WO2021255045A1

WO2021255045A1 - Administering medicament

Info

Publication number: WO2021255045A1
Application number: PCT/EP2021/066148
Authority: WO
Inventors: Irio Giuseppe Calasso; Matteo De Donatis; Nadine TROES; Tommaso Borghi; Marco PIRINOLI
Original assignee: Stevanato Group S.P.A.; Nuova Ompi S.R.L. Unipersonale
Priority date: 2020-06-15
Filing date: 2021-06-15
Publication date: 2021-12-23

Abstract

A system includes a medicament cassette and a medicament delivery device. The medicament cassette includes a cassette body; a cartridge positioned within the cassette body, the cartridge comprising a medicament; and a lock. The lock blocks an access port of the cartridge. The medicament delivery device includes an opening configured to receive the medicament cassette; a key configured to unlock the lock of the medicament cassette; a fluid pathway; a needle coupled to the fluid pathway at a first end of the fluid pathway; and a cannula coupled to the fluid pathway at a second end of the fluid pathway, the cannula being configured to be inserted into a patient.

Description

ADMINISTERING MEDICAMENT

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Application Serial No. 63/039,368, filed on June 15, 2020, which is incorporated by reference herein in its entirety.

TECHNICAL FIELD

This disclosure relates to the administration of a medicament using a delivery device.

BACKGROUND

Certain medical conditions require that a patient receive continuous or periodic administration of medicaments. These medicaments are often provided as liquid solutions to be injected transdermally, intramuscularly, or intravenously. For example, diabetic patients may require insulin infusions at regular intervals. In an effort to facilitate these infusions, various portable medicament delivery devices have been developed.

When using these delivery devices, a patient’s access to certain medicaments, such as narcotic substances used for medical treatment, needs to be restricted in order to avoid uncontrolled access to the medicine and substance abuse. Standard reservoirs for pharmaceuticals used with these delivery devices, such as glass cartridges or other containers prefilled with medicaments, however do not restrict a person from freely accessing the medicament. For example, many standard prefilled medicament cartridges can be accessed by simply inserting a needle connected to a syringe into the cartridge to extract the medicament from the cartridge. In addition, such standard reservoirs do not offer any tamper evidence to indicate whether a person has attempted to access the medicament in an unauthorized manner.

In addition, many portable dispenser devices require that a user transfer medicament from a sterile vial into a container inside the portable dispenser device using a syringe or special apparatus. While the vials containing the medicament are typically sterile, such sterility is difficult to maintain during transfer of the medicament from the vial to the portable dispensing device. SUMMARY

In an example implementation, a medicament cassette device includes a cassette body defining an opening configured to receive a medicament cartridge containing medicament; and a lock within the cassette body moveable between a locked position and an unlocked position, wherein the lock blocks an access port of a medicament cartridge positioned within the opening of the cassette body when the lock is positioned in the locked position.

In an aspect combinable with the example implementation, the lock includes two or more magnets movable between the locked position and the unlocked position.

In another aspect combinable with any of the previous aspects, the magnets include magnetic disks each including an opening therethrough, the opening in each of the magnetic disks are misaligned when the lock is in a locked position.

In another aspect combinable with any of the previous aspects, the openings through each of the magnetic disks are aligned and the access port of the medicament cartridge is exposed when the lock is in an unlocked position; and unlocking the lock includes applying a magnetic field to the lock.

In another aspect combinable with any of the previous aspects, the magnetic disks include a top disk including a first north pole and a first south pole, the top disk defining a first opening through the south pole of the top disk; and a bottom disk including a second north pole and a second south pole, the bottom disk defining a second opening through the second south pole of the bottom disk; and the first south pole of the top disk is misaligned with the second south pole of the bottom disk when the lock is positioned in a locked position.

In another aspect combinable with any of the previous aspects, applying the magnetic field to the lock causes at least one of the top disk or the bottom disk to rotate to align the first opening and the second opening.

In another aspect combinable with any of the previous aspects, the medicament cassette device further includes a cap, wherein the lock is positioned within the cap; and a seal positioned between the medicament cartridge and the cap when the medicament cartridge is inserted into the opening defined by the cassette body.

In another aspect combinable with any of the previous aspects, the lock includes a mechanical lock that covers the access port of the medicament cartridge when the lock is positioned in a locked position. In another aspect combinable with any of the previous aspects, the lock is a first lock; and the cassette device further includes a second lock positioned within the cassette body opposite the first lock.

In another aspect combinable with any of the previous aspects, the medicament cassette device further includes a plunger configured to pump the medicament out of the medicament cassette device.

In another example implementation, a system includes a medicament cassette device and a medicament delivery device including a device body configured to reside apart from the medicament cassette device and couple to the medicament cassette device. The medicament cassette device includes a cassette body; and a lock within the cassette body configured to block an access port of a medicament cartridge positioned within the cassette body when the lock is positioned in a locked position. The medicament delivery device is configured to deliver medicament contained within the medicament cartridge to a patient.

In an aspect combinable with the example implementation, the lock includes two or more magnets each comprising an opening therethrough, the opening in each of the magnets being misaligned when the lock is in a locked position.

In another aspect combinable with any of the previous aspects, the openings through each of the two or more magnets are aligned and the access port of the medicament cartridge is exposed when the lock is in an unlocked position; and unlocking the lock comprises applying a magnetic field to the lock to cause at least one of the two or more magnets to rotate to align each of the openings.

In another aspect combinable with any of the previous aspects, the magnetic field is generated by the medicament delivery device.

In another aspect combinable with any of the previous aspects, coupling the medicament cassette device to the medicament delivery device causes the medicament delivery device to automatically generate the magnetic field.

In another aspect combinable with any of the previous aspects, the medicament delivery device includes a needle; and the medicament contained within the medicament cartridge is accessed by inserting the needle of the medicament delivery device through the openings through each of the two or more magnets when the lock is in an unlocked position. In another example implementation, a method includes coupling a medicament cassette device to a medicament delivery device, the medicament cassette device including a cassette body; and a lock within the cassette body configured to block an access port of a medicament cartridge positioned within the cassette body when the lock is positioned in a locked position; and unlocking the lock using the medicament delivery device.

In an aspect combinable with the example implementation, unlocking the lock using the medicament delivery device includes generating a magnetic field using the medicament delivery device.

In another aspect combinable with any of the previous aspects, the lock includes two or more magnets each comprising an opening therethrough; and unlocking the lock includes generating a magnetic field by the medicament delivery device to cause at least one of the two or more magnets to rotate to align the openings through each of the two or more magnets.

In another aspect combinable with any of the previous aspects, the method further includes inserting a needle of the medicament delivery device through the openings through each of the two or more magnets when the lock is in an unlocked position.

In another example implementation, a method includes determining that a cartridge including a medicament is positioned within a body of a medicament delivery device; detecting, using a sensor of the medicament delivery device, that the medicament delivery device is positioned in a priming position; and in response to detecting that the medicament delivery device is positioned in a priming position: causing an indicator on the medicament delivery device to indicate that the medicament delivery device is positioned in the priming position; and priming a fluid path contained within the medicament delivery device.

In an aspect combinable with the example implementation, the method further includes in response to detecting that priming the fluid path is complete, causing the indicator on the medicament delivery device to indicate that priming of the medicament delivery device is complete.

In another aspect combinable with any of the previous aspects, the indicator on the medicament delivery device includes a light emitting diode (LED) visible from an exterior of the body of the medicament delivery device; causing the indicator to indicate that the medicament delivery device is positioned in the priming position includes causing the LED to operate in a first manner; and causing the indicator to indicate that priming of the medicament delivery device is complete includes causing the LED to operate in a second, different manner.

In another aspect combinable with any of the previous aspects, the method further includes in response to determining that the cartridge is positioned within the body of the medicament delivery device, causing the indicator on the medicament delivery device to indicate that the medicament delivery device is activated.

In another aspect combinable with any of the previous aspects, causing the indicator on the medicament delivery device to indicate that the medicament delivery device is activated includes causing the LED to operate in a third manner.

In another aspect combinable with any of the previous aspects, a needle of the medicament delivery device is prevented from deploying until priming of the medicament delivery device is complete.

In another aspect combinable with any of the previous aspects, the fluid path of the medicament delivery device is primed based at least partly on a user engaging a control of the medicament delivery device.

In another aspect combinable with any of the previous aspects, priming the fluid path contained within the medicament delivery device includes forcing a predetermined volume of the medicament out of the cartridge and through the fluid path contained within the medicament delivery device.

In another aspect combinable with any of the previous aspects, positioning the medicament delivery device in the priming position includes rotating the medicament delivery device into an upright position.

In another aspect combinable with any of the previous aspects, the sensor is configured to detect movement of the medicament delivery device or a position of the medicament delivery device.

In another aspect combinable with any of the previous aspects, the sensor is at least one of an accelerometer, a gyroscope, a tilt sensor, or a tilt ball switch.

In another example implementation, a medicament delivery device includes a device body defining an opening for receiving a medicament cartridge; a sensor configured to detect when the device body is in a priming position; and an indicator configured to indicate when the device body is in the priming position. In an aspect combinable with the example implementation, the sensor includes at least one of an accelerometer, a gyroscope, a tilt sensor, or a tilt ball switch.

In another aspect combinable with any of the previous aspects, the indicator is further configured to indicate when a process of priming the medicament delivery device is complete.

In another aspect combinable with any of the previous aspects, the indicator includes a light emitting diode (LED) visible from an exterior of the device body.

In another aspect combinable with any of the previous aspects, the LED is configured to operate in a first manner to indicate that the medicament delivery device is positioned in a priming position; and the LED is configured to operate in a second, different manner to indicate when a process of priming of the medicament delivery device is complete.

In another aspect combinable with any of the previous aspects, the indicator is further configured to indicate when the medicament cartridge has been inserted into the device body.

In another aspect combinable with any of the previous aspects, the medicament delivery device further includes a second sensor configured to detect when the medicament cartridge has been inserted into the device body.

In another aspect combinable with any of the previous aspects, the medicament delivery device further includes a controller communicably coupled to the sensor and configured to control the indicator to indicate when the device body is in the priming position based at least partly on one or more signals received from the sensor.

In another example implementation, a system includes a medicament cartridge containing a medicament; and a medicament delivery device. The medicament delivery device includes a device body defining an opening for receiving the medicament cartridge; a sensor configured to detect when the device body is in a priming position; and an indicator configured to indicate when the device body is in the priming position.

In another example implementation, a method includes inserting a medicament cartridge containing medicament into a medicament delivery device; placing the medicament delivery device containing the medicament cartridge in a sterilization chamber; and introducing sterilization gas into the sterilization chamber.

In an aspect combinable with the example implementation, the method further includes limiting movement of a plunger of the medicament cartridge within the medicament cartridge while introducing sterilization gas into the sterilization chamber, wherein limiting movement of the plunger of the medicament cartridge within the medicament cartridge comprises controlling at least one of a pressure within the sterilization chamber, a temperature within the sterilization chamber, or a length of time performing sterilization to limit movement of the plunger within the medicament cartridge.

In another aspect combinable with any of the previous aspects, limiting movement of the plunger of the medicament cartridge within the medicament cartridge comprises limiting movement of the plunger within the medicament cartridge below a specified threshold distance

In another aspect combinable with any of the previous aspects, the plunger includes a plurality of ribs; and the threshold distance is less than a distance between two adjacent ribs of the plunger

In another aspect combinable with any of the previous aspects, the distance between the two adjacent ribs of the plunger is in a range of 0.5 mm to 4 mm.

In another aspect combinable with any of the previous aspects, the plunger includes a plurality of ribs; and the threshold distance is less than a width of a rib of the plurality of ribs.

In another aspect combinable with any of the previous aspects, the width of the rib is 1 mm.

In another aspect combinable with any of the previous aspects, limiting movement of the plunger of the medicament cartridge within the medicament cartridge includes positioning a fixed piston adjacent the plunger prior to introducing sterilization gas into the sterilization chamber.

In another aspect combinable with any of the previous aspects, limiting movement of the plunger of the medicament cartridge within the medicament cartridge includes positioning a spacer between the plunger and a fixed piston prior to introducing sterilization gas into the sterilization chamber.

In another aspect combinable with any of the previous aspects, limiting movement of the plunger of the medicament cartridge within the medicament cartridge includes positioning a spacer coupled to a lever between the plunger and a piston prior to introducing sterilization gas into the sterilization chamber, the lever limiting movement of the spacer during sterilization.

In another aspect combinable with any of the previous aspects, the medicament delivery device is not sterilized prior to inserting the medicament cartridge into the medicament delivery device. In another aspect combinable with any of the previous aspects, the medicament cartridge is inserted into the medicament delivery device under non-aseptic conditions.

In another aspect combinable with any of the previous aspects, introducing sterilization gas into the sterilization chamber sterilizes a fluid path of the medicament delivery device and a septum covering an access port of the medicament cartridge.

In another example implementation, a system includes a medicament delivery device including a device body; a medicament cartridge containing a medicament and configured to be inserted into the medicament delivery device, the medicament cartridge including a plunger; and a sterilization chamber configured to receive the medicament delivery device containing the medicament cartridge, wherein movement of the plunger within a body of the medicament cartridge is limited during gas sterilization of the medicament delivery device containing the medicament cartridge inside the sterilization chamber.

In an aspect combinable with the example implementation, limiting movement of a plunger of the medicament cartridge within the medicament cartridge includes controlling at least one of a pressure within the sterilization chamber, a temperature within the sterilization chamber, or a length of time performing sterilization to limit movement of the plunger within the medicament cartridge.

In another aspect combinable with any of the previous aspects, the system further includes a fixed piston adjacent the plunger prior to introducing sterilization gas into the sterilization chamber, wherein the fixed piston is configured to prevent movement of the plunger during sterilization.

In another aspect combinable with any of the previous aspects, the system further includes a spacer between the plunger and a fixed piston prior to introducing sterilization gas into the sterilization chamber, wherein the space and the fixed piston are configured to prevent movement of the plunger during sterilization.

In another aspect combinable with any of the previous aspects, the system further includes a spacer coupled to a lever positioned between the plunger and a piston prior to introducing sterilization gas into the sterilization chamber, the lever being configured to limit movement of the spacer during sterilization. In another aspect combinable with any of the previous aspects, introducing sterilization gas into the sterilization chamber sterilizes a fluid path of the medicament delivery device and a septum covering an access port of the medicament cartridge.

In another example implementation, a method includes positioning a medicament cartridge containing medicament into a medicament delivery device; positioning the medicament delivery device containing the medicament cartridge in a sterilization chamber; and introducing sterilization gas into the sterilization chamber, wherein displacement of a plunger of the medicament cartridge is limited during sterilization by controlling at least one of a pressure within the sterilization chamber, a temperature within the sterilization chamber, or a length of time performing sterilization.

The details of one or more implementations of the subject matter described in this disclosure are set forth in the accompanying drawings and the description below. Other features, aspects, and advantages of the subject matter will become apparent from the description, the drawings, and the claims.

DESCRIPTION OF DRAWINGS

FIG. l is a half cross-sectional schematic of an example medicament cassette containing a cartridge.

FIGS. 2A and 2B are detail, schematic illustrations of an example lock of the medicament cassette of FIG. 1, where FIG. 2 A shows the lock closed and FIG. 2B shows the lock open.

FIG. 3 is a top view of an example delivery device for administering the medicament contained in the medicament cassette of FIG. 1.

FIG. 4 is an example process for administering medicaments using the medicament cassette of FIG. 1.

FIG. 5 is a series of half cross-section schematics illustrating an example process of attaching the medicament cassette of FIG. 1 to a delivery device.

FIGS. 6A-6C are illustrations of an example process for priming a delivery device used to administer medicaments contained in the medicament cassette of FIG. 1.

FIG. 7 is a half cross-sectional schematic of an example medicament delivery system.

FIG. 8 is a half cross-sectional schematic of the delivery system of FIG. 7 illustrating an example process for administering medicaments. FIGS. 9A-9C are illustrations of an example process for priming a delivery device used to administer medicaments.

FIG. 10 is an illustration of an example process for sterilizing a delivery device used to administer medicaments.

FIGS. 11, 12, 13A, and 13B are illustrations of example medicament cartridges and example devices for controlling movement of a plunger within the example medicament cartridges during a sterilization process.

DETAILED DESCRIPTION

This specification encompasses devices, systems, and methods for administering a medicament to a patient. In particular, this specification encompasses administering a medicament to a patient using a cassette that prevents uncontrolled access to the medicament.

FIG. 1 is an illustration of an example cassette 100 for housing a medicament. The cassette 100 includes a cassette body 102, a cap 104, a plunger 106, and a protective foil 112 covering the cap 104.

As can be seen in FIG. 1, the cassette 100 is configured to house a medicament cartridge 108 within the cassette body 102. The cartridge 108 is configured to house a medicament to be distributed to a patient using a drug delivery device (such as device 300 of FIG. 3). While the medicament can be nearly any medicament in liquid form, in some implementations, the cartridge 108 houses a narcotic medicament discussed above as requiring special measures to prevent uncontrolled access to the narcotic. The cartridge 108 can take many forms. In some implementations, the cartridge 108 is a glass vial or plastic vial. In some implementations, the cartridge 108 is provided as a foil bag. As depicted in FIG. 1, the cartridge 108 includes an access port 122 through which the medicament contained within the cartridge 108 can be accessed.

As can be seen in FIG. 1, the cartridge 108 also includes a rigid head 138 that interfaces with the cap 104 of the cassette 100. In some implementations, the head 138 of the cartridge 108 defines a profile that is configured to be inserted into the cap 104 of cassette 100, and the fit between the head 138 of the cartridge 108 and the cap 104 of the cassette 100 attaches and seals the cartridge 108 to the cassette 100. In some implementations, the head 138 of the cartridge 108 and the cap 104 of the cassette 100 are attached using a suitable attachment method, such as a friction fit, a snap fit, a magnetic attachment, an adhesive, etc.

The cassette body 102 can take many different forms. In some implementations, the cassette body 102 is entirely or partially composed of one or more transparent materials, such as glass or plastic or another transparent material, to allow for a person to view the cartridge 108 within the cassette 100. In some implementations, the cassette body 102 is opaque metal, plastic, glass or other material and includes a transparent viewing window to allow for visibility of the cartridge 108 within the cassette 100.

As depicted in FIG. 1, in some implementations, the cassette body 102 is entirely cylindrical, extending along a longitudinal axis. But, other configurations are within the concepts herein. In some implementations, the cassette body 102 is sized and shaped such that the cassette 100 can only be inserted into a specified delivery device (e.g., delivery device 300 of FIG. 3). In other instances, the cassette 100 can be more universal, fitting multiple different configurations of delivery devices. In some implementations, the exterior of the cassette body 102 is asymmetric and/or includes ribs or another feature that allow for the insertion of the cartridge into the drug delivery device only in a specific orientation. In some implementations, as depicted in FIG. 1, the cassette body 102 is sized such that it encompasses the entire cartridge 108. In some implementations, the cassette body 102 may be configured to cover only a portion of the cartridge 108.

In some implementations, the cassette 100 is configured to couple to specific types of cartridges 108. In other instances, the cassette 100 can be more universal, fitting multiple different sizes and configurations of cartridges 108.

As depicted in FIG. 1, in some implementations, the cartridge 108 includes a moveable plunger 106 for ejecting fluid from the cartridge 108. The plunger 106 can be actuated by a driving unit of a drug delivery device (e.g., delivery device 300 of FIG. 3) to force fluid out of the cartridge 108 and into the fluidic pathway of the delivery device. In some implementations, the plunger 106 is made of or contains a hard material, such as a hard rubber, glass, metal, or plastic, in order to prevent access to the medicament contained within the cartridge 108 from the plunger side 114 of the cartridge 108. For example, the plunger 106 can be made of a material having a hardness sufficient to prevent a user from piercing through the plunger 106 with a needle attached to a syringe to access the contents of the cartridge 108. The plunger 106 can be configured to distribute the force applied to the fluid within the cartridge 108 evenly in order to reduce frictional forces.

In some implementations, a protective covering 116 is provided at the plunger end 114 of the cassette 100 to prevent unauthorized access to the contents of the cartridge 108 through the plunger end 114 of the cassette 100 (e.g., via piercing the plunger 106 with a needle). The protective covering 116 can be made of a hard material in order to prevent a user from piercing through the protective covering 116 with a needle attached to a syringe and penetrating the plunger 106 to access the contents of the cartridge 108. The protective covering 116 can be configured to distribute the force applied to the plunger 106 within the cartridge 108 evenly in order to increase dose accuracy. The protective covering can be configured to have an attachment (not show in the figure) to interlock with the driving unit of the drug delivery device.

Still referring to FIG. 1, in some implementations, the cassette 100 includes a protective foil 112 that covers the cap end 118 of the cassette 100. The foil 112 is designed to maintain sterility of the cassette 100 and the medicaments contained within the cartridge 108 inside the cassette 100. For example, the protective foil 112 can be configured to maintain aseptic sterility of the end and interior of the cassette 100 and the medicament contained therein by sealing off access to the access port 122 of the cartridge 108. The protective foil 112 can be formed of any suitable material, such as plastic, aluminum, aluminum composites, or another material. In some examples, the foil 112 is nonwoven polymer fiber foil, such as Tyvek^®, a registered trademark of DuPont de Nemours, Inc. In some implementations, the protective foil 112 is composed of material that is permeable to sterilization fluids, such as ethylene oxide (ETO), nitrogen oxide (NO2), vaporized hydrogen peroxide (VHP), or supercritical carbon dioxide (sCCk). In some implementations, the protective foil 112 is composed of material that is impermeable to sterilization gasses. As will be described in further detail herein, in some implementations, the protective foil 112 is removed prior to insertion of the cassette 100 into a drug delivery device.

In some implementations, the cassette 100 includes a seal 120 that is positioned between the cartridge 108 and the cap 104 (e.g., between the head 138 of the cartridge 108 and the cap 104). As can be seen in FIG. 1, seal 120 establishes a closed volume around the access port 122 of the cartridge 108 and prevents (entirely or to limit to a specified degree) contamination of the sterility of the volume chamber between the protective foil 112 and the access port 122 of the cartridge 108. Seal 120 also helps prevent (entirely or limit to a specified degree) leakage of the medicament out of the cartridge 108 into the cassette body 102. Seal 120 can include any suitable type of seal 120, and in some implementations, is an O-ring seal, a flat gasket, or another type of seal.

As can be seen in FIG. 1, the cap 104 of the cassette 100 includes a lock 110 for preventing unauthorized access to the medicaments contained with the cartridge 108. In some implementations, the lock 110 is configured to be opened by a key provided by a corresponding portable drug delivery device (such as delivery device 300 of FIG. 3). For example, as depicted in FIG. 1, the cassette 100 can include a lock 110 that blocks the access port 122 of the cartridge 108 when closed, i.e., locked, and a drug delivery device configured to be used in conjunction with the cassette 100 can include a key to open, i.e., unlock, the lock 110 of the cassette 100. As will be described in further detail herein, the delivery device can include a key that interacts with the lock 110 such that portions of the lock 110 are rearranged to form an opening through the lock 110. Once open, the lock 110 exposes the access port 122 of the cartridge 108, allowing the medicament contained within the cartridge 108 to be administered to a patient using the drug delivery device attached to the cassette 100.

Referring to FIGS. 1, 2 A, and 2B, in some implementations, the lock 110 in the cap 104 of the cassette 100 includes a pair of magnetic disks 124, 126 that are arranged in series within the cap 104. As can be seen in FIG. 2A, each of the disks 124, 126 is polarized to include two poles: a north pole 130, 132 and a south pole 134, 136. In addition, each of the disks 124, 126 includes an opening 140, 142 through its south pole 134, 136. When the lock 110 is not subjected to a magnetic field, the south pole 134 of the top disk 124 is attracted to the north pole 132 of the bottom disk 126. As a result, the openings 140, 142 through the disks 124, 126 are misaligned, which causes the disks 124, 126 to block the access port 122 of the cartridge 108, as depicted in FIGS. 1 and 2 A.

In order open the lock 110 of the cassette 100, a particular magnetic field is applied to the lock 110, which causes the disks 124, 126 to rotate to align each of the openings 140, 142 therethrough and expose the access port 122 of the cartridge 108, as depicted in FIG. 2B. For example, as depicted in FIG. 2B, the medicament delivery device 200 can generate a magnetic field 210 with a south polarity positioned on opposite sides of the delivery device 200 proximate the disks 124, 126 of the lock 110 when the cassette 100 is inserted into the medicament delivery device 200. Due to the magnetic field 210 generated by the medicament delivery device 200 and the alignment of the poles 130, 132, 134, 136 of the disks 124, 126, one of disks 124, 126 of the lock 110 (e.g., the bottom disk 126) rotates to align its north pole 132 with the south magnetic field 210 generated by the delivery device 200, while the other disk 124, 126 (e.g., the top disk 124) remains stationary since its north pole 130 is already aligned with the south magnetic field 210 generated by the delivery device 200. As a result, the south poles 134, 136 of each of the disks 124, 126 are aligned with one another and the openings 140, 142 through each of the disks 124, 126 are aligned. As depicted in FIG. 2B, the access port 122 of the cartridge 108 is exposed through the aligned openings 140, 142 in the disks 124, 126, and can then be accessed by a needle or other fluid pathway of the delivery device 200 through the openings in the disks 124, 126 of the lock 110.

By requiring the application of a particular magnetic field to align the openings 140, 142 through the disks 124, 126 and expose the access port 122 of the cartridge 108, the lock 110 effectively prevents access to the medicament stored within the cartridge 108 prior to insertion of the cassette 100 into a delivery device. In some implementations, a controller of the delivery device 200 (e.g., controller 312 of FIG. 3) can be used to control the magnetic field 210 generated by the delivery device 200. Thus, a controller of the delivery device 200 can be used to control opening and closing of the lock 110, and, as result, can control access to the medicament stored within the cartridge 108.

While the lock 110 is depicted as including two disks 124, 126, three or more disks may be used to form the lock 110 of the cassette 100. By increasing the number of magnetic disks used to form the lock 110, the complexity of the magnetic field that must be applied to open the lock 110 can be increased, thus increasing the difficulty for a user to open the lock 110 outside of the medicament delivery device 200 and gain unrestricted access to the medicament contained within the cartridge 108.

In addition, while the lock 110 has been depicted as being formed of magnetic disks, in some implementations, the lock 110 is a mechanical mechanism that is opened using a mechanical key inside a drug delivery device. For example, the lock 110 can include a mechanical lock that covers the access port 122 of the cartridge when in a locked state. Upon insertion of the cassette 100 into a drug delivery device (such as device 300 of FIG. 3), a key within the drug delivery device interfaces with and mechanically unlocks the lock 110, which exposes access port 122 of the cartridge 108 such that the cartridge can be accessed by a needle and can be connected to a fluid pathway of the delivery device. Yet other configurations of lock 110 are contemplated herein.

In some implementations, the cassette 100 does not include a protective foil, and the lock 110 is configured to seal the cassette 100 and maintain sterility.

While the cassette 100 has been described as having a lock on a single end of the cassette 100, in some implementations, a lock is provided on both ends of the cassette 100.

The cassette 100 can be implemented in many different types of drug delivery devices, including wearables, injection pens, syringes and other types of devices. For convenience of discussion, FIG. 3 depicts an example delivery device 300 for delivering the medicament contained within the cassette 100, and in particular a wearable drug delivery device. As depicted in FIG. 3, in some implementations, the delivery device 300 includes an adhesive component 302 for attaching the delivery device 300 to the skin of a patient. The delivery device 300 can be a disposable delivery system, an assembly of disposable and reusable components, or a fully reusable delivery system. For example, as depicted in FIG. 3, the delivery device 300 can include a disposable component 306 and a reusable component 308. The delivery device 300 can be either fully assembled or partially assembled prior to usage. The delivery device 300 can be configured to inject a medicament into a patient subcutaneously, intravenously, or intramuscularly.

In some implementations, the delivery device 300 is configured to automatically insert a needle or cannula into the patient upon application of the device to the patient’s skin. In some implementations, the delivery device 300 is configured to conduct priming of the fluid pathways of the delivery device automatically upon initialization of the device 300.

In some implementations, the delivery device 300 includes a spring-loaded door 304 that remains open until a cassette 100 is properly inserted within the delivery device 300.

The delivery device 300 includes one or more fluid pathways (e.g., fluid pathway 512 of FIG. 5) that are configured to couple to a cassette 100 and facilitate flow of the medicament from within the cartridge 108 of the cassette 100, through the delivery device 300 to the patient. In some implementations, the delivery device 300 includes a motor configured to drive the plunger 106 to push fluid and/or to drive a pump to draw fluid out of the cartridge 108 and through the fluid pathways of the delivery device 300 to the patient. In some embodiments, the delivery device 300 is a passive device (i.e., a device that does not include an energy source, such as a battery, to operate the delivery device 300 and deliver the medicament to the patient). In some embodiments, the delivery device 300 is a semi-passive device that requires at least some energy to be provided by an external source, such as from a handheld implement, to operate the delivery device 300 and/or pump the medicament through the delivery device 300 into the patient.

In some implementations, the delivery device 300 is configured to administer medicament according to a basal profile. In some implementations, the delivery device 300 can provide on-demand bolus injections of the medicament. In some implementations, the delivery device 300 is configured to control bolus injections to prevent multiple consecutive bolus deliveries.

In some implementations, the delivery device 300 includes an LED indicator 310 that can be used to indicate one or more steps of the medicament administration process (e.g., initialization, normal operation, empty cartridge, device removal). In some implementations, the delivery device 300 includes a rechargeable battery and one or more electronic components. In some implementations, the delivery device 300 is waterproof.

In some implementations, the reusable component 308 includes a controller 312 coupled to and controlling one or more components of the delivery device 300. For example, the controller 312 can be used to control the motor of the delivery device 300 in order to control the delivery of medicament into the patient in response to detecting that the delivery device 300 is primed for delivery. In addition, the controller 312 can be used to control the deployment of the needle or cannula of the delivery device 300 into the patient upon a priming phase of the delivery device 300 being completed. Further, the controller 312 can be used to control the LED indicator 310 to indicate the particular steps in the delivery device 300 initialization and priming process. The priming phase can be considered complete when, for example, based on determining that a certain internal procedure is completed, such as determining that a specific movement has been performed by a piston of the device (e.g., as sensed by the cradle), or after detecting that a certain amount of time has elapsed since a flow of medicament was activated, or based on a sensor detecting that the medicament has entered a particular portion of the flow path of the delivery device 300.

The controller 312 can include one or more processors with embedded or separate computer-readable medium storing instructions (such as delivery device control instructions and other instructions) executable by the one or more processors to perform the operations described herein (such as pump operations).

A process 400 of administering a medicament using a medicament cassette 100 with a delivery device will now be described with reference to FIGS. 1, 4, 5, 6A-6C, and 9A-9C.

Packaging containing the cassette 100 with a cartridge 108 prefilled with medicament (and any reusable components of the delivery device) is opened (402), and the cassette 100 and any disposable components of the delivery device are removed from the packing (404). The cassette 100 and any disposable components of the delivery device can be packaged together or separately. Upon removing the cassette 100 and any disposable components of the delivery device from the packaging, a user visually inspects the cassette 100 and the disposable components of the delivery device to ensure their integrity (406). For example, a user may visually inspect a protective foil 112 positioned over the cap 104 of the cassette 100 to confirm that the protective foil 112 is in place and undamaged. The user may also inspect a cannula of the delivery device to ensure that it is retracted and undamaged.

After visually inspecting the cassette 100 and disposable delivery device components and confirming their integrity, the user attaches the cassette to the drug delivery device (408). As depicted in FIG. 5, in some implementations, the cassette includes a protective foil 112 positioned over the cap 104 of the cassette 100, and the user removes the protective foil 112 prior to inserting the cassette 100 into the delivery device 500. In some implementations, the delivery device 500 includes a disposable component and a reusable component, and the cassette 100 is inserted into the disposable component of the delivery device 500. In some implementations, the delivery device 500 includes a springdoaded door 504 that is biased open, and attaching the cassette 100 to the delivery device 500 includes inserting the cassette 100 into an opening 502 within the delivery device 500 and closing the door 504 over the opening 502. As previously discussed, inserting the cassette 100 into the delivery device 500 can cause the delivery device 500 to automatically unlock the lock 110 of the cassette 100 to expose the access port 122 of the cartridge 108. For example, as depicted in FIG. 5, the delivery device 500 includes a key 210 (e.g., a magnetic field) that opens the lock 110 of the cassette 100. As previously described, a controller of the delivery device 500 (e.g., controller 312 of FIG. 3) can be used to control the key 210 (e.g., magnetic field) of the delivery device 500 in order to control access to the medicament contained within the cartridge 108. If the drug delivery device includes a reusable component and a disposable component, the user clamps the reusable component to the disposable component after inserting the cassette 100 into the disposable component of the delivery device (410)

Once the cassette 100 is attached to the delivery device 500 and the reusable and disposable components of the delivery device are coupled to one another, the infusion site is prepared (412), a liner covering an adhesive of the delivery device is removed (414), and the delivery device is attached to the skin of the patient (416).

Once the delivery device is attached to the patient’s skin, the delivery device is initialized

(418).

FIGS. 6A-6C depict an example initialization process for a delivery device 500. For example, as depicted in FIG. 6A, to initialize the delivery device 500, a needle 510 within the delivery device 500 connected to a fluid pathway 512 of the delivery device 500 is inserted through the access port 122 of the cartridge 108 to fluidly connect the cartridge 108 to the fluid pathway 512 of the delivery device 500. In some implementations, the cartridge 108 includes a septum covering the access port 122, and the needle 510 of the delivery device 500 pierces the septum to access the contents of the cartridge 108. In some implementations, the needle 510 of the delivery device 500 is arranged within the delivery device 500 such that inserting and pushing the cassette into the delivery device 500 causes the needle 510 of the delivery device 500 to push through the access port 122 of the cartridge 108. In some implementations, the delivery device 500 includes an mechanical mechanism, such as an actuator, a motor or a spring, that causes the needle 510 to move towards cartridge 108 such that the needle 510 is inserted through the access port 122 to establish a fluid connection between the cartridge 108 and the fluid pathway 512 of the delivery device 500. In some implementations, a piston of the cartridge 108 causes the cartridge 108 to move towards the needle 510 within the delivery device 500 until the needle 510 is inserted through the access port 122 of the cartridge 108. A controller (e.g., controller 312 of FIG. 3) of the delivery device 500 can be used to control an actuator, a motor, a spring, or a piston in order to cause the needle 510 to be inserted through the access port 122 and establish a fluid connection between the cartridge 108 and the fluid pathway 512.

As depicted in FIG. 6B, once the fluid pathway 512 of the delivery device 500 is fluidly connected to the cartridge 108, the fluid pathway is primed with medicament from the cartridge 108. In some implementations, the delivery device 500 confirms that a needle or cannula used for administering the medicament to the patient is not deployed prior to priming the fluid pathway 512 in order to avoid premature release of medicament outside the delivery device 500. In some implementations, a controller of the delivery device 500 (e.g., controller 312 of FIG. 3) can communicate with one or more sensors to detect whether the needle or cannula used for administration of the medicament to the patient has been deployed. In some implementations, the fluid pathway of the delivery device 500 is primed with a predefined volume of medicament from the cartridge 108.

FIG. 9A-9C depict another example process for initializing the delivery device and priming the fluid pathway of the delivery device. Referring to FIG. 9A, the delivery device 900 is activated by the user once a cassette containing a medicament cartridge (e.g., cassette 100 of FIG. 1) is inserted into the delivery device 900 (or if the delivery device 900 is prefilled, once the delivery device 900 is removed from its packing). An indicator on the delivery device 900 can be used to indicate the state of the delivery device 900. For example, indicator 902 can include one or more light emitting diodes (LEDs) and during activation of the delivery device 900, the LED(s) of indicator 902 display a first color, such as red, to indicate that the delivery device 900 is activated. In some implementations, a controller of the delivery device 900 (e.g., controller 312 of FIG. 3) can communicate with one or more sensors of the delivery device 900 to detect when a cassette has been inserted into the delivery device 900, and can control the LED indicator 902 to indicate that the delivery device 900 is activated.

Referring to FIG. 9B, once the delivery device 900 is activated, the user rotates the delivery device 900 to orient the delivery device 900 in an upright position 904 for priming. The LED 902 on the delivery device 900 flashes a second color, such as green, once the delivery device 900 is in the upright position 904 to indicate that the delivery device 900 is in the correct position for priming. In some implementations, the delivery device 900 includes a sensor 906 for detecting movement of the delivery device 900 or for detecting the position of the delivery device 900. The sensor 906 can include any suitable sensor for detecting motion, such as an accelerometer, a gyroscope, a tilt sensor, such as a tilt ball switch, etc. In some implementations, a controller of the delivery device 900 (e.g., controller 312 of FIG. 3) can communicate with the sensor 906 of the delivery device 900 to detect when the delivery device 900 has been rotated into the upright position 904 for priming, and can control the LED indicator 902 to indicate that the delivery device 900 is correctly positioned for priming. Upon being placed in the correct upright position 904, the delivery device 900 automatically forces a small amount of medicine through a fluid path contained within the body of the delivery device 900 (e.g., fluid path 512 of FIG. 5). In some implementations, a controller of the delivery device 900 (e.g., controller 312 of FIG. 3) can communicate with the sensor 906 of the delivery device 900 to detect when the delivery device 900 has been rotated into the upright position 904 for priming, and can automatically control one or more mechanical mechanisms of the delivery device 900 to initiate priming in response to detecting that the delivery device is in the correct position for priming. In some embodiments, after positioning the delivery device 900 in the correct upright position 904, the user engages a control on the delivery device 900 (e.g., presses a button), which causes the delivery device 900 to force a small amount of medicine through the fluid path contained within the body of the delivery device 900. In some implementations, a controller of the delivery device 900 (e.g., controller 312 of FIG. 3) can communicate with the control on the delivery device 900 to detect when the user has engaged the control, and, in response, can control one or more mechanical mechanisms of the delivery device 900 to initiate priming. By priming the fluid path of the delivery device 900 with medicament, most of the air contained within the fluid path (or within a cartridge coupled to the fluid path) is forced out of the fluid path prior to administration of the medicament.

Referring to FIG. 9C, once the fluid path of the delivery device 900 has been primed, the LED 902 on the delivery device stops flashing and changes to solid green to indicate that priming of the device is complete. In some implementations, a needle of the delivery device used to deliver medicament to the patient (e.g., needle 514 of FIG. 6C) will not deploy until priming of the fluid path is complete. In some implementations, a controller of the delivery device 900 (e.g., controller 312 of FIG. 3) can communicate with one or more sensors, of the delivery device 900 to detect when the delivery device 900 been primed, and can control the LED indicator 902 to indicate that priming of the delivery device 900 is complete. Some example types of sensors used to detect when the delivery device 900 has been primed can include a rotation sensor of the motor of the delivery device 900 (e.g., a Hall sensor or encoder of the delivery device 900) or a current sensor configured to detect the resistance opposed by the plunger of the cartridge in the delivery device 900.

In some implementations, the indicator 902 includes a sound generator, such as a speaker or buzzer. By including a sound generator as an indicator 902 for the delivery device 900, conditions of the delivery device (e.g., active, in proper priming position, priming complete) can be indicated by different sound tones, different sound sequences, or different sound intensities.

In some implementations, the indicator 902 includes or a haptic feedback generator, such as a vibration generator. By including a hepatic generator as an indicator for the delivery device 900 conditions of the delivery device (e.g., active, in proper priming position, priming complete) can be indicated different vibration sequences, vibration frequencies, or vibration intensities.

Utilizing a sound generator or hepatic generator as an indicator for the delivery device 900 which is particularly beneficial for visually impaired users or situations in which the delivery device is placed on a portion of the body is not easily accessible by the eye.

Referring to FIG. 6C, once the fluid pathway 512 of the delivery device 500 is primed, a needle or cannula 514 connected to an end of fluid pathway 512 opposite needle 510 is deployed for insertion into the patient. In some implementations, the needle or cannula 514 is only deployed if the delivery device 500 detects a connection between the delivery device 500 and the patient’s skin. In some implementations, a controller of the delivery device 500 (e.g., controller 312 of FIG. 3) can communicate with one or more sensors to detect whether a connection between the delivery device 500 and the patient’s skin has been established. In addition, a controller of the delivery device 500 (e.g., controller 312 of FIG. 3) can control one or more mechanical mechanisms, such as an actuator, a motor, or a spring, in order to control the deployment of the needle or cannula 514 in response to detecting that priming is complete and a connection between the delivery device 500 and the patient’s skin has been established.

Once the delivery device 500 is initialized and attached to the patient’s skin, the medicament contained within the cartridge 108 is administered to the patient using the delivery device (420). As previously discussed, in some implementations, the delivery device 500 is configured to administer the medicament according to a basal profile. In some implementations, the delivery device 500 allows for on-demand bolus injections of the medicament. In some implementations, the delivery device 500 is configured to control bolus injections to prevent multiple consecutive bolus deliveries. In some implementations, the delivery device 500 is configured to only administer medicament when the delivery device 500 detects that the delivery device 500 is coupled to the patient’s skin. In some implementations, a controller of the delivery device 500 (e.g., controller 312 of FIG. 3) can be used to control a motor of the delivery device 500 (or one or more mechanical mechanisms) to control the delivery of medicament into the patient according to a particular delivery profile.

Once administration of the medicament is complete (e.g., once the cartridge 108 of the cassette 100 is empty), the delivery device 500 is removed from the patient’s skin (422). The cassette 100 and any disposable components of the delivery device 500 are removed from the reusable components of the delivery device 500 (424) and discarded (426). In some implementations, the delivery device 500 is fully disposable and both the cassette 100 and the delivery device 500 can be discarded together.

If the delivery device 500 includes reusable components, the reusable components of the delivery device 500 are cleaned (428) and charged if required (430) for subsequent uses.

While the cartridge 108 has been described as being separate from the delivery device and manually loaded into a delivery device by a user using a cassette 100, in some implementations, the cartridge is pre-loaded into the delivery device as an integral unit. For example, FIG. 7 depicts an example delivery device 700 with a medicament-filled cartridge 710 pre-loaded into the delivery device 700, with the entire delivery device 700, including the cartridge 710, being disposable. The delivery device 700 and the cartridge 710 can be separately assembled under sterile conditions, and the cartridge 710 can be attached to the delivery device 700 under sterile conditions prior to packaging of the delivery device 700.

Further, in some implementations, the cartridge 108 is configured to be coupled directly to a delivery device without being provided within a cassette body 102. For example, as depicted in FIG. 7, a head 738 of a cartridge 710 can be configured to couple to a cap 704 inside a delivery device 700. The cap 704 of the delivery device 700 combined with the seal 720 of the cartridge 710 seals the cartridge 710 to the fluid pathway 724 of the delivery device 700 and prevents (entirely or limit to a specified degree) leaks between the cartridge 710 and the delivery device 700.

As depicted in FIG. 7, the cartridge 710 can include a head 738 with a protective foil 706 sealing the cartridge 710 prior to use. The cartridge 710 also includes a sealing device 720 for sealing the cartridge 710 to the delivery device 700 during use. Seal 720 can include any suitable type of seal 720, and in some implementations, is an O-ring seal, a flat gasket, or another type of seal. The delivery device 700 includes a protective foil 708 sealing the fluid pathway 724 of the delivery device 700 prior to use of the delivery device 700. The delivery device 700 also includes a cap 704 for coupling the head 738 of cartridge 710 to the delivery device 700. In some implementations, the head 738 of the cartridge 710 defines a profile that corresponds to the cap 704 of the delivery device 700 such that the head 738 of the cartridge 710 is gripped by the cap 704 of the delivery device 700, which helps seal the cartridge 108 to the delivery device 700.

As depicted in FIG. 8, prior to administration of the medicament contained within the cartridge 710, the protective foil 706 on the cartridge 710 and the protective foil 708 on the delivery device 700 are each removed. In some implementations, a user removes each protective foil 706, 708 after attaching the delivery device 700 to a patient. In some implementations, the protective foils 706, 708 are each coupled to a liner covering an adhesive of the delivery device 700, and removal of the liner to expose the adhesive also removes the protective foils 706, 708.

In some implementations, the delivery device includes one or more internal mechanical components that removes the protective foils 706, 708 prior to administration of the medicament.

In order to administer the medicament within the cartridge 710 to a patient, a needle 722 of the delivery device 700 is inserted into the cartridge 710 to establish a fluid connection between the cartridge 710 and the fluid pathway 724 of the delivery device 700. In some implementations, the delivery device 700 includes a mechanical mechanism, such as an actuator, a motor, or a spring, that causes the needle 722 to move towards the cartridge 710 such that the needle 722 is inserted through an access port of the cartridge 710 to establish a fluid connection between the cartridge 710 and the fluid pathway 724 of the delivery device 700. In some implementations, a piston of the cartridge 710 causes the cartridge 710 to move within the delivery device 700 towards the needle 722 until the needle 722 is inserted through the access port of the cartridge 710. A controller (e.g., controller 312 of FIG. 3) of the delivery device 700 can be used to control an actuator, a motor, a spring, or a piston in order to cause the needle 510 to be inserted into the cartridge 710 and establish a fluid connection between the cartridge 710 and the fluid pathway 724.

Sterility of a fluid path within the medicament delivery device (e.g. fluid path 724 of FIG. 7) can be maintained using several techniques. For example, a pre-filled cartridge (e.g., cartridge 710 of FIG. 7) can be loaded into a pre-sterilized medicament delivery device in an aseptic environment. In some implementations, the medicament delivery device includes an aseptic connector that creates a sterile continuum along a fluid flow path of the medicament delivery device. In some implementations, a disinfectant, such as ultraviolet LEDs, is built into the medicament delivery device to automatically disinfect the fluid path of the medicament delivery device after the cartridge is positioned within the medicament delivery device. Using such a disinfectant enables a pre-filled medicament cartridge to be loaded into a pre-sterilized medicament delivery device in a non-aseptic environment.

In some implementations, the medicament delivery device is sterilized using gas-based sterilization. FIG. 10 depicts an example of a process of sterilizing the medicament delivery device using one or more sterilization gasses. As can be seen in FIG. 10, a pre-filled medicament cartridge 1010 containing a medicament is loaded into a medicament delivery device 1012. The medicament delivery device 1012 need not be sterilized and can be loaded in a non-aseptic environment. Once the medicament cartridge 1010 is loaded into the medicament delivery device 1012, the medicament delivery device 1012 containing the medicament cartridge 1010 can be placed in a sterilization chamber 1014 and sterilization gas 1016 can be introduced into the sterilization chamber 1014 to sterilize the fluid path 1018 of the medicament delivery device 1012 and a septum 1020 covering the access port 1022 of the cartridge 1010. Some example sterilization gasses 1016 suitable for sterilizing the fluid path 1018 of the medicament delivery device 1012 and the septum 1020 covering the access port 1022 of the cartridge 1010 can include ethylene oxide (ETO), nitrogen dioxide (NO2), and vaporized hydrogen peroxide (VHP). In some implementations, the septum 1020 covering the access port 1022 of the cartridge and a plunger 1024 positioned at an end of the cartridge 1010 opposite the septum are formed of material that is impermeable to the sterilization gas 1016, such as certain types of rubber. In some implementations, the types of material used to form the the septum 1020 and plunger 1024 are selected based on a known gas permeability of the various material types (e.g., oxygen permeability of each material type), as this gas permeability value can be used to determine the permeability of each type of material to the particular sterilization gas being used to sterilize the delivery device 1012. In some implementations, the septum 1020 and the plunger 1024 are each formed of bromobutyl material.

The pressure, temperature, and exposure time within the sterilization chamber 1014 can be controlled to ensure sterilization of the septum 1020 covering the access port 1022 of the cartridge 1010 and the fluid path 1018 of the medicament delivery device 1012, while preventing (entirely or limit to a specified degree) contamination of the medicament contained within the cartridge 1010. For instance, in order to prevent contamination of the medicament contained within the cartridge 1010, the amount of movement of the plunger 1024 within the cartridge 1010 is minimized, or limited to a small specified amount of movement, to prevent (entirely or limit to specified degree) sterilization gasses trapped between the ribs 1026 of the plunger 1024 from contaminating the medicament. In some implementations, the pressure, temperature, and exposure time within the sterilization chamber 1014 is controlled such that the plunger 1024 is displaced during sterilization a distance that this less than the width of a single rib 1026 of the plunger 1024. In some implementations, the cartridge 1010 is a 3 mL cartridge and the width of each rib 1026 of the plunger 1024 is about 1 mm, and, therefore, the pressure, temperature, and exposure time within the sterilization chamber 1014 is controlled such that the plunger 1024 is displaced less than 1 mm during sterilization. In some implementations, the pressure, temperature, and exposure time within the sterilization chamber 1014 is controlled such that the plunger 1024 is displaced by a distance that is less than the distance between two adjacent ribs 1026 of the plunger 1024 (e.g., about 4 mm).

In some implementations, the acceptable amount of displacement of the plunger 1024 that can occur during sterilization without contaminating the medicament in the cartridge 1010 is related to the amount of air contained within the cartridge 1010, which can be a function of the method used to fill the cartridge 1010 with medicament. For example, medicament cartridges 1010 can be filled from the top of the cartridge 1010 using a bulk filling method, which results in less than about 10 pL of air being trapped within the cartridge 1010. Medicament cartridges 1010 containing 10 pL of air or less can tolerate plunger displacement during sterilization up to a distance equal to the distance between two adjacent ribs 1026 of the plunger 1024 (e.g., about 4 mm) without contaminating the medicament within the cartridge 1010. In contrast, medicament cartridges 1010 filled from the bottom of the cartridge 1010 typically contained about 50 pL of air trapped within the cartridge 1010. Medicament cartridges 1010 containing 20 pL or more of air can only tolerate plunger displacement during sterilization up to a distance equal to the width of a single rib 1026 of the plunger 1024 (e.g., about 1 mm) without contaminating the medicament within the cartridge 1010. Therefore, the pressure, temperature, and exposure time within the sterilization chamber 1014 can be controlled based on the amount of the air contained within the cartridge 1010 to ensure sterilization of the septum 1020 covering the access port 1022 of the cartridge 1010 and the fluid path 1018 of the medicament delivery device 1012, while preventing contamination of the medicament contained within the cartridge 1010. The relationship between the pressure within the sterilization chamber 1014, the size of the air bubble contained within the pre-filled medicament cartridge 1010, and the distance between the ribs 1026 of the plunger 1024 is described in equation 1 below. p< /(bubble size, rib distance) equation 1

Equation 2 below provides a model for determining a temperature and pressure at which to perform sterilization in order to ensure that the displacement of the plunger 1024 during sterilization is sufficiently small such that contamination of the medicament in the cartridge is prevented: equation 2

wherein l represents the distance the plunger is displaced during sterilization, y represents the distance between adjacent ribs of the plunger of the medicament cartridge, d represents the inner diameter of the plunger of the medicament cartridge, Vo represents the volume of the air bubble contained within the medicament cartridge under normal conditions (e.g., ambient temperature, atmospheric pressure, etc.), To represents the temperature within the medicament cartridge under normal conditions (e.g., ambient temperature), P₀ represents the pressure of the medicament cartridge under normal conditions (e.g., atmospheric pressure),

AT represents the change in temperature during the sterilization cycle, and AP represents the change in pressure during the sterilization cycle. By adjusting the parameters AT, AP of the sterilization process, the distance (/) that the plunger of the medicament is displaced during sterilization can be controlled to ensure that the displacement distance (/) is smaller than the distance between adjacent ribs of the plunger (y).

In some implementations, particular methods of filling the cartridge 1010 can be selected to minimize the amount, or limit below a small specified amount, of air contained within the cartridge 1010, which can result in reduced plunger displacement during gas sterilization at a particular pressure. Additionally or alternatively, plungers having a larger ribs 1026 can be used to allow for larger displacement of the plunger 1024 during sterilization without increased risk of contamination of the medicament in the cartridge 1010. For example, plunger 1024 having thicker ribs 1026 results in a larger distance that the plunger 1024 can travel before sterilization gasses trapped between end of the plunger 1024 and the rib 1026 adjacent the end of the plunger 1024 are released into the cartridge 1010. As such, the relationship between rib size of the plunger 1024 and the size of the air bubble contained within the cartridge can be controlled to control movement of the plunger 1024 within the cartridge 1010 below a threshold amount of displacement (e.g., a distance less than the thickness of a rib of the plunger 1024).

Equations 3 and 4 below provide a model for predicting the movement of a plunger 1024 within a cartridge 1010 during gas sterilization based on a variety of factors. m a = ( P_lnt — P_ext)A — CfV^F° equation 3

wherein y represents linear displacement of the medicament cartridge during sterilization, m represents the mass of the plunger, a represents plunger acceleration, P_lnt represent internal pressure, P_ext represents external pressure, A represents the cross section area of the plunger, F₀ and Cf represent coefficients for friction empirical law, v represents plunger velocity, T represents temperature, R represents the universal constant of gas, n represents the molar amount of gas in the cartridge, and h represents the plunger/liquid air gap within the cartridge.

In some implementations, movement of the plunger of the medicament cartridge during sterilization is prevented mechanically in order to prevent contamination of the medicament in the cartridge. For example, in some implementations, a piston 1112 used to push the medicament outside of the cartridge 1110 during delivery of the medicament is positioned at the end of the cartridge 1110 adjacent the plunger 1124. As can been seen in FIG. 11, the piston 1112 is placed in contact with the plunger 1124 prior to performing sterilization of a delivery device into which the cartridge 1110 is inserted (e.g., during assembly of the cartridge 1110 with medicament delivery device 1012). The piston 1112 is fixed at an initial position and does not move during sterilization except due to tolerances. Therefore, because the plunger 1124 is placed in contact with the fixed piston 1112 prior to sterilization, the plunger 1024 movement is impeded by the piston 1112 itself during sterilization.

As depicted in FIG. 12, in some implementations, a spacer 1214 is placed between the plunger 1224 of the cartridge 1210 and a fixed piston 1212. For example, movement of the plunger 1224 during the sterilization cycle can be impeded by the spacer 1214 positioned between the plunger 1224 and the fixed piston 1212, which does not move during sterilization, as the plunger 1024 presses against the spacer 1214.

As depicted in FIG. 13 A, in some implementations, a spacer 1314 in contact with the plunger 1324 is prevented from moving during sterilization by a lever 1316 or system of levers that is attached to the cartridge body 1308 via a cartridge holder 1318 and is in contact with the spacer 1314 during sterilization procedures. As depicted in FIG. 13B, after sterilization is complete, the plunger 1324 can be moved (for example, during a procedure that is performed shortly before the use of the device), and the movement of the piston 1312 causes the lever 1316 to move into a retracted position and out of contact with the spacer 1314. Once the lever is moved out of contact with the spacer 1314, the piston 1312 can press against the spacer 1314, which causes the plunger 1324 to move within the cartridge body 1308 in order to deliver the medicament.

While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or on the scope of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially be claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single product or packaged into multiple products.

Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain some cases, multitasking and parallel processing may be advantageous.

Claims

WHAT IS CLAIMED IS:

1. A medicament cassette device comprising: a cassette body defining an opening configured to receive a medicament cartridge containing medicament; and a lock within the cassette body moveable between a locked position and an unlocked position, wherein the lock blocks an access port of a medicament cartridge positioned within the opening of the cassette body when the lock is positioned in the locked position.

2. The medicament cassette device of claim 1, wherein the lock comprises two or more magnets movable between the locked position and the unlocked position.

3. The medicament cassette device of claim 2, wherein the magnets comprise magnetic disks each comprising an opening therethrough, the opening in each of the magnetic disks are misaligned when the lock is in a locked position.

4. The medicament cassette device of claim 3, wherein: the openings through each of the magnetic disks are aligned and the access port of the medicament cartridge is exposed when the lock is in an unlocked position; and unlocking the lock comprises applying a magnetic field to the lock.

5. The medicament cassette device of claim 3 or claim 4, wherein: the magnetic disks comprise: a top disk comprising a first north pole and a first south pole, the top disk defining a first opening through the south pole of the top disk; and a bottom disk comprising a second north pole and a second south pole, the bottom disk defining a second opening through the second south pole of the bottom disk; and the first south pole of the top disk is misaligned with the second south pole of the bottom disk when the lock is positioned in a locked position.

6. The medicament cassette device of claim 5, wherein applying the magnetic field to the lock causes at least one of the top disk or the bottom disk to rotate to align the first opening and the second opening.

7. The medicament cassette device of any one of claims 1-6, further comprising: a cap, wherein the lock is positioned within the cap; and a seal positioned between the medicament cartridge and the cap when the medicament cartridge is inserted into the opening defined by the cassette body.

8. The medicament cassette device of any one of claims 1-7, wherein: the lock comprises a mechanical lock that covers the access port of the medicament cartridge when the lock is positioned in a locked position.

9. The medicament cassette device of any one of claims 1-8, wherein: the lock is a first lock; and the cassette device further comprises a second lock positioned within the cassette body opposite the first lock.

10. The medicament cassette device of any one of claims 1-9, further comprising a plunger configured to pump the medicament out of the medicament cassette device.

11. A system comprising: a medicament cassette device comprising: a cassette body; and a lock within the cassette body configured to block an access port of a medicament cartridge positioned within the cassette body when the lock is positioned in a locked position; and a medicament delivery device comprising a device body configured to reside apart from the medicament cassette device and couple to the medicament cassette device, wherein the medicament delivery device is configured to deliver medicament contained within the medicament cartridge to a patient.

12. The system of claim 11, wherein the lock comprises two or more magnets each comprising an opening therethrough, the opening in each of the magnets being misaligned when the lock is in a locked position.

13. The system of claim 12, wherein: the openings through each of the two or more magnets are aligned and the access port of the medicament cartridge is exposed when the lock is in an unlocked position; and unlocking the lock comprises applying a magnetic field to the lock to cause at least one of the two or more magnets to rotate to align each of the openings.

14. The system of claim 13, wherein the magnetic field is generated by the medicament delivery device.

15. The system of claim 13 or claim 14, wherein coupling the medicament cassette device to the medicament delivery device causes the medicament delivery device to automatically generate the magnetic field.

16. The system of any one of claims 13-15, wherein: the medicament delivery device comprises a needle; and the medicament contained within the medicament cartridge is accessed by inserting the needle of the medicament delivery device through the openings through each of the two or more magnets when the lock is in an unlocked position.

17. A method comprising: coupling a medicament cassette device to a medicament delivery device, the medicament cassette device comprising a cassette body; and a lock within the cassette body configured to block an access port of a medicament cartridge positioned within the cassette body when the lock is positioned in a locked position; and unlocking the lock using the medicament delivery device.

18. The method of claim 17, wherein unlocking the lock using the medicament delivery device comprises generating a magnetic field using the medicament delivery device.

19. The method of claim 17 or claim 18, wherein: the lock comprises two or more magnets each comprising an opening therethrough; and unlocking the lock comprises generating a magnetic field by the medicament delivery device to cause at least one of the two or more magnets to rotate to align the openings through each of the two or more magnets.

20. The method of any one of claims 17-19, further comprising inserting a needle of the medicament delivery device through the openings through each of the two or more magnets when the lock is in an unlocked position.

21. A method comprising: determining that a cartridge comprising a medicament is positioned within a body of a medicament delivery device; detecting, using a sensor of the medicament delivery device, that the medicament delivery device is positioned in a priming position; and in response to detecting that the medicament delivery device is positioned in a priming position: causing an indicator on the medicament delivery device to indicate that the medicament delivery device is positioned in the priming position; and priming a fluid path contained within the medicament delivery device.

22. The method of claim 21, further comprising: in response to detecting that priming the fluid path is complete, causing the indicator on the medicament delivery device to indicate that priming of the medicament delivery device is complete.

23. The method of claim 21 or claim 22, wherein: the indicator on the medicament delivery device comprises a light emitting diode (LED) visible from an exterior of the body of the medicament delivery device; causing the indicator to indicate that the medicament delivery device is positioned in the priming position comprises causing the LED to operate in a first manner; and causing the indicator to indicate that priming of the medicament delivery device is complete comprises causing the LED to operate in a second, different manner.

24. The method of any one of claim 23, further comprising: in response to determining that the cartridge is positioned within the body of the medicament delivery device, causing the indicator on the medicament delivery device to indicate that the medicament delivery device is activated.

25. The method of claim 24, wherein: causing the indicator on the medicament delivery device to indicate that the medicament delivery device is activated comprises causing the LED to operate in a third manner.

26. The method of any one of claims 21-25, wherein a needle of the medicament delivery device is prevented from deploying until priming of the medicament delivery device is complete.

27. The method of any one of claims 21-26, wherein the fluid path of the medicament delivery device is primed based at least partly on a user engaging a control of the medicament delivery device.

28. The method of any one of claims 21-27, wherein priming the fluid path contained within the medicament delivery device comprises forcing a predetermined volume of the medicament out of the cartridge and through the fluid path contained within the medicament delivery device.

29. The method of any one of claims 21-28, wherein positioning the medicament delivery device in the priming position comprises rotating the medicament delivery device into an upright position.

30. The method of any one of claims 21-29, wherein the sensor is configured to detect movement of the medicament delivery device or a position of the medicament delivery device.

31. The method of claim 30, wherein the sensor is at least one of an accelerometer, a gyroscope, a tilt sensor, or a tilt ball switch.

32. A medicament delivery device comprising: a device body defining an opening for receiving a medicament cartridge; a sensor configured to detect when the device body is in a priming position; and an indicator configured to indicate when the device body is in the priming position.

33. The medicament delivery device of claim 32, wherein the sensor comprises at least one of an accelerometer, a gyroscope, a tilt sensor, or a tilt ball switch.

34. The medicament delivery device of claim 32 or claim 33, wherein the indicator is further configured to indicate when a process of priming the medicament delivery device is complete.

35. The medicament delivery device of any one of claims 32-34, wherein the indicator comprises a light emitting diode (LED) visible from an exterior of the device body.

36. The medicament delivery device of claim 35, wherein: the LED is configured to operate in a first manner to indicate that the medicament delivery device is positioned in a priming position; and the LED is configured to operate in a second, different manner to indicate when a process of priming of the medicament delivery device is complete.

37. The medicament delivery device of any one of claims 32-36, wherein the indicator is further configured to indicate when the medicament cartridge has been inserted into the device body.

38. The medicament delivery device of claim 37, further comprising a second sensor configured to detect when the medicament cartridge has been inserted into the device body.

39. The medicament delivery device of any one of claims 32-38, further comprising a controller communicably coupled to the sensor and configured to control the indicator to indicate when the device body is in the priming position based at least partly on one or more signals received from the sensor.

40. A system comprising: a medicament cartridge containing a medicament; and a medicament delivery device comprising: a device body defining an opening for receiving the medicament cartridge; a sensor configured to detect when the device body is in a priming position; and an indicator configured to indicate when the device body is in the priming position.

41. A method comprising: inserting a medicament cartridge containing medicament into a medicament delivery device; placing the medicament delivery device containing the medicament cartridge in a sterilization chamber; and introducing sterilization gas into the sterilization chamber.

42. The method of claim 41, further comprising: limiting movement of a plunger of the medicament cartridge within the medicament cartridge while introducing sterilization gas into the sterilization chamber, wherein limiting movement of the plunger of the medicament cartridge within the medicament cartridge comprises controlling at least one of a pressure within the sterilization chamber, a temperature within the sterilization chamber, or a length of time performing sterilization to limit movement of the plunger within the medicament cartridge.

43. The method of claim 42, wherein limiting movement of the plunger of the medicament cartridge within the medicament cartridge comprises limiting movement of the plunger within the medicament cartridge below a specified threshold distance.

44. The method of claim 43, wherein: the plunger comprises a plurality of ribs; and the threshold distance is less than a distance between two adjacent ribs of the plunger.

45. The method of claim 44, wherein the distance between the two adjacent ribs of the plunger is in a range of 0.5 mm to 4 mm.

46. The method of claim 43, wherein: the plunger comprises a plurality of ribs; and the threshold distance is less than a width of a rib of the plurality of ribs.

47. The method of claim 46, wherein the width of the rib is 1 mm.

48. The method of any one of claims 42-47, wherein limiting movement of the plunger of the medicament cartridge within the medicament cartridge comprises positioning a fixed piston adjacent the plunger prior to introducing sterilization gas into the sterilization chamber.

49. The method of any one of claims 42-48, wherein limiting movement of the plunger of the medicament cartridge within the medicament cartridge comprises positioning a spacer between the plunger and a fixed piston prior to introducing sterilization gas into the sterilization chamber.

50. The method of any one of claims 42-49, wherein limiting movement of the plunger of the medicament cartridge within the medicament cartridge comprises positioning a spacer coupled to a lever between the plunger and a piston prior to introducing sterilization gas into the sterilization chamber, the lever limiting movement of the spacer during sterilization.

51. The method of any one of claims 41-50, wherein the medicament delivery device is not sterilized prior to inserting the medicament cartridge into the medicament delivery device.

52. The method of any one of claims 41-51, wherein the medicament cartridge is inserted into the medicament delivery device under non-aseptic conditions.

53. The method of any one of claims 41-52, wherein introducing sterilization gas into the sterilization chamber sterilizes a fluid path of the medicament delivery device and a septum covering an access port of the medicament cartridge.

54. A system comprising: a medicament delivery device comprising a device body; a medicament cartridge containing a medicament and configured to be inserted into the medicament delivery device, the medicament cartridge comprising a plunger; and a sterilization chamber configured to receive the medicament delivery device containing the medicament cartridge, wherein movement of the plunger within a body of the medicament cartridge is limited during gas sterilization of the medicament delivery device containing the medicament cartridge inside the sterilization chamber.

55. The system of claim 54, wherein limiting movement of a plunger of the medicament cartridge within the medicament cartridge comprises controlling at least one of a pressure within the sterilization chamber, a temperature within the sterilization chamber, or a length of time performing sterilization to limit movement of the plunger within the medicament cartridge.

56. The system of claim 54 or claim 55, further comprising a fixed piston adjacent the plunger prior to introducing sterilization gas into the sterilization chamber, wherein the fixed piston is configured to prevent movement of the plunger during sterilization.

57. The system of claim 54 or claim 55, further comprising a spacer between the plunger and a fixed piston prior to introducing sterilization gas into the sterilization chamber, wherein the space and the fixed piston are configured to prevent movement of the plunger during sterilization.

58. The system of claim 54 or claim 55, further comprising a spacer coupled to a lever positioned between the plunger and a piston prior to introducing sterilization gas into the sterilization chamber, the lever being configured to limit movement of the spacer during sterilization.

59. The system of any one of claims 54-58, wherein introducing sterilization gas into the sterilization chamber sterilizes a fluid path of the medicament delivery device and a septum covering an access port of the medicament cartridge.

60. A method comprising: positioning a medicament cartridge containing medicament into a medicament delivery device; positioning the medicament delivery device containing the medicament cartridge in a sterilization chamber; and introducing sterilization gas into the sterilization chamber, wherein displacement of a plunger of the medicament cartridge is limited during sterilization by controlling at least one of a pressure within the sterilization chamber, a temperature within the sterilization chamber, or a length of time performing sterilization.