Fluid delivery device manifold switchable from fill position for filling reservoir from primary container to injection position to inject fluid from reservoir

Abstract

A manifold having a mobile part and a fixed part is provided for convenient configuration of a fluid delivery device for filling or for injection using a monodirectional pump. Fixed part ports are fluidically connected to reservoir, pump mechanism, and injection outlet (e.g., catheter) of the fluid delivery device. Mobile part ports are selectively aligned with a primary container used for filling and fixed part ports, depending movement of the mobile part relative to the fixed part for a filling position or an injection position of the manifold. Different manifolds are provided that use various connections between the mobile part and the primary container (e.g., a vial adapter, a syringe) to allow for use of different types of primary containers for filling and to impart the selected movement of the mobile part relative to the fixed part for the desired position of the manifold for storage, filling or injection.

Description

FLUID DELIVERY DEVICE MANIFOLD SWITCHABLE FROM FILL POSITION FOR FILLING RESERVOIR FROM PRIMARY CONTAINER TO INJECTION POSITION TO INJECT FLUID FROM RESERVOIRBACKGROUNDField:

[0001] Illustrative embodiments relate generally to an injection module with a manifold in a fluid delivery device that is switchable from a fill position to an injection position to enable a pump used for drug delivery to also be used for a filling operation.Description of Related Art:

[0002] Bolus and / or infusion pump therapy generally requires an infusion cannula, typically in the form of an infusion needle or a flexible catheter, that pierces the patient's skin and through which, infusion of a medicament takes place. Infusion pump therapy offers the advantages of continuous infusion, precision dosing, and programmable delivery schedules.

[0003] To facilitate drug delivery therapy, there are generally two types of pumps, namely, conventional pumps and patch pumps. Conventional pumps require the use of a disposable component, typically referred to as an infusion set, tubing set or pump set, which conveys the medicament from a reservoir within the pump into the skin of the user. The infusion set consists of a pump connector, a length of tubing, and a hub or base from which a cannula, in the form of a hollow metal infusion needle or flexible plastic catheter extends. The base typically has an adhesive that retains the base on the skin surface during use. The cannula can be inserted onto the skin manually or with the aid of a manual or automatic insertion device. The insertion device may be a separate unit required by the user.

[0004] Another type of pump is a patch pump. Unlike a conventional infusion pump and infusion set combination, a patch pump is an integrated device that combines most or all of the fluidic components, including the fluid reservoir, pumping mechanism and mechanism for automatically inserting the cannula, in a single housing which is adhesively attached to an infusion site on the patient's skin, and does not require the use of a separate infusion or tubing set. A patch pump containing a medicament adheres to the patient’s skin and delivers themedicament over a period of time or at a selected time via an integrated subcutaneous cannula. Some patch pumps may wirelessly communicate with a separate controller device, while others are completely self-contained. Such devices can be replaced on a frequent basis, such as every three days, when the medicament reservoir is exhausted or when complications may otherwise occur, such as restriction in the cannula or the infusion site.

[0005] As patch pumps are designed to be a self-contained unit that is worn by the user (e.g., patient), it is preferable to be as small as possible so that it does not interfere with the activities of the user. Thus, in order to minimize discomfort to the user, it would be preferable to minimize the overall thickness of the patch pump. However, in order to minimize the thickness of the patch pump, the constituent parts of the patch pump should be reduced in size and possibly in number as much as possible.

[0006] Some patch pumps can be designed with reservoirs that are integrated as opposed to a patch pump in which a pre-filled cartridge is inserted into the patch pump housing. Patch pumps with integrated reservoirs may require filling after patch pump assembly at the manufacturing stage, or at the end user stage wherein a healthcare provider or patch pump wearer provides a medicament to the patch pump reservoir using a filling method. A need exists for a mechanism and / or process to improve automatic filling of a reservoir in a patch pump.SUMMARY

[0007] The above and other problems are overcome, and additional advantages are realized, by illustrative embodiments.

[0008] It is an aspect of illustrative embodiments to provide a manifold for a fluid delivery device that delivers a fluid medicament to a patient, the fluid delivery device having a pump mechanism for providing a controlled amount of the medicament from a reservoir to an injection outlet, medicament from a primary container being provided to the reservoir by a filling operation, the manifold comprising: an adapter part configured to be connected to the primary container during the filling operation; a fixed part comprising a fixed part housing with fixed part ports arranged therein and configured for fluidic connection to the pump mechanism, the reservoir, and to the injection outlet; and a mobile part. The mobile part isconfigured to be movable relative to the fixed part and at least releasably connected to the adapter part, the mobile part being configured with mobile part ports that are selectively aligned with a primary container used for the filling operation and with fixed part ports depending position of the mobile part relative to the fixed part.

[0009] In accordance with aspects of illustrative embodiments, the mobile part ports are chosen from a port that is fluidically connected to the reservoir, at least one port that is selectively connected to at least one of an inlet and an outlet of the pump mechanism, and a port that is located at an end of an interior fluid channel extending to a part of the mobile part housing that is fluidically connected to a primary container inserted into the adapter part and configured to receive fluid from the primary container during the filling operation.

[0010] In accordance with aspects of illustrative embodiments, at least part of the mobile part is received within the fixed part.

[0011] In accordance with aspects of illustrative embodiments, the mobile part moves relative to the fixed part using a motion selected from translating, rotating, and pivoting.

[0012] In accordance with aspects of illustrative embodiments, the mobile part comprises a mobile part housing having the mobile part ports arranged thereon.

[0013] In accordance with aspects of illustrative embodiments, the adapter part is configured to be connected to a primary container and to the mobile part such that rotation of the primary container imparts rotation to the mobile part relative to the fixed part.

[0014] In accordance with aspects of illustrative embodiments, the adapter part comprises a Luer lock interface configured to cooperate with a primary container having a Luer lock and chosen from a vial adapter and a syringe.

[0015] In accordance with aspects of illustrative embodiments, a syringe is connected to the adapter part, and the mobile part ports are configured to be offset relative to a fixed part port with fluidic connection to an inlet of the pump mechanism during the filling operation to fill the reservoir manually via the syringe.

[0016] In accordance with aspects of illustrative embodiments, the mobile part of the manifold has a lever member. The adapter part comprises a stationary adapter part configured to be fluidically connected to the mobile part housing, and a movable adapter partwith a foot that depresses the lever member and rotates the mobile part relative to the fixed part when the movable adapter part is translated relative to the stationary adapter part.

[0017] In accordance with aspects of illustrative embodiments, the manifold further comprises a sensor deployed with respect to a part of the manifold chosen from the mobile part, the fixed part and the adapter part to determine at least one of the position of the mobile part relative to the fixed part, and an operational mode of the manifold, the operational mode of the manifold being chosen from a storage positon, a filling position and an injection position.

[0018] In accordance with aspects of illustrative embodiments, the pump is a monodirectional pump.

[0019] In accordance with aspects of illustrative embodiments, the adapter part comprises a connector part configured to fluidically connect the mobile part housing to a primary container deployed with respect to the adapter part, the connector part having at least one blade. The mobile part has at least one clip member that retains the blade when the primary container is rotated a selected amount of degrees and imparts rotation to the mobile part to place the manifold in a filling position during the filling operation. For example, the clip member can have a sloped edge that engages the blade when the primary container is rotated a selected amount of degrees and imparts rotation to the mobile part to align selected ones of the mobile part ports with the fixed part ports for injection. For example, the sloped edge can be dimensioned to stabilize the adapter part relative to the manifold yet allow removal of the primary container from the adapter part.

[0020] In accordance with aspects of illustrative embodiments, the fixed part housing comprises a cam guide, and the manifold further comprises a rotating ring with a pin and a spring dimensioned to be deployed along a longitudinal axis of the mobile part so that the pin can follow the cam guide, the cam guide being configured to guide the pin to a cam guide filling position and thereby translate the mobile part relative to the fixed part from a first position to a second position when a primary container is connected to the vial adapter and pressed for the filling operation to compress the spring and place the manifold in a filling position. The cam guide is configured to guide the pin to a cam guide injection position and thereby translate the mobile part relative to the fixed part back to the first position when theprimary container connected to the vial adapter is pressed again to release the spring to place the manifold in an injection position.

[0021] In accordance with aspects of illustrative embodiments, the mobile part translates relative to the fixed part from a first position to a second position when a primary container is connected to the adapter part and pressed to place the manifold in a filling position, and can translate a position different from the second to place the manifold in an injection position. The mobile part has a mobile part housing having the mobile part ports arranged thereon using a first port interface and a second port interface, the first port interface having a plurality of ports that can be selectively fluidically coupled to a pair of the fixed part ports that are fluidically connected to an inlet and an outlet of the pump mechanism and arranged along a longitudinal axis of the mobile part, depending on whether the manifold is placed in the filling position or the injection position.

[0022] In accordance with aspects of illustrative embodiments, the second port interface can have a port that can be fluidically coupled to a fixed part port that connects to the reservoir when the manifold is placed in any of the filling position and the injection position.

[0023] In accordance with aspects of illustrative embodiments, the mobile part is fluidically connected to the injection outlet by a catheter fluid path and the mobile part has at least part of the catheter fluid path disposed therein. The plurality of ports in the first port interface comprises a proximal port that is fluidically connected to the adapter part, a distal port that is fluidically connected to the catheter fluid path, and a third port arranged between the proximal port and the distal port and fluidically connected to an interior fluid channel that extends from the third port to the port in the second port interface that is fluidically coupled to the reservoir.

[0024] Additional and / or other aspects and advantages of illustrative embodiments will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the illustrative embodiments. The illustrative embodiments may comprise apparatuses and methods for operating same having one or more of the above aspects, and / or one or more of the features and combinations thereof. The illustrative embodiments may comprise one or more of the features and / or combinations of the above aspects as recited, for example, in the attached claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The above and / or other aspects and advantages of the illustrative embodiments will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, of which:

[0026] FIGs. 1 and 2 are, respectively, a top perspective and a side view of an example patch pump as a wearable fluid delivery device;

[0027] FIG. 3 is a block diagram of example components of an example fluid delivery device constructed in accordance with an example embodiment;

[0028] FIGs. 4A and 4B are block diagrams of example wearable delivery patch components employed, respectively, for filling a reservoir, and injecting from the reservoir, using a manifold constructed in accordance with an example embodiment and a monodirectional pump;

[0029] FIG. 5 depicts components in an example fluid delivery device connected to a manifold constructed in accordance with an example embodiment;

[0030] FIGs. 6A and 6B are, respectively, a cross-section view of a manifold constructed in accordance with a first embodiment in a storage position and attached to a vial adapter, and an enlarged partial cross-section view of the manifold in FIG. 6A;

[0031] FIGs. 6C and 6D are, respectively, a cross-section view of the manifold in FIGs. 6A and 6B in a filling position and with a primary container inserted into the vial adapter, and an enlarged partial cross-section view of the manifold in FIG. 6C;

[0032] FIGs. 6E and 6F are, respectively, a cross-section view of the manifold in FIGs. 6A and 6B in an injection position and with the primary container still inserted into the vial adapter, and an enlarged partial cross-section view of the manifold in FIG. 6E;

[0033] FIG. 7 is an exploded view of the manifold in FIG. 6A;

[0034] FIG. 8 is a perspective view of a mobile part deployed in the manifold in FIG. 6A;

[0035] FIG. 9 is a cross-section view of the mobile part deployed in the manifold in FIG. 6A;

[0036] FIG. 10A is a cross-section view of the manifold in FIG. 6A;

[0037] FIG. 10B is an exploded side view of the fixed part of the manifold shown in FIG. 10 A;

[0038] FIG. 11 A is a perspective view of a manifold constructed in accordance with a second embodiment in a storage position and attached to a vial adapter;

[0039] FIG. 1 IB is a perspective view of the manifold in FIG. 11 A in a filling position;

[0040] FIG. 11C is a perspective view of the manifold in FIG. 11 A in an injection position and with a primary container still inserted into the vial adapter;

[0041] FIG. 12 is an exploded view of a primary container and the vial adapter shown in FIG. 11 A;

[0042] FIG. 13 is a cross-section of a mobile part of the manifold in FIG. 11 A;

[0043] FIG. 14 is a perspective view of the mobile part shown in FIG. 13;

[0044] FIGs. 15A and 15B are respective cross-section views of the manifold in FIG.11 A;

[0045] FIG. 16 is an exploded view of the manifold in FIG. 11 A;

[0046] FIGs. 17A, 17B and 17C are different perspective views of the mobile part of the manifold in FIG. 11 A;

[0047] FIGs. 18A and 18B are, respectively, a cross-section view of a manifold constructed in accordance with a third embodiment in a storage position and attached to a vial adapter, and an enlarged partial cross-section view of the manifold in FIG. 18 A;

[0048] FIGs. 18C and 18D are, respectively, a cross-section view of the manifold in 18A and 18B in a filling position and with a primary container inserted into the vial adapter, and an enlarged partial cross-section view of the manifold in FIG. 18C;

[0049] FIGs. 18E and 18F are, respectively, a cross-section view of the manifold in FIGsl8A and 18B in an injection position, and an enlarged partial cross-section view of the manifold in FIG. 18E;

[0050] FIG. 19 is a cross-section of a mobile part of the manifold in FIG. 18 A;

[0051] FIG. 20 is a perspective view of the mobile part shown in FIG. 19;

[0052] FIG. 21 is a cross-section view of the manifold in FIG. 18 A;

[0053] FIGs. 22A, 22B and 22C are respective exploded views of the manifold in FIG. 18A and illustrating example arrangement of mobile part ports relative to a selected position with respect to a fixed part of the manifold in FIG. 18 A;

[0054] FIG. 23 is a cross-section view of a manifold constructed in accordance with a fourth embodiment and attached to a Luer lock;

[0055] FIG. 24 is a perspective view of the mobile part of the manifold shown in FIG. 23;

[0056] FIG. 25 is a cross-section of a mobile part of the manifold in FIG. 23;

[0057] FIG. 26 is an exploded view of the manifold in FIG. 23 with a vial adapter;

[0058] FIG. 27 is a perspective view of the via adapter shown in FIG. 26;

[0059] FIGs. 28A, 28B, 28C and 28D are different perspective views of the mobile part of the manifold in FIG. 23;

[0060] FIG. 29 is a perspective view of a manifold constructed in accordance with a fifth embodiment;

[0061] FIG. 30 is a perspective view of the mobile part of the manifold shown in FIG. 29; and

[0062] FIG. 31 is a cross-section of a mobile part of the manifold in FIG. 29.

[0063] Throughout the drawing figures, like reference numbers will be understood to refer to like elements, features and structures.DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0064] Reference will now be made in detail to illustrative embodiments, which are depicted in the accompanying drawings. The embodiments described herein exemplify, but do not limit, the illustrative embodiments by referring to the drawings.

[0065] As will be appreciated by one skilled in the art, there are numerous ways of carrying out the examples, improvements, and arrangements of a fluid delivery device in accordance with embodiments disclosed herein. Although reference will be made to the illustrative embodiments depicted in the drawings and the following descriptions, the embodiments disclosed herein are not meant to be exhaustive of the various alternative designs and embodiments that are encompassed by the disclosed technical solutions, andthose skilled in the art will readily appreciate that various modifications can be made, and various combinations can be made without departing from the scope of the disclosed technical solutions.

[0066] In accordance with example embodiments of the present disclosure, an improved patch pump design for a wearable fluid delivery device is provided that employs fluid pathways in a manifold for filling a reservoir with medicament and injection of the medicament into a patient. In accordance with an advantageous aspect of the example embodiments, the improved patch pump design allows for filling the reservoir in the patch pump using a manifold and the pump mechanism of the fluid delivery device. As described further herein, example embodiments of a manifold cooperate with other components of the patch pump to operate in a filling position (e.g., to facilitate fluid flow from a primary container such as a vial to the reservoir), and in an injection position (e.g., to facilitate fluid flow from the reservoir to the needle and / or catheter) using the pump mechanism, allowing a user such as the patient or the patient’s caregiver the autonomy to automatically fill the patch pump in a convenient manner and thereby obviating the need, expense and inconvenience of going to a clinical setting for a healthcare provider to fill the patch pump.

[0067] FIGs. 1 and 2 illustrate an example patch pump 10 for use as a wearable fluid delivery device. The patch pump 10 comprises an enclosure or housing 12 with activation buttons 20 and an insertion mechanism 22. The housing 12 can have an adhesive pad 16 provided on its baseplate 14 and a liner 18 that are configured to allow a user to remove the liner 18 and place a tacky side of the adhesive pad 16 on a patient’s skin to adhere the patch pump 10 to the patient. The insertion mechanism 22 is shown in an undeployed position in FIG. 1. In FIG. 2, the adhesive pad 16 and liner 18 are not shown for clarity to depict the insertion mechanism 22 in a deployed position whereby a needle 26 and / or catheter 24 extend from the housing 12 for insertion into a patient’s skin. As described herein, an example patch pump has a catheter 24 and needle 26 assembly for insertion of the catheter and needle into a patient and then retraction of the needle. An example insertion mechanism is described in PCT international application WO 2015 / 164653 which is incorporated herein by reference. It is to be understood that the insertion mechanism can alternatively employ a hollow needle, for example.

[0068] The patch pump 10 comprises other components arranged in the enclosure 12. FIG. 3 is an example block diagram of example components of the patch pump 10. The patch pump 10 comprises a reservoir 28, the insertion mechanism 22, and a fluid displacement module 30 that can include a motor 32 with associated motor housing and gearbox, gear train 36, a pump mechanism 38 (e.g., a positive displacement pump), and fluid paths indicated at 40a, 40b, 40c and 40d described below and illustrated in accordance with example embodiments. The patch pump 10 further comprises electrical components such as a power module (e.g., battery 42), and an electrical module 44 comprising a controller 46, a motor driver 48, optional sensing module 50 to sense fluid flow conditions (e.g. occlusion), optional audio driver 52 (e.g., to indicate dosing in progress, low reservoir, occlusion, successful pairing with external device, or other condition), and an optional visual driver 54, and an optional wireless driver 56 for wireless communication between the fluid delivery device and an optional remote pump control device 58 (e.g., a smartphone or dedicated controller). As described below, the controller 46 can be programmed or otherwise configured to control the motor and therefore the pump mechanism 38 for perform filling and injection operations via example embodiments of the technical solution described herein. The initiating of the pump mechanism 38, also after referred to herein as the pump 38, to either commence filling the reservoir 28 from a primary container 60, or to commence injecting by controllably moving fluid from the reservoir 28 to the needle 26 and / or catheter 24 inserted into the patient’s skin can be automatic (e.g., in response to a sensor that detects position of a component in the insertion mechanism 22) or manual (e.g., controlled by the user via a user interface to the patch pump such as the wireless controller 58 or using the activation buttons 20 or other control device provided on the patch pump housing 12).

[0069] FIGs. 4A and 4B illustrate example patch pump 10 components employed for filling a reservoir 28 and for injecting from the reservoir 28 using a manifold 70 constructed in accordance with an example embodiment to be operational with a monodirectional pump. The manifold 70 has fluid pathways indicated generally at 72 whereby use of various ones of the pathways is selectable depending on stage of use (e.g., storage, filling, injection). The manifold 70 can be fluidically connected to patch pump 10 components such as the pump mechanism 38, the reservoir 28 (e.g., a flexible reservoir as described in PCT internationalapplication WO 2017 / 053284 which is incorporated herein by reference), a catheter / needle hub or assembly indicated as 24,26, and a primary container 60 (e.g., a syringe, or vial or other container with a Luer lock). The example schematic of the fluid pathways 72 in the manifold 40 shown in FIG. 4A illustrates a filling stage whereby fluid from the primary container 60 is provided to an inlet of the pump mechanism 38 via a fluid channel 72a in the manifold 70, and the pump mechanism 38 provides fluid from its outlet through a fluid channel 72b in the manifold 70 to the reservoir 28. The example schematic of the fluid pathways 72 in the manifold 40 shown in FIG. 4B illustrates an injection stage whereby fluid from the reservoir 28 is provided to an inlet of the pump mechanism 38 via a fluid channel 72c in the manifold 70, and the pump mechanism 38 provides fluid from its outlet through a fluid channel 72d in the manifold 70 to the catheter and / or needle hub (e.g. indicated at 94 in FIGs. 4A and 4B). As indicated at 40d in FIG. 3 and in accordance with a fifth embodiment described below in connection with FIGs. 29 through 31, a manifold 70 is provided that is configured to accommodate manual filling using a syringe and therefore the pump mechanism 38 is not used draw fluid from the primary container 60 during filling. All of the example embodiments of the present disclosure advantageously provide for device configuration compatibility and simple device modification from manual to automatic filling.

[0070] FIG. 5 depicts components in an example patch pump 10 connected to a manifold 70 constructed in accordance with an example embodiment. The manifold 70 is a fluidic connection 70a to a primary container 60 such as a vial using an adapter part 80 which has a seal 82. The manifold 70 has fluidic connections 70b, 70c to the inlet and outlet of the pump mechanism 38, which is shown attached to a motor 32. The manifold 70 has a fluidic connection 70d to the reservoir 28. The manifold 70 also has a fluidic connection 70e to the catheter fluid path to the insertion mechanism 22. As described below in accordance with different example embodiments, the manifold 70 is configured to switch among its fluid pathways 72 for filling or injection by way of a user-friendly mechanical operation (e.g., a user depresses or rotates the primary container 60 to impart mechanical movement of manifold 70 components to switch pathways 72 from a filling position as illustrated in FIG. 4 A to an injection position as illustrated in FIG. 4B) to enable a user to fill the reservoir 28 directly from a primary container 60 in a convenient manner. Manifold fluid pathways 72 ofexample embodiments of a manifold 70 described herein can also be configured in an initial storage position that can be used during storage to close one or more fluid pathways 72.

[0071] A number of different example embodiments of the manifold 70 are described herein which implement the above described principles of operation using different example configurations of a manifold. Briefly, a first example embodiment of the manifold 70 is shown and described herein with reference to FIGs. 6A through 10B that uses a linear movement approach for switching pathways 72 to attain a filling position from a storage position, and an injection position. Second, third, fourth and fifth example embodiments of the manifold 70 are shown and described herein that use a rotational movement approach for switching pathways 72. The second example embodiment of the manifold 70 is shown in FIGs. 11 A through 17C. The third example embodiment of the manifold 70 is shown in FIGs. 18A through 22C. The fourth example embodiment of the manifold 70 is shown in FIGs. 23 through 28D. The fifth example embodiment of the manifold 70 is shown in FIGs. 29 through 31.

[0072] In accordance with the first example embodiment shown in FIGs. 6A through 10B, a fluid container 60 (e.g., a vial of medicament) is fluidically connected to the fluid delivery device or patch pump 10 via an adapter part 80.

[0073] The adapter part is connected to a manifold 70 of the fluid delivery device 10 that comprises a fixed part 84, a mobile part 86, a rotating ring 102, and a spring 104. Parts of the manifold 70 are movable from a storage position (FIGs. 6A and 6B) to a filling position (FIGs. 6C and 6D) and to an injection position (FIGs. 6E and 6F). The selection of the position of the manifold 70 is controlled by depressing a vial 60 and its connected adapter part 80 relative to the fixed part 84.

[0074] The fixed part 84 comprises a manifold housing 100 having a manifold housing lid 100a as shown in FIGs. 10A and 10B. The manifold housing 100 is configured to slidably receive at least a portion of the mobile part 86 therein. A proximal end of the mobile part 86 is configured to cooperate with the adapter part 80 to fluidically connect and receive the fluid from the primary container 60 as indicated at 70a in FIG. 10A. The manifold housing 100 has a pair of ports indicated 118b, 118c that can be fluidically connected to the inlet and outlet ports of the pump mechanism 38 for the fluidic connections 70b, 70c, and aport indicated at 118d that can be fluidically connected to the reservoir 28 for the fluidic connections 70d. Seals 100b can be provided in the manifold housing 100 as shown in FIG. 7.

[0075] With reference to FIGs. 7, 8 and 9, the mobile part 86 has a mobile part housing 106 that is provided with a first port interface 108 and a second port interface 110 for arrangement of a plurality of mobile part ports 112. The first port interface 108 has a plurality of ports 112a, 112b, 112c that can be selectively fluidically coupled to the pair of ports 70b, 70c of the manifold housing 100 that connect to the inlet and outlet of the pump mechanism 38, depending on whether the manifold 70 is operated in its filling position (FIGs. 6C and 6D) or its injection position (FIGs. 6E and 6F). The second port interface 110 has a port 112d that can be fluidically coupled to the port 70d of the manifold housing that connects to the reservoir 28, regardless of whether the manifold 70 is operated in its filling position or its injection position. Seals 108a and 110a can be provided with respect to the first port interface 108 and the second port interface 110 to prevent leakage of fluid when mobile part ports 112 are aligned with respective fixed part ports 118.

[0076] The adapter part can be removably connected to the proximal end of the mobile part 86 and, when connected, also fluidically connected to a fluid channel 116 in the mobile part housing that extends from the proximal end of the mobile part to a proximal port 112a in the first port interface 108. A distal end of the mobile part 86 comprises a fluid channel 114 that operates as at least part of the catheter fluid path 70e employed for injection. The first port interface 108 further comprises a distal port 112c that is fluidically connected to the interior fluid channel 114 that extends from the distal port to the distal end of the mobile part that forms part of the catheter fluid path 70e. The first port interface 108 also has a third port 112b arranged between the proximal port 112a and the distal port 112c and fluidically connected to an interior fluid channel 120 that extends from the third port 112b to ports 112d and 112e in the second port interface that are fluidically coupled to the reservoir 28 when the manifold 70 is in the filling position and injection position, respectively.

[0077] The pair of ports 118b, 118c in the manifold housing 100 can be arranged along a longitudinal axis of the fixed part 84, for example. The proximal port 112a, distal port 112c and third port 112b of the first port interface 108 can also be arranged along thelongitudinal axis of the mobile part 86, for example, and disposed relative to the pair of ports for 118b, 118c alignment to achieve the above-described fluidic connections when the manifold is in the filling position and the injection position.

[0078] With continued reference to FIGs. 6 A through 10B, the movement of the mobile part 86 relative to the fixed part 84 of the manifold 70 can be achieved using a rotating ring 120 and spring 104 arranged around the mobile part 86 and within the manifold housing 100 (e.g., concentrically between the manifold housing 100 and the manifold housing lid 100a). The rotating ring 102 can be provided with a pin 122 that traverses a cam guide 124 provided on the fixed part 84. The cam guide 124 can be configured to allow the ring pin 122 to follow a square cycle as illustrated in FIGs. 6B, 6D and 6F. The cam guide 124 can be configured as two parts including corresponding edges and detents in the manifold housing 100 and a corresponding groove in the interior of the manifold housing lid 100a. It is to be understood that other mechanical features can be used with regard to the mobile part 86 and the fixed part 84 of the manifold 70 to achieve relative translational movement and therefore selected alignment of the ports 112a, 112b, 112c in the first port interface 108 with the pair of ports 118b, 118c in the fixed part 84 that make fluidic connections 70b, 70c with the inlet and outlet of the pump mechanism 38 for filling or injection.

[0079] The first example embodiment is advantageous because it provides a compact arrangement for a fluid delivery device 10 to fill its reservoir 28 as well as operate in an injection mode. The manifold 70 reduces dead volume of fluid in fluid channels as compared with the fluid delivery device described with reference to above-referenced WO 2015 / 164653 and WO 2017 / 053284. Switching to the filling position and to the injection position of the manifold 70 is simply achieved via activation by a primary container 60 (e.g. a vial) such as pressing on the vial to facilitate movement of the ring pin 122 along different portions of the cam guide 124. An optional component 150 shown in FIGs. 11 A through 1 IB can be provided to detect a position of a manifold component to automatically control the pump mechanism 38. The first example embodiment also provides a monostable system when the manifold 70 is in the injection position since the detents of the cam guide 124 are configured to stabilize the mobile part 86 in the injection position relative to the fixed part 84.

[0080] In accordance with the second example embodiment shown in FIGs. 11 A through 17C, a manifold 70 is provided that can be rotated to selectively achieve a filling position with respect to the inlet and outlet of the pump mechanism 38, a primary container 60 and the reservoir 28, or an injection position with respect to the inlet and outlet of the pump mechanism 38, the reservoir 28 and the catheter 24 in the insertion mechanism 22. A fluid container 60 (e.g., a vial of medicament) is fluidically connected to the fluid delivery device 10 via an adapter part 80. The adapter part 80 has fixed piece 130, and a movable piece 132, and a manifold connector 134 that is fluidically connected to the manifold 70. A seal 136 is provided between the fixed piece 84 and movable piece 86.

[0081] The moveable piece 132 can be translated toward the manifold 70 by manually pressing on a vial 60 inserted into the adapter part 80, and retracted away from the manifold 70 using a spring (not shown) therein. The moveable piece 132 has a foot assembly 138 that translates relative to the adapter part and the manifold connector 134 and toward the manifold 70 when the vial 60 is pressed toward the manifold 70. The foot assembly 138 engages a lever member 140 provided on a proximal end of a mobile 86 part of the manifold 70 to turn the mobile part 86 a selected amount (e.g., 90 degrees of rotation) relative to a fixed part 84 of the manifold. As described more below, the mobile part 86 of the manifold has a plurality of ports 112 that are selectively aligned with respect to ports 118 provided in the fixed part 84 of the manifold to provide fluid pathways 72 between different groups of components of the fluid delivery device 10 during filling of the reservoir 28 from the vial 60 as compared with during an injection of the fluid delivery device 10.

[0082] The mobile part 86 of the manifold 70 comprises a housing 142, at least part of which is slidably received in the fixed part housing 144 to enable rotation of the mobile part 86 with respect to the fixed part 84. The plurality of ports 112 in the mobile part 86 of the manifold can include a first port 112a disposed at one end of an interior fluid channel 116 that extends between the port 112a and the proximal end of the mobile part and can be fluidically connected to the adapter part 80. Additional ports 112b, 112c and 112d are disposed in the mobile part housing 142 around the circumference thereof and are spaced relative to each other for selective alignment with ports 118b, 118c, and 118d in the fixed part 84 of the manifold as described below. One of these additional ports 112c is disposed at oneend of another interior fluid channel 114 which extends to the distal end of the mobile part 86 and which constitutes at least part of the catheter fluid path 70e employed for injection. It is to be understood the ports 112 on the mobile part 86 can be placed using different arrangements, depending on the locations of the ports 118 on the fixed part 84 of the manifold 70, and therefore different from the arrangement shown in FIGs. 13, 14, 16 and 17A through 17C.

[0083] In the illustrated second example embodiment shown in FIGs. 11 A through 17C, the fixed part 84 of the manifold is provided with a pair of ports 118b, 118c that are fluidically connected to the inlet and outlet ports of the pump mechanism 38, and with a port 118d that is fluidically connected to the reservoir 28. A distal end of the fixed part 84 of the manifold is configured to accommodate the extension therefrom of the catheter fluid path 70e associated with the distal end of the mobile part. A proximal portion of the fixed part 84 of the manifold is provided with stabilizing arms 144a, 114b that prevent translation of the mobile part 86 longitudinally with respect to the fixed part 84, and limit the degree of rotation of lever members 140a, 140b provided on the mobile part 86 and therefore limit the rotation of the mobile part 86 relative to the fixed part 84..

[0084] With further reference to FIGs. 11 A through 17C, the mobile part 86 is provided with four ports 112a, 112b, 112c, 112c arranged around the circumference of its housing 142, including a first port 112b that is radially aligned with the lever member 140a contacted by the foot assembly 138, a second port 112d that is arc-shaped and aligned with the port 118d in the fixed part that is fluidically connected to the reservoir 28, and a third port 112a and a fourth port 112c disposed respectively on either side of the second port 112d. The fourth port 112c can be the above-referenced port that is disposed at one end of the interior fluid channel 114 that extends to the distal end of the mobile part 86 and constitutes at least part of the catheter fluid path 70e employed for injection.

[0085] The lever member 140a can be slightly longer than the other lever member 140b to facilitate the foot assembly 138 pressing on the lever member 140a to rotate the mobile part 86. When the foot assembly 138 is not pressing on the lever member 140a to rotate the mobile part 86 and the manifold 70 is in a storage position (FIG. 11 A) or in an injection position (FIG. 11 C), the first port 112b is aligned with the fixed member port 118bto the inlet of the pump mechanism 38, the fourth port 112c is aligned with the fixed member port to the outlet of the pump mechanism 38, the third port 112a is not aligned with a port in the fixed member, and the fixed part port 118d that is fluidically connected to the reservoir 28 is aligned to the second port 112d proximally to an end of its arc shape. This configuration allows the pump mechanism 38 to draw fluid from the reservoir 28 and output fluid from the reservoir to the catheter fluid path 70e. The housing 142 itself operates as an interior fluid channel between the second port and the first port to draw fluid from the reservoir 28.

[0086] When the foot assembly 138 is pressing on the lever member 140a and has rotated the mobile part 86 of the manifold 70 to a filling position, the first port 112b is aligned with the fixed member port 118c to the outlet of the pump mechanism 38, the third port 112a is aligned with the fixed member port 118b to the inlet of the pump mechanism 38, the fourth port 112c is not aligned with a port in the fixed member 84, and the fixed part port 118d that is fluidically connected to the reservoir 28 is aligned to the second port 112d proximally to the other end of its arc shape. This configuration allows the pump mechanism 38 to draw fluid from the vial 60 and to output fluid to the reservoir 28. The housing 142 itself operates as an interior fluid channel between the first port 112b and the second port 112d to output fluid to the reservoir 28. A seal 86a can be overmolded to the exterior of the mobile part 86 and and a seal 86b can be provided between the distal ends of the mobile part 86 and the fixed part 84 to prevent leakage from the mobile part housing 142.

[0087] An optional component 150 can be provided to a lever member (e.g., lever member 140b) to detect its position and therefore whether the manifold 70 is in a filling position or an injection position to permit automated control of the pump mechanism 38. For example, the optional component 150 can be a spring to attain a monostable position of the manifold, and can also act as a sensor for measuring force applied to the spring (e.g., compression or extension of the spring) or other sensor characteristic. The second example embodiment is advantageous because it provides a compact arrangement for a fluid delivery device 10 to fill its reservoir 28 as well as operate in an injection mode. Switching to the filling position and to the injection position of the manifold 70 is simply achieved via activation by a primary container 60 (e.g. a vial) such as pressing on the vial 60 to facilitate movement of the moveable piece 132 of the adapter part 80 to impart rotation of the mobilepart 86 when the foot assembly 138 presses on the lever member 140a. The second example embodiment also provides a monostable system wherein the vial is compressed continuously to transfer fluid from the primary container 60 to fill the reservoir 28.

[0088] In accordance with the third example embodiment shown in FIGs. 18A through 22C, a manifold 70 is provided having a fixed part 84 and a mobile part 86 having respective pluralities of ports 118 and 112 that are arranged substantially the same as those described in the second example embodiment shown in FIGs. 11 A through 17C, but a different connector 160 is employed on the adapter part 80 for releasably connecting the vial to the mobile part 86. Further, by way of an example, the outlet for the catheter fluid path 70e is illustrated as extending from the circumferential side wall of the fixed part housing 164 versus its distal end as shown in FIGs. 15A and 15B for the second example embodiment, and therefore create a more direct connection to the catheter 24 than the interior fluid path 114 to the catheter employed in the second example embodiment.

[0089] The manifold 70 can be rotated to selectively achieve a filling position with respect to the inlet and outlet of the pump mechanism 38, a primary container 60 and the reservoir 28, or an injection position with respect to the inlet and outlet of the pump mechanism 38, the reservoir 28 and the catheter 24 in the insertion mechanism 22. The manifold 70 is operator controlled, and bistable whereby the degree of rotation is accomplished by manually turning a primary container 60 of fluid (e.g., a vial of medicament) which is removably inserted in the adapter part 80. The adapter part has a seal 82 and internal dimensions that frictionally prevent the vial 60 from rotating relative to the adapter part 80 when inserted therein, but permit rotation of the vial 60 to impart rotation of the adapter part relative to the manifold 70. As described below, the adapter part 80 is provided with additional features 160 that facilitate rotation needed to select a filing position from a storage position, and to select an injection position, as illustrated in FIGs. 18A through 22C.

[0090] The adapter part 60 has a manifold connector 160 that is fluidically connected to a stem provided at the proximal end of the mobile part 86 of the manifold. The manifold connector 160 has blade members 166a, 166b on a distal end thereof that can engage clip members 168a, 168b provided on the proximal end of the mobile part 86 of the manifold 70to turn the mobile part 86 a selected amount (e.g., -45 degrees of rotation from a storage position to a filling positon, and 90 degrees of rotation from the filling position to an injection position, although it is to be understood that rotation amount can be other values) relative to a fixed part 84 of the manifold. A proximal portion of the fixed part housing 164 of the manifold is provided with stabilizing arms 164a, 164b that prevent translation of the mobile part 86 longitudinally with respect to the fixed part 84, and limit rotation of the mobile part by providing end stop positions for the clip members 168a, 168b. As described above in connection with the second embodiment, the mobile part 86 of the manifold has a plurality of ports 112 that are selectively aligned with respect to ports 118 provided in the fixed part 84 of the manifold to provide fluid pathways 72 between different groups of components of the fluid delivery device 10 that are used during filling of the reservoir 28 from the vial 60 as compared with during an injection. It is to be understood the ports 112 on the mobile part can be placed using different arrangements, depending on the locations of the ports 118 on the fixed part of the transfer module, and therefore different from the arrangement shown in FIGs. 18A through 22C. Further, it is to be understood that the degrees of rotation of the mobile part 86 relative to the fixed part 84 of the manifold 70 to achieve a desired position (e.g., a storage position, a filling position, an injection position) can be different depending on the locations of the ports 112 and 118 on the mobile part 86 and the fixed part 84.

[0091] The clip members 168a, 168b are spaced from each other circumferentially to accommodate the blade members 166a, 166b for their initial placement relative to the manifold 70. In the storage position illustrated in FIGs.l8A and 18B, the ports 112 and 118 in the mobile part 86 and the fixed part 84 are aligned such that fluid paths from the manifold70 to the pump mechanism inlet and outlet are closed. The blade members 166a, 166b are angled, and the clip members 168a, 168b have a lip 170 such that when the vial 60 is turned a selected amount (e.g., 45 degrees of rotation from a storage position to the filling positon), edges of the blade members 166a, 166b are received under corresponding ones of the lips 170. When in this filling positon, the first port 112b is aligned with the fixed member port 118c to the outlet of the pump mechanism 38, the third port 112a is aligned with the fixed member port 118b to the inlet of the pump mechanism 38, the fourth port 112c is not aligned with a port in the fixed member 84, and the fixed part port 118d that is fluidicallyconnected to the reservoir 28 is aligned to the second port 112d proximally to an end of its arc shape. This configuration allows the pump mechanism 38 to draw fluid from the vial 60 and to output fluid to the reservoir 28. The housing 162 itself operates as an interior fluid channel between the first port 112b and the second port to output fluid to the reservoir 28. A seal can be overmolded to the exterior of the mobile part and provided between the distal ends of the mobile part and the fixed parts to prevent leakage from the mobile part housing.

[0092] The clip members 168a, 168b are also provided with sloped edges 172 such that, when the vial 60 is turned a selected amount (e.g., 90 degrees of rotation from the filling position to the injection positon), the blade members 166a, 166b travel along the edges 172 a selected amount to align the ports 112 and 118 accordingly. For example, the first port 112b is aligned with the fixed member port 118b to the inlet of the pump mechanism 38, the fourth port 112c is aligned with the fixed member port 112c to the outlet of the pump mechanism 38, the third port 112a is not aligned with a port in the fixed member 844, and the fixed part port 118d that is fluidically connected to the reservoir 28 is aligned to the second port 112d proximally to an end of its arc shape. This configuration allows the pump mechanism 38 to draw fluid from the reservoir 28 and output fluid from the reservoir to the catheter fluid path 70e. The housing 162 itself operates as an interior fluid channel between the second port and the first port to draw fluid from the reservoir 28. Furthermore, the sloped edges 172 of the clip members 168a, 168b are configured to stabilize the adapter part 80 and allow for removal of the vial 60 from the adapter part 80.

[0093] The third example embodiment is advantageous because it provides a compact arrangement and simple assembly for a fluid delivery device 10 to fill its reservoir 28 as well as operate in an injection mode. Switching to the filling position and to the injection position of the manifold 70 is simply achieved via activation by a primary container 60 (e.g., a vial) such as screwing and unscrewing the vial 60 once it is inserted into the adapter part 80, which provides for intuitive activation for a user. Also, an optional component 150 (e.g., a spring indicated at 150 in FIGs. 11 A-l 1 C) can be provided to a clip member 168a, 168b or a blade member 166a, 166b or other component of the adapter part 80 or the manifold 70 to detect the mobile part 86 position and therefore whether the manifold 70 is in a filling position or an injection position to permit automated control of the pump mechanism 38.

[0094] In accordance with the fourth example embodiment shown in FIGs. 23 through 28D, a manifold 70 is provided that is similar to the third example embodiment shown in FIGs. 18A through 22C, except the proximal end of the mobile part housing 182 has a circumferential channel 180 configured to cooperate with an adapter part 80 comprising a Luer lock interface 184 therein. The fixed part 84 is substantially the same as described in connection with the third example embodiment shown in FIGs. 23 through 28D in terms of its ports 118 and stabilizing arms 164a, 164b. By way of an example, the outlet for the catheter fluid path 70e is illustrated as extending from the circumferential side wall of the fixed part 84 versus its distal end as shown in FIGs. 15A and 15B for the second example embodiment, and therefore create a more direct connection to the catheter than the interior fluid path to the catheter employed in the second example embodiment.

[0095] The mobile part 84 of the manifold 70 has four ports 112 including, for example, a port 112a that is located at the end of an interior fluid channel 116 that extends to the proximal end of the mobile part 84 to receive fluid from a connected vial 60, two ports 112b, 112c that can be selectively connected to the pump mechanism 38’s inlet and outlet depending on the selected position of the manifold 70 (e.g., filling position, injection position) whereby one of the ports can be fluidically to the fixed part outlet 70e to the catheter fluid path , and a port 112d for connection to the reservoir 28. The port 112d for connection to the reservoir can have be arc-shaped to maintain fluid connection to and from the port regardless of rotation of the manifold 70 to the filling position or to the injection position and corresponding engagement of the inlet and outlet of the pump mechanism 38.

[0096] As with the third example embodiment described above with reference to FIGs. 18A through 22C, a vial 60, when connected to the adapter part 80 via the Luer lock interface 184 therein, can be screwed and unscrewed by a user to impart rotation to the mobile part 84 of the manifold 70. For example, the ports 112 and 118 on the mobile part and the fixed part of the manifold 70 are arranged such that the mobile part can be rotated a selected amount relative to the fixed part (e.g., -45 degrees) to change from a storage position to a filling positon, and different selected amount rotation (e.g., 90 degrees) to change from the filling position to an injection position. The arrangement of the stabilizing arms 164a,164b of the fixed part 84 relative to lever members 186a, 186b on the mobile part 86 limits the range of rotation.

[0097] The fourth example embodiment is advantageous because it provides a compact arrangement and simple assembly for a fluid delivery device 10 to fill its reservoir as well as operate in an injection mode. Switching to the filling position and to the injection position of the manifold 70 is simply achieved via activation by a primary container 60 (e.g. a vial) such as screwing and unscrewing the vial 60 once inserted into the adapter part 80, which provides for intuitive activation for a user. Also, an optional component 150 can be provided to a lever member 186a, 186b or stabilizing arm 164a, 164b or other component of the adapter part 80 or the manifold 70 to detect the mobile part position and therefore whether the manifold 70 is in a filling position or an injection position to permit automated control of the pump mechanism 38.

[0098] In accordance with the fifth example embodiment shown in FIGs. 29 through 31, a manifold 70 is provided that is similar to the fourth example embodiment shown in FIGs. 18A through 22C, except that a circumferential channel 190 at the proximal end of the mobile part housing 192 cooperates with a Luer lock of a syringe 60 to manually fill the reservoir 28, and the mobile part ports 118 are modified relative to the fourth example embodiment because filling the reservoir does not involve the pump mechanism 38. The fixed part 84 is substantially the same as described in connection with the fourth example embodiment shown in FIGs. 23 through 28D in terms of its ports 118 and stabilizing arms 164a, 164b and outlet 70e for the catheter fluid path extending from the circumferential side wall of the fixed part 84.

[0099] The mobile part 86 of the manifold has four ports including, for example, a port that is located at the end of an interior fluid channel that extends to the proximal end of the mobile part to receive fluid from a connected syringe, two ports that can be selectively connected to the pump mechanism inlet and outlet depending on the selected position of the manifold (e.g., an optional storage position and an injection position) whereby one of the ports can be fluidically connected to the fixed part outlet to the catheter fluid path and a port for connection to the reservoir 28.

[0100] As with the third example embodiment described above with reference to FIGs. 18A through 22C, a syringe or vial adapter or any container with a Luer connection, when connected to the mobile part of the manifold via its Luer lock, can be screwed and unscrewed by a user to impart rotation to the mobile part of the manifold. For example, the ports 112 and 118 on the mobile part 86 and the fixed part 84 of the manifold 70 are arranged such that the mobile part 86 can be rotated a selected amount relative to the fixed part 84 (e.g., -45 degrees) to change from a storage position to a filling positon, and different selected amount rotation (e.g., 90 degrees) to change from the filling position to an injection position. The arrangement of the stabilizing arms 164a, 164b of the fixed part 84 relative to lever members 196a, 196b of the mobile part 86 limits the range of rotation. Unlike the fourth example embodiment, the port 112a that receives fluid from the syringe can be aligned with the fixed part port or outlet for the reservoir when the user imparts rotation to the mobile part via the syringe to place the manifold in the filling position. It is to be understood for this embodiments and other example embodiments having a Luer connection integrated into the manifold 70 that the Luer lock or connection can be male or female to accommodate different containers and / or adapters.

[0101] The fifth example embodiment is advantageous because it provides a compact arrangement and simple assembly for a fluid delivery device 10 to fill its reservoir 28 as well as operate in an injection mode. Switching to the filling position and to the injection position of the manifold 70 is simply achieved via activation by a primary container 60 (e.g. a syringe) such as screwing and unscrewing the syringe once connected to the moblile part 86, which provides for intuitive activation for a user. The fourth and fifth example embodiments described herein illustrate an advantage of versatile configuration in that only the mobile part 86 needs to be changed in the manifold 70 to configure the fluid delivery device 10 for pump- assisted or automatic filling as in the fourth example embodiment, or manual filling as in the fifth example embodiment that accommodates a syringe as a primary container 60. Also, an optional component 150 can be provided to a lever member 196a, 196b or stabilizing arm 164a, 164b or other component of the adapter part or the manifold 70 to detect the mobile part position and therefore whether the manifold 70 is in a filling position or an injection position to permit automated control of the pump mechanism. Further, an interface can beprovided between the mobile part and the fluid delivery device 10 electronics that detects a change in the manifold 70 to know whether to switch from manual to automatic filling or vice versa.

[0102] In the above example embodiments, ports 118 in the mobile part 86 are selectively aligned with a primary container 60 used for filling and the ports 118 in the fixed part, depending on whether the mobile part 86 is moved (e.g., translated a selected amount and / or rotated a selected number of degrees) relative to the fixed part 84 for a filling position of the manifold 70 or for an injection position of the manifold 70. It is to be understood that movement between the mobile part and the fixed part can be translational, rotational, pivotal or other type of movement, or a combination of different movement, depending on the configuration of the mobile part 86 relative to the fixed part 84 and the attachment mechanism used for coupling the manifold 70 to the primary container 60.

[0103] It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the above description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," and "mounted," and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

[0104] The above-presented description and figures are intended by way of example only and are not intended to limit the illustrative embodiments in any way except as set forth in the following claims. It is particularly noted that persons skilled in the art can readily combine the various technical aspects of the various elements of the various illustrative embodimentsthat have been described above in numerous other ways, all of which are considered to be within the scope of the claims.

Claims

CLAIMS:

1. A manifold for a fluid delivery device that delivers a fluid medicament to a patient, the fluid delivery device having a pump mechanism for providing a controlled amount of the medicament from a reservoir to an injection outlet, medicament from a primary container being provided to the reservoir by a filling operation, the manifold comprising: an adapter part configured to be connected to the primary container during the filling operation; a fixed part comprising a fixed part housing with fixed part ports arranged therein and configured for fluidic connection to the pump mechanism, the reservoir, and to the injection outlet; and a mobile part configured to be movable relative to the fixed part and at least releasably connected to the adapter part, the mobile part being configured with mobile part ports that are selectively aligned with a primary container used for the filling operation and with fixed part ports depending position of the mobile part relative to the fixed part.

2. The manifold of claim 1, wherein the mobile part ports are chosen from a port that is fluidically connected to the reservoir, at least one port that is selectively connected to at least one of an inlet and an outlet of the pump mechanism, and a port that is located at an end of an interior fluid channel extending to a part of the mobile part housing that is fluidically connected to a primary container inserted into the adapter part and configured to receive fluid from the primary container during the filling operation.

3. The manifold of claim 1, wherein at least part of the mobile part is received within the fixed part.

4. The manifold of claim 1, wherein the mobile part moves relative to the fixed part using a motion selected from translating, rotating, and pivoting.

5. The manifold of claim 1, wherein the mobile part comprises a mobile part housing having the mobile part ports arranged thereon.

6. The manifold of claim 1, wherein the adapter part is configured to be connected to a primary container and to the mobile part such that rotation of the primary container imparts rotation to the mobile part relative to the fixed part.

7. The manifold of claim 1, wherein the adapter part comprises a Luer lock interface configured to cooperate with a primary container having a Luer lock and chosen from a vial adapter and a syringe.

8. The manifold of claim 1, wherein a syringe is connected to the adapter part, and the mobile part ports are configured to be offset relative to a fixed part port with fluidic connection to an inlet of the pump mechanism during the filling operation to fill the reservoir manually via the syringe.

9. The manifold of claim 1, wherein the mobile part of the manifold has a lever member; wherein the adapter part comprises a stationary adapter part configured to be fluidically connected to the mobile part housing, and a movable adapter part with a foot that depresses the lever member and rotates the mobile part relative to the fixed part when the movable adapter part is translated relative to the stationary adapter part.

10. The manifold of claim 1, further comprising a sensor deployed with respect to a part of the manifold chosen from the mobile part, the fixed part and the adapter part to determine at least one of the position of the mobile part relative to the fixed part, and an operational mode of the manifold, the operational mode of the manifold being chosen from a storage positon, a filling position and an injection position.

11. The manifold of claim 1, wherein the pump is a monodirectional pump.

12. The manifold of claim 1, wherein the adapter part comprises a connector part configured to fluidically connect the mobile part housing to a primary container deployed with respect to the adapter part, the connector part having at least one blade; wherein the mobile part has at least one clip member that retains the blade when the primary container is rotated a selected amount of degrees and imparts rotation to the mobile part to place the manifold in a filling position during the filling operation.

13. The manifold of claim 12, wherein the clip member has a sloped edge that engages the blade when the primary container is rotated a selected amount of degrees and imparts rotation to the mobile part to align selected ones of the mobile part ports with the fixed part ports for injection.

14. The manifold of claim 13, wherein the sloped edge is dimensioned to stabilize the adapter part relative to the manifold yet allow removal of the primary container from the adapter part.

15. The manifold of claim 1, wherein the fixed part housing comprises a cam guide, and the manifold further comprises a rotating ring with a pin and a spring dimensioned to be deployed along a longitudinal axis of the mobile part so that the pin can follow the cam guide, the cam guide being configured to guide the pin to a cam guide filling position and thereby translate the mobile part relative to the fixed part from a first position to a second position when a primary container is connected to the vial adapter and pressed for the filling operation to compress the spring and place the manifold in a filling position; and wherein the cam guide is configured to guide the pin to a cam guide injection position and thereby translate the mobile part relative to the fixed part back to the first position when the primary container connected to the vial adapter is pressed again to release the spring to place the manifold in an injection position.

16. The manifold of claim 1, wherein the mobile part translates relative to the fixed part from a first position to a second position when a primary container is connected to the adapterpart and pressed to place the manifold in a filling position, and can translate a position different from the second to place the manifold in an injection position; wherein the mobile part has a mobile part housing having the mobile part ports arranged thereon using a first port interface and a second port interface, the first port interface having a plurality of ports that can be selectively fluidically coupled to a pair of the fixed part ports that are fluidically connected to an inlet and an outlet of the pump mechanism and arranged along a longitudinal axis of the mobile part, depending on whether the manifold is placed in the filling position or the injection position.

17. The manifold of claim 16, wherein the second port interface has a port that can be fluidically coupled to a fixed part port that connects to the reservoir when the manifold is placed in any of the filling position and the injection position.

18. The manifold of claim 16, wherein the mobile part is fluidically connected to the injection outlet by a catheter fluid path and the mobile part has at least part of the catheter fluid path disposed therein; wherein the plurality of ports in the first port interface comprise a proximal port that is fluidically connected to the adapter part, a distal port that is fluidically connected to the catheter fluid path, and a third port arranged between the proximal port and the distal port and fluidically connected to an interior fluid channel that extends from the third port to the port in the second port interface that is fluidically coupled to the reservoir.

Images