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WO2024188692A1 - Dispositif d'administration de médicament - Google Patents

Dispositif d'administration de médicament Download PDF

Info

Publication number
WO2024188692A1
WO2024188692A1 PCT/EP2024/055585 EP2024055585W WO2024188692A1 WO 2024188692 A1 WO2024188692 A1 WO 2024188692A1 EP 2024055585 W EP2024055585 W EP 2024055585W WO 2024188692 A1 WO2024188692 A1 WO 2024188692A1
Authority
WO
WIPO (PCT)
Prior art keywords
extension part
diameter extension
cap
medicament delivery
proximal
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/EP2024/055585
Other languages
English (en)
Inventor
Justin Stewart
Meng-Jhen CHIOU
Yun Hsuan Chang
Jung-Chien CHOU
Pei-Hsin Liu
Chiao-Yi CHIU
Chin-Wei Chang
Wen-An CHANG
Pei Yu Chao
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 WO2024188692A1 publication Critical patent/WO2024188692A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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
    • A61M5/3205—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
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/42—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 having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/422—Desensitising skin

Definitions

  • the present invention relates to a medicament delivery device for obese patients.
  • medicament delivery devices are developed for self-administration, i.e., a user performs the medicament delivery her-, or himself. This requires a medicament delivery device, which is as safe to use and as easy to handle as possible.
  • the risk of human errors must be minimized, the number of actions needed to be performed in order to receive a dose need to be reduced and the device must be intuitive and ergonomic to use.
  • Medicament delivery devices such as autoinjectors and manual injectors, often have a needle shield or needle cover that extends in the proximal direction from the housing.
  • the needle shield protects the needle from exposure before medicament delivery.
  • the needle shield may be arranged to move along the longitudinal axis of the housing in a distal direction further into the housing, when the medicament delivery device is pushed towards an injection site. The needle is thus exposed so that it can penetrate the patient’s skin. For autoinjectors, this movement of the needle shield may cause the medicament delivery device to become activated to discharge medicament via the needle.
  • US 2014/0114247 A1 relates to an injection device comprising a housing, a container holder arranged within said housing, the container holder being configured for accommodating a medicament container having a needle attached to one end thereof and a stopper sealingly and slidable arranged inside the medicament container at the other end thereof, a drive unit comprising a plunger rod and plunger drive means, the plunger drive means being slidable arranged in relation to the plunger rod, being rotationally locked to the plunger rod and being rotatable in relation to the housing.
  • US 2019/0022334 A1 relates to a safety device for a pre-filled syringe with an injection needle comprising a support body adapted to mount the pre-filled syringe, a needle shield slidably arranged with respect to the support body, a retention and locking means for retaining and locking the needle shield with respect to the support body in a first and a second advanced position and in a retracted position.
  • the needle shield comprises an annular flange adapted to rest on the skin of the patient receiving an injection.
  • EP 3 007 752 A1 relates to an injection device having a contact surface for pressing against the skin of a patient.
  • the contact surface comprises an inwardly extending or radially extending flange or be at the end of a tapered or flared portion of the sliding sleeve to provide an improved contact area.
  • US 10398854 B2 relates to an injector such as a needle-type autoinjector having a flexible flange disposed at an injection end of the injector for stretching or pinching the skin of the injection site.
  • the flexible flange may be removably attached to the injector or integrated into the injector during manufacturing.
  • the amount of subcutaneous tissue present, the weight of the patient, muscle mass, and subcutaneous fat at the injection site may be different. That is, the tissue at the injection site may be softer compared to a normal-weight patient due to the different fat to muscle ratio and thickness of the tissue.
  • the soft skin may fold around the at least part of medicament delivery device and the interaction between the medicament delivery device with the folding skin in obese patients may create friction, which results in that a higher activation force is required.
  • the above problems contribute to a different resistance of the skin against the activation mechanism of the medicament delivery device.
  • the medicament delivery device may not be activated correctly.
  • a medicament delivery device generally comprises a housing body configured to receive and/or hold the main functional components: an activation system, a medicament delivery system, and a drive assembly.
  • the housing body may be configured to receive a cap to cover a proximal end portion of the medicament delivery device.
  • the cap is usually removed prior to use of the device.
  • a medicament delivery system generally comprises a delivery member configured to deliver an injection into the tissue.
  • a typical delivery member is a needle.
  • an activation system is configured to activate the injection, i.e. to affect an energy release from the drive assembly to the medicament delivery system.
  • An example the activation system is a push button at the distal end of the housing body configured to activate the drive assembly.
  • the present disclosure does not provide a solution for the medicament delivery system, activation system, and/or the drive assembly.
  • An object of the present disclosure is to provide a medicament delivery device which solves, or at least mitigates, problems of the prior art.
  • the above problems are among those solved by the present disclosure as defined in the appended claims.
  • a medicament delivery device comprises a housing body with a generally tubular shape configured to hold a medicament delivery system and a drive assembly; and a delivery member cover: configured to cover at least a proximal portion of the medicament delivery system, configured to move, when pressed against tissue at an injection site, coaxially within the housing body from a first proximal position to at least a second more distal position, and further configured to activate, by movement from the first position towards the second position, the drive assembly to initiate medicament delivery.
  • the medicament delivery device further comprises a diameter extension part provided on a proximal end portion of the housing body: configured to move on the proximal end portion of the housing body from a distal position, in which a proximal end portion of the diameter extension part is essentially flush with the proximal end portion of the housing body, to a proximal position in which the proximal end portion of the diameter extension part is essentially flush with the proximal end portion of the delivery member cover in the first position, and configured to prevent, during the movement of the delivery member cover from the first position towards the second position, a contact between the tissue and the delivery member cover or the housing body.
  • the medicament delivery device further comprises guiding means formed at an inner surface of the diameter extension part and/or an outer surface of a proximal portion of the housing body, and configured to guide the movement of the diameter extension part.
  • the medicament delivery device further comprises stopping means formed at an inner surface of the diameter extension part and/or an outer surface of a proximal portion of the housing body; and configured to stop the movement of the diameter extension part at the proximal and distal position.
  • the delivery member cover further comprises cap engagement means configured to engage with corresponding means on an inner surface of a cap; and the cap engagement means hold the cap such that the movement of the diameter extension part is blocked at the distal position.
  • a plurality of annular teeth is formed on the proximal end portion of the housing body; and the diameter extension part comprises engagement means configured to engage with the plurality of annular teeth.
  • the diameter extension part further comprises cap engagement means configured to engage with corresponding means on an inner surface of a cap; and the cap engagement means hold the cap such that the movement of the diameter extension part is blocked at the distal position.
  • the cap engagement means are configured to transfer a proximal directed force applied to the cap during removal to the diameter extension part such that the diameter extension part moves in a proximal direction until the second position is reached; and the cap engagement means are further configured to disengage after the second position is reached.
  • the housing body comprises an annular flange on the outer surface of the proximal end portion of the housing body; and the diameter extension part comprises an annular flange or sections of an annular flange on an inner surface of the distal end portion of the diameter extension part configured to engage with the annular flange on the outer surface of the proximal end portion of the housing body.
  • the diameter extension part further comprises cap engagement means configured to engage with corresponding means on an inner surface of a cap; and the cap engagement means hold the cap such that the movement of the diameter extension part is blocked at the distal position.
  • the diameter extension part is configured to engage with a proximal cap structure, configured to block the movement of the delivery member cover when engaged.
  • the diameter extension part further comprises an annular inner flange at the proximal end portion of the diameter extension part configured to minimize a gap between the diameter extension part and the delivery member cover.
  • the main factor for the optimization of the activation force for obese patients is the ratio between the outer diameter of the housing body and the outer diameter of the needle cover, because this factor directly influences the amount of contact between parts of the device and the skin of the injection site.
  • a further factor is the internal resistance force of the activation mechanism, e.g., the spring force of the needle cover.
  • the spring force of the needle cover e.g., the spring force of the needle cover.
  • a lower spring force will reduce the aforementioned problems; however, the optimization is limited because a certain spring force is required to ensure the device functionality as well as to fulfill industry requirements for medicament delivery devices. Thus, in this disclosure this factor is not optimized.
  • Fig. 5 illustrates the results of a simulation of an injection with different Models of injectors into obese skin 10.
  • results of four different Models of embodiments of the disclosure are shown.
  • the Models differ in the respective amount of diameter extension.
  • In the rows of Fig. 5 two different amounts of force are applied. All figures show results for the same tissue.
  • Model #1 has no diameter extension and ratio of 0.79. That is, the outer diameter of the needle cover is smaller than the inner diameter of the housing body.
  • Model #2 has a diameter extension and a ratio of 0.92.
  • Model 3 has a ratio of 1.
  • Model 4 has a ratio of 1 .9.
  • the shape of the folding tissue 10 is changed to an extent that the contact between the skin of the injection site and the moving end portion during activation, i.e., needle shield and/or housing body, is reduced or prevented.
  • a ratio of about 1 between the outer diameter of the needle shield 2 and the housing body 1 is a preferred ratio for embodiments of this disclosure.
  • a smaller ratio still allows for some contact with the tissue during activation and a higher ratio does not further optimize the activation force.
  • the optimum ratio was determined for an essentially flat and circular contact surface with the tissue 10.
  • Other shapes of contact surfaces are possible. Concave, convex, or complex axial shapes and/or elliptical or complex radial shapes are possible.
  • a comparable ratio is obtained, however, for small deviations from a circular shape the overall effect will be the same.
  • the ratio is about 1 and the outer diameter of the housing body is essentially the same as the diameter of the extended surface area portion, the activation force is optimized and the contact with the tissue (except for the intended injection site contact area) is minimized.
  • Fig. 6 shows three different embodiments of the disclosure at the same push pressure.
  • the embodiments on the left, Model #5 and Model#5b are similar to Model #1 and Model #3 as discussed before, respectively.
  • the embodiments of Model #5a has a ratio of about 1 .
  • the embodiment Model #6 also has a ratio of about 1 , thus it also corresponds to Model #3 as discussed above, but additionally comprises a sleeve portion projecting distally from contact surface.
  • Model #5a and Model #5b the tissue is in contact with the side surface of the needle cover and the movement of the housing body 1 is not completed, see the two solid lines and the distance A therebetween.
  • the skin is only in contact with the sleeve portion and the movement is already completed.
  • the provision of a sleeve portion further optimizes the activation force.
  • distal direction refers to the direction pointing away from the dose delivery site during use of the medicament delivery device.
  • distal part/end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during 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 this refers to the part/end of the delivery device, orthe parts/ends of the members thereof, which during 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 and along the device or components thereof, typically in the direction of the longest extension of the device and/or component.
  • transverse refers to a direction generally perpendicularto 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 refersto a direction extending radially relative to the axis
  • rotation refersto rotation relative to the axis.
  • Fig. 1A shows a perspective view of a device according to a first embodiment of the present disclosure with a cap.
  • Fig. 1 B shows a perspective view of a needle cover of a device according to the first embodiment of the present disclosure.
  • Fig. 1 C shows a perspective view of a device according to the first embodiment of the present disclosure without a diameter extension part.
  • Fig. 1 D shows a perspective cross sectional view of the diameter extension part of a device according to the first embodiment of the present disclosure.
  • Fig. 1 E shows a perspective view of a device according to the first embodiment of the present disclosure.
  • Fig. 1 F shows a cross sectional side view of a device according to the first embodiment of the present disclosure with the cap.
  • Fig. 1G shows a cross sectional side view of a device according to the first embodiment of the present disclosure with the cap removed and the diameter extension part in a proximal position.
  • Fig. 2A shows a perspective cross sectional view of a device according to a second embodiment of the present disclosure with a cap.
  • Fig. 2B shows a perspective cross sectional view of a device according to the second embodiment of the present disclosure with the cap in a proximal position.
  • Fig. 2C shows a perspective cross sectional view of a device according to the second embodiment of the present disclosure without the cap in a proximal position.
  • Fig. 2D shows a perspective cross sectional view of a device according to the second embodiment of the present disclosure without the cap in a distal position.
  • Fig. 2E shows a perspective view of a diameter extension part of a device according to the second embodiment of the present disclosure.
  • Fig. 2F shows a perspective view of an alternative diameter extension part of a device according to the second embodiment of the present disclosure.
  • Fig. 3A shows a perspective cross sectional view of a device according to a third second embodiment of the present disclosure with a cap in a distal position.
  • Fig. 3B shows a perspective cross sectional view of a device according to the third second embodiment of the present disclosure with the cap removed in a proximal position.
  • Fig. 3C shows a perspective cross sectional view of a diameter extension part of a device according to the third second embodiment of the present disclosure.
  • Fig. 3D shows a perspective cross sectional view of an alternative diameter extension part of a device according to the third second embodiment of the present disclosure.
  • Fig. 4A shows a cross sectional side view of a device according to a fourth embodiment of the present disclosure.
  • Fig. 4B shows a schematic side view of the device according to the fourth embodiment of the present disclosure.
  • Fig. 4C shows a schematic side view of the device according to the fourth embodiment of the present disclosure with a separated cap.
  • Fig. 5 shows results of a numerical simulation of the activation for different embodiments of the present disclosure.
  • the medicament delivery device of embodiments according to the present disclosure may comprise a housing configured to house the components of a medicament delivery device.
  • the housing may be tubular.
  • the housing may extend along an axis L, which is the longitudinal axis of the tubular shaped housing.
  • the housing has a proximal end and a distal end.
  • the housing has a body which extends between the proximal end and the distal end.
  • the medicament delivery device may further comprise a delivery member cover, also referred to as needle shield.
  • the delivery member cover may be generally tubular or tubular.
  • the delivery member cover is arranged in the housing and extends proximally from a proximal opening of the housing body.
  • the delivery member cover may be configured to be moved linearly relative to the housing body along the axis L.
  • the delivery member cover is configured to be moved linearly from an extended position to a retracted position relative to the housing body. In the retracted position the delivery member cover is received further by the housing body.
  • the medicament delivery device may further comprise a drive assembly (not shown) arranged in the housing.
  • the drive assembly may be any drive assembly used in an autoinjector or a manual injector which activates or triggers medicament delivery by movement of the delivery member cover from the extended position towards the retracted position. Examples of suitable drive assemblies are for example disclosed in WO2011/123024 WO2019/011688, WO2019/011689, WO2019/011690, and WO2019/063267 incorporated herein by reference.
  • Fig. 1A to 1G illustrate a first embodiment according to the present disclosure.
  • Fig. 1A shows a perspective view of a device according to a first embodiment of the present disclosure with a cap.
  • Fig. 1 B shows a perspective view of a needle cover of a device according to the first embodiment of the present disclosure.
  • Fig. 1 C shows a perspective view of a device according to the first embodiment of the present disclosure without a diameter extension part.
  • Fig. 1 D shows a perspective cross sectional view of the diameter extension part of a device according to the first embodiment of the present disclosure.
  • Fig. 1 E shows a perspective view of a device according to the first embodiment of the present disclosure.
  • Fig. 1A shows a perspective view of a device according to a first embodiment of the present disclosure with a cap.
  • Fig. 1 B shows a perspective view of a needle cover of a device according to the first embodiment of the present disclosure.
  • Fig. 1 C shows a perspective view of a device according to the
  • FIG. 1 F shows a cross sectional side view of a device according to the first embodiment of the present disclosure with the cap.
  • Fig. 1G shows a cross sectional side view of a device according to the first embodiment of the present disclosure with the cap removed and the diameter extension part in a proximal position.
  • the device comprises a tubular diameter extension part 4 provided at the proximal end portion of the housing body 1.
  • the diameter extension part 4 has an inner diameter corresponding to an outer diameter of the housing body 1 and is configured to slide on the outer surface of the housing body 1 from a first distal position to a second proximal position.
  • the guiding means may be formed on the housing body 1 and/orthe diameter extension part 4.
  • the guiding means may be formed as slots and/or recesses 11 a and 11 b.
  • stopping means are provided to stop the movement of the diameter extension part 4 on the outer surface of a proximal end portion of the housing body 1 at the first and second position, respectively.
  • the stopping means may be formed on the housing body 1 (stopping means 13) and/or the diameter extension part 4 (stopping means 41).
  • the stopping means may be formed as a fully annular flange or sections of an annular flange 13. See Fig. 1C and Fig. 1 D. Additionally or alternatively, the stopping means may be formed as knobs and/or recesses.
  • the needle cover 2 comprises cap engagement means 21 configured to engage with corresponding means at a cap 3. See Fig. 1 E.
  • the diameter extension part 4 When the diameter extension part 4 is in the distal position, it does not extend the housing body 1 in a proximal direction, i.e., the needle cover 2 is exposed. In this position the cap 3 may be attached to the device, i.e., the respective engagement means are engaged. Preferably, in this position the proximal movement of the diameter extension part 4 is blocked by the cap 3. See Fig. 1A.
  • a user may remove the cap 3, e.g., by pulling the cap 3 along the axis L in a proximal direction until the engagement means disengage. After the disengagement, the diameter extension part 4 can feely move on the housing body 1 between the first and the second position.
  • a contact between the diameter extension part 4 and the tissue may be possible but does not negatively bias the activation and/or injection movement, because friction between the tissue and the needle cover 2 and/or the housing body 1 is prevented.
  • the diameter extension part 4 comprises cap engagement means 43, see Fig. 2F, configured to engage with corresponding engagement means on an inner surface of a cap 3.
  • the diameter extension part 4 is locked in the most distal position and the needle cover 2 is protected by the cap 3.
  • the cap 3 is pulled in a proximal direction along the axis L. Because the cap 3 and the diameter extension part 4 are engaged and the engagement force is higher than the friction between the teeth 12 and the diameter extension part 4, the diameter extension part 4 is also pulled forward with the cap 3, as shown in Fig. 2B.
  • the diameter extension part 4 reaches the most proximal position, the last tooth 12a engages and blocks a further movement of the diameter extension part 4 with the cap 3.
  • the cap engagement means 43 disengage and the cap 3 is removed from the device.
  • the diameter extension part 4 is in the proximal position, regardless of the orientation of the device. Even if the proximal end of the device is pointed upwards against gravity, the diameter extension part 4 still remains in the proximal position and the needle cover 2 remains protected, because the friction of the teeth 12 is higher than the gravity force on the diameter extension part 4.
  • the cap 3 may engage with the diameter extension part 4 in an alternative way. Still the cap 3 is configured to move the diameter extension part 4 into a proximal position when the cap 3 is removed.
  • Figs. 3Ato 3D illustrate a third embodiment of the present disclosure.
  • Fig. 3A shows a perspective cross sectional view of a device according to a third second embodiment of the present disclosure with a cap in a distal position.
  • Fig. 3B shows a perspective cross sectional view of a device according to the third second embodiment of the present disclosure with the cap removed in a proximal position.
  • Fig. 3C shows a perspective cross sectional view of a diameter extension part of a device according to the third second embodiment of the present disclosure.
  • Fig. 3D shows a perspective cross sectional view of an alternative diameter extension part of a device according to the third second embodiment of the present disclosure.
  • annular housing flange 13 is provided on the outer surface of the proximal end portion of the housing body 1.
  • the annular housing flange 13 is configured to engage with an annular flange or sections of an annular flange 44b provided on the inner surface of the diameter extension part 4 at a distal end of the diameter extension part 4. See Fig. 3C.
  • the annular housing flange 13 and the inner flange 44b of the diameter extension part 4 are configured to engage, when the diameter extension part 4 is in the second position, i.e., it is essentially flush with the needle cover 2. See Fig. 3B.
  • the diameter extension part 4 further comprises cap engagement means 43 configured to engage with corresponding means formed on the inner surface of the cap 3.
  • the cap engagement means are two sets of knobs 43 formed equidistantly on the circumference of the outer surface of the diameter extension part 4. See Fig. 3C.
  • the corresponding means is an annular recess on the inner surface of the cap 3. That is, the cap 3 can be attached in any rotational position.
  • the cap engagement means may be formed as an annular recess 45 on an outer surface of the diameter extension part 4, see Fig. 3D.
  • guiding means for the diameter extension part 4 are not necessary but optional.
  • the diameter extension part 4 further comprises an annular flange 44a formed on the inner surface of the proximal end of the diameter extension part 4.
  • the proximal flange 44a increases the contact surface and bridges a gap between the diameter extension part 4 and the needle cover 2.
  • This inner flange 44a may be comprised in all embodiments of the disclosure to improve the contact between the tissue of the injection site and to reduce the activation force.
  • Figs. 4Ato 4C illustrate a fourth embodiment of the present disclosure.
  • Fig. 4A shows a cross sectional side view of a device according to a fourth embodiment of the present disclosure.
  • Fig. 4B shows a schematic side view of the device according to the fourth embodiment of the present disclosure.
  • Fig. 4C shows a schematic side view of the device according to the fourth embodiment of the present disclosure with a separated cap.
  • a diameter extension part 34 is configured to force fittingly engage with a cap proximal structure 33. That is, the cap 3 of the fourth embodiment comprises two parts, a proximal structure 33, which is configured to be removed from the device; and the stay-on part 34, which is configured to separate from the proximal structure 33 and to remain on the needle cover 2 in order to from a diameter extension part, as defined above. See Fig. 4A and 4B.
  • the cap proximal structure 33 may comprise a rigid needle shield, RNS, remover 35.
  • the 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 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, Behget'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, C1 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
  • 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-1 a, interferon beta-1 b, peginterferon beta-1 a, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizuma
  • 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-ibritumo
  • 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, DHA

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

Abstract

L'invention concerne un dispositif d'administration de médicament comprenant un corps de boîtier (1) de forme généralement tubulaire configurée pour contenir un système d'administration de médicament et un ensemble d'entraînement ; et un couvercle d'élément de distribution (2) configuré pour recouvrir au moins une partie proximale du système d'administration de médicament, conçu pour se déplacer, lorsqu'il est pressé contre un tissu à un site d'injection, de manière coaxiale à l'intérieur du corps de boîtier (1) d'une première position proximale à au moins une seconde position plus distale, et conçu en outre pour activer, par déplacement de la première position vers la seconde position, l'ensemble d'entraînement afin de déclencher l'administration d'un médicament. Le dispositif d'administration de médicament comprend en outre une partie d'extension de diamètre (4) disposée sur une partie d'extrémité proximale du corps de boîtier (1), configurée pour se déplacer sur la partie d'extrémité proximale du corps de boîtier (1) depuis une position distale, dans laquelle une partie d'extrémité proximale de la partie d'extension de diamètre est essentiellement au même niveau que la partie d'extrémité proximale du corps de boîtier (1), à une position proximale dans laquelle la partie d'extrémité proximale de la partie d'extension de diamètre est essentiellement au même niveau que la partie d'extrémité proximale du couvercle d'élément de distribution (2) dans la première position, et configurée pour empêcher un contact entre le tissu et le couvercle d'élément de distribution (2) ou le corps de boîtier (1) pendant le déplacement du couvercle d'élément de distribution (2) de la première position vers la seconde position.
PCT/EP2024/055585 2023-03-14 2024-03-04 Dispositif d'administration de médicament Pending WO2024188692A1 (fr)

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US202363451956P 2023-03-14 2023-03-14
US63/451,956 2023-03-14
EP23163591.3 2023-03-22
EP23163591 2023-03-22

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WO2011123024A1 (fr) 2010-03-31 2011-10-06 Shl Group Ab Dispositif d'administration de médicament comprenant un moyen de signalisation de retour d'informations
US20140114247A1 (en) 2011-06-17 2014-04-24 Shl Group Ab Injection Device
US20150032061A1 (en) * 2013-07-24 2015-01-29 Raumedic Ag Medical Injection Device
EP3007752A1 (fr) 2013-06-11 2016-04-20 Cilag GmbH International Dispositif d'injection
WO2019011690A1 (fr) 2017-07-12 2019-01-17 Shl Medical Ag Ensemble d'administration pour un dispositif de distribution de médicament et dispositif de distribution de médicament comprenant celui-ci
WO2019011689A1 (fr) 2017-07-12 2019-01-17 Shl Medical Ag Ensemble de transport pour dispositif d'administration de médicament et dispositif d'administration de médicament le comprenant
WO2019011688A1 (fr) 2017-07-12 2019-01-17 Shl Medical Ag Ensemble d'administration pour dispositif d'administration de médicament et dispositif d'administration de médicament le comprenant
US20190022334A1 (en) 2011-01-04 2019-01-24 Sanofi-Aventis Deutschland Gmbh Safety device for a pre-filled syringe and an injection device
US20190046740A1 (en) * 2012-10-15 2019-02-14 Sanofi-Aventis Deutschland Gmbh Medicament Delivery Device with Use Indicator
WO2019063267A1 (fr) 2017-09-28 2019-04-04 Shl Medical Ag Unité d'entraînement pour dispositif d'administration de médicament
US20190266921A1 (en) * 2016-02-25 2019-08-29 Carebay Europe Ltd Automatic injection training device
US10398854B2 (en) 2012-10-19 2019-09-03 Amgen Inc. Autoinjector

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011123024A1 (fr) 2010-03-31 2011-10-06 Shl Group Ab Dispositif d'administration de médicament comprenant un moyen de signalisation de retour d'informations
US20190022334A1 (en) 2011-01-04 2019-01-24 Sanofi-Aventis Deutschland Gmbh Safety device for a pre-filled syringe and an injection device
US20140114247A1 (en) 2011-06-17 2014-04-24 Shl Group Ab Injection Device
US20190046740A1 (en) * 2012-10-15 2019-02-14 Sanofi-Aventis Deutschland Gmbh Medicament Delivery Device with Use Indicator
US10398854B2 (en) 2012-10-19 2019-09-03 Amgen Inc. Autoinjector
EP3007752A1 (fr) 2013-06-11 2016-04-20 Cilag GmbH International Dispositif d'injection
US20150032061A1 (en) * 2013-07-24 2015-01-29 Raumedic Ag Medical Injection Device
US20190266921A1 (en) * 2016-02-25 2019-08-29 Carebay Europe Ltd Automatic injection training device
WO2019011690A1 (fr) 2017-07-12 2019-01-17 Shl Medical Ag Ensemble d'administration pour un dispositif de distribution de médicament et dispositif de distribution de médicament comprenant celui-ci
WO2019011689A1 (fr) 2017-07-12 2019-01-17 Shl Medical Ag Ensemble de transport pour dispositif d'administration de médicament et dispositif d'administration de médicament le comprenant
WO2019011688A1 (fr) 2017-07-12 2019-01-17 Shl Medical Ag Ensemble d'administration pour dispositif d'administration de médicament et dispositif d'administration de médicament le comprenant
WO2019063267A1 (fr) 2017-09-28 2019-04-04 Shl Medical Ag Unité d'entraînement pour dispositif d'administration de médicament

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