WO2025228678A1 - Sous-ensemble pour un dispositif d'administration de médicament - Google Patents

Sous-ensemble pour un dispositif d'administration de médicament

Info

Publication number
WO2025228678A1
WO2025228678A1 PCT/EP2025/060320 EP2025060320W WO2025228678A1 WO 2025228678 A1 WO2025228678 A1 WO 2025228678A1 EP 2025060320 W EP2025060320 W EP 2025060320W WO 2025228678 A1 WO2025228678 A1 WO 2025228678A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle cover
locking ring
sub
assembly
axially
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/EP2025/060320
Other languages
English (en)
Inventor
Nils Ronquist
Ming-Ting Yin
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 WO2025228678A1 publication Critical patent/WO2025228678A1/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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body

Definitions

  • the present disclosure generally relates to medical devices for medicament administration.
  • the medicament is typically comprised in a medicament container within the medicament delivery device, the medicament container being configured to expel the medicament via some type of delivery member, such as a needle.
  • a medicament delivery action may be activated by activating a drive member configured to act on the medicament container, whereafter medicament is continuously expelled from the medicament container via the needle until the end of the medicament delivery action.
  • the medicament delivery device may comprise a cap. If the cap is unintentionally removed, unintentional activation of the medicament delivery device may occur.
  • An object of the present disclosure is to provide a sub-assembly for a medicament delivery device, and a medicament delivery device, which solves, or at least mitigates problems of the prior art.
  • a sub-assembly for a medicament delivery device configured to expel medicament from a medicament container.
  • the sub- assembly comprises: a housing having a proximal end and a distal end; a needle cover configured to move axially relative to the housing, the needle cover comprising a first locking structure; an outer cap arranged proximal of the needle cover and being rotationally locked to the proximal end of the housing; the outer cap comprising a second locking structure; and wherein the needle cover is configured to rotate relative to the housing from a first position in which the first and second locking structures are engaging to axially lock the outer cap to the needle cover, into a second position in which the first and second locking structures are disengaged and the outer cap is no longer axially locked to the needle cover.
  • cap removal can be performed first when the needle cover has been rotated relative to the housing from the first to the second position.
  • cap removal is prevented owing to the first and second locking structures, prior to rotation of the needle cover from the first to the second position.
  • the cap removal prevention is undone, or is released, by rotation of the needle cover from the first to the second position.
  • the cap removal action is performed by axially moving the outer cap (e.g. by pulling the outer cap) subsequent to rotating the needle cover from the first to the second position.
  • the first and second locking structures are arranged to engage when the needle cover is arranged in the first position, and are arranged to disengage when the needle cover is rotationally moved from the first to the second position, such that the first and second locking structures are disengaged, or released from each other, when the needle cover is arranged in the second position.
  • the needle cover maybe rotationally moved from the first to the second position by various means, e.g. induced by a user of the sub-assembly, such as e.g. by activating switch physically coupled to the needle cover, or by directly interacting with the needle cover through an opening in the housing.
  • distal direction 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.
  • 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 sub-assembly further comprises a locking ring configured to rotate relative to the housing from a first state in which the needle cover is arranged in the first position, into a second state in which the needle cover is arranged in the second position.
  • a locking ring configured to rotate relative to the housing from a first state in which the needle cover is arranged in the first position, into a second state in which the needle cover is arranged in the second position.
  • the locking ring is configured to induce a rotational movement of the needle cover from the first position to the second position.
  • the locking ring may e.g. be arranged in an opening, or an indentation, of the housing, or be arranged distally of the housing.
  • the locking ring is preferably configured to interact with the needle cover, e.g.
  • the housing of the sub-assembly may be inactive for the cap removal action other for rotationally locking the outer cap.
  • the locking ring may, to at least some degree, be configured to rotate relative to the needle cover.
  • the locking ring maybe configured to be rotated by a predetermined degree prior to interacting with the needle cover, and inducing a rotational movement of the latter.
  • a safety margin for inducing the rotational movement of the needle cover from the first to the second position by the locking ring is provided.
  • the locking ring maybe arranged to be rotated by 90° as the needle cover rotate by less than 45 0 , and/or maybe arranged to be rotated by at least 45 0 prior to interacting with the needle cover.
  • the locking ring is arranged radially outside of the needle cover and is axially immovable relative to the housing.
  • the locking ring maybe arranged close to the needle cover, e.g. adjacent the needle cover.
  • interaction between the locking ring and the needle cover is facilitated.
  • the locking ring is axially immovable relative to the housing, it is axially fixed relative to the housing.
  • the locking ring is annular, is a circlip or a has half-circular shape.
  • the integration of the locking ring to the housing, or adjacent the housing, is facilitated.
  • the rotation of the locking ring may be facilitated.
  • the locking ring comprises a first blocking surface arranged to abut a second blocking surface of the needle cover in the first state of the locking ring to prevent a proximal movement of the needle cover, wherein the first blocking surface is arranged distant to the second blocking surface in the second state of the locking ring to no longer prevent proximal movement of the needle cover.
  • the needle cover may be biased in the proximal direction, e.g. by a needle cover spring arranged distally of the needle cover, and therefore biased to move in the proximal direction.
  • the needle cover may move, or may at least be free to move, in the proximal direction.
  • the previously mentioned needle cover spring may exert a force on the needle cover to move the needle cover in the proximal direction.
  • the first and second blocking surface in the first state of the locking ring, may be arranged axially aligned, and in the second state of the locking ring, the first and second blocking surface may be arranged axially offset.
  • the axial movement of the needle cover in the proximal direction may be combined with a rotational movement of the needle cover.
  • the needle cover maybe arranged to move rationally and axially in the proximal direction upon movement of the locking ring from the first to the second state.
  • the locking ring is arranged to move the needle cover from the first position to the second position when moving from the first state to the second state.
  • the locking ring may e.g. be arranged to interact with the needle cover, e.g. by being in contact with the needle cover, e.g. by a protrusion extending radially inwards and towards the needle cover.
  • the needle cover comprises a first abutment surface
  • the locking ring comprises a second abutment surface
  • the locking ring is configured to move the needle cover from the first position to the second position by the second abutment surface pushing and abutting the first abutment surface.
  • the locking ring comprises a rib extending axially along at least a portion of an inner surface of the locking ring, the rib comprising the second abutment surface and/ or wherein the needle cover comprises a protrusion extending axially along at least a portion of an outer surface of the needle cover, the protrusion comprising the first abutment surface.
  • the rib may e.g. be formed as a radially protruding rib, wherein the second abutment surface is a radial surface or transversal surface, facing in a direction perpendicular to the axial axis.
  • the protrusion extending axially along at least a portion of an outer surface of the needle cover may be a radially protruding protrusion, wherein the first abutment surface is a radial surface or transversal surface, facing in a direction perpendicular to the axial axis.
  • the rib of the inner surface of the locking ring is configured interact with the protrusion of the outer surface of the needle ring such that second abutment surface abuts and pushes the first abutment surface to bring the needle cover into its second position, as the locking ring is moved from the first state to the second state.
  • the needle cover is further configured to move axially in the proximal direction when the needle cover rotates from the first position to the second position.
  • the needle cover maybe configured to move axially and rotationally from the first position to the second position. In other words, in the second position, the needle cover has been moved axially in the proximal direction, as well as rotationally, relative to the first position.
  • the locking ring is configured to axially move the needle cover in the proximal direction.
  • the locking ring may e.g. be arranged to interact with the needle cover, e.g. by being in contact with the needle cover, e.g. by a protrusion extending radially inwards and towards the needle cover.
  • a protrusion extending radially inwards and towards the needle cover.
  • Such radially extending protrusion is typically arranged to face at least partly in the proximal direction.
  • the locking ring comprises a ramping rib extending circumferentially along at least a portion of an inner surface of the locking ring, the ramping rib comprising the second abutment surface and/or wherein the needle cover comprises a radial protrusion extending radially out from an outer surface of the needle cover, the radial protrusion comprising the first abutment surface.
  • the ramping rib may e.g. be formed as a radially protruding ramping rib, wherein the second abutment surface is facing at least partly in the radial or transversal direction (i.e.
  • the radial protrusion extending radially out from the outer surface of the needle cover maybe a radially protruding protrusion, wherein the first abutment surface is facing at least partly in the radial or transversal direction (i.e. facing in a direction at least partly perpendicular to the axial axis) and facing at least partly in the distal direction.
  • the ramping rib of the inner surface of the locking ring is configured interact with the radial protrusion of the outer surface of the needle ring such that second abutment surface abuts and pushes the first abutment surface to move the needle cover axially in the proximal direction.
  • the needle cover comprises a pushing surface configured to abut a receiving surface of the housing and/or the outer cap as the needle cover is rotationally and axially moved from the first position to the second position, wherein at least one of the pushing surface and the receiving surface is chamfered for rotating the needle cover as the pushing surface pushes and abuts the receiving surface. That is, as the needle cover is moved axially in the proximal direction, the interaction between the pushing surface and the receiving surface induces the rotational movement of the needle cover.
  • at least one of the pushing surface and the receiving surface is chamfered, e.g. by facing at least partly in the radial or transversal direction (i.e.
  • the needle cover may be moved from the first position to the second position.
  • the sub-assembly further comprises a rear member arranged distally relative to the housing, wherein the rear member is provided with a radially flexible structure with an axially extending end tab, and wherein the axially extending end tab is received by an axial recess of the locking ring when the locking ring is in the first state such that the locking ring is rotationally fixed in the first state to the rear member, and wherein the radially flexible structure is configured to be pushed radially inwards such that the axially extending end tab is disengaged from the axial recess of the locking ring.
  • the radially flexible structure may e.g. be configured to be pushed radially inwards by an inner wall of the medicament delivery device.
  • the radially flexible structure may be configured to be pushed radially inwards when a cassette unit holding the medicament container is inserted into and connected to the sub-assembly.
  • the proximal end of the housing has a noncircular radial cross section.
  • an advantageous structure for rotationally locking the outer cap to the housing is provided.
  • the portion of the outer cap interacting with the proximal end of the housing, typically a distal portion of the outer cap, may have a corresponding non-circular radial cross section.
  • the non-circular radial cross section of the proximal end of the housing maybe described as that an outer surface of the proximal end of the housing has a perimeter that has a non-circular cross-sectional shape.
  • the non-circular radial cross section of the outer cap may be described as that an inner surface of the outer cap has a cross- sectional shape that corresponds to the non-circular cross-sectional shape of the proximal end of the housing.
  • the radial cross-sections are typically taken through a longitudinal axis of the sub-assembly.
  • the outer cap comprises a distal portion configured to press-fit to the proximal end of the housing.
  • the distal portion may be press-fitted to the proximal end of the housing, wherein rotation of the outer-cap is prevented owing to the press-fit relative to the proximal end of the housing.
  • the first and second locking structures are axially aligned when the needle cover is arranged in the first position, wherein the first and second locking structures are axially offset when the needle cover is arranged in the second position.
  • an advantageous structure for preventing axial movement of the outer cap relative to the housing when the needle cover is arranged in the first position, and for enabling axial movement of the outer cap relative to the housing (i.e. during a cap removal action) when the needle cover is arranged in the second position are provided.
  • the first and second locking structures are arranged to engage by a snap-fit structure.
  • an advantageous structure for providing a lockingly interaction between the outer cap and the needle cover is provided.
  • first and second locking structures are arranged such that engagement by the snap-fit structure is provided when the needle cover is arranged in the first position, and disengagement of the snap- fit structure is provided when the needle cover is moved to the second position and/or is arranged in the second position.
  • the snap-fit structure may e.g. be comprised of a male-female coupling, wherein the male-part or female-part of the snap-fit structure is comprised in the first locking structure, and the other one of the male-part and female-part is comprised in the second locking structure.
  • the first locking structure comprises a radially protruding arm
  • the second locking structure comprises a receiving recess arranged to receive the radially protruding arm in the first position of the needle cover.
  • an advantageous structure for providing a lockingly interaction between the outer cap and the needle cover is provided.
  • the first and second locking structures are arranged such that locking interaction by the protruding arm in the receiving recess is provided when the needle cover is arranged in the first position, wherein the protruding arm is moved out from the receiving recess when the needle cover is moved from the first position to the second position, such that disengagement of the protruding arm from the receiving recess is provided when the needle cover is arranged in the second position.
  • a medicament delivery device configured to expel medicament from a medicament container, the medicament delivery device comprising the subassembly according to the first aspect.
  • the medicament delivery device is typically configured to expel medicament from the medicament container after cap removal.
  • the medicament container is a syringe.
  • the medicament container typically comprises a medicament delivery member in the form of a needle, which is protected by a needle shield.
  • the medicament container maybe comprised in a disposable cassette which maybe inserted into the sub-assembly.
  • Fig. i is a perspective view of a medicament delivery device and a subassembly thereof according to embodiments of the present disclosure
  • Fig. 2 is an exploded view of the medicament delivery device and a subassembly of Fig. i and according to embodiments of the present disclosure
  • Fig. 3 is a perspective view of a needle cover according to embodiments of the present disclosure.
  • Fig. 4 is a perspective view of an outer cap according to embodiments of the present disclosure.
  • Fig. 5 is a cross sectional view the outer cap in Fig. 4 being axially locked to the needle cover of Fig. 3;
  • Fig. 6 is a perspective view of a locking ring according to embodiments of the present disclosure;
  • Figs. 7-8 are various perspective views of a needle cover according to embodiments of the present disclosure.
  • Fig. io is a perspective view of a housing according to embodiments of the present disclosure.
  • Fig. n are perspective views of a locking ring and a rear element according to embodiments of the present disclosure.
  • Fig. i shows an example of a medicament delivery device i such as an autoinjector or an injection device, and a subassembly n of such medicament delivery device 1, according to embodiments of the present disclosure.
  • the medicament delivery device i is configured to expel medicament from a medicament container 15 via a medicament delivery member, e.g. a needle, to a user at a dose delivery site.
  • the medicament delivery device 1 extends from a proximal end la to a distal end ib relative to an 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 sub-assembly n of Fig. i comprises a housing 3 having a proximal end 3a and a distal end 3b relative to the axis 112.
  • the medicament container 15 is inserted into the sub-assembly 11, e.g. via a disposable cassette, such that the medicament container 15 is housed inside the housing 3.
  • the sub-assembly 11 further comprises a needle cover 5 at the proximal end la and being configured to cover, and exposing, the needle by moving axially relative to the housing 3.
  • the sub-assembly 11 comprises an outer cap 2 removably attached to the housing 3 for covering the needle cover 5 and protecting the sub-assembly 11 from unintentional activation.
  • the outer cap 2 has been moved to the side for increased visibility of the needle cover 5, but it should be understood that the outer cap 2, when being attached to the housing 3, is arranged proximally of the housing 3.
  • FIG. 2 is an exploded view of the subassembly 11 and the medicament delivery device 1 in Fig. 1, the arrangement of the outer cap 2, the needle cover 5 and the housing 3 is shown.
  • the sub-assembly 11 may further comprise a needle cover spring 7 arranged to bias the needle cover 5 in the proximal direction.
  • the needle cover spring 7 may e.g. be biased in between an internal structure of the needle cover 5 and the housing 3.
  • the needle cover 5 may be pre-tensioned, or spring- loaded, in the proximal direction.
  • the sub-assembly may further comprise a locking ring 6 configured to rotate relative to the housing 3.
  • the locking ring 6 is typically arranged radially outside of the needle cover 5 and is axially immovable relative to the housing 3, as shown in Fig. 1.
  • the locking ring 6 of Fig. 2 is annular.
  • the sub-assembly 11 may further comprise a rear member 17 arranged distally relative to the housing 3. As shown in both Figs. 1 and 2, the locking ring 6 is arranged in between the housing 3 and the rear member 17.
  • the rear member 17, the locking ring 6 and the housing 3 together form an outer structure of the sub-assembly 11 or the medicament delivery device 1.
  • the rear member 17, the locking ring 6 and the housing 3 typically comprises corresponding outer surfaces arranged at the same, or substantially the same, radial position.
  • the sub-assembly n may further comprise a rear cap 4 at the distal end ib.
  • the rear cap 4 being attached to the rear member 17.
  • the outer cap 2 is shown together with an optional needle shield remover 2g, which typically is attached to an interior structure of the outer cap 2.
  • the medicament container 15 is shown together with an optional needle shield 16, here being exemplified as a rigid needle shield, RNS, arranged to protect the needle of the medicament container 15.
  • RNS rigid needle shield
  • the needle shield 16 may be a flexible needle shield, FNS.
  • the needle shield 16 maybe referred to as an RNS/FNS 16.
  • the needle shield remover 2g is configured to interact with the RNS/FNS 16 and to remove the RNS/FNS 16 upon a cap removal action in which the outer cap 2 is detached from the housing 3.
  • the outer cap 2 is rotationally locked to the proximal end 3a of the housing 3.
  • the proximal end 3a of the housing is noncircular.
  • the non-circular radial cross section of the proximal end 3a of the housing 3 may be described as that an outer surface 3c of the proximal end 3b of the housing 3 has a perimeter that has a non-circular cross-sectional shape.
  • the radial cross-section is typically taken through the axis 112 of the sub-assembly 11.
  • Fig. 3 showing a perspective view of the needle cover 5, and Fig. 4 showing a perspective of the outer cap 2.
  • the needle cover 5 extends from a proximal end 5a to a distal end 5b relative to the axis 112.
  • the outer cap 2 extends from a proximal end 2a to a distal end 2b relative to the axis 112, and is arranged to be detachably attached to the housing 3 to cover at least a portion of the needle cover 5 including the proximal end 5a thereof.
  • the needle shield remover 2g has been removed for increased visibility.
  • the needle cover 5 comprises a first locking structure 30, which in the example of Fig. 3 is arranged at the proximal end 5b.
  • the locking structure 30 is arranged in an outer surface 5c of the needle cover 5.
  • the outer surface 5c is facing radially outwards.
  • the outer cap 2 comprises a second locking structure 40 arranged in the interior of the outer cap 2. That is, the outer cap 2 is hollow, and comprises a receiving recess 2f in which said portion of the needle cover 5 including the proximal end 5a is received when the outer cap 2 is attached to the housing 3.
  • the receiving recess 2f is at least partly defined by an inner surface 2c, wherein the second locking structure 40 is arranged in the inner surface 2c.
  • the inner surface 2c is facing radially inwards.
  • the inner surface 2c of the outer cap 2 may be correspondingly shaped, e.g. have a radial cross section which is non-circular.
  • the radial cross-section is typically taken through the axis 112 of the subassembly 11.
  • a portion of the outer cap 2 at the distal end 2b thereof is configured to be press-fitted to the proximal end 3a of the housing 3 (also shown in Fig. 5).
  • the first and second locking structures 30, 40 are arranged to engage to axially lock the outer cap 2 to the needle cover 5. Hereby, the outer cap 2 cannot be removed by being pulled in the proximal direction, when the first and second locking structures 30, 40 are engaged.
  • the needle cover 5 is configured to rotate relative the housing 3. That is, the needle cover 5 is configured to rotate relative to the housing 3 from a first position in which the first and second locking structures 30, 40 are engaging to axially lock the outer cap 2 to the needle cover 5 into a second position in which the first and second locking structures 30, 40 are disengaged and the outer cap 2 is no longer axially locked to the needle cover 5.
  • the outer cap 2 can be removed by a cap removal action, typically by being moved or pulled in the proximal direction.
  • the first locking structure 30 comprises a protruding arm 31, and the second locking structure 40 comprises a receiving recess 41 arranged to receive the radially protruding arm 31 in the first position of the needle cover 5.
  • the radially protruding arm 31 extends radially outwards from the outer surface 5c of the needle cover 5.
  • the radially protruding arm 31 also extends axially from the proximal end 5a of the needle cover 5 in the distal direction.
  • the receiving recess 41 is formed by a radially extending structure 2d of the inner surface 2c but may alternatively be formed by a radial indentation in the inner surface 2.
  • the receiving recess is at least partly defined by a proximally facing surface 42 of the radially extending structure 2d.
  • the protruding arm 31 is rotationally moved out from the receiving recess 41, until the needle cover 5 is moved to its second position whereby the first and second locking structures 30, 40 are axially offset.
  • the outer cap 2 is no longer prevented from being moved axially as the protruding arm 31 is no longer is axially aligned with the proximally facing surface 42. Therefore, in the second position of the needle cover 5, the outer cap 2 is no longer axially locked to the needle cover 5, and may thus be removed.
  • the first and second locking structures 30, 40 maybe are arranged to engage by a snap-fit structure, typically by that at least a portion of the radially extending structure 2d is flexible, and that the protruding arm 31 is configured to move into the receiving recess 41 by pushing the flexible portion of the radially extending structure 2d (i.e. deflecting it), wherein when the protruding arm 31 is received in the receiving recess 41, the flexible portion of the radially extending structure 2d moves, or flexes back, to snap- lock the protruding arm 31 in the receiving recess 41.
  • first and second locking structures 30, 40 are arranged such that engagement by the snap-fit structure 31, 41 is provided when the needle cover 5 is arranged in the first position, and disengagement of the snap-fit structure 31, 41 is provided when the needle cover 5 is moved to the second position and/ or is arranged in the second position.
  • the rotation of the needle cover 5 maybe induced by the locking ring 6.
  • the locking ring 6 may be configured rotate relative to the housing 5 from a first state in which the needle cover 5 is arranged in the first position, into a second state in which the needle cover 5 is arranged in the second position.
  • the locking ring 6 may be configured to induce a rotational movement of the needle cover 5 from the first position to the second position by releasing a pre-tensioned needle cover 5 enabling movement of the needle cover 5 in the proximal direction (combined with a rotational movement, as will be described later), and/ or by abutting and pushing the needle cover 5 as the locking ring 6 is moved from the first state to the second state.
  • Fig. 6 shows a perspective view of the locking ring 6.
  • the needle cover 5 comprises a first abutment surface 50 and the locking ring 6 comprises a second abutment surface 60.
  • the locking ring 6 is configured to move the needle cover 5 from the first position to the second position by the second abutment surface 60 pushing and abutting the first abutment surface 50, as the locking ring 6 is moved from the first state to the second state.
  • the locking ring 6 is arranged to move the needle cover 5 from the first position to the second position when moving from the first state to the second state.
  • the needle cover 5 comprises a protrusion 51 extending axially along at least a portion of the outer surface 5c of the needle cover 5, the protrusion 51 comprising the first abutment surface 50.
  • the locking ring 6 comprises a rib 61 extending axially along at least a portion of an inner surface 6c of the locking ring 6, the rib 61 comprising the second abutment surface 60.
  • the inner surface 6c of the locking ring 6 is facing radially inwards.
  • the rib 61 may e.g.
  • the second abutment surface 60 may extend axially along the axis 112.
  • the protrusion 51 extending axially along at least a portion of the outer surface 5c of the needle cover 5 maybe a radially protruding protrusion 51.
  • the first abutment surface 50 may thus be a radial surface, or a transversal surface, facing in a direction perpendicular to the axis 112.
  • the first abutment surface 50 may extend axially along the axis 112.
  • the rib 61 of the locking ring 6 is configured interact with the protrusion 51 of the needle ring 5 such that second abutment surface 61 abuts and pushes the first abutment surface 51 to bring the needle cover 5 into its second position, as the locking ring 6 is moved from the first state to the second state.
  • the needle cover 5 may be rotationally moved from the first to the second position by other means than by moving the locking ring 6, e.g. induced by a user of the sub-assembly 11, such as e.g. by activating a switch physically coupled to the needle cover 5, or by directly interacting with the needle cover 5 through an opening in the housing 3.
  • Figs. 7-8 showing perspective views of an alternative needle cover 105
  • Fig. 9 showing a perspective view of an alternative locking ring 106.
  • the needle cover 105 maybe correspondingly arranged as the needle cover 5 of Fig. 3, and the locking ring 106 maybe correspondingly arranged as the locking ring 6 of Fig. 6, but with differences as described in the following.
  • the needle cover 105 may replace the needle cover 5 in the subassembly 11 of the medicament delivery device 1
  • the locking ring 106 may replace the locking ring 6 in the sub-assembly 11 of the medicament delivery device 1.
  • the needle cover 105 comprises a first abutment surface 150 and the locking ring 106 comprises a second abutment surface 160.
  • the locking ring 106 is configured to induce the rotationally movement of the needle cover 105 from the first position to the second position, by releasing the needle cover 105 to move axially in the proximal direction and/or by abutting and pushing the needle cover axially in the proximal direction, wherein the needle cover 105 is configured to interact with the housing 3 and/ or the outer cap 2 to rotate upon moving axially in the proximal direction.
  • the needle cover 105 may comprises a protrusion 151 extending radially along at least a portion of an outer surface 105c of the needle cover
  • the locking ring 106 may comprise a rib 161 extending axially along at least a portion of an inner surface 106c of the locking ring
  • the rib 161 comprising a second abutment surface 160.
  • the outer surface 105c of the needle cover 105 is facing radially outwards and the inner surface 106c of the locking ring 106 is facing radially inwards.
  • the rib 161 of the locking ring 106 maybe formed as a ramping rib 161 extending circumferentially along at least a portion of the inner surface 106c of the locking ring 106.
  • the ramping rib 161 is typically extending radially inwards from the inner surface 106c.
  • the protrusion 151 of the needle cover 105 maybe formed as a radial protrusion 151 extending radially outwards from the outer surface 105c of the needle cover 105.
  • the second abutment surface 160 of the ramping rib 161 is facing at least partly in the radial or transversal direction (i.e.
  • a geometrical normal extending from the second abutment surface 160 is directed at least partly proximally and is angled relative to the axis 112.
  • the first abutment surface 150 of the radial protrusion 151 is facing at least partly in the radial or transversal direction (i.e. facing in a direction at least partly perpendicular to the axial axis) and facing at least partly in the distal direction.
  • a geometrical normal extending from the first abutment surface 150 is directed at least partly distally and is angled relative to the axis 112.
  • the ramping rib 161 of the locking ring 106 is configured interact with the radial protrusion 151 of the needle ring 105 such that second abutment surface 160 abuts and pushes the first abutment surface 150 to move the needle cover 105 axially in the proximal direction, as the locking ring 106 is moved from the first state to the second state.
  • the locking ring 106 is configured to axially move the needle cover 105 in the proximal direction.
  • the needle cover 105 may comprise at least one pushing surface 15 od, 15 oe configured to abut a receiving surface 3d, 2 e of the housing 3 and/or the outer cap 2.
  • a first pushing surface i5od is arranged in a distal portion of the needle cover 105
  • a second pushing surface 150 is arranged in a proximal portion of the needle cover 105.
  • a first receiving surface 3d is extending from an inner facing surface of the housing 3, and as shown in Fig. 4, a second receiving surface 2e is comprised in the radially extending structure 2d.
  • the first pushing surface isod of the needle cover and the first receiving surface 3d of the housing 3 forms a first rotating structure of the sub-assembly 11
  • the second pushing surface 150c of the needle cover 105 and the second receiving surface 2e of the outer cap 2 forms a second rotating structure of the sub-assembly 11.
  • At least one of the first and second rotating structures is typically needed for inducing a rotation of the needle cover 105 as it moves axially in the proximal direction.
  • the first pushing surface isod of the needle cover 105 interacts with the first receiving surface 3d of the housing 3
  • the second pushing surface 150c of the needle cover 105 interacts with the second receiving surface 2e of the outer cap 2, such that the needle cover 105 is rotated.
  • the needle cover 105 is configured to rotate from the first to the second position as it is moved axially in the proximal direction.
  • At least one of the pushing surfaces isod, 150c and the receiving surface 3d, 2e in each one of the first and second rotating structures is chamfered for inducing the rotating movement of the needle cover 105 from the first position to the second position.
  • the first pushing surface isod of the needle cover 105 is chamfered
  • the second receiving surface 2e of the outer cap 2 is chamfered.
  • the needle cover 105 will rotate from the first to the second position, whereby the first and second locking structures 30, 40 are disengaged, as previously described.
  • the needle cover 105 may be pre-tensioned in the proximal direction by the needle cover spring 7, wherein such proximal movement is prevented by the locking ring 106 when being arranged in the first state.
  • the locking ring 106 may comprise a first blocking surface 162 arranged to abut a second blocking surface 152 of the needle cover 105 (shown in Fig. 7) in the first state of the locking ring 106.
  • the first blocking surface 162 and the second blocking surface 152 are arranged axially aligned to prevent an axial movement of the needle cover 105 in the proximal direction.
  • the first blocking surface 162 is brought distant to the second blocking surface 152, to be axially offset relative to the second blocking surface 152, whereby the needle cover 105 may move, or may at least be free to move, in the proximal direction.
  • the locking ring 106 does no longer prevent proximal movement of the needle cover 105.
  • the previously mentioned needle cover spring 7 may exert a force on the needle cover 105 in the proximal direction.
  • the described feature of the locking ring 106 preventing axial movement of the needle cover 105 in the proximal direction may, or may not, be combined with the previously described feature of moving the needle cover 105 axially in the proximal direction (by the first abutment surface 150 and the second abutment surface 160).
  • the feature of moving the needle cover 105 axially in the proximal direction by the first abutment surface 150 and the second abutment surface 160 may be omitted, and the needle cover 105 may be simply released from its axially locked position (in which it is axially locked from moving in least the proximal direction) by rotating the locking ring 106 from the first state to the second state and thereby axially offsetting the first blocking surface 162 and the second blocking surface 152, and thereby initiate the axial movement in the proximal direction, typically combined with the induced rotational movement of the needle cover 105 by the first rotating structure and/or the second rotating structure as previously described.
  • FIG. 11 showing perspective views of the locking ring 106 and the rear member 17.
  • the rear member 17 is typically arranged distally relative to the housing 3, and distally relative to the locking ring 106.
  • the rear member 17 comprises a radially flexible structure 17b with an axially extending end tab 17c.
  • the locking ring 106 comprises an axial recess io6d configured to engage with the axially extending end tab 17c of the radially flexible structure 17b.
  • two oppositely arranged radially flexible structure 17b may be configured to engage with two corresponding axial recesses io6d, the two axial recesses io6d being arranged opposite each other.
  • the axially extending end tab 17c is received by the axial recess io6d of the locking ring 106 when the locking ring 106 is in the first state.
  • the locking ring 106 is rotationally fixed to the rear member 17 in the first state, and thus cannot be rotated relative to the housing 3.
  • the radially flexible structure 17b is configured to be pushed radially inwards whereby the axially extending end tab 17c is disengaged from the axial recess io6d of the locking ring 106, and the locking ring 106 is thereby no longer rotationally locked to the rear member 17.
  • the locking 106 is prevented from being moved from the first state to the second state by the interaction between the axially extending end tab 17c of the rear member 17 and the axial recess io6d of the locking ring 106.
  • unintentional activation of the sub-assembly 11, and e.g. unintentional movement of the locking ring 106 from the first state to the second state can be avoided.
  • the medicament delivery device 1, or the sub-assembly 11 is configured to receive a disposable cassette unit comprising the medicament container 15
  • the radially flexible structure 17b may be configured to be pushed radially inwards by an inner wall of the disposable cassette unit as the disposable cassette unit is loaded into the medicament delivery device 1, or the sub-assembly 11 thereof.
  • the medicament delivery device 1 may be triggered to discharge medicament from the medicament container 15, or at least be triggered to allow activation of the medicament container 15, by movement of the needle cover 5, typically in the distal direction.
  • the medicament delivery device 1 may comprises a drive member, such as a biased drive member or motor driven expulsion member, e.g. a plunger rod.
  • the drive member may be configured to be moved axially inside the medicament delivery device 1 upon activation. Such activation may e.g. be achieved by an actuator arranged in the distal end ib of the medicament delivery device 1, or by activation upon movement of the needle cover 5.
  • the drive member is typically configured to be moved proximally from a first axial position.
  • the drive member may be motor driven or may manually driven, or may have a biased or spring-loaded structure.
  • a spring such as a coil spring, may be arranged inside the medicament delivery device 1.
  • the drive member may be released, or may be enabled to be released by activating the actuator, from its biased condition.
  • the drive member maybe held in its biased condition by means of a holding sleeve or the like. The holding sleeve may be displaced to release the drive member from its biased condition by means of the actuator and/ or by means of movement of the needle cover 5.
  • the motor may be activated to drive the drive member upon such distal movement of the needle cover 5.
  • 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 and/ or dyslipidemia, cardiovascular disease, diabetes (e.g.
  • psoriasis psoriatic arthritis
  • 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, Behqet'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 hypog
  • Exemplary types of drugs that could be included in the medicament containers, and administrated by the medicament 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 medicament containers, and administrated by the medicament 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 medicament containers, and administrated by the medicament 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-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci 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,
  • Exemplary drugs that could be included in the medicament containers, and administrated by the medicament 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-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravul
  • Exemplary drugs that could be included in the medicament containers, and administrated by the medicament 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, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Y
  • Exemplary drugs that could be included in the medicament containers, and administrated by the medicament 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 medicament containers, and administrated by the medicament 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 medicament containers, and administrated by the medicament 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 5000 U/mL Heparin Lock Flush Solution.
  • SWFI sterile water for injection
  • compositions including, but not limited to, any drug described herein are also contemplated for use in the medicament containers, and administrated by 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.
  • Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or maybe 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 medicament containers, and administrated by 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

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

Abstract

La présente invention concerne un sous-ensemble (11) pour un dispositif (1) d'administration de médicament conçu pour expulser un médicament d'un récipient pour médicament (15). Le sous-ensemble (11) comprend : un boîtier (3) présentant une extrémité proximale (3a) et une extrémité distale (3b) ; un protège-aiguille (5, 105) conçu pour se déplacer axialement par rapport au boîtier (3), le protège-aiguille (5, 105) comprenant une première structure de verrouillage (30) ; un capuchon externe (2) disposé à proximité du protège-aiguille (5) et qui est verrouillé en rotation à l'extrémité proximale (3a) du boîtier (3) ; le capuchon externe (2) comprenant une seconde structure de verrouillage (40) ; le protège-aiguille (5, 105) étant conçu pour tourner par rapport au boîtier (3) à partir d'une première position dans laquelle les première et seconde structures de verrouillage (30, 40) viennent en prise pour verrouiller axialement le capuchon externe (2) au protège-aiguille (5, 105), dans une seconde position dans laquelle les première et seconde structures de verrouillage (30, 40) sont désolidarisées et le capuchon externe (2) n'est plus verrouillé axialement au protège-aiguille (5, 105).
PCT/EP2025/060320 2024-04-29 2025-04-15 Sous-ensemble pour un dispositif d'administration de médicament Pending WO2025228678A1 (fr)

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EP24172989 2024-04-29

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230078909A1 (en) * 2020-03-26 2023-03-16 Shl Medical Ag Locking mechanism for a medicament delivery device
WO2023126249A1 (fr) * 2022-01-03 2023-07-06 Shl Medical Ag Sous-ensemble d'une unité de cassette de médicament

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230078909A1 (en) * 2020-03-26 2023-03-16 Shl Medical Ag Locking mechanism for a medicament delivery device
WO2023126249A1 (fr) * 2022-01-03 2023-07-06 Shl Medical Ag Sous-ensemble d'une unité de cassette de médicament

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