Drug delivery system status indicator

Abstract

A novel display device and the like for displaying the status of bolus delivery to a patient via a medical system is provided. The present disclosure relates to a display device comprising one or more plungers within an elongated cavity, the display device intended to provide a user with at least one piece of information regarding the current status of a delivery system, the display device comprising at least one movable element configured to reach a predetermined position depending on the status of the delivery system. [Selected figure] Figure 2

Description

[Technical field]

[0001] Disclosed herein is a display device configured to provide a user with information, for example, the status of a delivery system, such as a drug delivery system that may be configured to inject a single bolus dose. Further disclosed herein are examples of delivery systems that may be used in conjunction with the display device, as well as other possible features and devices. [Background technology]

[0002] New therapies developed by pharmaceutical companies require new generation delivery systems that must allow for the infusion of a predetermined amount of fluid into a patient over a period of time. Some therapies require the infusion of the entire contents of a reservoir into a single bolus.

[0003] Preferentially, the delivery system is for single use only, so that after use the delivery system may be disposed of. Such a system may be inexpensive, easy to use and contain no electronic components.

[0004] Described herein are various embodiments of smart, inexpensive indicators for delivery systems, delivery systems, and other embodiments or features, such as valve devices, fill indicators, fault indicators, and the like. Summary of the Invention

[0005] Disclosed herein is a display device comprising one or more movable elements (e.g., single plunger, two plungers, etc.) configured to display at least one of an infusion status, a fill level, and a fault. Further disclosed herein is a valve that allows for occlusion of the fluid pathway and the delivery system.

[0006] One of the goals of the disclosed embodiments is to directly or indirectly present to the user at least one piece of information (preferentially at least two, more preferentially three) related to the current status of the delivery system. Preferentially, the device is configured to provide a signal (e.g. visual signal, discrete signal, etc.) indicating at least one of the following states or information: before injection, during injection, at the end of injection, before reservoir filling, during reservoir filling, at the end of reservoir filling, fill level, fluid flow condition, reservoir ready to fill, ready to inject, injection in progress, filling in progress, fault, leak, etc. The display device comprises at least one movable element (e.g. plunger) configured to reach a predetermined position depending on the status of the delivery system.

[0007] A first aspect of the present disclosure relates to a display device for displaying the status of a bolus delivery to a patient via a medical system. The medical system (such as a delivery system) preferentially comprises a reservoir having an internal compartment for storing a solution to be delivered, and a transdermal device. The display device comprises: a fluid port adapted to be coupled to at least one of the reservoir and the transdermal device; A first end; A second end. a body containing or surrounding the internal cavity, the body having a first end and a second end defining a major axis; a first movable element and a second movable element disposed within the internal cavity and configured to move relative to the body through the internal cavity in a direction parallel to the major axis; It may comprise:

[0008] The first movable element is preferentially in pressure communication with at least one of the internal compartment and the transdermal device. The display device is preferentially configured to provide an indication of at least two of the following states by different positions of the first movable element and the second movable element within the internal cavity: before injection, during injection, and at the end of injection.

[0009] The display may further comprise a position indication window disposed on an outer surface of the display and configured to provide an external visual indication of a position of at least one of the first movable element and the second movable element.

[0010] The fluid port may be in fluid communication with at least one of an interior compartment of the reservoir and the transdermal device.

[0011] The internal cavity may include a first variable volume, a second variable volume, and a third variable volume defined by an inner wall of the internal cavity and at least the first and second movable elements. The first variable volume may be in fluid communication with the fluid port. The first movable element may strictly separate the first and second variable volumes. The second movable element may include a fluid path (e.g., a through hole) configured to achieve fluid communication between the second and third variable volumes.

[0012] The first movable element can be configured to urge the second movable element from the first position to the second position.

[0013] The first movable element may be configured to perform a forward and backward movement. In some embodiments, the first movable element may be configured to perform a forward and backward movement, while the second movable element performs a simple movement caused by the forward movement of the first movable element. The display device may further comprise a biasing means configured to induce at least a backward movement of the first movable element and the second movable element.

[0014] The display device may further comprise a vent configured to achieve pressure equilibrium between the third variable volume and an external environment. In some embodiments, the reservoir is pressurized with a fluid (e.g., a pressurized gas) and the third variable volume may be in fluid or pressure communication with the pressurized fluid to induce retraction movement of the first movable element.

[0015] A second aspect of the present disclosure relates to a medical system adapted to deliver a solution to a patient, the medical system comprising: A display device as described herein; a reservoir, which may have a movable wall; a transdermal device in fluid communication with a patient; a fluid pathway extending from the interior compartment of the reservoir to the transdermal device; a housing enclosing a cavity of the medical system within which the movable wall may move; (at least one) vent device configured to achieve pressure equilibrium between the system cavity and the external environment; It may comprise:

[0016] The display device and / or the medical system may further include a valve device configured to block a portion of the fluid path. The first movable element of the display device may be configured to block a portion of the fluid path when the first movable element is in a predetermined position (e.g., an initial position).

[0017] The medical system may further comprise a removable occlusion device configured to occlude the (at least one or all) vent devices at least during the reservoir filling process or dwell period.

[0018] The medical system may further comprise a pressurized reservoir in pressure communication with the movable wall of the reservoir. The display may comprise a separate cavity in fluid and / or pressure communication with the pressurized reservoir. The display may comprise a separate movable element configured to move within the separate cavity, e.g., along a direction parallel to a major axis of the display. The separate part of the display may provide an indication related to a state of the pressurized reservoir, such as an obstruction or a leak, depending on different positions of the separate movable element within the separate cavity.

[0019] The cavity and the separate cavity may be strictly separated from each other. In some embodiments, fluid communication is opened between both cavities and the pressurized fluid in the pressurized reservoir may induce a retraction movement of at least one movable element (e.g. the first movable element described above).

[0020] A third aspect of the present disclosure relates to a display device for displaying the status of a delivery system. The delivery system preferentially comprises a first reservoir having a first internal compartment for storing a first fluid. The display device comprises: a body including an internal cavity having a fluid port in pressure communication with the first internal compartment, the internal cavity may further include a first end and a second end defining a major axis; at least one movable element disposed within the cavity and configured to move relative to the internal cavity in a direction parallel to the main axis, the at least one movable element may be configured to move in response to a pressure of a first fluid stored in the first internal compartment, the at least one movable element may have at least two different positions, i.e. a first position and a second position; a position indication window disposed near at least one of the first position and the second position, the position indication window being disposed on an exterior (or side) of the display device (or of the delivery system) such that the position indication window provides a visual indication of the position of the at least one movable element; It may comprise:

[0021] The display device may indicate at least one state of the delivery system through different positions of the at least one movable element.

[0022] The display device may provide an indication of at least one of the following conditions: Before injection, During injection, At the end of the infusion, Before filling the reservoir, While the reservoir is filling, At the end of reservoir filling, Ready for injection, Ready to fill, Injection in progress, Filling in progress, Disability, and Leakage.

[0023] At least one movable element can be in pressure communication with a first fluid contained in the first interior compartment.

[0024] The at least one movable element may include at least one of a first plunger and a second plunger.

[0025] The fluid port can be in fluid communication with a first fluid contained in the first interior compartment.

[0026] The first fluid stored in the first internal compartment may be intended to be delivered to a patient. In another embodiment, the first fluid stored in the first internal compartment is intended to pressurize a second reservoir having a second internal compartment that stores a second fluid intended to be delivered to a patient.

[0027] A fourth aspect of the present disclosure relates to a delivery system comprising a housing enclosing a system cavity (e.g., an internal cavity of the delivery system that may be defined at least by the housing), a vent device, and an indicator (as described herein). The first reservoir preferentially comprises a movable wall configured to vary a first internal compartment of the first reservoir. The movable membrane may be configured to move at least partially into the system cavity. The vent device preferentially achieves an equilibrium pressure between the system cavity and an external environment of the system.

[0028] The system may further comprise an occlusion device (which may be removable) configured to occlude the vent device during at least one of filling of the first reservoir and a dwell period prior to use.

[0029] A fifth aspect of the present disclosure relates to a display device for displaying an injection status of a medical device adapted to deliver a solution to a patient. The display device may include a body, an elongated cavity having a first end and a second end (defining a main axis) arranged in the body, and at least two plungers (a first plunger and a second plunger, optionally a separate plunger) configured to move relative to the elongated cavity (e.g. along a direction parallel to the main axis). Preferentially, the first plunger and the second plunger are arranged to define at least one variable volume in the elongated cavity, for example the following three variable volumes: a first variable volume defined between the first end of the elongated cavity and the first plunger; a second variable volume defined between the first plunger and the second plunger; and A third variable volume formed between the second plunger and the second end of the elongated cavity. The first plunger may be configured to move in response to a pressure of a solution intended to be delivered.

[0030] The first plunger may form a fluid-tight wall between the first variable volume and the second variable volume.

[0031] The first variable volume, the second variable volume, and the third variable volume may include a fluid, such as a liquid or a gas, e.g., air or a compressible fluid. The first variable volume may be configured to receive a volume fraction of the solution that may be expelled from the first variable volume at the end of the injection.

[0032] The first plunger is capable of forward and backward movement.

[0033] The first plunger (or first variable volume) is in pressure communication with a solution intended to be injected into the patient, and a pressure gradient or pressure fluctuation of this solution can cause or enable movement of the first plunger.

[0034] For example, the first plunger (or the first variable volume) may be in pressure communication with a reservoir that contains a solution intended to be injected. The reservoir may be a pressurized reservoir. The medical device may include a reservoir and a housing within which the reservoir is disposed.

[0035] The first end of the cavity may include a fluid port in fluid communication with the solution intended to be delivered, for example, the fluid port may be in fluid communication with a reservoir that stores the solution or with a fluid path between an internal compartment of the reservoir and an outlet of the medical device.

[0036] The second plunger may move depending on the first plunger. For example, the first plunger may push the second plunger from one position to a predefined position that may be visible or hidden from the user. To this end, the display device may comprise one or more windows to allow at least one of the first plunger and the second plunger to be visible at the predefined position(s).

[0037] The second plunger may include a throughbore configured to provide fluid communication between the second variable volume and the third variable volume.

[0038] The display device may enable a discrete visual signal indicating a fluid flow condition depending on the position of at least one of the first and second plungers, and depending on the position of the plunger, the plunger may be visible or hidden from the user to indicate the status of the medical device, such as ready for injection, injection in progress, end of injection, etc.

[0039] The elongated cavity may further include a mechanical stop (also referred to as a stop member) disposed between the first end and the second end to maintain at least one of the first plunger and the second plunger in a predetermined position.

[0040] The second end may include a vent to provide pressure equilibrium between the third variable volume and the external environment.

[0041] The display device may further include a biasing device disposed between the first plunger and the second plunger.

[0042] A sixth aspect of the present disclosure relates to a display device for displaying an injection status of a medical device adapted to deliver a solution to a patient. The display device may include a body, an elongated cavity having a first end and a second end, disposed in the body, and a first plunger configured to move relative to the elongated cavity. Preferentially, the first plunger may be disposed in the elongated cavity and configured to have at least one (stable) position. More preferentially, the first plunger may be configured to have at least two different positions, for example three different positions, namely a first initial position, a second position, and a third position.

[0043] The first plunger may be configured to move in response to the pressure of the solution intended to be delivered.

[0044] The first plunger is capable of forward and backward movement.

[0045] The first plunger may form a fluid-tight wall between the first variable volume and the second variable volume. The first variable volume may be defined between a first end of the cavity and the first plunger, and the second variable volume may be defined between the first plunger and another end of the cavity, which may be a second end, for example an end opposite the first end.

[0046] The first plunger (or first variable volume) is in pressure communication with a solution intended to be injected into the patient, and a pressure gradient or pressure fluctuation of this solution can cause or enable movement of the first plunger.

[0047] For example, the first plunger (or the first variable volume) may be in pressure communication with a reservoir that contains a solution intended to be injected. The reservoir may be a pressurized reservoir. The medical device may include a reservoir and a housing within which the reservoir is disposed.

[0048] The first end of the cavity may include a fluid port in fluid communication with the solution intended to be delivered, for example, the fluid port may be in fluid communication with a reservoir that stores the solution or with a fluid path between an internal compartment of the reservoir and an outlet of the medical device.

[0049] The display device may enable a discrete visual signal indicating a fluid flow condition depending on the position of the first plunger. Depending on the position of the first plunger, the plunger may be visible or hidden from the user to indicate a status of the medical device such as ready for injection, injection in progress, end of injection, etc. To this end, the display device may include one or more windows to allow the first plunger to be visible in at least one of the first initial position, the second position, and the third position.

[0050] The elongated cavity may further include a mechanical stop (also referred to as a stop member) disposed between the first end and the second end to maintain the first plunger in a predetermined position (the first initial position, the second position, or the third position).

[0051] The second end may include a vent to provide pressure equilibrium between the second variable volume and the external environment.

[0052] The display may further include a biasing device disposed between the first plunger and the second end of the cavity.

[0053] The display may include a second plunger that may be disposed in the cavity between the first plunger and the second end of the cavity. The second plunger may move in response to the first plunger (e.g., in response to the movement of the plunger according to a predetermined path / direction). For example, the first plunger may push the second plunger from a position to a predetermined position that may be visible to the user or hidden from the user. To this end, the display may include one or more windows to allow at least one of the first plunger and the second plunger to be visible at the predetermined position(s).

[0054] The second plunger may include a through hole configured to provide fluid communication between a volume defined between the first plunger and the second plunger and another volume defined between the second plunger and the second end.

[0055] A seventh aspect of the present disclosure relates to a display device for displaying an injection status of a medical device adapted to deliver a solution to a patient, the display device comprising: a body having a window and an elongated cavity disposed within the body, the elongated cavity having a first end and a second end; a first plunger configured to provide a visual signal through the window and to move relative to the elongated cavity; a compressible visual element configured to provide a visual signal through the window; may include.

[0056] Preferentially, the first plunger and the compressible visual element are disposed within the elongated cavity. The compressible visual element may be configured to be compressed within the cavity between the second end of the cavity and the first plunger when the plunger moves towards the second end of the cavity.

[0057] The first plunger may be configured to move in response to the pressure of the solution intended to be delivered.

[0058] The first plunger has an advancing and retracting motion and a compressible visual element may be used as a biasing means to exert a force on the first plunger that opposes the solution pressure.

[0059] The first plunger (or first variable volume) is in pressure communication with a solution intended to be injected into the patient, and a pressure gradient or pressure fluctuation of this solution can cause or enable movement of the first plunger.

[0060] For example, the first plunger (or the first variable volume) may be in pressure communication with a reservoir that contains a solution intended to be injected. The reservoir may be a pressurized reservoir. The medical device may include a reservoir and a housing within which the reservoir is disposed.

[0061] The first end of the cavity may include a fluid port in fluid communication with the solution intended to be delivered, for example, the fluid port may be in fluid communication with a reservoir that stores the solution or with a fluid path between an internal compartment of the reservoir and an outlet of the medical device.

[0062] The display device may enable discrete visual signals indicating fluid flow conditions depending on the position of at least one of the first plunger and the compressible visual element. Depending on the position of the plunger and the compressible visual element, the plunger and / or the compressible visual element may be visible or hidden from the user to indicate the state of the medical device, such as ready to inject, in progress, or end of injecting. When the medical device is in a first state, the compressible visual element is visible in the window, e.g., the user sees an orange color indicating that the medical device is ready to inject. When the medical device is in a second state, the cavity wall is visible in the window, e.g., the user sees a green color indicating that the solution is flowing to the patient. When the medical device is in a third state, the plunger is visible in the window, e.g., the user sees a blue color indicating that the injecting is end.

[0063] The elongated cavity may further include a mechanical stop disposed between the first and second ends for maintaining at least one of the first plunger and the compressible visual element in place.

[0064] The second end may include a vent to provide pressure equilibrium with the external environment (with the volume between the second end and the end of the compressible visual element or the end of the first plunger).

[0065] The display device may further comprise a biasing means. The biasing means may be a trapped gas between the first plunger and the second end or the compressible visual element.

[0066] The compressible visual element may be a plunger having an elongated body configured to collapse when compressed.

[0067] An eighth aspect of the present disclosure relates to a medical device adapted to deliver a solution to a patient, the medical device may include a display device, a pressurized reservoir for storing the solution, an outlet port in fluid communication with the patient, and a fluid pathway from the interior of the pressurized reservoir to the outlet port.

[0068] The display device can be one of the disclosed displays. For example, the display device can include an elongated cavity disposed within the medical device, the elongated cavity having a first end and a second end, and a first plunger configured to move relative to the elongated cavity.

[0069] Preferentially, the indicator is in pressure communication with the fluid path.

[0070] The first plunger may be configured to move in response to pressure of a solution contained within the pressurized reservoir or a fluid present in a portion of the fluid pathway.

[0071] The first plunger is capable of forward and backward movement.

[0072] The first plunger may form a fluid-tight wall between the first variable volume and the second variable volume. The first variable volume may be defined between a first end of the cavity and the first plunger, and the second variable volume may be defined between the first plunger and another end of the cavity, which may be the second end, e.g., the end opposite the first end. The display device may also include a separate plunger disposed in the cavity, e.g., between the first plunger and the second end, to divide the second variable volume into a second variable volume and a third variable volume.

[0073] The first plunger (or the first variable volume) may be in pressure communication with a solution initially stored in a pressurized reservoir or present in a portion of the fluid pathway, and a pressure gradient or pressure fluctuation in this solution may cause or enable movement of the first plunger.

[0074] Preferentially, the medical device comprises a housing in which part of the display device, part of the reservoir and part of the fluid path may be arranged.

[0075] The display may enable a discrete visual signal indicating fluid flow conditions depending on the position of the plunger(s). Depending on the position of the plunger(s), the plunger(s) may be visible or hidden from the user to indicate the status of the medical device, such as ready for injection, injection in progress, end of injection, etc. To this end, the display and / or the medical device may include one or more windows to allow the plunger(s) to be visible in at least one position.

[0076] One of the goals of the disclosed embodiments is to prevent free flow prior to activation of the delivery system, for example, when a user fills the reservoir.

[0077] A ninth aspect of the present disclosure provides a valve device disposed in the fluid pathway as described above, the valve device being configured to allow the solution to flow to the outlet when a pressurized reservoir or solution pressure reaches a predetermined threshold.

[0078] A tenth aspect of the present disclosure relates to a display device configured to provide an indication regarding at least one of the status of filling and drug delivery of a drug reservoir. The display device preferentially comprises a body having a cavity. The cavity includes a first end and a second end defining a major axis. The display device comprises an inlet port in pressure communication with an internal compartment of the drug reservoir. The display device further comprises at least one movable element (preferentially a first movable element and a second movable element) and at least one visual indicator arranged in the vicinity of possible positions of the movable element. The display device provides an indication by the visual indicator and different positions of the movable element within the cavity.

[0079] An eleventh aspect of the present disclosure relates to a display device configured to provide an indication of a status of a pressurized reservoir. The pressurized reservoir may be configured to apply pressure against the drug reservoir (e.g., against a movable wall of the drug reservoir). The display device may comprise a body having a first cavity having a first end and a second end defining a major axis. The display device preferentially comprises a movable element (e.g., a plunger) configured to move within the cavity along a direction parallel to the major axis. The display device may further comprise a fluid port that may be in fluid communication with the pressurized reservoir, the movable element being in pressure communication with a pressurized fluid stored in the pressurized reservoir. The display device is preferentially configured to indicate a fault (e.g., a leak) in the pressurized reservoir by a position of the movable element within the first cavity.

[0080] In some embodiments, the display device may further comprise a second cavity within which one or more separate movable elements are configured to provide an indication regarding at least one of the filling and delivery status of the drug reservoir as described herein.

[0081] Preferentially, the device does not require any power source such as a battery or electronics connected to the display or valve device. The (linear) movement is due to the pressure of the solution in the drug reservoir and / or in the fluid path (between the reservoir and the outlet device).

[0082] The present disclosure will be better understood in light of the following detailed description, including the non-limiting examples illustrated by the following figures. [Brief description of the drawings]

[0083] [Figure 1] FIG. 1 shows an embodiment of a drug delivery system prior to injection, comprising a propellant reservoir (here a liquefied gas), a drug reservoir strictly separated from the gas reservoir, and a display device with two plungers. [Diagram 2] FIG. 2 shows the same device (from FIG. 1) after actuation, in which the two plungers are translated into the left portion of the cylinder until the air pressure in that portion is approximately equal to the drug reservoir pressure; a membrane between the propellant reservoir and the drug reservoir transfers the gas pressure to the drug. [Diagram 3] FIG. 2 shows the same device (of FIG. 1) at the end of injection, when the pressure at the communication port drops to zero, inducing movement of the solid plunger towards its initial position. [Figure 4] FIG. 13 is a side view of an example of a plunger having a 45° sealing lip. [Figure 5a] A diagram showing a first position associated with the state "ready to inject" according to one embodiment in which the display device has a single plunger with a mechanical stop (e.g., a conical narrowing) that can be configured to allow for the definition of three different plunger positions. [Figure 5b] A figure showing a second position associated with the status "injection in progress" according to one embodiment in which the display device includes a single plunger having a mechanical stop (e.g., a conical narrowing) that can be configured to allow for the definition of three different plunger positions. [Figure 5c] A figure showing a third position associated with the state "end of injection" according to one embodiment in which the display device has a single plunger with a mechanical stop (e.g., a conical narrowing) that can be configured to allow for the definition of three different plunger positions. [Figure 5d]FIG. 2 shows (below) that in one embodiment, the display device comprises a single plunger having a mechanical stop (e.g., a conical narrowing) that can be configured to allow definition of three different plunger positions, and that three windows (or at least one) located in front of the injection status indicator can be configured to allow visualization of the plunger. [Figure 6a] A diagram showing clearly defined positions of the two plungers before injection, according to one embodiment in which the display device comprises a first mechanical stop (left part of the cylinder) and a second mechanical stop (conical narrowing in the right part of the cylinder). [Figure 6b] A diagram showing clearly defined positions of the two plungers during injection, according to one embodiment in which the display device comprises a first mechanical stop (left part of the cylinder) and a second mechanical stop (conical narrowing in the right part of the cylinder). [Figure 6c] A diagram showing clearly defined positions of the two plungers after injection, according to one embodiment in which the display device comprises a first mechanical stop (left part of the cylinder) and a second mechanical stop (conical narrowing in the right part of the cylinder). [Figure 6d] FIG. 13 shows an embodiment in which one or more windows may be placed in front of the injection status indicator to allow visualization of the plunger, where the indicator comprises a first mechanical stop (left portion of the cylinder) and a second mechanical stop (conical narrowing in the right portion of the cylinder). [Figure 7a] FIG. 2 shows the state in which the plunger is not visible before injection, in one embodiment in which the display device has two plungers and two different windows, where the second plunger can be red and the first plunger green. [Figure 7b] FIG. 1 shows an embodiment in which the display device has two plungers and two different windows, where the second plunger is red and the first plunger can be green, showing the second plunger being visible through a window located in the left part of the cylinder during injection. [Figure 7c]FIG. 2 shows a state in which the first plunger becomes visible through a window located in the right part of the cylinder at the end of injection, in one embodiment in which the display device has two plungers and two different windows, where the second plunger can be red and the first plunger green. [Figure 8] FIG. 14 shows an embodiment in which a dual plunger injection status indicator comprises two vertical and horizontal windows, with the plungers in an intermediate position immediately after actuation, the second plunger bore not shown for clarity, and the horizontal window being useful in determining that an injection has been actuated since the plungers are no longer in their initial position and are not visible through at least one of the vertical windows. [Figure 9a] FIG. 13 shows a state prior to injection where only the second plunger is visible, according to an embodiment where the display device includes a vent device, e.g., the cavity (third variable volume) is open to atmosphere. [Figure 9b] A figure showing a state in which the second plunger moves toward the end of the cavity during injection and the first plunger becomes visible in the left window, in one embodiment in which the display device is equipped with a vent device, e.g., the cavity (third variable volume) is open to the atmosphere. [Figure 9c] FIG. 13 shows a state in which the first plunger becomes visible through a window located in the right part of the cylinder at the end of injection, in one embodiment in which the display device is equipped with a vent device, e.g., the cavity (third variable volume) is open to the atmosphere. [Figure 10a] FIG. 1 illustrates an example of a display device with a compressible visual element and a plunger. [Figure 10b] FIG. 1 illustrates an example of a display device with a compressible visual element and a plunger. [Figure 10c] FIG. 1 illustrates an example of a display device with a compressible visual element and a plunger. [Figure 11a] FIG. 13 shows an embodiment in which the display device comprises two windows and at least two plungers, with the cylinder optionally open to the atmosphere, with only the second plunger visible prior to injection. [Figure 11b]A diagram showing a state in which during injection, the second plunger moves toward the end of the cylinder and a first part of the first plunger becomes visible in the left window, in one embodiment in which the display device comprises two windows and at least two plungers, and the cylinder is optionally open to the atmosphere. [Figure 11c] A figure showing a state in which at the end of injection only the second part of the first plunger (or a separate plunger, e.g. the third plunger) is visible through a window located in the right part of the cylinder, in one embodiment in which the display device comprises two windows and at least two plungers, and the cylinder is optionally open to the atmosphere. [Figure 12a] A figure showing clearly defined positions of the two plungers before injection, in one embodiment in which the display device comprises a biasing device (e.g., a spring) disposed between the first and second plungers. [Figure 12b] A diagram showing clearly defined positions of two plungers during injection, according to one embodiment in which the display device comprises a biasing device (e.g., a spring) disposed between the first and second plungers. [Figure 12c] A figure showing clearly defined positions of the two plungers after injection, according to one embodiment in which the display device comprises a biasing device (e.g., a spring) disposed between the first and second plungers. [Figure 12d] FIG. 13 shows an embodiment in which the display device includes a biasing device (e.g., a spring) disposed between the first and second plungers, and a window disposed in front of the injection status indicator can be configured to allow visualization of the plunger. [Figure 13a] 13A-13C show clearly defined positions of the plunger prior to injection, according to one embodiment in which the display comprises a biasing device (eg, a spring) and a single plunger. [Figure 13b] 13A-13C show clearly defined positions of the plunger during injection according to one embodiment in which the display device comprises a biasing device (e.g., a spring) and a single plunger. [Figure 13c]13A-13C show clearly defined positions of the plunger after injection according to one embodiment in which the display device comprises a biasing device (e.g., a spring) and a single plunger. [Figure 13d] A figure showing an embodiment in which the display device comprises a biasing device (e.g., a spring) and a single plunger, where a window located in front of the injection status indicator can be configured to allow visualization of the plunger. [Figure 14] FIG. 1 shows an example of a drug delivery system that may include a propellant reservoir (here a liquefied gas), a drug reservoir strictly separated from the gas reservoir, and a display device having a first plunger with a second plunger and a protrusion, where the protrusion of the first plunger may be configured to block flow unless the pressure in the reservoir exceeds a predetermined value, and the protrusion may be considered a valve device in the fluid pathway, prior to injection. [Figure 15] FIG. 1 shows an example of a pre-injection drug delivery system comprising a propellant reservoir (here a liquefied gas), a drug reservoir strictly separated from the gas reservoir, a display device having at least one plunger used as a valve device to cut off flow unless the pressure in the reservoir exceeds a predefined value, and a needle offset from the cylinder, with a first variable volume being part of the fluid path or dividing the fluid path into two distinct parts, the first part being in fluid communication with the internal compartment of the reservoir and the second part being in fluid communication with an outlet device (e.g. a needle). [Figure 16] FIG. 1 shows an example of a pre-injection drug delivery system comprising a propellant reservoir (here a liquefied gas), a drug reservoir strictly separated from the gas reservoir, a needle, a valve device and a display device, the display device comprising a first plunger and a second plunger, the valve device comprising a plunger and a bung adapted to move inside a cavity, the presence of a plunger stopper exerts drug pressure on the top surface of the plunger, and the user may have to remove the bung to allow the plunger of the valve device to open the fluid path, and the display device is optional. [Figure 17]FIG. 1 shows an example of a pre-injection drug delivery system comprising a propellant reservoir (here liquefied gas), a drug reservoir strictly separated from the gas reservoir, a needle, a display device and a valve device, which may comprise a plunger and a bung inside a cavity that communicates directly with an outlet device, said cavity comprising a spring and a vented screw-type adjustable bung, where the pressure of the drug is exerted on the top surface of the plunger due to the presence of a plunger structuring, and where a display device is optional. [Figure 18] FIG. 1 shows an example of a pre-injection drug delivery system comprising a propellant reservoir (here liquefied gas), a drug reservoir strictly separated from the gas reservoir, an indicator device, and a valve device comprising an elastomeric membrane used as a crack valve and a double bevel needle (exit device), with an indicator device being optional. [Figure 19] FIG. 1 shows an example of a pre-injection drug delivery system, comprising a propellant reservoir (here a liquefied gas), a drug reservoir strictly separated from the gas reservoir, a display device, an elastomeric membrane used as a crack valve, and a needle, with the display device being optional. [Figure 20] FIG. 1 shows an example of a pre-injection drug delivery system comprising a propellant reservoir (here a liquefied gas), a drug reservoir strictly separated from the gas reservoir, a double bevel needle, a display device, and a valve device having a cylinder and a plunger used as a crack valve, where the display device is optional and the plunger of the valve device is configured to move through the cylinder. [Figure 21] FIG. 1 shows an example of a drug delivery system during injection, comprising a propellant reservoir (here, for example, butane at 20° C.), a drug reservoir strictly separated from the gas reservoir, a double bevel needle, a display device, and a valve device having a cylinder and a plunger into which the needle is inserted after activation of the device, the display device being optional. [Figure 22a] FIG. 1 is a diagram showing a general concept of a display device according to the present disclosure. [Figure 22b] FIG. 1 is a diagram showing a general concept of a display device according to the present disclosure. [Figure 22c] FIG. 1 is a diagram showing a general concept of a display device according to the present disclosure. [Figure 23a] FIG. 1 illustrates another possible embodiment of the present disclosure. [Figure 23b] FIG. 1 illustrates another possible embodiment of the present disclosure. [Figure 23c] FIG. 1 illustrates another possible embodiment of the present disclosure. [Figure 23d] FIG. 1 illustrates another possible embodiment of the present disclosure. [Figure 23e] FIG. 1 illustrates another possible embodiment of the present disclosure. [Figure 24] 11A-11C are multiple views showing possible infusion status indicators. [Diagram 25] FIG. 1 is a schematic diagram showing possible connections according to one embodiment of the delivery system. [Figure 26] FIG. 1 is a schematic diagram showing the general structure of one embodiment of a delivery system. [Figure 27a] FIG. 2 is a schematic diagram showing one state of the delivery system. [Figure 27b] FIG. 2 is a schematic diagram showing another state of the delivery system. [Figure 27c] FIG. 13 is a schematic diagram showing yet another state of the delivery system. [Fig. 27d] FIG. 13 is a schematic diagram showing yet another state of the delivery system. [Figure 27e] FIG. 13 is a schematic diagram showing yet another state of the delivery system. [Figure 28a] FIG. 1 illustrates one possible embodiment of a delivery system. [Figure 28b] FIG. 13 illustrates another possible embodiment of the delivery system. [Figure 28c] FIG. 13 illustrates yet another possible embodiment of the delivery system. [Figure 29a] FIG. 1 illustrates one possible embodiment of a delivery system. [Figure 29b] FIG. 13 illustrates another possible embodiment of the delivery system. [Figure 30a] FIG. 1 shows a delivery system including a filling indicating device having a first movable element and a second movable element. [Figure 30b] FIG. 1 shows a delivery system including a filling indicating device having a first movable element and a second movable element. [Figure 30c] FIG. 1 shows a delivery system including a filling indicating device having a first movable element and a second movable element. [Figure 31a] FIG. 1 shows a possible filling indicator. [Figure 31b] FIG. 1 shows a possible filling indicator. [Fig. 31c] FIG. 1 shows a possible filling indicator. [Figure 32a] FIG. 32a shows a first side of a possible display device, and FIG. 32a' shows a second side of a possible display device. [Figure 32b] FIG. 32b' shows a first side of a possible display device and FIG. 32b' shows a second side of a possible display device. [Fig. 32c] FIG. 32c' shows a first side of a possible display device and FIG. 32c' shows a second side of a possible display device. [Fig. 32d] FIG. 32d' shows a first side of a possible display device and FIG. 32d' shows a second side of a possible display device. [Figure 32e] FIG. 32e' shows a first side of a possible display device and FIG. 32e' shows a second side of a possible display device. [Fig. 32f] FIG. 32f' shows a first side of a possible display device and FIG. 32f' shows a second side of a possible display device. [Figure 33a] FIG. 33a shows a first side of a possible display device, and FIG. 33a' shows a second side of a possible display device. [Figure 33b] FIG. 33b' shows a first side of a possible display device and FIG. 33b' shows a second side of a possible display device. [Figure 33c] FIG. 33c' shows a first side of a possible display device and FIG. 33b' shows a second side of a possible display device. [Fig. 33d]FIG. 33d' shows a first side of a possible display device and FIG. 33d' shows a second side of a possible display device. [Figure 33e] FIG. 33e' shows a first side of a possible display device and FIG. 33e' shows a second side of a possible display device. [Fig. 33f] FIG. 33f' shows a first side of a possible display device and FIG. 33f' shows a second side of a possible display device. [Figure 34a] FIG. 34a shows a first side of a possible display device, and FIG. 34a' shows a second side of a possible display device. [Figure 34b] FIG. 34b' shows a first side of a possible display device and FIG. 34b' shows a second side of a possible display device. [Fig. 34c] FIG. 34c' shows a first side of a possible display device and FIG. 34b' shows a second side of a possible display device. [Fig. 34d] FIG. 34d' shows a first side of a possible display device and FIG. 34d' shows a second side of a possible display device. [Figure 34e] FIG. 34e' shows a first side of a possible display device and FIG. 34e' shows a second side of a possible display device. [Fig. 34f] FIG. 34f' shows a first side of a possible display device and FIG. 34f' shows a second side of a possible display device. [Figure 35a] FIG. 35a shows a first side of a possible display device, and FIG. 35a' shows a second side of a possible display device. [Figure 35b] FIG. 35b' shows a first side of a possible display device and FIG. 35b' shows a second side of a possible display device. [Figure 35c] FIG. 35c' shows a first side of a possible display device and FIG. 35b' shows a second side of a possible display device. [Fig. 35d] FIG. 35d' shows a first side of a possible display device and FIG. 35d' shows a second side of a possible display device. [Figure 35e]FIG. 35e' shows a first side of a possible display device and FIG. 35e' shows a second side of a possible display device. [Fig. 35f] FIG. 35f' shows a first side of a possible display device and FIG. 35f' shows a second side of a possible display device. [Figure 36a] FIG. 13 shows another possible display device. [Figure 36b] FIG. 13 shows another possible display device. [Figure 36c] FIG. 13 shows another possible display device. [Fig. 36d] FIG. 13 shows yet another possible display device. [Figure 36e] FIG. 13 shows yet another possible display device. [Fig. 36f] FIG. 13 shows yet another possible display device. [Figure 37a] FIG. 1 illustrates a possible delivery system. [Figure 37b] FIG. 1 illustrates a possible delivery system. [Figure 37c] FIG. 1 illustrates a possible delivery system. [Figure 38] FIG. 1 is a schematic diagram showing possible connections according to one embodiment of the delivery system. [Figure 39] FIG. 1 is a schematic diagram showing possible connections according to one embodiment of the delivery system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0084] In the following detailed description, reference is made to the accompanying drawings, which form a part of this specification and in which, by way of example, several embodiments of the apparatus, systems and methods are shown. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. Thus, the following detailed description should not be taken in a limiting sense. Features described herein may be included in various embodiments.

[0085] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are intended to facilitate understanding of certain terms used frequently herein and are not intended to limit the scope of the present disclosure.

[0086] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include embodiments having plural references unless the content clearly dictates otherwise.

[0087] As used in this specification and the appended claims, any directions referred to herein, such as "up," "down," "left," "right," "upper," "lower," and other directions or orientations, are described herein for clarity with respect to the figures and are not intended to limit the actual device or system. The devices and systems described herein can be used in several directions and orientations.

[0088] As used in this specification, the words "have," "having," "include," "including," "comprise," "comprising," and the like are used in their open-ended sense and generally mean "including, but not limited to."

[0089] As used herein, the term "substantially" is a broad term and is used in its ordinary sense, including but not limited to, broadly, but not necessarily entirely, what is specified.

[0090] As used herein, "at least one of A, B, and C," "at least one of A, B, or C," "selected from the group consisting of A, B, C, and combinations thereof," and the like are used in their open-ended sense, including "A alone, or B alone, or C alone, or any combination of A, B, and C," unless the context clearly indicates otherwise.

[0091] As used herein, "plunger" and the like are used in their non-limiting sense and generally refer to a movable part that is disposed within a cavity and configured to (optionally rigidly) separate said cavity into two distinct portions.

[0092] As used herein, "cylinder" and the like are used in their non-limiting sense and generally refer to a solid formed by a line moving parallel to itself by leaning on a flat curve.

[0093] As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0094] This application claims the benefit of priority from European Patent Application Publication No. 18157250.4, filed on February 16, 2018 in the name of Debiotech SA, the entire disclosure of which is incorporated herein by reference. Furthermore, this application claims the benefit of the priority of EP 18182850.0, filed July 11, 2018, EP 18215745.3, filed December 21, 2018, EP 19151323.3, filed January 11, 2019, EP 19151324.1, filed January 11, 2019, EP 19151325.8, filed January 11, 2019, and EP 19155800.6, filed February 6, 2019, in the name of Debiotech SA, the entire disclosures of which are incorporated herein by reference.

[0095] Example of operation principle Figures 22a, 22b and 22c show an example of the general concept of a display device as described herein. The shape and size are not representative. In these figures, only one moving element is depicted, but the basic concept is the same for two moving elements, and therefore both reference numbers are used for this moving element (11, 12). In these figures, the display device displays information about the status of the injection, but the basic concept is the same for other embodiments described herein.

[0096] The delivery system (1) comprises a reservoir (5) adapted to store a medical fluid (e.g., a non-compressible fluid such as a drug or other solution that can be infused into a patient, preferentially a liquid), a pump device (22) adapted to move the medical fluid stored in the reservoir, an outlet device (10) (e.g., an outlet port or a transdermal device) adapted to be in fluid communication with the patient, and a fluid pathway (18) providing fluid communication between the reservoir (5) and the outlet device (10).

[0097] For ease of explanation, the reservoir (5) is also referred to as a drug reservoir, but this designation does not limit the type of fluid that may be stored in the reservoir. For example, the drug reservoir may store a solution, e.g., a liquid solution, preferentially a medical fluid, such as a pharmaceutical, a nutritional, a biological or bioactive agent, a hormonal or gene-based substance, as well as other substances.

[0098] The drug reservoir (5) may comprise a movable wall (e.g., a plunger, a flexible membrane, etc.). The drug reservoir may further comprise a rigid portion. At least one of the movable wall and the rigid portion defines an internal compartment intended to receive a medical fluid to be injected into the patient. The drug reservoir may further comprise one or more outlets. The outlets of the reservoir are in fluid communication with at least one of the patient, the outlet device (10) and the display device (2). Preferentially, the fluid pressure in the drug reservoir is substantially transmitted to at least a part of the fluid path and / or the display device.

[0099] Preferentially, the pump device comprises a pressure device adapted to apply pressure to the drug reservoir (e.g., to a movable wall of the drug reservoir (5)) to move the medical fluid from an internal compartment of the drug reservoir to the outside (e.g., via its outlet). The pressure device may comprise a spring, a propellant chamber containing, for example, a liquefied gas, an expandable battery, a gas-generating cell, Nitinol wire, a Belleville washer, a Belleville spring, Expancel beads, a shape memory alloy, a shape memory polymer, a plunger, etc.

[0100] In some embodiments, the pump device is configured to inject the entire contents of the reservoir as a single bolus.

[0101] The exit device (10) may comprise a connection port, an exit port, a needle, a cannula, a tube, a connector, a percutaneous device, or the like.

[0102] Preferentially, the display device (2) comprises a body in which a cavity (13) (also called a cylinder, even if its shape is not essential) is arranged. The cavity (13) may comprise a first end (14) and a second end (15), both of which may define a main axis. At least one movable element (11, 12) is arranged in the cavity and is configured to move relative to the cavity, for example along the main axis or in a direction parallel to the main axis. The at least one movable element is configured to move in response to the pressure of the solution (for example the pressure present in the drug reservoir). The at least one movable element may comprise a plunger.

[0103] In some embodiments, the display indicates the status of the injection with a single plunger (e.g., with an advance and retract movement), while in other embodiments, the display indicates the status of a delivery system using two or more different plungers (e.g., a first plunger and / or a second plunger).

[0104] Preferentially, the display device is in pressure communication with at least one of the drug reservoir and the outlet device. For example, pressure present in an internal compartment of the drug reservoir may be transmitted to the display device to move at least one movable element through the cavity.

[0105] The display device may be in fluid communication with the internal compartment of the drug reservoir (and / or with the outlet device) to transmit fluid pressure to the display device. More specifically, the outlet of the drug reservoir (5) may be in fluid and / or pressure communication with the display device (2).

[0106] In some embodiments, the outlet of the reservoir is in fluid communication with the patient and the display device, where during drug delivery, a portion of the medical fluid (intended to be injected into the patient) fills the cavity at least partially (e.g., a first variable volume as described herein), and at the end of the injection, the biasing means induces a retraction movement of at least one of the movable elements that empties the cavity and injects the remaining medical fluid (temporarily stored in the cavity of the display device) into the patient.

[0107] The fluid path may comprise a T-shaped flow path adapted to receive the solution at a pressure approximately equal to the fluid pressure in the drug reservoir. The T-shaped flow path may comprise a first fluid port in fluid communication with the outlet of the reservoir, a second fluid port in pressure communication and / or fluid communication with the display device, and a third fluid port in fluid communication with the outlet device (and / or in fluid communication and / or pressure communication with the valve device). The T-shaped flow path is configured to provide fluid communication from at least one of the first fluid port, the second fluid port, and the third fluid port to one of the other of said fluid ports. The T-shaped flow path is described herein to illustrate the principle, and other types of flow paths may provide the same technical features.

[0108] The valve device may be configured to block at least one of a first fluid port, a second fluid port, and a third fluid port, the first fluid port may be configured to allow solution to flow from the interior compartment of the reservoir (from the outlet of the reservoir) to the T-shaped flow path, the second fluid port may be configured to be operably coupled to the display device, and the third fluid port may be configured to allow solution to flow from the T-shaped flow path to the outlet device.

[0109] The T-shaped flow path may be in fluid communication with an inlet port of a delivery system. The T-shaped flow path may further comprise a separate port in fluid communication with the inlet port of the delivery system. The inlet port of the delivery system may be configured to be in fluid communication with an internal compartment of the drug reservoir.

[0110] According to Figures 14 and 22, when the plunger is in a predetermined position (eg, the first position and / or the third position), a portion of the plunger may extend through a portion of the T-shaped channel.

[0111] The drug reservoir may include an inlet adapted to fill the drug reservoir with the solution to be delivered (e.g., when the drug reservoir is initially or sold empty). The inlet may be in fluid communication with an inlet port of the delivery system. The inlet may be different from the outlet of the reservoir. In another embodiment, the inlet may also be the outlet of the reservoir. In this case, the outlet of the reservoir is in fluid communication with the inlet. Additionally, the inlet of the drug reservoir may be in fluid or pressure communication with a display device. In this case, the display device may also be used to provide information related to the filling of the drug reservoir.

[0112] The delivery system may include a housing within which the drug reservoir (5), the pump device (22), the valve device (3), the fluid pathway (18) and / or the display device (2) may be at least partially disposed.

[0113] According to Fig. 22a, the plunger device (11, 12) is in an initial position which may indicate that the delivery system is in a ready-to-inject or ready-to-use state, which may be the initial state of the delivery system.

[0114] If the plunger arrangement comprises a valve device (3), the valve device may block the fluid path between the reservoir and the outlet arrangement when the plunger is in the initial position. This valve device may prevent solution from reaching the outlet arrangement before activation of the delivery system, for example when a user fills the drug reservoir. The valve device may be a movable element (e.g. the first plunger) inserted into a part of the fluid path or a rod mechanically coupled to a part of the plunger, as described below.

[0115] Turning now to FIG. 22b, after actuation of the delivery system, the drug reservoir (5) is pressurized by the pressure device and medical fluid flows through the fluid path, moving the movable elements (11, 12) relative to the cavity (e.g., linearly (22) following an axis defined by both ends of the cavity). The volume defined between the first movable element and the first end of the cavity increases and may receive a volume fraction of the medical fluid. The movable elements move towards a predetermined position and the display indicates that injection is in progress. This position may be maintained until the drug reservoir is emptied.

[0116] When the movable element is in fluid communication with the medical fluid, the cavity includes a fluid port and a volume fraction of the medical fluid fills a portion of the cavity (between the end with the fluid port and the plunger device).

[0117] If the display device (2) comprises only one movable element, the movable element is moved. If the display device comprises two different movable elements, both movable elements are moved, for example the first movable element may be moved by the fluid pressure and the second movable element may be moved by the first movable element (for example pushed by the first movable element or due to a compressed gas pocket between the first and second movable elements). During this stage the volume between the second movable element and the second end of the cavity is reduced. If the second end does not comprise a vent, the gas in this volume is compressed.

[0118] If the display device comprises a valve device (3), when the pressure device is actuated the fluid pressure in the drug reservoir increases until it reaches a predetermined threshold required to open the valve device.

[0119] 22c, when the drug reservoir is empty, the fluid pressure of the medical fluid decreases until it reaches atmospheric pressure (or interstitial pressure if the outlet device comprises a transdermal device). The indicator may be configured to move at least one of the first and second movable elements toward the first end to indicate that the infusion is complete. The volume between the first movable element and the first end decreases. If this volume is receiving a volume fraction of the medical fluid, the movement of the movable element expels the solution through the pathway to the outlet device.

[0120] The cavity may be cylindrical or rectangular prism shaped.

[0121] FIG. 1 shows an optional vent (40) that may be required in some embodiments.

[0122] Examples of Delivery Systems An example of a delivery system adapted to include a display device was subsequently disclosed in European Patent Application Publication No. 18182850.0, filed July 11, 2018, and European Patent Application Publication No. 19151324.1, filed January 11, 2018, in the name of Debiotech SA, the entire disclosures of which are incorporated herein by reference.

[0123] As shown in Fig. 25, the delivery system (101) may comprise a first reservoir (111) adapted to store a medical fluid (such as a drug, medicinal or other fluid). The medical fluid may be a liquid or a gas, e.g., an incompressible fluid, and is intended to be delivered to the patient (102), e.g., via a transdermal device (107). The transdermal device (107) may be in fluid communication with the first reservoir (111) and may comprise, e.g., a needle, a cannula, one or more microneedles, or other means adapted or configured to deliver the medical fluid to or on the patient's body.

[0124] The delivery system (101) may further comprise a pressurizing means (114) which may be operatively coupled (106) to the first reservoir (111). For example, the pressurizing means (114) may be adapted or configured to pressurize the first reservoir (111) to cause a flow of medical fluid from the first reservoir (111) to the patient (102). For example, if the first reservoir (111) comprises a movable wall (e.g. a flexible membrane), the pressurizing means (114) may be configured to act on the movable wall to pressurize the first reservoir.

[0125] In some embodiments, the pressurization means may comprise a propellant chamber containing, for example, a liquefied gas having a vapor pressure at 20° C. comprised in the range [+0.1 bar; +10 bar]. The device may comprise a valve that is opened during operation of the system and allows pressurization of the first reservoir (111), for example by transmitting pressure applied to a movable wall of the first reservoir (111).

[0126] The delivery system (101) may further comprise an actuation means (115) which may be operatively coupled to the pressurization means (114). For example, the actuation means (115) may be adapted or configured to allow pressurization of the first reservoir.

[0127] In some embodiments, the pressurizing means may comprise a second reservoir and the actuation means may comprise a third reservoir in fluid or pressure communication with the pressurizing means. The actuation means may further comprise a valve arrangement and a fluid pathway that allows fluid communication between the second reservoir (of the pressurizing means) and the third reservoir (of the actuation means), for example when the valve arrangement is in an open position.

[0128] The third reservoir of the operating means may be configured or adapted to store a compressed fluid, such as a propellant. The propellant may be a liquefied gas that exhibits a large value of vapor pressure at ambient temperature. The pressure range is therefore determined by the occurrence of this vapor pressure within a given range of operating temperatures, typically between 5°C and 40°C. Considering isobutene as the propellant, this pressure (absolute) is, for example, 1.86 bar at 5°C, 3 bar at 20°C and 5.25 bar at 40°C.

[0129] According to another embodiment, the pressurizing means (114) may comprise a spring, a resilient device, an actuator acting on the first reservoir (e.g. a movable wall, a flexible wall, a plunger, etc.), and the acting means (115) may comprise an element adapted to release or generate gas, such as a battery or other chemical element, or to act on the pressurizing means (114).

[0130] The delivery system may be intended for a single use, such that after a single use / delivery, the delivery system is discarded, e.g., may be discarded entirely.

[0131] The delivery system may be configured to deliver the entire amount of solution contained in the first storage compartment in a single bolus such that once the trigger device is actuated, the delivery system will infuse the solution into the patient until the first storage compartment is substantially empty.

[0132] The delivery system may be adapted to inform the patient of the completion of delivery via an indicator device as disclosed herein.

[0133] Preferentially, the delivery system does not comprise any electronic elements configured to deliver the solution and / or pressurize the first reservoir and / or control the pressurizing means (114) and / or the actuation means (115). However, in some embodiments, the delivery system may comprise electronic devices configured to control and / or monitor the delivery. For example, the display device may comprise several electronic elements such as a pressure sensor, a processor and / or a light indicator (such as an LED). However, preferentially, the delivery system and the display device are configured to operate without electronic elements and / or batteries.

[0134] The delivery system (101) disclosed in FIG. A first reservoir (111), A second reservoir (112), and Third reservoir (113) The present invention is provided with at least one of the following:

[0135] In some embodiments, the first reservoir (111) comprises a first storage compartment, a first movable wall (e.g., a flexible wall / membrane) configured to change the capacity of the first reservoir (111) (e.g., the volume of the storage compartment), and an exit port that allows the solution to exit the storage compartment. The exit port is configured to be in fluid communication with a transdermal device (107), for example, when the delivery system delivers the solution to a patient.

[0136] The first reservoir may include an inlet port for filling the storage compartment with a solution (e.g., a medical fluid) intended to be delivered to the patient. The inlet port and the outlet port may be the same port, or the inlet port may be a different port than the outlet port.

[0137] In some embodiments, the second reservoir (112) comprises a second storage compartment and a second movable wall (e.g., a flexible wall / membrane) configured to change the volume of the second reservoir (112) (e.g., the volume of the second storage compartment). More specifically, the change in the volume of the second storage compartment induces a movement of the second movable wall (e.g., a movement / deformation / stretching of the flexible membrane). The second reservoir may comprise an inlet port. The second reservoir (112) may comprise an outlet port configured to expel the propellant from the second reservoir, for example, at the end of delivery.

[0138] Preferentially, the first reservoir (111) and the second reservoir (112) comprise a reservoir interface (106) configured to provide pressure communication between the first reservoir and the second reservoir when the first movable wall and the second movable wall are in at least partial contact.

[0139] In some embodiments, the third reservoir (113) comprises a third storage compartment (113a) configured to store a compressed fluid (in a compressed state), such as a propellant. The third reservoir may comprise a rigid wall such that the volume of the third storage compartment is constant. The third reservoir comprises an outlet port configured to be in fluid communication with the second storage compartment in a delivery state such that the compressed fluid flows from the third storage compartment to the second storage compartment.

[0140] The delivery system may further comprise a display device (109). The display device may be operatively coupled (e.g., in pressure communication, fluid communication, etc.) to at least one of the first reservoir, the second reservoir, the third reservoir, and the transdermal device. The display device (109) may be configured to provide a user with information regarding a status or description of an element of the delivery system or the filling process, such as one of: occluded, ready, ready to actuate, ready to fill, ready to inject, delivery in progress, error, reservoir compartment full, reservoir compartment empty, delivery completed, etc.

[0141] The delivery system may comprise a skin-adherable unit (103) configured to secure the delivery system to the patient's skin. The skin-adherable unit may comprise a first side having an adhesive surface facing the patient's skin surface for adhesion, and a removable cover for covering the skin-adherable unit. The skin-adherable unit may further comprise a frame and a coupling device configured to (optionally removably) secure the delivery system.

[0142] The delivery system may further comprise at least one of a trigger device (108), a vent device (116), one or more valve devices (104, 126), a fluid pathway (105), and the like.

[0143] As disclosed in Figures 27a, 27b, 27c, 27d and 27e, the interface (106) of the reservoir may comprise a cavity defined by at least a first surface (106a) of the first movable wall and a second surface (106b) of the second movable wall. Preferentially, the first surface (106a) is disposed opposite the second surface (106b). The interface (106) of the reservoir may be such that the first surface (106a) is and / or spaced apart from the second surface (106b) when the delivery system is in a first state (e.g., an initial state of the delivery system); When the delivery system is in the second state (e.g., the delivery state of the delivery system), it may contact the second surface (106b). It can be configured as follows.

[0144] The reservoir interface cavity may have a variable volume depending on the delivery and / or filling conditions, and is preferentially vented by a vent device (116) as described below.

[0145] The vent device (116) (e.g., an opening) is intended to allow fluid communication at least between the interior of the delivery system and the environment outside the delivery system. The vent device may be configured to keep the cavity of the interface (106) of the reservoir vented. In particular, the vent device may be configured to achieve pressure equilibrium of the interface cavity of the reservoir when at least one of the volumes of the first and second storage compartments varies. However, the system may comprise an occlusion device configured to occlude the vent device (116) at least during the filling process or the storage period.

[0146] The vent device may include a hydrophobic membrane, filter, or coating configured to prevent the inflow of water into the housing. The vent device may include a baffle configured to prevent the insertion of a straight rigid tip.

[0147] One example of a vent device that may be included in the delivery system is described in US Pat. No. 9,872,955, the entire disclosure of which is incorporated herein by reference.

[0148] Figures 27a, 27b, 27c, 27d and 27e show different possible states of the delivery system, particularly of the first and second reservoirs.

[0149] Initial state: In some embodiments, as disclosed in Figures 27a and 27b, the first storage compartment may initially not store any medical fluid (e.g., before delivery, when the delivery system is in a packaged state), and the volume of the first storage compartment may initially be minimal. In this case, the first storage compartment may initially be substantially empty. The movable wall may contact (or be very close to or closest to) the opposite inner wall of the first reservoir (e.g., over a substantial length of the first storage compartment), for example, against the inner wall of the rigid portion of the first reservoir (111).

[0150] In another embodiment (such as the state of the system shown in FIG. 27d), the first storage compartment may initially store the medical fluid, in which case the volume of the first storage compartment may be at its maximum.

[0151] In either case, preferentially, the movable walls of the first and second reservoirs do not come into contact, so as not to exert any unintended pressure on the first reservoir. Furthermore, the interface of the reservoirs may be vented by a vent device. Alternatively, a removable occlusion device may temporarily block the vent device.

[0152] In an initial state of the delivery system, the gap (117) between the first surface (106a) of the first movable wall and the second surface (106b) of the second movable wall may be at a maximum and / or the volume of the interface cavity (144) of the reservoir may be at a maximum.

[0153] Preferentially, the volume of the second storage compartment is initially minimal, although the second storage compartment may not be empty and may initially store a fluid, such as a gas (e.g. air trapped during the manufacturing process).

[0154] The third reservoir (not shown in FIG. 27) preferentially comprises only rigid walls, the volume of the third storage compartment is constant, and the third storage compartment may or may not initially store compressed fluid.

[0155] Filling process: If the first storage compartment does not initially store medical fluid, the user must fill the first storage compartment before use, and the first reservoir may include an inlet port configured to fill the first storage compartment with medical fluid.

[0156] FIG. 27c shows the filling of the first reservoir via the syringe (121), where the volume of the first storage compartment increases and the volume of the interface cavity (144) of the reservoir decreases. The first face (106a) of the first movable wall moves towards the second reservoir, e.g. towards the second face (106d) of the second movable wall. Fluid (e.g. gas trapped in the interface cavity of the reservoir) can be released / vented to the outside of the delivery system through the vent device (116). If the vent device is clogged or blocked by the removable occlusion device, the pressure in the first storage compartment (111a) and / or the pressure in the interface cavity (144) of the reservoir will increase as the first reservoir fills. As described herein, the display device can detect this pressure increase and provide a filling indication to the user.

[0157] If the third storage compartment does not initially store compressed fluid, the user must fill the third storage compartment prior to use, and the third reservoir may include an inlet port configured to fill the third storage compartment with compressed fluid.

[0158] Drug-full state: At the end of the filling process, the gap between the first surface (106a) of the first movable wall and the second surface (106b) of the second movable wall is substantially reduced. The first surface (106a) of the first movable wall and the second surface (106b) of the second movable wall may or may not be in contact. Pressure, if any, on the first movable wall must be limited and must not induce flow of solution to the patient.

[0159] In this state, the display may indicate that the delivery system is ready to inject or that the drug reservoir is full.

[0160] Activation / Delivery Status After the trigger device is actuated (e.g., immediately or after a predetermined period of time), the trigger device initiates a change in state of the delivery system. The valve device (104 disclosed in FIG. 26) switches from a first state / position (closed position) to a second state / position (open position). The second state / position of the valve device induces a flow of compressed fluid from the third storage compartment to the second storage compartment. The second movable wall moves towards the first reservoir due to the fluid pressure of the compressed fluid. The fluid pressure of the compressed fluid entering the second reservoir induces a displacement (bending) of the second movable wall which exerts pressure on the first movable wall.

[0161] At least during delivery, the second movable wall is configured to contact the first movable wall over at least 50%, preferentially at least 80%, more preferentially at least 90%, for example (substantially) 100%, of a surface of the first movable wall.

[0162] The fluid pressure of the second reservoir is transferred (at least partially or substantially) to the first reservoir, and in particular to the solution stored in the first storage compartment, and the pressure induces a flow of the solution into the transdermal device.

[0163] The volume of the second storage reservoir and / or the amount of compressed fluid is adapted to have a substantially constant fluid pressure during a predetermined period of delivery. For example, this predetermined period can be at least 50%, preferentially at least 80%, more preferentially at least 90% of the period required to substantially empty the first storage compartment, for example at least equal to the period required to substantially empty the first storage compartment. In the latter case, the fluid pressure is constant throughout the entire period of delivery.

[0164] Display unit body The display device may include a body having a cavity in fluid or pressure communication with the fluid pathway via a fluid port or via an element configured to transmit pressure to a plunger disposed within the cavity.

[0165] At least a part of the display device may be made of transparent plastic, for example, polypropylene (PP), polycarbonate (PC), polyethylene (PE), polyolefin, cycloolefin copolymer (COC), cycloolefin polymer (COP). The inner surface of the cylinder may be coated, for example, by PEG, silicone, or parylene. A lubricant (such as silicone oil) may also be used to improve the movement of the plunger. The plunger(s) is made of rubber or silicone or any other hard elastomeric material. However, the friction of the plunger against the cavity wall may prevent undesired movement of the plunger during the process of filling the reservoir.

[0166] The first variable volume may be configured to receive a volume fraction of a solution intended to be infused into the patient, and thus the wall material of this volume may comprise a material that is compatible with the solution.

[0167] Moving elements In some embodiments, the movable element may be a plunger or other element that may be configured to move through / into a cavity of the display device. For simplicity of explanation, the movable element is illustrated herein as a plunger.

[0168] The plunger may include a lip configured to slide against the cavity wall and achieve a tight interface. For example, the plunger may exhibit a structured or sealing lip that improves tightness and / or makes friction dependent on the direction of movement. In another embodiment, one plunger may only move in one direction (as shown in FIG. 4). The orientation of the lip may be included between +90° and -90°.

[0169] A first embodiment of the display device comprises a single plunger. The single plunger (also called the first plunger) may be configured to perform at least one motion through the cavity, more preferentially two motions through the cavity, for example forward and backward motions. The first plunger may be configured to move in response to the pressure of the solution intended to be delivered (in response to the fluid pressure in the drug reservoir).

[0170] The single plunger may be disposed within the cavity and define a first variable volume between a first end of the cavity and the single plunger and a second variable volume between a second end of the cavity and the single plunger.

[0171] Initially, the plunger may be in a first initial position. When the solution pressure increases (caused by the actuation of the delivery), it induces the movement of the first plunger along the first path until the first plunger reaches the second position. Preferentially, at this stage, the first variable volume increases and the second variable volume decreases. The second position may be maintained while the solution pressure is within a predetermined range or greater than a predetermined value (which may be required for the flow of the solution to the patient). When the solution pressure decreases, the biasing means (compressed gas, spring, etc.) may move the first plunger along a second direction (e.g. opposite to the first path, e.g. towards the first position) until the third position or the first position is reached. Preferentially, at this stage, the first variable volume decreases and the second variable volume increases.

[0172] A second embodiment of the display device comprises two (or more, for example three) plungers. The first plunger may be configured to perform at least one movement through the cavity, more preferentially two movements through the cavity, for example a forward and backward movement. The first plunger may be moved depending on the pressure of the solution intended to be delivered.

[0173] The first and second plungers (and more plungers) may be disposed within the cavity to define a first variable volume between a first end of the cavity and the first plunger, a second variable volume between the first plunger and the second plunger, and a third variable volume between the second plunger and the second end of the cavity.

[0174] Initially, the first plunger may be in a first initial position. When the solution pressure increases (caused by the actuation of the delivery), the solution pressure induces the movement of the first plunger according to the first path to the second position. Preferentially, at this stage, the first variable volume increases, the second variable volume is constant or decreases, and the third variable volume is constant or decreases. The second position may be maintained while the solution pressure is within a predetermined range or greater than a predetermined value (which may be required for the flow of the solution to the patient). When the solution pressure decreases, the biasing means (compressed gas, spring, etc.) may move the first plunger according to a second direction (e.g., opposite to the first path, e.g., towards the first position) to the third position or to the first position. Preferentially, at this stage, the first variable volume decreases, the second variable volume increases, and the third variable volume is constant. The second plunger may be configured to perform at least one movement through the cavity, or two movements through the cavity, for example, forward and backward movements. One movement of the second plunger may be triggered by the pressure of the solution intended to be delivered and / or by the movement of the first plunger. For example, the solution pressure may trigger a movement of the first plunger pushing the second plunger along the same path. Initially, the second plunger may be in a first initial position. When the solution pressure increases (triggered by the actuation of delivery), the solution pressure and / or the first plunger induces a movement of the second plunger according to a first direction to a second position. The second position may be maintained while the solution pressure is within a predetermined range or greater than a predetermined value (which may be required for the flow of the solution to the patient). When the solution pressure decreases, a biasing means (compressed gas, spring, etc.) may move the second plunger according to a second direction (e.g. opposite to the first direction, e.g. towards the first position) to a third position or to the first position. In another embodiment, the second plunger remains in its second position even if the solution pressure decreases at the end of delivery.

[0175] At least one plunger includes a surface against which fluid pressure is applied. A surface of the first plunger may be configured to contact the solution to be delivered, where the solution exerts a force (due to fluid pressure in the drug reservoir) against this surface that causes movement of the plunger.

[0176] The second plunger (12) may, for example, have a fluid passage (such as a porous element such as a through hole) extending from one end of the second plunger to an opposite end of the second plunger along an axis parallel to the axis of the elongated cavity (i.e., the axis of rotation of the cylindrical elongated cavity).

[0177] The plunger may be configured to slide against the elongated wall of the cavity, and further, a sealing material (e.g., the plunger may include the sealing material) may be disposed between the plunger and the elongated wall of the cavity to provide a sealing interface between a volume defined downstream of the plunger and another volume defined upstream of the plunger.

[0178] Display cavity As described above, the display device comprises a body including an (internal) cavity that may have at least one reservoir and / or fluid port adapted to be coupled to a transdermal device. The cavity further comprises a first end and a second end defining a major axis. The first end may comprise the fluid port.

[0179] The second end of the cavity can be connected to a communication port that is in fluid communication with the external environment of the device. The communication port can be closed (a termination obtained using a plug or heat welding, UV welding, overwelding, US welding, overmolding, etc.). Thus, the initial air volume is trapped inside the cavity, for example at atmospheric pressure, 1013 millibar absolute (1 atm).

[0180] In some embodiments, the display device comprises at least one of a first fluid port in fluid or pressure communication with the medical fluid reservoir and a second fluid port in fluid or pressure communication with the pressurized reservoir.

[0181] One or more movable elements are movably disposed within the cavity, and the interior walls of the cavity and the movable elements (walls or surfaces) define at least one variable volume.

[0182] In some embodiments, the display device comprises two distinct cavities: a first cavity in fluid or pressure communication with the medical fluid reservoir and a second cavity in fluid or pressure communication with the pressurized reservoir. The first cavity may be strictly separate from the second cavity.

[0183] Position of the moving element The first movable element is configured to have at least two different positions, namely a first initial position and a second position. Preferentially, the first movable element is configured to move from the first initial position to the second position and then from the second position to the first initial position or to the third position.

[0184] The first movable element can be configured to reach the second position when the solution is flowing to the patient. The first movable element can be configured to remain in the second position for a substantial portion of the duration of solution delivery.

[0185] In the case where the display device comprises two different movable elements, the second movable element is configured to have two different positions, namely a fourth initial position and a fifth position. The second movable element may be configured to move from the fourth initial position to the fifth position and then remain at the fifth position. The second movable element may be configured to reach the fifth position when the solution is flowing to the patient. The second movable element may be configured to remain at the fifth position after the end of solution delivery.

[0186] Stopping member The indicator may include a first mechanical stop (23) (also called stop member) used to define the position of the plunger during injection (see FIG. 6). After activation of the device, the plunger is to reach the first mechanical stop, which may be located at the end side of the cavity, taking into account the worst specified pressure conditions. For example, if the device runs on liquefied gas (such as butane), the worst conditions are met at the lowest specified temperature, which corresponds to the minimum value of the propellant vapor pressure and therefore the injection pressure.

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[0187] The stop member may be at the first end of the cavity or at the second end of the cavity, may be located within the cavity, for example against an inner wall of the cavity, or may be a magnetic element (or a ferromagnetic element) cooperating in a magnetic way with the moving element (comprising a magnetic element or a ferromagnetic element). The stop member may be dedicated to one or more moving elements.

[0188] As disclosed in Figures 5, 6, 12 and 13, the stop member (23) may be configured to stop the at least one moving element and allow the movement of the at least one moving element according to a single direction. Thus, the movement of the at least one moving element may be limited to only one direction by the stop member.

[0189] Some figures (see, for example, FIG. 7) do not show the stop member since it may be obscured by a portion of the cavity body.

[0190] The stop member may be configured to prevent displacement of the movable element unless a pressure threshold is reached, for example as described below under the heading "Indicators with Threshold Effect".

[0191] Zero Adjustment Magnet Initialization / zeroing of the moving element position can be done using a magnet placed inside the cylinder. This magnet can be used as a mechanical stop. The main drawback is that MRI compatibility is lost unless the magnet is mechanically fixed at manufacture after positioning of the moving element.

[0192] Indicators with threshold effect The indicator may be configured such that the plunger requires a minimum pressure to initiate its displacement. Thus, for example, during filling of the drug reservoir, even if pressure occurs (e.g. due to filling), this pressure is not sufficient to initiate the movement of the plunger. It is interesting not to change the plunger position during this stage. The initial displacement is fixed by the large pressure generated during device actuation, which pressure on the plunger is by design much larger than the frictional forces.

[0193] The plunger can reach its post-actuation position (right part of the cavity) During the final pressure release, when the liquid in the communication port is no longer pressurized, the plunger may move towards its initial position without reaching that point due to the threshold effect.

[0194] This threshold effect can be obtained by: Friction between the cylinder and the plunger: Friction controlled by the tolerance between the cylinder and plunger diameter Friction controlled by structuring of the cylinder and / or plunger Friction controlled by the presence of a sealing lip (see e.g. Figure 4) Friction caused by the internal shape of the cylinder or the external shape of the plunger (see, for example, Figure 5) An embodiment of an injection status indicator with only one plunger is shown in Figure 5. The presence of a conical narrowing inside the cavity allows the definition of three different positions of the plunger: Initial position = plunger in the right part of the cavity Injection position = plunger in the left part of the cavity End of injection = plunger in middle predefined position (cone narrowing) FIG. 5d shows an example of a window placed on the body of the display device that allows visualization and thus determination of the injection status in an unambiguous manner.

[0195] Filling stage The display device may be configured to display an indication to a user regarding the filling stage. The position of the movable element may be reached when a sufficient amount of solution has been filled into the drug reservoir.

[0196] In some embodiments, as shown in Figures 23a-23f, the display device (2) may comprise an indication of the end of filling. In this example, the display device (2) further comprises four different states / positions (of one or more movable elements). A first plunger (11) (e.g. a solid first plunger) and a second plunger (12) (e.g. a perforated plunger) are located inside the cavity. Preferentially, the delivery system (not shown) further comprises a valve device (not shown), such as a free-flow prevention valve having a predefined opening threshold (described below), said predefined opening threshold being substantially greater than the maximum reservoir pressure occurring during reservoir filling.

[0197] Three volumes are defined: a first variable volume between the first plunger (11) and the first end (14) of the cavity, a second variable volume between the two plungers (11, 12) in which a biasing means (29) (such as a compressible spring) may be arranged (acting on both plungers), and a third variable volume between the second plunger (12) and the second end (15) of the cavity. Optionally, the third variable volume may be vented via a vent device (28). The two plungers are initially arranged to the right of the stop member (23).

[0198] When the delivery system (1) is initially empty, the user must fill the drug reservoir (5). For this purpose, the drug reservoir may be provided with an inlet port (38) in fluid communication with an internal compartment of the drug reservoir (as disclosed in FIG. 1). The user may use a syringe to fill the drug reservoir (5) with a solution.

[0199] Position 1 (Fig. 23a): Before filling, the biasing element (29) maintains the two plungers against the stop member (23) and the first end (14) of the cavity. If the display device has the window arrangement of Fig. 23e, only the second plunger (12) is visible through window 1. If the display device has the window arrangement of Fig. 23f, only the first plunger (11) is visible through window 1. In another embodiment, neither the first nor the second plunger may be visible through any window before filling of the reservoir.

[0200] When the user fills the drug reservoir, the solution initially stored in the syringe is displaced to the interior of the drug reservoir, and the membrane (7) moves in response to the injection volume in the drug reservoir.

[0201] Position 2 (Fig. 23b): After filling, the first plunger (11) is visible through the window 2. The reservoir is filled with a slight pressure P fill This pressure causes the solid plunger to move to the left, compressing the spring. The spring stiffness is adjusted to force the first plunger to reach the protrusion of the second plunger.

[0202] To generate sufficient pressure in the drug reservoir during (or at the end of) filling, the injection volume of the solution may be greater than the volume of the internal compartment of the drug reservoir, in which case the volume of the internal compartment of the drug reservoir may be configured such that the end of filling is characterized by a peak of pressure in the drug reservoir that causes the first plunger to reach a predetermined position.

[0203] Optionally, the pressure may further be generated due to elasticity of the membrane, where the elasticity of the membrane may be configured such that the end of filling is characterized by a peak of pressure in the drug reservoir that causes the first plunger to reach a predetermined position.

[0204] Position 3 (FIG. 23c): During injection (after delivery activation), a large injection pressure P injcauses both plungers to move to the left. If the delivery system includes a valve device, the valve device opens the fluid pathway to allow solution to flow to the outlet device.

[0205] If the display device has the window arrangement of Figure 23e, only the second plunger (12) is visible through the window 3. If the display device has the window arrangement of Figure 23f, only the first plunger (11) is visible through the window 3.

[0206] Optionally, the second plunger (the protrusion of the second plunger) may be configured to maintain the first plunger in place during this stage and / or to prevent over-compression of the spring. The second plunger may include a through hole that provides pressure equilibrium or fluid communication between the second and third variable volumes.

[0207] Position 4 (Fig. 23d): After injection, the first plunger (11) is now visible through the window 4. The pressure in the cavity containing the drug drops to zero at the end of the injection. Under the action of the spring, the first plunger moves to the right until it reaches the stop member (23).

[0208] In this example, two different window arrangements are shown in Figures 23e and 23f. The window arrangement of Figure 23e provides a set of windows that allows the first plunger and the second plunger to view the status of the delivery system. The window arrangement of Figure 23f provides a set of windows that allows only one plunger (e.g., the first plunger) to view the status of the delivery system.

[0209] In another embodiment as shown in Figures 28a, 28b, 28c, 29a, and 29b, a delivery system (201) comprises a housing (202), an internal compartment such as a cavity (203), a reservoir module (204), and a fluid path (205). The module reservoir may comprise at least one of a first reservoir, a second reservoir, and a third reservoir as described herein.

[0210] Preferentially, the delivery system (201) comprises one or more vent devices (207). The vent devices (207), also called openings, vents or vent ports, may be provided to induce air into the housing to allow pressure equilibration inside the device. The vent devices may further allow for regulation of the air flow (e.g. according to pressure changes) to allow pressure equilibration and / or air movement (including oxygen) to one or more elements of the device that require, at least in part, communication with the surrounding air for operation. Such one or more elements may include a power source (such as a zinc-air battery), a display device (209) (see FIG. 30a).

[0211] In some embodiments, a selective membrane (such as a hydrophobic membrane layer) may cover the vent device (207) to prevent water from entering the delivery system or cavity. In some embodiments, at least one vent device is provided in proximity to at least one of the reservoir module (204), the display device (209), and the power source (212).

[0212] The fluid pathway (205) may include at least one of a pump device, a needle (206), a pressure transducer, and other elements (sensors, filters, etc.). For ease of explanation, the term "needle" is used to refer to the outlet device of the delivery system. The outlet device may be a needle, a transdermal device, or a port intended to be coupled to a transdermal device.

[0213] The reservoir module may comprise a first reservoir (also referred to as a drug reservoir as described herein) intended to be filled (as described above) and / or to store a solution. The first reservoir may comprise a movable wall (such as a flexible membrane, a plunger, etc.) that at least partially defines the internal compartment of the first reservoir. The first reservoir may comprise two movable walls (e.g., two flexible membranes) sealed together that at least partially define the internal compartment of the first reservoir. The first reservoir may comprise a movable wall (e.g., a flexible membrane) and a rigid wall sealed together that at least partially define the internal compartment of the first reservoir. The first reservoir may further comprise one or more fluid ports (e.g., an inlet port and / or an outlet port) intended to allow the filling process of the internal compartment (used as an inlet port) and / or to allow fluid communication with a fluid path (used as an outlet port). A filter may cover the outlet port of the first reservoir, for example disposed within the internal compartment.

[0214] The reservoir module may further comprise a pump device configured to move a solution stored within an internal compartment of the first reservoir, for example, by applying a positive pressure to the first reservoir (such as a pressurized gas, a liquefied gas, a spring exerting a force on a wall of the reservoir, etc.) The pump device may comprise a second reservoir (as described herein) having a movable wall that exerts a force on the movement of the first reservoir.

[0215] In Figures 28a, 28b, 29a, and 29b, a delivery system is shown that includes a removable occlusion device (208) that is intended to occlude at least one of the vent device (207) and the needle (206). In Figure 28c, the same delivery system is shown after removal of the occlusion device (208). The removable occlusion device (208) may include a first portion configured to maintain the needle in a sterile condition and a second portion configured to close the vent device. For example, the first portion may include, form, or close a cavity in which the needle is kept sterile, and the second portion may include a sealing surface to seal an interior compartment of the housing (e.g., cavity).

[0216] According to Fig. 30a, Fig. 30b and Fig. 30c, the display device comprises at least one movable element (e.g. one or more plungers (221, 222)) and a cavity inside which the at least one movable element may move. The at least one movable element (221, 222) may divide the cavity of the display device into two different volumes (a first volume (224) and a second volume (225)). The at least one movable element (221, 222) may provide a hermetic separation between the first volume (224) and the second volume (225). The first volume (224) and / or the second volume (225) may be defined by at least one of the walls of the cavity and at least one of the movable elements (e.g. the first plunger). The first volume (224) and / or the second volume (225) may be configured to increase and / or decrease as the movable element moves into the cavity of the pressure transducer.

[0217] Preferentially, the first volume (224) is in pressure communication with at least one of the first cavity (217), the fluid path (205), and the at least one reservoir of the reservoir module (204). For example, the display device may further have a fluid port (such as a first opening (226)) that provides fluid communication between the first cavity (217) and the first volume (224) of the cavity of the display device. The first plunger (221) may comprise a wall having a first face that receives the pressure present in the first cavity (217). The second plunger (222) may be arranged in the cavity of the display device (209), for example in the second volume (225). The second plunger (222) may be configured to be pushed, for example, by the first plunger, to move into the cavity. The second plunger may comprise a fluid communication means (such as a through hole) configured to prevent the second volume from being sealedly separated into two separate volumes. The display device (209) disclosed in Figures 30a, 30b, and 30c is a possible embodiment and may be replaced with another display device described herein, or vice versa.

[0218] The display device may include at least one window (223) configured to indicate a position of the at least one plunger within the cavity of the display device (209). A first opening and / or position (of the at least one plunger) may provide information related to a first condition of the delivery system or reservoir.

[0219] According to FIG. 30a, before the filling process, the volume of the internal compartment of the reservoir is minimal and the at least one plunger is in a first position in the pressure transducer. The first window may indicate the position of the at least one plunger. During the filling process, the pressure in the first cavity (217) increases and transfers this pressure to the first volume as the reservoir is filled. The at least one plunger moves as the pressure increases and / or the reservoir is filled. According to FIG. 30b, at the end of the filling process, the volume of the internal compartment of the reservoir is maximal and the at least one plunger is in a second predetermined position in the pressure transducer. The second window may indicate the position of the at least one plunger. According to FIG. 30c, once the filling process is finished, the filling device (219) may be removed and the removable occlusion device (208) is removed.

[0220] When the removable occlusion device (208) is removed, excess pressure present in the first cavity may escape through the vent device (207). In some embodiments, the second volume (225) may be sealed and / or comprised of biasing means, which may cause retraction of at least one plunger (e.g., the first plunger (221)) as excess pressure escapes through the vent device (207). In some embodiments, the at least one plunger may comprise a second plunger (222) (as described above), and if the second plunger comprises a fluid communication means, only the first plunger (221) may retract to or towards the first position. In this case, the second plunger may remain substantially in the second position.

[0221] A similar embodiment is disclosed in FIG. 31, which shows several views of a possible indicator (or filling gauge) that can be used with the system described herein. One example of another possible system is described in EP 18182850.0, which is incorporated herein by reference. In this embodiment, the indicator (209) or the visible part of the indicator (209) is located at the bottom of the device and is therefore only visible during the filling process. As shown in FIG. 31a, FIG. 31b and FIG. 31c, the filling volume can be indicated by the position of the plunger. In FIG. 31a, the two plungers (221, 222) to the left of the indicator are shown before filling. In FIG. 31b, the two plungers (221, 222) to the right of the indicator are shown immediately after filling and before removing the occlusion device from the vent device. In FIG. 31c, the first plunger (221) to the left of the indicator and the second plunger (222) to the right of the indicator are shown after removing the occlusion device. A text display or a scale display may indicate the volume filled by the second plunger.

[0222] In some embodiments, the display may provide indications regarding filling (of the first reservoir) and delivery. In some embodiments, the display may comprise a first side and a second side, the first side configured to provide an indication regarding filling and the second side configured to provide an indication regarding delivery. Some embodiments with such features are shown in Figures 32-35.

[0223] For example, Figures 32a, 32b, 32c, 32d, and 32e show a first side (301) of a display device (300) that may provide an indication regarding the filling of the first reservoir, and Figures 32a', 32b', 32c', 32d', and 32e' show a second side (302) of the display device (300) that may provide an indication regarding delivery. Each side includes at least one of a visual element (305) and a viewing window (306). Figures 32a, 32b, and 32c show the movement of the first and second movable elements (303, 304) (also called plungers) during filling of the first reservoir. The display device may include a first end (308) and a second end (309) that define a major axis (310). The display device (300) may further comprise a fluid port (307) coupled to at least one of the first reservoir and the transdermal device (or others as described in some embodiments herein). The delivery system (not shown) may comprise a vent device and a dedicated removable occlusion device (as described above).

[0224] The delivery system may be configured to prompt the user to expose a first side of the display device during drug loading. For example, the delivery system may comprise an upper surface and a lower surface. The lower surface may comprise an inlet port of the first reservoir and expose a first side (301) (e.g., a first visible side or surface) of the display device (300), and the upper surface may expose a second side (302) (e.g., a second visible side or surface). An example of such a delivery system is shown in FIG. 37. According to this embodiment, the delivery system (400) may comprise a reservoir module (407) (as described above), an inlet port (403). The delivery system may comprise a first surface (401) (e.g., a lower surface) and a second surface (402) (e.g., a top surface). In this example, the first surface is opposite the second surface, but other arrangements may be possible. The first side (401) may expose a first side (405) of the display (404), and the second side (402) may expose a second side (406) of the display (404). The first side may further comprise access to the inlet port (403). Thus, during the filling process, the user may have to turn the delivery system upside down. In this position, the inlet port and the first side are visible to the user, but the second side is not. In other words, when the first side is visible to the user, the second side may be hidden or invisible, and / or when the second side is visible to the user, the first side may be hidden or invisible.

[0225] In Fig. 32a and Fig. 32a', the positions of the first and second plungers are shown before the filling process. During the filling process (see Fig. 32b and Fig. 32b'), the volume of the first reservoir increases, but since the interior of the delivery system cannot be vented by the vent device (due to the removable occlusion device as described above), the pressure in the first reservoir and / or the interior of the delivery system increases. This pressure increase triggers the movement of the first and second plungers. The relative positions of the first and second plungers with respect to the visual elements (text, icon, symbol, scale, etc.) can provide an indication of the filling volume (e.g., here 3 milliliters). At the end of the filling process (see Fig. 32c and Fig. 32c'), the removable occlusion device may be removed, and at least one of the first plunger (303) and the second plunger (304) performs a retraction movement (e.g., to an initial position or to a predetermined position). The retraction movement may be caused by a biasing means, for example pressurized gas, a spring, a biasing element, or the like.

[0226] For example, if the volume defined between the second end (309) and at least one of the first plunger (303) and the second plunger (304) is sealed, the air or gas trapped in this space may be pressurized due to at least the first motion, acting as a counterforce (other embodiments of this display device are possible as described herein). Thus, when the removable occlusion device is removed from the vent device, the pressure in the first reservoir and / or inside the delivery system is balanced with the environment outside the delivery system. The pressure of the trapped air / gas induces a retraction movement of at least one of the first plunger (303) and the second plunger (404). If the second plunger includes a through hole (as shown in FIG. 32), only the first plunger performs the retraction movement.

[0227] In Figures 32c and 32c' there is shown a display device (300) providing the information "The (first) reservoir is filled and the delivery system is ready for use".

[0228] To avoid misunderstanding, the position of the plunger at the end of the filling process may be different from the position of the plunger when the delivery system injects. The delivery system may be configured, for example, to generate more pressure during delivery and thus provide another position for at least one of the first and second plungers.

[0229] Figure 32d' shows the indicator when the delivery system is delivering solution to the patient, and Figure 32e' shows the indicator at the end of delivery.

[0230] Similar features are shown in Figures 33-35. The main difference is that the display device may include a fluid path (311) that allows fluid communication between two volumes separated by a second plunger. Figure 33 shows a plunger that may be pierced with a needle (310). Figures 34 and 35 show a fluid path (311) located in the body of the display device, for example at the second end, to bypass the second plunger.

[0231] Visual elements and display windows The display device (and / or the housing of the delivery system) may include a window configured to allow at least one of the first plunger and the second plunger to be visible from outside the body or housing of the delivery system, the window being positioned such that at least one of the first plunger and the second plunger is visible in a predetermined position.

[0232] A dual visual element with (one or more) windows (e.g., with at least two different plungers or compressible visual elements) may be a robust solution since complete infusion of the drug is ensured by visualization of both plungers at the end of the injection.

[0233] The window(s), visual indicator and / or cavity (inner wall of the cavity) may be colored to improve monitoring of the injection status. Figure 7 shows an example of an indicator with a first plunger (11) and an associated second plunger (12). Here only two windows (24) are used. Before injection, the plungers (11, 12) are not visible. After actuation, the second plunger (12) is visible. The first plunger (11) finally becomes visible after the injection is completed (mechanical stop not shown in Figure 7).

[0234] The display device may include markers to identify the infusion status. The markers may be text, icons, colors, other visual means, etc. These markers may be created by pad printing, inkjet printing, or laser marking, stickers, etc.

[0235] The display device may comprise a longitudinal window (24) along the cylinder to verify the position of the plungers at any time and thus check for eventual failure. This feature is particularly useful during manufacturing to verify the correct initial positioning of the plungers (11, 12). This feature may be used to distinguish between an initial state (no plungers visible) and an intermediate or failure state corresponding to the two plungers (11, 12) being located between two perpendicular observation windows. The movement of the plungers may be slow (especially in the case of injection of viscous drugs) and therefore the time required to reach the first mechanical stop (also called stop member) (23) may be substantially long.

[0236] An alternative solution may include a single window (24) with markers that identify the injection status.

[0237] As disclosed in FIG. 9, the system may include two "solid" plungers (11, 12) and a cylinder open at both ends. The two plungers are initially not in contact, as shown in FIG. 9a. The plunger (12) not in contact with the liquid to be injected moves against a mechanical stop (which may be the second end of the cavity) and the plunger in contact with the liquid moves to an intermediate position. Compression of the air between the plungers allows the retraction movement of the plunger in contact with the liquid (11), limiting the dead volume of the device as shown in FIG. 9. This latter configuration is particularly useful for positioning the plungers during manufacturing.

[0238] Three solid plungers of different colors may be used, with each plunger only visible during one predefined stage of the injection. A typical example is shown in Figure 11. In another embodiment, two plungers are used, at least one of which includes two different colors.

[0239] In all embodiments, the window(s) may be tinted to improve distinction between different injection conditions.

[0240] The second plunger (12) may be replaced with a compressible visual element (31), as shown in Figure 10. In this embodiment, the display may comprise a single window.

[0241] The different proposed embodiments can be combined to form alternative solutions for the injection status indicator.

[0242] The windows may be equipped with color filters to change the perception of the color of the plunger. For example, the plunger may be yellow, the first window may be equipped with a blue filter, and the second window may be equipped with a magenta (or red) filter. When the plunger is located under the first window, the user will see a green color, and when the plunger is located under the second window, the user will see a red (or orange) color.

[0243] Figure 24 shows some external views of a possible injection status indicator (2) that can be used with the system described herein. An example of a possible system is described in EP 18182850.0 or EP 19151324.1. Figures 24a, 24b and 24c show an illustration of this indicator as it appears on the top shell of the device. This purely mechanical injection status indicator can have at least one of three different states: 1 point: Ready for injection (Figure 24a) 2 points: Injection in progress (Figure 24b) 3 points: end of infusion (Figure 24c).

[0244] The "End of Injection" indication is only visible when the reservoir membrane is completely collapsed against the bottom of the reservoir case. This indication is not visible in case of cannula blockage. For a particular dosage and viscosity, a maximum injection period will be indicated in the user manual, so that if the injection status indicator still shows "injection in progress" after this maximum period, the user can infer that the full dose has not yet been administered (e.g. in case of total blockage). The high pressure generated by the propellant vapor will limit the occurrence of blockages in the cannula.

[0245] Biasing means The biasing means may be a spring, a compressible gas or an elastic element. The biasing means is used to retract the first plunger to its final position, for example from the second position to the third position or to the first position.

[0246] In some embodiments (described herein), air (trapped, gas, pressurized gas) is used as a biasing means to retract the plunger in contact with the liquid at the end of the injection. An alternative embodiment uses a compression spring (25) located inside the cylinder for that purpose. A typical example is shown in FIG. 12. The injection status indicator here comprises a second plunger (12), a green plunger (11) and a compression spring (25) in between. The second plunger (12) may be perforated for initial positioning to prevent the development of pressure between the plungers during assembly. Before injection, only the second plunger (12) is visible in the first window (24) 1. After actuation, the pressure of the liquid pushes the first plunger (11) and the compression of the spring also pushes the second plunger (12). When the second plunger (12) is visible in the second window (24), the injection is in progress. Finally, drug pressure release at the end of the injection induces a retraction movement of the first plunger (11) so that it becomes visible in the third window (24). A mechanical stop (23) (a conical narrowing of the cylinder) may be used to fix the final position of the first plunger after injection.

[0247] An alternative embodiment may include a single spring (25) and plunger (11) inside a cylinder with one stop limiter (23) as shown in Figure 13. This mechanism is similar to that described in Figure 5, but the restoring force used for the plunger's retraction movement after injection is no longer compressed air but a compressed spring. The plunger can be repeatedly viewed in each of the three windows shown in Figure 13d depending on the injection state (ready to inject, injection in progress and injection finished).

[0248] Figures 36a, 36b and 36c show different positions of the first and second plungers where the biasing means (312) can be a spring device that pushes the first plunger against the first end, while Figures 36d, 36e and 36f show different positions of the first and second plungers where the biasing means can be a spring device that pulls the first plunger against the first end.

[0249] FIG. 38 shows a delivery system comprising a first reservoir (501) (with a movable wall) in fluid communication with a patient (504) via a fluid path (503). The delivery system further comprises a second reservoir (502) configured to store a pressurized fluid and to apply pressure to the movable wall of the first reservoir (501), and a display device (500). The display device is in fluid or pressure communication with at least one of the first and second reservoirs via a dedicated fluid port. As mentioned above, the display device may comprise a cavity, a first movable element (507) and a second movable element (508). In this case, the pressurized fluid may be used to effect a retraction movement of the first movable element (507). However, no movement may occur if the pressurized fluid simultaneously applies pressure to the movable wall and in the cavity of the display device (as soon as delivery is triggered). Thus, the pressurized fluid must be controlled to enable the first movement of the first movable element.

[0250] In some embodiments, the display or delivery system may include a valve control (506, 506') to prevent the pressurized fluid from prematurely pressurizing the display. In a first embodiment, the valve control may include a valve (506) that controls the flow of pressurized fluid through a fluid path (505) that connects the second reservoir to the display (500). In a second embodiment, the valve control may include an assembly (506) having a needle and a penetrable wall. The needle may be positioned with a second movable element (508) to allow fluid communication when the second movable element is pressed against the penetrable wall. Although both embodiments are shown in FIG. 38, the valve (506) and the assembly (506') may be two different embodiments of the valve control.

[0251] Anti-free flow valve Reservoir filling, whatever the nature of the reservoir itself, may pressurize the drug and cause a free flow. In order to prevent this unwanted flow of drug (free flow) (which may be problematic if filling is performed before the placement of the device on the patient and the introduction of the cannula or needle into the patient's skin), it is first proposed to use the plunger (11) in contact with the liquid as a valve device. Figure 14 shows an example of a plunger with a protrusion, or a shape (cylindrical shape) that allows to block the flow as long as the drug pressure does not exceed a predefined value (which may depend on the plunger friction against the inner wall of the cylinder and the surface of the plunger that is subjected to the drug reservoir pressure after activation). At the end of the injection, the valve may be in the closed position again if no mechanical stop is used (see Figure 5 for a typical example of a mechanical stop, for example, on the retraction movement of the plunger).

[0252] 14, the T-shaped flow path as described above includes a third fluid port in fluid communication with the outlet device (e.g., to a needle). The third fluid port may be cylindrical in shape to improve the tightness of this valve at low pressure.

[0253] Such a valve is an alternative to previous solutions to blocking flow at low pressure, including the use of hydrophobic porous media between the reservoir and the needle, mitral valves, etc.

[0254] An alternative embodiment shows an off-axis needle on the cylinder as shown in Figure 15. A schematic cross-section of the device is shown excluding the off-axis needle, which is fully illustrated for clarity. A solid plunger (11), intended to come into contact with the liquid, blocks flow from the reservoir to the needle until the drug pressure exceeds a predefined threshold.

[0255] In Figure 15, a fluid path without a T-shaped passage is shown. The first end of the cavity is a first fluid port providing fluid communication between the outlet and the cavity of the reservoir and acting as an inlet; a second fluid port that provides fluid communication between the cavity and the outlet device and serves as an outlet; The fluid path is divided into two portions: a first portion on the upstream side of the cavity and a second portion on the downstream side of the cavity.

[0256] The indicator device may further be used as a valve device that closes the fluid path when the fluid pressure is below a predetermined threshold. The valve may be closed before delivery activation and after completion of injection by forward and backward movement of the first plunger.

[0257] Anti-free-flow valve with controlled opening threshold Another embodiment of the present disclosure is shown in FIG. 16. This device is similar to the device disclosed in FIG. 1, except for the presence of a valve device (3) (also called a valve) in front of the needle inlet. This valve may comprise a separate (movable) plunger (32), a valve cavity (37) initially filled with a compressible gas (e.g. air), and / or a bung (27). At rest (before the device is activated), the upper surface of the plunger (32) is partially subjected to the pressure inside the communication chamber, for which a mechanical stop (26) (also called a plunger stopper) is used. This plunger itself may exhibit structuring or texturing, again leading to the same effect. During assembly, the introduction of the bung compresses the air contained inside the cavity. Controlling the pressure inside the cavity at the time of manufacture by design makes it possible to adjust the pretension (or opening threshold) of the valve, for example by introducing a bung with a well-controlled volume to always generate the same initial pressure inside the cavity. Activation of the device generates a large pressure in the reservoir. This pressure pushes against the top of the second solid plunger, causing it to move perpendicular to the direction of the needle, freeing the fluid path through the needle. At the end of the injection, the second plunger will reclose the needle inlet.

[0258] The opening threshold is usually greater than the maximum pressure that can occur during filling under normal circumstances. The opening threshold may be adjustable using a threaded tap that is adjusted more or less according to the target value of the valve pretension.

[0259] An alternative embodiment comprises a compression spring inside a cavity, said cavity being vented. The pretension can again be adjusted by controlling the initial spring compression, for example using a threaded plug which is used to control the initial length of the compression spring, as shown in FIG. 17, where the plug is also vented.

[0260] Crack Valve In another embodiment, the access chamber comprises a flexible membrane in front of the needle inlet with a bevel on both ends as shown in Figure 18. The flexible membrane is pierced by the needle and opens the fluid path to the drug when the reservoir pressure exceeds a pre-defined value. The membrane is made of an elastomeric material to allow large deflections and prevent cracking prior to needle piercing.

[0261] In another embodiment, the membrane fractures simply under pressure (mechanical failure due to excessive strain induced by large applied pressure after actuation) and the needle has a single bevel at the exit (see FIG. 19).

[0262] In another embodiment, the valve is a plunger (32). As shown in FIG. 20, a solid plunger (32) is placed in a second cylinder that communicates directly with the inlet and communication port of the needle. Actuation of the device causes the needle to pierce the plunger as shown in FIG. 21. The plunger may be partially introduced into the needle during manufacture to limit the dead volume of the device by reducing the size of the volume between the (valve's) plunger and the needle. This also prevents the patient from injecting a large amount of air at the beginning of the injection. At the end of the injection, compressible gas may be trapped in the valve cavity (37), which may cause the plunger to move towards its initial position and block the flow. The compressible gas may be substituted with a biasing element such as a spring.

[0263] Leakage / Fault Detection In some embodiments, the display device may be configured to indicate a fault or leakage event of the pressurizing means, if the delivery system comprises such pressurizing means.

[0264] FIG. 39 shows a delivery system that may include at least one of a first indicator (510) and a second indicator (520). The first indicator (510) device may be configured to provide an indication regarding the status of the first reservoir (501), e.g., the delivery status of the fluid stored in the first reservoir (501), and the second indicator (520) may be configured to provide an indication regarding the status of the second reservoir (502), e.g., a fault or leakage event in the second reservoir (502). The first indicator may include the same features as the indicators described herein. The second indicator may include a body (which may be an extension of the body of the first indicator) having an internal cavity. The internal cavity may include a first end and a second end that define a major axis of the cavity. The movable element (521) may be configured to move through the internal cavity in response to the pressure of the pressurized fluid in the second reservoir (502) after triggering of the delivery system.

[0265] When the delivery system is triggered, the pressurized fluid induces a first movement of the movable element (521) to a predetermined position. If no obstruction or leakage event occurs, the movable element must remain in this position (until the end of delivery and / or after). If an obstruction or leakage event occurs (e.g., leakage of the pressurized fluid), the movable element will perform a backward movement, for example, if the pressure of the pressurized fluid is less than the force of the counterforce (biasing means) (523). The biasing means can be a spring or other elements disclosed herein (trapped air, gas, etc.). The display device (530) is an embodiment that comprises the first display device and the second display device (510, 520) in the same body. [Explanation of symbols]

[0266] 1 Delivery device 2 Display device 3 Valve device 4. Pressure Equipment 5 Drug Reservoir 6 Propellant Reservoir 7 Flexible or movable membrane 8. Housing 9 Communication or fluid ports 10 Exit device 11 First plunger 12 Second plunger 13 Cavity 14 First end of cavity 15 Second end of the cavity 16 Through hole 17 Venting Equipment 18 Fluid Path 19 Main unit 20. Linear displacement of plunger (or plungers) 21 Drug name and amount display 22 Pumping equipment 23 Stops / Mechanical Stops 24(one or more) windows 25 Springs / biasing elements 26 Plunger stopper 27 Stopper 28 Vent 29 Springs / biasing elements 30 Elastomer membrane 31 Compressible Visual Elements 32 Movable bulkhead or plunger 33 T-shaped channel 34 First fluid port 35 Second Fluid Port 36 Third Fluid Port 37 Valve Cavity 101 Delivery System 102 patients 103 Skin-adhesive unit 104 Valve device 105 Fluid Path 106 Reservoir Interface 106a First flexible membrane / movable wall 106b Second flexible membrane / movable wall 106c Third flexible membrane / movable wall 107 Injection device 108 Trigger Device 109 Display 110 Housing 111 First Reservoir 111a Storage compartment of first container 112 Second Reservoir 112a Storage compartment of second container 113 Third Reservoir 114 Pressurizing device / means 115 Actuating device / means 116 Venting Device 117 Gap 121 Syringe 122 Inlet Port 126 Valve device 201 Delivery System 202 Housing 203 Housing cavities or internal compartments 204 Reservoir Module 204a Reservoir inner compartment 205 Fluid Path 206 needles 207 Venting Device 208 Removable Obturator 209 Display device or filling sensing or pressure transducer or pressure sensor 210 Display 212 Power supply 213 Entrance 214 Bulkhead (penetrable) 215 Movable wall 216 Pumping Equipment 217 First Cavity 219 Filling equipment 221 First Plunger 222 Second Plunger 223 Window 224 First Volume 225 Second Volume 226 Aperture 300 display device 301 First Aspect 302 The Second Aspect 303 First movable element (plunger, etc.) 304 Second moving element (plunger, etc.) 305 Visual Elements 306 Display window 307 Fluid Port 308 First End 309 Second End 310 needles 311 Fluid Path 312 Actuation means 400 Delivery System 401 First Side 402 Second Side 403 Inlet Port 404 Display device 405 First Aspect 406 Second Aspect 407 Reservoir Module 500 display device 501 First Reservoir 502 Second Reservoir 503 Fluid Path 507 Moving Elements 508 Moving Elements 510 First display device 520 Second display device 530 Display device

Claims

1. 1. A display device for indicating a status of bolus delivery to a patient via a medical system comprising a transdermal device and a reservoir having an internal compartment for containing a solution to be delivered, said display device comprising: a body including an internal cavity having a fluid port adapted to be coupled to at least one of the reservoir and the transdermal device, a first end and a second end, the first end and the second end defining a major axis; a first movable element and a second movable element disposed within the internal cavity and configured to move relative to the body in a direction parallel to the major axis through the internal cavity, the first movable element being in pressure communication with at least one of the internal compartment and the transdermal device; Equipped with said display device displays at least two states from the following list by different positions of said first and second movable elements in said internal cavity: before injection, during injection, and at the end of said injection; A display device comprising: a first movable element configured to move in a first direction due to an increase in pressure of the solution to be delivered and to move in a second direction opposite to the first direction due to a decrease in pressure of the solution to be delivered; and a second movable element configured to move with the movement of the first movable element in the first direction and to substantially remain in that position when the first movable element moves in the second direction.

2. 10. The display device of claim 1, further comprising a position indication window disposed on an outer surface of the display device and configured to provide an external visual indication of the position of at least one of the first movable element and the second movable element.

3. The display device of claim 1 or 2, wherein the fluid port is in fluid communication with at least one of the interior compartment of the reservoir and the transdermal device.

4. 4. The display device of claim 1, wherein the internal cavity comprises a first variable volume, a second variable volume, and a third variable volume defined by an inner wall of the internal cavity and at least the first movable element and the second movable element.

5. The display device of claim 4 , wherein the first variable volume is in fluid communication with the fluid port.

6. 6. A display device as claimed in claim 4 or 5, wherein the first movable element strictly separates the first variable volume and the second variable volume.

7. The display device of any one of claims 4 to 6, wherein the second movable element comprises a through hole configured to provide fluid communication between the second variable volume and the third variable volume.

8. A display device according to any preceding claim, wherein the first movable element is arranged to urge the second movable element from a first position to a second position.

9. A display device as claimed in any preceding claim, wherein the first movable element is arranged to undergo forward and backward movement.

10. A display device as claimed in any one of claims 1 to 8, wherein the first movable element is configured to perform a forward and backward movement, and the second movable element performs a simple movement caused by the forward movement of the first movable element.

11. 11. A display device as claimed in claim 9 or 10, further comprising biasing means arranged to induce said retracting movement of said first movable element.

12. The display device of any one of claims 4 to 7, further comprising a vent configured to provide pressure equilibrium between the third variable volume and an external environment.

13. 1. A medical system adapted to deliver a solution to a patient, the medical system comprising:

13. A display device according to any one of claims 1 to 12, wherein the reservoir further comprises a movable wall and the transdermal device is in fluid communication with the patient; a fluid pathway extending from the interior compartment of the reservoir to the transdermal device; a housing enclosing a cavity of the medical system within which the movable wall may move; a vent device configured to achieve pressure equilibrium between the cavity of the medical system and an external environment; A medical system that has:

14. The medical system of claim 13 , wherein the display device further comprises a valve device configured to block a portion of the fluid path.

15. The medical system of claim 13 , wherein the first movable element is configured to block a portion of the fluid path when the first movable element is in an initial position.

16. The medical system of any one of claims 13 to 15, further comprising a removable occlusion device configured to occlude the vent device at least during a filling process or dwell period of the reservoir.

Images