Patent Description:
Many potentially valuable medicines or compounds, including biologicals, are not orally active due to poor absorption, hepatic metabolism or other pharmacokinetic factors. Additionally, some therapeutic compounds, although they can be orally absorbed, are sometimes required to be administered so often it is difficult for a patient to maintain the desired schedule. In these cases, parenteral delivery is often employed or could be employed.

Effective parenteral routes of drug delivery, as well as other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration include puncture of the skin with a needle or stylet. Insulin is an example of a therapeutic fluid that is self-injected by millions of diabetic patients. Users of parenterally delivered drugs may benefit from a wearable device that would automatically deliver needed drugs/compounds over a period of time.

To this end, there have been efforts to design portable and wearable devices for the controlled release of therapeutics. Such devices are known to have a reservoir such as a cartridge, syringe, or bag, and to be electronically controlled. These devices suffer from a number of drawbacks including the user/caregiver manually loading the reservoir with medication, which may be inconvenient, time consuming, and susceptible to user error, drug leakage, and/or contamination. <CIT> describes an infusion set connector for a fluid reservoir. <CIT> describes a drug delivery device with disposable cartridge and disposable injector. <CIT> a fluid interconnection scheme between reservoir, pump and filling member.

In accordance with one aspect of the present invention, a parenteral drug delivery system for delivering medication to a patient. The delivery system includes a container configured to hold the medication, an intermediate port connector, and a delivery device. The port connector may be fixedly coupled to the container and removably coupled to the delivery device in a convenient, reliable, and sealed manner. During a delivery process, the port connector may convey the medication from the container to the delivery device for delivery to the patient.

In accordance with another aspect of the present invention, a container assembly is provided for holding a medication for delivery to a patient via a delivery device. The container assembly includes a container configured to hold the medication and a port connector coupled to the container and having a delivery port with an inlet and an outlet. The delivery port includes a pin, a first seal, and a second seal. The port connector has: a sealed configuration in which the first and second seals are positioned in sealed engagement with the pin to close the delivery port; an intermediate configuration in which the first seal is positioned in sealed engagement with the delivery device and the second seal is positioned in sealed engagement with the pin; and a delivery configuration in which the first seal is positioned in sealed engagement with the delivery device and the delivery port is positioned in fluid communication with a fluid passageway of the delivery device.

These aspects of the invention are not meant to be exclusive and other features, aspects, and advantages of the present invention will be readily apparent to those of ordinary skill in the art when read in conjunction with the appended claims and accompanying drawings.

These and other features and advantages of the present invention will be better understood by reading the following detailed description, taken together with the drawings wherein:.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

The terms "drug", "medication", "fluid", "liquid" and/or "therapeutic fluid" are used synonymously to refer to any substance contained within the reservoir or container. The term "drug reservoir", "reservoir" and "container" are also used synonymously to refer to element <NUM>.

Various embodiments are described and shown herein for a container and/or reservoir for holding fluid and a device / system / method for connecting the container and/or reservoir to a device for delivering and/or pumping the fluid from the container and/or reservoir to, for example, a patient/user. Various devices may be connected to the container and/or reservoir, including but not limited to, those shown and described in <CIT> and entitled Fluid Delivery Systems and Methods (Attorney Docket No. E70); <CIT> and entitled Infusion Pump Assembly (Attorney Docket No. G75); and <CIT> and entitled Infusion Pump Assembly, now U. Publication No. <CIT> (Attorney Docket No. K40).

Referring to <FIG>, a parenteral drug delivery system <NUM> is shown for delivering medication <NUM>, which may include, but is not limited to, basal and/or bolus insulin formulations or other liquid/fluid medications, into a user's skin <NUM>. Delivery system <NUM> includes a container assembly having a drug reservoir or container <NUM> coupled to an intermediate port connector <NUM>. Delivery system <NUM> further includes a delivery device <NUM> with a drive mechanism <NUM> configured to move medication <NUM> from container <NUM> to the user <NUM>. Further detail of the elements of delivery system <NUM> are described below.

Container <NUM> of delivery system <NUM> is configured to hold medication/fluid <NUM>. Container <NUM> may be constructed of one or more flexible materials, such as cyclo olefin polymers (COP), cyclic olefin copolymers (COC), or other pharmaceutically suitable materials. Container <NUM> may also be coated (e.g., laminated or coextruded) with a pharmaceutically suitable film, such as a poly-chloro-tri-fluoro-ethylene (PCTFE) film (e.g., Aclar). The PCTFE layer may serve as a water barrier to provide moisture vapor retention. In illustrated embodiment, container <NUM> is substantially flat in an unfilled state and expands when in a filled state. In one embodiment, the flexibility of container <NUM> is achieved with an elastomeric tie layer in addition to the COP or COC material layer. In another embodiment, the container flexibility is provided with a softer material layer, such as low density polyethylene (LDPE) multilayered with the COP or COC. In some embodiments, the multilayer construction of container <NUM> includes an outer PCTFE layer (e.g., <NUM> micrometers (µm) thick), an inner COP layer (e.g., <NUM>) adapted to contact the contained drug, an intermediate adhesive layer adjacent the PCTFE layer, and an intermediate linear LDPE layer (e.g., <NUM>) between the adhesive layer and the COP. In some embodiments, the multilayer construction of container <NUM> includes an elastomeric tie-layer positioned in place of or adjacent to the adhesive layer. In some embodiments, the multilayer construction of container <NUM> includes an outer PCTFE layer, an inner COC layer (e.g., <NUM>) adapted to contact the contained drug, and an elastomeric tie-layer between the PCTFE and COC layers. Any other configurations may be used in various embodiments.

In some embodiments, container <NUM> may have a generally flat shape resembling a bag, but in various embodiments, the shape may vary. According to one embodiment, container <NUM> is pre-filled with fluid/medication <NUM> before being supplied to a user <NUM>. However, in some embodiments, container <NUM> may be filled manually by caregiver/user <NUM>. One embodiment of a filling process is described below.

In some embodiments, port connector <NUM> of the container assembly may be constructed of one or more rigid thermoplastic materials, such as COP or COC material which contacts the drug in container <NUM>. In some embodiments, port connector <NUM> may also include portions made of flexible elastomeric materials. In various embodiments, port connector <NUM> may be fixedly coupled (e.g., heat sealed, adhered, ultrasonic welded, or any other method of fixedly coupling) to container <NUM> and removably coupled to delivery device <NUM>. In some embodiments, port connector <NUM> is comprised of COP or COC material which contacts the corresponding COP or COC layer of container <NUM> when coupled together. In various embodiments, port connector <NUM> includes a first filling port (for example, in some embodiments, port connector <NUM> includes a septum) configured to convey medication <NUM> from a filling apparatus (not shown) into container <NUM> during the drug filling process. In various embodiments, port connector <NUM> also includes a second delivery port configured to convey medication <NUM> from container <NUM> to delivery device <NUM> when the components are coupled together following the connection process. Both the filling process and the connection process are described further below.

In some embodiments, delivery device <NUM> of the illustrative delivery system <NUM> is an infusion-type pump device. Drive mechanism <NUM> of such an infusion-type delivery device <NUM> may include a motor-operated and/or valve controlled pump, for example. As shown in <FIG>, the infusion-type delivery device <NUM> may also include a flexible tube <NUM>, an infusion base <NUM> that rests upon or adheres to the user's skin <NUM>, and an infusion needle/catheter <NUM>, that extends into the patient's skin <NUM>. In various embodiments, delivery device <NUM> is an injection-type device, such as a bolus injector. Drive mechanism <NUM> of such an injection-type delivery device <NUM> may include a button-operated piston, a spring, a chemical engine, and/or other suitable drive mechanisms, for example.

Referring now also to <FIG>, one embodiments of a port connector <NUM> is shown. In various embodiments, the port connector <NUM> may include a fill port <NUM> in fluid communication with a container <NUM> (shown in phantom). The fill port <NUM> may be used to the fill container <NUM> with medication <NUM> during the filling process, which is described below. In some embodiments, the port connector <NUM> may also include a delivery or outlet port <NUM> having an inlet <NUM> in fluid communication with container <NUM> and an outlet <NUM> in selective fluid communication with delivery device <NUM>. The delivery port <NUM> may be used to convey medication <NUM> from container <NUM> to delivery device <NUM> during a delivery process.

Referring now also to <FIG> and <FIG>, in various embodiments, fill port <NUM> is arranged along a first axis A1, inlet <NUM> of delivery port <NUM> is arranged along a second axis A2, and outlet <NUM> of delivery port <NUM> is arranged along a third axis A3. In various embodiments, where the first axis A1 is oriented at <NUM> degrees, the second axis A2 may be oriented at about <NUM> degrees and the third axis A3 may be oriented perpendicular to first axis A1 at about <NUM> degrees. However, in various embodiments, the orientation of fill port <NUM> and delivery port <NUM> may vary.

In various embodiments, inlet <NUM> of delivery port <NUM> may be at least partially defined by wall <NUM> of port connector <NUM>. A partial wall <NUM> is shown in <FIG>, with the rest of inlet <NUM> being defined by container <NUM> (shown in phantom). In some embodiments, inlet <NUM> is defined entirely by wall <NUM> of port connector <NUM>.

In various embodiments, outlet <NUM> of delivery port <NUM> may be defined by wall <NUM> of port connector <NUM>. Wall <NUM> is cylindrical, as shown in the embodiments shown in <FIG>, however, in other embodiments; wall <NUM> may be any shape. As shown in <FIG>, outlet <NUM> of delivery port <NUM> illustratively includes a pin <NUM> with a head <NUM> configured to move along axis A3, a shoulder <NUM> that extends radially inward from wall <NUM>, a first seal <NUM> (e.g., a first O-ring) positioned around pin <NUM> and below shoulder <NUM>, and a second seal <NUM> (e.g., a second O-ring) also positioned around pin <NUM> and below shoulder <NUM>. In various embodiments, first seal <NUM> and second seal <NUM> may be separate components, however, in some embodiments, first seal <NUM> and second seal <NUM> may be coupled together as a single integral component. In one embodiment, seals <NUM>, <NUM> are made of flexible elastomeric material. However, in various embodiments, seals <NUM>, <NUM> may be made from any material.

Referring now also to <FIG>, an exemplary connection and delivery process performed using port connector <NUM> is described below.

<FIG> shows port connector <NUM> in a sealed configuration, wherein outlet <NUM> of delivery port <NUM> is sealed closed, and disconnected from the delivery device <NUM>. In various embodiments, the first seal <NUM> and second seal <NUM> are both positioned in sealed engagement with wall <NUM> and pin <NUM> of delivery port <NUM> (i.e., illustratively positioned between wall <NUM> and pin <NUM>) to close outlet <NUM> of delivery port <NUM>. However, in other embodiments, the first seal <NUM> and second seal <NUM> may be positioned differently. Using first seal <NUM> and second seal <NUM> in combination around pin <NUM> forms primary and back-up seals that maintain the integrity of delivery port <NUM> even in the event of a seal failure. In this sealed configuration, first seal <NUM> and second seal <NUM> may block medication <NUM> (<FIG>) in container <NUM> from escaping through the closed outlet <NUM> of delivery port <NUM>. Also, first seal <NUM> and second seal <NUM> may block contaminants from entering container <NUM> through the closed outlet <NUM> of delivery port <NUM> to maintain the integrity of medication <NUM> (<FIG>). In various embodiments, container <NUM> and port connector <NUM> may be stored in this sealed configuration for several weeks, months, or years, for example.

<FIG> shows port connector <NUM> in an aligned and sealed configuration, wherein outlet <NUM> of delivery port <NUM> is aligned with fluid passageway <NUM> of delivery device <NUM>. The illustrative delivery device <NUM> includes a socket <NUM> that is sized and shaped to receive wall <NUM> of port connector <NUM> in the aligned configuration and subsequent configurations. The illustrative delivery device <NUM> also includes a post <NUM> that is centrally located in socket <NUM> and configured to engage pin <NUM> along axis A3. In the embodiment shown in <FIG>, fluid passageway <NUM> follows an L-shaped path through post <NUM>, with a first portion <NUM> of fluid passageway <NUM> traveling radially inward through post <NUM> in a direction perpendicular to axis A3 and a second portion <NUM> of fluid passageway <NUM> traveling axially through post <NUM> along axis A3. The delivery port <NUM>, socket <NUM>, and post <NUM> are configured to cooperate to form the port connection between container <NUM> and the delivery device <NUM>, as disclosed in greater detail herein.

Referring now also to <FIG>, the port connector <NUM> is in an intermediate configuration, wherein delivery port <NUM> of port connector <NUM> forms a sealed connection with delivery device <NUM>. In the embodiment shown in <FIG>, this intermediate configuration is achieved by a downward force on upper surface <NUM> of port connector <NUM> along axis A3 and moving wall <NUM> of port connector <NUM> into socket <NUM> of delivery device <NUM>. This downward movement is transferred to shoulder <NUM>, first seal <NUM>, and second seal <NUM> of port connector <NUM>. However, pin <NUM> of port connector <NUM> contacts post <NUM> of delivery device <NUM> and is prevented from traveling downward into delivery device <NUM>. As a result, first seal <NUM> and second seal <NUM> move downward relative to pin <NUM> of port connector <NUM> and toward post <NUM> of delivery device <NUM>. In the intermediate configuration shown in <FIG>, first seal <NUM> separates from pin <NUM> of port connector <NUM> and moves into sealed engagement with post <NUM> of delivery device <NUM>, while second seal <NUM> remains in sealed engagement with pin <NUM> of port connector <NUM>. Thus, port connector <NUM> forms a convenient, reliable, sealed connection with delivery device <NUM> while also maintaining the sealed delivery port <NUM> to block fluid flow through port <NUM>.

Referring now also to <FIG>, port connector <NUM> is in a final or delivery configuration, wherein delivery port <NUM> of port connector <NUM> forms a fluid connection with fluid passageway <NUM> of delivery device <NUM>. In this embodiment, the delivery configuration is achieved by the continued downward force on upper surface <NUM> of port connector <NUM> along axis A3 until wall <NUM> of port connector <NUM> is seated in socket <NUM> of delivery device <NUM>. As in the above-described intermediate configuration, this downward movement is transferred to shoulder <NUM>, first seal <NUM>, and second seal <NUM> of port connector <NUM>. In the delivery configuration of <FIG>, first seal <NUM> and second seal <NUM> both separate from pin <NUM> of port connector <NUM> (i.e., move axially apart from pin <NUM>) and move into sealed engagement with post <NUM> of delivery device <NUM>. Inlet <NUM> of delivery port <NUM> is now exposed to fluid passageway <NUM> of delivery device <NUM> through the open outlet <NUM> of delivery port <NUM>. Stated differently, inlet <NUM> of delivery port <NUM> is now placed in fluid communication with fluid passageway <NUM> of delivery device <NUM>. In use, medication <NUM> (<FIG>) from container <NUM> is free to travel through delivery port <NUM> around the freed pin <NUM> of port connector <NUM> and into fluid passageway <NUM> of delivery device <NUM>. Using first seal <NUM> and second seal <NUM> in combination around post <NUM> forms primary and back-up seals that maintain the integrity of fluid passageway <NUM> even in the event of a seal failure.

Port connector <NUM> may present certain benefits/advantages in addition to those discussed above. For example, port connector <NUM> may have a small size and a small dead-volume, which may enable use in tight spaces. Also, port connector <NUM> may be constructed with rigid, well-toleranced thermoplastic parts, which may enable robust operation with minimal debris. In the illustrative embodiment, the force to create the port connection is applied through the rigid parts, for example, rigid post <NUM> pushes on rigid pin <NUM>, rather than through flexible or elastomeric parts. Further, only a small portion of the elastomeric seal (<NUM>, <NUM>) comes into contact with the fluid throughout the positioning of container <NUM> from the sealed configuration to the delivery configuration; accordingly, the fluid exerts minimal, if any, shear on the elastomeric seals.

Another exemplary port connector <NUM>' is shown in <FIG>. The second port connector <NUM>' is similar to the above-described first port connector <NUM>, with like reference numerals identifying like elements, except as described below. Port connector <NUM>' includes a delivery port <NUM>' having an inlet <NUM>' and an outlet <NUM>'. Delivery port <NUM>' of port connector <NUM>' includes a moveable pin <NUM>', a shoulder <NUM>', a first seal <NUM>', and a second seal <NUM>'. In <FIG>, seals <NUM> and <NUM> of the first port connector <NUM> were positioned together below shoulder <NUM>. In <FIG>, by contrast, seals <NUM>' and <NUM>' of the second port connector <NUM>' are separated and positioned on opposing sides of shoulder <NUM>'. More specifically, first seal <NUM>' is positioned below shoulder <NUM>', and second seal <NUM>' is positioned above shoulder <NUM>'.

The connection process associated with the second port connector <NUM>' is similar to the connection process associated with the above-described first port connector <NUM>, except as described below. In the aligned and sealed configuration of <FIG>, first seal <NUM>' and second seal <NUM>' are both positioned in sealed engagement with pin <NUM>' and wall <NUM>' of port connector <NUM>'. In the intermediate configuration of <FIG>, first seal <NUM>' moves into sealed engagement with post <NUM>' of delivery device <NUM>' and remains sealingly engaged with wall <NUM>', while second seal <NUM>' remains in sealed engagement with pin <NUM>' and wall <NUM>' of port connector <NUM>'. In the delivery configuration of <FIG>, first seal <NUM> and second seal <NUM> of the first port connector <NUM> both moved into sealed engagement with post <NUM> of delivery device <NUM>. In the delivery configuration of <FIG>, by contrast, second seal <NUM>' remains in sealed engagement with pin <NUM>' and wall <NUM>' of the second port connector <NUM>'. However, inlet <NUM>' of port connector <NUM>' opens downward below second seal <NUM>', which exposes inlet <NUM>' of port connector <NUM>' to fluid passageway <NUM>' of delivery device <NUM>'. In use, medication <NUM> (<FIG>) from container <NUM>' is free to travel through delivery port <NUM>' below second seal <NUM>' of port connector <NUM>' and into fluid passageway <NUM>' of delivery device <NUM>'.

A third exemplary port connector <NUM>" is shown in <FIG>. The third port connector <NUM>" is similar to the above-described port connectors <NUM> and <NUM>', with like reference numerals identifying like elements, except as described below. Port connector <NUM>" includes a delivery port <NUM>" having an inlet <NUM>" and an outlet <NUM>". Delivery port <NUM>" of port connector <NUM>" includes a wall <NUM>", a shoulder <NUM>", and a first seal <NUM>". Additionally, delivery port <NUM>" of port connector <NUM>" includes a moveable ball seal <NUM>".

The connection process associated with the third port connector <NUM>" is similar to the connection processes associated with the above-described port connectors <NUM> and <NUM>', except as described below. In the sealed configuration of <FIG> and the aligned configuration of <FIG>, first seal <NUM>" and ball seal <NUM>" are both positioned in sealed engagement with wall <NUM>" of port connector <NUM>". In the intermediate configuration of <FIG>, first seal <NUM>" moves into sealed engagement with post <NUM>" of delivery device <NUM>", while ball seal <NUM>" remains in sealed engagement with wall <NUM>" of port connector <NUM>". In the delivery configuration of <FIG>, inlet <NUM>" of port connector <NUM>" moves downward below ball seal <NUM>", which exposes inlet <NUM>" of port connector <NUM>" to fluid passageway <NUM>" of delivery device <NUM>". In use, medication <NUM> (<FIG>) from container <NUM>" is free to travel through delivery port <NUM>" below ball seal <NUM>" of port connector <NUM>" and into fluid passageway <NUM>" of delivery device <NUM>".

A fourth exemplary port connector <NUM>‴ is shown in <FIG>. The fourth port connector <NUM>"' is similar to the above-described port connectors <NUM>, <NUM>', and <NUM>", with like reference numerals identifying like elements, except as described below. Port connector <NUM>‴ includes a delivery port <NUM>‴ having an inlet <NUM>‴ and an outlet <NUM>‴. Delivery port <NUM>‴ of port connector <NUM>‴ includes a plug or septum <NUM>‴ (e.g., butyl elastomer material) configured to selectively interact with needle <NUM>‴ of delivery device <NUM>‴. Port connector <NUM>‴ may have a sealed configuration (not shown), in which septum <NUM>‴ seals outlet <NUM>‴ of delivery port <NUM>‴. Port connector <NUM>‴ may also have a delivery configuration, as shown in <FIG>, in which needle <NUM>‴ punctures septum <NUM>‴ to expose outlet <NUM>‴ of delivery port <NUM>‴ to fluid passageway <NUM>‴ in needle <NUM>‴ of delivery device <NUM>‴.

An exemplary filling process performed using a port connector to fill a container with medication will now be described with reference to <FIG>. While reference is made to port connector <NUM> in <FIG>, it is understood that the filling process may be performed using any of the other above-described port connectors <NUM>', <NUM>", and <NUM>‴.

Referring now also to <FIG> show port connector <NUM> in an open or filling configuration, wherein a filling adapter <NUM> is positioned in fluid communication with an open fill port <NUM> of port connector <NUM>. Outer surface <NUM> of adapter <NUM> is configured to frictionally engage a corresponding fitting of a filling head or nozzle, which may contain a medication supply tube (not shown). In the illustrated embodiment of <FIG>, outer surface <NUM> of adapter <NUM> has a hexagonal shape, but it is also within the scope of the present disclosure for outer surface <NUM> of adapter <NUM> to be threaded or otherwise shaped to engage the filling head or nozzle. This open configuration allows medication <NUM> (<FIG>) from the supply tube to flow through adapter <NUM>, through the open fill port <NUM> of port connector <NUM>, and into container <NUM> (<FIG> and <FIG>).

Referring now also to <FIG> show port connector <NUM> in a sealed configuration, wherein adapter <NUM> is removed and replaced with a plug <NUM> (e.g., a butyl elastomer plug) to close fill port <NUM> of port connector <NUM>. Adapter <NUM> may be broken, cut, or otherwise removed from fill port <NUM> and replaced with plug <NUM>. In the illustrated embodiment, plug <NUM> is pushed through the central bore of filling adapter <NUM> and into port <NUM> immediately following the filling of the container and prior to removing adapter <NUM> from port connector <NUM>. Adapter <NUM> may be integrally molded to port connector <NUM> or alternatively be a separate component that is coupled to port connector <NUM> prior to filling and handling and then dissembled from port connector <NUM> after stoppering port <NUM> with plug <NUM>.

Referring now also to <FIG>, in various embodiments, including in any one or more of the embodiments described and shown herein, a headless pin <NUM> may be used rather than a pin <NUM> with a head <NUM> (see <FIG>). In various embodiment, it may be desirable/beneficial for the pin <NUM> to have a head <NUM> for many reasons, including, but not limited to, the head <NUM> may serve as a mating hard-stop surface on the delivery port <NUM> when the pin <NUM> is inserted into the delivery port <NUM> during manufacture. In various other embodiments, the shape, size, height, width, etc., of the pin <NUM> and head <NUM> may be any shape, size, height, width, etc..

However, in various embodiments, a headless pin <NUM> may be desirable/beneficial for many reasons, including, but not limited to, the headless pin <NUM> has smaller radial dimensions than a pin <NUM> with a head <NUM> and the delivery port <NUM> may therefore have smaller dimensions; the headless pin <NUM> may be smaller in overall length than, for example, a pin <NUM> with a head <NUM>, thereby the headless pin <NUM> may allow the delivery port <NUM> to be shorter; a headless pin <NUM> is essentially easier to manufacture as, in some embodiments, it may be extruded and cut to length rather than injection molded and this may improve tolerances that may be held on the headless pin <NUM> and obviates the need for a draft angle on the pin <NUM> with a head <NUM>; during assembly, the headless pin <NUM> may be inserted into the deliver port <NUM> from either side of the delivery port <NUM>; the cross-sectional area of the headless pin <NUM> may be minimized and therefore the pressure difference on either side of the headless pin <NUM> results in a smaller force, relative to a pin <NUM> with a head <NUM>, which has a larger cross sectional area and therefore, the headless pin <NUM> is less likely to move when the delivery port <NUM> is pressurized; and the headless pin <NUM> may have additional features, including, but not limited to, indentations that may be used to aid in position and retention of the headless pin <NUM> in the delivery port <NUM> (see <FIG>).

Referring now also to <FIG>, the pin <NUM> may be fabricated with positioning and retention features <NUM> that engage the seal <NUM>, <NUM> at defined positions in the various embodiments. In various embodiments, the positioning and retention features <NUM> may be any shape and/or size and there may be more than one, depending on one or more considerations, including the seal shape and size. For example, the positioning and retention features <NUM> may be oval in shape (see <FIG>), wherein this shape may be beneficial/desirable for many reasons, including but not limited to, the seals <NUM>, <NUM> mate with the retention feature <NUM>, thereby helping to locate the pin <NUM>, and preventing it from moving. Still referring to <FIG>, in some embodiments, there may be more than one retention feature <NUM> (see <FIG>, for example), and, in other embodiments, there may be a single retention feature <NUM> (see, for example, <FIG>). The retention feature <NUM> may be any size or shape desirable, for example, in some embodiments, the shape may be round or oval (see <FIG>), and in other embodiments, the shape may be asymmetric and/ or square (see <FIG>. The retention feature <NUM> retains the pin <NUM>, in some embodiments, in one direction, while allowing it to slip more easily in the other direction. In various embodiments, the retention feature <NUM> may be shaped and or sized differently than shown and in various embodiments, there may be more than one and / or more than two retention features <NUM>.

Referring now also to <FIG>, another embodiment of a pin <NUM> is shown. In various embodiments, the pin <NUM> may include a bead <NUM>. In various embodiments, the bead <NUM> helps maintain the location of the pin <NUM> during transit and may reduce displacement of the pin <NUM> during manufacture. In various embodiments, the pin <NUM> may be manufactured as a cut extruded rod. In various embodiments, this embodiment of the pin <NUM> may make the total height <NUM> lower than other embodiments.

Referring now also to <FIG>, another embodiment of the pin <NUM> is shown. In some embodiments, a shim <NUM> may be used to reduce the length of the pin <NUM>. In various embodiments, this embodiment of the pin <NUM> may make the total height <NUM> lower than other embodiments.

Referring now also to <FIG>, in various embodiments, features of the pin <NUM> may be overlapped by using a conical surface and therefore, the pin <NUM> nests into a cone geometry and saves total height <NUM>. In various embodiments, this embodiment of the pin <NUM> may make the total height <NUM> lower than some other embodiments.

Referring now also to <FIG>, in various embodiments, the pin <NUM> has wing features <NUM>, which are retained by angled surfaces <NUM> in the retaining ring of the port <NUM>. In various embodiments, the pin <NUM> is rotated as the connector is assembled. In various embodiments, rotating the pin <NUM> as the connector is assembled may overcome `spring back' of the pin <NUM>. Single feature datums both seal and pin saving a wall thickness of material. In various embodiments, this embodiment of the pin <NUM> may make the total height <NUM> lower than other embodiments.

Referring now also to <FIG>, in various embodiments, the pin <NUM> may not include a flange or wing, and in various embodiments, this may decrease the size of the pin <NUM>. In various embodiments, this embodiment of the pin <NUM> may make the total height <NUM> lower than other embodiments.

Referring now also to <FIG>, in some embodiments, the shape and size of the seals may vary. In some embodiments, the seal <NUM> may include a quad-ring geometry. In some embodiments, the aspect ratio of a quad-ring geometry seal <NUM> may provide a more compact design, leading to a seal <NUM> that has minimal depth. In various embodiments of the device using a quad-ring seal <NUM>, the retention features <NUM> may vary to accommodate the different shape of the quad-ring seal <NUM>.

While this invention has been described as having exemplary designs, the present invention can be further modified within the scope of this disclosure. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claim 1:
A container assembly for holding a medication (<NUM>) for delivery to a patient using a delivery device (<NUM>) comprising a socket (<NUM>), a post (<NUM>) and a fluid passageway (<NUM>), the container assembly comprising:
a container (<NUM>) configured to hold the medication (<NUM>); and
a port connector (<NUM>) for co-operating with the delivery device, wherein the port connector is coupled to the container (<NUM>);
the port connector (<NUM>) having a delivery port (<NUM>) with an inlet (<NUM>) and an outlet (<NUM>), wherein the outlet (<NUM>) of the delivery port (<NUM>) is defined by a wall (<NUM>) of the port connector (<NUM>);
characterized in that:
the delivery port (<NUM>) includes a shoulder (<NUM>), a pin (<NUM>), a first seal (<NUM>) and a second seal (<NUM>), wherein the wall (<NUM>) is moveable relative to the pin (<NUM>) and into the socket (<NUM>) of the delivery device (<NUM>), the shoulder (<NUM>) is configured to transfer movement of the port connector (<NUM>) to the first seal (<NUM>), and the first seal (<NUM>) is movable relative to the pin (<NUM>) and towards the post (<NUM>) of the delivery device, to move the port connector from a sealed configuration to an intermediate configuration and to a delivery configuration;
wherein in the sealed configuration the first and second seals (<NUM>, <NUM>) are positioned in sealed engagement with the pin (<NUM>) to close the delivery port (<NUM>);
in the intermediate configuration the first seal (<NUM>) is positioned in sealed engagement with the delivery device and the second seal (<NUM>) is positioned in sealed engagement with the pin, wherein the delivery port (<NUM>) of the port connector (<NUM>) forms a sealed connection with the delivery device (<NUM>), while the second seal (<NUM>) in sealed engagement with the pin (<NUM>) blocks fluid flow from the inlet (<NUM>) through the delivery port (<NUM>); and
in the delivery configuration the first seal (<NUM>) is positioned in sealed engagement with the delivery device (<NUM>) and the delivery port (<NUM>) is positioned in fluid communication with the fluid passageway (<NUM>) of the delivery device (<NUM>).