A fluid delivery device manifold can be switched from a fill position for filling a reservoir from a primary container to an injection position for injecting fluid from the reservoir

Abstract

A manifold with a movable part and a fixed part is provided for configuring a fluid delivery device for filling or injection using a unidirectional pump. The fixed part port is fluidly connected to the fluid delivery device's reservoir, pump mechanism, and injection outlet, such as a conduit. Depending on the movement of the movable part relative to the fixed part in the filling or injection position of the manifold, the movable part port is selectively aligned with a main container for filling and the fixed part port. Various manifolds are provided that use various connections between the movable part and the main container, such as a vial adapter and a syringe, to allow filling with different types of main containers and to impart selected movement to the movable part relative to the fixed part for a desired position of the manifold for storage, filling, or injection.

Description

Technical Field

[0001] The illustrative embodiments generally relate to an injection module with a manifold in a fluid delivery device, which can switch from a filling position to an injection position so that a pump used for drug delivery can also be used for filling operations. Background Technology

[0002] Bolus and / or infusion pump therapy typically requires an infusion cannula (usually in the form of an infusion needle or flexible catheter) that punctures the patient's skin and through which the drug is infused. Infusion pump therapy offers advantages such as continuous infusion, precise drug delivery, and programmable delivery planning.

[0003] To facilitate drug delivery therapy, two types of pumps are generally available: conventional pumps and patch pumps. Conventional pumps require disposable components, often called infusion kits, tubing kits, or pump kits, which deliver medication from a reservoir within the pump to the user's skin. Infusion kits include a pump connector, a section of tubing, and a base or socket from which a cannula, in the form of a hollow metal infusion needle or a flexible plastic catheter, extends. The base typically has an adhesive that holds it to the skin surface during use. The cannula can be inserted into the skin manually or using a manual or automated insertion device. The insertion device can be a standalone unit as needed by the user.

[0004] Another type of pump is the patch pump. Unlike conventional infusion pumps and infusion kits, patch pumps are integrated devices that combine most or all of the fluid components—including a fluid reservoir, pumping mechanism, and a mechanism for automatic cannula insertion—into a single housing that adhesively attaches to the infusion site on the patient's skin, eliminating the need for separate infusion kits or tubing kits. The drug-containing patch pump adheres to the patient's skin and delivers the drug over a period of time or at selected intervals via an integrated subcutaneous cannula. Some patch pumps can communicate wirelessly with a separate controller device, while others are completely independent. Such devices may require frequent replacement, such as every three days, when the drug reservoir runs out or other abnormalities such as cannula or infusion site limitations occur.

[0005] Since the patch pump is designed as a stand-alone unit worn by a user (e.g., a patient), it is preferable that it be as small as possible so as not to interfere with the user's activities. Therefore, to minimize user discomfort, it is preferable to minimize the overall thickness of the patch pump. However, to minimize the thickness of the patch pump, the dimensions of its constituent parts should be minimized as much as possible, and their number should also be minimized as much as possible.

[0006] Some patch pumps can be designed with an integrated reservoir, unlike patch pumps where a pre-filled cartridge is inserted into the patch pump housing. Patch pumps with integrated reservoirs may require filling during the manufacturing stage after patch pump assembly or at the end-user stage (where a healthcare provider or patch pump wearer uses a filling method to deliver medication to the patch pump reservoir). A mechanism and / or process is needed to improve the automated filling of reservoirs in patch pumps. Summary of the Invention

[0007] The above and other problems are solved by illustrative examples, and additional advantages are achieved.

[0008] One aspect of the illustrative embodiment provides a manifold for a fluid delivery device that delivers a fluid medication to a patient, the fluid delivery device having a pump mechanism for providing a controlled amount of medication from a reservoir to an injection outlet, the medication from a main container being provided to the reservoir via a filling operation, the manifold comprising: an adapter part configured to be connected to the main container during the filling operation; a fixed part including a fixed part housing having a fixed part port disposed therein, the fixed part port being configured for fluid connection to the pump mechanism, the reservoir, and the injection outlet; and a movable part. The movable part is configured to be movable relative to the fixed part and at least releasably connected to the adapter part, the movable part being configured to have a movable part port selectively aligned with the main container for the filling operation and the fixed part port according to the position of the movable part relative to the fixed part.

[0009] According to an aspect of the exemplary embodiment, the active part port is selected from: a port fluidly connected to the reservoir, at least one port selectively connected to at least one of the inlet and outlet of the pump mechanism, and a port located at the end of an internal fluid channel extending to a portion of the active part housing, the portion of the active part housing being fluidly connected to a main container inserted into the adapter part and configured to receive fluid from the main container during the filling operation.

[0010] According to an aspect of the illustrative embodiment, at least a portion of the movable part is received within the fixed part.

[0011] According to an illustrative embodiment, the movable part moves relative to the fixed part using a motion selected from translation, rotation, and pivoting.

[0012] According to an aspect of an exemplary embodiment, the movable part includes a movable part housing on which the movable part port is disposed.

[0013] According to an aspect of an illustrative embodiment, the adapter part is configured to connect to the main container and the movable part such that rotation of the main container imparts rotation to the movable part relative to the fixed part.

[0014] According to an aspect of an exemplary embodiment, the adapter component includes a Luer lock interface configured to mate with a main container having a Luer lock and selected from vial adapters and syringes.

[0015] According to an illustrative embodiment, the syringe is connected to the adapter part, and the active part port is configured to be offset relative to the fixed part port, which is fluidly connected to the inlet of the pump mechanism, during the filling operation to manually fill the reservoir via the syringe.

[0016] According to an illustrative embodiment, the movable part of the manifold has a rod member. The adapter part includes a fixed adapter part configured to be fluidly connected to the housing of the movable part, and a movable adapter part having a foot that presses against the rod member and causes the movable part to rotate relative to the fixed part when the movable adapter part translates relative to the fixed adapter part.

[0017] According to an aspect of an exemplary embodiment, the manifold further includes a sensor deployed relative to a component of the manifold selected from the moving part, the fixed part, and the adapter part to determine at least one of an operating mode of the manifold and a position of the moving part relative to the fixed part, the operating mode of the manifold being selected from a storage position, a filling position, and an injection position.

[0018] According to an aspect of the illustrative embodiment, the pump is a unidirectional pump.

[0019] According to an illustrative embodiment, the adapter part includes a connector part configured to fluidly connect the movable part housing to a main container deployed relative to the adapter part, the connector part having at least one blade. The movable part has at least one clamping member that holds the blade when the main container rotates by a selected degree and imparts rotation to the movable part so that the manifold is in a filling position during a filling operation. For example, the clamping member may have a beveled edge that engages the blade when the main container rotates by a selected degree and imparts rotation to the movable part so that a selected movable part port is aligned with a fixed part port for injection. For example, the beveled edge may be sized to stabilize the adapter part relative to the manifold while allowing removal of the main container from the adapter part.

[0020] According to an illustrative embodiment, the fixed part housing includes a cam guide, and the manifold further includes a rotating ring with a pin and a spring, the spring being sized to be deployed along the longitudinal axis of the movable part such that the pin can move along the cam guide. The cam guide is configured to guide the pin to a cam guide filling position, thereby translating the movable part relative to the fixed part from a first position to a second position when the main container is connected to the vial adapter and pressed for a filling operation, compressing the spring and placing the manifold in the filling position. The cam guide is configured to guide the pin to a cam guide injection position, thereby translating the movable part relative to the fixed part back to the first position when the main container connected to the vial adapter is pressed again, releasing the spring and placing the manifold in the injection position.

[0021] According to an illustrative embodiment, when the main container is connected to the adapter part and pressed, the movable part translates relative to the fixed part from a first position to a second position to place the manifold in a filling position, and the movable part can translate to a position different from the second position to place the manifold in an injection position. The movable part has a movable part housing on which movable part ports are arranged via a first port interface and a second port interface. The first port interface has a plurality of ports that are selectively fluidly connected to a pair of fixed part ports depending on whether the manifold is placed in the filling position or the injection position. The pair of fixed part ports are fluidly connected to the inlet and outlet of the pump mechanism and are arranged along the longitudinal axis of the movable part.

[0022] According to an aspect of the exemplary embodiment, the second port interface may have a port that is fluidly coupled to a fixed part port connected to the reservoir when the manifold is placed in either the filling position or the injection position.

[0023] According to an illustrative embodiment, the movable part is fluidly connected to the injection outlet via a conduit fluid path, and the movable part has at least a portion of the conduit fluid path disposed therein. A plurality of ports in the first port interface include a proximal port fluidly connected to the adapter part, a distal port fluidly connected to the conduit fluid path, and a third port disposed between the proximal port and the distal port and fluidly connected to an internal fluid channel extending from the third port to a port in the second port interface fluidly coupled to the reservoir.

[0024] Additional and / or other aspects and advantages of the exemplary illustrative embodiments will be set forth in the following description, or will become apparent from the description, or may be learned by practice of the exemplary illustrative embodiments. Exemplary illustrative embodiments may include apparatus and methods for operating having one or more of the foregoing aspects, and / or one or more features, and combinations thereof. Exemplary illustrative embodiments may include, for example, one or more features and / or combinations of the foregoing aspects as described in the appended claims. Attached Figure Description

[0025] The above and / or other aspects and advantages of the exemplary embodiments will be more readily understood when read in conjunction with the accompanying drawings, based on the following detailed description, in which:

[0026] Figure 1 and Figure 2 These are a top perspective view and a side view of an exemplary patch pump as a wearable fluid delivery device;

[0027] Figure 3 A block diagram of exemplary components of an exemplary fluid delivery device constructed according to an exemplary embodiment;

[0028] Figure 4A and Figure 4B This is a block diagram of an exemplary wearable delivery patch component, which is used to fill a reservoir and inject from the reservoir using a manifold and a one-way pump constructed according to an exemplary embodiment, respectively.

[0029] Figure 5 A component connected to a manifold constructed according to an exemplary embodiment of a fluid delivery device is depicted;

[0030] Figure 6A and Figure 6BThese are, respectively, cross-sectional views of a manifold constructed according to the first embodiment, located in a storage position and attached to a vial adapter, and... Figure 6A A partially enlarged cross-sectional view of the manifold;

[0031] Figure 6C and Figure 6D They are respectively Figure 6A and Figure 6B A cross-sectional view of the manifold in the filling position (with the main container inserted into the vial adapter), and Figure 6C A partially enlarged cross-sectional view of the manifold;

[0032] Figure 6E and Figure 6F They are respectively Figure 6A and Figure 6B A cross-sectional view of the manifold in the injection position (with the main container still inserted into the vial adapter), and Figure 6E A partially enlarged cross-sectional view of the manifold;

[0033] Figure 7 for Figure 6A An exploded view of the manifold in the diagram;

[0034] Figure 8 For deployment in Figure 6A A three-dimensional view of the moving parts in the manifold;

[0035] Figure 9 For deployment in Figure 6A A cross-sectional view of the moving parts in the manifold;

[0036] Figure 10A for Figure 6A A cross-sectional view of the manifold in the middle;

[0037] Figure 10B for Figure 10A An exploded side view of the fixed parts of the manifold shown;

[0038] Figure 11A A perspective view of a manifold constructed according to the second embodiment, located in a storage position and attached to a vial adapter;

[0039] Figure 11B for Figure 11A A three-dimensional view of the manifold in the filled position;

[0040] Figure 11C for Figure 11A A three-dimensional view of the manifold in the injection position, with the main container still inserted into the vial adapter;

[0041] Figure 12 main container and Figure 11AAn exploded view of the vial adapter shown;

[0042] Figure 13 for Figure 11A A cross-sectional view of the moving parts of the manifold;

[0043] Figure 14 for Figure 13 A perspective view of the moving parts shown;

[0044] Figure 15A and 15B for Figure 11A The corresponding sectional view of the manifold in the diagram;

[0045] Figure 16 for Figure 11A An exploded view of the manifold in the diagram;

[0046] Figure 17A , Figure 17B and Figure 17C for Figure 11A Different perspective views of the moving parts of the manifold;

[0047] Figure 18A and Figure 18B These are cross-sectional views of a manifold constructed according to the third embodiment, located in the storage position and attached to the vial adapter, and... Figure 18A A partially enlarged cross-sectional view of the manifold;

[0048] Figure 18C and Figure 18D They are respectively Figure 18A and Figure 18B A cross-sectional view of the manifold in the filling position (with the main container inserted into the vial adapter), and Figure 18C A partially enlarged cross-sectional view of the manifold;

[0049] Figure 18E and Figure 18F They are respectively Figure 18A and Figure 18B A cross-sectional view of the manifold in the injection position, and Figure 18E A partially enlarged cross-sectional view of the manifold;

[0050] Figure 19 for Figure 18A A cross-sectional view of the moving parts of the manifold;

[0051] Figure 20 for Figure 19 A perspective view of the moving parts shown;

[0052] Figure 21 for Figure 18A A cross-sectional view of the manifold in the middle;

[0053] Figure 22A , Figure 22B and Figure 22C They are respectively Figure 18A An exploded view of the manifold, with examples illustrating the active part port relative to the target. Figure 18A An exemplary arrangement of selected locations of the fixing parts of the manifold;

[0054] Figure 23 A cross-sectional view of a manifold constructed according to the fourth embodiment and attached to a Luer lock;

[0055] Figure 24 for Figure 23 A perspective view of the moving parts of the manifold shown;

[0056] Figure 25 for Figure 23 A cross-sectional view of the moving parts of the manifold;

[0057] Figure 26 for Figure 23 Exploded view of the manifold and vial adapter;

[0058] Figure 27 for Figure 26 A perspective view of the vial adapter shown;

[0059] Figure 28A , Figure 28B , Figure 28C and Figure 28D for Figure 23 Different perspective views of the moving parts of the manifold;

[0060] Figure 29 A perspective view of the manifold constructed according to the fifth embodiment;

[0061] Figure 30 for Figure 29 A perspective view of the moving parts of the manifold shown; and

[0062] Figure 31 for Figure 29 A cross-sectional view of the moving parts of the manifold.

[0063] In all the accompanying drawings, similar reference numerals will be understood to refer to similar elements, features, and structures. Detailed Implementation

[0064] Reference will now be made in detail to the exemplary embodiments depicted in the accompanying drawings. The embodiments described herein are illustrative examples with reference to the accompanying drawings, but are not intended to be limiting.

[0065] As those skilled in the art will understand, there are various ways to implement examples, modifications, and arrangements of the fluid delivery apparatus according to the embodiments disclosed herein. Although illustrative embodiments depicted in the accompanying drawings and the following description are to be referenced, the embodiments disclosed herein are not intended to be exhaustive of all alternative designs and embodiments covered by the disclosed technical solutions, and those skilled in the art will readily understand that various modifications and combinations can be made without departing from the scope of the disclosed technical solutions.

[0066] According to exemplary embodiments of the present disclosure, an improved patch pump design for a wearable fluid delivery device is provided, the patch pump design utilizing a fluid passage in a manifold to fill a reservoir with medication and inject the medication into a patient. An advantageous aspect of the exemplary embodiments, the improved patch pump design allows for filling of the reservoir in the patch pump using a manifold and the pump mechanism of the fluid delivery device. As further described herein, exemplary embodiments of the manifold cooperate with other components of the patch pump to operate using the pump mechanism in a filling position (e.g., to facilitate fluid flow from, for example, a main container of a vial to the reservoir) and an injection position (e.g., to facilitate fluid flow from the reservoir to a needle and / or catheter), thereby enabling a user (e.g., a patient or a patient's caregiver) to autonomously and conveniently fill the patch pump, thus avoiding the need, cost, and inconvenience of traveling to a clinical setting to seek medical attention from a healthcare provider to fill the patch pump.

[0067] Figure 1 and Figure 2 An example patch pump 10 is illustrated as a wearable fluid delivery device. The patch pump 10 includes a housing or casing 12 having an activation button 20 and an insertion mechanism 22. The casing 12 may have an adhesive pad 16 and a liner 18 disposed on its substrate 14, the liner being configured to allow a user to remove the liner 18 and place the adhesive side of the adhesive pad 16 onto the patient's skin to adhere the patch pump 10 to the patient. The insertion mechanism 22... Figure 1 It is displayed as being in an undeployed location. Figure 2 For clarity, the adhesive pad 16 and liner 18 are not shown to depict the insertion mechanism 22 in a deployment position, in which the needle 26 and / or catheter 24 extend from the housing 12 for insertion into a patient's skin. As described herein, the exemplary patch pump has a catheter 24 and needle 26 assembly for inserting the catheter and needle into the patient, followed by needle retraction. An exemplary insertion mechanism is described in PCT International Application WO2015 / 164653, which is incorporated herein by reference. It should be understood that this insertion mechanism may alternatively employ, for example, a hollow needle.

[0068] The patch pump 10 includes other components arranged in the housing 12. Figure 3 This is an exemplary block diagram of exemplary components of a patch pump 10. The patch pump 10 includes a reservoir 28, an insertion mechanism 22, and a fluid displacement module 30, which may include a motor 32 with an associated motor housing and gearbox, a gear train 36, a pump mechanism 38 (e.g., a positive displacement pump), and fluid paths designated 40a, 40b, 40c, and 40d, described below and illustrated by example according to exemplary embodiments. The patch pump 10 further includes electrical components such as a power module (e.g., a battery 42) and an electrical module 44, which includes a controller 46, a motor driver 48, an optional sensing module 50 for sensing fluid flow conditions (e.g., blockage), an optional audio driver 52 (e.g., for indicating that drug delivery is in progress, the reservoir level is low, there is a blockage, successful pairing with an external device, or other conditions), 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, controller 46 can be programmed or otherwise configured to control the motor, and thus the pump mechanism 38, for performing filling and injection operations via exemplary embodiments of the technical solutions described herein. Activation of the pump mechanism 38 (also referred to herein as pump 38) can be automatic (e.g., in response to a sensor detecting the position of a component in insertion mechanism 22) or manual (e.g., controlled by a user via a patch pump user interface (e.g., wireless controller 58) or using an activation button 20 or other control device disposed on patch pump housing 12) to begin filling reservoir 28 from main container 60, or to begin injection by controllably moving fluid from reservoir 28 to needle 26 and / or catheter 24 inserted into the patient's skin.

[0069] Figure 4A and Figure 4B The examples illustrate components of an exemplary patch pump 10 used for filling and injecting from a reservoir 28 using a manifold 70 constructed according to an exemplary embodiment, the manifold 70 cooperating with a unidirectional pump. The manifold 70 has a fluid passage generally designated 72, wherein various passages can be selected for use depending on the stage of use (e.g., storage, filling, injection). The manifold 70 may be fluidly connected to components of the patch pump 10, such as the pump mechanism 38, the reservoir 28 (e.g., a flexible reservoir as described in PCT International Application WO2017 / 053284, which is incorporated herein by reference), catheter / needle hubs or assemblies (designated 24, 26), and the main container 60 (e.g., a syringe, or vial, or other container with a Luer lock). Figure 4AAn exemplary schematic diagram of the fluid passage 72 in the manifold 40 shown illustrates the filling stage, wherein fluid from the main container 60 is provided to the inlet of the pump mechanism 38 via fluid passage 72a in the manifold 70, and the pump mechanism 38 provides fluid from its outlet to the reservoir 28 via fluid passage 72b in the manifold 70. Figure 4B An exemplary schematic diagram of the fluid passage 72 in the manifold 40 illustrates the injection phase, wherein fluid from the reservoir 28 is provided to the inlet of the pump mechanism 38 via fluid passage 72c in the manifold 70, and the pump mechanism 38 provides fluid from its outlet to the catheter and / or needle hub (e.g., in...) via fluid passage 72d in the manifold 70. Figure 4A and Figure 4B The winning designation is 94). Figure 3 As shown in 40d and in conjunction with the following text Figures 29 to 31 The fifth embodiment described provides a manifold 70 configured to accommodate manual filling using a syringe, and therefore without using the pump mechanism 38 to draw fluid from the main container 60 during filling. All exemplary embodiments of this disclosure advantageously provide device configuration compatibility and simple device modifications from manual filling to automatic filling.

[0070] Figure 5 The diagram depicts components in an exemplary patch pump 10 connected to a manifold 70 constructed according to an exemplary embodiment. The manifold 70 is a fluid connection 70a to a main container 60 (e.g., a vial) using an adapter part 80 with a seal 82. The manifold 70 has fluid connections 70b, 70c to an inlet and outlet of a pump mechanism 38, shown as attached to a motor 32. The manifold 70 has a fluid connection 70d to a reservoir 28. The manifold 70 also has a fluid connection 70e to a conduit fluid path leading to an insertion mechanism 22. As described below, according to various exemplary embodiments, the manifold 70 is configured to impart mechanical movement to components of the manifold 70 through user-friendly mechanical operation (e.g., a user pressing or rotating the main container 60 to impart mechanical movement), to open passage 72 from such... Figure 4A The example shown illustrates the switch to the fill position as follows: Figure 4B The injection position illustrated herein can be switched between its fluid passage 72 for filling or injection, allowing the user to conveniently fill the reservoir 28 directly from the main container 60. The manifold fluid passage 72 of the exemplary embodiment of the manifold 70 described herein can also be configured in an initial storage position, which can be used to close one or more fluid passages 72 during storage.

[0071] This document describes several different exemplary embodiments of manifold 70, which use different exemplary configurations of manifolds to achieve the above-described operating principles. In short, references are made herein to... Figures 6A to 10BA first exemplary embodiment of the manifold 70 is shown and described, which uses a linear movement method to switch passage 72 from a storage position to a filling position and an injection position. Second, third, fourth, and fifth exemplary embodiments of the manifold 70 are shown and described herein, which use a rotational movement method to switch passage 72. Figures 11A to 17C A second exemplary embodiment of the manifold 70 is shown. Figures 18A to 22C A third exemplary embodiment of the manifold 70 is shown. Figures 23 to 28D A fourth exemplary embodiment of the manifold 70 is shown. Figures 29 to 31 The fifth exemplary embodiment of the manifold 70 is shown in the figure.

[0072] according to Figures 6A to 10B In the first exemplary embodiment shown, the fluid container 60 (e.g., a vial of medicine) is fluidly connected to the fluid delivery device or patch pump 10 via an adapter part 80.

[0073] The adapter component is connected to the manifold 70 of the fluid delivery device 10, the manifold including a fixed component 84, a movable component 86, a rotating ring 102, and a spring 104. The components of the manifold 70 can be accessed from a storage location ( Figure 6A and Figure 6B Move to the fill position ( Figure 6C and Figure 6D ) and injection site ( Figure 6E and Figure 6F The position of the manifold 70 is selected by pressing the vial 60 and its connected adapter part 80 relative to the fixed part 84.

[0074] like Figure 10A and Figure 10B As shown, the fixed part 84 includes a manifold housing 100 having a manifold housing cover 100a. The manifold housing 100 is configured to slidably receive at least a portion of the movable part 86 therein. The proximal end of the movable part 86 is configured to cooperate with the adapter part 80 to fluidly connect to the main container 60 and receive fluid from the main container 60, such as... Figure 10A As shown in 70a. The manifold housing 100 has: a pair of ports designated 118b and 118c, which are fluidly connected to the inlet and outlet ports of the pump mechanism 38 to form fluid connections 70b and 70c; and a port designated 118d, which is fluidly connected to the reservoir 28 to form a fluid connection 70d. Figure 7 As shown, a seal 100b may be provided in the manifold housing 100.

[0075] refer to Figure 7 , Figure 8 and Figure 9The movable part 86 has a movable part housing 106, which is provided with a first port interface 108 and a second port interface 110 for arranging a plurality of movable part ports 112. The first port interface 108 has a plurality of ports 112a, 112b, 112c, which, depending on the manifold 70, are in their filling position ( Figure 6C and Figure 6D ) or at its injection site ( Figure 6E and Figure 6F The manifold 70 operates within a pump mechanism 38. These ports are selectively fluidly connected to a pair of ports 70b, 70c of the manifold housing 100, which are connected to the inlet and outlet of the pump mechanism 38. A second port interface 110 has a port 112d, which is fluidly connected to port 70d of the manifold housing, connected to the reservoir 28, regardless of whether the manifold 70 is operating in its filling or injection position. Seals 108a and 110a can be provided relative to the first port interface 108 and the second port interface 110 to prevent fluid leakage when the moving part port 112 is aligned with the corresponding stationary part port 118.

[0076] The adapter component can be removably connected to the proximal end of the movable component 86, and when connected, is also fluidly connected to a fluid channel 116 in the housing of the movable component, the fluid channel extending from the proximal end of the movable component to a proximal port 112a in the first port interface 108. The distal end of the movable component 86 includes a fluid channel 114 that operates as at least a portion of a catheter fluid path 70e for injection. The first port interface 108 further includes a distal port 112c fluidly connected to the internal fluid channel 114, the internal fluid channel extending from the distal port to the distal end of the movable component forming part of the catheter fluid path 70e. The first port interface 108 also has a third port 112b, which is disposed between the proximal port 112a and the distal port 112c and is fluidly connected to an internal fluid channel 120, which extends from the third port 112b to ports 112d and 112e in the second port interface, and which are fluidly connected to the reservoir 28 when the manifold 70 is in the filling and injection positions, respectively.

[0077] For example, a pair of ports 118b, 118c in the manifold housing 100 may be arranged along the longitudinal axis of the fixed part 84. The proximal port 112a, distal port 112c and third port 112b of the first port interface 108 may also be arranged along the longitudinal axis of the movable part 86 and aligned with the pair of ports 118b, 118c to achieve the aforementioned fluid connection when the manifold is in the filling position and the injection position.

[0078] Continue to refer to Figures 6A to 10B The movement of the movable part 86 relative to the fixed part 84 of the manifold 70 can be achieved using a rotating ring 102 and a spring 104, the rotating ring and spring 104 being arranged around the movable part 86 and within the manifold housing 100 (e.g., concentrically arranged between the manifold housing 100 and the manifold housing cover 100a). The rotating ring 102 may be provided with a pin 122 passing through a cam guide 124 disposed on the fixed part 84. The cam guide 124 may be configured to allow the ring pin 122 to move along, for example... Figure 6B , Figure 6D and Figure 6F The example illustrates a square circular trajectory movement. The cam guide 124 can be configured in two parts, including corresponding edges and latches in the manifold housing 100 and corresponding slots inside the manifold housing cover 100a. It should be understood that relative translational movement between the moving part 86 and the stationary part 84 of the manifold 70 can be achieved using other mechanical features, and thus a selected alignment can be achieved between ports 112a, 112b, 112c in the first port interface 108 and a pair of ports 118b, 118c in the stationary part 84, which form fluid connections 70b, 70c with the inlet and outlet of the pump mechanism 38 for filling or injection.

[0079] The first exemplary embodiment is advantageous because it provides a compact arrangement for the fluid delivery device 10 to fill its reservoir 28 and to operate in injection mode. Compared to the fluid delivery devices described with reference to WO2015 / 164653 and WO2017 / 053284 cited above, the manifold 70 reduces the dead volume of the fluid in the fluid passage. Switching between the manifold 70 and the injection position is easily achieved by activation of the main container 60 (e.g., a vial), such as by pressing the vial to move the ring pin 122 along different portions of the cam guide 124. It can be configured... Figures 11A to 11B The optional component 150 shown is used to detect the position of the manifold component to automatically control the pump mechanism 38. The first exemplary embodiment also provides a monostable system when the manifold 70 is in the injection position because the throttle of the cam guide 124 is configured to stabilize the movable part 86 relative to the fixed part 84 in the injection position.

[0080] according to Figures 11A to 17CThe second exemplary embodiment shown provides a manifold 70 that can be rotated to selectively achieve a filling position relative to the inlet and outlet of the pump mechanism 38, the main container 60, and the reservoir 28, or an injection position relative to the inlet and outlet of the pump mechanism 38, the reservoir 28, and the conduit 24 in the insertion mechanism 22. A fluid container 60 (e.g., a vial of a drug) is fluidly connected to a fluid delivery device 10 via an adapter part 80. The adapter part 80 has a retainer 130, a movable part 132, and a manifold connector 134 fluidly connected to the manifold 70. A seal 136 is disposed between the retainer 84 and the movable part 86.

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

[0082] The movable part 86 of the manifold 70 includes a housing 142, at least a portion of which is slidably received within a fixed part housing 144, allowing the movable part 86 to rotate relative to the fixed part 84. A plurality of ports 112 in the movable part 86 may include a first port 112a disposed at one end of an internal fluid passage 116 extending between port 112a and a proximal end of the movable part, and fluidly connected to the adapter part 80. Additional ports 112b, 112c, and 112d are disposed around the periphery of the movable part housing 142 and spaced apart from 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, port 112c, is disposed at one end of another internal fluid passage 114 extending to a distal end of the movable part 86 and forming at least a portion of a catheter fluid path 70e for injection. It should be understood that the port 112 on the movable part 86 can be arranged differently depending on the position of the port 118 on the fixed part 84 of the manifold 70, and therefore can be arranged with... Figure 13 , Figure 14 , Figure 16 and Figures 17A to 17C The arrangements shown are different.

[0083] exist Figures 11A to 17C In the second exemplary embodiment shown, the manifold's stationary part 84 is provided with a pair of ports 118b, 118c fluidly connected to the inlet and outlet ports of the pump mechanism 38, and a port 118d fluidly connected to the reservoir 28. The distal end of the manifold's stationary part 84 is configured to receive an extension of the conduit fluid path 70e associated with the distal end of the movable part. The proximal portion of the manifold's stationary part 84 is provided with stabilizing arms 144a, 114b, which prevent the movable part 86 from longitudinally translating relative to the stationary part 84 and limit the degree of rotation of the rod members 140a, 140b provided on the movable part 86, thereby limiting the rotation of the movable part 86 relative to the stationary part 84.

[0084] Further reference Figures 11A to 17CThe movable part 86 is provided with four ports 112a, 112b, 112c, 112c arranged around the periphery of its housing 142, including: a first port 112b radially aligned with a rod member 140a in contact with the leg assembly 138; a second port 112d arcuately aligned with a port 118d fluidly connected to the reservoir 28 in the fixed part; and a third port 112a and a fourth port 112c respectively disposed on each side of the second port 112d. The fourth port 112c may be the aforementioned port disposed at one end of an internal fluid channel 114, which extends to the distal end of the movable part 86 and forms at least a portion of a catheter fluid path 70e for injection.

[0085] Rod member 140a may be slightly longer than the other rod member 140b to allow the leg assembly 138 to press against rod member 140a to rotate movable part 86. When the leg assembly 138 is not pressing against rod member 140a to rotate movable part 86 and manifold 70 is in the stored position ( Figure 11A ) or injection site ( Figure 11C In this configuration, the first port 112b is aligned with the fixed member port 118b leading to the inlet of the pump mechanism 38, the fourth port 112c is aligned with the fixed member port leading to the outlet of the pump mechanism 38, the third port 112a is not aligned with the port in the fixed member, and the fixed member port 118d fluidly connected to the reservoir 28 is aligned with the second port 112d near one end of the arcuate shape of the second port. This configuration allows the pump mechanism 38 to draw fluid from the reservoir 28 and output fluid from the reservoir to the conduit fluid path 70e. The housing 142 itself acts as an internal fluid passage between the second port and the first port to draw fluid from the reservoir 28.

[0086] When the support assembly 138 is pressing the lever assembly 140a and has rotated the movable part 86 of the manifold 70 to the filling position, the first port 112b is aligned with the fixed member port 118c leading to the outlet of the pump mechanism 38, the third port 112a is aligned with the fixed member port 118b leading to the inlet of the pump mechanism 38, the fourth port 112c is not aligned with the port in the fixed member 84, and the fixed member port 118d fluidly connected to the reservoir 28 is aligned with the second port 112d near the other end of the arcuate shape of the second port. This configuration allows the pump mechanism 38 to draw fluid from the vial 60 and output fluid to the reservoir 28. The housing 142 itself acts as an internal fluid passage between the first port 112b and the second port 112d to output fluid to the reservoir 28. The seal 86a can be molded over the outside of the movable part 86, and the seal 86b can be disposed between the distal ends of the movable part 86 and the fixed part 84 to prevent leakage from the movable part housing 142.

[0087] Optional component 150 can be provided to the lever member (e.g., lever member 140b) to detect its position, thereby detecting whether manifold 70 is in a filling or injection position, to allow for automated control of pump mechanism 38. For example, optional component 150 can be a spring to obtain the monostable position of the manifold and can also act as a sensor to measure the force applied to the spring (e.g., compression or tension of the spring) or other sensor characteristics. The second exemplary embodiment is advantageous because it provides a compact arrangement for the fluid delivery device 10 to fill its reservoir 28 and operate in injection mode. Switching between the manifold 70 and injection positions is easily achieved by activation of the main container 60 (e.g., a vial), such as pressing the vial 60 to facilitate movement of the movable part 132 of the adapter part 80, thereby imparting rotation to the movable part 86 when the foot assembly 138 presses the lever member 140a. The second exemplary embodiment also provides a monostable system in which the vial is continuously compressed to deliver fluid from the main container 60 to fill the reservoir 28.

[0088] according to Figures 18A to 22C The third exemplary embodiment shown provides a manifold 70 having a fixed part 84 and a movable part 86, the fixed part 84 and the movable part 86 having corresponding plurality of ports 118 and 112, the arrangement of the plurality of ports being consistent with... Figures 11A to 17C The second exemplary embodiment shown is substantially the same as that described, except that a different connector 160 is used on the adapter part 80 for releasably connecting the vial to the movable part 86. Furthermore, as an example, the outlet of the conduit fluid path 70e is illustrated as extending from the circumferential sidewall of the fixed part housing 164, rather than as in the second exemplary embodiment. Figure 15A and Figure 15B As shown, it extends from its distal end, thus forming a more direct connection to the conduit 24 compared to the internal fluid path 114 leading to the conduit used in the second exemplary embodiment.

[0089] The manifold 70 can be rotated to selectively achieve either a filling position relative to the inlet and outlet of the pump mechanism 38, the main container 60, and the reservoir 28, or an injection position relative to the inlet and outlet of the pump mechanism 38, the reservoir 28, and the conduit 24 in the insertion mechanism 22. The manifold 70 is operator-controlled and bistable, wherein the angle of rotation is achieved by manually rotating the main container 60 of the fluid (e.g., a vial of medicine) removably inserted into the adapter part 80. The adapter part has a seal 82 and internal dimensions that, when the vial is inserted, prevent rotation of the vial 60 relative to the adapter part 80 by friction, but allow rotation of the vial 60 to impart rotation to the adapter part relative to the manifold 70. As described below, the adapter part 80 is provided with additional features 160 that facilitate the rotation required to select the filling position from the reservoir position and the injection position, such as... Figures 18A to 22C The example shown illustrates this.

[0090] The adapter component 60 has a manifold connector 160 fluidly connected to a post located at the proximal end of a movable component 86 of the manifold. The manifold connector 160 has blade members 166a, 166b at its distal end, which can engage clamping members 168a, 168b located at the proximal end of the movable component 86 of the manifold 70 to rotate the movable component 86 relative to the fixed component 84 of the manifold by a selected amount (e.g., -45 degrees from the storage position to the filling position, and 90 degrees from the filling position to the injection position; however, it should be understood that the rotation amount can be other values). The proximal portion of the fixed component housing 164 of the manifold is provided with stabilizing arms 164a, 164b, which prevent longitudinal translation of the movable component 86 relative to the fixed component 84 and limit the rotation of the movable component by providing end-stop positions for the clamping members 168a, 168b. As described above in conjunction with the second embodiment, the movable part 86 of the manifold has a plurality of ports 112, which are selectively aligned with respect to ports 118 disposed in the fixed part 84 of the manifold to provide a fluid passage 72 between different components of the fluid delivery device 10 during the filling of the reservoir 28 from the vial 60, compared to the injection process. It should be understood that the ports 112 on the movable part can be arranged differently depending on the position of the ports 118 on the fixed part of the delivery module, thus... Figures 18A to 22C The arrangement shown is different. Furthermore, it should be understood that in order to achieve the desired position (e.g., storage position, filling position, injection position), the degree of rotation of the movable part 86 relative to the fixed part 84 of the manifold 70 may vary depending on the positions of the ports 112 and 118 on the movable part 86 and the fixed part 84.

[0091] Clamping members 168a and 168b are circumferentially spaced apart to accommodate blade members 166a and 166b for initial placement of the blade members relative to the manifold 70. Figure 18A and Figure 18B In the storage position illustrated, ports 112 and 118 in the movable part 86 and the fixed part 84 are aligned to close the fluid path from the manifold 70 to the pump mechanism inlet and outlet. The blade members 166a and 166b are angled, and the clamping members 168a and 168b have lips 170 such that when the vial 60 is rotated by a selected amount (e.g., 45 degrees from the storage position to the filling position), the edges of the blade members 166a and 166b are received below the corresponding lips 170. When in the filling position, the first port 112b is aligned with the fixed member port 118c leading to the outlet of the pump mechanism 38, the third port 112a is aligned with the fixed member port 118b leading to the inlet of the pump mechanism 38, the fourth port 112c is not aligned with the port in the fixed member 84, and the fixed member port 118d fluidly connected to the reservoir 28 is aligned with the second port 112d near one end of the arcuate shape of the second port. This configuration allows the pump mechanism 38 to draw fluid from the vial 60 and output fluid to the reservoir 28. The housing 162 itself acts as an internal fluid passage between the first port 112b and the second port to output fluid to the reservoir 28. A seal can be molded over the exterior of the moving part and can be positioned between the distal ends of the moving part and the fixed part to prevent leakage from the housing of the moving part.

[0092] The clamping members 168a and 168b are also provided with an inclined edge 172 such that when the vial 60 is rotated by a selected amount (e.g., 90 degrees from the filling position to the injection position), the blade members 166a and 166b travel along the edge 172 by the selected amount to align the ports 112 and 118 accordingly. For example, the first port 112b is aligned with the fixed member port 118b leading to the inlet of the pump mechanism 38, the fourth port 112c is aligned with the fixed member port 112c leading to the outlet of the pump mechanism 38, the third port 112a is not aligned with the port in the fixed member 844, and the fixed member port 118d fluidly connected to the reservoir 28 is aligned with the second port 112d near one end of the arcuate shape of the second port. This configuration allows the pump mechanism 38 to draw fluid from the reservoir 28 and output fluid from the reservoir to the conduit fluid path 70e. The housing 162 itself acts as an internal fluid passage between the second port and the first port to draw fluid from the reservoir 28. In addition, the inclined edges 172 of the clamping members 168a, 168b are configured to stabilize the adapter part 80 and allow the vial 60 to be removed from the adapter part 80.

[0093] The third exemplary embodiment is advantageous because it provides a compact arrangement and simple assembly for the fluid delivery device 10 to fill its reservoir 28 and operate in injection mode. Switching between the manifold 70 and the filling and injection positions is easily achieved by activating the main container 60 (e.g., a vial) – such as by tightening and loosening the vial 60 after it is inserted into the adapter part 80, providing intuitive activation for the user. Furthermore, optional components 150 (e.g., in…) can be… Figures 11A-11C A spring (marked as 150) is provided to clamping members 168a, 168b or blade members 166a, 166b or adapter part 80 or other parts of manifold 70 to detect the position of moving part 86, thereby detecting whether manifold 70 is in the filling position or the injection position, so as to allow automatic control of pump mechanism 38.

[0094] according to Figures 23 to 28D The fourth exemplary embodiment shown provides a manifold 70, the manifold being connected to... Figures 18A to 22C The third exemplary embodiment shown is similar, except that the proximal end of the movable part housing 182 has a circumferential channel 180 configured to mate with an adapter part 80, which includes a Luer lock interface 184. Regarding the port 118 of the fixing part 84 and the stabilizing arms 164a, 164b, the fixing part is coupled with... Figures 23 to 28D The fixing parts described in the third exemplary embodiment shown are substantially the same. As an example, the outlet of the conduit fluid path 70e is illustrated as extending from the circumferential sidewall of the fixing part 84, rather than as in the second exemplary embodiment. Figure 15A and Figure 15B As shown in the diagram, it extends from its distal end, thus forming a more direct connection to the catheter compared to the internal fluid path to the catheter used in the second exemplary embodiment.

[0095] The movable part 86 of the manifold 70 has four ports 112, including: a port 112a, for example, located at one end of an internal fluid passage 116 extending to the proximal end of the movable part 84 to receive fluid from the connected vial 60; two ports 112b and 112c, which are selectively connected to the inlet and outlet of the pump mechanism 38 depending on a selected position of the manifold 70 (e.g., filling position, injection position), one of which is fluidly connected to the fixed part outlet 70e leading to the conduit fluid path; and a port 112d for connection to the reservoir 28. The port 112d for connection to the reservoir may be arc-shaped to maintain fluid connection between the inlet and outlet ports regardless of whether the manifold 70 is rotated to the filling or injection position and the corresponding engagement of the inlet and outlet of the pump mechanism 38.

[0096] References above Figures 18A to 22C Similar to the described third exemplary embodiment, when vial 60 is connected to the adapter part 80 via Luer lock interface 184 in the adapter part 80, the user can tighten and loosen vial 60 to impart rotation to the movable part 84 of manifold 70. For example, ports 112 and 118 on the movable and fixed parts of manifold 70 are arranged such that the movable part can be rotated relative to the fixed part by a selected amount (e.g., -45 degrees) to change from a storage position to a filling position, and can be rotated by a selected different amount of rotation (e.g., 90 degrees) to change from a filling position to an injection position. The arrangement of the stabilizing arms 164a, 164b of the fixed part 84 relative to the rod members 186a, 186b on the movable part 86 limits the range of rotation.

[0097] The fourth exemplary embodiment is advantageous because it provides a compact arrangement and simple assembly for the fluid delivery device 10 to fill its reservoir and operate in injection mode. Switching between the manifold 70 and the injection position is easily achieved by activating the main container 60 (e.g., a vial) – such as by tightening and loosening the vial 60 after it has been inserted into the adapter part 80, providing intuitive activation for the user. Furthermore, optional components 150 can be provided to the lever members 186a, 186b or the stabilizing arms 164a, 164b or other components of the adapter part 80 or manifold 70 to detect the position of the moving parts, thereby detecting whether the manifold 70 is in the filling or injection position, allowing for automated control of the pump mechanism 38.

[0098] according to Figures 29 to 31 The fifth exemplary embodiment shown provides a manifold 70, the manifold being connected to... Figures 18A to 22C The fourth exemplary embodiment shown is similar, except that the circumferential channel 190 at the proximal end of the movable part housing 192 engages with the Luer lock of the syringe 60 for manual filling of the reservoir 28, and the movable part port 118 is modified relative to the fourth exemplary embodiment because the filling reservoir does not involve the pump mechanism 38. Regarding the port 118 and the stabilizing arms 164a, 164b, and the outlet 70e for the conduit fluid path extending from the circumferential sidewall of the fixed part 84, the fixed part 84 is coupled with... Figures 23 to 28D The fixing parts described in the fourth exemplary embodiment shown are substantially the same.

[0099] The manifold's movable part 86 has four ports, including: a port located at one end of an internal fluid channel that extends to the proximal end of the movable part to receive fluid from a connected syringe; two ports that can be selectively connected to an inlet and an outlet of a pump mechanism depending on a selected location of the manifold (e.g., an optional storage location and an injection location), one of which can be fluidly connected to a fixed part outlet leading to the conduit fluid path; and a port for connection to a reservoir.

[0100] References above Figures 18A to 22C Similar to the described third exemplary embodiment, when a syringe or vial adapter or any container with a Luer connection is connected to the moving part of the manifold via its Luer lock, the user can tighten and loosen it to impart rotation to the moving part of the manifold. For example, ports 112 and 118 on the moving part 86 and the fixed part 84 of the manifold 70 are arranged such that the moving part 86 can be rotated relative to the fixed part 84 by a selected amount (e.g., -45 degrees) to change from a storage position to a filling position, and can be rotated by a selected different amount of rotation (e.g., 90 degrees) to change from a filling position to an injection position. The arrangement of the stabilizing arms 164a, 164b of the fixed part 84 relative to the rod members 196a, 196b of the moving part 86 limits the range of rotation. Unlike the fourth exemplary embodiment, when the user imparts rotation to the moving part via the syringe to position the manifold in the filling position, the port 112a receiving fluid from the syringe can be aligned with the port of the fixed part or the outlet of the reservoir. It should be understood that, for this embodiment and other exemplary embodiments having a Luer connection integrated into the manifold 70, the Luer lock or connection may be convex or concave to accommodate different containers and / or adapters.

[0101] The fifth exemplary embodiment is advantageous because it provides a compact arrangement and simple assembly for the fluid delivery device 10 to fill its reservoir 28 and operate in injection mode. Switching between the manifold 70 and the injection position is easily achieved by activating the main container 60 (e.g., a syringe), such as by tightening and loosening the syringe after it is connected to the movable part 86, which provides intuitive activation for the user. The fourth and fifth exemplary embodiments described herein illustrate the advantage of a universal configuration: by simply changing the movable part 86 in the manifold 70, the fluid delivery device 10 can be configured for pump-assisted filling or automatic filling as in the fourth exemplary embodiment, or for manual filling adapted to the syringe of the main container 60 as in the fifth exemplary embodiment. Furthermore, optional components 150 can be provided to the lever members 196a, 196b or the stabilizing arms 164a, 164b or adapter parts or other components of the manifold 70 to detect the position of the movable part, thereby detecting whether the manifold 70 is in the filling or injection position, to allow for automatic control of the pump mechanism. In addition, an interface can be provided between the moving parts and the electronics of the fluid delivery device 10, which detects changes in the manifold 70 to determine whether to switch from manual filling to automatic filling and vice versa.

[0102] In the exemplary embodiments described above, the port 118 in the movable part 86 is selectively aligned with the ports 118 in the main container 60 for filling and the fixed part, depending on whether the movable part 86 moves relative to the fixed part 84 (e.g., translates by a selected amount and / or rotates by a selected degree) to achieve a filling position or an injection position of the manifold 70. It should be understood that the movement between the movable and fixed parts can be translation, rotation, pivoting, or other types of movement, or a combination of different movements, depending on the configuration of the movable part 86 relative to the fixed part 84 and the attachment mechanism for connecting the manifold 70 to the main container 60.

[0103] Those skilled in the art will understand that this disclosure, in its application, is not limited to the construction details and component arrangements set forth in the above description or illustrated in the accompanying drawings. The embodiments described herein can have other embodiments and can be practiced or performed in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes only and should not be considered limiting. The use of the terms “comprising,” “including,” or “having,” and variations thereof, is intended to cover the items listed thereafter and their equivalents and additional items. Unless otherwise limited, the terms “connected,” “linked,” “mounted,” and variations thereof are used extensively herein and cover direct and indirect connections, linkages, and installations. Additionally, the terms “connected” and “linked,” and variations thereof, are not limited to physical or mechanical connections or linkages. Furthermore, terms such as upper, lower, bottom, and top are relative and are for illustrative purposes only, not for limitation.

[0104] The descriptions and figures given above are merely illustrative and not intended to limit the exemplary embodiments in any way, except as set forth in the claims below. It should be particularly noted that those skilled in the art can readily combine various technical aspects of the various elements of the various exemplary embodiments described above in many other ways, all of which are considered to be within the scope of the claims.

Claims

1. A manifold for a fluid delivery device that delivers a fluid medication to a patient, the fluid delivery device having a pump mechanism for providing a controlled amount of medication from a reservoir to an injection outlet, the medication from a main container being provided to the reservoir via a filling operation, the manifold comprising: An adapter component configured to connect to the main container during the filling operation; A fixing component, the fixing component including a fixing component housing having a fixing component port disposed therein, and the fixing component port being configured for fluid connection to the pump mechanism, the reservoir, and the injection outlet; as well as A movable part, configured to be movable relative to the fixed part and at least releasably connected to the adapter part, the movable part being configured to have a movable part port that is selectively aligned with the main container for the filling operation and with the fixed part port, depending on the position of the movable part relative to the fixed part.

2. The manifold according to claim 1, wherein, The movable part port is selected from the following: a port fluidly connected to the reservoir, at least one port selectively connected to at least one of the inlet and outlet of the pump mechanism, and a port located at the end of an internal fluid channel extending to a portion of the movable part housing, the portion of the movable part housing being fluidly connected to a main container inserted into the adapter part and configured to receive fluid from the main container during the filling operation.

3. The manifold according to claim 1, wherein, At least a portion of the movable part is received within the fixed part.

4. The manifold according to claim 1, wherein, The movable part moves relative to the fixed part using a motion selected from translation, rotation, and pivoting.

5. The manifold according to claim 1, wherein, The movable part includes a movable part housing on which the movable part port is arranged.

6. The manifold according to claim 1, wherein, The adapter component is configured to connect to the main container and the movable component such that rotation of the main container imparts rotation to the movable component relative to the fixed component.

7. The manifold according to claim 1, wherein, The adapter component includes a Luer lock interface configured to mate with a main container having a Luer lock and selected from vial adapters and syringes.

8. The manifold according to claim 1, wherein, The syringe is connected to the adapter part, and the movable part port is configured to be offset relative to the fixed part port, which is fluidly connected to the inlet of the pump mechanism during the filling operation, in order to manually fill the reservoir via the syringe.

9. The manifold according to claim 1, wherein, The moving parts of the manifold have rod components; The adapter component includes a fixed adapter component configured to be fluidly connected to the housing of the movable component, and a movable adapter component having a foot that presses against the rod member and causes the movable component to rotate relative to the fixed component when the movable adapter component translates relative to the fixed adapter component.

10. The manifold of claim 1, further comprising a sensor deployed relative to a part of the manifold selected from the movable part, the fixed part, and the adapter part, to determine at least one of an operating mode of the manifold and a position of the movable part relative to the fixed part, the operating mode of the manifold being selected from a storage position, a filling position, and an injection position.

11. The manifold according to claim 1, wherein, The pump is a unidirectional pump.

12. The manifold according to claim 1, wherein, The adapter component includes a connector component configured to fluidly connect the movable component housing to a main container deployed relative to the adapter component, the connector component having at least one blade; The movable part has at least one clamping member that holds the blade when the main container rotates by a selected degree and the movable part is given rotation to position the manifold in the filling position during the filling operation.

13. The manifold according to claim 12, wherein, The clamping member has a beveled edge that engages with the blade when the main container is rotated by a selected degree and the movable part is given rotation so that the selected movable part port is aligned with the fixed part port for injection.

14. The manifold according to claim 13, wherein, The dimensions of the inclined edge are set to stabilize the adapter component relative to the manifold, while allowing the main container to be removed from the adapter component.

15. The manifold according to claim 1, wherein, The fixed part housing includes a cam guide, and the manifold further includes a rotating ring with a pin and a spring, the spring being sized to be deployed along the longitudinal axis of the movable part such that the pin can move along the cam guide, the cam guide being configured to guide the pin to a cam guide filling position, thereby translating the movable part relative to the fixed part from a first position to a second position when the main container is connected to the vial adapter and pressed for filling operation, to compress the spring and place the manifold in the filling position; as well as The cam guide is configured to guide the pin to the cam guide injection position, thereby causing the movable part to translate back to the first position relative to the fixed part when the main container connected to the vial adapter is pressed again, to release the spring and place the manifold in the injection position.

16. The manifold according to claim 1, wherein, When the main container is connected to the adapter part and pressed, the movable part translates relative to the fixed part from a first position to a second position to place the manifold in the filling position, and the movable part can also translate to a position different from the second position to place the manifold in the injection position; The movable part has a movable part housing on which movable part ports are arranged via a first port interface and a second port interface. The first port interface has multiple ports that are selectively fluidly connected to a pair of fixed part ports depending on whether the manifold is in the filling position or the injection position. The pair of fixed part ports are fluidly connected to the inlet and outlet of the pump mechanism and are arranged along the longitudinal axis of the movable part.

17. The manifold according to claim 16, wherein, The second port interface has a port that, when the manifold is placed in either the filling position or the injection position, is fluidly connected to a fixed part port connected to the reservoir.

18. The manifold according to claim 16, wherein, The movable part is fluidly connected to the injection outlet via a conduit fluid path, and the movable part has at least a portion of the conduit fluid path disposed therein; The plurality of ports in the first port interface include a proximal port fluidly connected to the adapter component, a distal port fluidly connected to the conduit fluid path, and a third port disposed between the proximal port and the distal port and fluidly connected to an internal fluid channel, the internal fluid channel extending from the third port to a port in the second port interface fluidly connected to the storage device.

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