Purifying device, system and method for purifying a needle for delivering a medicament

Abstract

The present disclosure relates to a purifying device for a medicament delivery device. The purifying device comprises a needle shield removal unit, configured to remove a needle shield from a needle for delivering a medicament from the medicament delivery device, and a purifying unit comprising a purifying chamber, wherein the purifying chamber is configured to receive the needle for purifying the needle.

Description

[0001] Title

[0002] Purifying device, system and method for purifying a needle for delivering a medicament

[0003] Background

[0004] Medicament delivery devices are designed to deliver a medicament / drug, e.g. from a medicament container retained therein or reservoir of the medicament delivery device. For example, medicament delivery devices may be used for injecting the medicament into a human or animal body via a needle.

[0005] Before a first use, the needle may be protected and kept sterile by a needle shield. When the needle shield is removed from the needle, e.g. for performing an injection, the needle may not be sterile anymore.

[0006] For reducing the risk of harm to a patient / user, which may be caused by a contaminated needle, the International Organization for Standardization (ISO) requires that a new needle is used for each injection. However, it is known that users tend to use the same needle for more than one injection as a needle change for each injection is inconvenient. However, the needle may become dirtier with every injection performed therewith. This further increases the risk of harm to the patient.

[0007] From a technical point of view, the need for a needle change depends on the drug formulation and a potential risk of clogging of the needle. However, especially when injecting insulin, it does not seem necessary to change the needle for each injection.

[0008] Therefore, the current situation is unsatisfying and inefficient from an ecologic and economic perspective.

[0009] In the following the term "distal" refers to directions, ends or surfaces which are arranged or are to be arranged to face or point towards a dispensing end of the medicament delivery device, of the system or of components thereof. In other words, the term "distal" refers to the direction towards an injection site and / or a tip of an injection needle of the device. On the other hand, the term “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and / or from the distal end of the medicament delivery device or components thereof. Accordingly, the term "proximal" refers to the direction pointing away from the injection site and / or a tip of an injection needle of the device. For example, the distal end may be the end closest to the dispensing end and / or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and / or towards the proximal end. A distal surface may face towards the distal end and / or away from the proximal end. The dispensing end may be the needle end where a needle is arranged or a needle or needle unit is or is to be mounted to the device, for example.

[0010] In the following, the terms "axial" direction and / or "longitudinal” direction may refer to a main extension direction of a device, a unit, a structure, a feature or an element described in the context. The main extension direction may be a direction in which the dimension of the device, the unit, the structure, the feature or the element described, is the largest. The "axial" direction and / or "longitudinal” direction may coincide with a symmetry axis of the device, the unit, the structure, the feature or the element described. Alternatively or additionally, the "axial" direction and / or "longitudinal” direction may coincide with the proximal-distal direction.

[0011] In the following, a "radial" direction refers to a direction, which is perpendicular to the longitudinal direction and intersects the longitudinal direction. In other words, a radial axis intersects a longitudinal axis, while a 90 degree angle is formed between the axes.

[0012] In the following, an "azimuthal" and / or "circumferential" direction refers to a direction which is perpendicular to the radial direction and to the longitudinal direction.

[0013] The present disclosure relates to a purifying device for a medicament delivery device, a system comprising the purifying device, a needle shroud unlock device, a method for delivering a medicament from a medicament delivery device and a method for purifying a needle for delivering a medicament from a medicament delivery device.

[0014] It is an object of the present disclosure to provide devices, a system and a method for cleaning and / or purifying a needle for delivering a medicament from a medicament delivery device.

[0015] The object is solved by the purifying device according to claim 1 , the system according to claim 14 and the method according to claim 15. Further embodiments are described in the dependent claims. According to an aspect of the present disclosure, a purifying device for a medicament delivery device is provided. The purifying device may comprise a needle shield removal unit and / or a purifying unit.

[0016] The needle shield removal unit may be configured to remove a needle shield from a needle for delivering medicament from the medicament delivery device. For example, the needle shield removal unit may be configured to remove the needle shield from the needle before a first use of the medicament delivery device and / or when the needle is connected to the medicament delivery device.

[0017] The purifying unit may comprise a purifying chamber. The purifying chamber may be configured to receive the needle for purifying the needle. Purifying may encompass cleaning and / or sanitizing the needle, e.g. when the needle is not sterile or not sterile anymore.

[0018] The medicament delivery device may be an injection device, e.g. a variable dose device, a fixed dose device, an autoinjector or a user driven injection device, e.g. a syringe. In one embodiment, the medicament delivery device may be configured to retain a medicament container comprising a medicament. The medicament container may be a cartridge, a barrel or a syringe. The medicament container may be pre-filled. In one embodiment, the medicament container may be a pre-filled syringe. In one embodiment, the medicament delivery device may comprise a medicament container or a reservoir containing the medicament.

[0019] In one embodiment, the medicament delivery device may comprise a needle for delivering medicament from the medicament container. The needle may be fluidly connected to the medicament container. Alternatively, the medicament delivery device may be configured to be connectable to a needle, e.g. to a needle carrier device or needle hub comprising the needle, thereby fluidly connecting the needle to the medicament container.

[0020] The needle shield may be a soft needle shield (SNS) or a rigid needle shield (RNS). The needle shield may be configured to protect the needle against damage and keep the needle clean and / or sterile, e.g. before the first use of the medicament delivery device. The needle shield may further be configured to prevent a user of the medicament delivery device, e.g. a patient, from touching the needle. The needle shield may be detachably connected to the needle and / or the needle carrier device before a first use of the needle. If the needle is part of the medicament delivery device, the needle shield may be detachably connected to the medicament delivery device, e.g. a needle attachment element thereof, before the first use. Depending on the type of medicament delivery device, the purifying device may be comprised in a cap, e.g. a distal end cap, of the medicament delivery device. The cap may be detachably connected to the medicament delivery device, e.g. before the first use of the medicament delivery device. The cap may comprise a body configured to define an outer geometry of the cap. The body may be configured to interact with the medicament delivery device, e.g. a distal end of a housing of the medicament delivery device, thereby preventing the cap from falling off the medicament delivery device. The body may further provide a gripping surface to the user, allowing the user to grip the cap for moving the cap with respect to the medicament delivery device, e.g. pulling the cap off the medicament delivery device.

[0021] In one embodiment, the needle shield removal unit may comprise a needle shield engagement feature, e.g. a grabber, configured to engage the needle shield for removing the needle shield from the needle.

[0022] In one embodiment, the grabber may comprise one or more engagement protrusions. The engagement protrusions may protrude in a radial inward direction and / or in a distal direction. The engagement protrusions may be evenly distributed around a circumference of the grabber. For example, there may be 2, 3, 4, 5, 6, 8, 10, 12 or more engagement protrusions. Alternatively, there may be one engagement protrusion. The engagement protrusion may extend along a part or the whole inner circumference of the grabber.

[0023] Due to the engagement of the engagement protrusions with the needle shield, a distal movement of the needle shield removal unit relative to the medicament delivery device causes a corresponding distal movement of the needle shield relative to the needle, when the needle is connected, e.g. attached, to the medicament delivery device. The relative distal movement between the needle shield and the needle may pull the needle shield off the needle, thereby exposing at least a distal portion of the needle, which may be configured for penetrating an injection site. In one embodiment, the needle shield engagement feature may be configured to retain the needle shield in the needle shield removal unit, after the needle shield has been removed from the needle.

[0024] In one embodiment, the purifying device may be configured to be connectable to the medicament delivery device or the needle in at least one, preferably at least two positions. In a first position, the purifying device may be connected to the medicament delivery device or the needle such that the purifying unit may interact with the needle. In particular, in the first position, at least a portion of the needle to be purified may be in contact with a purifying agent. In other words, in the first position, the purifying device may purify at least a portion of the needle, thereby preparing the needle for an upcoming injection. In one embodiment, in the first position, a whole free length of the needle, i.e. a length of the needle which extends from the medicament delivery device, e.g. the needle attachment element, may be in contact with the purifying agent.

[0025] In a second position, the purifying device may be connected to the medicament delivery device or the needle such that the needle shield removal unit may interact with the needle shield. For example, the second position may be a position of the purifying device relative to the medicament delivery device or the needle before the first use of the medicament delivery device or the needle. The purifying device may be in the second position only before the first use of the needle. Contrary to that, the purifying device may assume the first position more than once, e.g. every time after the medicament delivery device has been used and the purifying device is (re-) connected to the needle or the medicament delivery device.

[0026] In one embodiment, the needle shield removal unit may be integrally formed with the purifying unit. Alternatively or additionally, the needle shield removal unit may be detachable from the purifying device, e.g. from the purifying unit or a body of the purifying device, such that a separation of the needle shield removal unit from the purifying device is possible.

[0027] In one embodiment, the purifying chamber may be configured such that a distal part thereof cannot be pierced by the needle.

[0028] In one embodiment, the purifying unit may comprise a sealing element configured to seal the purifying chamber. The purifying chamber may contain a purifying agent or purifying medium. The purifying agent or purifying medium may be a substance in a liquid, gaseous or solid state. In one embodiment, the purifying agent or purifying medium may comprise one of, more of or all of alcohol, ozone, sterilium, ethanol, propanol, isopropanol solutions, bleaching agents (e.g. hydrogen peroxide, chlorine dioxide, ethylene oxide, formaldehyde.

[0029] The purifying agent or purifying medium may be configured for cleaning and / or sanitizing and / or purifying the needle. Especially when the needle is not sterile, e.g. after the needle shield has been removed from the needle once or after the needle has been used, the purifying agent or purifying medium may clean and / or sanitize and / or purify a portion of the needle with which it is in contact. Thus, said portion may be prepared for penetrating the user’s skin another time. This might decrease the risk of harm to a user caused by a contaminated or dirty needle.

[0030] In one embodiment, the sealing element may be a foil and / or a septum. The foil and / or the septum may be connected, e.g. attached, to the purifying unit, e.g. to the purifying chamber and / or a reception space. In one embodiment, the sealing element may be attached to the purifying unit by an adhesive. Alternatively, or additionally, the sealing element may be connected to the purifying unit by a mounting ring or a crimp clamp. The mounting ring or crimp clamp may be mounted via a transition fit connection.

[0031] The foil and / or the septum may be detachable from the purifying unit, e.g. by the user gripping the foil and / or the septum and pulling it off the purifying unit. Alternatively, or additionally, the foil and / or the septum may be pierceable by the needle.

[0032] In one embodiment the purifying chamber and / or the needle cap unit may comprise a proximal end in the shape of a mushroom (e.g. comprise a "mushroom head"). In one embodiment the purifying chamber may be sealed by a septum. The septum may be held down by a foil. In one embodiment the foil may be configured to be shrank to the mushrooms head and septum.

[0033] In one embodiment, the purifying chamber may be configured to receive a purifying container with a purifying agent. In other words, the purifying chamber may not contain the purifying agent, but rather provide a space for receiving a purifying container containing the purifying agent. In this case, the needle is cleaned and / or sanitized and / or purified when it enters the purifying container. In one embodiment, the purifying container may be a blow-fill-seal container.

[0034] In one embodiment, the container may comprise or consist of a soft material, e.g. Polypropylene (PP). The container may be configured to seal the purifying unit and enable piercing the container with at least marginal or no damage on the needle.

[0035] In one embodiment, a proximal end of the purifying container may have a thinner wall thickness than in other portions thereof, e.g. the longitudinally extending sidewall. This may facilitate the piercing of the purifying container by the needle, thereby reducing the risk of damaging or bending the needle, when the needle pierces the purifying container before entering it.

[0036] In one embodiment, the purifying unit may comprise a suspension element. The suspension element may be configured to secure the purifying container to the medicament delivery device. For example, the purifying container may be secured to the needle attachment element such that it contacts a distal end of the needle attachment element. Alternatively, the purifying container may be secured to the medicament container, the reservoir or a needle carrier device.

[0037] In one embodiment, the suspension element may have a honeycomb structure. The honeycomb structure may be compressed, when the needle enters the purifying container to a certain penetration depth. For example, a distal end of the needle attachment element, the reservoir or the needle carrier device may compress the honeycomb structure thereby deforming the honeycomb structure, when the needle enters the purifying container to a certain penetration depth. The deformation of the honeycomb structure may cause a proximal opening of the honeycomb structure to widen such that it may receive a distal portion of the distal end of the needle attachment element, the reservoir or the needle carrier device. In other words, the honeycomb structure may partially surround needle attachment element, the reservoir or the needle carrier device. The honeycomb structure may then interact with an outer surface of the needle attachment element, the reservoir or the needle carrier device, thereby securing the purifying container to the needle attachment element, the reservoir or the needle carrier device, e.g. by friction.

[0038] In one embodiment, the purifying unit and the needle shield removal unit may be arranged one after another along the longitudinal direction of the purifying device. In one embodiment, longitudinal axes and / or symmetry axes of the purifying unit and the needle shield removal unit may coincide.

[0039] In one embodiment, the needle shield removal unit may be integrally formed with the purifying unit.

[0040] In one embodiment, an opening of the needle shield removal unit may be arranged on an opposite end of the purifying device with respect to an opening of the purifying unit. The opening of the needle shield removal unit may be an opening through which the needle shield enters the needle shield removal unit, e.g. when the needle shield is connected to the needle before the first use of the needle. The opening of the purifying unit may be an opening through which the needle and / or the needle carrier and / or the needle attachment element and / or a distal end of the medicament container enters the purifying unit.

[0041] In one embodiment, the opening of the needle shield removal unit may be arranged on the same end of the purifying device as the opening of the purifying unit. In other words, the opening of the needle shield removal unit and the opening of the purifying unit may face the same direction.

[0042] In one embodiment, the needle shield removal unit may be detachably connected to the purifying device, e.g. to the body and / or to the purifying unit. For example, there may be a predetermined breaking point between the needle shield removal unit and the purifying unit, allowing the needle shield removal unit to be detached / separated from the purifying unit when the breaking point is broken. Alternatively, or additionally, the purifying device may comprise means for releasably connecting the needle shield removal unit to the purifying device, without breaking the connection.

[0043] In one embodiment, the purifying unit may comprise a status indication feature. The status indication feature may be configured to provide a feedback to the user regarding the status of the purifying device. The feedback may be a visual feedback and / or an acoustic feedback and / or a haptic feedback.

[0044] In one embodiment, the status indication feature may comprise a print or visible marking for providing a visual feedback to the user.

[0045] Alternatively, or additionally, the status indication feature may comprise a flexible arm, e.g. a snap arm, configured to interact with the body of the purifying device, e.g. a status indication recess of the body, thereby providing an acoustic and / or a haptic feedback to the user.

[0046] In one embodiment, when the purifying unit is moved proximally relative to the body, the flexible arm may be deflected by a surface of the body, e.g. a distal surface and / or a radial inner surface. When the purifying unit reaches a final position with respect to the needle, i.e. when the needle has reached a maximum penetration depth in the purifying chamber of the purifying container, the snap arm may align with the status indication recess. When aligned, the snap arm may return to its non-deflected and relaxed state. Returning to the relaxed state may cause an acoustic and / or a haptic feedback, e.g. when a protrusion of the snap arm hits against an inner surface of the body.

[0047] The penetration depth may be predetermined such that the needle does not contact an inner distal end surface of the purifying chamber.

[0048] In one embodiment, the status indication feature may be configured to be connectable to, e.g. coupled to the medicament delivery device, e.g. the housing thereof.

[0049] According to an aspect of the present disclosure, a needle shroud unlock device for a medicament delivery device is provided. The needle shroud unlock device may be configured to unlock a needle shroud of the medicament delivery device from a locked out position. In the locked out position, the needle shroud covers the needle of the medicament delivery device and is secured against any movement relative to the medicament delivery device, e.g. the housing thereof, which would expose the needle of the medicament delivery device. The needle shroud may move to a locked out position, when the medicament delivery device is removed from the injection site, e.g. after an injection or when an injection is interrupted. The distal movement of the needle shroud towards the locked out position may be driven by a drive element, e.g. a needle shroud spring.

[0050] In one embodiment, the needle shroud unlock device may be configured to reset the needle shroud of the medicament delivery device, after the needle shroud has been unlocked from its locked out position. In this context, unlocked may mean that the needle shroud may move relative to the medicament delivery device, e.g. the housing, such that the relative movement may expose at least a distal portion of the needle.

[0051] In one embodiment, the needle shroud may be reset by moving the needle shroud proximally relative to the housing of the medicament delivery device. When reaching a certain position relative to the housing, a portion of the needle shroud may interact with a lock element. The lock element may be configured to releasably secure the needle shroud against a distal movement relative to the medicament delivery device, e.g. the housing.

[0052] In one embodiment, the needle shroud may be released from its interaction with the lock element, when the medicament delivery device is triggered, e.g. for performing an injection. The released needle shroud may move distally, e.g. driven by the needle shroud spring, relative to the medicament delivery device, e.g. the housing thereof, when a proximal force applied to the needle shroud is smaller than a distal force applied to the needle shroud by the needle shroud spring. For example, the needle shroud may be driven distally by the needle shroud spring when the medicament delivery device is removed from the injection site, e.g. after an injection or when the injection is interrupted. When reaching a final distal position with respect to the housing, the needle shroud may cover the needle. In this position, the needle shroud may be configured to be secured against any movement relative to the medicament delivery device, e.g. the housing thereof, which would (re-)expose the needle. In other words, the needle shroud may be in its locked out position.

[0053] In one embodiment, the needle shroud unlock device may comprise the purifying device, the purifying unit and / or the purifying chamber according to one of the embodiments described in the foregoing. For example, the needle shroud unlock device may comprise a purifying element. The purifying element may comprise the purifying unit and / or the purifying chamber as described in the foregoing.

[0054] In one embodiment, the needle shroud unlock device may comprise an unlock element and / or a push element. In one embodiment, the unlock element may comprise the purifying unit or the purifying chamber as described in the foregoing. In another embodiment, the push element may comprise the purifying unit or the purifying chamber as described in the foregoing.

[0055] According to an aspect of the present disclosure, a system is provided. The system may comprise the purifying device according to one of the embodiments described in the foregoing. The system may further comprise a medicament delivery device as described in the foregoing.

[0056] In one embodiment, the medicament delivery device may be configured to retain a medicament container with a medicament, e.g. a pre-filled syringe or a pre-filled cartridge. In one embodiment, the medicament delivery device may be configured to comprise a medicament container e.g. a reservoir. The medicament container may be configured to retain a medicament or may comprise the medicament.

[0057] In one embodiment, the medicament delivery device may be connectable to or connected to a needle for delivering the medicament from the medicament delivery device. The needle may be comprised in the medicament delivery device. Alternatively, the medicament delivery device may be configured to be connectable to the needle, wherein the needle may be comprised, for example, in a needle carrier device or needle hub. The needle may be configured to establish a fluid connection between the medicament container, containing the medicament to be delivered, and the injection site.

[0058] In one embodiment, the medicament delivery device may be an injection device. In one embodiment, the medicament delivery device may be a variable dose injection device. In one embodiment, the medicament delivery device may be a fixed dose injection device. In one embodiment, the medicament delivery device may be an injection device in which the delivery process is manually driven, e.g. by the user. In one embodiment, the medicament delivery device may be an autoinjector. In one embodiment, the medicament delivery device may be a pen-device, i.e. a device having a pen-shape. In one embodiment, the medicament delivery device may be device with a flat form factor.

[0059] According to an aspect of the present disclosure, a method for dispensing or delivering a medicament from a medicament delivery device or a system is provided. The method may comprise the step of using the medicament delivery device or the system. The medicament delivery device or the system may be a medicament delivery device or a system as described in the foregoing.

[0060] According to an aspect of the present disclosure, a method for purifying a needle for delivering a medicament from a medicament delivery device is provided. The method may comprise the step of connecting a purifying unit of a purifying device to the needle such that a portion of the needle to be purified contacts a purifying agent. For example, the portion of the needle to be purified may be immersed in the purifying agent. The purifying agent may be configured to clean and / or sanitize and / or purify the portion of the needle with which it is in contact.

[0061] The needle may be a needle of a medicament delivery device or a needle connectable to a medicament delivery device as described in the foregoing. The purifying unit and / or the purifying device may be a purifying unit and / or a purifying device according to one of the embodiments described in the foregoing.

[0062] In one embodiment, the method may comprise the step of removing a needle shield from the needle in order to expose a portion of the needle, e.g. a distal end of the needle which may be configured to pierce an injection site, e.g. a patient’s skin.

[0063] In one embodiment, if the needle is connectable to the medicament delivery device, the needle shield may be removed from the needle, when the needle is connected to the medicament delivery device. For example, removing the needle shield from the needle may comprise pulling the needle shield off the needle, while the needle may remain connected to the medicament delivery device.

[0064] In one embodiment, the method may comprise the step of positioning the purifying device or the purifying unit with respect to the needle. Positioning may include translating the purifying device or the purifying unit with respect to the needle in at least one of the longitudinal direction, the radial direction and / or the azimuthal direction of the needle.

[0065] In one embodiment, the method may comprise the step of orienting or aligning the purifying device or the purifying unit with respect to the needle such that the purifying unit may be connected to the needle, e.g. such that the needle may enter the purifying unit. Orienting or aligning may include rotating the purifying device or the purifying unit around at least one of the longitudinal direction, the radial direction and / or the azimuthal direction of the needle.

[0066] In one embodiment, the method may comprise the step of separating a needle shield removal unit from the purifying device, e.g. the purifying unit and / or the body. Separating the needle shield removal unit from the purifying device may comprise detaching the needle shield removal unit from the purifying unit. In one embodiment, detaching the needle shield removal unit from the purifying unit may enable access to an opening of the purifying unit. In other words, when attached to the purifying unit, the needle shield removal unit may close the opening of the purifying unit. In one embodiment, the method may comprise the step of separating at least one sealing element from the purifying unit. When connected to the purifying unit, the at least one sealing element may close at least one opening of the purifying unit. The purifying unit may have several openings, e.g. an opening of the reception space and an opening of the purifying chamber. Hence, separating the at least one sealing element from the purifying unit may enable access to the at least one opening of the purifying unit, e.g. the opening the reception space and / or the opening of the purifying chamber.

[0067] In one embodiment, the method may comprise the step of piercing at least one sealing element sealing the purifying chamber. Alternatively or additionally, the method may comprise the step of piercing a purifying container with the needle, so that the needle may come into contact with the purifying medium. The purifying container may be received in the purifying chamber.

[0068] The aspects and embodiments of the present disclosure provide the advantage that a needle for discharging a medicament from a medicament delivery device may be cleaned and / or sanitized and / or purified, when it is not sterile. Sterility of the needle may be compromised by the use of the medicament delivery device or removal of the needle shield from the needle. Cleaning and / or sanitizing and / or purifying the needle may reduce the risk of harm for the user, if the needle is not replaced after an injection, in other words, when the user re-uses the needle. Re-using the needle may be beneficial in terms of costs and waste. Hence, the aspects and embodiments of the present disclosure may be beneficial for economic and ecologic reasons.

[0069] Brief description of the drawings

[0070] Figures 1A to 1G illustrate embodiments of medicament delivery devices according to the present disclosure.

[0071] Figures 2A and 2B illustrate embodiments of purifying devices according to the present disclosure.

[0072] Figures 3A and 3B illustrate embodiments of purifying devices according to the present disclosure.

[0073] Figure 4A illustrates an embodiment of a purifying device according to the present disclosure.

[0074] Figures 4B and 40 illustrate embodiments of purifying containers according to the present disclosure. Figures 5A and 5B illustrate an embodiment of a purifying device and its interaction with a medicament delivery device according to the present disclosure.

[0075] Figures 6A to 6C illustrate an embodiment of a purifying device and its interaction with a medicament delivery device according to the present disclosure.

[0076] Figure 7A illustrates an embodiment of a purifying device according to the present disclosure.

[0077] Figure 7B illustrates an interaction of the purifying device of Figure 7A with a medicament delivery device according to the present disclosure.

[0078] Figure 8 illustrates an embodiment of a purifying device and its interaction with a medicament delivery device according to the present disclosure.

[0079] Figures 9 to 11 illustrate embodiments of needle shroud unlock devices according to the present disclosure.

[0080] Figure 12 illustrates a method for purifying a needle of a medicament delivery device according to the present disclosure.

[0081] Figure 13 illustrates a system according to the present disclosure.

[0082] Figure 14 illustrates an expanded structural formula, molecular formula, and molecular weight of fitusiran, e.g. sodium form.

[0083] Description of the exemplary embodiments

[0084] Identical elements, elements of the same kind and identically or similarly acting elements may be provided with the same reference numerals in the Figures.

[0085] Figures 1 A through 1 D illustrate an embodiment of a medicament delivery device 100 of the present disclosure in different stages of operation. The following general description of the medicament delivery device 100 applies to the medicament delivery devices 100a, 100b of Figures 1E and 1F, if not indicated otherwise.

[0086] The medicament delivery device 100 may comprise a device body or housing 60. The housing 60 may comprise a viewing window through which an interior of the housing 60 may be seen, at least partially. The housing 60 may be provided to retain and / or may retain a medicament container, e.g. a pre-filled syringe 70, in its interior. The medicament, e.g. a liquid medicament or drug Dr, may be arranged in the pre-filled syringe 70. It should be noted that the following use of the term pre-filled syringe 70 does not limit the design of the container to a pre-filled syringe. Rather, containers other than a prefilled syringe may also be considered for implementation, e.g. cartridges. The housing 60 may be provided to retain and / or may retain a needle 71 , see Figure 1C. In other words, the needle 71 may be arranged or may be arranged in the housing 60. The needle 71 can be an integral part of the medicament container, e.g. the pre-filled syringe 70, such that it is permanently or releasably connected to a body of the medicament container. Alternatively, the needle 71 can be permanently or releasably connected to the medicament delivery device 100. In the first case, the medicament container may be a syringe. In the second case, the medicament container may be a cartridge. In case a cartridge is used as medicament container, initially, the medicament container and the needle can be fluidly disconnected and fluid communication between the medicament container interior and the needle 71 may only established during operation of the medicament delivery device 100. An optional medicament container carrier, such as a syringe holder 800, may be used to support and / or carry the medicament container within the housing 60.

[0087] The medicament delivery device may comprise a drive mechanism 101 configured to drive a drug delivery operation. The drive mechanism 101 may comprise a plunger 1000. The medicament delivery device 100, e.g. the drive mechanism 101, may further comprise a drive energy source, e.g. a drive spring 1100 (not shown), such as a compression spring or a torsion spring. The drive energy source may be arranged to drive the plunger 1000 in a distal direction D relative to the medicament container during the drug delivery operation. During this movement, a plunger stopper 1200 (see Figures 1E to 1 F, not shown in Figures 1A to 1D), which may be movably retained in the medicament container to seal the medicament container, may be displaced towards an outlet of the medicament container thereby dispensing the drug Dr through the outlet. The outlet may be formed or defined by the needle 71, see Figure 1C.

[0088] Other potential drive energy sources different from the drive spring 1100 comprise an electrical power cell or battery for driving the plunger 1000 by a motor or a reservoir suitable to provide gas pressure, where the gas pressure can be used to drive the drug delivery operation.

[0089] The medicament delivery device 100 may be an autoinjector. The energy for driving the drug delivery operation in an autoinjector may be provided by components integral to drug delivery device 100 and does not have to be loaded into the device by the user during the operation of device 100 as is the case in many spring-driven pen-type variable dose injectors, where, usually, the energy is loaded into the spring by the user during a dose setting procedure. The device 100 may be a pen-type device.

[0090] The medicament delivery device 100 may expediently be a single shot device, i.e. it is provided to dispense only one dose. Alternatively, the medicament delivery device 100 may be a multishot device configured to dispense more than one dose from the same medicament container. The dose may correspond to a fraction of the amount of drug contained within the medicament container or to the entire amount. In the first case, the medicament container is not entirely emptied when the medicament delivery device 100 is operated or shot.

[0091] The pre-filled syringe 70 and / or the needle 71 may be axially secured within the medicament delivery device 100, e.g. within the housing 60, or may be movable relative to the housing 60, e.g. for piercing the skin. In the first case, the user may have to perform the movement for piercing the skin with needle 71. In the second case, piercing of the skin by the needle 71 may be driven by a needle insertion mechanism of the medicament delivery device 100. Automatic needle retraction may be used as well.

[0092] As depicted in Figure 1A, the medicament delivery device 100 may further comprise a cap 200. The cap 200 may be arranged at a distal end of the medicament delivery device 100. The cap 200 may be detachably connected to the remainder of device 100, e.g. the housing 60 and / or another component or member of the medicament delivery device 100. The cap 200 may cover the distal end of the remainder of the medicament delivery device 100 and / or a needle passage opening through which needle 71 , e.g. a distal needle tip, may protrude to pierce the skin for the drug delivery operation. The cap 200 may comprise a needle shield remover configured to engage a needle shield (e.g. a rigid needle shield, RNS, or a soft needle shield, SNS), which may cover the needle 71 , such that the needle shield is removed from the needle 71 together with the cap 200, e.g. when the cap 200 is detached or disconnected from device 100.

[0093] Figure 1B illustrates the medicament delivery device 100 with the cap 200 being removed. The device 100 may be in a state ready to be operated, e.g. ready to perform a drug delivery operation when the operation is triggered. As depicted, the medicament delivery device 100 may further comprise a needle shroud 50. The needle shroud 50 may protrude distally from the housing 60 and / or may have been covered by the cap 200 when the cap 200 was still attached to the housing 60. The needle shroud 50 may be movable relative to the housing 60, e.g. in a proximal direction P, from an initial position or first position X to a second position or trigger position Y. The needle shroud 50 may be provided to extend beyond the distal tip of needle 71 which may protrude from the housing 60 before the drug delivery operation is commenced. In the first position X, the needle shroud 50 may be locked against a movement in the distal direction D relative to the housing 60, e.g. by an interaction between the needle shroud 50 and the plunger 1000. From the first position X, the needle shroud 50 may be movable in the proximal direction P relative to housing 60, at least until reaching the trigger position Y. During this proximal movement, e.g. before the needle shroud 50 reaches the second position Y, the needle 71 may pierce the skin of the user. During the movement of the needle shroud 50 from the first position X to the second position Y, the needle shroud 50 may interact with the plunger 1000, e.g. rotate the plunger 1000, such that due to this interaction the needle shroud 50 is free to move in the distal direction D relative to the housing 60, when the needle shroud 50 has reached the second position Y.

[0094] The needle shroud 50 may serve as a trigger member of the medicament delivery device 100, which, when displaced proximally from the initial or first position X depicted in Figure 1 B to the second or trigger position Y (see Figure 1C) and may automatically initialize the drug delivery operation, preferably when it reaches the second position Y. For example, the drug delivery operation can be initialized by removing a mechanical lock which prevents movement of plunger 1000 in the distal direction D or by moving the plunger 1000 to disengage a mechanical lock via moving the needle shroud 50. Alternatively, the needle shroud 50 may enable triggering of the drug delivery operation via a trigger member, e.g. a trigger button which may be disposed on the proximal end of the housing 60, when moved from the first position X to the second position Y. In this case, the trigger member may be operated by the user to initiate the drug delivery operation. Alternatively, operating the trigger member to initiate the drug delivery operation may only be possible when the needle shroud 50 is in the second position Y.

[0095] In yet another alternative, the needle shroud 50 may only be provided to prevent needle stick injuries before and / or after use of medicament delivery device 100. In this case, the needle shroud 50 may be completely decoupled from the drive mechanism 101 and / or may not be involved in triggering or enabling triggering of the drug delivery operation at all.

[0096] The needle shroud 50 may be provided to bear against the skin of a user during injection. Hence, the distal surface of the needle shroud 50 may provide a bearing surface or a skin contact surface 501. The skin contact surface 501 may delimit and / or extend around a needle passage opening provided in needle shroud 50. The skin contact surface 501 may be ring-like, oval, elliptic, rectangular, quadratic, etc., circumferentially closed and / or be defined by an inward protrusion protruding radially from an inner wall of needle shroud 50, e.g. a distal cylindrical portion thereof. The skin contact surface 501 may be the distal end surface of needle cover 500, e.g. facing distally. The syringe 70 with the needle 71 may be axially fixed in the device 100. In this case, needle insertion into the skin may be done manually by the user instead of displacing the syringe 70 relative to the housing 60. Figure 1C illustrates needle shroud 50 in the second position Y relative to device body. This is the position when the drug delivery operation has been initiated, can be initiated, and / or when the needle 71 pierces the skin, for example. The needle 71 may protrude axially from the skin contact surface 501 of the medicament delivery device 100 (particularly through the needle passage opening in needle shroud 50) and, by the distance with which it protrudes over the skin contact surface 501, penetrate the skin (the skin is not shown in this representation). This distance may be characteristic for or be equal to the injection depth. The device 100 may be maintained in contact with the skin until the drug delivery operation of drug Dr has been completed, which may be indicated by an optional audible, tactile, and / or visual indication or feedback provided by the medicament delivery device 100.

[0097] After the drug delivery operation has been completed, e.g. the plunger 1000 has moved distally, the device 100 may be removed from the skin. The needle shroud 50 may be biased relative to the housing 60 towards the first position by a needle shroud spring (not shown). Thus, when the device 100 is removed from the skin, the needle shroud 50 may be moved towards the first position X with respect to the housing 60 by the needle shroud spring. Specifically, the needle shroud 50 may be moved distally, e.g. beyond its first position X, into a final, third or locked out position Z relative to the housing 60 (see Figure 1D). In this position the needle shroud 50 may be axially locked relative to the housing 60 against movement in the proximal direction P, e.g. by a locking engagement between a needle shroud lock element 51 (not shown in Figure 1) of the needle shroud 50 and a corresponding securing element 61 (not shown in Figure 1) of the medicament delivery device 100. The securing element 61 may be part of the housing 60, e.g. it may be formed by a distally facing surface thereof.

[0098] The needle shroud lock element 51 may be flexible allowing a, predominantly, radial displacement thereof with respect to the longitudinal axis A when the needle shroud 50 transitions from one position to another position. For example, the needle shroud lock element 51 may comprise a snap arm with a radial protrusion and / or and inclined surface facilitating a radial deflection of the needle shroud lock element 51. The radial protrusion may protrude radially inwardly (see Figure 1 F) or outwardly (see Figure 1E) depending on the geometry and / or position of the securing element 61. In other words, the needle shroud lock element 51 in engagement with the securing element 61 may provide an inside (Figure 1 F) or outside (Figure 1 E) needle shroud lock.

[0099] Alternatively or additionally, the securing element 61 may comprise a flexible portion allowing for a relative movement of the securing element 61 with respect to the needle shroud lock element 51 for engaging and / or disengaging the needle shroud lock element 51 and the securing element 61.

[0100] When the needle shroud lock element 51 and the securing element 61 are engaged, the needle shroud 50 is in its locked out position Z in which it cannot be displaced proximally relative to housing 60, e.g. into the second position Y and / or into the first position X. In the locked out position Z, a cover portion 502 of the needle shroud 50 protrudes farther distally from the device body 60 than a tip of the needle 71. This may protect the user from needle stick injuries after use.

[0101] In order to re-use the medicament delivery device 100, e.g. when medicament from the same medicament container shall be injected in more than one injection, the needle shroud 50 must be unlocked from its locked out position Z, which it assumed after the previous injection. Thus, the needle shroud lock element 51 and the securing element 61 must be disengaged to allow a proximal movement of the needle shroud 50 relative to the housing 60, thereby enabling the user to pierce the skin another time with the same needle 71.

[0102] For the sake of facilitating the understanding of the following Figures, certain features and / or elements of the described needle shroud unlock device 30 are depicted only once.

[0103] Nonetheless, these features and elements may exist several times, e.g. distributed around a circumference and / or with an axial offset along the longitudinal axis A, depending on the geometry of the medicament delivery device 100 and the features thereof, e.g. the needle shroud 50, the housing 60, the needle shroud lock element 51 and / or the securing element 61. For example, the features and elements of the needle shroud unlock device 30 may be distributed uniformly around the circumference, i.e. with similar angular offsets therebetween or between functionally linked groups of features. Alternatively, the distribution may be non- uniform.

[0104] The foregoing description applies to medicament delivery devices 100 in general. As regards the structures and mechanism of locking the needle shroud 50 in its locked out position Z, the interaction between the needle shroud lock out element 51 and the securing element 61 may be realized in different ways. For the sake of facilitating the understanding, the following explanations focus on medicament delivery devices 100 in which the needle shroud 50 comprises the needle shroud lock element 51 and the housing 60 comprises the securing element 61. The lock out may be an inside or outside needle shroud lock out, as described in the foregoing. In particular, Figure 1 E illustrates a distal portion of a medicament delivery device 100 realized as a medicament delivery device 100a, in which the needle shroud lock element 51 comprises a radial outward protrusion. Accordingly, the securing element 61 is realized as a radial inward protrusion, e.g. protruding from an outer shell of the housing 60. This design is called an outside needle shroud lock out.

[0105] Figure 1F illustrates a distal portion of medicament delivery device 100 realized as a medicament delivery device 100b, in which the needle shroud lock element 51 comprises a radial inward protrusion. Accordingly, the securing element 61 is realized differently, e.g. by a distally facing surface of the housing 60 which is positioned radially inside of the needle shroud 50. This design is called an inside needle shroud lock out.

[0106] Apart from the structures and mechanism of locking the needle shroud in its locked out position Z, other features of the medicament delivery devices 100a, 100b, e.g. the medicament container, may be identical.

[0107] Figure 1G illustrates an embodiment of a medicament delivery device of the present disclosure. The medicament delivery device may be a syringe 70, e.g. a pre-filled syringe. The syringe 70 may comprise a reservoir 74 with a medicament, e.g. a liquid medicament. A plunger stopper 1200 may be movably arranged within the reservoir 74. The plunger stopper 1200 may be configured to seal the reservoir 74 and, when moving in the distal direction D relative to the reservoir 74, discharge the medicament from the reservoir 74, e.g. through a needle 71 (not visible). The needle 71 may be configured to pierce the user’s body and inject the discharged medicament into the user’s body.

[0108] The syringe 70 may comprise a plunger 1000 by a witch the user may induce a movement of the plunger stopper 1200, e.g. by pressing the plunger 1000 distally with respect to the reservoir 74.

[0109] The syringe 70 may comprise a needle shield 73 for covering the needle 71 and / or keeping the needle 71 sterile before a first use of the syringe 70. The needle shield 73 may comprise a proximal part 73a and a distal part 73b.

[0110] The needle 71 may be connected to the syringe 70, e.g. physically attached to the reservoir 74, by a needle attachment element 72. The needle attachment element 72 may be integrally formed with a body of the syringe 70 or, alternatively, the needle attachment element 72 may be connectable to or connected to the reservoir 74. The needle 71 may extend distally beyond a distal end of the needle attachment element 72. In the following, different embodiments of a purifying unit 15 according to the present disclosure will be exemplarily explained with respect to Figures 2 to 4. It should be noted that these explanations may apply to all aspects and embodiments described in the present disclosure, in particular to all aspects and embodiments of purifying devices 10, 20, 30, 31, needle shroud unlock devices 7a, 7b, 7c and medicament delivery devices 70, 100, 100a, 100b, if not explicitly indicated otherwise.

[0111] Figure 2A illustrates an embodiment of a purifying unit 15 according to the present disclosure. The purifying unit 15 may be configured to be connected to a medicament delivery device 70, 100, 100a, 100b, e.g. a needle 71 connected thereto, in order to purify at least a portion of the needle 71.

[0112] The purifying unit 15 comprises a purifying chamber 16 with a purifying medium. The purifying chamber 16 is sealed by a sealing element, e.g. a foil 40a, detachably connected to the purifying unit 15, e.g. by an adhesive. The foil 40a may comprise a flap 41, enabling the patient to grip the foil 40a for removing the foil 40a from the purifying unit 15. Alternatively, or additionally, the foil 40a may be pierceable. As shown on the right-hand side of Figure 2A, when the foil 40a is removed from the purifying unit 15, a needle 71 may enter the purifying chamber 16, through an opening 15f of the purifying unit 15. When entering the purifying chamber 16, the needle 71 may come into contact with the purifying medium. The purifying medium may clean and purify a portion of the needle 71 with which it is in contact.

[0113] The purifying unit 15 may further comprise a flange 19. The flange 19 may be provided at a distal end of the purifying unit 15. The flange 19 may comprise a proximal surface 19a facing the proximal direction P and a distal surface 19b facing the distal direction D. The flange 19, e.g. the proximal surface 19a thereof, may be configured to interact with a portion of the medicament delivery device 70, 100, 100a, 100b, e.g. a housing 60 thereof. The interaction may limit a proximal movement of the purifying unit 15 relative to the medicament delivery device 70, 100, 100a, 100b, when connecting the purifying unit 15 to the medicament delivery device 70, 100, 100a, 100b.

[0114] Alternatively, or additionally, the flange 19, e.g. the proximal surface 19a therefor, may be configured to interact with a portion of a purifying device 10, 20, 30, 31, e.g. a distal end surface 14a of a body 14 of the purifying device 20, as shown in Figure 6C. The interaction may limit a proximal movement of the purifying unit 15 with respect to the medicament delivery device 70, 100, 100a, 100b or the purifying device 10, 20, 30, 31. In other words, the interaction may limit a penetration depth of the needle 71 in the purifying chamber 16. This may be beneficial for avoiding damage of the needle 71.

[0115] In one embodiment not illustrated, the purifying unit 15 may comprise a stop feature for limiting the penetration depth of the needle 71 in the purifying chamber 16. For example, the stop feature may be provided by a proximal surface of the purifying unit 15 interacting with medicament delivery device 70, 100, 100a, 100b, e.g. with the housing 60, the needle shroud 50, the reservoir 74 or the needle attachment element 72.

[0116] Figure 2B illustrates an embodiment of a purifying unit 15 according to the present disclosure. The purifying unit 15 of Figure 2B may partially correspond to the purifying unit 15 of Figure 2A. Regarding the similarities between the embodiments illustrated in Figures 2A and 2B, reference is made to the explanations given in the context of Figure 2A.

[0117] As compared to the purifying unit 15 of Figure 2A, the purifying unit 15 of Figure 2B additionally comprises a reception space 15d. The reception space 15d may be configured to receive a distal portion of the medicament delivery device 70, 100, 100a, 100b, e.g. the needle attachment element 72, through the opening 15f.The reception space 15d may comprise a sealing element attachment feature 15e, e.g. an annular surface 15e facing the proximal direction P.

[0118] The purifying chamber 16 of the illustrated embodiment may be sealed by a pierceable foil 40b. The pierceable foil 40b may be connected to the annular surface 15e by an adhesive. The foil 40b may be configured to limit the distal movement of the needle 71 relative to the purifying chamber 16, e.g. by interacting with the needle attachment element 72, when contacting the needle attachment element 72.

[0119] Figure 3A illustrates an embodiment of a purifying unit 15 according to the present disclosure. The purifying unit 15 of Figure 3A may partially correspond to the purifying unit 15 of Figures 2A and 2B. Regarding the similarities between the embodiments illustrated in Figure 3A and Figures 2A and 2B, reference is made to the explanations given in the context of Figures 2A and 2B.

[0120] As compared to the purifying unit 15 of Figure 2B, the purifying unit 15 of Figure 3A additionally comprises a mounting ring recess 15a. The mounting ring recess 15a may be formed on an inner surface of the reception space 15d. For example, the mounting ring recess 15a may be a groove, especially a circumferential groove. Thus, the reception space 15d may be configured to receive a mounting ring 35. As illustrated, the mounting ring 35 may comprise a radial outward protrusion 35a. The radial outward protrusion 35a may be configured to interact with the mounting ring recess 15a, when the mounting ring 35 is received in the reception space 15d. If the mounting ring recess 15a is a circumferential groove, attaching the mounting ring 35 may be facilitated as the mounting ring 35 may be connected to the mounting ring recess 15a independently from its rotation around the longitudinal direction of the purifying unit 15.

[0121] The mounting ring 35 may be configured to secure the sealing element, which may be a septum 42, to the purifying unit 15. As illustrated, the mounting ring 35 may secure the septum 42 to the sealing element attachment feature 15e, such that the septum 42 seals the purifying chamber 16. The mounting ring 35 may comprise an opening through which the needle 71 may pass for penetrating the septum 42 and entering the purifying chamber 16.

[0122] Figure 3B illustrates an embodiment of a purifying unit 15, which is partially similar to the purifying unit 15 illustrated in Figures 2A, 2B and 3A. Regarding the similarities between the embodiments, reference is made to the explanations given in the context of these Figures.

[0123] The purifying unit 15 of Figure 3B comprises a septum 42 which is secured to the purifying unit 15 via a crimp clamp 36. As shown, the purifying unit 15 may comprise a crimp clamp protrusion 15b formed at a proximal end of the purifying unit 15. The crimp clamp protrusion 15b is configured to interact with a corresponding radial inward protrusion 36a of the crimp clamp 36, when the crimp clamp 36 is connected to the purifying unit 15. For the sake of facilitating the connection of the crimp clamp 36 to the purifying unit 15, the purifying unit 15 may comprise a crimp clamp recess 15c formed distally of the crimp clamp protrusion 15b such that the radial inward protrusion 36a may engage the crimp clamp protrusion 15b easily.

[0124] The crimp clamp 36 may be configured such that a proximal end surface thereof is pierceable by the needle 71 (not shown), during connection of the purifying element 15 to the needle 71. Alternatively, the crimp clamp 36 may comprise an opening at its proximal end surface through which the needle 71 may pass for penetrating the septum 42 and entering the purifying chamber 16.

[0125] The purifying unit 15 may further be configured such that an outer diameter of a distal portion of the purifying unit 15, i.e. a portion between the crimp clamp recess 15c and flange 19, is equal to or larger than an outer diameter of the crimp clamp 36, when the crimp clamp 36 is connected to the purifying unit 15. This may facilitate connecting the purifying unit 15 to the needle 71 and / or the medicament delivery device 70, 100, 100a, 100b. Figure 3C illustrates an embodiment of a purifying unit 15, which is partially similar to the purifying unit 15 illustrated in Figures 2A, 2B and 3B. Regarding the similarities between the embodiments illustrated in Figure 3B and Figures 2A and 2B, reference is made to the explanations given in the context of Figures 2A and 2B and 3B. In this embodiment, the purifying unit 15 may comprise a mushroom head shape 15g. The purifying element may comprise a foil 37 configured to secure the sealing element, which may be a septum 42, to the purifying unit 15.

[0126] The foil 37 may be configured to be shrank over the mushroom head as shown in the Figure. A needle 71 may therefore have to penetrate the foil 37 and the septum 42 to enter the purifying chamber 16 (not shown).

[0127] Figure 3D illustrates an embodiment of a purifying unit 15, which is partially similar to the purifying unit 15 illustrated in Figures 2A, 2B and 3A. Regarding the similarities between the embodiments illustrated in Figure 3A and Figures 2A and 2B, reference is made to the explanations given in the context of Figures 2A and 2B and 3A.

[0128] In this embodiment, however the mounting ring 35 comprises and / or is implemented with the sealing element, which may be a septum 42. The mounting ring 35 may be received and / or held in the opening 15f of the purifying unit 16 by a transition fit connection.

[0129] A needle 71 may therefore have to penetrate the septum 42 through an aperture 35b of the mounting ring 35 to enter the purifying chamber 16 (not shown).

[0130] Figure 4A illustrates an embodiment of a purifying unit 15 according to the present disclosure. The purifying unit 15 of Figure 4A may partially correspond to the purifying units 15 described in the foregoing, especially the purifying unit 15 illustrated in Figure 2A. Regarding the similarities between the embodiments, reference is made to the explanations given in the foregoing.

[0131] The purifying chamber 16 as illustrated in Figure 4A is configured to receive a purifying container 43. The purifying container 43 may comprise the purifying medium. The purifying chamber 16, e.g. an inner sidewall, may be configured to interact with a sidewall of the purifying container 43 thereby limiting a relative movement of the purifying container 43 within the purifying chamber 16.

[0132] Figure 4B illustrates an embodiment of a purifying container 43 according to the present disclosure. At a proximal end 44, the purifying container 43 may have a thinner wall thickness than in other portions thereof. Alternatively, or additionally, as illustrated in Figure 4C, the purifying container 43 may comprise a suspension element 45. The suspension element 45 may be configured to secure the purifying container 43 to the medicament delivery device 70, 100, 100a, 100b, e.g. to the needle attachment element 72. As shown, the suspension element 45 may comprise a honeycomb structure which may be deformed by the needle attachment element 72 when the needle 71 is received within the purifying container 43. The deformation of the honeycomb structure may cause an interaction between the suspension element 45 and the needle attachment element 72 thereby securing the purifying container 43 to the medicament delivery device 70, 100, 100a, 100b.

[0133] In the following, embodiments of purifying devices 10, 20, 30, 31, needle shroud unlock devices 7a, 7b, 7c, medicament delivery devices 70, 100, 100a, 100b, a system 600, and a method for purifying a needle, are described. Where appropriate, reference is made to foregoing explanations by using the same reference signs. It shall be understood that the foregoing explanations, in part or entirely, apply to the embodiments described in the following, if not explicitly indicated otherwise.

[0134] Figures 5A and 5B illustrate an embodiment of a purifying device 10 and a medicament delivery device 100 according to the present disclosure. The purifying device 10 may comprise a needle shield removal unit 11 and a purifying unit 15, as described in the foregoing. The needle shield removal unit 11 may comprise a needle shield engagement feature 12, e.g. a grabber 12, configured to interact with a needle shield 73 (not shown), before a first use of the medicament delivery device 100. Due to the interaction, the needle shield 73 may be removed from the needle 71 , when the purifying device 10 is pulled off the medicament delivery device 100 in the distal direction D (see Figure 5A).

[0135] As illustrated, the needle shield removal unit 11 may comprise an orientation feature 13, e.g. a visual orientation feature such as a print an outer surface of the needle shield removal unit 11. The orientation feature 13 may indicate an orientation of the purifying unit 10 with respect to the medicament delivery device 100, e.g. via an arrow pointing towards the purifying unit 15.

[0136] The purifying unit 15 may comprise a purifying chamber 16 (not visible) with the purifying agent. As illustrated, an opening 15f of the purifying unit 15 may be sealed by a sealing element, e.g. a removable foil 40a. Thereby, the foil 40a may seal the purifying chamber 16, as well. The removable foil 40a may comprise a flap 41 for facilitating removal of the foil 40a from the purifying unit 15. Removal of the foil 40a may be required before the needle 71 can be purified in the purifying chamber 16. In other words, it may not be intended that the foil 40a is pierced by the needle 71, when connecting the purifying unit 15 to the medicament delivery device 100 for purifying the needle 71.

[0137] Figure 5B illustrates the purifying device 10 connected to the medicament delivery device 100, after the foil 40a has been removed. Compared to the illustration in Figure 5A, the purifying device 10 has been rotated by 180 degrees around its radial or its circumferential direction. The needle 71 (not visible) may enter the purifying chamber 16 (not visible) such that it is received therein. The purifying agent within the purifying chamber 16 may purify the needle 71 , when the needle 71 is received in the purifying chamber 16.

[0138] As illustrated, an outer diameter of the needle shield removal unit 11 may be larger than an outer diameter of the purifying unit 15. For example, the outer diameter of the needle shield removal unit 11 may correspond to an outer diameter of a housing 60 of the medicament delivery device 100, while the outer diameter of the purifying unit 15 may be smaller than or equal to an inner diameter of an inner surface of the housing 60 such that the purifying element 15 may move into the housing 60, when the purifying device 10 is connected to the medicament delivery device 100.

[0139] The purifying device 10 may comprise a stop feature 11a, e.g. a distal surface. The stop feature 11a may be provided between the needle shield removal element 11 and the purifying element 15. The stop feature 11a may interact with the medicament delivery device 100, e.g. a surface of the housing 60 such as a distal end surface 60a, thereby limiting a movement of the purifying device 10 relative to the medicament delivery device 100 in the proximal direction P. In other words, the interaction between the stop feature 11a and the distal end surface 60a may limit a penetration depth of the needle 71 in the purifying chamber 16.

[0140] Figures 6A to 6C illustrate an embodiment of a purifying device 20 and a medicament delivery device 100 according to the present disclosure. The purifying device 20 may comprise a needle shield removal unit, illustrated as a grabber 12, a purifying unit 15 and a body 14.

[0141] The grabber 12 may comprise engagement protrusions 12a configured to interact with the needle shield 73, in particular a distal part 73b thereof, for removing the needle shield 73 from the needle 71, e.g. when the purifying device 20 is moved distally with respect to the housing 60 of the medicament delivery device 100. The grabber 12 may be connected to the body 14 via a grabber engagement element 21b of the body 14 interacting with a grabber recess 21a of the grabber 12 such that a distal movement of the body 14 relative to the needle 71 causes a corresponding distal movement of the grabber 12 relative to the needle 71. The body 14 may comprise an opening 14b (see Figure 6B) through which the purifying unit 15 may pass inside the body 14. The body 14 may comprise at least one distal stop recess 22b configured to interact with a respective body engagement element 22a of the purifying unit 15. The purifying unit 15 may be movable relative to the body 14 in the longitudinal direction. The interaction between the distal stop recess 22b and the body engagement element 22a may prevent a separation of the purifying unit 15 from the body 14, when the purifying unit 15 moves in the distal direction D relative to the body 14.

[0142] The body 14 may be configured to interact with the housing 60 of the medicament delivery device 100, e.g. via friction, when the purifying device 20 is connected to the medicament delivery device 100 (see Figures 6A and 6C).

[0143] The purifying unit 15 may comprise a purifying chamber 16 containing a purifying agent or purifying medium. The purifying unit 15 may comprise a flange 19 with a proximal surface 19a and a distal surface 19b. The user may grip the flange 19 for moving the purifying unit 15 relative to the housing 60, e.g. in the distal direction D, in order to remove the needle shield 73 from the needle 71. In particular, a movement of the purifying unit 15 in the distal direction D relative to the needle 71 , may cause a corresponding movement of the body 14 relative to the needle 71 , due to the interaction between the body engagement element 22a and the distal stop recess 22b. Further, due to the interaction between the grabber engagement element 21b and the grabber recess 21 , the grabber 12 may move relatively to the needle 71 , thereby removing the needle shield 73 from the needle 71. The grabber 12 may be configured to retain the needle shield 73 therein. After the needle shield 73 has been removed from the needle 71 , medicament may be delivered from the medicament delivery device 100 through the needle 71.

[0144] In one embodiment, the grabber engagement element 21b may comprise one or more flexible arms 21b each having a radial inward protrusion. The radial inward protrusion may have an inclined surface such that, when a proximal force is applied to the grabber 12, a distal portion of the grabber recess 21a may cause the one or more flexible arms 21b to deflect in a radial outward direction, thereby disengaging the one or more radial inward protrusions of the arms 21b from the grabber recess 21a. The grabber 12 may then be separated from the purifying device 20.

[0145] Additionally, or alternatively, the grabber 12 may be separated by a tilting movement of the grabber 12 (not shown). Tilting the grabber 12 may cause at least one of the one or more flexible arms 21b to deflect in a radial outward direction, thereby disengaging the at least one of the one or more radial inward protrusions of the arms 21b from the grabber recess 21a. The grabber 12 may then be separated from the purifying device 20. Alternatively, or additionally, the grabber 12 may be separated from the purifying device 20 by breaking one or more predetermined breaking points (not shown) between the grabber 12 and the purifying device 20, e.g. between the grabber 12 and one or both of the body 14 and the purifying unit 15.

[0146] As shown in Figure 6B, the separation of the grabber 12 from the purifying device 20 may open an opening 15f of the purifying unit 15, thereby opening the purifying chamber 16.

[0147] In one embodiment, when the user intends to purify the needle 71 , the user may connect the purifying device 20 to the medicament delivery device 100, after the grabber 12 has been separated from the purifying device 20. There is no need of rotating the purifying device 20 as compared to its orientation before the needle shield 73 had been removed, as the opening 15f of the purifying unit 15 and the opening 11b of the needle shield removal unit 11 both face in the proximal direction P.

[0148] As illustrated in Figure 6C, the user may connect the body 14 of the purifying device 20 to the housing 60 of the medicament delivery device 100 such that the body 14 is secured to the housing 60, e.g. via friction. Then, the user may move the purifying unit 15 relative to the body 14 in the proximal direction P, e.g. via moving the flange 19 proximally. This may cause the needle 71 to enter the purifying chamber 16 (see Figure 6C). The proximal movement of the purifying unit 15 relative to the body 14, and therefore penetration depth of the needle 71 inside the purifying chamber 16, may be limited by an interaction between the proximal surface 19a of the flange 19 and a distal surface 14a of the body 14.

[0149] The purifying unit 15 may comprise a status indication feature, e.g. a flexible snap arm 23a, configured to interact with the body 14, e.g. a status indication recess 23b of the body 14, thereby providing a feedback to the user regarding the position of the purifying element 15 with respect to the needle 71 and / or the medicament delivery device 100. The snap arm 23a may comprise a protrusion, e.g. a radial outward protrusion 24a, with an inclined surface. The inclined surface may interact with the body 14, e.g. the distal surface 14a, when the purifying unit 15 is moved proximally relative to the body 14. The interaction may cause a deflection of the snap arm 23a in a radial inward direction. The snap arm 23a may remain deflected during the proximal movement of the purifying unit 15 relative the body 14 until the protrusion 24a aligns with the status indication recess 23b. Upon alignment, the snap arm 23a may return to its non-deflected state. This may cause a portion of the snap arm 23a to hit against a portion of the body 14, e.g. an inner surface of the opening 14b and / or a surface of the status indication recess 23b. The contact may create an acoustic and / or haptic feedback to the user. The feedback may indicate that the needle 71 is in a final position in the purifying chamber 16. In other words, the feedback may indicate to the user that the purifying device 20 is properly connected to the medicament delivery device 100.

[0150] In Figure 6C the status indication recess 23b and the distal stop recess 22b of the body are shown not aligned in the axial direction. The embodiments are however not limited to this and according to some embodiments the status indication recess 23b and the distal stop recess 22b of the body may however be aligned in the axial direction (not shown).

[0151] Figures 7A and 7B illustrate an embodiment of a purifying device 30 and a medicament delivery device 100 according to the present disclosure. In Figure 7A, the purifying device 30 is rotated by 180 degrees around the radial or the circumferential direction compared to the illustration in Figure 7b.

[0152] The purifying device 30 may comprise a purifying unit 15. The purifying device 30 may be configured to be connected to the medicament delivery device 100 after a needle shield 73 (not shown) has been removed from a needle 71 (not shown). The purifying device 30 may be a device dedicated for purifying the needle 71 , only. In other words, the purifying device 30 may not comprise a needle shield removal unit 11.

[0153] The purifying unit 15 may comprise a purifying chamber 16, as described in the foregoing, especially in the context of Figures 2 to 4. The purifying unit 15 may further comprise a flange 19 with a proximal surface 19a and a distal surface 19b. As regards the function and interactions of the purifying unit 15, the purifying chamber 16 and the flange 19 with parts of the medicament delivery device 100 and the needle 71 (not visible), reference is made to the foregoing explanations.

[0154] Figures 8 illustrates an embodiment of a purifying device 31 and a medicament delivery device 70 according to the present disclosure. The illustrated medicament delivery device 70 is a syringe 70 as described in the foregoing, especially with respect to Figure 1G.

[0155] The syringe 70 may comprise a reservoir 74 and a needle 71 connected to the reservoir 74, e.g. attached thereto via a needle attachment element 72. The syringe 70 may comprise a needle shield 73 for protecting the needle 71 and / or keeping the needle 71 sterile as described in the foregoing. The purifying device 31 may comprise a needle shield removal unit 11 and a purifying unit 15 which may be arranged in parallel to each other within the purifying device 31 (see the illustration in the middle of Figure 8). In other words, the longitudinal axes of the needle shield removal unit 11 and the purifying unit 15 may be parallel.

[0156] The needle shield removal unit 11 may comprise a needle shield engagement feature 12 for removing the needle shield 73 from the needle 71. The needle shield removal unit 11 may be configured to retain the needle shield 73 after removal. As regards further details of the needle shield removal unit 11 and / or the needle shield engagement feature 12, reference is made to the foregoing.

[0157] The purifying device 31 may be configured to be connectable to the syringe 70 in two different positions, as described in the foregoing. In the first position, the purifying device 31 may be connected to the syringe 70 such that the purifying unit 15 interacts with the needle 71. In the second position, the purifying device 31 may be connected to the syringe 70 such that the needle shield removal unit 11 interacts with the needle shield 73 while the needle 71 does not interact with the purifying unit 15.

[0158] An opening 11b of the needle shield removal unit 11 and an opening 15f of the purifying unit 15 both face the proximal direction P. Hence, the purifying device 31 may not need to be rotated for moving between the second and the first position.

[0159] The purifying unit 15 may comprise a reception space 15d and a purifying chamber 16. The purifying chamber 16 of the illustrated embodiment may contain a purifying agent or purifying medium. The reception space 15d and / or the purifying chamber may be closed at a proximal end, e.g. sealed by a removable foil 40a with a flap 41. The foil 40a may for example seal the purifying unit, e.g. the purifying chamber against dry outs.

[0160] As illustrated in the right illustration of Figure 8, the reception space 15d may comprise an annular surface 15e facing the proximal direction P. The annular surface 15e may further provide a stop surface for the needle attachment element 72. In detail, a distal movement of the needle 71 relative to the purifying chamber 16 may be stopped by an interaction of the needle attachment element 72 with the annular surface 15e.

[0161] Figure 9 illustrates an embodiment of a needle shroud unlock device 7a according to the present disclosure. The needle shroud unlock device 7a may comprise an unlock element 1 and a push element 2. The unlock element 1 may be configured to unlock a needle shroud 50 (not shown) of a medicament delivery device 100, 100a, 100b (not shown) from a locked out position. In the locked out position, the needle shroud 50 covers a needle 71 (not shown) of the medicament delivery device 100, 100a, 100b and is secured against any movement relative to the medicament delivery device, e.g. a housing 60 (not shown) thereof, which would expose the needle 71. The needle shroud 50 may move to a locked out position when the medicament delivery device 100, 100a, 100b is removed from the injection site, e.g. after an injection or when an injection is interrupted.

[0162] In one embodiment, the needle shroud unlock device 7a may be configured to reset the needle shroud 50 of the medicament delivery device 100, 100a, 100b, after the needle shroud 50 has been unlocked from its locked out position. In this context, unlocked may mean that the needle shroud 50 may move relative to the medicament delivery device100, 100a, 100b, e.g. the housing 60, such that the relative movement may expose at least a distal portion of the needle 71.

[0163] In one embodiment, the needle shroud 50 may be reset by moving the needle shroud 50 proximally relative to the housing 60. For example, the needle shroud 50 may be moved proximally relative to the housing 60 by moving the push element 2 proximally relatively to the unlock element 1 of the needle shroud unlock device 7a. When reaching a certain position relative to the housing 60, a portion of the needle shroud 50 may interact with a lock element. The lock element may be configured to releasably secure the needle shroud 50 against a distal movement relative to the medicament delivery device 100, 100a, 100b, e.g. the housing 60.

[0164] In one embodiment, the needle shroud 50 may be released from its interaction with the lock element, when the medicament delivery device 100, 100a, 100b is triggered, e.g. for performing an injection. The released needle shroud 50 may move distally, e.g. driven by a needle shroud spring (not shown), relative to the medicament delivery device 100, 100a, 100b, e.g. the housing 60, when a proximal force applied to the needle shroud 50 is smaller than a distal force applied to the needle shroud 50, e.g. by the needle shroud spring.

[0165] For example, the needle shroud 50 may be driven distally by the needle shroud spring when the medicament delivery device 100, 100a, 100b is removed from the injection site, e.g. after an injection or when the injection is interrupted. When reaching its most distal position, the needle shroud 50 may cover the needle 71 and may be secured against any movement relative to the medicament delivery device 100, 100a, 100b, e.g. the housing 60, which would (re-)expose the needle 71. In other words, the needle shroud 50 may be in its locked out position.

[0166] In the illustrated embodiment, the push element 2 may comprise a purifying chamber 3, sealed by a sealing element 4. The purifying chamber 3 may comprise a purifying agent. The purifying chamber 3 may correspond to the purifying chamber 16 described in the foregoing. The push element 2 may further comprise a reception space 5. The reception space 5 may correspond to the reception space 15d described in the foregoing. The push element 2 may further comprise a flange 8. The flange 8 may correspond to the flange 19 described in the foregoing. Hence, apart from a distal end, the push element 2 may have the same design and / or provide the same functions as the purifying unit 15 described in the foregoing as regards cleaning and / or sanitizing and / or purifying the needle 71.

[0167] Figure 10 illustrates an embodiment of a needle shroud unlock device 7b according to the present disclosure. The needle shroud unlock device 7b may partially correspond to the needle shroud unlock device 7a of Figure 9. Regarding the similarities between the embodiments, reference is made to the explanations given in the context of Figure 9.

[0168] The needle shroud unlock device 7b may comprise an unlock element 1 , a push element 2 and a purifying element 6. The purifying element 6 may comprise a purifying chamber 3, a sealing element 4 and a reception space 5. The purifying chamber 3, the sealing element 4 and / or the reception space 5 may correspond to the purifying chamber 16, the sealing element 40a, 40b, 42 and / or the reception space 15d as described in the foregoing. Hence, apart from the flange 19, which is not present in Figure 10, the purifying element 6 may correspond to the purifying unit 15 described in the foregoing.

[0169] Figure 11 illustrates an embodiment of a needle shroud unlock device 7c according to the present disclosure. The needle shroud unlock device 7c may partially correspond to the needle shroud unlock device 7a of Figure 9 and the needle shroud unlock device 7b of Figure 10. Regarding the similarities between the embodiments, reference is made to the explanations given in the context of Figure 9 and Figure 10.

[0170] The needle shroud unlock device 7c may comprise an unlock element 1 and a push element 2. The unlock element 1 may comprise a purifying chamber 3, a sealing element 4 and the reception space 5. The purifying chamber 3, the sealing element 4 and / or the reception space 5 may correspond, respectively, to the purifying chamber 16, the sealing element 40a, 40b, 42 and / or the reception space 15d as described in the foregoing.

[0171] Figure 12 illustrates steps of a method for purifying a needle 71 for delivering a medicament from a medicament delivery device 70, 100, 100a, 100b according to the present disclosure. The method comprises the step of connecting S400 a purifying unit 15 of a purifying device 10, 20 30, 31 to the needle 71 such that a portion of the needle 71 to be purified contacts a purifying agent. The purifying agent may be configured to clean and / or sanitize and / or purify the portion of the needle with which it is in contact.

[0172] The needle 71 may be a needle 71 of a medicament delivery device 70, 100, 100a, 100b or a needle 71 connectable to a medicament delivery device 70, 100, 100a, 100b, e.g. via a needle carrier, as described in the foregoing. The purifying unit 15 and / or the purifying device 10, 20 30, 31 may be a purifying unit 15 and / or a purifying device 10, 20 30, 31 according to one of the embodiments described in the foregoing.

[0173] In one embodiment, the method may comprise the step of removing S100 a needle shield 73 from the needle 71 in order to expose a distal end of the needle 71. The distal end may be configured to pierce an injection site.

[0174] In one embodiment, the method may comprise the step of separating S201 at least one sealing element 40a, 40b, 40c, 42 from the purifying unit 15, thereby opening a reception space 15d and / or a purifying chamber 16 of the purifying unit.

[0175] In one embodiment, the method may comprise the step of separating S202 a needle shield removal unit 11 from the purifying device 10, 20, 30, 31. Separating the needle shield removal unit 11 from the purifying device 10, 20, 30, 31 may comprise detaching the needle shield removal unit 11 from the purifying unit 15.

[0176] In one embodiment, the method may comprise the step of positioning S301a the purifying device 10, 20, 30, 31 or the purifying unit 15 with respect to the needle 71. Positioning may include translating the purifying device 10, 20, 30, 31 or the purifying unit 15 in at least one of the longitudinal direction, the radial direction and / or the azimuthal direction of the needle 71.

[0177] In one embodiment, the method may comprise the step of orienting or aligning S301b the purifying device 10, 20, 30, 31 or the purifying unit 15 with respect to the needle 71 such that the purifying unit 15 may be connected to the needle 71 such that the needle 71 may enter the purifying unit 15 through an opening 15f. In detail, at least a portion of the needle 71 may enter a purifying chamber 16 or a purifying container 43. Orienting or aligning S301b may include rotating the purifying device or the purifying unit around at least one of the longitudinal direction, the radial direction and / or the azimuthal direction of the needle 71.

[0178] In one embodiment, the method may comprise the step of piercing at least one sealing element 40a, 40b, 40c, 42 or a purifying container 43 of the purifying unit 15 with the needle 71 , so that a portion of the needle 71 that enters the purifying chamber 16 or the purifying container 43 comes into contact with the purifying medium.

[0179] Figure 13 schematically illustrates an embodiment of a system 600 according to the present disclosure. The system 600 comprises a medicament delivery device and a purifying device. In the illustrated example, the system 600 comprises the medicament delivery device 100 and the purifying device 10, as described in the foregoing. However, it should be understood that the system 600 may comprise any combination of a medicament delivery device, e.g. one of the medicament delivery devices 70, 100, 100a, 100b as described in the foregoing, and a purifying device, e.g. one of the purifying devices 10, 20, 30, 31 as described in the foregoing. Figures 5A, 5B, 6A, 6C, 7B and 8 illustrate further exemplary embodiments of the system 600 according to the present disclosure.

[0180] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0181] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0182] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0183] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders.

[0184] Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0185] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide. Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0186] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0187] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0188] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0189] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine. Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0190] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0191] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0192] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0193] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0194] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0195] Further examples of APIs for the prophylaxis of hemophilia A or B, with or without inhibitors, include an siRNA targeting antithrombin. An example of an siRNA targeting antithrombin is fitusiran. The term “prophylaxis” and “prophylactic treatment” are used interchangeably herein.

[0196] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0197] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0198] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0199] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0200] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0201] Fitusiran as the API for the medicament in the device

[0202] Fitusiran is a synthetic, chemically modified double-stranded small interfering RNA (siRNA) oligonucleotide covalently linked to a tri-antennary N-acetyl-galactosamine (GalNAc) ligand targeting AT3 mRNA in the liver, thereby suppressing the synthesis of antithrombin. See, e.g., Pasi et al., N Engl J Med. (2017) 377(9):819-28. The nucleosides in each strand of fitusiran are connected through either 3’-5’ phosphodiester or phosphorothioate linkages, thus forming the sugar-phosphate backbone of the oligonucleotide.

[0203] The sense strand and the antisense strand contain 21 and 23 nucleotides, respectively. The 3’ end of the sense strand is conjugated to the GalNAc containing moiety (referred to herein as L96) through a phosphodiester linkage. The sense strand contains two consecutive phosphorothioate linkages at its 5’ end. The antisense strand contains four phosphorothioate linkages, two at the 3’ end and two at the 5’ end. The 21 nucleotides of the sense strand hybridize with the complementary 21 nucleotides of the antisense strand, thus forming 21 nucleotide base pairs and a two-base overhang at the 3’-end of the antisense strand. See also U.S. Pat. 9,127,274, U.S. Pat. 11,091,759, US2020 / 0163987A1, and WO 2019 / 014187, the entire contents each of which are expressly incorporated herein by reference.

[0204] The two nucleotide strands of fitusiran are shown below: sense strand: 5’Gf-ps-Gm-ps-Uf-Um-Af-Am-Cf-Am-Cf-Cf-Af-Um-Uf-Um-Af-Cm-Uf-Um- Cf-Am-Af-L96 3’ (SEQ ID NO:1), and antisense strand: 5’ Um-ps-Uf-ps-Gm-Af-Am-Gf-Um-Af-Am-Af-Um-Gm-Gm-Uf-Gm-Uf- Um-Af-Am-Cf-Cm-ps-Am-ps-Gm 3’ (SEQ ID N0:2), wherein

[0205] Af = 2’ -deoxy- 2’-fluoroadenosine

[0206] Cf = 2’ -deoxy- 2’-fluorocytidine

[0207] Gf = 2’ -deoxy- 2’-fluoroguanosine

[0208] Ilf = 2’ -deoxy- 2’-fluorouridine

[0209] Am = 2’-O-methyladenosine

[0210] Cm = 2’-O-methylcytidine

[0211] Gm = 2’-O-methylguanosine

[0212] Um = 2’-O-methyluridine

[0213] (hyphen) = 3’-5’ phosphodiester linkage sodium salt

[0214] “-ps-” = 3’-5’ phosphorothioate linkage sodium salt and wherein L96 has the following formula:

[0215] (I).

[0216] As used herein, the terms 2’ -deoxy- 2’-fluoroadenosine and 2’-fluoroadenosine may be used interchangeably.

[0217] As used herein, the terms 2’ -deoxy- 2’-fluorocytidine and 2’-fluorocytidine may be used interchangeably.

[0218] As used herein, the terms 2’ -deoxy- 2’-fluoroguanosine and 2’-fluoroguanosine may be used interchangeably.

[0219] As used herein, the terms 2’ -deoxy- 2’-fluorouridine and 2’-fluorouridine may be used interchangeably.

[0220] The expanded structural formula, molecular formula, and molecular weight of fitusiran, e.g. in sodium form, are shown in Figure 12.

[0221] The structure of fitusiran can also be described using the following diagram, wherein the X is O:

[0222]

[0223] Fitusiran is shown in Figure 12 in sodium salt form.

[0224] In some embodiments, the device delivers fitusiran in an aqueous solution, wherein fitusiran is at a concentration of about 40 to about 200 mg / mL (e.g., about 50 to about 150 mg / mL, about 80 to about 110 mg / mL, or about 90 to about 110 mg / mL). As used herein, values intermediate to recited ranges and values are also intended to be part of this disclosure. In addition, ranges of values using a combination of any of recited values as upper and / or lower limits are intended to be included. In further embodiments, the pharmaceutical formulation comprises fitusiran in an aqueous solution at a concentration of about 40, about 50, about 75, about 100, about 125, about 150, or about 200 mg / mL. In certain embodiments, fitusiran is provided in an aqueous solution at a concentration of about 100 mg / mL.

[0225] The term “deliver,” “delivers,” or “delivering” is intended to mean “administer,” “administers,” or “administering.”

[0226] Unless specifically stated or otherwise evident from the context, as used herein, the term “approximately” or "about" refers to a value that is within an acceptable error range for a particular value determined by a person of ordinary skill, a portion of which will depend on how the measurement or determination is made. For example, “approximately” or "about" may mean a range of up to 10% (ie, ±10%). Therefore, “approximately” or "about" can be understood as greater than or less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1 %, 0.05%, 0.01%, or 0.001%. When a specific value is provided in this disclosure, unless otherwise stated, the meaning of “approximately” or "about" should be assumed to be within an acceptable error range for that specific value.

[0227] While the fitusiran dosage weight described herein refers to the weight of fitusiran free acid (active moiety), administration of fitusiran to patients herein refers to administration of fitusiran sodium (drug substance) provided in a pharmaceutically suitable aqueous solution (e.g., a phosphate-buffered saline at a physiological pH). For example, about 100 mg / mL fitusiran means about 100 mg of fitusiran free acid (equivalent to about 106 mg fitusiran sodium, the drug substance) per mL. Unless otherwise indicated, a fitusiran weight recited in the present disclosure is the weight of fitusiran free acid (the active moiety).

[0228] In some embodiments, a pharmaceutical formulation in the device comprises fitusiran in a phosphate-buffered saline. The phosphate concentration in the solution may be about 1 to about 10 mM (e.g., about 2, about 3, about 4, about 5, about 6, about 7, about 8, or about 9 mM), with a pH of about 6.0-8.0. The pharmaceutical formulations herein may include a stabilizing agent such as EDTA. The pharmaceutical formulations may be preservative-free. In some embodiments, the fitusiran pharmaceutical formulation in the device is preservative-free and comprises, consists of, or consists essentially of about 100 mg of fitusiran per mL of an approximately 5 mM phosphate buffered saline (PBS) solution. In some embodiments, the fitusiran pharmaceutical formulation in the device is preservative-free and comprises, consists of, or consists essentially of fitusiran in an approximately 5 mM phosphate buffered saline (PBS) solution. The PBS solution is composed of sodium chloride, dibasic sodium phosphate (heptahydrate), and monobasic sodium phosphate (monohydrate). Sodium hydroxide solution and diluted phosphoric acid may be used to adjust the pH of the formulation to about 7.0 or about 7.1.

[0229] In some embodiments, the fitusiran formulation in the device for subcutaneous delivery contains fitusiran in a 5 mM phosphate buffered saline having 0.64 mM Na^PCL, 4.36 mM Na2HPC>4, and 84 mM NaCI at pH 7.0. In certain embodiments, the formulation of fitusiran solution for subcutaneous delivery is shown in Table 1 below:

[0230] Table 1. Exemplary Fitusiran Formulation

[0231] *q.s.: quantum satis

[0232] In some embodiments, the formulation of fitusiran solution for subcutaneous delivery with the device can be described as shown in Table 2 below.

[0233] Table 2. Exemplary Fitusiran Formulation

[0234] In some embodiments, the device may be used to deliver a single dose of fitusiran wherein the single dose comprises about 20 to about 80 mg of fitusiran (e.g., about 20 mg, about 25 mg, about 30 mg, about 40 mg, about 50 mg, or about 80 mg). In some embodiments, the device may be used to deliver single dose of fitusiran, wherein the single dose comprises about 1 to about 30 mg of fitusiran (e.g., about 1.25 mg, about 2.5 mg, about 5 mg, about 10 mg, about 20 mg, or about 30 mg).

[0235] In one embodiment, the device may be used to deliver a single dose of about 80 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 50 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 20 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 30 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 10 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 5 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 2.5 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 1.25 mg of fitusiran.

[0236] In some embodiments, the single dose of fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL). Other delivery volumes described herein may also be used. In one embodiment, the device may be used to deliver a single dose of about 80 mg of fitusiran in about 0.8 mL (about 100 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 50 mg of fitusiran in about 0.5 mL (about 100 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 20 mg of fitusiran in about 0.5 mL (about 40 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 30 mg of fitusiran in about 0.5 mL (about 60 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 10 mg of fitusiran in about 0.5 mL (about 20 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 5 mg of fitusiran in about 0.5 mL (about 10 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 2.5 mg of fitusiran in about 0.5 mL (about 5 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 1.25 mg of fitusiran in about 0.5 mL (about 2.5 mg fitusiran / mL).

[0237] In one embodiment, the device delivers fitusiran at a prophylactically effective amount to prophylactically treat hemophilia (e.g., hemophilia A or B, in a patient with or without inhibitors) in a patient in need thereof (e.g., a hemophilia A or B patient, with or without inhibitors). “Prophylactically effective amount” refers to the amount of fitusiran that helps the patient with hemophilia A or B, with or without inhibitors to achieve a desired clinical endpoint such as reducing the Annualized Bleeding Rate (ABR), Annualized Joint Bleeding Rate (AjBR), Annualized Spontaneous Bleeding Rate (AsBR), or the frequency of bleeding episodes. As used herein in the context of fitusiran, the term “treat” “treating,” or “treatment” includes prophylactic treatment of the disease and refers to achievement of a desired clinical endpoint.

[0238] A hemophilia A or B patient with inhibitors refers to a patient who has developed alloantibodies to the factor he / she has previously received (e.g., factor VIII for hemophilia A patients or factor IX for hemophilia B patients). A hemophilia A or B patient with inhibitors may become refractory to replacement coagulation factor therapies. A patient without inhibitors refers to a patient who does not have such alloantibodies. The present treatment methods may be beneficial for hemophilia A patients with inhibitors, as well as for hemophilia B patients with inhibitors.

[0239] As used herein, a patient with “hemophilia A or B, with or without inhibitors,” or refers to 1) a hemophilia A patient with inhibitors, or 2) a hemophilia B patient with inhibitors, 3) a hemophilia A patient without inhibitors, or 4) a hemophilia B patient without inhibitors. As used herein, a patient refers to a human patient. A patient can also refer to a human subject.

[0240] In some embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 50 mg of fitusiran once every two months (or every eight weeks). In other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 50 mg of fitusiran every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 80 mg of fitusiran every two months (or every eight weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 80 mg of fitusiran every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 20 mg of fitusiran every two months (or every eight weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 20 mg of fitusiran every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 10 mg of fitusiran every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of fitusiran at about 30 mg every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of fitusiran at about 5 mg every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of fitusiran at about 2.5 mg every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of fitusiran at about 1.25 mg every month (or every four weeks).

[0241] Accordingly, provided herein is a method of prophylactic treatment of a patient with hemophilia A or hemophilia B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). Fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0242] As an example, a method of prophylactic treatment of a patient with hemophilia A or hemophilia B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0243] Further provided herein is a method of reducing the frequency of bleeding episodes in a patient with hemophilia A or B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). Fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0244] As an example, a method of reducing the frequency of bleeding episodes in a patient with hemophilia A or B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0245] Also, provided herein is a method of reducing the ABR in a patient with hemophilia A or B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). Fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0246] As an example, a method of reducing the ABR in a patient with hemophilia A or B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL). Also, provided herein is a method of reducing the AjBR in a patient with hemophilia A or B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). The fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0247] As an example, a method of reducing the AjBR in a patient with hemophilia A or B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0248] Also, provided herein is a method of reducing the AsBR in a patient with hemophilia A or B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). Fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0249] As an example, a method of reducing the AsBR in a patient with hemophilia A or B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0250] Similar drug delivery devices as the ones discussed above are described in WO2015 / 004049 A1 , WO 2015 / 004052 A1, WO2015 / 144870 A1 , WO2016 / 193374 A1, WO2016 / 193343 A1, WO2016 / 193375 A1, WO2016 / 193346 A1 , WO2016 / 193348 A1 , WO2016 / 193352 A1, WO2016 / 193353 A1, WO2016 / 193355 A1 , WO2019 / 086561 A 1 , WO2019 / 086562 A1, WO2019 / 086575 A1, WO2019 / 086563 A1 , WO2019 / 086564 A1 , WO2019 / 086576 A1, W02019 / 101613 A1, W02020 / 069994 A1 , W02020 / 200995 A1 , W02020 / 245206 A1, W02020 / 074570 A1 , W02022 / 003093 A1 , WO2022 / 106504 A1 , WO2017 / 089263 A1 , WO2016 / 193344 A1, WO2016 / 193356 A1, W02019 / 101689 A1 , WO2020 / 239844 A1 , EP1743666B1, US20050101919, US7955304, US7442185, US8308695, and US8529510, the entire disclosure content of each of which is included by reference for all purposes into the present disclosure.

[0251] Although embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the system, process, manufacture, method or steps described in the present disclosure. As one of ordinary skill in the art will readily appreciate from the disclosure of the present disclosure, systems, processes, manufacture, methods or steps presently existing or to be developed later that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such systems, processes, methods or steps. The embodiments mentioned in the first part of the description may be combined with each other. The embodiments of the description of Figures may also be combined with each other. Further, it is possible to combine embodiments mentioned in the first part of the description with examples of the second part of the description which relates to Figures 1 to 14.

[0252] Reference numerals

[0253] A longitudinal axis

[0254] D distal direction

[0255] P proximal direction

[0256] X first needle shroud position

[0257] Y second needle shroud position

[0258] Z locked out needle shroud position

[0259] 1 unlock element

[0260] 2 push element

[0261] 3 purifying chamber

[0262] 4 sealing element

[0263] 5 reception space

[0264] 6 purifying element

[0265] 7a needle shroud unlock device

[0266] 7b needle shroud unlock device

[0267] 7c needle shroud unlock device

[0268] 8 flange

[0269] 10 purifying device

[0270] 11 needle shield removal unit

[0271] 11a stop feature

[0272] 11b opening of needle shield removal unit

[0273] 12 needle shield engagement feature

[0274] 12a grabber engagement protrusion

[0275] 13 o ri e ntati o n f eatu re

[0276] 14 body of purifying device

[0277] 14a distal end surface

[0278] 14b distal opening

[0279] 15 purifying unit

[0280] 15a mounting ring recess

[0281] 15b crimp clamp protrusion

[0282] 15c crimp clamp recess

[0283] 15d reception space

[0284] 15e annular surface 15f opening of purifying unit

[0285] 16 purifying chamber

[0286] 19 flange

[0287] 19a proximal surface

[0288] 19b distal surface

[0289] 20 purifying device

[0290] 21a grabber recess

[0291] 21 b grabber engagement element

[0292] 22a body engagement element

[0293] 22b distal stop recess

[0294] 23a status indication feature

[0295] 23b status indication recess

[0296] 24a protrusion

[0297] 30 purifying device

[0298] 31 purifying device

[0299] 35 mounting ring

[0300] 35a radial outward protrusion

[0301] 36 crimp clamp

[0302] 36a radial inward protrusion

[0303] 37 foil

[0304] 40a foil

[0305] 40b foil

[0306] 40c foil

[0307] 41 flap

[0308] 42 septum

[0309] 43 blow-fill-seal container

[0310] 44 proximal end of blow-fill-seal container

[0311] 45 suspension element

[0312] 50 needle shroud

[0313] 51 needle shroud lock element

[0314] 60 housing

[0315] 60a distal end surface

[0316] 61 securing element

[0317] 70 syringe 71 needle

[0318] 72 needle attachment element

[0319] 73 needle shield

[0320] 73a proximal part

[0321] 73b distal part

[0322] 74 reservoir

[0323] 100 medicament delivery device

[0324] 100a medicament delivery device with outside needle shroud lock

[0325] 100b medicament delivery device with inside needle shroud lock

[0326] 101 drive mechanism

[0327] 200 cap

[0328] 501 skin contact surface

[0329] 502 cover portion

[0330] 600 system

[0331] 800 syringe holder

[0332] 1000 plunger

[0333] 1200 stopper

[0334] S100 remove needle shield from needle

[0335] 5201 separate sealing element from purifying unit

[0336] 5202 separate needle shield removal unit from purifying device

[0337] S301a position purifying device

[0338] S301b orient / align purifying unit

[0339] S400 connect purifying unit to needle

Claims

Claims1. A purifying device (10, 20, 30, 31 ) for a medicament delivery device (70, 100, 100a, 100b), the purifying device (10, 20, 30, 31) comprising: a needle shield removal unit (11) configured to remove a needle shield (73) from a needle (71) for delivering a medicament from the medicament delivery device (70, 100, 100a, 100b); and a purifying unit (15) comprising a purifying chamber (16), wherein the purifying chamber (16) is configured to receive the needle (71) for purifying the needle (71).

2. The purifying device (10, 20, 30, 31) of claim 1, wherein the purifying unit (15) comprises a sealing element (40a, 40b, 40c, 42) configured to seal the purifying chamber (16), wherein the purifying chamber (16) contains a purifying agent.

3. The purifying device (10, 20, 30, 31) of claim 2, wherein the sealing element (40a, 40b, 40c, 42) is a foil (40a, 40b, 40c) or a septum (42), which is pierceable by the needle (71) and / or detachable from the purifying chamber (16).

4. The purifying device (10, 20, 30, 31) of claim 3, wherein the foil (40a, 40b, 40c) or the septum (42) is connected to the purifying unit (15) by a mounting ring (35), a crimp clamp (36) and / or an adhesive.

5. The purifying device (10, 20, 30, 31) of claim 1, wherein the purifying chamber (16) is configured to receive a purifying container (43) with a purifying agent.

6. The purifying device (10, 20, 30, 31) of claim 5, wherein the purifying container (43) is a blow-fill-seal container.

7. The purifying device (10, 20, 30, 31) of claim 5 or 6, wherein at a proximal end (44), the purifying container (43) has a thinner wall thickness than in other portions thereof.

8. The purifying device (10, 20, 30, 31) of any one of claims 5 to 7, wherein the purifying container (43) comprises a suspension element (45) configured to secure the purifying container (43) to the medicament delivery device (70, 100, 100a, 100b).

9. The purifying device (10, 20, 30, 31) of any one of the preceding claims, wherein the purifying unit (15) and the needle shield removal unit (11) are arranged one after another along a longitudinal direction of the purifying device (10, 20, 30, 31).

10. The purifying device (10, 20, 30, 31) of any one of the preceding claims, wherein an opening (11b) of the needle shield removal unit (11) is arranged on an opposite end of the purifying device (10, 20, 30, 31) with respect to an opening (15f) of the purifying unit (15).

11. The purifying device (10, 20, 30, 31 ) of any one of claims 1 to 9, wherein the needle shield removal unit (11) is detachably connected to the purifying device (10, 20, 30, 31).

12. The purifying device (10, 20, 30, 31) of any one of claims 1 to 9, wherein an opening (11b) of the needle shield removal unit (11) is arranged on the same end of the purifying device (10, 20, 30, 31) as an opening (15f) of the purifying unit (15).

13. The purifying device (10, 20, 30, 31) of any one of the preceding claims, wherein the purifying unit (15) comprises a status indication feature (23a) configured to provide a feedback regarding the status of the purifying device (10, 20, 30, 31) to a user.

14. A system comprising: a purifying device (10, 20, 30, 31) according to any one of the preceding claims; and a medicament delivery device (70, 100, 100a, 100b), wherein the medicament delivery device (70, 100, 100a, 100b) is configured to be connectable to or connected to a needle (71) for delivering a medicament from the medicament delivery device (70, 100, 100a, 100b); and wherein, optionally, the medicament delivery device (70, 100, 100a, 100b) is configured to retain a medicament container with the medicament or to comprise a medicament container with the medicament.

15. Method for purifying a needle (71) for delivering a medicament from a medicament delivery device (70, 100, 100a, 100b), the method comprising the step of: connecting (S400) a purifying unit (15) of a purifying device (10, 20, 30, 31) according to one of claims 1 to 13 to the needle (71) such that a portion of the needle (71) to be purified contacts a purifying agent.

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