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WO2025051546A1 - Dispositif d'injection sur le corps et dispositif d'administration de médicament - Google Patents

Dispositif d'injection sur le corps et dispositif d'administration de médicament Download PDF

Info

Publication number
WO2025051546A1
WO2025051546A1 PCT/EP2024/073520 EP2024073520W WO2025051546A1 WO 2025051546 A1 WO2025051546 A1 WO 2025051546A1 EP 2024073520 W EP2024073520 W EP 2024073520W WO 2025051546 A1 WO2025051546 A1 WO 2025051546A1
Authority
WO
WIPO (PCT)
Prior art keywords
movable member
injection device
body injection
button
skin penetration
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/073520
Other languages
English (en)
Inventor
Lukas Bannwart
Torbjörn Neby
René ZANDER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SHL Medical AG
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 WO2025051546A1 publication Critical patent/WO2025051546A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1583—Needle extractors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor

Definitions

  • the present disclosure generally relates to medical devices, in particular to on-body injection devices.
  • the injection device usually comprises a pump and a motor that drives the pump.
  • US 11 185 629 B2 discloses a dosing apparatus for on-body use.
  • the dosing apparatus comprises container, a rotary drive, a pump, a puncture cannula, and an indwelling cannula.
  • the rotary drive drives a barrel cam, which initially blocks a pretensioned control element from moving. When the barrel cam is rotated, the control element is released. Movement of the control element causes a first and a second runner to move downwards.
  • the puncture cannula runs in the longitudinal direction within the indwelling cannula. Movement of the first and the second runner cause the puncture cannula and the indwelling cannula to move concurrently with a respective one of the first runner and the second runner. As the control element is moved further, it causes the first runner to move back up. This results in the puncture cannula being withdrawn upward from the indwelling cannula.
  • Devices that comprise the drug to be administered, a motor, and pump, such as the one disclosed in US 11 185 629 may be relatively large and may therefore be quite visible.
  • a general object of the present disclosure is to provide an on-body injection device that solves or at least mitigates the problems of the prior art.
  • an on-body injection device comprising: a housing, wherein the housing has a body side wall configured to bear against the skin of a user, wherein the housing is provided with a medicament inlet
  • the on-body injection device comprising: a movable member channel arranged in the housing, a movable member arranged in the movable member channel, the movable member channel having a fluid inlet in fluid communication with the medicament inlet, and a fluid outlet.
  • an on on-body injection device comprising the housing, a button to be operated by the user to move from an initial position to a release position, a skin penetration device configured to move from a starting position to a skin penetration position, and a moveable structure for moving the skin penetration device from the starting position to the skin penetration position.
  • the button is configured to engage with the movable structure when the button is in the initial position, preventing the movable structure from moving.
  • the button is configured to cooperate with the movable structure when the button is operated by the user and moved to the release position, causing the movable structure to move from its initial position to an intermediate position, and bringing the skin penetration device from the starting position to the skin penetration position.
  • the on-body injection device may further comprise a sensor configured to detect that the on- body injection contacts the skin of a user.
  • the housing may have a body side wall configured to bear against the skin of a user.
  • the on-body injection may further comprise a locking member operably connected with the sensor to be moved from a locking position to a release position.
  • the locking member in its locking position may prevent the button from being moved from its initial position to the release position.
  • the locking member may comprise a cam surface and the sensor may comprise a protrusion.
  • the cam surface and the protrusion may provide the operable connection.
  • a movement of the sensor from the locking position to the release position in a first direction results in a movement of the locking member in a second direction to its release position.
  • the second direction is preferably perpendicular to the first direction.
  • the button may comprise one or more abutment portions abutting to the movable structure when the button is in the initial position. This may prevent the movable structure from moving.
  • the button may be configured to disengage from the movable structure when the button is operated by the user and moved to the release position, causing the movable structure to move from its initial position to an intermediate position.
  • the button may comprise one or more locking member for locking the button in its release position with the housing.
  • the sensor may comprise a main body arranged within the housing.
  • the sensor may further comprise one or more contact member protruding from the housing through the body side wall.
  • the sensor may comprise one or more resilient member support supporting a resilient member biasing the sensor protruding from the housing in a direction away from the housing.
  • the on- body injection device may further comprise one or more resilient member biasing the sensor protruding from the housing in a direction away from the housing.
  • the skin penetration device may comprise a cannula configured to move out from the housing via the body side wall when the skin penetration device is moved from the starting position to the skin penetration position.
  • the housing may have a distal side wall opposite to the body side wall and a sidewall connecting the body side wall and the distal side wall, wherein the movable structure is configured to move towards the sidewall.
  • the movable structure may be pretensioned in its initial position.
  • the on-body injection device may further comprise one or more resilient member for pre-tensioning the moveable member.
  • the movable structure may have a first cam surface configured to cooperate with the skin penetration device to cause the skin penetration device to move from the starting position to the skin penetration position as the structure is moved to the intermediate position.
  • the movable structure may be by pretension configured to continue to move from the intermediate position to a final structure position, causing the movable structure to bring part of the skin penetration device from the skin penetration position to a final position.
  • the final position may be the same as the starting position.
  • the movable structure may have a second cam surface configured to cooperate with the skin penetration device to cause the skin penetration device to move from the skin penetration position to the final position.
  • the housing may be is provided with a medicament inlet.
  • the on-body injection device may further comprise a movable member channel arranged in the housing.
  • a movable member may be arranged in the movable member channel.
  • the movable member channel may have a fluid inlet in fluid communication with the medicament inlet. It may also have a fluid outlet.
  • the movable member may be configured to move in the movable member channel, by a built- up overpressure inside the movable member channel relative to a pressure on the movable member outside the movable member channel from a first movable member position in which the movable member blocks the fluid outlet to a second movable member position. In the first movable member position the movable member may block the fluid outlet, and in the second movable member position the fluid outlet may be in fluid connection with the fluid inlet.
  • the button may comprise one or more blocking member preventing the movable member from movement before the button is operated by the user.
  • the on-body injection device may further comprise a conduit connected to the skin penetration device and to the fluid outlet.
  • the housing may have a distal side wall, wherein the movable member is configured to move in a direction from the body side wall towards the distal side wall when the movable member is moved from the first movable member position to the second movable member position.
  • the movable member may have an internal channel extending from a lower end of the movable member along a longitudinal axis of the movable member.
  • the internal channel may be in fluid communication with the fluid inlet.
  • the on-body injection device may further comprise a gas filter configured to allow air to pass through and to block liquid from passing through.
  • the gas filter seals the internal channel.
  • a medicament delivery device comprising the on-body injection device of the first aspect.
  • Fig. 5 shows an exploded perspective view of the interaction between the moveable structure and the skin penetration device
  • Fig. 6 is a perspective cross-sectional view of the on-body injection device.
  • the medicament pump device 5 comprises a housing 5a.
  • the medicament pump device 5 comprises an electric motor, an energy storage device such as a battery configured to power the electric motor, and pump configured to be driven by the electric motor, arranged in the housing 5a.
  • the pump is configured to pump medicament from the medicament container to the on-body injection device 3 via the hose 7.
  • Fig. 1 shows a perspective view of the on-body injection device 3.
  • the on-body injection device 3 comprises a housing 9.
  • the housing 9 includes a distal side wall 9a and an opposing body side wall 9b.
  • the body side wall 9b faces the injection site.
  • An outer surface of the body side wall 9b may be provided with an adhesive or adhesive layer 8 which allows the on-body injection device 3 to adhere to a user's skin.
  • the distal side wall 9a faces away from the injection site.
  • the body side wall 9b comprises a through-opening 9d (see Fig. 6) through which a puncture cannula and an indwelling cannula can pass.
  • the housing 9 is provided with a medicament inlet 11.
  • the medicament inlet 11 is configured to be connected to the hose 7.
  • the medicament inlet 11 extends through a wall 9c of the housing 9 and provides a fluid connection between the exterior and the interior of the housing 9.
  • the on-body injection device 3 comprises a skin penetration device 21.
  • the skin penetration device 21 may be of the type disclosed in US11185629, which in US11185629 comprises a first runner, a second runner movable relative to the first runner, a puncture cannula and an indwelling cannula as described in column 8, lines 4-60, which is incorporated herein by this reference.
  • the skin penetration device 21 comprises an indwelling cannula 21a and a puncture cannula 21b which is movably arranged within the indwelling cannula 21a.
  • the on-body injection device 3 comprises a conduit 22 configured to connect to a fluid outlet 13b (described in detail below) with the skin penetration device 21.
  • the conduit 22 connects the fluid outlet 13b with the cannula 21a.
  • the particular shape of the conduit 22 as depicted is optional, and the conduit 22 may be other sizes or shapes - at a minimum, the conduit is simply a fluid connection between the fluid outlet 13b and the medicament delivery member (in this example a cannula).
  • the on-body injection device 3 comprises a movable structure 23.
  • the movable structure 23 is in the present example a cam element.
  • the movable structure 23 is pretensioned by resilient member in a direction transverse to and being away from a movable member 15.
  • the movable structure 23 is configured to move away from the movable member 15 in a direction that is generally perpendicular to the movement of the movable member 15 from the first movable member position to the second movable member position (to be described below). This direction is generally parallel with the body side wall 9b.
  • the skin penetration device 21 is arranged to move from a starting position to a skin penetration position.
  • the movable structure 23 is configured to actuate the skin penetration device 21 from the starting position to the skin penetration position and from the skin penetration position to a final position.
  • the movable structure 23 has a first cam surface 23a configured to cooperate with the skin penetration device 21 to cause the skin penetration device 21 to move from the starting position to the skin penetration position as the movable structure 23 is moved to an intermediate position.
  • the movable structure 23 may have an inverse U-shape section in vertical cross-section when observe from in the direction transverse to the movable member 15 so that two first cam surfaces 23a are provided in planes parallel to one another.
  • the skin penetration device 21 has a runner 21c, configured to cooperate with the first cam surface 23a when the movable structure 23 is moved away from the movable member 15.
  • the skin penetration device Corresponding to the two first cam surfaces 23a, the skin penetration device has two runners 21c.
  • the movable structure 23 has a second cam surface 23b configured to cooperate with the skin penetration device 21 to cause the skin penetration device 21 to move from the skin penetration position to the final position when the movable structure 23 is moved from the intermediate position further towards the sidewall 9c.
  • the puncture cannula 21b is moved back into the housing 9.
  • the indwelling cannula 21a is held in a position in which it penetrates the injection site. Due to the inverse U-shape, two second cam surfaces 23b are provided in the parallel planes.
  • the first cam surface 23a and the second cam surface 23b define planes that intersect each other.
  • the on-body injection device 3 comprises resilient members 24 (one of which is shown in Fig. 6) on a resilient member support 23c which provide the pretension on the movable structure 23.
  • the resilient members 24 may for example be springs such as coil springs.
  • the on-body injection device 3 may comprise only one resilient member, or more than two resilient members.
  • the on-body injection device comprises a sensor 40 to detect that the on-body injection contacts the skin of a user. It also comprises a button 30 to be operated by the user to move from an initial position to a release position. The button 30 protrudes from the distal side wall 9a of the housing 9.
  • the button 30 is configured to engage with the movable structure 23 when the button 30 is in the initial position. This engagement prevents the movable structure 23 from moving.
  • the button has an abutment portion 32 that in the shown embodiment extends in distal-proximal direction.
  • the moveable structure 23 has a corresponding abutment surface 23d. Due to the force of the resilient member 24, the moveable structure 23 is forced with its abutment surface 23d against the abutment portion 32 of the button 30. Thus, in this initial position of the button 30, the moveable structure 23 is prevented from movement, and is thus prevented from releasing the skin penetration device 21.
  • the button 30 is configured to cooperate with the movable structure 23 when the button 30 is operated by the user and moved to the release position, causing the movable structure 23 to move from its initial position to an intermediate position, bringing the skin penetration device 21 from the starting position to the skin penetration position.
  • the button 30 is prevented from being operated by the user until the sensor 40 detects that the on-body injection device 3 contacts the skin of a user.
  • the on-body injection device 3 further comprises a locking member 50 that is operably connected with the sensor 40 so that the locking member 50 is moved from a locking position to a release position.
  • the button 30 In the locking position of the locking member 50, the button 30 is prevented from being operated by the user.
  • the locking member 50 in its locking position abuts at least one portion of the button 30. That is, the locking member 50 in its locking position prevents the button 30 from being moved from its initial position to the release position.
  • the button comprises one or more locking protrusions 31, such as protruding pins, extending in distal-proximal direction and being in contact with the locking member 50. In the shown embodiment, the locking protrusions 31 contact a distal surface of the locking member 50.
  • the locking member 50 comprises a cam surface 51 and the sensor 40 comprises a protrusion
  • a movement of the sensor 40 from the locking position to the release position in a first direction results in a movement of the locking member 50 in a second, preferably perpendicular, direction to its release position.
  • the locking member 50 would move sidewards. When moving sidewards, the distal surface of the locking member 50 would no longer contact the locking protrusions 31, and so the button 30 is free to be operated and to be moved proximally towards the skin of a user.
  • the button 30 may further comprise one or more locking members 33 for locking the button 30 in its release position with the housing 9.
  • the corresponding locking element 9e of the housing is shown in Fig. 6. A snap-connection is thus provided.
  • the sensor 40 comprises a main body 42 arranged within the housing 9.
  • the sensor 40 further comprises one or more contact member 43 protruding from the housing 9 through the body side wall 9b. These contact members 43 are intended to contact the skin of the user.
  • the sensor 40 further comprises one or more resilient member support 42 supporting a resilient member 43 (one of which is shown in Fig. 6) biasing the sensor 40 protruding from the housing 9 in a direction away from the housing 9.
  • the on-body injection device 3 comprises a movable member channel 13 arranged inside the housing 9.
  • the movable member channel 13 may be an integral part of the housing 9 or may be a separate component attached directly or indirectly to the housing 9.
  • the movable member channel 13 is a piston channel.
  • the movable member channel 13 has a proximal surface defined by the body side wall 9b of the housing 9. The movable member channel 13 extends from the body side wall 9b towards the distal side wall 9a of the housing 9.
  • the movable member channel 13 has a fluid inlet 13a, which is in fluid communication with the medicament inlet 11.
  • the movable member channel 13 has a fluid outlet 13b.
  • the fluid outlet 13b is arranged axially offset from the fluid inlet 13a along a longitudinal axis of the movable member channel 13.
  • the fluid outlet 13b is further away from the body side wall 9b of the housing 9 than the fluid inlet 13a.
  • the fluid inlet and the fluid outlet may be offset in the circumferential direction of the movable member channel, or they may be both circumferentially and axially offset relative to each other.
  • the fluid outlet 13b is according to the example provided on an inner surface of the movable member channel 13.
  • the on-body injection device 3 comprises a movable member 15 arranged in the movable member channel 13.
  • the movable member 15 is a piston.
  • the movable member could be another shape, such as a ball, or a disc.
  • the movable member could be compressible (soft) or incompressible (rigid).
  • the movable member is connected to the movable member channel 13 via a fluid-tight connection.
  • the movable member could also be a rotatable component such as a flexible arm or a trapdoor.
  • the movable member 15 could comprise a membrane that gas can pass through but that liquid cannot pass through.
  • the movable member 15 provides sealing between the inner surface of the movable member channel 13 and the outer surface of the movable member 15.
  • the on-body injection device 3 may comprise a sealing ring 17 arranged around the movable member 15, for example in a circumferential groove provided in the outer surface of the movable member 15.
  • the movable member 15 is configured to move in the movable member channel 13 from a first movable member position, shown in Fig. 6, to a second movable member position (not shown).
  • the movable member 15 is configured to move in a direction from the body side wall 9b towards the distal side wall 9a when the movable member 15 is moved from the first movable member position to the second movable member position.
  • the movable member 15 is thus linearly movable inside the movable member channel 13.
  • the moveable member channel 13 is shown extending perpendicular to the dose delivery site, but could be orientated in a different direction. Additionally, as an alternative to linear movement of the moveable member 15, the movable member 15 could be arranged to rotate, or to rotate and move linearly, in the movable member channel 13. In the first movable member position, the movable member 15 blocks the fluid outlet 13b.
  • the movable member 15 blocks the fluid inlet 13a from fluid communication with the fluid outlet 13b.
  • the movable member 15 is arranged such that the fluid inlet 13a is in fluid communication with the fluid outlet 13b.
  • a lower end of the movable member 15 may in this case have at least partly passed the fluid outlet 13b.
  • the movable member 15 has an internal channel 15a which extends along the longitudinal axis of the movable member 15, from the lower end of the movable member 15 to an upper end of the movable member 15.
  • the internal channel 15a forms a through-opening in the movable member 15.
  • the term 'lower end' is used to refer to an end that is closer to a user's skin during use; and the term 'upper end' is used to refer to an end being opposed to the lower end, namely that the end that is away from the user's skin or being further distance to the user's skin during use.
  • the moveable member 15 is prevented from movement by button 30.
  • the button comprises a blocking member 34 that cooperates with the moveable member 15.
  • the button 30 has two distal-proximal extending blocking member 34 that abut against a corresponding surface or edge of the moveable member 15.
  • the blocking member 34 has an inclined contact surface so that movement of the button in proximal direction causes the blocking member 34 to flex outwards so that the moveable member 15 is then free to move from the first movable member position to the second movable member position.
  • the blocking member 34 is designed and shaped such that any pressure applied by the fluid onto the moveable member 15 is not high enough to cause flexing of the blocking member 34.
  • the looking member 50 is configured to block the moving of the movable member 15 when the looking member 50 is in the initial position.
  • the on-body injection device 3 may comprise a gas filter (not shown).
  • the gas filter is fluidly connected to the ambient thereby the gas can flow to the ambient via the gas filter.
  • the gas filter is fixed to the movable member 15, although this is optional, with the gas filter alternatively attached to another part of the on-body injection device - as the idea is that the gas filter should allow gas out of the fluid path (i.e. the path the fluid takes between a medicament container and a medicament delivery member (skin penetration device) such as a needle or a cannula) without allowing fluid out of the fluid path, the gas filter could also be elsewhere in the fluid path.
  • the gas filter is arranged to seal an end of the internal channel 15a distal from the body side of the on-body injection device.
  • the gas filter is configured to allow air to pass through it and to block liquid from passing through.
  • the gas filter may for example comprise a polytetrafluoroethylene (PTFE) membrane.
  • PTFE polytetrafluoroethylene
  • the gas filter could be arranged to seal the internal channel elsewhere on the internal channel rather than at an end of the internal channel 15a distal from the body side of the on-body injection device, such as at an end of the internal channel 15a proximal to the body side of the on-body injection device and/or anywhere between the axial ends of the internal channel.
  • the gas filter could also be elsewhere along the fluid path. Particularly in cases where the movable member is not a piston (as mentioned above), it may be beneficial (or necessary) to move the gas filter to elsewhere along the fluid path (or to provide a second gas filter elsewhere along the fluid path).
  • the hose 7 may be filled with air.
  • the button 30 is engaged with the movable member 15, which is in the first movable member position.
  • the runner 21c is interlocked with the moveable structure 23.
  • the skin penetration device 21 is in the starting position.
  • the pump of the medicament pump device 5 has started pumping the medicament through the hose 7 to the on-body injection device 3. This pushes the air through the medicament inlet 11 into the on-body injection device 3.
  • the air flows into the movable member channel 13, up through the internal channel 15a of the movable member 15, exiting the movable member 15 through the gas filter.
  • the medicament has entered into the movable member channel 13 through the medicament inlet 11 and flows up through the internal channel 15a towards the gas filter. Since the gas filter does not let liquid pass through it, the movable member 15 is ready to be lifted inside the movable member channel 13 which lifting is, however, still prevented by the button 30 with its blocking member 34. As a back pressure is created, the pump device 5 could detect this, stops pumping and wait for the user to apply the on-body injection device 3 and a user input through to start infusion.
  • the user applies the on-body injection device 3 to the skin and attaches the on-body injection device to the skin by the adhesive layer 8.
  • the sensor 40 is activated, i.e., moved inwards, and this movement is translated into a movement of the locking member 50 so that the on-body injection device is ready to be activated by the user by pressing the button.
  • the user may simply lift the on-body injection device again, and re-position it.
  • the sensor is returned to its initial position due to the resilient member 45, and also the locking member 50 is moved back into its initial position, again blocking the button 30.
  • the user can activate the button 30 by pushing it.
  • This movement of the button 30 releases the moveable structure 23.
  • the button 30 is moved to such an extent towards the release position such that it disengages from the moveable structure 23.
  • the moveable structure 23 is moved in a direction away from the movable member 15.
  • the first cam surface 23a cooperates with the runner 21c, causing the skin penetration device 21 to move from the start position to the skin penetration position.
  • the runner 21c is moved to the skin penetration position in a direction towards the body side wall 9b. This causes the cannula 21a to puncture the injection site and to enter the injection site.
  • the blocking member 34 of the button releases the moveable member 15 so that it can begin to move from the first movable member position to the second movable member position.
  • an overpressure is built up inside the movable member channel 13 relative to the pressure outside the movable member channel 13 due to the medicament which accumulates inside the movable member channel 13, which causes the movable member 15 to move, or the user is starting the infusion on the device.
  • the moveable structure 23 moves from the intermediate position to a final structure position.
  • the second cam surface 23b cooperates with the runner 21c, which is moved back in a direction towards the distal end wall 9a.
  • the puncture cannula 21b is moved back into the housing 9.
  • the indwelling cannula 21a is held in a position in which it penetrates the injection site 33, because a lower side 23d of the structure 23 holds the runner 21c in the skin penetration position.
  • the on-body injection devices/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 rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), hypercholesterolaemia and/or dyslipidemia, cardiovascular disease, diabetes (e.g.
  • psoriasis psoriatic arthritis
  • spondyloarthritis spondyloarthritis
  • hidradenitis suppurativa Sjogren's syndrome
  • migraine cluster headache
  • multiple sclerosis neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute
  • Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and/or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro- apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, 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 delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modul
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-la, interferon beta-lb, peginterferon beta-la, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-
  • Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as 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-ibritum
  • Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the "innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.
  • Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • adjuvant or neoadjuvant 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.
  • Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer's solution, Heparin Lock Flush solution, 100 U/mL Heparin Lock Flush Solution, or
  • compositions including, but not limited to, any drug described herein are also contemplated for use in the 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.
  • Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.
  • Exemplary drugs that could be included in the 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, mFOLFOX6, mFOLFOX7, 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,
  • the on-body injection device (3) according to clause 4 wherein the locking member (50) in its locking position prevents the button (30) from being moved from its initial position to the release position.
  • the on-body injection device (3) according any one of clauses 4 to 7, wherein locking member (50) in its locking position abuts at least one portion of the button (30).
  • the button (30) comprises one or more abutment portions abutting to the movable structure (23) when the button (30) is in the initial position, preventing the movable structure (23) from moving.
  • the on-body injection device (3) according to clause 10, wherein the button (30) is configured to disengage from the movable structure (23) when the button (30) is operated by the user and moved to the release position, causing the movable structure (23) to move from its initial position to an intermediate position.
  • the button (30) comprises one or more locking member (33) for locking the button (30) in its release position with the housing (9).
  • the on-body injection device (3) according any one of clauses 2 to 12, wherein the sensor
  • (40) comprises a main body (42) arranged within the housing (9). 14.
  • the on-body injection device (3) according any one of clauses 2 to 13, wherein the sensor
  • (40) comprises one or more contact member (43) protruding from the housing (9) through the body side wall (9b).
  • the sensor (40) comprises one or more resilient member support (42) supporting a resilient member biasing the sensor (40) protruding from the housing (9) in a direction away from the housing (9).
  • the skin penetration device (21) comprises a cannula (21a, 21b) configured to move out from the housing (9) via the body side wall (9b) when the skin penetration device (21) is moved from the starting position to the skin penetration position.
  • the housing (9) has a distal side wall (9a) opposite to the body side wall (9b) and a sidewall (9c) connecting the body side wall (9b) and the distal side wall (9a), wherein the movable structure (23) is configured to move towards the sidewall (9c).
  • the on-body injection device (3) according to any one of the preceding clauses, wherein the housing (9) is provided with a medicament inlet (11), the on-body injection device (3) further comprising: a movable member channel (13) arranged in the housing (9), a movable member (15) arranged in the movable member channel (13), the movable member channel (13) having a fluid inlet (13a) in fluid communication with the medicament inlet (11), and a fluid outlet (13b).
  • buttons (30) comprises one or more blocking member (34) preventing the movable member (15) from movement before the button (30) is operated by the user.
  • a medicament delivery device (1) comprising the on-body injection device (3) according any one of the preceding clauses.
  • the medicament delivery device (1) comprising a hose (7) connected to the medicament inlet (11) of the on-body injection device (3), and a medicament pump device (5) comprising: a medicament pump device housing (5a), and a motor and a pump arranged in the medicament pump device housing (5), wherein the motor is configured to drive the pump, and wherein the pump is configured to pump medicament (31) to the on-body injection device (3) via the hose (7).
  • a method of locking the on-body injection device comprising: engaging the button (30) with the movable structure (23) when the button (30) is in the initial position to prevent the movable structure (23) from moving.

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  • Health & Medical Sciences (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'injection sur le corps (3) comprenant un boîtier (9), le boîtier (9) ayant une paroi latérale de corps (9b) conçue pour s'appuyer contre la peau d'un utilisateur, un capteur (40) conçu pour détecter que l'injection sur le corps est en contact avec la peau d'un utilisateur, un bouton (30) devant être actionné par l'utilisateur pour se déplacer d'une position initiale à une position de libération, un dispositif de pénétration cutanée (21) conçu pour se déplacer d'une position de départ à une position de pénétration cutanée, une structure mobile (23) pour déplacer le dispositif de pénétration cutanée (21) de la position de départ à la position de pénétration cutanée, le bouton (30) étant conçu pour venir en prise avec la structure mobile (23) lorsque le bouton (30) se trouve dans la position initiale, empêchant la structure mobile (23) de se déplacer, le bouton (30) étant conçu pour coopérer avec la structure mobile (23) lorsque le bouton (30) est actionné par l'utilisateur et déplacé vers la position de libération, amenant la structure mobile (23) à se déplacer de sa position initiale à une position intermédiaire, amenant le dispositif de pénétration cutanée (21) de la position de départ à la position de pénétration cutanée, et le bouton (30) étant empêché d'être actionné par l'utilisateur jusqu'à ce que le capteur (40) détecte que l'injection sur le corps entre en contact avec la peau d'un utilisateur.
PCT/EP2024/073520 2023-09-06 2024-08-22 Dispositif d'injection sur le corps et dispositif d'administration de médicament Pending WO2025051546A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202363536797P 2023-09-06 2023-09-06
US63/536,797 2023-09-06
EP23210928 2023-11-20
EP23210928.0 2023-11-20

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WO2025051546A1 true WO2025051546A1 (fr) 2025-03-13

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110046456A1 (en) * 2008-02-08 2011-02-24 Hoerdum Elo Lau Assembly Comprising Inserter, Cannula Part and Base Part
US20120209183A1 (en) * 2006-02-09 2012-08-16 Gray Larry B Adhesive and peripheral systems and methods for medical devices
US20190160225A1 (en) * 2016-08-02 2019-05-30 Sanofi-Aventis Deutschland Gmbh Medicament Delivery Device
US20190358393A1 (en) * 2016-11-10 2019-11-28 Sensile Medical Ag Drug delivery device
US11185629B2 (en) 2016-06-08 2021-11-30 Shl Medical Ag Dosing apparatus and injection device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120209183A1 (en) * 2006-02-09 2012-08-16 Gray Larry B Adhesive and peripheral systems and methods for medical devices
US20110046456A1 (en) * 2008-02-08 2011-02-24 Hoerdum Elo Lau Assembly Comprising Inserter, Cannula Part and Base Part
US11185629B2 (en) 2016-06-08 2021-11-30 Shl Medical Ag Dosing apparatus and injection device
US20190160225A1 (en) * 2016-08-02 2019-05-30 Sanofi-Aventis Deutschland Gmbh Medicament Delivery Device
US20190358393A1 (en) * 2016-11-10 2019-11-28 Sensile Medical Ag Drug delivery device

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