WO2020129002A1

WO2020129002A1 - Infusion device with occluding device

Info

Publication number: WO2020129002A1
Application number: PCT/IB2019/061189
Authority: WO
Inventors: Eric Chappel
Original assignee: Debiotech S.A.
Priority date: 2018-12-21
Filing date: 2019-12-20
Publication date: 2020-06-25

Abstract

An infusion device comprises a housing, a cavity arranged into the housing, a reservoir comprising an internal compartment and arranged into the housing, a fluid pathway comprising an outlet in fluid communication with the reservoir internal compartment, a vent device configured for communicating ambient air into the cavity, and a removably occluding device configured to occlude at least one of the vent device and the outlet.

Description

Infusion device with occluding device

FIELD OF DISCLOSURE

The present disclosure relates generally to medical devices, systems and methods, and more particularly to small, smart, portable infusion devices for the delivery of various substances to a patient such as pharmaceuticals, nutritional formulas, biologically derived or active agents, hormonal and gene-based material, and other substances. Even more particularly, the present disclosure is directed to systems and methods for an infusion device comprising a vent.

STATE OF THE ART

Infusion devices may comprise a vent for different purposes. For example, the infusion devices comprising a semi or fully flexible reservoir may be vented to maintain pressure equilibrium between the interior of the infusion device (in which the reservoir is arranged) and the ambient atmosphere. Indeed, pressure differences between the infusion device interior and the ambient atmosphere can hamper pump flow accuracy and accordingly affect drug delivery. If a reservoir is enclosed in a sealed housing, reduction in reservoir volume during emptying can induce a relative negative pressure. Increasing of negative pressure (building of vacuum) may require higher torque and may thus hamper pumping accuracy. Pressure disequilibrium can also happen during altitude changes during flying or mountaineering. Under such circumstances, the relatively high pressure within a sealed housing can cause undesirable (i.e. , uncontrolled) drug delivery. Furthermore, during reservoir filling, a positive volume change of the drug reservoir induces a lowering of the volume of the cavity surrounding the drug reservoir and can cause another undesirable drug delivery. The use of vent may be also useful to prevent the generation of a counter-pressure during this phase. Vents may also be required to equilibrate pressure for gauge pressure sensors or to provide oxygen to Zinc-air batteries.

Examples of vent structure have been described in the US patent US9872955, which is integrated by reference to this document. Several drawbacks can, however, be associated with such an infusion device:

• The vent may allow the entry of bacteria into the infusion device,

• The vent may render the internal compartment of the infusion device non- sterile.

• A reservoir comprising a flexible wall may be not compatible with a sterilization process (for example Ethylene Oxide sterilization process (EtO or EO)). Indeed the standard EO sterilization process may include preconditioning under severe conditions (100%RH, high temperature>50°C) and exposure to very low pressure (50 mbar absolute). Thus if a residual air is present inside the drug reservoir before the sterilization process, it will expand by a factor 20 in such conditions, leading to potential overexpansion of the flexible wall.

• A pumping device requiring to be arranged into a vented cavity may be not compatible with a sterilization process (for example Ethylene Oxide sterilization process (EtO or EO) or storing condition (for example into a fridge). For example, condensation may form into the vented cavity once the caregiver removes the package from the fridge.

GENERAL DESCRIPTION OF THE DISCLOSURE

A first aspect of the disclosure provides an infusion device which may comprise at least one of a housing, a cavity arranged into the housing, a reservoir comprising an internal compartment and arranged into the housing, a fluid pathway comprising an outlet (which may comprise a needle and/or a pierceable septum) in fluid communication with the reservoir internal compartment, a vent device configured for communicating ambient air into the cavity, and a removably occluding device configured to occlude (for example hermetically) at least one of the vent device and the outlet. The outlet may be just protected in order to maintain the outlet sterilized.

In some embodiments, the occlude device is configured to occlude hermetically the vent device and/or to maintain the outlet sterilized. In some embodiments, the removably occluding device is configured to close hermetically the vent device in order maintain the cavity sealed at least until the withdrawn of the removably occluding device.

In some embodiments, the removably occluding device is configured to maintain the outlet in a sterilized state at least until the withdrawn of the removably occluding device.

The infusion device may further comprise a pressure transducer comprising a surface subjected to the fluid pressure inside the cavity. The pressure transducer may be configured to provide information related to a status of the reservoir and/or the infusion device. The pressure transducer may be configured to provide information related to a level of filling of the reservoir internal compartment.

The removably occluding device may be configured to maintain sealed at least one of the fluid pathways and the cavity during a sterilization process of the infusion device.

The infusion device may further comprise at least one of an electronic part and a power supply device. The power supply device may be configured to power the electronic part. The power supply device may require an air exposition to enable its operation and may be arranged into the cavity.

The infusion device may further comprise an inlet port in fluid communication with the reservoir internal compartment sealed by a pierceable septum.

The reservoir may comprise a movable wall for example a flexible wall or a plunger.

A second aspect of the disclosure provides a removably occluding device for a medical device which may comprise at least one of a housing, a reservoir, a fluid pathway comprising an outlet (which may comprise a needle and/or a pierceable septum) in fluid communication with the reservoir, a vent device configured for providing a fluidic communication between an exterior environment of the medical device and an internal part of the housing in which the reservoir may be at least partially arranged. Preferentially, the removably occluding device comprises a first part configured to maintain the outlet in a sterilized state and a second part configured to close the vent device. The first part may comprise a cavity in which the outlet is kept sterilized. The second part may comprise a sealing surface in order to hermetically seal the internal part of the housing.

A third aspect of the disclosure discloses a process for manufacturing and preparing an infusion device comprising the steps of:

• providing an infusion device comprising at least one of a housing, a cavity arranged into the housing, a reservoir comprising an internal compartment and arranged into the housing, a fluid pathway comprising an outlet (which may comprise a needle and/or a pierceable septum)in fluid communication with the reservoir internal compartment, a vent device configured for communicating ambient air into the cavity;

• occluding the vent device by a removably occluding device; and

• after occluding the vent device, performing the sterilization of the infusion device.

The process may further comprise at least one of the steps of:

• Filling the internal compartment;

• Removing the occluding device (for example after the step of filling); and

• Activating the infusion device.

In some embodiments, the infusion device may comprise a first part and a second part. The second part may comprise at least one of the housing, the cavity, the reservoir, the fluid pathway, the outlet/needle, and the vent device. The process may further comprise at least one of the steps of:

• Performing sterilization of at least one of the first part and the second part (for example before the step of occluding the vent device); and

• Assembling the first part with the second part (for example before the step of sterilization of the infusion device).

A fourth aspect of the disclosure provides a filling detection device or a filling detection process of an infusion device. The infusion device may comprise a housing, a cavity arranged into the housing, a reservoir comprising an internal compartment intended to be filled with a solution and arranged into the housing, a fluid pathway comprising an outlet (such as a needle) in fluid communication with the internal compartment, a vent device configured for communicating ambient air into the cavity, and a removably occluding device configured to occlude the vent device at least during the filling of the internal compartment. Preferentially, the filling detection device comprises at least one of a pressure transducer and an indicator intended to provide information related to a filling level of the internal compartment. After the filling, the removably occluding device may be removed.

The pressure transducer may comprise a wall having the first surface subjected to the pressure present into the cavity. The wall may comprise a second surface (may be opposed to the first surface) for example subjected to the atmospheric pressure. The wall may be configured to move when the pressure present into the cavity varies. For example, the wall may comprise a movable wall such as a flexible wall/membrane or a plunger. The indicator may issue a visual, acoustic, or touch-based warning. The indicator may comprise a screen, a LED, vibrator, a speaker, an opening, a window (to see the position of the pressure transducer, for example, a plunger). For example, as described hereafter, the pressure transducer may comprise a cavity in which at least one plunger may move and the indicator may comprise a window configured to see the movement or the position of at least one plunger.

LIST OF FIGURES

The present disclosure will be better understood at the light of the following detailed description which contains non-limiting examples illustrated by the following figures:

Figures 1a, 1b and 1c show potential embodiments of an infusion device.

Figures 2a and 2b show potential embodiments of an infusion device.

Figure 3 shows an embodiment with a semi-flexible reservoir.

Figures 4a, 4b, and 4c show an infusion device comprising two cavities.

Figures 5a, 5b, and 5c show an infusion device comprising a filling device having a plunger.

Figures 6a and 6b show an infusion device comprising a filling device in fluid communication with the fluid pathway.

Figure 7 shows an infusion device with a pumping device. Figure 8 shows an embodiment with a pumping device.

Figure 9 shows several views of a potential filling indicator.

Figure 10 shows an infusion device with another pumping device.

LIST OF ELEMENTS

1 infusion device

2 housing

3 cavity or internal compartment of the housing

4 reservoir

4a internal compartment of the reservoir

5 fluid pathway

6 needle

7 vent device

8 removably occluding device

9 filling sensing or pressure transducer or pressure sensor

10 indicator

11 electronic device

12 power supply

13 inlet

14 septum (pierceable)

15 movable wall

16 pumping device

17 first cavity

18 second cavity

19 filling device

20 other unit

21 first plunger

22 second plunger

23 window

24 first volume

25 second volume

26 opening

27 inlet valve 28 pumping chamber

29 pressure sensor

30 outlet valve

DETAILED DESCRIPTION OF THE DISCLOSURE

In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration several embodiments of devices, systems and methods. 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. The following detailed description, therefore, is not to be taken in a limiting sense.

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

As used in this specification and the appended claims, the singular forms "a", "an", and "the" encompass embodiments having plural referents, unless the content clearly dictates otherwise.

As used in this specification and the appended claims, any direction referred to herein, such as "top", "bottom", "left", "right", "upper", "lower", and other directions or orientations are described herein for clarity in reference to the figures and are not intended to be limiting of an actual device or system. Devices and systems described herein may be used in a number of directions and orientations.

As used herein, "have", "having", "include", "including", "comprise", "comprising" or the like are used in their open-ended sense, and generally mean "including, but not limited to.

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" or the like are used in their open-ended sense including " only A, or only B, or only C, or any combination of A, B and C" unless the content clearly dictates otherwise.

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

The present application claims the benefit of the priority of the patent application EP

18215745.3 filed on 21 December 2018, EP 19151325.8 filed on 11 January 2019, EP

19151323.3 filed on 11 January 2019, EP 19151324.1 filed on 11 January 2019, EP 19155800.6 filed on 6 February 2019, PCT/IB2019/051237 filed on 15 Februyary 2019, and in PCT/IB2019/055742 filed on 5 July 2019 in the name of Debiotech SA, the entire disclosure of which is incorporated herein by reference.

According to an aspect of the disclosure, as shown by the figures 1 and 2, the infusion device (1) comprises a housing (2), an internal part (of the infusion device) such as a cavity (3), a reservoir (4), and a fluid pathway (5).

Preferentially, the reservoir is at least partially arranged into the internal part of the infusion device. The housing may define at least a part of the internal part of the infusion device.

Preferentially, the infusion device (1) comprises one or more vent devices (7). In some embodiments, a vent device (7) (also referred as an opening, a vent, or a vent port) may be provided to the housing of the infusion device (1) so as to direct air to enable, for example, establishing pressure equilibrium within the interior of the device. The vent device may further enable airflow regulation (e.g., according to pressure changes) to perform pressure equilibration and/or enable air (including oxygen) transfer to one or more elements of the device that require communication with ambient air, at least in part, to operate. Such one or more elements may include a power supply (12) (such as a zinc-air battery) (not shown in figures 1 and 2), a pressure transducer (9) (not shown in figures 1 and 2).

In some embodiments, a selective membrane (such as a hydrophobic membrane layer) covers the vent device (7) to prevent water from entering into the infusion device or the cavity. In some embodiments, at least one vent device is provided in the proximity of at least one of the reservoir (4), a pressure transducer (9) and power supply (12).

The reservoir comprises an internal compartment (4a) intended to be filled and/or to store a solution (for example a liquid solution), such as pharmaceuticals, nutritional formulas, biologically derived or active agents, hormonal and gene-based material, and other substances. The reservoir may comprise a movable wall (such as a flexible membrane, a plunger,...) defining at least in part the internal compartment of the reservoir. The reservoir may comprise two movable walls sealed together defining at least in part the internal compartment of the reservoir. The reservoir may comprise a movable wall and a rigid wall sealed together and defining at least in part the internal compartment of the reservoir. The reservoir may further comprise at least one of an inlet port intended to allow a filling process of the internal compartment (4a) and an outlet port in fluid communication with the fluid pathway (5). A filter may cover the outlet port, for example, arranged into the internal compartment (4a).

Preferentially, the fluid pathway (5) is configured to provide a flow of the solution stored in the internal compartment of the reservoir from the reservoir to the outlet. The fluid pathway (5) may comprise at least one of a pumping device (not shown in the figures 1 and 2), a needle (6), a pressure transducer (not shown in the figures 1) (such as a pressure sensor), and other element (such as sensor, filter,...).

Preferentially, the outlet is configured to allow fluidic access to the fluid pathway from the exterior (of the infusion device). The outlet may extend outwardly from the infusion device. The outlet may comprise a pierceable septum, a needle, a transcutaneous device or port intended to be connected to a transcutaneous device. In order to simplify the description, the term“needle” may be used to refer to the outlet of the infusion device.

Preferentially, the pumping device (not shown in figures 1 and 2) is configured to move the solution from the internal compartment of the reservoir to the outlet. As shown by the figure 10, the pumping device (16)may be configured to exert a positive pressure to the internal compartment of the reservoir (pressurized gas, liquefied gas, spring applying a force wall of the reservoir,...). As shown by figure 3, the pumping device may be arranged between the reservoir (4) and the needle (6). In this case, the pumping device may comprise at least one of a pumping chamber, a sensor (such as a pressure sensor for example arranged into the pumping chamber), a peristaltic pump, a plunger, and a flexible membrane.

The figures 1 a, 1 b, 2a, and 2b show an infusion device comprising a removably occluding device (8) intended to occlude at least one of the vent device (7) and the needle (6). The figures 1 c and 2c show the same infusion device but after removing the occluding device (8). The removably occluding device (8) may comprise at least one of a first part configured to maintain the needle in a sterilized state and a second part configured to close the vent device. For example, the first part may comprise or form or close a cavity in which the needle is kept sterilized. And the second part may comprise a sealing surface in order to hermetically seal the internal compartment of the housing (for example the cavity).

In some embodiments, the removably occluding device (8) may be configured to close hermetically (even in (high and/or low) pressure condition) one or more (preferentially all) vent or opening of the delivery device.

In some embodiments, the removably occluding device may be or comprise a tape glued to the vent device and/or to the outlet.

In some embodiments, the removably occluding device may comprise a gripping area (such as a strip) configured to be grasped by the user such that the user can grasp the gripping area to remove the removably occluding device.

In some embodiments, the removably occluding device and/or the housing may comprise a lock device (such as a clip device) configured to lock (temporarly) the removably occluding device to the housing. The lock device may be unlock by the user in order to remove the removably occluding device.

In some embodiments, the removably occluding device (8) is configured to allow a sterilization process of the infusion device (1). For example some sterilization process require a variation of the pressure (pull vacuum and/or generate overpressure) (for example EO sterilization), thus in order to prevent any movement of the movable wall or deterioration inside the internal part of the delivery device (due to the pressure gradient during), the removably occluding device may be configured to close hermetically (even in (high and/or low) pressure condition) one or more (preferentially all) vent or opening of the delivery device during at least a part of the sterilisation process.

Preferntially, the removably occluding device is configured to be removably fixed against the vent device (or the outlet) in order to close the openings of the vent device (or the outlet) while at least a part of the remaining area of the infusion device is in contact with the air ambient or the fluid of the sterilisation process.

In some embodiments, the infusion device may further comprise a pressure transducer (which may be used as a filling sensor). The pressure transducer may comprise an electronic part (for example if the pressure transducer is a pressure sensor) (or not).

In some embodiments, the infusion device may further comprise an electronic device configured to operate (for example) with the pressure transducer. The electronic device may comprise at least one of an LED, speaker, vibrator, screen, wire, power source,... The electronic device may further comprise a processor which may be configured to receive the signal of the pressure transducer and to activate or to initiate the infusion device (turn on or launch the infusion) when or after the processor has received a signal from the pressure transducer, for example a signal related to the filling process. The processor may be configured to inform the user about the filling process (for example end of filling).

The figures 3, 4, and 10 show an embodiment of the infusion device (1) comprising a reservoir (4) having a movable wall (15), a fluid pathway (5), a pumping device (16), a needle (6), at least one vent device (7, 7a, 7b) occlude by a removably occluding device (8), and optionally a pressure transducer (9) and/or a filling sensor (9) . A filling device (19) (such as a syringe) may be used to fill the internal compartment of the reservoir for example via the pierceable septum (14) of an inlet (13) of the reservoir (4).

Figure 3 shows a first cavity (17) while the figures 4a, 4b, and 4c show a first cavity (17) and a second cavity (18). Both may be vented by at least one (preferentially dedicated) vent device (7, 7a, 7b). The first cavity (17) may be vented by the first vent device (7, 7a) and the second cavity may be vented by the second vent device (7b). In some embodiments, the vent device is arranged between the first cavity and the second cavity in order to provide fluid communication between the first and the second cavities. The removably occluding device is configured to occlude at least one of the first vent device (7a) and the second vent device (7b).

In some embodiments, the housing of the infusion device may comprise hard housing in such a manner the volume of the internal compartment (for example the first and/or the second cavities) of the infusion device is constant. During filling as the vent device occludes the air (trapped in the first cavity) will be pressurized since the available volume will decreases as the reservoir is filled with a solution (assumed to be incompressible). Moreover, the movable wall of the reservoir transmits the pressure from the reservoir internal compartment to the first cavity during the whole process. This pressure may be used to activate and optionally to detect the end of filling. The infusion device may comprise a filling detection device including a filling sensor such as a pressure transducer configured to detect the pressure increasing and an indicator configured to inform the filling status. After the filling process and preferentially before the infusion to the patient, the removably occluding device may be removed. After removing, the overpressure may escape through at least one of the vent device(s) (7, 7a, 7b) and the internal pressure equilibrates with external atmospheric pressure. The infusion device may be configured (the vent device, the removably occluding device, the outlet, the cavity, the movable wall, the pumping device, and/or the fluid pathway) in such a way that the overpressure in the reservoir causes a priming of at least a part of the fluid pathway (for example until the outlet). In the same spirits, the infusion device may be configured in such a manner that when the removably occluding device is removed from the outlet, a residual pressure may cause the priming. For example the removably occluding device may comprise a small cavity in which the air trapped in the fluid pathway may flow (the volume of this small cavity may be determined by the volume of the fluid pathway), and/or the removably occluding device may comprise an hydrophobe membrane in such that when the solution (liquid) reaches the removably occluding device the air trapped goes out and but not the solution. In some embodiments, the removably occluding device or the infusion device may be configured in such a manner that when the removably occluding device is removed, the outlet is the first to be unoccluded and then/after the vent device or inversely the vent device is the first to be unoccluded and then/after the outlet. For example, if the reservoir is filled with 0.6ml of an incompressible fluid, considering a first cavity of 3ml, a relative pressure of 200 mbar will be generated in the reservoir and in the first cavity, considering that this compression process is isothermal.

By contrast to the prior art method foreseen to detect the end of filling, they are a lot of improvements, including the fact that the film becomes less critical in term of safety because there is no risk of anticipated infusion (no pressure at all in the drug reservoir after cap removal (the removal occluding device) because the nominal reservoir volume is larger than 0.6ml). Moreover, all process steps associated with this film are also less critical and tolerances can be released. Finally, the measurement of the filling pressure is much simpler and less critical to safety.

In some embodiments, the infusion device may comprise a dedicated pressure transducer sensing the fluid pressure into the first cavity (or in the second cavity if both cavities are in fluid communication (without substantial flow restriction)). The pressure transducer may comprise a first surface subjected to the pressure present into the first cavity (in which the reservoir is arranged). In some embodiments, the pressure transducer may have a reference port in pressure communication with the external environment of the infusion device or with the second cavity.

According to the figures 5a, 5b, and 5c, the pressure transducer comprises at least one plunger (21 , 22) and a cavity in which the at least one plunger (21 , 22) may move. The at least one plunger (21 , 22) may divide the cavity of the pressure transducer into two distinct volumes (a first volume (24) and a second volume (25)). The at least one plunger (21 , 22) may provide a hermetic separation between the first volume (24) and the second volume (25). The first volume (24) and/or the second volume (25) may be defined by at least one of the walls of at least one of the cavity and the plunger (for example a first plunger). The first volume (24) and/or the second volume (25) may be configured to increase and/or decrease as the plunger moves into the cavity of the pressure transducer.

Preferentially, the first volume (24) is in pressure communication with the first cavity (17). For example, the pressure transducer may further have a first opening (26) providing fluid communication between the first cavity (17) and the first volume (24) of the pressure transducer cavity. A first plunger (21) may comprise a wall having a first surface subjected to the pressure present into the first cavity (17). A second plunger (22) may be arranged into the cavity of the pressure transducer (9), for example into the second volume (25). The second plunger (22) may be configured to move into the cavity for example pushed by the first plunger. The second plunger may comprise fluid communication means (such as a through-hole) configured to prevent the second volume into two additional volumes hermetically separated.

The pressure transducer may comprise at least one window (23) configured to show the position of at least one plunger into the cavity of the pressure transducer (9). A first opening and/or position (of the at least one plunger) may provide information related to a first state of the delivery device or reservoir.

According to figure 5a, 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 into the pressure transducer. A first window may show the position of the at least one plunger. During the filling process, the pressure into the first cavity (17) increases and transmits this pressure into the first volume as the reservoir is filled. The at least one plunger moves as the pressure increases and/or as the reservoir is filled. According to the figure 5b 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 determined position into the pressure transducer. A second window may show the position of the at least one plunger. According to figure 5c, once the filling process has been ended, the filling device (19) may be removed and the removably occluding device (8) is removed. Once the removably occluding device has been removed, the overpressure present into the first cavity may exit through the vent device (7). In some embodiments, the second volume (25) may be hermetically closed, thus the pressure present into the second cavity may cause a back movement of the at least one plunger (for example the first plunger (21)) as the overpressure exits through the vent device (7). In some embodiments, the at least one plunger may comprise a second plunger (22) (as described above), if the second plunger comprises a fluid communication means, only the first plunger (21) may go back to or in the direction to the first position. In this case, the second plunger may substantially stay in the second position.

A similar embodiment has been disclosed by figures 9 which show several views of a potential filling indicator (9) (or filling gauge) which may be used with the system described in this document. An example of another potential system has been described by the EP patent application EP18182850.0, which is incorporated by reference in the present application. As described in this application, the system may contain a semi-flexible drug reservoir that is initially collapsed against the rigid part, and user-filled with a syringe. This action inflates the drug reservoir membrane, which is thermoformed to prevent the generation of pressure onto the drug as the filling is completed. The cavity surrounding the reservoir membrane may initially closed by a plug (an occlusion device) that covers the reservoir vent (for example the vent device) and, optionally the needle. During filling, a positive pressure generated inside this cavity will move a low-friction plunger inside a transparent cylinder, equilibrating the pressure inside the container. The filling gauge (9), which is located on the bottom of the device, is only visible during the filling process. As shown in figures 9a, b, and c, the fill volume is indicated by the position of a plunger. The figure 9a shows two plungers (21 , 22) at the left of the indicator, before the filling. The figure 9b shows two plungers (21 , 22) at the right of the indicator, just after the filling before to remove the occlusion device from the vent device. The figure 9c shows a first plunger (21) at the left of the indicator and a second plunger at the right (22), after the occlusion device removal. A textual indication or gradual indication may indicate the fill volume by the second plunger.

According to the embodiments of the Figures 6a and 6b, the pressure transducer is in pressure communication with the fluid present into the fluid pathway. For example, the pressure transducer may be a pressure sensor arranged into the fluid pathway (5). Thus the pressure transducer may comprise a first surface subjected to the fluid pressure present into the fluid pathway. In some embodiments, the pressure transducer may have a reference port in pressure communication with the external environment of the infusion device or with the second cavity. In figure 6b, preferentially, the first cavity is isolated from the second cavity. In some embodiments, it is expected that the pressure generated during the filling induces a small liquid flow through the reservoir outlet to pressurize the fluidic pathway downstream the reservoir outlet. The presence of the valve between the reservoir and the pressure transducer may be problematic and some actuations of the pumping device may be necessary to secure the sensing.

Figure 7 shows an infusion device (1) comprising two cavities (17, 18) but the second cavity may be optional. The infusion device may comprise at least one of a pumping device (16), an electronic device (11), and another unit (20) (for example a power supply (12)) which may be arranged into the first or second cavities. The electronic device (11) may be connected to at least one of the pumping device (16) and the other unit (20).

In some embodiments, the power supply requires communication with ambient air to operate (at least partly). The vent device may be configured to vent the cavity in which the power source is arranged to provide a fluidic communication or a pressure equilibration between this cavity and the air ambient. Thus, as long as the removably occluding device occludes the vent device, the infusion device cannot be operatable. When (or once) the removably occluding device is removed, the power supply operates and the infusion device is activated or initiated and may start the infusion. For example, the power supply may comprise a battery Zinc-Air.

In some embodiments shown by the figure 8, the pumping device (16) may comprise an inlet in fluid communication with the outlet of the reservoir and an outlet in fluid communication with the needle. The pumping device may further comprise at least one of an inlet valve (27), a pumping chamber (28), at least one pressure sensor (29) and an outlet valve (30). The at least one pressure sensor (29) may comprise at least one of a first pressure sensor (29) and a second pressure sensor (30). The first pressure sensor (29) may be arranged between an inlet valve (27) and an outlet valve (30). The second pressure sensor (29) may be arranged downstream the outlet valve (30), in other terms between the outlet valve (30) and an outlet of the infusion device (1). The first and/or the second pressure may comprise a first surface in fluid or pressure communication with the fluid present into the fluid pathway (5). The first and/or the second pressure sensor may comprise a second surface (which may be arranged opposite to the first surface) in fluid or pressure communication with the fluid present into the second cavity (18) or with the air ambient.

The first pressure sensor may be used as a filling sensor (9). In this case, if the infusion device comprises a second cavity (18) (as described above) and if the second surface of the pressure sensor is in fluid or pressure communication with the second cavity, then the first cavity (17) has to be isolated (not in pressure communication with) from the second cavity (18). Indeed, in this case, the sensor measures the difference of pressure between the fluid pathway (5) (and thus the first cavity) and the second cavity. It is expected that the pressure generated during the filling induces a small liquid flow through the reservoir outlet to pressurize the fluidic pathway downstream of the outlet. The presence of the inlet valve may be problematic and some actuations are probably necessary to secure the measurement.

The second pressure sensor may be used as a filling sensor (9). In this case, if the infusion device comprises a second cavity (18) (as described above) and if the second surface of the pressure sensor is in fluid or pressure communication with the second cavity, then the first cavity (17) has to be in fluid or pressure communication with the second cavity (18) (via for example a vent device or an opening arranged between the two cavities). Furthermore, if the second cavity comprises a second vent device (7b) then the second vent device has to be occluded during the filling. And if the first cavity comprises a first vent device (7a) then the first vent device has to be occluded during the filling. The pressure generated in both the first and second cavities during filling will push the second surface of the second pressure sensor as well as the outlet valve of the pumping device that will be forced close. Therefore the pressure of the first surface of the second pressure sensor will remain at atmospheric pressure, at least during the filling process (a few seconds). Time response may be faster than for the method using the first pressure sensor.

In some embodiments, the infusion device comprises two distinct parts, for example, a first part and a second part. The first part may comprise the first cavity (17) and the second part may comprise the second cavity (18). The sterilization of such infusion device may comprise the steps of:

- performing sterilization of at least one of the first part and the second part,

- occluding the vent device by a removably occluding device; and

- after occluding the vent device, performing the sterilization of the infusion device.

The sterilization process may comprise the steps of:

- Providing an infusion device (for example one of the infusion devices described above) comprising a first part and a second part, at least one of the first part and the second part comprising at least one vent device,

- performing first sterilization of at least one of the first part and the second part,

- assembling the first part to the second part in order to form a single piece,

- occluding the at least one vent device by a removably occluding device; and - after occluding the vent device, performing second sterilization of the infusion device.

The first sterilization may be optional. The step of occluding may be performed before or after the step of assembling (preferentially after). Preferentially, the second sterilization is an EO sterilization. As described above, the removably occluding device may be configured to protect the needle.

Claims

1. An infusion device comprising:

• A housing,

• A cavity arranged into the housing,

• A reservoir comprising an internal compartment and arranged into the housing,

• A fluid pathway comprising an outlet in fluid communication with the reservoir internal compartment,

• A vent device configured for communicating ambient air into the cavity, and

• A removably occluding device configured to occlude at least one of the vent device and the outlet.

2. Infusion device of the claim 1 , wherein the removably occluding device is configured to close hermetically the vent device in order maintain the cavity sealed at least until the withdrawn of the removably occluding device.

3. Infusion device of any one of the previous claims, wherein the removably occluding device is configured to maintain the outlet in a sterilized state at least until the withdrawn of the removably occluding device.

4. Infusion device of any one of the previous claims further comprising a pressure transducer comprising a surface subjected to the fluid pressure inside the cavity.

5. Infusion device of the claim 4 wherein the pressure transducer is configured to provide information related to a status of the reservoir and/or the infusion device.

6. Infusion device of the claim 4 wherein the pressure transducer is configured to provide information related to a level of filling of the reservoir internal compartment.

7. Infusion device of any one of the previous claims, wherein the removably occluding device is configured to maintain sealed at least one of the fluid pathway and the cavity during a sterilization process of the infusion device.

8. Infusion device of any one of the previous claims further comprising an electronic part.

9. Infusion device of the claim 8 further comprising a power supply device configured to power the electronic part, wherein the power supply device requires an air exposition to enable its operation and wherein the power supply device is arranged into the cavity.

10. Infusion device of any one of the previous claims further comprising an inlet port in fluid communication with the reservoir internal compartment sealed by a pierceable septum.

1 1. Infusion device of any one of the previous claims, wherein the reservoir comprises a movable wall.

12. A removably occluding device for medical device comprising a housing, a cavity arranged into the housing, a reservoir, a fluid pathway comprising an outlet in fluid communication with the reservoir, a vent device configured for providing a fluidic communication between an exterior environment of the medical device and an internal compartment of the housing, wherein the removably occluding device comprises a first part configured to maintain the outlet in a sterilized state and a second part configured to close the vent device.

13. Removably occluding device of claim 12, wherein the first part comprises a cavity/area in which the outlet is kept sterilized.

14. Removably occluding device of the claim 12 or 13, wherein the second part comprises a sealing surface in order to hermetically seal the internal compartment of the housing.

15. A process for manufacturing and preparing an infusion device comprising the steps of:

• providing an infusion device comprising a first part and a second part including a housing, a cavity arranged into the housing, a reservoir comprising an internal compartment and arranged into the housing, a fluid pathway comprising outlet in fluid communication with the reservoir internal compartment, a vent device configured for communicating ambient air into the cavity;

• performing sterilization of at least one of the first part and the second part,

• occluding the vent device by a removably occluding device; and

16. Process of the claim 15 further comprising at least one of the steps of:

• Filling the internal compartment;

• Removing the occluding device;

• Assembling the first part with the second part; and

• Activating the infusion device.

17. A filling detection device of an infusion device comprising a housing, a cavity arranged into the housing, a reservoir comprising an internal compartment intended to be filled with a solution and arranged into the housing, a fluid pathway comprising an outlet in fluid communication with the internal compartment, a vent device configured for communicating ambient air into the cavity, and a removably occluding device configured to occlude the vent device at least during the filling of the internal compartment, wherein the filling detection device comprises a pressure transducer and an indicator intended to provide information related to a filling level of the internal compartment.