Coded drug reservoir connection element with hinge

A cap for a cartridge having a bead at the distal end is disclosed. The cap comprises:a main body having a proximal end, a distal end, and a bore that receives the cartridge, the main body further comprising a first segment and a second segment; and a retention feature on the main body suitable for snapping under the bead of the cartridge for securing the cap to the cartridge.

TECHNICAL DISCLOSURE OF INVENTION

The present disclosure is generally directed to reservoirs, particularly reservoirs containing a medicament. More particularly, the disclosure is generally directed to a segmented cap for use with a reservoir and a reservoir holder so as to prevent unwanted reservoir cross use. As just one example, such medicament reservoirs may comprise an ampoule, a cartridge, a vial, or a pouch, and may be used with a medical delivery device. Exemplary medical delivery devices include, but are not limited to syringes, pen type injection syringes, pumps, inhalers, or other similar injection or infusing devices that require at least one reservoir containing at least one medicament.

BACKGROUND

Medicament reservoirs such as ampoules, cartridges, or vials are generally known. Such reservoirs are especially used for medicaments that may be self-administered by a patient. For example, with respect to insulin, a patient suffering from diabetes may require a certain amount of insulin to either be injected via a pen type injection syringe or infused via a pump. With respect to certain known reusable pen type drug delivery devices, a patient loads a cartridge containing the insulin into a proximal end of a cartridge holder. After the cartridge has been correctly loaded, the user may then be called upon to select a dose of medicament. Multiple doses may be dosed from the cartridge. Where the drug delivery device comprises a reusable device, once the cartridge is empty, the cartridge holder is disconnected from the drug delivery device and the empty cartridge is removed and replaced with a new cartridge. Most suppliers of such cartridges recommend that the user dispose of the empty cartridges properly. Where the drug delivery device comprises a disposable device, once the cartridge is empty, the user is recommended to dispose of the entire device.

Such known self-administration systems requiring the removal and reloading of empty cartridges have certain limitations. For example, in certain generally known systems, a user simply loads a new cartridge into the delivery system without the drug delivery device or without the cartridge having any mechanism of preventing cross use of an incorrect cartridge. That is, the drug delivery device does not have a mechanism for determining if the medicament contained in the cartridge is indeed the correct type of medicament to be administered by the patient. Alternatively, certain known drug delivery devices do not present a mechanism for determining if the correct type of medicament within the cartridge should be used with that particular drug delivery system. This potential problem could be exacerbated given that certain elderly patients, such as those suffering from diabetes, may have limited manual dexterity. Identifying an incorrect medicament is quite important, since the administration of a potentially incorrect dose of a medicament such as a short acting insulin in lieu of a long insulin could result in injury or even death.

Another concern that may arise with such disposable cartridges is that these cartridges are manufactured in essentially standard sizes and must comply with certain recognized local and international standards. Consequently, such cartridges are typically supplied in standard sized cartridges (e.g., 3 ml cartridges). Therefore, there may be a variety of cartridges supplied by a number of different suppliers and containing different medicaments but they may fit a single drug delivery device. As just one example, a first cartridge containing a first medicament from a first supplier may fit a medical delivery device provided by a second supplier. As such, a user might be able to load and then dispense an incorrect medicament (such as a rapid or basal type of insulin) into a drug delivery device without being aware that the medical delivery device was perhaps neither designed nor intended to be used with such a cartridge.

As such, there is a growing desire from users, health care providers, care givers, regulatory entities, and medical device suppliers to reduce the potential risk of a user loading an incorrect drug type into a drug delivery device. There is also, therefore, a desire to reduce the risk of dispensing an incorrect medicament (or the wrong concentration of the medicament) from such a drug delivery device.

There is, therefore, a general need to physically dedicate or mechanically code a cartridge to its drug type and design an injection device that only accepts or works with the dedication or coded features provided on or with the cartridge so as to prevent unwanted cartridge cross use. Similarly, there is also a general need for a dedicated cartridge that allows the medical delivery device to be used with only an authorized cartridge containing a specific medicament while also preventing undesired cartridge cross use.

There is also a general need to provide a dedicated cartridge that is difficult to tamper with so that the cartridge may not be compromised in that the cartridge can be used with an unauthorized drug or drug delivery device. Because such cartridges may be difficult to tamper with, they may also reduce the risk of counterfeiting: i.e., making it more difficult for counterfeiters to provide unregulated counterfeit medicament carrying products. It is an aim to provide means which reduces the potential risk of a user using an incorrect drug type cartridge.

SUMMARY

This aim is achieved by a cap for a cartridge having a bead at the distal end. The cap comprises a main body having a proximal end, a distal end, and a bore that receives the cartridge, the main body further comprising a first segment and a second segment. A retention feature is provided on the main body which is suitable for snapping under the bead of the cartridge for securing the cap to the cartridge.

The cap may serve as adaptor which is used with a cartridge or reservoir having a bead and a neck. The cap may be a adaptor top or vial adaptor. The cap may be used for securing the cartridge or reservoir within a drug delivery device. Preferably, the bore defines a diameter.

The distal end of the drug delivery device refers to that end of the drug delivery device which is closest to a dispensing end of the drug delivery device. The proximal end of the device refers to that end of the device which is furthest away from the dispensing end of the device. The distal end of the cartridge is the dispensing end of the cartridge. The distal portion of the cap refers to the portion that in use is closest to the distal end of the cartridge. The distal portion of the cap is the opposite portion.

In one embodiment the first segment is attached to the second segment by a hinge. The hinge may extend along at least a portion of a length of the main body of the cap from the proximal end to the distal end. Alternatively, the hinge may be located at the distal end of the main body. In one embodiment the hinge extends in a transverse direction. The hinge may extend along the radius on the distal top of the main body. Alternatively the hinge may extend on the distal top along another chord. The proximal portion of the main body may be moveable. In one embodiment the hinge is located at the proximal end of the main body.

The retention feature may be provided on the proximal end of the main body. In one embodiment the retention feature is a protrusion. In one embodiment the cap comprises at least one fastening mechanism for securing the first segment to the second segment. In one embodiment the retention feature includes at least one fastening mechanism for securing the first segment to the second segment, wherein the fastening mechanism may comprise a male element and a female element.

On embodiment of the cap further comprises a first coding feature that cooperates with a corresponding second coding feature of the drug delivery device, which enables securing the reservoir of the drug delivery device.

In one embodiment, the main body further comprises a thread configured for receiving a threaded needle hub, which enables attaching the needle hub. The first segment may comprise a first threaded portion and the second segment may comprise a second threaded portion.

In one embodiment the first segment and the second segment comprise a unitary main body. According to an exemplary arrangement, a cap for securing a reservoir within a drug delivery device is disclosed. The cap includes a main body having a proximal end, a distal end, and a bore defining a diameter that receives the reservoir. The main body includes a first segment and a second segment. These two segments may comprise a unitary main body. The cap also has a retention feature on the proximal end of the main body for securing the cap to the reservoir.

One embodiment of a drug delivery device comprises a dose setting mechanism; a reservoir holder or cartridge holder secured to the dose setting mechanism and a reservoir or cartridge contained within the reservoir holder or cartridge holder. A cap is secured to the reservoir or cartridge. The cap comprises a main body coupled to the reservoir or cartridge and having a proximal end, a distal end, and a bore defining a diameter that receives the reservoir or cartridge. The main body further comprises a first segment and a second segment; and a retention feature on the main body for securing the cap to the reservoir or cartridge.

In one embodiment, the first segment of the cap is attached to the second segment by a hinge. The hinge may extend along at least a portion of a length of the main body of the cap from the proximal end to the distal end. In one embodiment the hinge is located at the proximal end of the main body. A lower proximal portion of the main body may be moveable. In an alternative embodiment the hinge may be located at the distal end of the main body.

In one embodiment of the drug delivery device the retention feature may be a protrusion. The retention feature may include at least one fastening mechanism for securing the first segment to the second segment. One embodiment of the fastening mechanism includes a male element and a female element.

One embodiment of the drug delivery device further comprises a first coding feature that cooperates with a corresponding second coding feature of the drug delivery device so as to secure the reservoir to the drug delivery device.

In one embodiment of the drug delivery device the first segment of the cap comprises a first threaded portion and the second segment of the cap comprises a second threaded portion. The first segment and the second segment of the cap may comprise a unitary main body.

In another arrangement, a drug delivery device is provided. The drug delivery device includes a dose setting mechanism, a reservoir holder secured to the dose setting mechanism, a reservoir contained within the reservoir holder, and a cap for securing the reservoir within the reservoir holder. The cap includes a main body coupled to the reservoir and a proximal end, a distal end, and a bore defining a diameter that receives the reservoir. The main body also includes a first segment and a second segment. The cap also has a retention feature on the proximal end of the main body for securing the cap to the reservoir.

The terms “medicament”, “medication” and “drug”, as used herein, preferably mean a pharmaceutical formulation containing at least one pharmaceutically active compound,

wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

wherein the group-Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative;

or an Exendin-4 derivative of the sequence

or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative.

These as well as other advantages of various aspects will become apparent to those of ordinary skill in the art by reading the following detailed description, with appropriate reference to the accompanying drawings.

The scope of the invention is defined by the content of the claims. The invention is not limited to specific embodiments but comprises any combination of elements of different embodiments. Moreover, the invention comprises any combination of claims and any combination of features disclosed by the claims.

DETAILED DESCRIPTION

Referring toFIG. 1a, there is shown a drug delivery device100in the form of a pen type syringe. This drug delivery device100comprises a dose setting mechanism102, a reservoir or cartridge holder104, and a removable cap106. A proximal end105of the cartridge holder104and a distal end103of the dose setting mechanism102are removably secured together. The pen type syringe may comprise a re-usable or a disposable pen type syringe. Where the syringe comprises a re-usable device, the cartridge holder104and the dose setting mechanism102are removably coupled together. In a disposable device, they may be permanently coupled together. InFIG. 1a, the dose setting mechanism102comprises a piston rod109, such as a threaded piston rod that rotates when a dose is injected.

To inject a previously set dose, a double ended needle assembly (not shown) is attached to a distal end108of the cartridge holder104. Preferably, the distal end108of the cartridge holder104comprises a thread121(or other suitable connecting mechanism such as a snap lock, snap fit, form fit, or bayonet lock mechanism) so that the needle assembly may be removably attached to the distal end108of the cartridge holder104. When the drug delivery device100is not in use, the removable cap106can be releasably retained over the cartridge holder104.

An inner cartridge cavity111defined by the cartridge holder104is dimensioned and configured to securely receive and retain a reservoir or cartridge120. In an alternate embodiment, the cartridge120is inserted directly into the drug delivery device100without the use of a cartridge holder104.FIG. 1billustrates a perspective view of the cartridge120that may be used with the drug delivery device100illustrated inFIG. 1a. The cartridge120includes a generally tubular barrel122extending from a distal end130to a proximal end132. The distal end130is defined by an inwardly converging shoulder131.

At the distal end130, the cartridge120includes a smaller diameter neck126and this neck126projects distally from the shoulder131of the barrel122. Preferably, this smaller diameter neck126is provided with a large diameter annular bead and this bead extends circumferentially thereabout at the extreme distal end of the neck126. A pierceable septum or seal133is securely mounted across the open distal end defined by the neck126. The seal133may be held in place by a metallic sleeve or ferrule124. This ferrule124may be crimped around the circumferential bead at the distal end of the neck126. The medicament125is pre-filled into the cartridge120and is retained within the cartridge120, in part, by the pierceable seal133, the metallic sleeve or ferrule124, and the stopper128. The stopper128is in sliding fluid-tight engagement with the inner tubular wall of the barrel122. Axially directed forces acting upon the stopper128during dose injection or dose administration urges the medication125from the cartridge120though a double ended needle mounted onto the distal end108of the cartridge holder104and into the injection site. Such axially forces may be provided by the piston rod109.

A portion of the cartridge holder104defining the cartridge holder cavity111is of substantially uniform diameter represented inFIG. 1aby D1134. This diameter D1134is preferably slightly greater than the diameter D2136of the cartridge120. The interior of the cartridge holder104includes an inwardly-extending annual portion or stop that is dimensioned to prevent the cartridge120from moving within the cartridge holder104. In this manner, when the cartridge120is loaded into the cavity111of the cartridge holder104and the cartridge holder104is then connected to the dose setting mechanism102, the cartridge120will be securely held within the cartridge cavity111. More particularly, the neck126and ferrule124of the cartridge120are inserted in a proximal to distal direction into the open proximal end105of the cartridge holder104with the ferrule124eventually passing entirely into the cartridge holder104. With the cartridge holder104removably coupled to the dose setting mechanism102, the proximal end132of the cartridge120will typically abut a stop provided by the dose setting mechanism102.

A number of doses of a medicament125may be dispensed from the cartridge120. Preferably, the cartridge120contains a type of medicament125that must be administered often, such as one or more times a day. One such medicament125is insulin. A movable piston (not shown) is retained in a first end or proximal end132of the cartridge120and receives an axial force created by the piston rod109of the dose setting mechanism102.

The dose setting mechanism102comprises a dose setter117at the proximal end of the dose setting mechanism102. In one preferred arrangement, the dose setter117is rotated to set a dose. To administer this set dose, the user attaches the needle assembly (not shown) comprising a double ended needle on the distal end108of the cartridge holder104. In this manner, the needle assembly pierces the seal133of the cartridge120and is therefore in liquid communication with the medicament125. The user pushes on the dose setter117to inject the set dose. The same dose setting and dose administration procedure is followed until the medicament125in the cartridge120is expended and then a new cartridge120must be loaded in the drug delivery device100. To exchange an empty cartridge120, the user is called upon to remove the cartridge holder104from the dose setting mechanism102.

FIG. 2aillustrates a first embodiment of an example segmented cap200for use with a cartridge120or cartridge holder104that may be used with a pen type drug delivery device100, such as the drug delivery device100illustrated inFIG. 1a. The cap200may also be mechanically coded to the cartridge holder104to ensure that the correct cartridge120is used with the correct cartridge holder104and drug delivery device100.

The cap200has a main body202and may include a bore204that extends from a proximal end206to a distal end208of the main body202. The main body202may be separated into first and second segments209,210, which may be connected by a longitudinal hinge211that extends along at least a portion of a length of the cap200from the proximal end206to the distal end208. Alternatively, the first and second segments209,210may be independent from each other, and may be connected together during installation by snap fit features, adhesive, or welding, for example. As illustrated, the first segment209has a first threaded portion215and the second segment210has a second threaded portion217. When connected together during installation, the first threaded portion215and the second threaded portion217form an outer thread224(see, e.g.,FIG. 3). If these threaded portions215,217of these two segments209,210are misaligned with each other, it may be difficult to screw a needle onto the cap200. To reduce this problem, the mating edges located on the proximal end206of the cap200may be recessed with a chamfer.

When the cap200is in use, the bore204of the first segment209is placed over a ferrule124located at the distal end130of a cartridge120, such as ferrule124on cartridge120shown inFIG. 1b, and the second segment210is pushed together with the first segment209to surround all or part of the ferrule124. Preferably, the main body202has a diameter D3212that is slightly larger than the diameter D2 of the ferrule124of the cartridge120. Each segment209,210of the cap200further comprises an axially extending wall213that extends from a flange214located near the proximal end206of the main body202. These axially extending walls213extend towards the distal end208of the main body202.

Near the distal end208, the cap200may be provided with a pass through216. In one arrangement, the pass through216is sized and configured so that, when the cap200is placed over the ferrule124of the cartridge120and the segments209,210are secured together, the pass through216will expose a portion of the ferrule124of the cartridge120and will provide access to at least a portion of the pierceable seal133of the cartridge120.

Near the proximal end206, the cap200may include a retention feature218. The retention feature218may comprise a protrusion located within the bore204of the cap200. The retention feature218may be located on one or both of the first209and second210segments of the cap200. The retention feature218functions to secure the cap200to the cartridge120. Therefore, the retention feature218has an inner diameter that is smaller than the outer diameter of the ferrule124, making removal of the cap200from the cartridge120more difficult. Although the retention feature218is depicted as extending around the full diameter D3212of the cap200, it should be understood that the retention feature218may extend only around a portion of the diameter212of the cap200, or may be comprised of one or more separate features. The cap200may also include other suitable fastening features to secure the cap200to the drug delivery device100or to the cartridge holder104. For example, the cap200may fasten directly to the dose setting mechanism102such as using a bayonet lock or alternatively, it may clip into the cartridge holder104by way of a snap lock or a snap fit.

The retention feature218may further include a fastening mechanism. The fastening mechanism may comprise a male element220which may be connected to a female element222to secure the first segment209to the second segment210. Although the male element220is shown on the first segment209and the female element222is shown on the second segment210, it should be understood that the elements220,222may be reversed. Furthermore, it should be understood that any suitable fastening mechanism may be used to secure the first segment209to the second segment210.

In one arrangement, the cap200is intended for use with a standard double ended needle (not shown) wherein this needle comprises a hub having an internal thread. As such, an outer surface of the axially extending wall213of the main body202is provided with an outer thread224that receives such a hub of the double ended needle. Such an outer thread224could comprise a single or a double start outer thread. In addition, when such double ended needle is mounted onto the cap200, the piercing distal needle projects through the pass through216and into the pierceable seal133of the cartridge120.

The cap200may further include interlocking features to prevent rotation of the cap200relative to the cartridge holder104. The interlocking features may comprise protrusions with a triangular section pointed towards the distal end208. Alternatively, rotation of the cap200may be prevented by friction between the cap200and cartridge holder104.

In another embodiment, the cap200may be provided with at least one alignment feature (not shown), for example small protrusions or grooves, to ensure that both segments209,210of the cap200are correctly aligned when secured together. It should be understood that any suitable alignment features may be used.

In another arrangement, cap200may also include a first coding feature (not shown). The first coding feature may allow the cap200to be mechanically coded and cooperate with a second corresponding coding feature on the drug delivery device100. The second coding feature may alternatively be located on the cartridge holder104. Alternatively, the coding feature may comprise different colors of the cap200to distinguish between different drugs.

One advantage of the segmented cap200is that the cap200is tamper-evident. Removal of the cap200may damage the retention feature218, preventing the cap200from being attached to another cartridge120.

Another embodiment of an example cap300having a distal end308and a proximal end310is shown inFIGS. 4 and 5. In this embodiment, cap300may include a main body301having first and second segments302,304. The cap300has substantially the same structure as cap200, except that cap300includes a transverse hinge306at the distal end308of the cap300. Further, the cap300may include a retention feature312, shown inFIG. 5, which may be a protrusion located within the bore of the cap300. The retention feature312may be located on both the first302and second304segments of the cap300. The retention feature312may function in the same manner as retention feature218described above with respect to cap200.

The retention feature312may further include a fastening mechanism to secure the first segment302of the cap300to the second segment304. The fastening mechanism may include at least one first male element314which may be connected to at least one first female element318(shown inFIG. 5). The retention feature312may also include a second male element316that mates with a second female element320to further secure the first segment302to the second segment304. Although the male elements314,316are shown on the first segment302and the female elements318,320are shown on the second segment304, it should be understood that the elements may be reversed. Furthermore, it should be understood that any suitable fastening mechanism may be used to secure the first segment302to the second segment304.

FIG. 6shows yet another embodiment of a cap400. The cap400may include a main body401having a distal end402and a proximal end404. The cap400may also include a bore406through which a cartridge120, such as cartridge120inFIG. 1b, is received. In this embodiment, the cap400may be partially flexible, and may include a fastening mechanism, such as a pair of arms408,410, at the proximal end404of the cap400. The arms408,410may hinge or be flexible, so that they can snap under the ferrule124of the cartridge120, thereby locking the cap400to the cartridge120, in the same manner as retention feature218described above with respect to cap200.

FIG. 7shows yet another embodiment of a cap500of the. The cap500may include a main body501and a bore506that extends from a proximal end508to a distal end510of the cap500for surrounding the ferrule124of a cartridge120, such as ferrule124of cartridge120inFIG. 1b. The cap500has an axially extending wall504and a flange503.

Near the proximal end508, the cap500may include a flexible element such as hinge512.

Also near the proximal end508, the cap500may include a retention feature514. The retention feature514may function in the same manner as retention feature218described above with respect to cap200.

The cap500may further include a fastening mechanism to secure the hinged arm505to the main body501. The fastening mechanism may include at least one male element516that may be connected to at least one female element (not shown). Although the male element516is shown with its hinge512at the left hand end, it should be understood that the elements may be reversed. Furthermore, it should be understood that any suitable fastening mechanism may be used to secure the hinged arm505to the main body501.

The disclosed cap system results in a number of advantages. For example, the proposed cap system assists a user to distinguish between medicaments125, where used with mechanical coding, or colour, to distinguish from drugs without a cap200,300,400,500that may not be safe to use with the given drug delivery device100. This helps to ensure that a drug delivery device100can only be used with a medicament125for which the drug delivery device100is intended. Therefore, with the proposed cap system applied to a cartridge120, the cartridge120is prevented from being loaded into any other drug delivery device100by loading a cartridge120with an incorrect or unwanted interface. The cap system prevents a user from completing one or more of the following actions: fully inserting the cartridge120into an incorrect cartridge holder104or attaching the cartridge120and/or cartridge holder104onto an incorrect dose setting mechanism102.

The cap system also results in a low cost mechanism since the system does not require a large number of parts and can be manufactured in a cost effective manner. Moreover, there are quite a large number of different cap configurations that may be used. Consequently, with proposed cap system, a large number of medicaments125can be distinguished from one another. In addition, with the cap system, if a user attempts to load an incorrect reservoir or cartridge120into a cartridge holder104designed for a different cartridge120, the user will be alerted at an early stage of the assembly process.

Exemplary embodiments have been described. However, as those of skill in the art will recognize certain changes or modifications to such arrangements may be made. As just one example, features discussed herein may be taken from one arrangement and combined with features of other arrangements. Those skilled in the art will understand, however, that changes and modifications may be made to these arrangements without departing from the true scope and spirit of the present invention, which is defined by the claims.