Devices, systems, and methods of packaging for a pre-filled drug delivery device

A system for sterilizing a drug delivery device includes a drug delivery device having a first self-healing seal configured to seal a fluid reservoir disposed within the drug delivery device. A sealable container is configured to receive the drug delivery device therein. The sealable container has a base portion and a cover portion. The cover portion has a second self-healing seal positioned to align with the first self-healing seal when the drug delivery device is disposed within the sealable container. A fill port includes a fill path, the fill path being configured to pass through the first and second self-healing seals to fluidly couple the fill port to the reservoir of the drug delivery device. Other systems, methods, and devices of sterilization are also disclosed.

TECHNICAL FIELD

The present application generally relates to medication delivery devices, and more particularly to systems and methods for providing pre-filled sterilized drug delivery devices.

BACKGROUND

Conventional drug delivery devices are often provided to a user without a liquid drug prefilled in a drug container of the device. The patient is therefore often required to fill the drug device prior to use. This sequence is implemented because it can be difficult to completely sterilize a device that is pre-filled with the drug without damaging the drug. Conventional sterilization processes may require heat, radiation, or chemicals, all of which are capable of damaging most drugs.

Accordingly, there is a need for an improved system and method for aseptic filling of a terminally sterilized drug delivery device so that a terminally sterilized pre-filled device can be provided to the user. The system and method should avoid damage to the drug that can occur with heat, radiation, chemical sterilization techniques, or the like.

SUMMARY

The present disclosure in various embodiments includes systems and methods of packaging for a pre-filled drug delivery device. In an embodiment, a system for sterilizing a drug delivery device may include a drug delivery device that may have a first self-healing seal. The first self-healing seal may be configured to seal a fluid reservoir disposed within the drug delivery device. A sealable container may be for receiving the drug delivery device therein. The sealable container may have a base portion and/or may have a cover portion. A second self-healing seal may be disposed on the cover portion. The second self-healing seal may be positioned to substantially align with the first self-healing seal when the drug delivery device is disposed within the sealable container. A fill receiver may include a fill path. The fill path may be configured to pass through the first and second self-healing seals to fluidly couple the fill receiver to the reservoir of the drug delivery device. The fill receiver may include at least one sealing protrusion on an inner surface of the fill receiver. The fill receiver may include a one-way valve. The valve may be configured for flow in a direction toward the reservoir. At least one of the first self-healing seal and the second self-healing seal may comprise silicone. An alignment ring may be disposed on the cover portion between the first self-healing seal and the second self-healing seal and may be about the first self-healing seal. The base portion of the sealable container may be configured to position the device such that the first self-healing seal is substantially aligned with the second self-healing seal. A tub may be configured to contain the drug delivery device and the sealable container for sterilizing the system. The tub may be configured to position the drug delivery device for filling the fluid reservoir with a drug. The cover portion may be gas permeable. A plunger may be within the fluid reservoir and may be in a position controlling a volume of a fluid within the reservoir. Insulin may be disposed within the fluid reservoir. The first and second self-healing seals may be configured for a fill path to reversibly translate into the first and second self-healing seals to fluidly couple the fill path to the fluid reservoir such that a sterility of the device may be maintained and a fluid may not pass through the first and second self-healing seals. The cover portion may be removably adhered to the base portion. The first self-healing seal may abut the second self-healing seal.

In an aspect, a method for sterilizing a drug delivery device may include disposing a drug delivery device within a sealed container. The drug delivery device may have an empty reservoir. A fill path may be coupled to the reservoir by disposing the fill path through a first self-healing seal in the drug delivery device and through a second self-healing seal in a cover portion of the sealed container. The drug delivery device, the sealed container, and the fill path may be disposed in a tub. The drug delivery devices, sealed containers, and fill path may be subjected to terminal sterilization. The tub may be placed into an aseptic environment. A fill nozzle of a liquid drug dispensing system may be interfaced with the fill path of the drug delivery device. A liquid drug may be supplied into the reservoir. The fill path from the drug delivery device may be disengaged by removing the fill path from the first and second self-healing seals. The first self-healing seal may be aligned with the second self-healing seal. A plurality of assemblies comprising the drug delivery device, the sealed container, and the fill path may be arranged in the tub. The tub may be sealed. The tube may be unsealed. The drug delivery devices, sealed containers, and fill path may be subjected to terminal sterilization comprising ethylene oxide.

In an aspect, a device may include a housing. A fluid reservoir may be disposed within the housing. A fill port may be disposed on the housing. A first self-healing seal may be disposed within the fill port and may be configured to seal the fluid reservoir and substantially align with a second self-healing seal disposed on a container. The first and second self-healing seals may be configured for a fill path to reversibly translate into the first and second self-healing seals that may fluidly couple the fluid path to the fluid reservoir such that a sterility of the device may be maintained and a fluid cannot pass through the first and second self-healing seals. The first self-healing seal may comprise silicone.

DETAILED DESCRIPTION

The present disclosure is not limited to the particular embodiments described. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises” and/or “comprising,” or “includes” and/or “including” when used herein, specify the presence of stated features, regions, steps elements and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups thereof.

As used herein, the conjunction “and” includes each of the structures, components, features, or the like, which are so conjoined, unless the context clearly indicates otherwise, and the conjunction “or” includes one or the others of the structures, components, features, or the like, which are so conjoined, singly and in any combination and number, unless the context clearly indicates otherwise.

All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about”, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Other uses of the term “about” (i.e., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

This disclosure presents various systems, components, and methods related to drug delivery devices. Each of the systems, components, and methods disclosed herein provides one or more advantages over conventional systems, components, and methods.

The disclosed devices, systems and methods address issues relating to device sterilization and providing a device that is pre-filled with a liquid drug. The disclosed devices, systems, and methods facilitate aseptic filling of a terminally sterilized drug delivery device, resulting in a terminally sterilized pre-filled device. As mentioned, one problem with providing a pre-filled drug delivery device is that it can be difficult or impossible to sterilize the pre-filled device without damaging or otherwise disturbing the liquid drug, because conventional sterilization processes may require heat, radiation, or chemicals all of which are capable of damaging most drugs.

The disclosed systems and methods enable a terminally sterilized drug delivery device to be filled after it has been sterilized, and while it remains in its sterile packaging. By filling the drug delivery device through the sterile packaging, it is possible to provide a terminally sterilized device pre-filled to the user.

Advantages of the disclosed systems and methods may include allowing for sterilization of the drug delivery device without the drug being present in the device, allowing a pre-filled device to be provided to the user, thereby improving the user experience and reducing user steps, among others.

With reference toFIG. 1, an embodiment of a drug delivery device1according to the present disclosure is illustrated, which in some embodiments can be an OmniPod® (Insulet Corporation, Billerica, Mass.) insulin delivery device. The device1includes a liquid drug reservoir (not shown) within a housing.FIG. 2shows the location of a fill port2on an undersurface4of the drug delivery device1. The location of the fill port2is such that an axis perpendicular to a plane created by the fill port2is substantially directed to a fluid reservoir (not shown) within the housing of the device1. It will be appreciated that the fill port2can include a first self-healing seal6along its axis such as a silicone disc or other appropriate seal. The first self-healing seal6is configured to seal the reservoir. The fill port2can be fluidly coupled to the reservoir disposed within the drug delivery device1. Any of the fluid arrangements, including any of the drug delivery systems disclosed herein, can be part of a wearable or on-body drug delivery device or pump, such as an OmniPod® (Insulet Corporation, Billerica, Mass., USA) device and/or any of the drug delivery devices described in U.S. Pat. Nos. 7,303,549; 7,144,384; 7,137,964; 6,960,192; 6,740,059; 6,699,218; 9,402,950; 7,771,412; 7,029,455; 6,740,05; and 6,656,159, each of which is incorporated herein by reference in its entirety and for all purposes.

In various embodiments described here or otherwise within the scope of the present disclosure, a self-healing seal may comprise silicone, other vulcanized rubbers, polyurethane, or the like. Such self-healing seals may be reversibly pierced by an object (e.g., with a needle), and remain sealed after removal of the piercing object. These seals may maintain a sterility barrier even after a traumatic piercing, puncturing, or the like. The aperture left behind in the seal at the piercing site is small enough that a microbe cannot make its way through. The compressional forces within the seal onto itself leaves no air gap at the piercing site once the piercing object is removed.

With reference toFIG. 3, a side view of an embodiment of a drug delivery system according to the present disclosure is illustrated with a device1within a sealed container8, e.g. a blister pack. The drug delivery device1is sealed within the sealed container8, which includes a base portion10, that may be plastic, and a removable cover portion12. In this configuration, the drug delivery device1and sealed container8have yet to be sterilized. Because the device1and container8have yet to be sterilized, there is no liquid drug in the device1. The removable cover portion12may include a second self-healing seal14which can be positioned substantially aligned with the fill port2of the drug delivery device1. An alignment ring3may be disposed on a surface of the cover portion12that is facing the device1and interior of the base portion8. The alignment ring3is disposed between the first self-healing seal2and the second self-healing seal14, and may be positioned about the first self-healing seal2and/or the second self-healing seal14. The alignment ring3may include geometry that substantially aligns the first self-healing seal2with the second self-healing seal14. For example, the alignment ring3may be adhered to the cover portion12and include a circular lip that acts as a border around the first self-healing seal2such that the first and second self-healing seals2and14substantially align. The alignment ring3may instead, for example, be adhered to the underside of the device1and about the first self-healing seal2, and may include geometry that holds the second self-healing seal14substantially aligned with the first self-healing seal2.FIG. 4illustrates a top view of the sealed container8showing the position of the second self-healing seal14within the cover portion12. WhileFIGS. 3 and 4illustrate the seals2and14aligned with/through the cover12, in various embodiments the seals2and14may instead be aligned with/through the base portion10. For example, the device1and packaging (e.g., base portion10and cover12) may be positioned on an edge of the base portion10, and the seals2and14may be aligned with/through a side of the base portion rather than through the cover12. Such positioning of the device1and packaging may allow for efficient packaging in a sterility tub.

In various embodiments described here or otherwise within the scope of the present disclosure, a removable cover portion of a sealed container may be gas permeable, but not permeable to microbes, spores, and the like such that an aseptic barrier is maintained. Such materials for the removable cover portion may include polyurethane or the like. A cover portion may be welded or otherwise adhered to a base portion to form a container. The cover portion may seal a device within a container while the container and the contained device are subjected to sterilization. Should the container be subjected to a non-sterile atmosphere, the contained device will remain sterile.

With reference toFIG. 5, an illustrated partial cross-section view of an embodiment of a drug delivery device1according to the present disclosure is within the sealed container including the cover portion12. This illustration is an example alignment of the second self-healing seal14with the fill port2and the first self-healing seal6. In this view, the fill port2is fluidly coupled to a fluid reservoir16disposed within the drug delivery device1. A fill path18of a fill receiver20(not illustrated inFIG. 4) is illustrated in the fill position such that the needle portion21has pierced the first and second self-healing seals6and14, and is in fluid communication with the reservoir16. In some embodiments, the fill path18comprises a filling needle. The fill receiver20and fill path18may reversibly translate into the first and second self-healing seals6and14to fluidly couple the fluid path18to the reservoir16such that sterility of the device1is maintained and a fluid cannot pass through the first and second self-healing seals6and14. In various embodiments, the self-healing seals6and14may abut each other and may be adhered to each other.

In the illustrated position ofFIG. 5, the contained device1, cover portion12, and fill receiver20are ready for sterilization. In this position, the desired sterilization medium may flow about and through the permeable cover portion12and into and about the device1. The sterilization medium may also flow about and through the fill receiver20and fill path18and into the reservoir16. The result of sterilizing the components ofFIG. 5in this position is a device1, packaging (including the cover12and base portion of a container (not shown)), fill receiver20, and reservoir16that are all sterilized and ready to receive a liquid drug (e.g., insulin).

In the illustrated position ofFIG. 5, the sterilized fill receiver20and fluid reservoir16are ready for filling. A desired amount of liquid drug may be supplied (e.g., pumped) into the reservoir16via the fill path18of the fill receiver20. Once filling is complete the fill path18can be withdrawn, and the first and second self-healing seals6,14re-seal, maintaining the sterility of the device1and the interior of the sealed container8.

With reference toFIGS. 6 and 7, cross-section views of embodiments of exemplary fill receivers20according to the present disclosure are illustrated. The fill receiver20ofFIG. 6includes multiple sealing protrusions22disposed on an inner surface thereof for sealing against an outer surface of a fill nozzle24of a liquid drug dispensing system (not shown). The sealing protrusions22may be compressible to accommodate and provide a tight fit with the fill nozzle. The sealing protrusions22may instead be, e.g., O-rings or the like. Although not shown, it will be appreciated that the fill nozzle24may be coupled to a programmable robot which may position the fill nozzle24in substantial alignment with the fill receiver20of one or more drug delivery devices. The fill receiver20ofFIG. 7includes the aforementioned sealing protrusions22on an inner surface thereof for sealing against a fill nozzle (not shown inFIG. 7) of a fill station. The fill receiver20of this embodiment further includes a one-way valve26. In the illustrated embodiment, the one-way valve26includes a ball28for sealing an opening30of the fill receiver20. The ball28is pressed into engagement with a seat surrounding the opening30by a spring32. As will be appreciated, the one-way valve26may allow fluid to flow through the fill receiver20into the fill path18(by forcing the ball downward, out of engagement with the seat), but will prevent fluid from flowing in the reverse direction. It will be appreciated that any other appropriate one-way valve could be used in lieu of a ball valve.

With reference toFIG. 8, an embodiment of a method according to the present disclosure is illustrated. At step100, the fluid reservoir16of a drug delivery device1is in an empty configuration (i.e., no liquid drug is present), and the drug delivery device1is disposed within a sealed container8. A first self-healing seal6of the device1may be aligned with a second self-healing seal14of the container8. At step110, a fill path18is fluidly coupled to the reservoir16of the drug delivery device1. The fill path18may be disposed through a first self-healing seal6and a fill port2in the drug delivery device1and through a second self-healing seal14in the cover portion12of the sealed container8. The fill path18may be part of a fill receiver20. The fill receiver20may be configured to interface with a fill nozzle (not shown) for receiving liquid drug therefrom. In some embodiments, the fill receiver20includes a one-way valve26for sealing the fill path18after the reservoir16has been filled with liquid drug.

At step120, the drug delivery device1, coupled with the fill path18of the fill receiver20, is placed into a tub. In some embodiments, multiple sealed devices1with associated fill paths18, fill receivers20, and containers8can be placed into a single tub to be sterilized together. Multiple assemblies of the devices1, containers8, fill paths18, and fill receivers20may be arranged in the tub with spacing and positioning for sterilization and filling. At step130, the tub is sealed. At step140, the drug delivery devices1within the tub are subjected to terminal sterilization (e.g., ethylene oxide (EO), steam, gamma radiation, or the like). At step150, the sterile sealed tub is sent for aseptic filling. In some embodiments, the same environments and equipment used for aseptic filling of cartridges and vials is used to aseptically fill the drug delivery device(s)1.

At step160, the tub enters an aseptic environment and is cleaned. At step170the tub is unsealed and the drug delivery devices1therein are made available for filling. The drug delivery devices1may be arranged in a known and locatable manner within the tub such that a robot arm coupled to a fill nozzle24can be programed and/or operated to easily locate a fill path (i.e., second self-healing seal14, fill port2, and/or fill path18) of each drug delivery device1in the tub.

At step180the fill nozzle24interfaces with the fill path18of a targeted drug delivery device1and supplies fluid (drug) into the empty fluid reservoir16of the device1. A plunger88of the reservoir16moves as fluid is supplied to the reservoir16to a filled position. The plunger88may vary its position to control a volume of a fluid within the reservoir16. It will be appreciated that the position will be variable based on a desired fill volume.

At step190filling is complete and the fill receiver20(including fill path18) is disengaged from the drug delivery device1by removing (e.g., pulling) the fill path18through the first and second self-healing seals6and14. Removing the fill path18through the first and second self-healing seals6and14will not compromise the integrity of the sealed container8or the device1. The result is a pre-filled, sterilized drug delivery device1in its sterile packaging (sealed container8).

Certain embodiments of the present disclosure are described herein. It is, however, expressly noted that the present disclosure is not limited to these embodiments, but rather the intention is that additions and modifications to what is expressly described herein are also included within the scope of the disclosure. Moreover, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations are not made expressly herein, without departing from the spirit and scope of the disclosure. In fact, variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the disclosure. As such, the disclosure is not to be defined only by the illustrative description.