WO2016198540A2

WO2016198540A2 - Drug delivery device with extended protective cap

Info

Publication number: WO2016198540A2
Application number: PCT/EP2016/063193
Authority: WO
Inventors: Jesper Peter Windum; Cecilie Manz
Original assignee: Novo Nordisk A/S
Priority date: 2015-06-11
Filing date: 2016-06-09
Publication date: 2016-12-15
Also published as: WO2016198540A3

Abstract

A drug delivery assembly comprises a drug delivery device defining a general axis, and a tubular cap. The device comprises a cartridge holder distal portion adapted to receive and mount a drug-filled cartridge, and a body proximal portion comprising a dose setting and dose expelling mechanism. The cartridge holder distal portion comprises a rotational member arranged rotationally relative to the general axis for user-actuation of the cartridge holder distal portion between a receiving state and a holding state. The tubular cap is releasable attachable to the drug delivery device and adapted to circumferentially cover the cartridge holder distal portion as well as at least 50% of the length of the body proximal portion in a mounted state.

Description

DRUG DELIVERY DEVICE WITH EXTENDED PROTECTIVE CAP

The present invention generally relates to drug delivery devices adapted to be used and operated by a patient on his or her own hand. More specifically, the invention relates to a drug delivery device which can be stored safely and well protected when not in use.

BACKGROUND OF THE INVENTION

In the disclosure of the present invention reference is mostly made to the treatment of diabetes by delivery of insulin or other diabetes drugs, however, this is only an exemplary use of the present invention.

Drug delivery devices in the form of injection devices for subcutaneous administration of fluid drugs have greatly improved the lives of patients who must self-administer drugs and biological agents. Drug injection devices may take many forms, including simple disposable devices that are little more than an ampoule with an injection means or they may be highly sophisti- cated electronically controlled instruments with numerous functions. Regardless of their form, they have proven to be great aids in assisting patients to self-administer injectable drugs and biological agents. They also greatly assist care givers in administering injectable medicines to those incapable of performing self-injections. In particular pen-style drug delivery devices have proven to provide an accurate, convenient, and often discrete, way to administer drugs and biological agents, such as insulin. Typically, drug delivery devices use a pre-filled cartridge containing the medication of interest, e.g. 1.5 or 3.0 ml of insulin or growth hormone. The cartridge is typically in the form of a generally cylindrical transparent ampoule with a needle pierceable septum at one end and an opposed piston designed to be moved by a piston rod of the dosing and expelling mechanism of the drug delivery device. The drug delivery devices generally are of two types: "Disposable" devices and "durable" devices. A disposable device is provided with an integrated cartridge which cannot be replaced by the user; when the cartridge is empty the entire device is discarded. In contrast, a durable device is designed to allow a user to replace one cartridge with another cartridge, typically a new cartridge in place of an empty cartridge.

The most common type of drug delivery devices adapted to receive a drug filled cartridge and expel a dose therefrom are generally pen-formed and utilizes a so-called cartridge holder adapted to receive and mount a cartridge in the device. Correspondingly, most pen- formed drug delivery devices comprises a generally cylindrical cartridge holder for receiving and holding a generally cylindrical drug-filled cartridge in a mounted position, the cartridge comprising a proximally facing and axially displaceable piston, and a main body with a housing in which a drug expelling mechanism is arranged, the mechanism comprising an axially displaceable piston rod adapted to engage the piston of a mounted cartridge to thereby expel a dose of drug from the cartridge. Between the cartridge holder and the main body a connec- tion means is provided allowing a user to remove the cartridge holder from the main body and reattach it when a used cartridge has been exchanged with a new cartridge. The cartridge is in most cases inserted in the cartridge holder by axial movement through a proximal opening, see e.g. WO 2011/124631 , EP 0 937 474, WO 2011/092326 and WO 2014/005807. The connection means may be in the form of a threaded connection or a bayonet coupling. Depending on the design of the drug delivery device the piston rod has to be moved proximally (i.e. "reset") by rotation when an empty cartridge is exchanged with a full cartridge, or the piston rod can be reset by being pushed axially, e.g. by unlocking the piston rod when the cartridge holder is removed from the main body, this as disclosed in for example US 2009/0275914 and WO 2011/051366.

Alternatively, the drug delivery device may comprise an integrated (i.e. for the user nonremovable) cartridge holder adapted to axially receive a cartridge through a distal opening. Such a device is often named "front-loaded", see e.g. WO 2004/020026. The cartridge holder will typically be provided with gripping means adapted to hold and release an axially inserted cartridge. Although the cartridge holder is not removable from the device main body, in most designs it comprises components which are adapted to rotate relative to the device main body during cartridge exchange, i.e. when the cartridge holder is operated by the user to open and close the cartridge holder distal opening. For example, WO 2004/020026 discloses a front loaded device comprising a rotatable ring member arranged between the cartridge holder portion and the device main portion as well as a rotatable gripping member. WO 2015/ 075135 discloses a front loaded drug delivery device in which the entire outer part of the cartridge holder is adapted to be rotated by the user during cartridge exchange. Corresponding to the above-described "rear-loaded" devices also the front-loaded devices are provided with coupling reset means actuated during cartridge exchange and allowing the piston rod to be moved proximally.

For both front- and rear-loaded drug delivery devices the reset coupling means is in most cases arranged corresponding to the interface between the cartridge holder portion and the device main portion and is actuated by rotation, e.g. when a rear-loaded cartridge holder is removed and attached or when a front-loaded cartridge holder is actuated to be opened or closed. As a durable device of the above-described types is designed to be used for a number of years, e.g. four years, it is essential that it is protected against dirt and external influences which may damage the above-described coupling arrangements. Correspondingly, most du- rable drug delivery devices are supplied with e.g. a zipper-style padded case or a hinged hard-case.

Having regard to the above, it is an object of the present invention to provide a drug delivery device of the durable type which can be stored safely and well protected when not in use. It should be convenient and easy to use and should be provided in a cost-effective manner.

DISCLOSURE OF THE INVENTION

In the disclosure of the present invention, embodiments and aspects will be described which will address one or more of the above objects or which will address objects apparent from the below disclosure as well as from the description of exemplary embodiments.

Thus, in accordance with a first aspect of the invention a drug delivery assembly is provided comprising a drug delivery assembly and a tubular cap. The drug delivery device defines a general axis and comprises a cartridge holder distal portion adapted to receive and mount a drug-filled cartridge, the cartridge comprising an axially displaceable piston and a distal outlet portion, a piston rod adapted to engage a piston in a mounted cartridge, and a body proximal portion. The body proximal portion comprises a dose setting mechanism allowing a user to adjustably set a dose to be expelled, and a releasable expelling mechanism for driving the piston rod in a distal direction to thereby expel the set dose of drug from the cartridge, wherein the cartridge holder distal portion and the body proximal portion are arranged along the general axis. The cartridge holder distal portion comprises a rotational member arranged rotationally relative to the general axis for full or partly user- actuation of the cartridge holder distal portion between (i) a cartridge holder receiving state in which a cartridge can be received, and (ii) a cartridge holder holding state in which a received cartridge is held in an operational mounted position. The tubular cap is releasable attachable to the drug delivery device and adapted to circumferentially cover the cartridge holder distal portion as well as a portion of the length of the body proximal portion in a mounted state. By this arrangement a drug delivery assembly is provided in which the rotational interface between the cartridge holder distal portion and the body proximal portion is protected against dirt and external influences which may damage the interface and the associated components.

Although defined as separate functional structures the dose setting mechanism, the expelling mechanism and the piston rod will in most cases be designed as an integrated mechanism.

In a specific embodiment the cartridge holder distal portion comprises a distal opening adapted to receive a cartridge in a proximal direction, whereby a front-loaded drug delivery device is provided. In such a configuration the cartridge holder distal portion is operated fully between the receiving state and the holding state by rotation of the rotational member. The rotational member may be in the form of a sleeve enclosing at least a portion of a mounted cartridge, the actuation sleeve comprising inspection means allowing at least a portion of an enclosed cartridge portion to be visually inspected.

In a further specific embodiment the cartridge holder distal portion comprises a proximal opening adapted to receive a cartridge in a distal direction. In such a configuration the cartridge holder distal portion is removable from the body proximal portion by rotation followed by axial movement, the cartridge holder distal portion thereby forming the rotational member, whereby a rear-loaded drug delivery device is provided.

The body proximal portion may comprise a drive spring, the dose setting means allowing a user to simultaneously set the dose amount to be expelled and strain the drive spring corre- spondingly, the drive spring being arranged to drive the piston rod in the distal direction when the expelling mechanism is released.

The body proximal portion may comprise a housing defining the general axis, and the dose setting and dose expelling mechanism may comprise a scale member provided with a plurali- ty of dose size indices, the scale member being arranged rotationally corresponding to the general axis. The housing may comprise an opening arranged to show a scale member dose size indicia corresponding to a set dose, the tubular cap being adapted to cover the opening in the mounted state. The opening may be provided with a transparent window. In different embodiments the tubular cap may be adapted to cover more or less of the length of the body proximal portion in the mounted state, e.g. more than 25 %, more than 50% or more than 75%. In exemplary embodiments the body proximal portion comprises (i) dose setting means allowing a user to set a dose of drug to be expelled, and (ii) release means allowing a set dose of drug to be expelled, the cap when mounted being adapted to prevent a dose of drug to be set and/or expelled. The drug delivery assembly may further comprise cooperating releasable coupling means arranged on the drug delivery device respectively the cap, the coupling means preventing axial movement between the device and the cap.

In accordance with a second aspect of the invention a drug delivery assembly is provide comprising a drug delivery device defining a general axis in combination with a tubular cap. The drug delivery device comprises a cartridge holder distal portion and a body proximal portion. The latter comprises a dose setting and dose expelling mechanism comprising a piston rod adapted to engage and axially displace a piston in a mounted cartridge in a distal direction to thereby expel a dose of drug from the cartridge, a scale member provided with a plu- rality of dose size indices, the scale member being arranged rotationally corresponding to the general axis, and a housing comprising an opening arranged to show a scale member dose size indicia corresponding to a set dose. The tubular cap is releasable attachable to the drug delivery device and adapted to circumferentially cover, in a mounted state, the cartridge holder distal portion as well as the housing opening.

By this arrangement a drug delivery assembly is provided in which it is prevented to a high degree that dirt enters the interior of the body portion through the housing opening when the cap is mounted. The drug delivery device may be of the prefilled type in which the device is supplied to the user with a pre-mounted, non-removable drug-filled cartridge. For such a de- vice the assembly may be provided with the same additional features as described above for an assembly comprising a rotational interface.

As used herein, the term "drug" is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a cannula or hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension. Representative drugs include pharmaceuticals such as peptides (e.g. insulins, insulin containing drugs, GLP- 1 containing drugs as well as derivatives thereof), proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form. In the description of the exemplary embodiments reference will be made to the use of insulin containing drugs. Correspondingly, the term "subcutaneous" infusion is meant to encompass any method of transcutaneous delivery to a subject.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following exemplary embodiments of the invention will be further described with refer- ence to the drawings, wherein fig. 1 shows an embodiment of a drug delivery device,

fig. 2 shows a cap for the drug delivery device shown in fig. 1 , and

fig. 3 shows the cap of fig. 2 mounted on the drug delivery device of fig. 1.

In the figures like structures are mainly identified by like reference numerals. DESCRIPTION OF EXEMPLARY EMBODIMENTS

When in the following terms such as "upper" and "lower", "right" and "left", "horizontal" and "vertical" or similar relative expressions are used, these only refer to the appended figures and not necessarily to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are intended to serve illustrative purposes only. When the term member or element is used for a given component it generally indicates that in the described embodiment the component is a unitary component, however, the same member or element may alternatively comprise a number of sub-components just as two or more of the described components could be provided as unitary components, e.g. manufactured as a single injection moulded part. The term "assembly" does not imply that the described components necessarily can be assembled to provide a unitary or functional assembly during a given assembly procedure but is merely used to describe components grouped together as being functionally more closely related.

Turning to fig. 1 a pen-formed drug delivery device 1 is shown, comprising a distal cartridge holder portion 10 and a proximal body or drive assembly portion 20, the cartridge holder por- tion being adapted to receive and mount a drug-filled cartridge 30 having a distal needle- penetrable septum. The cartridge is provided with a piston adapted to be driven by a piston rod forming part of an expelling mechanism and may for example contain an insulin, GLP-1 or growth hormone formulation. Distal coupling means arranged on the cartridge or the cartridge holder allows a needle assembly 40 to be releasably mounted in fluid communication with the cartridge interior. The body proximal portion comprises an outer housing 21 in which a dose setting and drug expelling mechanism is arranged or integrated, the outer housing defining a general axis for the device. The mechanism comprises a scale member 23 provided with a plurality of dose size indices (not shown), the scale member being arranged rota- tionally corresponding to the general axis. The housing comprises a display opening (or window) 22 arranged to show a scale member dose size indicia corresponding to a set dose. A proximal-most rotatable combined dose setting and release member 50 (or "dose dial button" for short) serves to manually set a desired dose of drug shown in the display opening 22 which can then be expelled when the combined member is actuated by being moved distally, the dose dial button comprising a reduced-diameter neck portion 51 allowing it to be moved into the housing 21 corresponding to the length of the neck portion. Alternatively separate dose setting and release members may be provided. To prevent the drug delivery device from rolling on a surface the combined member is provided with a small projection 52. Depending on the type of expelling mechanism embodied in the drug delivery device, the expelling mechanism may comprise a spring as in the shown embodiment which is strained during dose setting and then released to drive the piston rod when the combined member is actuat- ed. Examples of such expelling mechanisms can be found in e.g. WO 2014/161952 disclosing an expelling mechanism comprising a helical torque spring, and US 8,048,037 disclosing an expelling mechanism comprising a clock-type spiral torque spring. Alternatively the expelling mechanism may be fully manual in which case the combined member moves proximally during dose setting corresponding to the set dose size, and then is moved distally by the us- er to expel the set dose.

The pen-formed drug delivery device may be provided with electronic circuitry providing logging means adapted to detect properties related to a dose expelling event, e.g. set or expelled dose and/or the time since last dose. The electronic circuitry may comprise a display, e.g. arranged at the proximally-facing end surface of the dose dial button, for displaying data related to a dose expelling event. Alternatively or in addition to the display, the electronic circuitry may comprise wireless communication means allowing the device to communicate with an exterior device, e.g. a smartphone or other computing device, via e.g. NFC or Bluetooth. To turn on the display to show e.g. data related to the last expelled dose, the user may ma- nipulate the dose dial button by e.g. rotating, pushing or pulling the button. The cartridge holder portion comprises a generally tubular cartridge holder member 11 rota- tionally attached to the body proximal portion corresponding to a rotational interface 15, the cartridge holder portion having openings 12 allowing a portion of the cartridge 30 to be inspected. The shown embodiment may represent two different kinds of a cartridge holder: (i) a releasable cartridge holder providing a traditional rear-loaded drug delivery device, or (ii) a non-releasable cartridge holder providing a front-loaded drug delivery device.

In respect of a rear-loaded device the cartridge holder member 11 comprises a proximal insertion opening and is attached to the body portion by means of e.g. a threaded connection or a bayonet coupling allowing the cartridge holder to be fully removed from the body portion to thereby allow a cartridge to be loaded or exchanged. When the cartridge holder is removed a coupling is actuated allowing the piston rod to be moved proximally, the coupling being locked again when the cartridge holder is re-attached. In respect of a front-loaded device the cartridge holder member portion 10 comprises a distal insertion opening adapted to receive a cartridge. The cartridge holder portion comprises cartridge holding means actuatable between a receiving state in which a cartridge can be received in a proximal direction, and a holding state in which a received cartridge is held in an operational mounted position. In the shown embodiment a user operated actuation member or sleeve 11 is provided being rotationally actuatable relative to the body portion between a loading state and an operational state, such that the cartridge holding means is actuated from the receiving state to the holding state when the actuation sleeve is actuated from the loading state to the operational state, and vice versa, e.g. by a rotation of 90 degrees. As the actuation sleeve encloses the majority of a mounted cartridge, the actuation sleeve is provid- ed with inspection openings 12 allowing a portion of an enclosed cartridge to be visually inspected. The cartridge holding means may comprise a pair of distal gripping jaws being moved towards the central axis when the cartridge holder is actuated from the receiving state to the holding state, and being moved away from the central axis when the cartridge holder is actuated from the holding state to the receiving state. An example of such a front-loaded drug delivery device is described in WO 2013/124118 which is hereby incorporated by reference.

In an alternative embodiment the rotational actuation member may be in the form of a ring member as shown in WO 2004/020026. In the shown embodiment the cartridge holder portion is provided with distal cap coupling means (see below) in the form of a circumferential groove 13.

Turning to fig. 2 a cap 60 for the drug delivery device 1 of fig. 1 is shown. The cap is in the form of a generally tubular member releasable attachable to the drug delivery device and adapted to cover the cartridge holder distal portion 10 as well as the body portion 20 in a mounted state, thereby covering and protecting the rotational interface 15. In the shown embodiment the distal end portion 61 of the cap adapted to accommodate a mounted needle assembly has a reduced diameter. In the shown embodiment the cap is provided with distal coupling means arranged inside the cap (not shown) and adapted to engage the above cartridge holder coupling means 13 by snap action. The coupling means may be formed integrally with the cap body, e.g. by injection moulding, or be in the form of a separate structure mounted in or on the tubular cap body, e.g. in the form of a distal plug member adapted to be inserted in an open distal end of a tubular member. In case the cartridge holder portion is provided as a releasable rear-loaded portion it should be assured that the cartridge holder can be removed should it be inserted into the cap when not attached to the proximal portion of the device. For example, if a coupling is provided between the cartridge holder and the cap, the coupling should prevent rotation of the cartridge holder as the proximal portion is inserted into the cap to connect to with the cartridge holder by rotation. Alternatively, the coupling means may be based on friction, e.g. a ring-formed elastomeric element may be attached to either of the pen body or cap body. For example, the proximal end of the cap may be provided with a circumferential elastomeric element, e.g. an O-ring or a lip element, adapted to sealingly engage the pen body and/or the button. Alternatively, a circumferential elastomeric element may be provided on the pen body proximal end and adapted to engage the interior of the cap.

In the shown embodiment the cap is provided at the proximal end with an eyelet projection 62 allowing a carrying strap, a cord or the like to be attached. Alternatively or in addition a traditional "shirt pocket clip" may be provided.

Turning to fig. 3 the cap 60 is shown mounted on the drug delivery device 1 of fig. 1 , thereby providing a drug delivery assembly 2. As appears, in the shown embodiment the length of the cap is chosen to cover only the body portion but not the neck portion or further portions of the dose dial button. Depending on the length of the cap and diameters of the cap respec- tively the dose dial button, the button may be prevented from being actuated by being moved distally. For example, if the cap is intended to serve as a means for preventing inadvertent dose release then the cap could be designed to prevent depression of the button, i.e. until the release force of the coupling between the cap and the pen is reached. For such a design an incorporated display may be turned on by e.g. pulling out the dose dial button. Alternatively, if the display is designed to be turned on by depression of the button then the length of the cap or the proximal cap diameter could be chosen to allow this with the cap mounted. In a further alternative (not shown) a rotational lock may be provided between the proximal end of the cap and the dose dial button to prevent inadvertent rotation of the button and thereby setting of a dose. In the shown embodiment the pen device and the cap essentially have constant diameters along their entire length, this providing a snug fit between the two components. In case the pen device has a stepped configuration the cap may or may not duplicate such a stepped configuration. In the above description of the preferred embodiments, the different structures and means providing the described functionality for the different components have been described to a degree to which the concept of the present invention will be apparent to the skilled reader. The detailed construction and specification for the different components are considered the object of a normal design procedure performed by the skilled person along the lines set out in the present specification.

Claims

1. A drug delivery assembly (2), comprising: a drug delivery device (1 ) defining a general axis, comprising:

- a cartridge holder distal portion (10) adapted to receive and mount a drug- filled cartridge (30), the cartridge comprising an axially displaceable piston and a distal outlet portion,

a piston rod adapted to engage a piston in a mounted cartridge, and a body proximal portion (20) comprising a dose setting mechanism allowing a user to adjustably set a dose amount to be expelled, and a releasable expelling mechanism for driving the piston rod in a distal direction to thereby expel the set dose amount of drug from the cartridge,

wherein the cartridge holder distal portion and the body proximal portion are arranged along the general axis, and

- wherein the cartridge holder distal portion comprises a rotational member

(11 ) arranged rotationally relative to the general axis for full or partly user-actuation of the cartridge holder distal portion between:

(i) a cartridge holder receiving state in which a cartridge can be received, and

(ii) a cartridge holder holding state in which a received cartridge is held in an operational mounted position, a tubular cap (60) releasable attachable to the drug delivery device and adapted to circumferentially cover the cartridge holder distal portion as well as at least 50% of the length of the body proximal portion in a mounted state.

2. A drug delivery assembly as in claim 1 , wherein: the cartridge holder distal portion comprises a distal opening adapted to receive a cartridge in a proximal direction,

- whereby a front-loaded drug delivery device is provided.

3. A drug delivery assembly as in claim 2, wherein the rotational member is in the form of a sleeve (11 ) enclosing at least a portion of a mounted cartridge, the actuation sleeve comprising inspection means (12) allowing at least a portion of an enclosed cartridge portion to be visually inspected.

4. A drug delivery assembly as in claim 1 , wherein:

the cartridge holder distal portion comprises a proximal opening adapted to receive a cartridge in a distal direction, and

the cartridge holder distal portion is removable by rotation from the body proximal portion (20), the cartridge holder distal portion thereby forming the rotational member,

whereby a rear-loaded drug delivery device is provided.

5. A drug delivery assembly as in any of claims 1-4, wherein the body proximal portion further comprises a drive spring, the dose setting means allowing a user to simultaneously set the dose amount to be expelled and strain the drive spring correspondingly, the drive spring being arranged to drive the piston rod in the distal direction when the expelling mechanism is released.

6. A drug delivery assembly as in any of claims 1-5, wherein: the body proximal portion comprises a housing (21 ) defining the general axis, and the dose setting and dose expelling mechanism comprises a scale member (23) provided with a plurality of dose size indices, the scale member being arranged rotationally corresponding to the general axis.

7. A drug delivery assembly as in any of claims 1-6, wherein: the housing comprises an opening (22) arranged to show a scale member dose size indicia corresponding to a set dose, and

the tubular cap (60) is adapted to cover the opening in the mounted state.

8. A drug delivery assembly as in any of claims 1-7, wherein: the tubular cap is adapted to cover at least 75% of the length of the body proximal portion in the mounted state.

9. A drug delivery assembly as in any of claims 1-8, wherein: the body proximal portion comprises (i) dose setting means (50) allowing a user to set a dose of drug to be expelled, and (ii) release means (50) allowing a set dose of drug to be expelled, and the cap, when mounted, prevents a dose of drug to be set and/or expelled.

10. A drug delivery assembly as in any of claims 1-9, further comprising cooperating re- leasable coupling means arranged on the drug delivery device respectively the cap, the cou- pling means preventing axial movement there between.