 10. During a subsequent axial rotation of the disposable cassette 4, the radially extending protrusion 19 slides on the curved distally facing surface 30 of the receiving interface 10 of the power module 3. The radially extending protrusion 19 slides on the curved distally facing surface 30 until the proximally facing surface 23 engages with a distally facing surface 32 of the receiving interface 10 to longitudinally lock the disposable cassette 4 in an attached position in the receiving interface 10.
As shown in Fig. 5, the receiving interface 10 comprises radially inner facing slots 38 (only one is shown in Fig. 5). The disposable cassette 4 shown in Fig. 3 comprises a second set of radially outwards extending protrusions 34 on the radially outwards facing surface 21 that are configured to engage with the corresponding radially inner facing slots 38 to rotationally lock the disposable cassette 4 in the receiving interface 10. Preferably, the second set of radially extending protrusions 34 are longitudinal ribs.
Fig. 6 is a perspective view of an activation interface 40 according to embodiments of the present disclosure. The activation interface 40 comprises a proximal end 40a and a distal end 40b. The proximal end 40a comprises protrusions 42 that extend in a proximal direction. The protrusions 42 are configured to receive the distally extending protrusions 29 of the cassette 4 when the cassette 4 is rotated as will be discussed further herein. Each one of the protrusions 42 comprises an inclined surface 45 adapted to receive the distally facing inclined surfaces 36 of the distally extending protrusions 28 of the disposable cassette 4 when the disposable cassette 4 is rotated axially from its attached position.
The activation interface 40 comprises a first distally extending arm 44 and second distally extending arm 54. Each one of the first and second distally extending arms 44, 54 comprises a cut-out 46, 56 at the distal end 40b of the cassette, the cut-outs 46, 56 being arranged diagonally with respect to each other so that the first and second distally extending arm 44, 54 are asymmetric.
The activation interface 10 further comprises longitudinal ribs 48 on the respective first and second distally extending arm 44, 54 (only the rib 48 of the first distally extending arm 44 is shown in Fig. 6), that are configured to fit in and slide in corresponding slots or grooves 39 (shown in Fig. 5) on a radially inwards facing surface of the receiving interface 10.
Figs. 7 and 8 are close-up views of the distal end 4b of the disposable cassette 4 inserted in the receiving interface 10 but not yet mounted by rotating the disposable cassette 4 in the receiving surface 10 as previously described. In Fig. 7, the first distally extending arm 44 of the activation interface 40 extends towards a first switch 90. On the opposite side, as is shown in Fig. 8, the second distally extending arm 54 extends towards a second switch 92. Further, a spring 95 is arranged to spring load the activation interface 40 away from the first switch 90 and the second switch 92.
As the disposable cassette 4 inserted in the receiving interface 10 and mounted by rotating the disposable cassette 4 in the receiving surface 10 as previously described, during the axial rotation of the disposable cassette 4, the radially extending protrusion 19 slides on the curved distally facing surface 30 of the receiving interface 10. This sliding motion on the curved surface 30 causes a distal axial motion of the disposable cassette 4 so that the distally facing surface 29 of the protrusions 28 abut against and push on a proximally facing surface 47 the activation interface 40 in a distal direction. In more detail, the distally facing inclined surfaces 36 interact with the inclined surfaces 45 of the protrusions 42 of the activation interface 40 when the disposable cassette 4 is rotated. The axial rotation for locking of disposable cassette 4 may be about 60 degrees with respect to the receiving interface 10. The spring 95 is compressed by the axial motion of the activation interface 40 caused by the force from the disposable cassette 4 moving distally when mounted in the receiving interface 10.
Thus, upon axial rotation of the disposable cassette 4, the first distally extending arm 44 of the activation interface 40 will activate the first switch 90. As the cut-out 46 of the first distally extending arm 44 is asymmetrically arranged with respect to the cut-out 56 of the second distally extending arm 54 (as shown by comparing Figs. 8 and 9), in the same position of the activation interface 40 in the receiving interface 10, the second distally extending arm 54 of the activation interface 40 does not reach to activate the second switch 92. Thus, the second switch 92 is not activated by mounting the disposable cassette 4 in the receiving interface 10.
The second switch 92 may be activated by moving the delivery member cover 7. Typically, upon exertion of a force of the delivery member cover 7 in the distal direction, e.g. by pushing a proximal end 7a of the delivery member cover 7 against a medicament delivery site, the distal end 7b of the delivery member cover interacts with the activation interface 40 causing the activation interface 40 to move further distally such that the second distally extending arm 54 reach to activate the second switch 92.
A rotation of the disposable cassette 4 in the opposite direction causes the activation interface 40 to move proximally by the force applied by the spring 95. This may cause deactivation of the first switch 90 and/or the second switch 92 depending on degree of rotation of the disposable cassette 4 that allow the activation interface 40 to move variable distances in the proximal direction. A further rotation in this opposite direction allows for dismounting the cassette 4 from the receiving interface 10 so that it can be disposed of. Subsequently, a new cassette 4 can be mounted to the receiving interface 10 as described herein.
Activation of the first switch 90 may e.g. cause activation of the electronic reader of the power module 3 to read the electronic tag 25. Activation of the second switch may e.g. actuate movement of the plunger rod 83 in the proximal direction to act on the medicament container 13 to expel medicament through the proximal end 2a of the medicament delivery member 2. As previously described, the plunger rod 83 is typically moved by the drive unit 82. The disposable cassette 4 may comprise a plunger rod adapter fitted in the tubular main body 11. The plunger rod adapter is preferably cylindrical and is adapted to be pushed proximally by the plunger rod 83 during a medicament delivery event. The proximal motion of the plunger rod adapter cause expulsion of a medicament from the medicament container 13.
Fig. 9 is a flow-chart describing steps of a method for automatic priming the medicament container 13 accommodated within the disposable cassette 4 of the medicament delivery device 1, according to embodiments of the present disclosure. Priming is the action of expelling air bubbles or gas bubbles from the medicament container prior to the medicament delivery event.
In a step S10, e.g. being a first step, a first priming parameter is determined, the first priming parameter being the orientation of the medicament delivery device 1 determined by the accelerometer 84. Thus, the accelerometer 84 may determine the orientation of the medicament delivery device 1, such as e.g. that the medicament delivery device 1 is oriented with the medicament delivery member 2 pointing upwards or downwards.
In a step S15, e.g. being a performed subsequent to step S10, the medicament delivery device 1 accommodating the cassette 4 is positioned such that the proximal end 2a of the medicament delivery member 2 points upwards. For example, upwards may here be defined as that the proximal end 2a of the medicament delivery member 2 points upwards along a vertical axis, or at least within 6o degrees of such vertical axis. Thus, the medicament delivery device 1 may be positioned with its centre axis 112 coinciding with a vertical axis (the vertical axis coinciding with the gravitational axis) and the proximal end 2a of the medicament delivery member 2 pointing upwards, or the medicament delivery device 1 may be positioned with its centre axis 112 angled at most 60 degrees (in all directions) relative to the vertical axis and the proximal end 2a of the medicament delivery member 2 pointing upwards within those 60 degrees. It should be noted that step S15 may be performed prior to step S10, i.e. the first priming parameter may be determined when the medicament delivery device 1 already is positioned such that the proximal end 2a of the medicament delivery member 2 points upwards.
In a step S30, a first priming criterium of the first priming parameter is fulfilled. The first priming criterium is fulfilled by a sub-step 830a of identifying a position of the medicament delivery device 1 such that the proximal end 2a of the medicament delivery member 2 points upwards. Thus, the fulfilment of the first priming criterium is achieved subsequent to steps S10 and S15.
In a step S20, e.g. being performed subsequent to step S10 and S15, a second priming parameter is determined, the second priming parameter being related to a physical action of moving a part of the medicament delivery device 1. The determination of the second priming parameter in step S20 may include further defining which part of the medicament delivery device 1 that is moved, and need not to include identifying the actual presence of such movement.
In a step S48, a second priming criterium of the second priming parameter is fulfilled. The second priming criterium is fulfilled after a step S40 of identifying a presence of the second priming parameter.
In a step S50, performed in response to fulfilling the first priming criterium in step S30 and fulfilling the second priming criterium in step S48, automatic priming of the medicament container 13 is performed by causing the drive unit 82 to automatically move the plunger rod 83 in the proximally direction to act on the medicament container 13 and release air or gas through the proximal end 2a of the medicament delivery member 2. Hereby, efficient automatic priming of the medicament container 13 is achieved. As the first priming criterium is fulfilled by step S30 when the medicament delivery device 1 accommodating the cassette 4 is identified as being positioned such that the proximal end 2a of the medicament delivery member 2 points upwards, and as the second priming criterium is fulfilled by step S48 when a physical action of moving a part of the medicament delivery device 1 is identified as being present, any trapped air or gas in the medicament container 13 is likely to be migrated to a location near the medicament delivery member 2, typically at the top of the medicament container 13, and can thus be expelled upon movement of the plunger rod 83 in the proximal direction. Preferably, the step S50 of automatic priming is performed in response to the step S30 of fulfilling the first priming criterium prior to the step S48 of fulfilling the second priming criterium, thereby improving the likelihood of trapped air or gas to migrate towards the top of the medicament container 13, prior to automatically moving the plunger rod 83 in the proximally direction.
As previously described, the disposable cassette 4 may comprise a plunger rod adapter adapted to be pushed proximally by the plunger rod 83. Thus, the proximal motion of the plunger rod adapter cause expulsion of air or gas through proximal end 2a of the medicament delivery member 2.
The step S50 may comprise the sub-step S52 of moving, by the drive unit 82, the plunger rod 83 to a predefined priming position. Thus, the priming of the medicament container 13 may be performed in a predefined manner.
The second priming parameter determined in step S20 will now be further exemplified.
In a sub-step S42 of step S40, the physical action of moving a part of the medicament delivery device 1 is identified by the accelerometer 83, wherein the second priming parameter is defined by such identification. Thus, the second priming parameter being related to the physical action of moving a part of the medicament delivery device may be defined as a physical action of moving a part of the medicament delivery device 1 which is detected by the accelerometer 83.
The sub-step S42 may comprise a first further sub-step 842a of identifying, by the accelerometer 83, a repetitive tapping of, or on, the medicament delivery device 1. Thus, a user may move the medicament delivery device 1 itself, e.g. by tapping it against a hard surface, or by using a finger to tap on the medicament delivery device 1. The first sub-step 842a may comprise identifying at least three successive tappings. The determination of the second priming parameter in step S20 may comprise defining the second priming parameter as a repetitive tapping of, or on, the medicament delivery device 1.
The sub-step S42 may comprise a second further sub-step 842b, typically instead of first sub-step 842a, of identifying a cap removal action. Thus, a user may remove the cap 5 from the disposable cassette 4 and thereby perform the cap removal action. The determination of the second priming parameter in step S20 may comprise defining the second priming parameter as a cap removal action.
Instead of identifying the physical action of moving a part of the medicament delivery device 1 by the accelerometer 83, the physical action of moving a part of the medicament delivery device 1 associated with the second priming parameter may be that of a installing the disposable cassette 4 into the receiving interface 10 described with reference to Figs. 8 and 9.
Thus, in a sub-step S44 of step 40, the disposable cassette 4 is installed into the power module 3 via the proximal receiving interface 10, and the physical action of moving a part of the medicament delivery device 1 is related to such disposable cassette installation action. Thus, the determination of the second priming parameter in step S20 may comprise defining the second priming parameter as a disposable cassette installation action.
For example, the physical action of moving a part of the medicament delivery device 1 associated with the second priming parameter may be related to a further sub-step 844a of sub-step S44, being movement to cause the activation of the first switch 90. Thus, by identifying the activation of the first switch 90, the second priming parameter is fulfilled S48.
Turning back to Fig. 2, the medicament delivery device 1 may comprise a control unit 85, the control unit 85 being configured to execute at least some of the steps descried with reference to Fig. 9. For example, the control unit may be configured to determine the first priming parameter, the first priming parameter being the orientation of the medicament delivery device 1 determined by the accelerometer 83, as described in step S10. The control unit 85 may be further be configured to determine the second priming parameter, the second priming parameter being related to the physical action of moving a part of the medicament delivery device 1, as previously described.
The control unit 85 may be configured to identify fulfilment of the first priming criterium of the first priming parameter as a position in which the medicament delivery device 1 accommodating the cassette 4 is arranged such that the proximal end 2a of the medicament delivery member 2 points upwards, as described in step S30. The control unit 85 may furthermore be configured to identify fulfilment of the second priming criterium by identifying a presence of the second priming parameter, as described in step S48.
The control unit 85 may be configured to perform automatic priming of the medicament container 13 in response to identifying fulfilment of the first and second priming criteria by causing the drive unit 82 to automatically move the plunger rod 83 in the proximally direction to act on the medicament container 13 and release air or gas through the proximal end 2a of the medicament delivery member 2. Correspondingly to the method described in the flow-chart of Fig. 9, the control unit 85 may be configured to define and identify the second priming parameter as the physical action of moving a part of the medicament delivery device which is detected by the accelerometer 83. Additionally, or alternatively, the control unit 85 may be configured to define and identify the second priming parameter as the physical action of moving a part of the medicament delivery device 1 which is detected by the accelerometer 83 as a cap removal action. Additionally, or alternatively, the control unit 85 may be configured to define and identify the second priming parameter as the physical action of moving a part of the medicament delivery device as movement related to installing the disposable cassette 4 into the power module 3 via the proximal receiving interface 10. The control unit may be configured to define and identify the second priming parameter as the physical action of moving a part of the medicament delivery device 1 as movement of the first switch 90.
A medicament delivery device (such as an autoinjector) may generally include various other components. For example, a sensor unit which may recognize medicament delivery events, such as the medicament delivery member inserted into an attachment portion of e.g., a pad, injection started, and medicament delivery event ends, a memory unit which is configured to store the recorded data during the medicament delivery event, a connectivity unit configured to transmit the stored data to a smart device or the network directly, a processing unit (e.g. the previously described control unit 85) configured to control the entire system and processes the data before transmitting it, and/or user interface units that are configured to provide feedback to the patient, such as status LEDs, haptic, and/or audio feedback.
When the medicament delivery device is placed into the attachment portion, the sensors inside of the pad are configured to recognize the event and give feedback to the patient via haptic/visual or audio elements.
When the medicament delivery event finishes, the sensors are configured to recognize the event and give feedback to the patient again. Further, the collected data is stored in the memory unit and may be transmitted to the smart device/network via the connectivity unit after the medicament delivery event finishes.
The sensor can be one of or the combination of the following: a mechanical switch, a Hall-effect sensor, an accelerometer.
The mechanical switch, hall-effect sensor, or accelerometer can be used for detection of the insertion of the medicament delivery member into an injection port.
The accelerometer can be used for detecting medicament delivery events.
Possible wireless communication methods include Bluetooth and Cellular Networks.
Bluetooth connectivity requires a smart device to transmit the stored data to the network and it requires a pairing action between the pad and the smart device before being able to use the supporting pad in case of 2-way connection. But it’s a cheaper alternative and it requires less space on PCB. A l-way connection does not require pairing.
The cellular network does not require any pairing process, it can be used as a plug-n-play device, no prior setup is needed, but it’s more expensive and it requires more space on PCB.
Depending on the requirements of the product any of those two technologies can be used.
The processing units, e.g. the previously mentioned control unit 85, may comprise processing circuitry, logic circuit and/or further control units, including a microprocessor, microcontroller, programmable digital signal processor or another programmable device. The processing circuitry may also, or instead, each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. Where the processing circuitry includes a programmable device such as the microprocessor, microcontroller or programmable digital signal processor mentioned above, the processor may further include computer executable code that controls operation of the programmable device.
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, xemplary drugs that could be included in the injection assemblies 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. Crohn’s disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-ia (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-ia' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)), immunoglobulins (primary immune deficiencies), 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, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. Pharmaceutical formulations 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. Pharmaceutical formulations may also include separately administered or co-formulated dispersion enhancers, such as hyaluronidase.
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.
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, CDygb 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, CDW137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B-lymphocyte cell adhesion molecule modulators, CDW123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY- ESO-i 0X40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapies, or TCR therapies.
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, mFOLFOXy, 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, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA- Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA/CO, EMA/EP, EP/EMA, TP/TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.
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. 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.
The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Claims

1. A method for automatic priming a medicament container (13) accommodated within a disposable cassette (4) of a medicament delivery device (1) having a proximal end (la) and a distal end (lb), the medicament container (13) comprising a medicament delivery member (2) having a proximal end (2a), and the medicament delivery device (1) comprising a power module (3) having a plunger rod (83) configured to act on the medicament container (13) to expel medicament via the proximal end (2a) of the medicament delivery member (2), a drive unit (82) configured to move the plunger rod (83) in the proximal direction, and an accelerometer (84) for determining orientation and acceleration of the medicament delivery device (1), the method comprising:
- determining (S10) a first priming parameter, the first priming parameter being the orientation of the medicament delivery device (1) determined by the accelerometer (84),
- determining (S20) a second priming parameter, the second priming parameter being related to a physical action of moving a part of the medicament delivery device (1),
- in response of fulfilling (S30) a first priming criterium of the first priming parameter by identifying (830a) a position of the medicament delivery device (1) accommodating the cassette (4) such that the proximal end (2a) of the medicament delivery member (2) points upwards, and fulfilling (S48) a second priming criterium of identifying (S40) a presence of the second priming parameter, performing automatic priming (S50) of the medicament container (13) by causing the drive unit (82) to automatically move the plunger rod (83) in the proximally direction to act on the medicament container (13) and release air or gas through the proximal end (2a) of the medicament delivery member (2).
2. The method according to claim 1, wherein the automatic priming (S50) is performed in response to fulfilling (S30) the first priming criterium prior to fulfilling (S48) the second priming criterium.
3. The method according to any one of the preceding claims, wherein the automatic priming (S50) is performed by moving (S52), by the drive unit (82), the plunger rod (83) to a predefined priming position.
4. The method according to any one of the preceding claims, further comprising identifying (S42) the physical action of moving a part of the medicament delivery device (1) by the accelerometer (83), wherein the second priming parameter is defined by such identification.
5. The method according to claim 4, wherein the physical action of moving a part of the medicament delivery device (1) identified (S42) by the accelerometer (83) is a repetitive tapping (842a) of, or on, the medicament delivery device (1).
6. The method according to claim 5, wherein the repetitive tapping of, or on, the medicament delivery device (1) comprises at least three successive tappings.
7. The method according to claim 4, wherein the disposable cassette (4) comprises a cap (5) protecting the medicament delivery member (2), and wherein the physical action of moving a part of the medicament delivery device (1) identified (S42) by the accelerometer (83) is a cap removal action (S42b).
8. The method according to any one of claims 1-4, wherein the power module (3) comprises a proximal receiving interface (10) adapted to receive the disposable cassette (4), the method further comprising installing (S44) the disposable cassette (4) into the power module (3) via the proximal receiving interface (10) and wherein the physical action of moving a part of the medicament delivery device (1) is related to such disposable cassette installation action (S44).
9. The method according to claim 8, wherein the power module (3) comprises an activation interface (40) and a first switch (90), and wherein the disposable cassette (4) comprises a tubular main body (11) and at least one distally extending protrusion (28) that extend distally away from a distal end (4b) of the tubular main body (11), the method further comprising, upon the disposable cassette installation action (S44), moving (844a) the distally extending protrusion (28) to abut against and push the activation interface (40) in a distal direction to actuate the first switch (90), wherein the physical action of moving a part of the medicament delivery device (1) is the movement (844a) to cause the activation of the first switch (90).
10. A medicament delivery device (1) comprising a disposable cassette (4) accommodating a medicament container (13), the medicament delivery device (1) having a proximal end (la) and a distal end (lb) and the medicament container (13) comprising a medicament delivery member (2) having a proximal end (2a), the medicament delivery device (1) comprising:
- a power module (3) having a plunger rod (83) configured to act on the medicament container (13) to expel medicament via the proximal end (2a) of the medicament delivery member (2),
- a drive unit (82) configured to move the plunger rod (83) in the proximal direction,
- an accelerometer (84) for determining orientation and acceleration of the medicament delivery device (1), and
- a control unit (85) configured to:
- determine a first priming parameter, the first priming parameter being the orientation of the medicament delivery device (1) determined by the accelerometer (83),
- determine a second priming parameter, the second priming parameter being related to a physical action of moving a part of the medicament delivery device (1), - identify fulfilment of a first priming criterium of the first priming parameter as a position in which the medicament delivery device (1) accommodating the cassette (4) is arranged such that the proximal end (2a) of the medicament delivery member (2) points upwards, and identify fulfilment of a second priming criterium by identifying a presence of the second priming parameter,
- perform automatic priming of the medicament container (13) in response to identifying fulfilment of the first and second priming criteria by causing the drive unit (82) to automatically move the plunger rod (83) in the proximally direction to act on the medicament container (13) and release air or gas through the proximal end (2a) of the medicament delivery member (2).
11. The medicament delivery device (1) according to claim 10, wherein the accelerometer (83) is configured to identify the physical action of moving a part of the medicament delivery device (1), and wherein the control unit (85) is configured to define the second priming parameter by such identification.
12. The medicament delivery device (1) according to claim 11, wherein the disposable cassette (4) comprises a cap (5) protecting the medicament delivery member (2), and wherein the accelerometer is configured to identify a cap removal action as the physical action of moving a part of the medicament delivery device (1).
13. The medicament delivery device (1) according to any one of claims toil, wherein the power module (3) comprises a proximal receiving interface (10) adapted to receive the disposable cassette (4), the control unit (85) being configured to identify installation of the disposable cassette (4) into the power module (3) via the proximal receiving interface (10) and to define the second priming parameter based on such disposable cassette installation action.
14. The medicament delivery device (1) according to claim 13, wherein the power module (3) comprises an activation interface (40) and a first switch (90), and wherein the disposable cassette (4) comprises a tubular main body (11) and at least one distally extending protrusion (28) that extend distally away from a distal end (4b) of the tubular main body (11) and is configured to, upon the disposable cassette installation action, move to abut against and push the activation interface (40) in a distal direction to actuate the first switch (90), wherein the control unit (85) is configured to define the second priming parameter as the activation of the first switch (90).
PCT/EP2023/087962 2023-03-02 2023-12-29 Method for automatic priming a medicament container WO2024179717A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190009029A1 (en) * 2015-12-30 2019-01-10 Ascendis Pharma A/S Front loaded auto injector for administering a medicament
WO2021255045A1 (en) * 2020-06-15 2021-12-23 Stevanato Group S.P.A. Administering medicament
EP3974012A1 (en) * 2020-09-29 2022-03-30 Ypsomed AG Priming event identification in delivery devices

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190009029A1 (en) * 2015-12-30 2019-01-10 Ascendis Pharma A/S Front loaded auto injector for administering a medicament
WO2021255045A1 (en) * 2020-06-15 2021-12-23 Stevanato Group S.P.A. Administering medicament
EP3974012A1 (en) * 2020-09-29 2022-03-30 Ypsomed AG Priming event identification in delivery devices

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