Patent Description:
Other types of valves that do not displace fluid when opening and closing are likely to be larger and of higher force. For example, rotary (stopcock) and shear valves use high compression seals (high force) to maintain seals. However, these valves typically use O-rings. Due to the tolerances of the O-rings at very small sizes, the force to actuate these valves may vary widely depending on the amount of compression on each O-ring.

Known valve assemblies are disclosed in <CIT>, <CIT>, <CIT>.

It would be beneficial to have a valve that has low actuation force and does not displace fluid when operating to provide greater accuracy in dosing.

Disclosed is an example of a valve system including a valve body, an inlet component, an outlet component and a valve tube. The valve body includes a first void and a second void. The inlet component is coupled to the first void and the outlet component is coupled to the second void. The valve body is a septum or septa. The valve tube includes a side port and is coupled to the first void, the inlet component, the second void, and the outlet component. The valve tube is positioned through the valve body stretching the septum or septa over the valve tube to create a seal.

In embodiments, the valve tube may be pierced through the valve body. The valve tube may be operable to be moved to a first position within the valve body to align the side port to the inlet component when fluid stored in an external reservoir coupled to the inlet component is to be drawn into the valve system and provided to a pump chamber coupled to the valve tube, and wherein the valve tube is moved to a second position within the valve body to align the side port to the outlet component when fluid stored in the pump chamber is to be pushed out of the valve system and on to a fluid path component coupled to the outlet component.

Disclosed is yet another example of a valve system. The valve system including a valve body, a first septum, a second septum, a first piston, a second piston and a tube. The first septum is positioned within the valve body. The second septum is positioned with the valve body and aligned with the first septum. The first piston is coupled to a first pump chamber and positioned on a first side of the aligned first septum and the second septum. The second piston is coupled to a second pump chamber and positioned on a second side of the aligned first septum and the second septum. The tube includes a first side port, a second side port, and a center plug positioned between the first and second side ports. The tube is positioned through the valve body stretching the septa over the tube to create a seal, and positioned between the first and second pistons. The first side port is coupled to an inlet component portion of the tube. The second side port is coupled to an outlet component portion of the tube. The inlet component portion is coupled to a reservoir storing a fluid and the outlet component portion coupled to a fluid path component.

Various examples provide valves and/or valve systems that operate without displacing fluid. The provided valves may be operated with a low actuation force and may be made to be relatively small (e.g., on a micro or miniature scale) to accommodate use within a wearable drug delivery device or pump system. Other examples are also disclosed.

Disclosed herein are one or more valve systems, components, and methods of use that solve one or more drawbacks of conventional valves, including those drawbacks described above. The disclosed valves may be made small with relatively few pieces and may be used in a wearable drug delivery device (e.g., drug delivery pump) to provide a liquid drug to a user.

In various examples, the valves disclosed herein may use a septum or septa. The use of septa allows for the use of lower durometer materials than may be used with a conventional O-ring based pump system. Further, the amount of compression may be controlled by the diameter of the tube instead of the tube, the inner diameter (ID) and outer diameter (OD) of an O-ring, and the barrel.

Disclosed herein are exemplary low actuation force, micro/miniature, and no fluid displacement valves (and/or valve systems and/or methods of use involving the same). As described, the disclosed valves solve the issues related to traditional O-ring seals at the micro/miniature scale. Process limitations of molding do not allow the molding tolerances of O-rings to scale proportionally as size is reduced. This may lead to much wider ranges of compression and thus increased ranges of force to actuate an O-ring seal as the size of the valve is reduced. Compounding the issue is the need for multiple seals to create non-displacing valves (a valve that does not change volume when actuated).

In various examples, one or more examples of valves are described that may use a side ported tube pierced through a septum or septa to create a low force, non-displacement, micro-miniature valve. By piercing through the septum or septa, the amount of seal force is more controlled than with an O-ring.

<FIG> illustrates a first exemplary valve system (or valve or valve component) <NUM> which is according to the invention. The valve system <NUM> may include a valve body <NUM>, an inlet component <NUM>, an outlet component <NUM>, and a valve tube <NUM>. The valve body <NUM> may be formed from silicone or may be formed from other compatible elastomeric material. The valve body <NUM> may be formed as a single molded piece or component, or as multiple molded pieces or components. The inlet component <NUM> may be a rigid tubing component that may be placed (as in a compression fit) into the valve body <NUM> or may be a tubing component bonded to the valve body <NUM>. Similarly, in other examples, the outlet component <NUM> may be a rigid tubing component that may be placed into the valve body <NUM> or may be a tubing component bonded to the valve body <NUM>. For example, the valve tube <NUM> may be a rigid tubing component. The valve tube <NUM> may be positioned (e.g., pierced) through the valve body <NUM> to create seals between the valve tube <NUM> and the inlet component <NUM> and/or the outlet component <NUM>. The valve tube <NUM> may include an opening and may be moved back and forth within the valve body <NUM> as described further herein. The valve tube <NUM> may include a closed end <NUM>. The closed end <NUM> may be crimped, welded, formed, capped, and/or filled.

<FIG> illustrates a cross-sectional side view of the valve system <NUM>. As shown, the valve system <NUM> may include a first opening or void <NUM> and a second opening or void <NUM>. The first void <NUM> may be coupled or connected to the inlet component <NUM>. The second void <NUM> may be coupled or connected to the outlet component <NUM>. As further shown, the valve tube <NUM> may include a side port <NUM>. The side port <NUM> may comprise one or more openings (e.g., aligned openings) in the valve tube <NUM>. The side port <NUM> may be formed using a grinding method, a laser cutting process, a machining process, or may be part of the original forming process for the valve tube <NUM> (e.g., through a molding process).

The valve body <NUM> may be considered to be a septum (or septa). As is shown in <FIG>, the valve tube <NUM> may, for example, be pierced through the septum (e.g., valve body <NUM>) stretching the septum over the valve tube <NUM> to create a seal. The valve body <NUM> may include the voids <NUM> and <NUM>, connected to the inlet and outlet components <NUM> and <NUM>, respectively, where no seal to the valve tube <NUM> is provided. The valve tube <NUM> may be connected to a pump head (not shown in <FIG>) that may either draw a fluid in through the side port <NUM> (from the inlet component <NUM>) or push the fluid out through the side port (through the outlet component <NUM>). The valve system <NUM> may function by being operable to move the side port <NUM> of the valve tube <NUM> between the voids <NUM> and <NUM> to connect and disconnect the pump head from the inlet and outlet components <NUM> and <NUM> as appropriate. In various examples, a pump (not shown in <FIG>) could also or alternatively be coupled to the valve tube <NUM>.

A direction of movement of the valve tube <NUM> within the valve body <NUM> is shown by <NUM>. As shown, the valve tube <NUM> may be moved linearly in the directions shown by <NUM> through the valve body <NUM>. The movement of the valve tube <NUM> may cause the side port <NUM> to change between being exposed to the inlet component <NUM> and the outlet component <NUM>. When transitioning between the inlet component <NUM> and the outlet component <NUM>, the side port <NUM> may be completely closed off from the inlet component <NUM> and the outlet component <NUM> to prevent any unintended flow of fluid.

In various examples, the valve system <NUM> may be used within or as part of a drug delivery device including, for example, a wearable drug delivery device. In various examples, the inlet component <NUM> may be coupled to a reservoir storing a liquid drug or any liquid therapeutic agent (or any fluid). In various examples, the outlet component <NUM> may be coupled to fluid path (e.g., including a cannula) that is coupled to a user or patient such that the liquid drug stored in the reservoir may be delivered to the user. In various examples, the liquid drug may be insulin and the valve system <NUM> may be part of a wearable insulin drug delivery device or system.

In various examples, the valve system <NUM> may be operable to pump in and/or pump out fluid without unintended fluid flow by maintaining a constant volume during transitions of coupling the side port <NUM> to either the inlet component <NUM> or the outlet component <NUM>. In various examples, the valve system <NUM> may be applied to a fluid path requiring various path separations. In various examples, the valve system <NUM> may include dual inlets and a single outlet and/or more voids or open spaces may be added to increase the number of valve stations. Any number of voids, valve stations, inlet, and/or outlet components may be accommodated.

<FIG> may represent a cross-sectional side view of a delivery system <NUM>. As shown in <FIG>, the delivery system <NUM> may include the valve system <NUM>. The delivery system <NUM> may further include a pump head component <NUM> coupled to the valve system <NUM>. The pump head component <NUM> may include a pump chamber <NUM> and a pump piston <NUM>.

<FIG> illustrates the delivery system <NUM> in a first or initial stage of operation. As shown, the delivery system <NUM> is ready to fill the pump chamber <NUM> with a fluid. The valve tube <NUM> may be coupled to the pump chamber <NUM>. The inlet component <NUM> may be coupled to a reservoir storing the fluid (not shown in this example). The outlet component <NUM> may be coupled to a cannula and/or other fluid path that is coupled to a user. The side port <NUM> is aligned with/open to the inlet component <NUM> and is closed to the outlet component <NUM>.

<FIG> illustrates a second stage of operation of the delivery system <NUM> (subsequent to the stage of operation of the delivery system <NUM> as shown in <FIG>). For example, the valve tube <NUM> may be operable to move to a first position within the valve body <NUM> to align the side port <NUM> to the inlet component <NUM> when fluid is available to the inlet component (e.g., fluid may be stored in an external reservoir (not shown) coupled to the inlet component) is to be drawn into the inlet component. As shown in <FIG>, the pump piston <NUM> is moved in a direction <NUM>. The movement of the pump piston <NUM> causes fluid to be drawn into the pump chamber <NUM> - through the inlet component <NUM>, through the valve tube <NUM>, and into the pump chamber <NUM> - as shown by arrow flow indicators <NUM>. As a result, all or a portion of the pump chamber <NUM> may be filled with the fluid. The pump piston <NUM> may operable to be moved by any suitable actuation system.

<FIG> illustrates a third stage of operation of the delivery system <NUM> (subsequent to the stage of operation of the delivery system <NUM> as shown in <FIG>). As shown in <FIG>, the valve tube <NUM> is operable to move in a direction <NUM>. The movement of the valve tube <NUM> may cause the side port <NUM> to be aligned with/open to the outlet component <NUM> (e.g., at a second position) and be closed to the inlet component <NUM>.

<FIG> illustrates a fourth stage of operation of the delivery system <NUM> (subsequent to the stage of operation of the delivery system <NUM> as shown in <FIG>). As shown in <FIG>, the pump piston <NUM> is moved in a direction <NUM> that aligns the side port <NUM> with outlet component <NUM>. The movement of the pump piston <NUM> causes fluid to be pushed in the direction (shown by directional arrows <NUM>) from the pump chamber <NUM> for delivery - i.e., from the pump chamber <NUM>, through the valve tube <NUM>, and through the outlet component <NUM> (as indicated by the directional arrows <NUM>) (and on to a cannula and/or fluid path for delivery to the user).

<FIG> illustrates a fifth stage of operation of the delivery system <NUM> (subsequent to the stage of operation of the delivery system <NUM> as shown in <FIG>). As shown in <FIG>, the side port <NUM> is realigned with the inlet component <NUM> to return to the state of operation shown in <FIG>. The delivery system <NUM> may repeat the steps illustrated in <FIG> (or a portion thereof) to implement a subsequent cycle of drawing in the fluid to the pump chamber <NUM> from the reservoir and pushing it out for delivery to a patient.

As an alternative to moving the valve tube <NUM>, the valve body <NUM> may be moved along the valve tube <NUM> to align the side port <NUM> appropriately with the outlet component <NUM>. For example, the valve body <NUM> may be configured and operable to be moved to a first position with respect to the valve tube <NUM> to align the side port <NUM> to the inlet component <NUM> when fluid is available to the inlet component <NUM> (e.g., stored in an external reservoir coupled to the inlet component <NUM>) to be drawn into the inlet component <NUM>. The valve body <NUM> may be configured and operable to be moved to a second position with respect to the valve tube <NUM> to align the side port <NUM> to the outlet component <NUM> when fluid is to be pushed out of the valve system <NUM> to the outlet component <NUM> for delivery of the fluid. The valve tube <NUM> and/or the valve body <NUM> may be moved by any suitable actuation system.

<FIG> illustrates a second exemplary valve system (or valve or valve component) <NUM>. As shown in <FIG>, the valve system <NUM> may include a first seal body component <NUM>, a second seal body component <NUM>, a third seal body component <NUM>, and a fourth seal body component <NUM>. Positioned between the seal body components may be a first septum <NUM>, a second septum <NUM>, and a third septum <NUM>. The valve system <NUM> may further include an inlet component <NUM>, an outlet component <NUM>, and a valve tube <NUM>. The valve tube <NUM> may include an opening <NUM>. The inlet component <NUM> may, for example, be coupled to a reservoir. The outlet component <NUM> may, for example, be coupled to a fluid path coupled to a user.

The valve system <NUM> may be coupled to a pump head (not shown in <FIG>) that may be used to draw in and push out fluid in a manner similar to the operation of valve system <NUM>. The valve tube <NUM> may be moved through the septa <NUM>-<NUM> and the openings/air cavities of the seal body components <NUM>-<NUM> to couple the opening <NUM> to the inlet component <NUM> or to the outlet component <NUM> to draw in fluid from a reservoir and/or push out fluid for delivery to a user.

<FIG> illustrates an exploded view of the valve system <NUM>. <FIG> shows the arrangement of the components of the valve system <NUM>. The seal bodies <NUM>-<NUM> may be rigid components. The septa <NUM>-<NUM> may be a soft material and/or compressible material. The seal bodies <NUM>-<NUM> may be arranged such that the interior openings or cavities may be aligned. The valve tube <NUM> may be of any shape and may be positioned through the openings of the seal bodies <NUM>-<NUM> and the septa <NUM>-<NUM>.

<FIG> illustrates a third exemplary valve system <NUM> which is according to the invention. As shown in <FIG>, the valve system <NUM> includes a valve body <NUM> and a side ported tube component <NUM>. The valve body <NUM> may be formed by injection molded thermoplastic. The side ported tube <NUM> may include a first opening or side port <NUM>, a second opening or side port <NUM>, and a plug <NUM>. The side ported tube <NUM> may be a rigid tubing placed into the valve body <NUM>. The valve body <NUM> may be considered to be a pump block of the valve system <NUM>.

The plug <NUM> may be installed into the tube <NUM> as a separate piece or component from the tube <NUM> or may be formed through spot-weld process, a crimping process, a swaging process, a filling/plugging process, any combination thereof, or the like. A first portion of the tube <NUM> may be or may form an inlet component <NUM> of the tube <NUM>. A second portion of the tube <NUM> may be or may form an outlet component <NUM> of the tube <NUM>. The plug <NUM> may help prevent fluid flowing through (e.g., by a liquid drug) between the inlet component <NUM> and the outlet component <NUM>. As with the other examples disclosed herein, the inlet component <NUM> may be coupled to a reservoir storing a liquid drug or other therapeutic agent and the outlet component <NUM> may be coupled to a fluid path (e.g., a cannula) coupled to a patient.

In various examples, the tube <NUM> may be formed of two or more tubes. For example, the tube <NUM> may be formed of two separate tubes having end caps joined together to form the plug <NUM> and capable of moving together as a single component.

As further shown in <FIG>, the valve system <NUM> may further include a first septum component <NUM> and a second septum component <NUM>. The first septum <NUM> and the second septum <NUM> may each be formed from liquid silicone rubber or other compatible elastomeric material. The first septum <NUM> and the second septum <NUM> may each be formed (e.g., molded) as a single component or piece or as multiple components or pieces. The first septum <NUM> and the second septum <NUM> may each be pierced by the tube <NUM>. The valve system <NUM> may further include a first piston <NUM> (e.g., a left piston based on the orientation of the valve system <NUM> as depicted in <FIG>) and a second piston <NUM> (e.g., a right piston based on the orientation of the valve system <NUM> as depicted in <FIG>). The first and second pistons <NUM> and <NUM> may be moved (e.g., linearly) within a first piston pump chamber <NUM> and a second piston pump chamber <NUM>, respectively.

In various example, components of the valve system <NUM> may be arranged in a symmetrical manner. For example, the first septum <NUM> and the second septum <NUM> may be aligned along a first axis and the pistons <NUM> and <NUM> may be aligned along a second axis, perpendicular to the first axis.

The arrangement of the components of the valve system <NUM> may form a low force, non-displacement, micro/miniature valve. The valve system <NUM> may provide a cross-flow valve that provide a two position, four-way ported valve that may alternatively connect the pump chambers <NUM> and <NUM> to the inlet component <NUM> and the outlet component <NUM> of the valve body <NUM>. By providing the tube <NUM> to pierce through the septa <NUM> and <NUM>, the amount of seal force may be more controlled than with an O-ring as described herein.

In various examples, the septa <NUM> and <NUM> may form radial seals with the valve body <NUM>. Each septum <NUM> and <NUM> may include two radial sealing faces to the valve body <NUM> separated with an opening or through-hole (e.g., a void) where no seal to the tube <NUM> is provided. The voids may create openings that may provide fluid channels to the side ported tube <NUM>.

The voids and design of the valve body <NUM> may create separate fluid channels coupling the piston pump chambers <NUM> and <NUM> and the inlet and outlet components <NUM> and <NUM>, based on the position of the valve tube <NUM>. The valve system <NUM> may operate by actuating/moving the side ported tube <NUM> to the correct position along each septum <NUM> and <NUM> prior to movement of the pistons <NUM> and <NUM> (e.g., prior to a stroke of the pistons <NUM> and <NUM>), thereby appropriately connecting and/or disconnecting the proper piston <NUM> and <NUM> from the inlet or outlet component <NUM> and <NUM> as described in more detail herein.

<FIG> illustrates an exploded view of a portion of the valve system <NUM>. Specifically, <FIG> illustrates an arrangement of the pump block <NUM>, the septa <NUM> and <NUM>, and the side ported tube <NUM> (the side ported tube <NUM> may also be referred to as a needle). The septa <NUM> and <NUM> are each represented as single piece components. The side ported tube <NUM> may be installed through the septa <NUM> and <NUM>.

In various examples, the valve body <NUM> and the septa <NUM> and <NUM> may be stationary or held fixed as the side ported tube <NUM> is actuated or moved. The side ported tube <NUM> may be moved linearly through the septa <NUM> and <NUM> and the valve body <NUM>. Linear actuation of the tube <NUM> allows the side ports <NUM> and <NUM> to change connections between the piston pump chambers <NUM> and <NUM> (not shown in <FIG>) and the inlet and outlet components <NUM> and <NUM>. Because the tube <NUM> is plugged by plug <NUM> between the two side ports <NUM> and <NUM>, there is no connection between the inlet component <NUM> and outlet component <NUM> of the tube <NUM> during operation which prevents unintended drug delivery.

<FIG> illustrates a cross-sectional side view of a portion of the valve system <NUM> (e.g., the portion of the valve system <NUM> depicted in <FIG>). <FIG> shows the fluid path provided within the valve system <NUM> between the side ported tube <NUM> and the piston pump chambers <NUM> and <NUM> (not shown in <FIG>). The design and arrangement of the septa <NUM> and <NUM> (relative to the design and arrangement of the valve body <NUM> and/or other components of the valve system <NUM>) may provide fluidic connections between channels within the valve body <NUM> and the channel provided by the tube <NUM> (e.g., the internal open areas of the tube <NUM>). The septa <NUM> and <NUM> also provide for two distinct face seals with the valve body <NUM> to prevent any fluid from leaking from the valve system <NUM>. In turn, this allows the side ported tube <NUM> to have access to the pump chambers <NUM> and <NUM>.

As shown in <FIG>, based on the position of the tube <NUM>, the side port <NUM> may be coupled to the pump chamber <NUM>. As such, fluid may be drawn into the valve system <NUM> (e.g., from an external reservoir or other fluid holding device) from the inlet component <NUM> and through the side port <NUM> as shown by flow arrows <NUM>. The flow arrows <NUM> show that fluid may be drawn into the pump chamber <NUM> and any channel in the valve body <NUM> coupled to the pump chamber <NUM>.

Further, based on the position of the tube <NUM>, the side port <NUM> may be coupled to the pump chamber <NUM>. As such, fluid may be pushed out of the valve system <NUM> (e.g., to an external fluid path and/or cannula coupled to a patient) from the side port <NUM> to the outlet component <NUM> as shown by flow arrows <NUM>. The flow arrows <NUM> show that fluid may be pushed out of the pump chamber <NUM> and any channel in the valve body <NUM> coupled to the pump chamber <NUM>.

<FIG> illustrates a close-up view of an example septum of the valve system <NUM> - for example, the septum <NUM>.

<FIG> illustrates a cross-sectional side view of an exemplary septum of the valve system <NUM> - for example, the septum <NUM> depicted in <FIG>. As shown in <FIG>, the septum <NUM> may include a first radial face seal <NUM> (to the valve body <NUM>) and a second radial face seal <NUM> (also to the valve body <NUM>). Further, the septum <NUM> may include an inner open area or channel <NUM> as well as a first angled opening or channel <NUM> and a second angled opening or channel <NUM> coupled to the inner channel <NUM>. Fluid may flow bidirectionally through the channel <NUM> as indicated by flow indicator <NUM> into the side ported tube <NUM> depending on the position of the tube <NUM>. Similarly, fluid may flow bidirectionally through the channel <NUM> as indicated by flow indicator <NUM> into the side ported tube <NUM> depending on the position of the tube <NUM>.

<FIG> illustrates example configurations of an exemplary septum of the valve system <NUM> - for example, the septum <NUM>. Septum <NUM>-<NUM> illustrates the septum <NUM> formed as multiple pieces or components. Septum <NUM>-<NUM> illustrates the septum <NUM> formed as a single piece or component.

<FIG> illustrate operation of the valve system <NUM>. Specifically, <FIG> illustrate a sequence of operations for drawing in and pumping out a portion of a fluid by the valve system <NUM> for delivery to a patient.

<FIG> illustrates the valve system <NUM> in a first or initial stage of operation. As part of a first step in the sequence of operations, the tube <NUM> is actuated to move in a direction <NUM> to set the side ports <NUM> and <NUM> in appropriate positions for valving. Specifically, the tube <NUM> is moved to position the side port <NUM> (i.e., the side port connected to the inlet component <NUM>) to be coupled to the piston <NUM>/piston pump chamber <NUM> (e.g., the left side piston as indicated in <FIG>). Further, the side port <NUM> (i.e., the side port coupled to the outlet component <NUM>) is positioned to be coupled the second piston <NUM>/piston pump chamber <NUM>. The side ports <NUM> and <NUM> may be coupled to the piston pump chambers <NUM> and <NUM>, respectively, through the flow channels in the septa <NUM> and <NUM> as described herein. As shown in <FIG>, a portion of a fluid <NUM> is positioned in the valve system <NUM> and occupies a portion of the flow channels formed in and/or coupled to the septa <NUM> and <NUM> and the piston pump chamber <NUM>. The piston pump chamber <NUM> (and any coupled channel) may be empty or devoid of any, or substantially any, fluid.

<FIG> illustrates a second stage of operation of the valve system <NUM> (subsequent to the stage of operation of the valve system <NUM> as shown in <FIG>). As shown in <FIG>, the pistons <NUM> and <NUM> are both operable to be actuated (e.g., in unison) to move in a direction <NUM>. As shown by flow indicators <NUM>, fluid <NUM> may be draw in from the inlet component <NUM> to the pump chamber <NUM>. Further, as shown by flow indicators <NUM>, the stored fluid <NUM> (e.g., the same fluid as the fluid <NUM> but referenced separately to distinguish locations of the fluids) may be pushed or pumped out through the outlet component <NUM>. The radial seals of the septa <NUM> and <NUM> (as described herein) may provide sealing against the pumping pressures along with the fluidic channels positioned between the tube <NUM> and the pump chambers <NUM> and <NUM>.

<FIG> illustrates a third stage of operation of the valve system <NUM> (subsequent to the stage of operation of the valve system <NUM> as shown in <FIG>). As shown in <FIG>, the tube <NUM> is actuated to move in a direction <NUM>. Specifically, the tube <NUM> is moved to position the side port <NUM> (i.e., the side port connected to the inlet component <NUM>) to be coupled to the piston <NUM>/piston chamber <NUM>. Further, the side port <NUM> (i.e., the side port coupled to the outlet component <NUM>) is positioned to be coupled the first piston <NUM>/piston chamber <NUM>. Further, as shown in <FIG>, the fluid <NUM> drawn in during the prior operational step is positioned within the pump chamber <NUM>. The pump chamber <NUM> may be devoid of any, or substantially any, fluid.

<FIG> illustrates a fourth stage of operation of the valve system <NUM> (subsequent to the stage of operation of the valve system <NUM> as shown in <FIG>). As shown in <FIG>, the pistons <NUM> and <NUM> are both actuated (e.g., in unison) to move in a direction <NUM>. As shown by flow indicators <NUM>, fluid <NUM> may be draw in from the inlet component <NUM> to the pump chamber <NUM>. Further, as shown by flow indicators <NUM>, the stored fluid <NUM> (e.g., the same fluid as the fluid <NUM> but referenced separately to distinguish locations of the fluids) may be pushed or pumped out through the outlet component <NUM>.

The valve system <NUM> may repeat the steps illustrated in <FIG> to implement a subsequent cycle of drawing in the fluid into the valve system <NUM> from the reservoir and pushing it out for delivery to a patient.

Each example described herein may be part of a drug delivery system including, for example, a wearable drug delivery system.

Claim 1:
A valve system, comprising:
a valve body (<NUM>) comprising a first void (<NUM>) and a second void (<NUM>);
an inlet component (<NUM>) coupled to the first void (<NUM>);
an outlet component (<NUM>) coupled to the second void (<NUM>);
a valve tube (<NUM>) coupled to the first void (<NUM>), the inlet component (<NUM>), the second void (<NUM>), and the outlet component (<NUM>), the valve tube (<NUM>) comprising a side port (<NUM>);
characterized in that
the valve body (<NUM>) is a septum or septa, and
in that the valve tube (<NUM>) is positioned through the septum or septa
stretching the septum or septa over the valve tube (<NUM>) to create a seal.