A medicament delivery assembly

Abstract

A medicament delivery assembly (1, 101) comprising: a package body (10, 110) having a rigid outer shell (11, 111) defining a hermetically sealed interior reservoir (12, 112); a medicament bag (20, 120) arranged inside the interior 5 reservoir (12, 112) forming an activation volume (30, 130) between the medicament bag (20, 120) and the package body (10, 110); a medicament delivery member (40, 140); a gas pressure port (50, 150) configured to provide the activation volume (30, 130) with a pressurized gas; and a manually operated pump (62, 64) configured to provide pressurized gas to 0 the activation volume (30, 130) via the gas pressure port (50, 150) for enabling the medicament bag (20, 120) to be compressed by the pressurized gas acting on the flexible outer shell (21, 121) of the medicament bag (20, 120) to expel the medicament via the medicament delivery member (40, 140).

Description

[0001] A MEDICAMENT DELIVERY ASSEMBLY

[0002] TECHNICAL FIELD

[0003] The present disclosure generally relates to medical devices for medicament administration.

[0004] BACKGROUND

[0005] A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and on-body devices. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations do still exist in the current technology.

[0006] The medicament is typically comprised in a medicament container or medicament bag within the medicament delivery device, the medicament bag being configured to expel the medicament via some type of delivery member, such as a needle. A medicament delivery action maybe activated by activating a drive member, such as a coil spring, configured to act on the medicament container, whereafter medicament is continuously expelled from the medicament container via the needle until the end of the medicament delivery action. However, the use of such drive members increases the complexity of het medicament delivery device. Moreover, in case medicament is to be delivered over a specific time, e.g. above i minute, the needed adaptation of the drive member adds further complexity to the device.

[0007] In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, which are set out in more detail below.

[0008] SUMMARY

[0009] An object of the present disclosure is to provide a medicament delivery assembly which solves, or at least mitigates problems of the prior art.

[0010] There is hence provided a medicament delivery assembly comprising a package body having a rigid outer shell defining a hermetically sealed interior reservoir; a medicament bag arranged inside the interior reservoir, the medicament bag having a flexible outer shell forming an activation volume between the flexible outer shell of the medicament bag and the rigid outer shell of the package body; a medicament delivery member configured to receive medicament from the medicament bag; a gas pressure port configured to provide the activation volume with a pressurized gas; and a manually operated pump configured to provide pressurized gas to the activation volume via the gas pressure port for enabling the medicament bag to be compressed by the pressurised gas acting on the flexible outer shell of the medicament bag to expel the medicament via the medicament delivery member.

[0011] Hereby, a manually operated medicament delivery assembly with low complexity is provided. Thus, a caretaker or the patient can handle the manually operated pump and supply pressurized gas to the gas pressure port in order to increase the gas pressure in the activation volume to compress the medicament bag resulting in the expel of the medicament via the medicament delivery member. Hereby, a medicament delivery action is performed by operating the manually operated pump. Typically, the gas pressure inside the activation volume is the only driving force for expelling the medicament via the medicament delivery member. Thus, the manually operated pump maybe the main, and sole, pressure source. By providing a hermitically sealed interior volume, and thus an hermetically sealed activation volume, pressurized gas maybe supplied to the activation volume via the gas pressure port, and then held trapped in the activation volume without further supply of pressurized gas. Hereby, a prolonged expel of the medicament via the medicament delivery device, even after the supply of pressurized gas to the activation volume has stopped, can be achieved. It should be understood that the medicament delivery assembly maybe disposable, i.e. to be used for one medicament delivery action and then disposed (thrown away), or may be at least partly disposable. For example, the manually operated pump maybe reusable, and the other parts of the medicament delivery assembly disposable. Hereby, the package body with the medicament bag and medicament delivery member including the gas pressure port may be disconnected from the manually operated pump and thrown away after the single usage. As an alternative, also the gas pressure port is re-usable. As a further alternative, the whole medicament delivery assembly is disposable, i.e. also the manually operated pump. In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located furthest away from the dose delivery site.

[0012] Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device.

[0013] When the term “proximal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located closest to the dose delivery site.

[0014] Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and / or component.

[0015] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0016] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and / or component. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

[0017] According to one embodiment, rigid outer shell of the package body is configured to hermetically seal the interior reservoir and activation volume from the surroundings. Thus, the activation volumes may be referred to as an hermetically sealed chamber. In other words, the package body provide for an air-tight interior reservoir and activation volume.

[0018] According to one embodiment, the medicament delivery device is configured to control fluid into, and out of, the activation volume. For example, the gas pressure port maybe the only fluid connection with the surroundings for the interior reservoir and activation volume. The gas pressure port is typically configured to control fluid into, and out of, the activation volume, and as there is no other (uncontrolled) openings in the rigid outer shell or the medicament bag, the gas is trapped inside the activation volume. However, it should be noted that the medicament delivery device may comprise a second controlled opening, such as a venting valve, e.g. arranged in the package body and separated from the gas pressure port, being configured to vent gas from the activation volume in a controlled manner.

[0019] According to one embodiment, the medicament delivery assembly is configured to, upon receiving the pressurized gas via the gas pressure port, hold the pressurized gas in the activation volume for a predetermined time interval without additional supply from the manually driver pump. Hereby, a caretaker (or the patient) can activate the medicament delivery assembly by supplying pressurized gas to the activation volume from the manually operated pump to thereby initiate expel of the medicament via the medicament delivery member. Thereafter, the operation of the manually operated pump can be stopped (such that no pressure source is used to supply the activation volume with pressurized gas), whereby the expel of the medicament via the medicament delivery member is continued for the remaining part of the predetermined time period. In other words, the medicament delivery assembly is configured to, during a first time interval, supply pressurized gas to the activation volume by the manually operated pump, and during a second time interval subsequent to the first time interval, in which no further supply of pressurized gas is supplied to the activation volume, continue to compress the medicament bag for continuous expel of medicament via the medicament delivery member. Thus, during the first time interval, the gas pressure in the activation volume is increased, and during the second time interval, the gas pressure inside the activation volume is reduced as the medicament bag is compressed and the activation volume increased. The predetermined time interval may be an overlapping interval between such first and second time intervals, and may e.g. be defined by the time in which the gas pressure in the activation volume is high enough for compressing the medicament bag to expel the medicament via the medicament delivery member.

[0020] For example, the activation volume maybe configured to, or be sized and dimensioned to, hold the pressurized gas for the predetermined time interval. This may e.g. be achieved by adapting the size and dimension of the activation volume with regards to the flow of the medicament expel of the medicament delivery member or of the medicament bag for the provided gas pressure compressing the medicament bag. For example, by determining the flow resistance of the expel of medicament of the medicament delivery member or of the medicament bag for the various provided gas pressures in the activation volume, the compression of the medicament bag over time can be determined in relation to the gas pressure of the activation volume. Hereby, the size and dimension of the activation volume can be adapted accordingly and for holding the pressurized gas (e.g. over a set threshold) for the predetermined time interval. However, it should be noted that the medicament delivery assembly may comprise a flow valve, e.g. arranged in or upstream of the medicament delivery member, wherein the flow valve and the activation volume are configured for achieving the pressurized gas in the activation volume for the predetermined time interval. Possibly, the gas pressure port or the manually operated pump contributes by disabling gas flow out of the activation volume. Hereby, a controlled amount of medicament may be expelled from the medicament delivery device in response to the flow valve and the gas pressure in the activation volume. The flow valve may e.g. be arranged in either one of, or at the interface between, the medicament bag and the medicament delivery member. However, according to at least one embodiment, the flow valve is omitted.

[0021] According to one embodiment, the manually operated pump is configured to provide pressurized gas to the activation volume above a set threshold, wherein the medicament bag is configured to be compressed by the pressurized gas in the activation volume above the set threshold to expel the medicament via the medicament delivery member. For example, the medicament bag (e.g. the flexible outer shell, the type of medicament, and / or the filling degree of medicament in the medicament bag) may be configured to be compressed by the pressurized gas at the set threshold such that medicament is expelled via the medicament delivery member. As mentioned previously, the medicament bag may be configured to be compressed by the pressurized gas in the activation volume above the set threshold also in response to the flow resistance of the medicament expelled from the medicament delivery member or the medicament bag (e.g. by the flow valve). Thus, the manually operated pump may be operated such that the gas pressure of the activation volume reaches the set threshold, wherein the pressurized gas at or above the set threshold acts on the flexible outer shell to compress the medicament bag such that the medicament is forced out of the medicament bag, into the medicament delivery member and expelled therefrom.

[0022] According to one embodiment, the set threshold is a first set threshold, wherein the medicament delivery assembly is configured such that the medicament bag withstand compression by the pressurized gas in the activation volume below a second set threshold in order to not expel medicament via the medicament delivery member. Hereby, a controlled stop of expel of medicament via the medicament delivery member is provided. For example, the medicament bag (e.g. the flexible outer shell, the type of medicament, and / or the filling degree of medicament in the medicament bag) may be configured to withstand compression by the pressurized gas below the second set threshold such that medicament is no longer expelled via the medicament delivery member. As mentioned previously, the flow resistance of the medicament expelled from the medicament delivery member or the medicament bag (e.g. by the flow valve) may be taken into account in the setting of the second set threshold. Thus, the manually operated pump maybe operated such that the gas pressure of the activation volume reaches the first set threshold, wherein the pressurized gas at or above the set threshold acts on the flexible outer shell to compress the medicament bag such that the medicament is forced out of the medicament bag, into the medicament delivery member and expelled therefrom, whereafter the manually operated pump is stopped, and the compression of the medicament bag continues until the gas pressure reaches the second set threshold.

[0023] According to one embodiment, the medicament bag is configured to be compressed by the pressurized gas to expel medicament via the medicament delivery member for a gas pressure in the activation volume above the first and second set threshold. For example, during the previously mentioned first time interval, the gas pressure is increased to be above the first set threshold, and also above the second set threshold, whereafter the pressurized gas compress the medicament bag to expel medicament via the medicament delivery member during the previously mentioned second time interval, until the gas pressure in the activation volume is below the second set threshold.

[0024] According to one embodiment, the predetermined time interval is determined in relation to the first and second set thresholds. For example, the time interval may be determined from the time when the gas pressure in the activation volume crosses the first set threshold from below, reaches above the second set threshold, until the second set threshold is crossed from above. For example, the second set threshold maybe the same as the first set threshold, or the second set threshold may be lower, or higher, than the first set threshold. According to one embodiment, the predetermined time interval is above i minute, preferably above 5 minutes, more preferably above 20 minutes. Hereby, the prolonged expel of the medicament via the medicament delivery device, even after the supply of pressurized gas to the activation volume has stopped, may be sufficient for the caretaker to handle another patient. For example, the predetermined time interval is between 1 and 30 minutes, such as e.g. between 1 and 20 minutes or between 5 and 20 minutes.

[0025] According to one embodiment, the assembly further comprises a check valve arranged in, or upstream of, the gas pressure port, the check valve being configured to allow pressurized gas to enter the activation volume, and to prevent pressurized gas to exit the activation volume via the gas pressure port. That is, the check valve is preferably arranged between the manually operated pump and the gas pressure port, or inside the gas pressure port. Hereby, the gas pressure in the activation volume maybe better controlled.

[0026] According to one embodiment, the assembly further comprises a tubing fluidly connecting the medicament delivery member with the medicament bag. Thus, during a medicament delivery action, the medicament is pushed out of the medicament bag and into the tubing prior to reaching the medicament delivery member at which it is expelled. The tubing is preferably shorter than 15 cm, preferably shorter than 10 cm. For example, the tubing has a length of between 5 cm and 15 cm, such as between 5 cm and 10 cm.

[0027] According to one embodiment, the medicament delivery member is a soft cannula or a rigid needle. For example, the soft cannula maybe combined with the previously mentioned tubing.

[0028] According to one embodiment, the assembly does not comprise an electrically operated pump for providing the pressurized gas to the activation volume via the gas pressure port. Preferably, the assembly does not comprise an electrically operated pump at all. Hereby, the operation of the assembly is made independent of an electrical source. Moreover, in case the whole assembly is made disposable, no electrically operated pump is thrown away. According to one embodiment, the assembly is free of electronics. Hereby, the operation of the assembly maybe made independent of electricity. Moreover, in case the whole assembly is made disposable, no electronics is thrown away. Electronics may here be defined as any basic discrete electronic device or physical entity part of an electronic system used to affect electrons or their associated fields. For example, the assembly maybe free of an electrical power source, electrically conducting wires and an electrically operated pump or other electrically operated pressure source.

[0029] According to one embodiment, the package body is configured to be attached to the skin of a patient during use. Thus, the package body may comprise an adhesive, or an adhesive layer, configured to face the patient during use, wherein the adhesive adheres the package body to the skin of the patient during use.

[0030] According to one embodiment, the assembly is a wearable medicament delivery assembly. Hereby, a patient of the medicament delivery assembly may wear the medicament delivery assembly. For example, the medicament delivery assembly may be wearable as the package body is attached to the skin of the patient. However, it should be noted that the medicament delivery assembly may further comprise a shoulder strap, or a harness, attached to the package body, enabling the medicament delivery assembly to sling across the body of the patient. According to one embodiment, the medicament delivery assembly comprises a belt strap holder configured to be held in a belt strap of the patient, wherein the belt strap holder comprises a first attachment structure and the package body comprises a second attachments structure being configured for releasable attachment to the first attachment structure, e.g. by a male-female interlocking structure. Hereby, the package body can be easily attached and re-attached to the belt strap holder.

[0031] According to one embodiment, the medicament delivery assembly is configured to be wearable near-body the patient. For example, the medicament delivery assembly is an on-body device, e.g., devices are categorized in two: body-worn, aka attached directly to the patient; or patient-worn, aka worn by means of a strap, belt, lanyard, etc, according to the definition of ISOn6o8. That is, the medicament delivery assembly may be wearable over or under the clothing of the patient, without being directly attached to the patient’s body, e.g. without being directly attached to the patient’s skin.

[0032] According to one embodiment, the manually operated pump is configurable in a first state in which gas is drawn into the pump, and in a second state in which gas is expelled from the pump. That is, the manually operated pump is configured to be operated manually in order to be brought from the first state and into the second state, typically repeatedly. The manually operated pump is typically a positive displacement pump.

[0033] According to one embodiment, the manually operated pump is a handoperated pump comprising a handle, a piston configured to be moved by the piston, and a chamber in which the piston is configured to be moved for pumping the gas. Thus, a user, such as a caretaker or the patient, can grip the handle by hand, move the handle in order to move the piston inside the chamber, wherein gas will be drawn into the chamber, optionally be pressurized inside the chamber, and then supplied to the activation volume via the gas pressure port. Thus, and with reference to the previously mentioned first and second state of the manually operated pump, the caretaker or patient may move the handle from a first position to a second position during the first state in order to draw gas, such as air, into the chamber, then the gas may optionally be compress in the chamber by that the piston is moved inside the chamber. Subsequently, the caretaker or patient may move the handle, typically in an opposite direction, from the second position to the first position, in order to provide pressurized gas in the activation volume via the gas pressure port.

[0034] The manually operated pump may e.g. be a syringe. According to a second aspect of the present disclosure, there is provided a medicament delivery device comprising the medicament delivery assembly of the first aspect of the present disclosure.

[0035] Effects and features of the second aspect are largely analogous to those described above in connection with the first aspect. Embodiments mentioned in relation to the first aspect are largely compatible with the second aspect. The medicament delivery device is typically configured to expel medicament from the medicament container after cap removal.

[0036] According to a third aspect of the present disclosure, instead of a manually operated pump, an electric or gas pump can be used. Thus, in the third aspect of the present disclosure, there is hence provided a medicament delivery assembly comprising a package body having a rigid outer shell defining a hermetically sealed interior reservoir; a medicament bag arranged inside the interior reservoir, the medicament bag having a flexible outer shell forming an activation volume between the flexible outer shell of the medicament bag and the rigid outer shell of the package body; a medicament delivery member configured to receive medicament from the medicament bag; a gas pressure port configured to provide the activation volume with a pressurized gas; and a pump configured to provide pressurized gas to the activation volume via the gas pressure port for enabling the medicament bag to be compressed by the pressurised gas acting on the flexible outer shell of the medicament bag to expel the medicament via the medicament delivery member.

[0037] In the third aspect, instead of continuously pumping gas into the activation volume, the activation volume only needs to be pressurized once. In other words, the pump is configured to deliver a predetermined amount of gas into the activation volume, then the pump is disconnected from the gas pressure port. The gas in the activation volume causes medicament within the medicament bag to be delivered. In a preferred embodiment, the predetermined amount of gas can be used to determine the deliverable dosage. For example, different patients might need different dosage respectively, instead of having multiple bags with multiple filled volumes respectively, all bags can have the same filled volume. The dosage difference in this case is controlled by different amounts of the gas.

[0038] According to one embodiment, the pump is releasably connected to the gas pressure port.

[0039] According to one embodiment, the medicament delivery assembly is packed within a single housing.

[0040] According to one embodiment, the dosage is configured to be set via a user interface of the single housing.

[0041] According to one embodiment, the dosage is configured to be set via a user interface of the pump. For example, the medicament delivery assembly can be used in an infusion center or an infusion room in a hospital. In this example, each patient receives a package body, caregivers can then carry a pump move from one patient to another to set a dose via the user interface of the pump and deliver the predetermined amount of pressurized gas.

[0042] It should be noted that using the pump and deliver the predetermined amount of pressurized gas to set a dose of the medicament can be used in all aspects of the disclosure mentioned above.

[0043] Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a / an / the element, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

[0044] BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0046] Fig. i shows an example of a medicament delivery assembly according to embodiments of the present disclosure; Fig. 2 shows an example of a medicament delivery assembly according to embodiments of the present disclosure;

[0047] Fig. 3 is a graph of the gas pressure in the activation volume over time according embodiments of the present disclosure;

[0048] Fig. 4 are schematical perspective views of a first and a second state of a manually operated pump according embodiments of the present disclosure; and

[0049] Fig. 5 is a perspective view of a wearable medicament delivery assembly and a patient wearing it according embodiments of the present disclosure.

[0050] DETAILED DESCRIPTION

[0051] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.

[0052] Fig. i shows a first example of medicament delivery assembly i according to the present disclosure. The medicament delivery assembly is interchangeably referred to as the assembly throughout the application.

[0053] The medicament delivery assembly i comprises a package body io having a rigid outer shell n defining a hermetically sealed interior reservoir 12. Moreover, the assembly i comprise a medicament bag 20 arranged inside the interior reservoir 12. The medicament bag 20 comprises a flexible outer shell 21 for holding a medicament. Thus, during use, the medicament is held within the flexible outer shell 21 of the medicament bag 20. The volume of the medicament bag 20 may e.g. be between 1.5 ml and 100 ml, such as e.g. between 2.5 ml, 10ml, 25, ml, 40 ml, 50ml, 75ml, and 100ml. As shown in Fig. i, there is a gap between the medicament bag and the rigid outer shell n of the package body io, forming an activation volume 30. Thus, the activation volume 30 is formed between the flexible outer shell 21 of the medicament bag 20 and the rigid outer shell 11 of the package body 10. In more detail, the activation volume 30 is arranged between an inner surface 11a of the rigid outer shell 11, and an outer surface 21a of the flexible outer shell 12. The inner surface 11a is thus facing the medicament bag 20 and the outer surface 21a of the flexible outer shell 12. Correspondingly, the outer surface 21a of the flexible outer shell 12 is facing the package body 10 and the inner surface 11a of the rigid outer shell 11. Thus, the activation volume 30 forms a portion of the interior reservoir 12. Hereby, both the interior reservoir 12 and the part of the interior reservoir 12 being the activation volume 30 are hermetically sealed. The medicament bag may e.g. comprise a multi-layer structure including the flexible outer shell 21 and the outer surface 21, wherein the multi-layer structure further comprises an innermost layer arranged in contact with the medicament of the medicament bag 20. The innermost layer is typically a non-interactive layer.

[0054] The package body 10 may be arranged next to the patient, or may alternatively be attached to the patient, e.g. to the skin of the patient by an adhesive.

[0055] The assembly 1 further comprises a gas pressure port 50 configured to provide the activation volume 30 with a pressurized gas, and a manually operated pump 62 configured to provide the pressurized gas to the activation volume 30 via the gas pressure port 50. By providing pressurized gas to the activation volume 30, the medicament bag 20 maybe compressed by the pressurized gas acting on the flexible outer shell 21 of the medicament bag 20 to expel the medicament out of the medicament bag 20. As shown in Fig. 1, the assembly 1 preferably comprises a check valve 52 arranged in the gas pressure port 50. The check valve 52 is configured to allow pressurized gas to enter the activation volume 30 by operating the manually operated pump 62, and to prevent pressurized gas to exit the activation volume 30 via the gas pressure port 50. Hereby, the gas pressure in the activation volume 30 may be better controlled.

[0056] The medicament delivery assembly 1 further comprises a medicament delivery member 40 configured to receive medicament from the medicament bag 20 upon compression of the medicament bag 20 by the pressurized gas in the activation volume 30. In the example of Fig. 1, the assembly 1 further comprises a tubing 42 arranged to fluidly connect the medicament inside the medicament bag 20 with the medicament delivery member 40. The medicament delivery member 40 may e.g. be a soft cannula comprised in an infusion set including a patch for adhesive attachment to the skin of the patient. Thus, during use, the medicament bag 20 is compressed by the pressurized gas acting on the flexible outer shell 21 of the medicament bag 20 to expel the medicament out of the medicament delivery member 40 during a medicament delivery action.

[0057] Turning to Fig. 2 showing a second example of medicament delivery assembly 101 according to the present disclosure.

[0058] The medicament delivery assembly 101 comprises a package body no having a rigid outer shell 111 defining a hermetically sealed interior reservoir 112. As for the example embodiment of Fig. 1, the assembly 101 comprise a medicament bag 120 arranged inside the interior reservoir 112. The medicament bag 120 comprises a flexible outer shell 121 for holding a medicament. Thus, during use, the medicament is held within the flexible outer shell 121 of the medicament bag 120. As for the example embodiment of Fig. 1, an activation volume 130 is formed between the flexible outer shell 121 of the medicament bag 120 and the rigid outer shell 111 of the package body 110. The package body no in Fig. 2 is arranged to be attached to the patient, preferably by an adhesive. For this, the package body 110 comprises a patient interacting side 110a comprising an adhesive configured to be attached to the skin of the patient. The assembly i further comprises a gas pressure port 150 configured to provide the activation volume 130 with a pressurized gas, and a pump 64, preferably, a manually operated pump 64 configured to provide the pressurized gas to the activation volume 130 via the gas pressure port 150. In the example embodiment of Fig. 2, the manually operated pump 64 is a syringe. Hereby, the medicament bag 120 maybe compressed by the pressurized gas in the activation volume 130 as the pressurized gas act on the flexible outer shell 121 of the medicament bag 120 to expel the medicament out of the medicament bag 120. As shown in Fig. 2, a medicament delivery member 140 in the form of a rigid needle is protruding from the package body no from the patient interacting side 110a. Correspondingly to the example embodiment of Fig. 1, the medicament delivery member 140 is configured to receive medicament from the medicament bag 120 upon compression of the medicament bag 120 by the pressurized gas in the activation volume 130. Thus, during use, the package body no is attached to the patient by that the patient interacting side 110a is attached to the skin of the patient via the adhesive, and the medicament bag 120 is compressed by the pressurized gas acting on the flexible outer shell 121 of the medicament bag 120 to expel the medicament out of the medicament delivery member 140. Even though not shown for the example embodiment of Fig. 2, the assembly 101 may comprise a check valve arranged in, or upstream of, the gas pressure port 150. Upstream here is referred to the flow of gas, flowing from the manually operated pump 64 and into the activation volume 130 via the gas pressure port 150.

[0059] Turning to Fig. 3 showing a graph of the gas pressure in the activation volume 30, 130 over time according to one example. Both the assembly 1 of Fig. 1 and the assembly 101 of Fig. 2 maybe operated by the manually operated pump 62, 64 to achieve the gas pressure evolvement of Fig. 3. Thus, further reference to the assemblies 1, 101 and the components thereof will be made in the following.

[0060] In the graph of Fig. 3, the gas pressure Pi of the activation volume 30, 130 is represented by the y-axis, and time t is of the gas pressure development in the activation volume 30, 130 is represented by the x-axis. The pressure Pi may e.g. be in bar, and extend from Po of 1 bar to P2 of 5 bar and time t in minutes extending from to of o minutes to at least t2 of 20 minutes.

[0061] For example, the manually operated pump 62, 64 maybe configured pressurize the gas in the activation volume 30, 130 to above a first set threshold Pti. This is exemplified in the graph of Fig. 3 as the gas pressure in the activation volume 30, 130 increases from Po to P2 during a first time interval til. Hereby, the gas pressure inside the activation volume 30, 130 is raised from Po to Pti and further above to P2. P2 is here the maximised gas pressure in the activation volume 30, 130. Thus, during the first time interval til, pressurized gas is supplied to the activation volume 30, 130 by the manually operated pump 62. Typically, the manually operated pump 62 is continuously or intermittently operated during the first time interval til in order for the gas pressure inside the activation volume 30, 130 to reach P2. As the gas pressure inside the activation volume 30, 130 reaches P2, the operation of the manually operated pump is typically stopped.

[0062] The medicament bag 20, 120 is preferably configured to be compressed by the pressurized gas in the activation volume 30, 130 to expel the medicament via the medicament delivery member 40, 140 as the gas pressure in the activation volume 30, 130 is above the first set threshold Pti.

[0063] Moreover, the medicament delivery assembly 1, 101 is preferably configured to, upon receiving the pressurized gas via the gas pressure port 50, 150, hold the pressurized gas in the activation volume 30, 130 for a predetermined time interval td without additional supply from the manually driver pump 62, 64. Preferably, the medicament delivery assembly 1, 101 is configured to hold the pressurized gas in the activation volume 30, 130 at a gas pressure above the first set threshold Pti for the predetermined time interval td.

[0064] Thus, during a second time interval ti2 subsequent to the first time interval til, in which no further supply of pressurized gas is supplied to the activation volume 30, 130, the pressurized gas of the activation volume 30, 130 continue to compress the medicament bag 20, 120 for continuous expel of medicament via the medicament delivery member 40, 140.

[0065] For example, the activation volume 30, 130 maybe configured to hold the pressurized gas for the predetermined time interval td by an adapted size and dimension of the activation volume 30, 130 with regards to the flow, such as known flow characteristics, of the medicament from the medicament delivery member 40, 140 (expel of medicament) or from the medicament bag 20, 120 (e.g. flow of medicament from the medicament bag 20, 120 to the medicament delivery member 40, 140, e.g. via the tubing 42). This is typically determined as a function of the provided gas pressures in the activation volume 30, 130 compressing the medicament bag 20, 120. For example, by determining the limiting flow resistance of the medicament from the medicament bag 20, 120 to the point of expel of medicament of the medicament delivery member 40, 140 for various provided gas pressures in the activation volume 30, 130, the compression of the medicament bag 20, 120 can be determined in relation to the gas pressure of the activation volume 30, 130, and the corresponding gas pressure evolvement of the activation volume 30, 130 over time. This may e.g. be achieved by a compression model. Thus, the size and dimension of the activation volume 30, 130 can be adapted accordingly and for holding the pressurized gas (e.g. over a set threshold) for the predetermined time interval td.

[0066] According to one embodiment, the assembly 1 comprises a flow valve 44, e.g. arranged as in the example embodiment of Fig. 1 upstream of the medicament delivery member 40, and downstream of the medicament bag 20, here being in the tubing 42. Hereby, the expel of medicament of the medicament delivery member 40 can be controlled by the flow valve 44. Thus, the flow valve 44 may also be used to control the gas pressure, and the gas pressure evolvement over time, in the activation volume 30. Thus, the flow valve 46 and the activation volume 30 may together be configured for holding the pressurized gas in the activation volume 30 for the predetermined time interval (e.g. over a set threshold). Additionally or alternatively, the gas pressure port 50 or the manually operated pump 42 may contribute to holding the pressurized gas in the activation volume 30 by disabling gas flow out of the activation volume 30 (e.g. by means of the previously mentioned check valve 52).

[0067] The medicament delivery assembly 1, 101 maybe configured such that the medicament bag 20, 120 withstand compression by the pressurized gas in the activation volume 30, 130 below a second set threshold Pt2 in order to not expel medicament via the medicament delivery member 40, 140. Thus, with analogous reasoning as provided above for the gas pressure evolvement, the assembly 1, 101 maybe configured such that the medicament bag 20, 120 withstand compression by the pressurized gas below the second set threshold Pt2. Hereby, as the gas pressure in the activation volume 30, 130 is reduced below the second set threshold Pt2, expel of medicament via the medicament delivery member 40, 140 is stopped or ceased. Thus, during the previously second time interval ti2, the gas pressure in the activation volume 30, 130 is reduced from P2 to Pt2.

[0068] Thus, during the first time interval til, the gas pressure in the activation volume 30, 130 is increased, and during the second time interval ti2, the gas pressure inside the activation volume 30, 130 is reduced as the medicament bag 20, 120 is compressed and the activation volume 30, 130 increased. The predetermined time interval td is thus at least partly overlapping with the first time interval til (from Pti to P2), and include the second time interval ti2 (from P2 to Pt2). Thus, the medicament bag 20, 120 is configured to be compressed by the pressurized gas in the activation volume 30, 130 to expel medicament via the medicament delivery member 40, 140 for a gas pressure in the activation volume 30, 130 above the first set threshold hold Pti, and above the second set threshold Pt2. For example, due to the inherent characteristics of a compressed medicament bag 20, 120, the second set threshold Pt2 maybe higher than the first set threshold Pti. For such example embodiments, the predetermined time interval td maybe defined to extend from a first time ti in which the gas pressure in the activation volume 30, 130 reaches the first set threshold Pti from below (e.g. reaches the first set threshold Pti from Po), to a second time t2 occurring subsequent to the first time ti and in which the gas pressure in the activation volume 30, 130 reaches below the second set threshold Pt2 from above (e.g. reaches the second set threshold Pt2 from P2). Thus, the predetermined time interval td maybe determined in relation to the first and second set thresholds Pti, Pt2.

[0069] The predetermined time interval td is typically above 1 minute, preferably above 5 minutes, more preferably above 20 minutes.

[0070] Hereby, a caretaker (or the patient) can activate the medicament delivery assembly 1, 101 by supplying pressurized gas to the activation volume 30, 130 by operating the manually operated pump 62, 64 to thereby initiate expel of the medicament via the medicament delivery member 40, 140 as the gas pressure reaches the first set threshold Pti. After pressurizing the activation volume 30, 130 (e.g. to the gas pressure P2), the caretaker may stop the operation of the manually operated pump 62, 64, and need not to supervise the assembly 1, 101 for the remaining part of the predetermined time interval td, as the activation volume 30, 130 is configured to hold the pressurized gas for a prolonged time, whereby the expel of the medicament via the medicament delivery member 40, 140 is continued until the gas pressure in the activation volume 30, 130 reaches and falls below the second set threshold Pt2.

[0071] It should be understood that the manually operated pump 62, 64 is not an electrically operated pump. Thus, the assemblies 1, 101 of Figs. 1 and 2 do not comprise an electrically operated pressure pump for providing the pressurized gas to the activation volume 30, 130 via the gas pressure port 50. Thus, the manually operated pump 62, 64 is configured to be manually operated, not electrically operated. For example, the whole assembly 1, 101 maybe free of electronics. Hereby, at least parts of the assembly 1, 101 may be disposable. For example, all parts of the assembly 1, 101 except for the manually operated pump 62, 64 are disposable. However, according to one embodiment, also the manually operated pump 62, 64 is also disposable. Turning to Fig. 4, showing an example embodiment of a manually operated pump 160, e.g. the manually operated pump 62 of the example embodiment in Fig. 1, or the manually operated pump 64 of the example embodiment in Fig. 2.

[0072] The manually operated pump 160 of Fig. 4 is a hand-operated pump comprising a handle 162, a piston 164 configured to be moved by the piston 162, and a chamber 166 in which the piston 164 is configured to be moved for pumping the gas. In the view to the left of Fig. 4, gas (or air) is sucked into the chamber via gas providing portion 168, symbolized by the dashed arrow, and in the view to the right of Fig. 4, gas (or air) is pumped from the chamber and out of the gas providing portion 168, again symbolized by the dashed arrow. Hereby, the manually operated pump 160 is configurable in a first state in which gas is drawn into the pump 160 (left view of Fig. 4), and in a second state in which pressurized gas is expelled from the pump 160 (right view of Fig. 4).

[0073] Thus, a user, such as a caretaker or the patient, can grip the handle 162 by hand, move the handle 162 from a first position to a second position during the first state in order to move the piston 164 inside the chamber 166, wherein gas will be drawn into the chamber 166. The user may then optionally move the handle 162 in order to move the piston 164 to pressurize the gas inside the chamber 166, typically in an opposite direction, from the second position towards the first position. This would typically be achieved by closing the gas providing portion 168 such that no gas can exit through the gas providing portion 168. Subsequently, the caretaker or patient may move the handle 162, typically all the way back to the first position, to move the piston 164 in order to expel gas through the gas providing portion 168.

[0074] Hereby, pressurized gas maybe provided to the activation volume 30, 130 via the gas pressure port 50, 150.

[0075] Fig. 5 shows an example embodiment in which the medicament delivery assembly 1 of Fig. 1 is attached to a patient 190. Here, the package body 10 of the assembly 1 is attached to the skin of the patient 190, and medicament is provided to the patient via the medicament delivery member 40 and the tubing 42 as previously described. Thus, the assembly 1 is in Fig. 5 shown as a wearable medicament delivery assembly 1.

[0076] The medicament delivery assembly 1, 101 described herein may be comprised in, or be referred to, as a medicament delivery device.

[0077] The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0078] Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behqet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE) -mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer. Exemplary types of drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies .

[0079] Exemplary drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0080] Exemplary drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-i / PD- Li) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T- lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domaincontaining protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD 80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0081] Exemplary drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

[0082] Exemplary drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

[0083] Exemplary drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0084] Exemplary drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5 -fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

[0085] Exemplary drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.

[0086] Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament bags, and administrated by the medicament delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

[0087] Exemplary drugs that could be included in the medicament bags, and administrated by the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0088] The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

[0089] Some other aspects of the invention are defined by the following clauses. 1. A medicament delivery assembly (1, 101) comprising: a package body (io, no) having a rigid outer shell (n, in) defining a hermetically sealed interior reservoir (12, 112), a medicament bag (20, 120) arranged inside the interior reservoir (12, 112), the medicament bag (20, 120) having a flexible outer shell (21, 121) forming an activation volume (30, 130) between the flexible outer shell (21, 121) of the medicament bag (20, 120) and the rigid outer shell (11, 111) of the package body (10, 110), a medicament delivery member (40, 140) configured to receive medicament from the medicament bag (20, 120), a gas pressure port (50, 150) configured to provide the activation volume (30, 130) with a pressurized gas, and a pump (62, 64) configured to provide pressurized gas to the activation volume (30, 130) via the gas pressure port (50, 150) for enabling the medicament bag (20, 120) to be compressed by the pressurized gas acting on the flexible outer shell (21, 121) of the medicament bag (20, 120) to expel the medicament via the medicament delivery member (40, 140).

[0090] 2. The assembly (1, 101) according to clause 1, wherein the pump (62, 64) is a manually operated pump (62, 64).

[0091] 3. The assembly (1, 101) according to clause 1 or 2, wherein the medicament delivery assembly (1, 101) is configured to, upon receiving the pressurized gas via the gas pressure port (50, 150), hold the pressurized gas in the activation volume (30, 130) for a predetermined time interval (td) without additional supply from the manually operated pump (62, 64).

[0092] 4. The assembly (1, 101) according to clause 3, wherein the pump (62, 64) is configured to provide pressurized gas to the activation volume (30, 130) above a set threshold (Pti), wherein the medicament bag (20, 120) is configured to be compressed by the pressurized gas in the activation volume (30, 130) above the set threshold (Pti) to expel the medicament via the medicament delivery member (40, 140).

[0093] 5. The assembly (1, 101) according to clause 4, wherein the set threshold (Pti) is a first set threshold (Pti), and wherein the medicament delivery assembly (1, 101) is configured such that the medicament bag (20, 120) withstand compression by the pressurized gas in the activation volume (30, 130) below a second set threshold (Pt2) in order to not expel medicament via the medicament delivery member (40, 140).

[0094] 6. The assembly (1, 101) according to clause 5, wherein the medicament bag (20, 120) is configured to be compressed by the pressurized gas to expel medicament via the medicament delivery member (40, 140) for a gas pressure in the activation volume (30, 130) above the first and second set threshold (Pti, Pt2).

[0095] 7. The assembly (1, 101) according to any one of clauses 5-6, wherein the predetermined time interval (td) is determined in relation to the first and second set thresholds (Pti, Pt2).

[0096] 8. The assembly (1, 101) according to any one of clauses 3-7, wherein the predetermined time interval (td) is above 1 minute, preferably above 5 minutes, more preferably above 20 minutes.

[0097] 8. The assembly (1) according to any one of the preceding clauses, wherein the pump is configured to provide a predetermined amount of pressurized gas to the activation volume (30, 130) via the gas pressure port (50, 150); and wherein the pump is configured to be disconnected from the gas pressure port (50, 150) after the predetermined amount of pressurized gas is provided to the activation volume (30, 130).

[0098] 9. The assembly (1) according to clause 8, wherein the assembly (1) is configured to deliver a predetermined amount of the medicament from the medicament bag (20, 120) via the medicament delivery member (40, 140); and wherein the predetermined amount of the medicament is determined by the predetermined amount of pressurized gas.

[0099] 10. The assembly (i) according to any one of the preceding clauses, further comprising a check valve (52) arranged in, or upstream of, the gas pressure port (50), the check valve (52) being configured to allow pressurized gas to enter the activation volume (30, 130), and to prevent pressurized gas to exit the activation volume (30, 130) via the gas pressure port (50).

[0100] 11. The assembly (1) according to any one of the preceding clauses, further comprising a tubing (42) fluidly connecting the medicament delivery member (40) with the medicament bag (20).

[0101] 12. The assembly (1, 101) according to any one of the preceding clauses, wherein the medicament delivery member (40, 140) is a soft cannula (40) or a rigid needle (140).

[0102] 13. The assembly (1, 101) according to any one of clauses 2-17 when dependent on clause 2, wherein the assembly (1, 101) does not comprise an electrically operated pump for providing the pressurized gas to the activation volume (30, 130) via the gas pressure port (50).

[0103] 14. The assembly (1, 101) according to any one of the preceding clauses, being a wearable medicament delivery assembly (1, 101).

[0104] 15. The assembly (1, 101) according to any one of the preceding clauses, wherein the pump is configurable in a first state in which gas is drawn into the pump, and in a second state in which gas is expelled from the pump.

[0105] 16. The assembly (1, 101) according to any one of clauses 2-17 when dependent on clause 2, wherein the manually operated pump is a handoperated pump comprising a handle, a piston configured to be moved by the piston, and a chamber in which the piston is configured to be moved for pumping the gas. 17- The assembly (i, 101) according to any one of clauses 2-17 when dependent on clause 2, wherein the manually operated pump is a syringe.

[0106] 18. A medicament delivery device comprising the medicament delivery assembly (1, 101) according to any one of clauses 1-17.

Claims

CLAIMS1. A medicament delivery assembly (1, 101) comprising: a package body (io, no) having a rigid outer shell (n, m) defining a hermetically sealed interior reservoir (12, 112), a medicament bag (20, 120) arranged inside the interior reservoir (12, 112), the medicament bag (20, 120) having a flexible outer shell (21, 121) forming an activation volume (30, 130) between the flexible outer shell (21, 121) of the medicament bag (20, 120) and the rigid outer shell (11, 111) of the package body (10, no), a medicament delivery member (40, 140) configured to receive medicament from the medicament bag (20, 120), a gas pressure port (50, 150) configured to provide the activation volume (30, 130) with a pressurized gas, and a pump (62, 64) configured to provide pressurized gas to the activation volume (30, 130) via the gas pressure port (50, 150) for enabling the medicament bag (20, 120) to be compressed by the pressurized gas acting on the flexible outer shell (21, 121) of the medicament bag (20, 120) to expel the medicament via the medicament delivery member (40, 140).

2. The assembly (1, 101) according to claim 1, wherein the pump (62, 64) is a manually operated pump (62, 64).

3. The assembly (1, 101) according to claim 2, wherein the medicament delivery assembly (1, 101) is configured to, upon receiving the pressurized gas via the gas pressure port (50, 150), hold the pressurized gas in the activation volume (30, 130) for a predetermined time interval (td) without additional supply from the manually operated pump (62, 64).

4. The assembly (1, 101) according to claim 3, wherein the pump (62, 64) is configured to provide pressurized gas to the activation volume (30, 130)above a set threshold (Pti), wherein the medicament bag (20, 120) is configured to be compressed by the pressurized gas in the activation volume (30, 130) above the set threshold (Pti) to expel the medicament via the medicament delivery member (40, 140).

5. The assembly (1, 101) according to claim 4, wherein the set threshold (Pti) is a first set threshold (Pti), and wherein the medicament delivery assembly (1, 101) is configured such that the medicament bag (20, 120) withstand compression by the pressurized gas in the activation volume (30, 130) below a second set threshold (Pt2) in order to not expel medicament via the medicament delivery member (40, 140).

6. The assembly (1, 101) according to claim 5, wherein the medicament bag (20, 120) is configured to be compressed by the pressurized gas to expel medicament via the medicament delivery member (40, 140) for a gas pressure in the activation volume (30, 130) above the first and second set threshold (Pti, Pt2).

7. The assembly (1, 101) according to any one of claims 5-6, wherein the predetermined time interval (td) is determined in relation to the first and second set thresholds (Pti, Pt2).

8. The assembly (1, 101) according to any one of claims 3-7, wherein the predetermined time interval (td) is above 1 minute, preferably above 5 minutes, more preferably above 20 minutes.

8. The assembly (1) according to any one of the preceding claims, wherein the pump is configured to provide a predetermined amount of pressurized gas to the activation volume (30, 130) via the gas pressure port (50, 150); and wherein the pump is configured to be disconnected from the gas pressure port (50, 150) after the predetermined amount of pressurized gas is provided to the activation volume (30, 130).

9. The assembly (1) according to claim 8, wherein the assembly (1) is configured to deliver a predetermined amount of the medicament from themedicament bag (20, 120) via the medicament delivery member (40, 140); and wherein the predetermined amount of the medicament is determined by the predetermined amount of pressurized gas.

10. The assembly (1) according to any one of the preceding claims, further comprising a check valve (52) arranged in, or upstream of, the gas pressure port (50), the check valve (52) being configured to allow pressurized gas to enter the activation volume (30, 130), and to prevent pressurized gas to exit the activation volume (30, 130) via the gas pressure port (50).

11. The assembly (1) according to any one of the preceding claims, further comprising a tubing (42) fluidly connecting the medicament delivery member (40) with the medicament bag (20).

12. The assembly (1, 101) according to any one of the preceding claims, wherein the medicament delivery member (40, 140) is a soft cannula (40) or a rigid needle (140).

13. The assembly (1, 101) according to any one of the preceding claims, wherein the pump is configurable in a first state in which gas is drawn into the pump, and in a second state in which gas is expelled from the pump.

14. The assembly (1, 101) according to any one of claims 2-13 when dependent on claim 2, wherein the manually operated pump is a handoperated pump comprising a handle, a piston configured to be moved by the piston, and a chamber in which the piston is configured to be moved for pumping the gas.

15. The assembly (1, 101) according to any one of claims 2-13 when dependent on claim 2, wherein the manually operated pump is a syringe.

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