Self-driven medicament container and medicament delivery device

Abstract

There is provided a self-driven medicament container (10, 10 ') for storing and discharging medicament in response to user interaction, the self-driven medicament container (10, 10') comprising: a reservoir body (2); a holder (3); a stopper (4) configured to divide the interior of the reservoir body (2) into a drive compartment (21) and a medicament compartment (22) containing the medicament and comprising an outlet (23) through which the medicament can be discharged in a dispensing operation. The self-driven medicament container (10, 10) further comprises: a drive element (5); a plunger having a shaft (61, 6T) with a locking element (62, 62 ') configured to engage the retainer (3) to prevent distal movement of the plunger relative to the reservoir body (2) and a contact element (63) configured to contact the stopper (4); and a release mechanism configured to disengage the locking element (62, 62 ') from the retainer (3) in response to the user interaction, thereby enabling the plunger to move distally relative to the reservoir body (2). The medicament compartment (22) is distal to the drive compartment (21). The stopper (4) is further configured to seal the medicament compartment (22) relative to the drive compartment (21). The drive element (5) is positioned in the drive compartment (21) before and after the locking element (62, 62 ') is disengaged from the retainer (3). The drive element (5) is configured to provide an axial force to the plunger when the locking element (62, 62 ') is disengaged from the holder (3) in order to move the plunger distally relative to the reservoir body (2), thereby moving the stopper (4) relative to the reservoir body (2) and expelling the medicament. Further, a medicament delivery device (100, 100 ') is provided, the medicament delivery device comprising the self-driven medicament container.

Description

BACKGROUND

[0001] The present disclosure relates to a self-powered medicament container for storing a medicament and expelling said medicament in a dispensing operation in response to a user interaction. The present disclosure further relates to a medicament delivery device comprising a self-powered medicament container.

[0002] Medicament containers storing a medicament are commonly used in medicament delivery devices. Conventional medicament containers comprise a medicament compartment containing the medicament and a bung which is axially movable relative to the medicament compartment in order to expel the medicament therefrom. The force for moving the bung is usually provided by a drive mechanism, e.g. a pre-tensioned compression spring and a plunger of the medicament delivery device. In an initial state, the medicament delivery device is blocked so that the plunger cannot be moved relative to the medicament container. In response to one or more user interactions, the medicament delivery device is activated via an activation element in order to unlock the plunger and enable the plunger to be moved relative to the medicament container. This relative movement is usually transmitted to the bung of the medicament container so that the medicament is expelled from the medicament compartment.

[0003] Disadvantageously, conventional medicament containers require a medicament delivery device for expelling the medicament, as those containers do not have a drive mechanism themselves which is capable of expelling the medicament in response to a user interaction. The drive mechanism needs to be adapted to the specific case of the medicament container to be used. This usually requires a redesign of several components of the medicament delivery device which is costly. Therefore, it would be advantageous to have a medicament container with an integrated drive mechanism which makes it possible to use it in less complex medicament delivery devices. SUMMARY

[0004] In the following, the term "distal" refers to the direction of the medicament container or medicament delivery device in which the medicament is expelled. Accordingly, the term "proximal" refers to the opposite direction. With regard to a pen-shaped medicament delivery device, the term "distal" refers to the direction towards the injection site and / or the tip of the injection needle of the device. Accordingly, the term "proximal" refers to the direction pointing away from the injection site and / or the tip of the injection needle of the device.

[0005] It is an object of the present disclosure to provide an improved medicament container.

[0006] This object is achieved by the subject matter disclosed herein, e.g. by the subject matter defined in the independent claims attached hereto. Advantageous refinements and developments are indicated in the dependent claims and / or in the following description.

[0007] One aspect of the present disclosure relates to a (self-powered) medicament container for storing and expelling a medicament in response to a user interaction. The medicament container comprises a reservoir body, a retainer, a stopper, a drive element, a plunger, and a release mechanism. The stopper is configured to divide an interior of the reservoir body into a drive compartment and a medicament compartment. The medicament compartment is configured to contain the medicament. The stopper can be configured to seal the medicament compartment relative to the drive compartment. The medicament compartment comprises an outlet through which the medicament can be expelled during a dispensing operation. The medicament compartment can be distal to the drive compartment.

[0008] The plunger has a shaft with a locking element configured to engage the retainer so as to prevent the plunger from moving distally relative to the reservoir body. For example, when engaged with the retainer, the locking element can abut a proximal surface of the retainer. The locking element can be formed at a proximal portion of the shaft. The shaft of the plunger can extend along a longitudinal axis of the reservoir body, such that a longitudinal axis of the shaft can be parallel to the longitudinal axis of the reservoir body. For example, the longitudinal axis of the shaft can be parallel to the longitudinal axis of the reservoir body before, during, and / or after the locking element is disengaged from the retainer.

[0009] The release mechanism is configured to disengage the locking element from the retainer in response to a user interaction, e.g. an activation movement. The disengagement enables the plunger to move distally relative to the reservoir body. The retainer can have an opening through which the shaft extends into the drive compartment, e.g. through the retainer.

[0010] The drive element is positioned in the drive compartment before and after the locking element is disengaged from the retainer. The drive element is configured to provide an axial force to the plunger so as to move the plunger distally relative to the reservoir body, e.g. when the locking element is disengaged from the retainer, thereby moving the stopper relative to the reservoir body and expelling the medicament. The drive element can be part of the medicament container, e.g. contained at least partially in the medicament container, e.g. in the drive compartment of the reservoir body. In particular, the drive element can be contained at least partially in the medicament container before, during, and / or after a dispensing operation. Since the drive element is part of the medicament container, the medicament container can be referred to as “self-powered” as it comprises the drive element and does not require an external drive element.

[0011] In one embodiment, a distal end of the shaft can be arranged to contact the stopper and to transmit movement of the plunger to the stopper.

[0012] In one embodiment, the shaft can further have a contact element configured to contact the stopper and to transmit movement of the plunger to the stopper. The contact element can have a larger cross-section than the shaft. The contact element can be formed at a distal end of the shaft.

[0013] In one embodiment, the contact element may have a plate-like shape, for example, such that the radial extension of the contact element is longer than its longitudinal extension, preferably at least twice the latter. The contact element may have a constant cross-section along its longitudinal axis. The cross-section of the contact element may be circular. The longitudinal axis of the contact element may be parallel to the longitudinal axis of the reservoir body. The contact element may be integrally formed with a shaft. Alternatively, the contact element may be connected to the shaft. The connection between the contact element and the shaft may prevent the shaft from rotating relative to the contact element. The angle formed between the longitudinal axis of the shaft and the proximal surface of the contact element may be 90 degrees. The contact element may be formed from a single piece of material.

[0014] The distal end surface of the contact element can be configured to contact the plug. The distal end surface can be a closed surface. The distal end surface can be configured to contact the plug across its entire cross-section. The distal end surface can be a flat surface. The cross-section of the distal end surface can correspond to the cross-section of the contact element, which can be circular. The diameter of the distal end surface can almost correspond to the diameter of the plug. Therefore, the contact interface between the contact element and the plug can be maximized. This improves force transmission to the plug and allows for uniform force distribution across the entire cross-section of the plug. However, the cross-section of the contact element can be smaller than the cross-section of the plug, such that the contact element does not contact the inner wall of the reservoir body.

[0015] The reservoir body has an internal wall surface that contacts the medication at least along the length of its medication compartment. The internal wall surface may define an internal cross-section of the reservoir body. In one embodiment, the internal cross-section of the reservoir body may be constant along the length of the reservoir body along which the stopper moves during a dispensing operation. In another embodiment, the internal cross-section of the reservoir body may be constant along its entire length. The shape of the internal cross-section may be defined by the shape of the internal wall surface. This cross-section may be perpendicular to the longitudinal axis of the reservoir body. The longitudinal axis may extend between the proximal and distal ends of the container. The internal wall surface of the reservoir body may be configured to continuously connect to the outer surface of the self-propelled medication container. Therefore, a single wall may exist to separate the interior of the reservoir body from the exterior of the reservoir body. In other words, when traveling from the interior of the reservoir body to the exterior of the reservoir body or the medication container, there may be no gap, only the wall of the reservoir body.

[0016] The drive element may be or may include a spring, preferably a compression spring. The drive element may surround the shaft. In other embodiments, the drive element may be disposed inside the shaft. The drive element may be formed of more than one spring. The drive element may contact the distal surface of the retainer. The drive element may be positioned between the retainer and the contact element, for example, between the distal surface of the retainer and the proximal surface of the contact element.

[0017] The release mechanism may include an activation element, for example, by activation movement. Activation movement may include axial and / or rotational movement of the activation element relative to the reservoir body. Axial movement of the activation element may be distal movement relative to the reservoir body. Activation movement that can be performed by the user may be converted into movement of the locking element relative to the retainer through interaction between the locking element and the activation element. Due to, for example, the relative movement between the locking element and the retainer, the self-driven reagent container can be activated.

[0018] In one embodiment, the activating element is a push-button. The push-button may have at least one guide groove. The retainer may have at least one guide element configured to interact with the guide groove of the push-button when the push-button is pushed in a distal direction relative to the reservoir body and / or the retainer and / or the locking element. Due to the interaction between the guide element and the guide groove, the push-button may be supported by the retainer in the radial direction.

[0019] The opening of the retainer can be configured such that when the locking element is disengaged from the retainer, the locking element can pass through the retainer in the distal direction.

[0020] After the dispensing operation, the proximal ends of the plunger, shaft, and / or locking elements can be inside the drive compartment.

[0021] In one embodiment, the locking element may be formed of two or more flexible arms configured to radially deflect inward in response to movement of the activating element relative to the reservoir body, for example, in response to an activation movement. The flexible arms of the locking element may be evenly distributed in the circumferential direction such that the angular offset between all the flexible arms is the same. Each flexible arm may include, for example, radial protrusions at its free end, which are configured to engage with a retainer. The free end may be the proximal end of the arm. Preferably, the protrusions project in a radially outward direction, such that the flexible arm is configured to deflect radially inward in response to movement of the activating element relative to the reservoir body.

[0022] In one embodiment, the retainer includes two additional openings. These openings may have a cross-section similar to the free end of the flexible arm, such that the free end of the flexible arm can pass through the retainer when the flexible arm is radially deflected outward due to movement of the activating element relative to the reservoir body.

[0023] In one embodiment, the self-propelled pharmaceutical container may include a mating feature that can be established between an engagement feature and a sloped surface. The engagement feature may be formed on one of a locking element and an activating element, and the sloped surface may be disposed on the other. When the mating is established and the engagement feature moves relative to the sloped surface, the locking element can disengage from the retainer. In other words, when movement of the activating element is converted into movement of the locking element via this mating, the locking element can disengage from the retainer. Preferably, the engagement feature slides along the sloped surface to disengage the locking element from the retainer.

[0024] In one embodiment, the flexible arm deflects as the engagement feature slides along the inclined surface. Preferably, the flexible arm deflects in a radially inward direction.

[0025] In one embodiment, the engagement feature may be the distal surface of the activation element. The inclined surface may be formed on the flexible arm such that, viewed from the distal end of the drug container, the inclined surface is inclined in a radially inward direction.

[0026] In one embodiment, the engagement feature may be the proximal surface of the flexible arm, and the inclined surface may be formed on the inner wall surface of the activation element. Viewed from the distal end of the drug container, the inclined surface may be inclined in a radially inward direction.

[0027] In one embodiment, the engagement feature may be an inclined surface having a different tilt angle compared to an inclined surface configured to interact with the engagement feature.

[0028] In one embodiment, the locking element may be formed of a stop bar, which may be configured to abut against a proximal surface of the retainer prior to user interaction. The locking element may be configured to rotate relative to the retainer in response to user interaction to align with an opening in the retainer. The opening is configured to allow the locking element to pass through the opening when it is aligned, for example, after user interaction.

[0029] In one embodiment, the opening may have a cross-section similar to that of the locking element, such that the locking element can pass through the opening in a distal direction after user interaction. In another embodiment, the opening may have a larger cross-section than the locking element.

[0030] The reservoir body may have a circular internal cross-section. The diameter of this circular cross-section may be constant, for example, along the length of the drug compartment. The outer surface of the reservoir body may form the outer surface of the self-propelled drug container. The outer surface of the reservoir body may define the external dimensions of the self-propelled drug container, such as its outer diameter.

[0031] The retainer can be fixed relative to the reservoir body in the axial and / or rotational directions. In one embodiment, the retainer can be mounted to the proximal end of the drive compartment. In another embodiment, the retainer can be mounted to the inner wall of the drive compartment. The retainer can be directly connected to the reservoir body, for example, to the proximal surface of the reservoir body or to the inner wall of the reservoir body. Thus, the retainer can form the proximal end of the reservoir body. The connection between the retainer and the reservoir body can be configured to counteract the driving force provided by the drive element.

[0032] Self-driven drug containers can be configured for use in syringe housings with activation mechanisms.

[0033] A self-propelled medication container may include a needle. The needle may be connected to an outlet, allowing medication to be dispensed through the needle. The self-propelled medication container may further include a needle guard, which may be attached to the self-propelled medication container, preferably to the distal end of the self-propelled medication container. The needle guard may surround the needle, thus protecting the needle from mechanical impact and maintaining its sterility.

[0034] Self-propelled drug containers with needles may include grippers that allow users to perform drug injections without using external devices to insert the self-propelled drug container into it, for example, without needing to insert the self-propelled drug container into a drug delivery device (such as an autoinjector).

[0035] Another aspect of this disclosure relates to a drug delivery device. The drug delivery device includes a self-driven drug container with a needle as described in one of the foregoing embodiments. The drug delivery device is configured to allow a user to inject a drug stored in the self-driven drug container into the user's body via the needle. The drug delivery device further includes an elongated housing and optionally an external button. The self-driven drug container abuts against the elongated housing. The elongated housing has a distal wall.

[0036] The self-propelled drug container may abut against the distal wall. The distal wall may provide a distal stop for the container. The distal wall may have an opening through which the needle and / or outlet may protrude distally beyond the housing. In other embodiments, the distal stop may be offset proximally from the distal wall of the device. An external button may be attached to a proximal portion of the housing. This attachment may be achieved via a snap-fit ​​mechanism.

[0037] The external button can be configured to interact with the release mechanism of the self-driven reagent container to disengage the locking element from the retainer. The external button can also interact with the activation element of the release mechanism.

[0038] In one embodiment, the external button may be connected to a release mechanism such that movement of the external button (e.g., any) can be directly translated into a corresponding movement of the activating element. In another embodiment, the external button may be connected to a release mechanism such that movement of the external button is translated into movement of the activating element in different spatial directions. For example, helical movement of the external button (i.e., axial and rotational movement) can be translated into axial movement of the release mechanism, or vice versa.

[0039] In one embodiment, the connection between the external button and the release mechanism can be achieved through friction between the proximal surface of the activation element and the distal surface of the external button.

[0040] In one embodiment, the connection between the external button and the release mechanism can be achieved through the interaction of engaging elements on the external button and / or the release mechanism.

[0041] In one embodiment, the disengagement of the locking element from the retainer can be caused by axial movement of the external button relative to the housing.

[0042] In one embodiment, the disengagement of the locking element from the retainer can be caused by the rotational movement of the external button relative to the housing.

[0043] In one embodiment, the disengagement of the locking element from the retainer can be caused by a combination of movement of the external button relative to the housing (e.g., a combination of axial movement and rotational movement (so-called helical movement)).

[0044] The drug delivery device may include a needle cannula movably connected to the housing. When in a first position, the needle cannula protrudes beyond the tip of the needle. The needle cannula may be in the first position after the drug has been dispensed from the self-propelled drug container and the drug delivery device has moved away from the injection site. The needle cannula may be in the first position before the drug delivery device is activated and / or before the needle pierces the user's skin. The first position may be the extended position of the needle cannula.

[0045] The needle cannula can be moved proximally relative to the housing to a second position. During this proximal movement, the outer wall surface of the needle cannula or at least the proximal end of the needle cannula can slide along the inner wall surface of the housing. In the second position, the tip of the needle protrudes distally beyond the needle cannula. In the second position, the distal end of the needle cannula may be more proximal than the distal end of the housing. Alternatively, in the second position, the distal end of the needle cannula may be at the same level as the distal end of the housing, or more distal than the distal end of the housing. The second position can also be a retracted position of the needle cannula.

[0046] In one embodiment, the needle cannula can be configured to activate the drug delivery device when the needle cannula is moved to its second position. In another embodiment, when the needle cannula is moved to its second position, the needle cannula can activate the drug delivery device via interaction with an external button.

[0047] The needle cannula may have an opening through which the needle can pass when the needle cannula moves proximally to its second position relative to the housing from its first position.

[0048] The medication delivery device may include a needle cannula spring. The needle cannula spring may be configured to provide an axial force to the needle cannula. Due to this axial force, the needle cannula can be moved from a second position to a first position, in which the needle cannula extends distally beyond the tip of the needle to avoid injury from the needle after the dispensing operation.

[0049] The drug delivery device may include a distal cap configured to be detachably attached to a housing or needle cannula. The distal cap may be configured to be detached from a housing or needle cannula by distal movement relative to the housing or needle cannula.

[0050] In one embodiment, the distal cap can be configured to engage with the needle shield of a self-propelled drug delivery device when attached to the drug delivery device. The distal cap may include an engagement recess that fits onto the needle shield, thereby supporting the needle shield in a radially outward direction. The distal cap can engage with the needle shield such that, due to this engagement, the needle shield can be removed from the self-propelled drug container when the distal cap is removed from the drug delivery device, for example, by moving the distal cap distally relative to the housing.

[0051] The housing may include a push-button lock configured to engage with an external button (e.g., its locking protrusion) when the needle sheath is in its first position to prevent the external button from moving distally relative to the housing. The push-button lock is configured to disengage from the external button due to interaction with the needle sheath when the needle sheath moves proximally relative to the housing to its second position.

[0052] In one embodiment, the push-button lock may include at least two blocking arms. The blocking arms may be configured to deflect radially outward due to interaction with the needle sheath as the needle sheath moves proximally relative to the housing. For example, as the needle sheath moves proximally relative to the housing, the proximal end of the needle sheath may slide along the blocking arm, thereby deflecting the free end of the blocking arm radially. Due to this radial deflection, the blocking arm may disengage from the external push-button. This allows the external push-button to move distally relative to the housing. The blocking arms may deflect radially outward or radially inward, depending on whether the proximal end of the needle sheath is radially inside or outside the blocking arm.

[0053] The needle sleeve spring can be positioned between the housing and the needle sleeve. Preferably, the needle sleeve spring can be positioned between the distal wall of the housing and the needle sleeve. More preferably, the needle sleeve spring can be positioned between the distal surface of the distal wall of the housing and the proximal inner surface of the needle sleeve.

[0054] The housing may include a protrusion at its distal end that extends the housing in a distal direction. The protrusion may be configured to attach the distal cap to the housing and / or axially guide the movement of the distal cap during attachment to or removal from the housing.

[0055] The shell may have a circular internal cross-section at least along a portion of its length. When the shell has a circular internal cross-section, the diameter of the shell may be constant.

[0056] In one embodiment, the drug delivery device may be an auto-injector.

[0057] In one embodiment, the drug delivery device may include a guiding unit, which is preferably attached to the housing. The needle cannula may include a guide pin, a torsion protection element, and / or a flexible rod. The guide pin may protrude outward from the outer wall of the needle cannula. The flexible rod may be separated by a through recess extending through the wall of the needle cannula. The flexible rod and the body of the needle cannula may be made from a single piece. The torsion protection element may include a rod that preferably extends in the axial direction of the needle cannula.

[0058] The guiding unit may include a first channel and a second channel. The first channel may initially extend in a sliding inclined portion contrary to the axial direction, and then extend substantially in the axial direction toward a bend in the first channel, and then return toward a dead end of the first channel. The extension toward the dead end may include a sliding inclined portion contrary to the axial direction and / or may be parallel to the axial direction. The dead end may be separated from the remainder of the first channel by barbs.

[0059] In the first state of the needle cannula, the guide pin can be arranged below the dead end of the first channel and in a portion at the beginning of the inclined portion of the first channel.

[0060] A torsion protection element for the needle cannula can be arranged within a second channel. During movement of the needle cannula relative to the guide unit, the torsion protection element can be guided by the second channel. The second channel can be straight and parallel to the direction of movement of the needle cannula. The torsion protection element within the second channel can serve as a protective element to prevent rotation of the needle cannula.

[0061] In the second state of the needle cannula, the needle cannula may be partially disposed within the guiding unit, for example, because the drug delivery device is partially disposed on the user's skin. In the second state of the needle cannula, the guide pin may move toward the bend within the first channel. As the guide pin passes the inclined portion of the first channel, the upper portion of the needle cannula may move perpendicular to the direction of movement of the needle cannula, and the flexible rod may flex because the remaining portion of the needle cannula is secured by a torsion protector within the second channel to prevent any rotation. The flexible rod is then biased.

[0062] In the third state of the needle cannula, the needle cannula can be fully pressed into the guide unit, for example, as if the user has placed the drug delivery device on his / her skin. Therefore, in the third state of the needle cannula, the needle can be exposed by the needle cannula. In this case, the guide pin has reached the bend of the first channel and can move within the bend perpendicular to the direction of movement of the needle cannula. In the third state of the needle cannula, the biased flexible rod can force the guide pin through the bend.

[0063] In the fourth state of the needle cannula, the flexible rod can be released, and the guide pin can move within the bend perpendicular to the direction of movement of the needle cannula.

[0064] In the fifth position of the needle cannula, the drug delivery device can be partially removed from the user's skin. The guide pin can be forced over the barbs of the first channel, allowing the flexible rod to be biased again. As the drug delivery device is removed from the user's skin, the needle cannula can be pushed out of the housing in the distal direction, for example by the needle cannula spring, allowing the guide pin to be forced over the barbs.

[0065] In the sixth position of the needle cannula, the drug delivery device can be completely removed from the user's skin. The needle cannula can completely cover the needle. The guide pin can snap into the dead end of the first channel, so that the needle cannula can be securely engaged with the guide unit.

[0066] It should be noted that the features described above and below in conjunction with different embodiments or aspects can be combined with each other, even if such combinations are not expressly disclosed herein. Further features, advantages, and conveniences of this disclosure, and in particular the proposed concepts, will become clear from the following description of exemplary embodiments in conjunction with the accompanying drawings.

[0067] The self-propelled pharmaceutical container disclosed herein offers the advantage that the pharmaceuticals stored therein can be discharged without the need for an external driving element or delivery device. Therefore, the self-propelled pharmaceutical container can be used as a stand-alone device.

[0068] When used in drug delivery devices (such as autoinjectors), self-driven drug containers offer the advantage of a simpler structure compared to conventional drug delivery devices. For example, the drug delivery device does not require a drive mechanism or drive element. Therefore, the drug delivery device can be less complex and has a lower risk of failure. Additionally, the drug delivery device can be used with self-driven drug containers of the same or different lengths without requiring structural adjustments. This results in cost savings and reduced waste. Nevertheless, if structural adjustments are necessary, the drug delivery device requires fewer parts to be adjusted, which simplifies the redesign process and reduces costs.

[0069] The advantage of the drug delivery device disclosed herein is that it has a simpler structure than conventional drug delivery devices because it does not require a drive mechanism or drive element. Accordingly, even when self-driven drug containers with different geometries are used therein, redesign may not always be necessary. Nevertheless, if redesign becomes necessary, the drug delivery device requires fewer parts to be adjusted, which simplifies the redesign process and reduces costs. Attached Figure Description

[0070] Figure 1 An embodiment of a self-driven pharmaceutical container prior to the dispensing operation is shown.

[0071] Figure 2 An example is shown where a self-driving reagent container is activated at the start of the dispensing operation after being activated through user interaction.

[0072] Figure 3 An embodiment of a self-driving reagent container at the end of a dispensing operation is shown.

[0073] Figure 4 Another embodiment of a self-driven pharmaceutical container prior to the dispensing operation is shown.

[0074] Figure 5A and Figure 5B An embodiment of a locking element for a self-driven pharmaceutical container is shown.

[0075] Figure 6A and Figure 6B They were shown respectively Figures 1 to 3 and Figure 4 An embodiment of the self-propelled medicine container shown in Figure 5 includes a needle.

[0076] Figure 7 An embodiment of the drug delivery device before it is activated by the user is shown.

[0077] Figures 8A to 8E Showing Figure 7 The different states of the drug delivery device during the dispensing operation.

[0078] Figure 9 An exemplary embodiment of the needle cannula and guide unit in a first state is shown.

[0079] Figure 10 Demonstrated in the second state Figure 9 The needle cannula and guide unit.

[0080] Figure 11 Demonstrates the third state Figure 9 The needle cannula and guide unit.

[0081] Figure 12 Demonstrates the fourth state Figure 9 The needle cannula and guide unit.

[0082] Figure 13 Demonstrates the fifth state Figure 9 The needle cannula and guide unit.

[0083] Figure 14 Demonstrates the sixth state Figure 9 The needle cannula and guide unit.

[0084] Figure 15 shows the expanded structural formula, molecular formula, and molecular weight of phenotype. Detailed Implementation

[0085] In the accompanying drawings, the same elements, elements of the same kind, and elements that function in the same or similar manner may be labeled with the same reference numerals.

[0086] Figure 1 An embodiment of a self-driven pharmaceutical container 10 according to one aspect of this disclosure is shown. The self-driven pharmaceutical container 10 includes a reservoir body 2, a holder 3, a stopper 4, a drive element 5, a plunger, and a release mechanism. The stopper 4 divides the interior of the reservoir body 2 into a drive compartment 21 and a pharmaceutical compartment 22. The pharmaceutical compartment 22 contains a pharmaceutical agent. The pharmaceutical compartment 22 includes an outlet 23 through which the pharmaceutical agent can be discharged during a dispensing operation. The stopper 4 seals the pharmaceutical compartment 22 toward the drive compartment 21.

[0087] The retainer 3 is attached to the proximal end of the drive compartment 22 and forms the proximal wall of the drive compartment 22. The retainer 3 has an opening 31.

[0088] The plunger has a shaft 61 with a locking element at its proximal end. The locking element is formed by two flexible arms 62, each having a radial protrusion at its free end. The protrusion of each flexible arm 62 engages the proximal surface of the retainer 3, thereby preventing the plunger from moving distally relative to the reservoir body 2.

[0089] Contact element 63 is located at the distal end of shaft 61 to contact plug 4 and transmit the movement of plunger to plug 4. Contact element 63 has a larger diameter than shaft 61.

[0090] The drive element 5 is entirely within the drive compartment 21 and extends between the distal surface of the retainer 3 and the proximal surface of the contact element 63. The drive element surrounds the shaft 61.

[0091] The release mechanism includes an activation element formed as a press-down button 7. The press-down button 7 has engaging features, particularly an inclined surface 71, which interacts with the inclined surface 64 of the flexible arm 62 as the press-down button 7 moves distally relative to the reservoir body 2, the retainer 3, and / or the plunger. The press-down button 7 further has guide grooves 72 that interact with the guide element 32 of the retainer 3, thereby radially supporting the press-down button during distal movement. The inclined surface 71 has a different inclination angle than the inclined surface 64.

[0092] like Figure 2 As shown, due to the interaction between inclined surface 71 and inclined surface 64, flexible arm 62 is radially deflected inward, causing the free end of flexible arm 62 to disengage from the proximal surface of retainer 3. This allows the plunger to move distally relative to reservoir body 2.

[0093] Due to the force provided by the drive element 5, the plunger moves distally, and the free end of the flexible arm 62 passes through the opening 31 of the retainer 3. Figure 2 (Not shown in the image). The distal movement of the plunger is transmitted to the stopper 4, which moves distally relative to the reservoir body 2, thereby dispensing the medicine stored in the medicine compartment 22 through the outlet 23.

[0094] Figure 3 The self-propelled medicine container 10 is shown at the end of the dispensing operation. The stopper 4 has reached its final distal position at the distal end of the reservoir body 2, and all medicine stored in the medicine compartment 22 has been discharged through the outlet 23. The free end of the flexible arm 62 is completely inside the drive compartment 21 after passing through the opening 31 of the retainer 3.

[0095] Figure 4Another embodiment of a self-driven medicine container 10' is shown. The plunger shaft 61' has a locking element forming a stop rod 62'. The stop rod 62' abuts against the proximal surface of the retainer 3, thereby preventing the plunger from moving distally relative to the reservoir body 2. Accordingly, the release mechanism has an activation element 7' adapted to cause rotation of the stop rod 62' relative to the retainer 3. The activation element 7' can be connected to the stop rod 62' in a rotationally fixed manner or in a manner suitable for causing rotational movement of the stop rod 62' relative to the retainer 3 in response to user interaction. Due to the rotational movement of the stop rod 62' relative to the retainer 3, the cross section of the stop rod 62' can be aligned with the opening 31' (not shown) of the retainer 3, as described below, thereby allowing movement of the plunger relative to the reservoir body 2.

[0096] Figure 4 The structure and other components of the self-propelled reagent container (even if not all are marked in detail) correspond to, for example, Figures 1 to 3 The structure and components of the self-propelled pharmaceutical container are shown.

[0097] like Figure 5A As shown, the shape of the opening 31' of the retainer 3 is adapted to the shape of the stop bar 62'. Due to the rotation of the stop bar 62' relative to the retainer 3, as exemplarily indicated by the arrow, the stop bar 62' aligns with the opening 31'. This causes the stop bar 62' to disengage from the retainer 3. Figure 5B The stop bar 62' is shown aligned with the opening 31'. In this position, the stop bar 62' can pass through the opening 31', thereby allowing the plunger to move distally relative to the reservoir body 2 (not shown).

[0098] After the stop bar 62' disengages from the proximal surface of the retainer 3, the dispensing operation and the interaction of the components are similar to those described above. Figures 1 to 3 The dispensing operation is described. At the end of the dispensing operation, the stop bar 62' is completely inside the drive compartment 21.

[0099] Figure 6A and Figure 6B They respectively showed according to Figures 1 to 3 and Figure 4 An embodiment of the self-propelled pharmaceutical container illustrated in Figure 5. Figure 6a and Figure 6B The self-propelled medication container also includes a needle 8, allowing the user to inject and dispense medication from the self-propelled medication container without additional injection devices. The needle is protected and kept sterile by a needle guard 24 (not shown) that can be attached to the distal end of the reservoir body 2.

[0100] Figure 7 An embodiment of a drug delivery device 100 according to one aspect of this disclosure is illustrated. The drug delivery device 100 includes... Figures 1 to 3The self-propelled drug container 10 is shown in Figure 6A. The drug delivery device 100 includes an elongated housing 200 and an external button 300. The elongated housing 200 has a distal wall 210 against which the self-propelled drug container 10 abuts. The distal wall 210 has an opening 211 through which the needle 8 protrudes distally beyond the housing 200. The external button 300 is connected to a proximal portion of the housing 200. The distal inner surface of the external button 300 abuts against the proximal surface of the activation button 7, such that distal movement of the external button 300 is transmitted to the activation button 7.

[0101] The drug delivery device 100 further includes a needle cannula 400 movably connected to the housing 200. When the needle cannula 400 is in a first position (i.e., before the drug delivery device 100 is activated and before piercing the user's skin), the needle cannula 400 protrudes beyond the distal end of the housing 200 and the tip of the needle 8. The needle cannula 400 has an opening 410 through which the needle 8 passes when the needle cannula 400 is moved proximally relative to the housing 200.

[0102] The drug delivery device 100 includes a needle sleeve spring 500 positioned between the distal wall 210 and the proximal inner surface 420 of the needle sleeve 400. When the needle sleeve spring 500 is compressed due to the proximal movement of the needle sleeve 400 relative to the housing 200, the needle sleeve spring 500 provides a distal force to the needle sleeve 400.

[0103] The drug delivery device 100 includes a distal cap 600 configured to be detachably attached to a housing 200. The distal cap 600 includes an engaging groove that fits onto a needle shield 24, thereby supporting the needle shield 24 in a radially outward direction. The distal cap 600 can be removed from the housing 200 by a user through distal movement relative to the housing 200. Due to engagement with the distal cap 600, the needle shield 24 can be removed from the reservoir body 2 when the distal cap 600 is removed from the housing 200.

[0104] The housing 200 further includes a push-button lock. The push-button lock includes two blocking arms 221 configured to engage with a locking protrusion 310 of the external button 300 when the needle cannula 400 is in its first position, thereby preventing distal movement of the external button 300 relative to the housing 200. The blocking arms 221 are flexible and configured to deflect radially outward due to interaction with the proximal end 430 of the needle cannula 400 as the needle cannula 400 moves proximally relative to the housing 200. Due to the radially outward deflection, the blocking arms 221 disengage from the locking protrusion 310. This allows the external button 300 to move distally relative to the housing 200.

[0105] The housing 200 includes a protrusion 212 at its distal end that extends the housing in a distal direction. The protrusion 212 is configured to attach a distal cap 600 to the housing and to axially guide movement of the distal cap when the distal cap 600 is attached to or removed from the housing 200.

[0106] Figures 8A to 8E The different states of the drug delivery device 100 during the dispensing operation are shown. Figure 8A In the initial position, the drug delivery device is in the self-propelled drug container inserted into the housing of the drug delivery device. The end cap remains attached to the housing, and the needle cannula is in the first position. Figure 8B The dispensing process has begun. The cap has been removed, and the user can press the distal end of the needle cannula against the desired injection site, allowing the needle cannula to move proximally to its second position within the housing, and the needle to pierce the user's skin (not shown). As the needle cannula moves proximally relative to the housing, the needle cannula spring is compressed.

[0107] like Figure 8C As shown, the user can then activate the medication delivery device by pushing the external button distally relative to the housing. This disengages the locking element of the self-driven medication container from the retainer. Due to the force of the driving element in the drive compartment, the plunger and stopper are pushed distally relative to the reservoir body. As the stopper moves distally relative to the reservoir body, the medication stored in the medication compartment is discharged through the outlet and needle. In other words, the medication is injected into the user's body.

[0108] Figure 8D This demonstrates the completion of the dispensing operation. The stopper has reached the distal wall of the reservoir body. Therefore, the medicine compartment has been emptied, and all the medicine has been injected into the user's body.

[0109] like Figure 8E As shown, when the user removes the drug delivery device from the injection site, the force of the needle sheath spring pushes the needle sheath distally relative to the housing and the needle, so that the tip of the needle is covered by the needle sheath.

[0110] Any invention described herein is not limited to the description in conjunction with exemplary embodiments. Rather, the invention and the associated disclosures include any new features and any combination of features, particularly any combination of features in the patent claims, even if the features or combinations are not expressly stated in the patent claims or exemplary embodiments.

[0111] Figure 9An exemplary embodiment of the needle cannula 400 in a first state and a cross-sectional side view of the guide unit 700 are shown. In the first state of the needle cannula 400, the drug delivery device 100 is not yet placed on the user's skin, and the needle cannula 400 protects the needle 8.

[0112] The needle cannula 400 includes a guide pin 90, a torsion protection element 92, and flexible rods 94. The guide pin 90 protrudes outward from the outer wall of the needle cannula 400. The flexible rods 94 are separated by through recesses extending through the wall of the needle cannula 400. Therefore, the flexible rods 94 and the body of the needle cannula 400 can be made from a single piece. The torsion protection element 92 can be included in the axial direction of the needle cannula (i.e., Figure 9 A rod extending vertically (in the middle).

[0113] The guide unit 700 includes a first channel 96 and a second channel 97. The first channel 96 initially extends in a sliding slope contrary to the axial direction, and then extends substantially in the axial direction toward a bend 98 of the first channel 96, and then returns toward a dead end 99 of the first channel 96. The dead end 99 is separated from the remainder of the first channel 96 by a barb 102. In a first state of the needle cannula 400, a guide pin 90 is arranged in the first channel 96 below the dead end 99 and in a portion at the beginning of the slope of the first channel 96.

[0114] A torsion protection element 92 of the needle cannula 400 is arranged within a second channel 97 and is guided by the second channel 97 during movement of the needle cannula 400 relative to the guide unit 700. The second channel 97 is straight and parallel to the direction of movement of the needle cannula 400. The torsion protection element 92 within the second channel 97 serves as a protective element to prevent rotation of the needle cannula 400.

[0115] Figure 10 Demonstrated in the second state Figure 9 The needle cannula 400 and the guide unit 700 are described. In a second state, the needle cannula 400 may be partially disposed within the guide unit 700, for example, since the drug delivery device 100 is partially disposed on the user's skin. In the second state, the guide pin 90 moves toward the bend 98 within the first channel 96. As the guide pin 90 passes the inclined portion of the first channel 96, the upper portion of the needle cannula 400 moves perpendicular to the direction of movement of the needle cannula 400, and the flexible rod 94 flexes because the remaining portion of the needle cannula 400 is fixed to prevent rotation by a torsion protector 92 within the second channel 97. Therefore, the flexible rod 94 is biased.

[0116] Figure 11 Demonstrates the third state Figure 9The needle cannula 400 and the guide unit 700. In the third state of the needle cannula 400, the needle cannula 400 is fully pressed into the guide unit 700, for example, when the user places the drug delivery device 100 on his / her skin. Therefore, in the third state of the needle cannula 400, the needle 8 is exposed by the needle cannula 400. In this case, the guide pin 90 has reached the bend 98 of the first channel 96 and can move within the bend 98 perpendicular to the direction of movement of the needle cannula 400. In the third state of the needle cannula 400, the biased flexible rod 94 forces the guide pin 90 through the bend 98.

[0117] Figure 12 Demonstrates the fourth state Figure 9 The needle cannula 400 and the guide unit 700. In the fourth state of the needle cannula 400, the flexible rod 94 is released, and the guide pin 90 has moved within the bend 98 perpendicular to the direction of movement of the needle cannula 400.

[0118] Figure 13 Demonstrates the fifth state Figure 9 The needle cannula 400 and guide unit 700. In the fifth state of the needle cannula 400, the drug delivery device 100 can be partially removed from the user's skin. The guide pin 90 is forced past the barb 102 of the first channel 100, causing the flexible rod 94 to be biased again. When the drug delivery device 100 is removed from the user's skin, the needle cannula 400 can be pushed out of the housing 200, for example, by a conventional needle cannula spring (not shown), causing the guide pin 90 to be forced past the barb 102.

[0119] Figure 14 Demonstrates the sixth state Figure 9 The needle cannula 400 and the guide unit 700. In the sixth state of the needle cannula 400, the drug delivery device 100 can be completely removed from the user's skin. The needle cannula 400 can completely cover the needle 8. The guide pin 90 snaps into the dead end 99 of the first channel 96, so that the needle cannula 400 is securely engaged with the guide unit 700.

[0120] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0121] As described below, a drug or pharmaceutical preparation may include at least one API or combination thereof in different types of pharmaceutical formulations for the treatment of one or more diseases. Examples of APIs 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-stranded 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 considered.

[0122] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug reservoirs" suitable for use with drug delivery devices. Drug reservoir 101a may be, for example, a cartridge, syringe, reservoir, or other robust or flexible vessel (bag) configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about 1 month to about 2 years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, the drug reservoir may be or may include a dual-chamber cartridge configured to separately store two or more components (e.g., API and diluent, or two different drugs) of the pharmaceutical preparation to be administered, one component in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during the dispensing of the components into a human or animal body.

[0123] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical barriers. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index 15.

[0124] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture of the above. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0125] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0126] Examples of insulin derivatives include, for instance, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29. LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (Degludec insulin, Tresiba®); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0127] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilamide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, tasglutide, abiglutide (Syncria®), duraglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, and 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, Tepirotide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0128] Examples of oligonucleotides include, for example, mirtamicin sodium (Kynamro®), a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia, or RG012 used to treat Alport syndrome.

[0129] Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, degliptin, saxagliptin, and berberine.

[0130] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0131] Examples of polysaccharides include glucosamine, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), a sodium hyaluronate.

[0132] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can immobilize complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable-region antibody-like binding proteins with cross-binding region orientation (CODV).

[0133] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0134] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0135] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0136] Other examples of APIs used for the prevention of hemophilia A or B (with or without inhibitors) include siRNAs that target antithrombin. An example of an antithrombin-targeting siRNA is fentoxin. The terms "prevention" and "prophylactic treatment" are used interchangeably herein.

[0137] It is also considered that a pharmaceutically acceptable salt of any API described herein may be used in a drug or pharmaceutical preparation in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0138] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, pharmaceutical formulations, devices, methods, systems, and embodiments of the APIs described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0139] Example drug delivery devices may involve needle-based injection systems, as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly categorized into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integrated, non-replaceable container.

[0140] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integrated, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0141] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device with a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device with an integrated, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied).

[0142] Fetrazol as an API in the device

[0143] Fetuximab is a synthetic, chemically modified double-stranded small interfering RNA (siRNA) oligonucleotide that is covalently linked to a tri-antennae N-acetyl-galactosamine (GalNAc) ligand targeting AT3 mRNA in the liver, thereby inhibiting the synthesis of antithrombin. See, for example, Pasi et al., N Engl J Med. [New England Journal of Medicine] (2017) 377(9):819-28. The nucleosides in each strand of feetuximab are linked by 3'-5' phosphodiester or thiophosphate bonds, forming the sugar-phosphate backbone of the oligonucleotide.

[0144] The sense strand and 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) via a phosphodiester bond. The sense strand contains two consecutive phosphate thioester bonds at its 5' end. The antisense strand contains four phosphate thioester bonds, two at the 3' end and two at the 5' end. The 21 nucleotides of the sense strand are hybridized 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. Patents 9,127,274, 11,091,759, US2020 / 0163987 A1, and WO 2019 / 014187, the entire contents of which are expressly incorporated herein by reference.

[0145] The two nucleotide chains of non-fortuccinyl are shown below:

[0146] The semantic chain is: 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

[0147] 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 NO: 2),

[0148] in,

[0149] Af = 2'-deoxy-2'-fluoroadenosine

[0150] Cf = 2'-deoxy-2'-fluorocytidine

[0151] Gf = 2'-deoxy-2'-fluoroguanosine

[0152] Uf = 2'-deoxy-2'-fluorouridine

[0153] Am = 2'-O-methyladenosine

[0154] Cm = 2'-O-methylcytidine

[0155] Gm = 2'-O-methylguanosine

[0156] Um = 2'-O-methyluridine

[0157] "-" (hyphen) = 3'-5' phosphate diester-linked sodium salt

[0158] "-ps-" = 3'-5' thiophosphate-linked sodium salt

[0159] Furthermore, L96 has the following formula:

[0160] (I).

[0161] As used herein, the terms “2’-deoxy-2’-fluoroadenosine” and “2’-fluoroadenosine” are used interchangeably.

[0162] As used herein, the terms “2’-deoxy-2’-fluorocytidine” and “2’-fluorocytidine” are used interchangeably.

[0163] As used herein, the terms “2’-deoxy-2’-fluoroguanosine” and “2’-fluoroguanosine” are used interchangeably.

[0164] As used herein, the terms “2’-deoxy-2’-fluorouridine” and “2’-fluorouridine” are used interchangeably.

[0165] The expanded structural formula, molecular formula, and molecular weight of phenotype are shown in Figure 15.

[0166] The structure of non-tocopherol can also be described by the following diagram, where X is O:

[0167] .

[0168] Fetozilan is shown in Figure 15 as a sodium salt.

[0169] In some embodiments, the device delivers fexoxilan in an aqueous solution 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). Values ​​between these ranges and values ​​are also intended to be part of this disclosure as used herein. Additionally, ranges using any combination of these values ​​as upper and / or lower limits are intended to be included. In other embodiments, the pharmaceutical preparation comprises fexoxilan at a concentration of about 40, about 50, about 75, about 100, about 125, about 150, or about 200 mg / mL in an aqueous solution. In some embodiments, fexoxilan is provided at a concentration of about 100 mg / mL in an aqueous solution.

[0170] The term “delivery” is intended to mean “application”.

[0171] Unless specifically stated or otherwise readily apparent from the context, as used herein, the terms “approximately” or “about” refer to a value within an acceptable margin of error for a particular value as determined by a person of ordinary skill in the art, a range which will depend on how the measurement or determination is performed. For example, “approximately” or “about” may mean a range of up to 10% (i.e., ± 10%). Thus, “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 specific values ​​are provided in this disclosure, unless otherwise stated, the meaning of “approximately” or “about” should be assumed to be within an acceptable margin of error for that specific value.

[0172] While the dosage and weight of fexoxicam described herein refer to the weight of fexoxicam free acid (active fraction), administration of fexoxicam to a patient herein refers to administration of fexoxicam sodium (active pharmaceutical ingredient) in a pharmaceutically appropriate aqueous solution (e.g., phosphate-buffered saline at physiological pH). For example, approximately 100 mg / mL fexoxicam means approximately 100 mg of fexoxicam free acid per mL (equivalent to approximately 106 mg of fexoxicam sodium, active pharmaceutical ingredient). Unless otherwise stated, the fexoxicam weights listed in this disclosure are the weight of fexoxicam free acid (active fraction).

[0173] In some embodiments, the pharmaceutical preparation in the device comprises fexoline in phosphate-buffered saline. The phosphate concentration in the solution may be from 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), and the pH may be about 6.0-8.0. The pharmaceutical preparation described herein may include stabilizers, such as EDTA. The pharmaceutical preparation may be preservative-free. In some embodiments, the fexoline pharmaceutical preparation in the device is preservative-free and contains about 100 mg of fexoline per mL of about 5 mM phosphate-buffered saline (PBS) solution, or is composed of or substantially composed of about 100 mg of fexoline. In some embodiments, the fexoline pharmaceutical preparation in the device is preservative-free and contains, consists of, or substantially consists of fexoline in about 5 mM phosphate-buffered saline (PBS) solution. The PBS solution consists of sodium chloride, disodium hydrogen phosphate (heptahydrate), and sodium dihydrogen phosphate (monohydrate). The pH of pharmaceutical preparations can be adjusted to approximately 7.0 or approximately 7.1 using sodium hydroxide solution and diluted phosphoric acid.

[0174] In some embodiments, the non-folic acid phosphate formulation in the device for subcutaneous delivery contains non-folic acid phosphate phosphate buffer at pH 7.0 with 0.64 mM NaH₂PO₄, 4.36 mM Na₂HPO₄, and 84 mM NaCl. In some embodiments, the pharmaceutical formulations of the non-folic acid phosphate phosphate solution for subcutaneous delivery are shown in Table 1 below:

[0175] Table 1. Exemplary non-toxican pharmaceutical preparations

[0176]

[0177] Appropriate amount: Appropriate amount

[0178] In some embodiments, pharmaceutical formulations for subcutaneous delivery of non-tuzelan solutions using a device may be described, as shown in Table 2 below.

[0179] Table 2. Exemplary non-toxican pharmaceutical preparations

[0180]

[0181] In some embodiments, the device can be used to deliver a single dose of fetoxil, wherein the single dose comprises about 20 mg to about 80 mg of fetoxil (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 can be used to deliver a single dose of fetoxil, wherein the single dose comprises about 1 mg to about 30 mg of fetoxil (e.g., about 1.25 mg, about 2.5 mg, about 5 mg, about 10 mg, about 20 mg, or about 30 mg).

[0182] In one embodiment, the device can be used to deliver a single dose of about 80 mg of fetacycline. In one embodiment, the device can be used to deliver a single dose of about 50 mg of fetacycline. In one embodiment, the device can be used to deliver a single dose of about 20 mg of fetacycline. In one embodiment, the device can be used to deliver a single dose of about 30 mg of fetacycline. In one embodiment, the device can be used to deliver a single dose of about 10 mg of fetacycline. In one embodiment, the device can be used to deliver a single dose of about 5 mg of fetacycline. In one embodiment, the device can be used to deliver a single dose of about 2.5 mg of fetacycline. In one embodiment, the device can be used to deliver a single dose of about 1.25 mg of fetacycline.

[0183] In some embodiments, a single dose of fexocylan can be delivered in a delivery volume of about 0.5 mL to about 1 mL (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.

[0184] In one embodiment, the device can be used to deliver a single dose of about 80 mg of fetacidin (about 100 mg fetacidin / mL) in about 0.8 mL. In one embodiment, the device can be used to deliver a single dose of about 50 mg of fetacidin (about 100 mg fetacidin / mL) in about 0.5 mL. In one embodiment, the device can be used to deliver a single dose of about 20 mg of fetacidin (about 40 mg fetacidin / mL) in about 0.5 mL. In one embodiment, the device can be used to deliver a single dose of about 30 mg of fetacidin (about 60 mg fetacidin / mL) in about 0.5 mL. In one embodiment, the device can be used to deliver a single dose of about 10 mg of fetacidin (about 20 mg fetacidin / mL) in about 0.5 mL. In one embodiment, the device can be used to deliver a single dose of about 5 mg of fetacidin (about 10 mg fetacidin / mL) in about 0.5 mL. In one embodiment, the device can be used to deliver a single dose of about 2.5 mg fetocilan (about 5 mg fetocilan / mL) in about 0.5 mL. In another embodiment, the device can be used to deliver a single dose of about 1.25 mg fetocilan (about 2.5 mg fetocilan / mL) in about 0.5 mL.

[0185] In one embodiment, the device delivers a preventatively effective dose of non-tuximab for preventative treatment of hemophilia in patients in need (e.g., hemophilia A or B patients with or without inhibitors). A “preventatively effective dose” refers to the amount of non-tuximab that helps patients with hemophilia A or B (with or without inhibitors) achieve desired clinical endpoints, such as a reduction in annualized bleeding rate (ABR), annualized joint bleeding rate (AjBR), annualized spontaneous bleeding rate (AsBR), or frequency of bleeding episodes. As used herein, in the context of non-tuximab, the term “treat / treating / treatment” includes preventative treatment of the disease and refers to achieving desired clinical endpoints.

[0186] Patients with hemophilia A or B who have inhibitors are those who have developed alloantibodies against a previously received factor (e.g., factor VIII for hemophilia A or factor IX for hemophilia B). Patients with hemophilia A or B who have inhibitors may have difficulty being treated with alternative clotting factor therapy. Patients without inhibitors are those who do not have such alloantibodies. This treatment approach may be beneficial for both hemophilia A and hemophilia B patients with inhibitors.

[0187] As used herein, a patient with "hemophilia A or B (with or without inhibitors)" may refer 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, "patient" refers to a human patient. "Patient" may also refer to a human subject.

[0188] In some embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with a subcutaneous dose of about 50 mg of fenostroside every two months (or every eight weeks). In other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with a subcutaneous dose of about 50 mg of fenostroside every month (or every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with a subcutaneous dose of about 80 mg of fenostroside every two months (or every eight weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with a subcutaneous dose of about 80 mg of fenostroside every month (or every four weeks). In still other embodiments, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with a subcutaneous dose of about 20 mg of fenostroside every two months (or every eight weeks). In yet another embodiment, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) at a subcutaneous dose of approximately 20 mg of fenestrated lanolin per month (or every four weeks). In yet another embodiment, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) at a subcutaneous dose of approximately 10 mg of fenestrated lanolin per month (or every four weeks). In yet another embodiment, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) at a subcutaneous dose of approximately 30 mg of fenestrated lanolin per month (or every four weeks). In yet another embodiment, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) at a subcutaneous dose of approximately 5 mg of fenestrated lanolin per month (or every four weeks). In yet another embodiment, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) at a subcutaneous dose of approximately 2.5 mg of fenestrated lanolin per month (or every four weeks). In yet another embodiment, the device can be used for prophylactic treatment of patients with hemophilia A or B (with or without inhibitors) with a subcutaneous dose of approximately 1.25 mg of fexocylan per month (or every four weeks).

[0189] Accordingly, this article provides a method for prophylactic treatment of patients with hemophilia A or hemophilia B (with or without inhibitors), comprising subcutaneously delivering a prophylactic dose of fetoxiclan to a patient in need using the device. The prophylactic dose of fetoxiclan can be any dose provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The prophylactic dose of fetoxiclan can 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 prophylactic dose of fetoxiclan can be delivered monthly (or every four weeks) or every two months (or every eight weeks). Fetoxiclan can be delivered in delivery volumes of about 0.5 mL to about 1 mL (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).

[0190] As an example, prophylactic treatment for patients with hemophilia A or hemophilia B (with or without inhibitors) may include subcutaneous delivery of approximately 50 mg of fexoside to the patient in need once a month (or every four weeks) or every two months (or every eight weeks) using this device. Approximately 50 mg of fexoside can be delivered in approximately 0.5 mL of PBS (concentration approximately 100 mg fexoside / mL).

[0191] Furthermore, this article provides a method for reducing the frequency of bleeding episodes in patients with hemophilia A or B (with or without inhibitors), comprising subcutaneously delivering a prophylactic dose of fetoxiclan to a patient in need using the device. The prophylactic dose of fetoxiclan can be any dose provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The prophylactic dose of fetoxiclan can 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 prophylactic dose of fetoxiclan can be delivered monthly (or every four weeks) or every two months (or every eight weeks). Fetoxiclan can be delivered in delivery volumes of about 0.5 mL to about 1 mL (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).

[0192] As an example, a method to reduce the frequency of bleeding episodes in patients with hemophilia A or B (with or without inhibitors) may include subcutaneously delivering approximately 50 mg of fexoside to the patient in need once a month (or every four weeks) or every two months (or every eight weeks) using this device. Approximately 50 mg of fexoside can be delivered in approximately 0.5 mL of PBS (concentration approximately 100 mg fexoside / mL).

[0193] Furthermore, this article provides a method for reducing the acute bleeding rate (ABR) in patients with hemophilia A or B (with or without inhibitors), comprising subcutaneously delivering a prophylactic dose of fetoxiclan to a patient in need using the device. The prophylactic dose of fetoxiclan can be any dose provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The prophylactic dose of fetoxiclan can 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 prophylactic dose of fetoxiclan can be delivered monthly (or every four weeks) or every two months (or every eight weeks). Fetoxiclan can be delivered in delivery volumes of about 0.5 mL to about 1 mL (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).

[0194] As an example, a method for reducing ABR in patients with hemophilia A or B (with or without inhibitors) may include subcutaneously delivering approximately 50 mg of fexoside to the patient in need once a month (or every four weeks) or every two months (or every eight weeks) using this device. Approximately 50 mg of fexoside can be delivered in approximately 0.5 mL of PBS (concentration approximately 100 mg fexoside / mL).

[0195] Furthermore, this article provides a method for reducing AjBR in patients with hemophilia A or B (with or without inhibitors), comprising subcutaneously delivering a prophylactic dose of fetoxiclan to a patient in need using the device. The prophylactic dose of fetoxiclan can be any dose provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The prophylactic dose of fetoxiclan can 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 prophylactic dose of fetoxiclan can be delivered monthly (or every four weeks) or every two months (or every eight weeks). Fetoxiclan can be delivered in delivery volumes of about 0.5 mL to about 1 mL (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).

[0196] As an example, a method for reducing AjBR in patients with hemophilia A or B (with or without inhibitors) may include subcutaneously delivering approximately 50 mg of fexoside to the patient in need once a month (or every four weeks) or every two months (or every eight weeks) using this device. Approximately 50 mg of fexoside can be delivered in approximately 0.5 mL of PBS (concentration approximately 100 mg fexoside / mL).

[0197] Furthermore, this article provides a method for reducing AsBR in patients with hemophilia A or B (with or without inhibitors), comprising subcutaneously delivering a prophylactic dose of fetoxiclan to a patient in need using the device. The prophylactic dose of fetoxiclan can be any dose provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The prophylactic dose of fetoxiclan can 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 prophylactic dose of fetoxiclan can be delivered monthly (or every four weeks) or every two months (or every eight weeks). Fetoxiclan can be delivered in delivery volumes of about 0.5 mL to about 1 mL (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).

[0198] As an example, a method for reducing AsBR in patients with hemophilia A or B (with or without inhibitors) may include subcutaneously delivering approximately 50 mg of fetoxil to the patient in need once a month (or every four weeks) or every two months (or every eight weeks) using this device. Approximately 50 mg of fetoxil can be delivered in approximately 0.5 mL of PBS (concentration approximately 100 mg fetoxil / mL).

[0199] Reference Signs

[0200] 2 storage body

[0201] 3 retainers

[0202] 4 plugs

[0203] 5 driving elements

[0204] 7,7' Activation Element

[0205] 8 needles

[0206] 10,10' Self-Propelled Pharmaceutical Container

[0207] 21 drive compartments

[0208] 22 pharmaceutical compartments

[0209] 23 Exports

[0210] 24 needle shield

[0211] 31, 31' opening

[0212] 32 guiding elements

[0213] 61, 61' axis

[0214] 62 flexible arms

[0215] 62' stop bar

[0216] 63 contact elements

[0217] 64 Inclined Surface

[0218] 71 Joining features

[0219] 72 guide grooves

[0220] 90 Guide Sales

[0221] 92 Torsion Protection Component

[0222] 94 flexible rod

[0223] 96 First Channel

[0224] 97 Second Channel

[0225] 98 bends

[0226] 99 Dead End

[0227] 100 Drug Delivery Device

[0228] 102 barbed hook

[0229] 200 housing

[0230] 210 distal wall

[0231] 211 opening

[0232] 212 protrusions

[0233] 221 blocking arm

[0234] 300 external buttons

[0235] 310 Locking Protrusion

[0236] 400 needle cannula

[0237] 410 opening

[0238] 420 Proximal Inner Surface

[0239] 430 proximal end

[0240] 500 needle sleeve spring

[0241] 600 end caps

[0242] 700 boot unit.

Claims

1. A self-driven medicament container (10, 10') for storing and expelling a medicament in response to a user interaction, the self-driven medicament container (10, 10') comprising: a reservoir body (2); a retainer (3); a stopper (4) configured to divide an interior of the reservoir body (2) into a drive compartment (21) and a medicament compartment (22), the medicament compartment (22) containing the medicament and comprising an outlet (23) through which the medicament can be expelled in a dispensing operation; and a drive element (5); a plunger having a shaft (61, 61') with a locking element (62, 62') configured to engage the retainer (3) to prevent the plunger from moving distally relative to the reservoir body (2) and a contact element (63) configured to contact the stopper (4); and a release mechanism configured to disengage the locking element (62, 62') from the retainer (3) in response to the user interaction, thereby enabling the plunger to move distally relative to the reservoir body (2), wherein the medicament compartment (22) is distal to the drive compartment (21); wherein the drive element (5) is positioned in the drive compartment (21) before and after the locking element (62, 62') is disengaged from the retainer (3); wherein the stopper (4) is further configured to seal the medicament compartment (22) relative to the drive compartment (21); and wherein the drive element (5) is configured to provide an axial force to the plunger when the locking element (62, 62') is disengaged from the retainer (3) in order to move the plunger distally relative to the reservoir body (2), thereby moving the stopper (4) relative to the reservoir body (2) and expelling the medicament.

2. The self-powered medicament container (10, 10') according to claim 1, wherein The reservoir body (2) has an interior wall surface in contact with the medicament, the interior wall surface defining an interior cross-section of the reservoir body (2).

3. The self-powered medicament container (10, 10') according to claim 2, wherein The interior cross-section of the reservoir body (2) is constant at least along a length of the reservoir body (2) along which the stopper (4) moves during the dispensing operation.

4. The self-driven medicament container (10, 10') according to claim 2 or 3, wherein The interior wall surface of the reservoir body is configured to be continuously connected to an outer surface of the self-driven medicament container.

5. The self-powered medicament container (10, 10') according to any of the claims 2 to 4, wherein, The interior cross-section is circular.

6. The self-powered medicament container (10, 10') according to any one of the preceding claims, wherein The drive element (5) is a spring.

7. The self-powered medicament container (10, 10') according to any one of the preceding claims, wherein, The release mechanism comprises an activation element (7, 7') configured to disengage the locking element (62, 62') from the retainer (3) when an activation movement is performed, wherein the activation movement comprises an axial and / or rotational movement of the activation element (7, 7') relative to the reservoir body (2).

8. The self-powered medicament container (10, 10') according to any one of the preceding claims, wherein, The shaft (61, 61') extends through an opening (31, 31') in the retainer (3) into the reservoir body (2) such that the locking element (62, 62') is proximal of the retainer (3) before said disengagement, and wherein the opening (31, 31') is configured such that the locking element (62, 62') is able to pass through the retainer (3) when the locking element (62, 62') has been disengaged from the retainer (3).

9. The self-driven medicament container (10, 10') according to claim 7 or 8, wherein An abutment can be established between an engagement feature formed on one of the locking element (62, 62') and the activation element (7, 7') and a ramped surface provided on the other one of the locking element (62, 62') and the activation element (7, 7'), wherein the locking element (62, 62') is disengaged from the retainer (3) when the abutment has been established and the engagement feature moves relative to the ramped surface, e.g. the engagement feature slides along the ramped surface.

10. The self-powered medicament container (10, 10') according to one of the claims 7 to 9, wherein The locking element (62, 62') is formed by two or more flexible arms (62) configured to be radially deflected in response to movement of the activation element (7) relative to the reservoir body (2).

11. The self-powered medicament container (10, 10') according to claim 10, wherein The flexible arms (62) are evenly distributed in a circumferential direction.

12. The self-powered medicament container (10, 10') according to one of the claims 7 to 9, wherein The locking element (62, 62') is formed by a stopper rod (62') configured to abut a proximal surface of the retainer (3) before the user interaction, and wherein the locking element (62') is configured to rotate relative to the retainer (3) in response to the user interaction so as to be aligned with an opening (31') of the retainer (3) such that the locking element (62') is able to pass through the opening (31') in a distal direction.

13. The self-powered medicament container (10, 10') according to any one of the preceding claims, wherein, The retainer (3) is mounted to a proximal end of the reservoir body (2) or to an inner wall of the reservoir body (2).

14. The self-powered medicament container (10, 10') according to any one of the preceding claims, wherein, The drive element (5) is entirely accommodated in a drive compartment (21) of the reservoir body (2).

15. The self-powered medicament container (10, 10') according to any one of the preceding claims, wherein, A distally facing end surface of the contact element (63) is a closed surface configured to contact the bung (4) over its entire cross section.

16. The self-powered medicament container (10, 10') according to any one of the preceding claims, wherein A longitudinal axis of the shaft (61, 61') is parallel to a longitudinal axis of the reservoir body (2) before the locking element (62, 62') is disengaged from the retainer (3).

17. A medicament delivery device (100, 100') comprising: a self-driven medicament container (10, 10') according to any of the preceding claims, a needle (8) connected to the outlet (23); an elongated housing (200) against which the self-driven medicament container (10, 10') abuts, wherein the elongated housing (200) has a distal end wall (210) having an opening (211) through which the needle (8) protrudes distally beyond the housing (200); and an outer button (300) connected to a proximal portion of the housing (200) and configured to interact with a release mechanism of the self-driven medicament container (10, 10') such that the locking element (62, 62') disengages from the holder (3) when the outer button (300) is moved distally relative to the housing (200).

18. The medicament delivery device (100, 100') according to claim 17, further comprising: a needle sleeve (400) movably connected to the housing (200) and in a first position protruding distally beyond a tip of the needle (8); wherein the housing (200) comprises a button lock (221) configured to engage with the outer button (300) to block distal movement of the outer button (300) relative to the housing (200) when the needle sleeve (400) is in its first position and configured to disengage from the outer button (300) when the needle sleeve (400) is moved proximally relative to the housing (200) to a second position.

19. A medicament delivery device (100, 100') according to claim 18, wherein, The button lock (221) comprises at least two blocking arms (221) configured to be deflected radially outwards due to interaction with the needle sleeve (400) when the needle sleeve (400) is moved proximally relative to the housing (200) from its first position to its second position.

Images