WO2012020091A1

WO2012020091A1 - Pen injector with rotating collar with coding features

Info

Publication number: WO2012020091A1
Application number: PCT/EP2011/063849
Authority: WO
Inventors: Richard James Vincent Avery; Joseph Butler
Original assignee: Sanofi-Aventis Deutschland Gmbh
Priority date: 2010-08-13
Filing date: 2011-08-11
Publication date: 2012-02-16

Abstract

A rotating mechanism or rotating member, e.g. a rotating collar (310) for attaching a cartridge holder (104, 304) and/or cartridge (120) within a dose setting mechanism (102, 300) is provided. The rotating mechanism comprises a main body (312) with an exterior surface, and an interior surface (313) defining an aperture (314), as well as at least one coding feature (309) provided on the interior surface (313). The aperture (314) of the rotating collar (310) is designed to contain at least a portion of a cartridge holder (104, 304) and/or cartridge (120). The rotating mechanism is rotatable between a first position and a second position. In the second position, at least a portion of the coding feature (309) of the rotating mechanism contacts and secures at least a portion of the cartridge holder (104, 304) and/or cartridge (120), thereby locking the cartridge holder (104, 304) and/or cartridge (120) within the rotating mechanism. The coding feature (309) comprises a hook-shaped feature designed to slide into a channel (308) of an extension (307) on the cartridge holder (104, 304) and/or the cartridge (120) and to be secured to the extension (307) when the rotating member is rotated from the first position into the second position, the hook-shaped feature being designed to prevent the rotating member from being removed from the second position within the channel (308). Furthermore, an assembly of such a rotating mechanism and a cartridge holder (104, 304) and/or cartridge (120) with corresponding coding features is disclosed.

Description

PEN INJECTOR WITH ROTATING COLLAR WITH CODING FEATURES

BACKGROUND

Field of Disclosure

The present disclosure is generally directed to reservoirs, particularly reservoirs containing a medicament or drug. More particularly, the present disclosure is generally directed to a rotating mechanism or rotating member for use with a reservoir and/or a reservoir holder so as to prevent unwanted 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 drug delivery devices, 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. The doses may be fixed or variable by the user. The medical delivery device, i.e. the drug delivery device may be a disposable device or a reusable device. 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 disposes 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/or 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 removal and subsequent cross use of an incorrect cartridge. 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 acting insulin could result in injury or even death. Some drug delivery devices or systems may use a color coding scheme to assist a user or care giver in selecting the correct cartridge to be used with a drug delivery device. However, such color coding schemes pose challenges to certain users, especially those users suffering from poor eyesight or color blindness: a situation that can be quite prevalent in patients suffering from diabetes.

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 which 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 a cartridge to its medication or drug type so as to prevent unwanted cartridge cross use. There is also a general need to provide a dedicated cartridge and/or a dedicated cartridge holder 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 or cartridge holders 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. The problem to be solved by the present disclosure is to provide a rotating mechanism, an assembly of a rotating mechanism and a cartridge holder and/or cartridge, and a drug delivery system which facilitate an administration of cartridge holders and/or cartridges.

SUMMARY

A rotating mechanism or a rotating or rotatable member for attaching a cartridge holder and/or cartridge to a dose setting mechanism is disclosed, the rotating mechanism comprising: a main body with an exterior surface, and an interior surface defining an aperture, and at least one coding feature provided on the interior surface of the main body. The aperture of the rotating mechanism may be designed to contain at least a portion of a cartridge holder and/or cartridge. The rotating mechanism may be rotatable between a first position and a second position and the rotating mechanism may be designed such that in the second position at least a portion of the coding feature interacts with at least a portion of a cartridge holder and/or cartridge, when the cartridge holder and/or cartridge is at least partially inserted into the aperture of the rotating mechanism, thereby locking the cartridge holder and/or cartridge within the rotating mechanism.

The rotation of the rotating mechanism or rotatable member from the first position to the second position may cause the coding feature of the rotating mechanism to affix to the cartridge holder and/or cartridge. The rotating mechanism may be part of a dose setting mechanism of a drug delivery system.

According to one aspect the coding feature comprises a hook-shaped feature designed to slide into a channel of an extension on the cartridge holder and/or the cartridge and to be secured to the extension when the rotating member is rotated from the first position into the second position, the hook-shaped feature being designed to prevent the rotating member from being removed from the second position within the channel. That means, the rotating member may be non-removably attached to the cartridge holder and/or cartridge.

Moreover, an assembly of an afore-mentioned rotating mechanism and a cartridge holder and/or cartridge is disclosed. The cartridge holder and/or cartridge may be at least partially inserted into the aperture of the rotating mechanism. At least a portion of the coding feature of the rotating mechanism may interact with at least a portion of the cartridge holder and/or cartridge, thereby locking the cartridge holder and/or cartridge within the rotating mechanism.

According to one aspect, the cartridge holder and/or cartridge may comprise a cartridge coding feature which is designed to code the cartridge holder and/or cartridge and to fit with the coding feature of the rotating mechanism, and wherein the coding feature of the rotating mechanism is affixed to the cartridge coding feature.

In one aspect, the cartridge holder and/or cartridge may comprise at least one axial extension, wherein the cartridge coding feature comprises at least one channel within the extension.

According to one aspect, the interaction of the coding feature of the rotating mechanism with the cartridge coding feature of the cartridge holder and/or cartridge may act as a fastening mechanism in order to affix the cartridge holder and/or cartridge to the rotating mechanism.

According to one aspect, the coding feature of the rotating member is secured with its hook-shaped feature within the channel of the extension on the cartridge holder and/or the cartridge, the hook- shaped feature preventing the rotating member from being removed from the channel. According to another aspect, the interaction of the coding feature of the rotating mechanism with the cartridge coding feature of the cartridge holder and/or cartridge may provide a coding functionality. The coding features only allow an appropriate cartridge holder and/or cartridge to be attached and secured to the rotating mechanism. This may prevent unwanted cross use of a cartridge holder and/or cartridge containing an incorrect medicament.

During assembly of the rotating member and a cartridge holder or cartridge, the aperture of the rotating member may be placed over the cartridge holder and/or the cartridge, which means that the cartridge holder or the cartridge may be axially inserted into the aperture. Once the cartridge holder or cartridge is axially inserted into the aperture, the rotating member and the cartridge holder and/or cartridge are in an assembled position. After the cartridge holder and/or cartridge and the rotating member are in the assembled position, the rotating member may be rotated in radial direction. The direction of rotation may be in a clockwise direction as viewed from the proximal end or top of the rotating member. But the direction of rotation may also be counter-clockwise as viewed from the top or proximal end or top of the rotating member. A visual indicator may be present on any of the cartridge holder and/or cartridge, and rotating member to show when the rotating member is fully rotated from a first position in a final second position. During assembly, in a first step the rotating member and the cartridge holder or cartridge preferably are axially moved towards each other and brought in an assembled position as explained above. In a second step, this pure axial assembly is followed by a preferably pure rotational movement of the rotating member from a first position into a second position, whereby the coding feature, preferably the hook-shaped feature, of the rotating member interacts with the coding feature of the cartridge holder and/or cartridge, preferably a channel within an extension on the cartridge holder and/or cartridge. In this way, the hook-shape feature may prevent the rotating member from being removed from the second position within the channel. That means the rotating member may be non- removably attached to the cartridge holder and/or cartridge.

Assembling the components may only be successful, if the coding features of the cartridge holder and/or cartridge fit with the coding features of the rotating member. This may prevent unwanted cross use of an incorrect cartridge holder and/or cartridge. Also rotation of the rotating member as explained above may only be successful, if the coding features of the cartridge holder and/or cartridge fit with the coding features of the rotating member. This may also prevent unwanted cross use of an incorrect cartridge holder and/or cartridge.

According to an exemplary arrangement, a rotating mechanism, especially a rotating collar for attaching a cartridge holder or cartridge assembly within a dose setting mechanism is provided. The rotating collar comprises a main body with an exterior surface, and an interior surface defining an aperture, as well as at least one coding feature, i.e. a collar coding feature, provided on the interior surface. The aperture of the rotating collar may be placed over a cartridge holder or cartridge assembly that comprises at least one cartridge coding feature, e.g. an axial extension with a channel or groove. The rotating collar may further be rotated from a first position to a second position. In the second position, at least a portion of the rotating collar coding feature contacts or affixes to at least a portion of the cartridge coding feature, i.e. at least a portion of the channel or groove of the axial extension of the cartridge holder or cartridge assembly, thereby locking the cartridge holder or cartridge assembly within the rotating collar.

In another alternative arrangement, a rotating mechanism, especially a rotating collar for attaching a cartridge within a dose setting mechanism is provided. The rotating collar comprises a main body with an exterior surface, and an interior surface defining an aperture, and at least one coding feature, i.e. a collar coding feature, provided on the interior surface. The aperture of the rotating collar may be placed over the cartridge, wherein the cartridge may be a molded cartridge that comprises at least one cartridge coding feature, and may be rotated from a first position to a second position. In the second position, at least a portion of the rotating collar coding feature contacts or affixes to at least a portion of the cartridge coding feature, thereby locking the cartridge within the rotating collar. According to one aspect, the exterior surface of the rotating collar may comprise at least one or preferably a plurality of grips. This allows a user to easily grip and handle the rotating collar.

According to another aspect, the rotation of the rotating collar from the first position to the second position may cause the collar coding feature to affix to the cartridge coding feature. After the rotating collar coding feature is affixed to the cartridge coding feature, the rotating collar coding feature may be configured such that it cannot subsequently be removed.

According to another aspect, the rotating collar is on a distal end of the dose setting mechanism. The rotating collar may be configured to be manually rotated from the first position to the second position by a user.

The rotating mechanism may be used within a dose setting mechanism comprising a rotating spindle, piston rod, lead screw or corresponding element for expelling a set dose from the cartridge. Moreover, the rotating mechanism may be used within a drug delivery device comprising a reusable drug delivery device.

Moreover, a drug delivery system is disclosed comprising a drug delivery device comprising a dose setting mechanism and an assembly of a rotating mechanism and a cartridge holder and/or cartridge as explained above. The assembly may be secured to the dose setting mechanism, e.g. via the rotating mechanism.

In one exemplary arrangement, a drug delivery system comprises a drug delivery device. The drug delivery device comprises a dose setting mechanism and a cartridge holder or cartridge assembly, wherein the cartridge holder or cartridge assembly may be secured to the dose setting mechanism. A cartridge may be contained within the cartridge holder or cartridge assembly, and the cartridge holder or cartridge assembly comprises at least one cartridge coding feature. The cartridge holder or cartridge assembly may comprise an extension which provides the cartridge coding feature, e.g. a channel or groove. A rotating mechanism, e.g. a rotating collar, is affixed to the dose setting mechanism. The rotating mechanism may be placed over the cartridge coding feature, i.e. the extension, of the cartridge holder or cartridge assembly, and may be configured to be rotated from a first position to a second position. In the second position, at least a portion of a coding feature on the rotating mechanism contacts or affixes to at least a portion of the cartridge coding feature, i.e. the extension, thereby locking the cartridge holder or cartridge assembly within the rotating mechanism.

According to an exemplary embodiment, the coding feature on the rotating mechanism comprises a hook-shaped feature. The hook-shaped feature may slide into the channel of the extension on the cartridge holder or cartridge assembly when the rotating mechanism is rotated. Moreover, the hook- shaped feature may become affixed or secured to the extension when the hook-shaped feature slides into the channel. Then, the rotating mechanism may be non-removably attached to the cartridge holder or cartridge assembly.

In a further embodiment, the rotating mechanism is configured to be manually rotated from the first position to the second position by a user. Moreover, the rotating mechanism may be provided on a distal end of the dose setting mechanism. According to one embodiment, the drug delivery device comprises a reusable drug delivery device. The cartridge may be removably contained within the cartridge holder or cartridge assembly. These features provide for a simple, fast and cost-effective loading of a new cartridge within the cartridge holder or cartridge assembly. The dose setting mechanism of the drug delivery device may comprise a rotating spindle, piston rod, lead screw or corresponding element for expelling a set dose from the cartridge.

These as well as other advantages of various aspects of the present disclosure 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 disclosure is defined by the content of the claims. The disclosure is not limited to specific embodiments but comprises any combination of elements of different embodiments. Moreover, the disclosure comprises any combination of claims and any combination of features disclosed by the claims. BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments are described herein with reference to the drawings, in which: Figure 1 illustrates an exemplary pen type drug delivery device;

Figure 2 illustrates a cartridge that may be loaded into a cartridge holder or cartridge assembly of the pen type drug delivery device illustrated in Figure 1 ; Figure 3 illustrates a first arrangement of a rotating mechanism, especially a rotating collar with a coding mechanism to connect a dose setting mechanism with a cartridge holder or cartridge assembly, that may be used with a pen type drug delivery device such as the drug delivery device illustrated in Figure 1 ; Figure 4 illustrates the rotating collar with coding mechanism and the cartridge holder or cartridge assembly illustrated in Figure 3 in the locked position; and

Figure 5 illustrates a cross-sectional view of the coding mechanism portion that may be used with the dose setting mechanism and the cartridge holder or cartridge assembly illustrated in Figures 3 and 4.

DETAILED DESCRIPTION

Referring to Figure 1 , there is shown a drug delivery device 100 in the form of a pen type injection device, e.g. a pen type syringe. This drug delivery device 100 comprises a dose setting mechanism 102, a cartridge holder 104 for carrying a cartridge 120, and a removable cap 106. A proximal end 105 of the cartridge holder 104 and a distal end 103 of the dose setting mechanism 102 are removably secured together. Where the device 100 comprises a re-usable device, the cartridge holder 104 and the dose setting mechanism 102 are removably coupled together. In a disposable device, they are permanently coupled together. In Figure 1 , the dose setting mechanism 102 comprises a spindle 109, piston rod or leadscrew, such as a threaded spindle 109, piston rod or leadscrew that rotates when a dose is injected. In particular, the threaded spindle 109 is helically moved in distal direction of the device 100 for expelling a predetermined amount of a medication out of the cartridge 120. The dose setting mechanism 102 comprises a dose setter 1 17 at the proximal end of the dose setting mechanism 102. In one preferred arrangement, the dose setter 1 17 is rotated to set and/or deliver a dose. To inject a previously set dose, a double ended needle assembly may be attached to a distal end 108 of the cartridge holder 104. Preferably, the distal end 108 of the cartridge holder 104 comprises a thread 121 (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 end 108 of the cartridge holder 104. When the drug delivery device 100 is not in use, the removable cap 106 can be releasably retained over the cartridge holder 104. An inner cartridge cavity 1 1 1 defined by the cartridge holder 104 is dimensioned and configured to securely receive and retain the cartridge 120.

Figure 2 illustrates a perspective view of the cartridge 120 that may be used with the drug delivery device 100, especially within the cartridge holder 104 illustrated in Figure 1. The cartridge 120 includes a generally tubular barrel 122 extending from a distal end 130 to a proximal end 132. The distal end 130 is defined by an inwardly converging shoulder 131 .

At the distal end 130, the cartridge 120 includes a smaller diameter neck 126 and this neck 126 projects distally from the shoulder 131 of the barrel 122. Preferably, this smaller diameter neck 126 is provided with a large diameter annular bead (not shown) and this bead extends circumferentially thereabout at the extreme distal end of the neck 126. A pierceable seal or septum 127 is securely mounted across the open distal end defined by the neck 126. The seal 127 may be held in place by a metallic sleeve or ferrule 124. This ferrule 124 may be crimped around the circumferential bead at the distal end of the neck 126. A medicament 125 may be pre-filled into the cartridge 120 and may be retained within the cartridge 120, in part, by the pierceable seal 127, the metallic sleeve 124, and the stopper 128. The stopper 128 is in sliding fluid-tight engagement with the inner tubular wall of the barrel 122. Axially directed forces acting upon the stopper 128 during dose injection or dose administration urges the medication 125 from the cartridge through a double ended needle mounted onto the distal end 108 of the cartridge holder 104 and into the injection site. Such axial forces may be provided by the spindle 109.

A portion of the cartridge holder 104 defining the cartridge holder cavity 1 1 1 is of substantially uniform diameter represented in Figure 1 by 134. This diameter is preferably slightly greater than the diameter D₂ 136 of the cartridge 120. The interior of the cartridge holder 104 includes an inwardly-extending annual portion or stop that is dimensioned to prevent the cartridge 120 from moving within the cartridge holder 104. In this manner, when the cartridge 120 is loaded into the cavity 1 1 1 of the cartridge holder 104 and the cartridge holder 104 is then connected to the dose setting member 102, the cartridge 120 will be securely held within the cartridge cavity 1 1 1 . More particularly, the neck 126 and metallic sleeve or ferrule 124 of the cartridge 120 are inserted in a proximal to distal direction into the open proximal end 105 of the cartridge holder 104 with the metallic sleeve or ferrule 124 eventually passing entirely into the holder 104. With the holder 104 removably coupled to the dose setting mechanism 102, the proximal end 132 of the cartridge 120 will typically abut a stop provided by the dose setting member 102. A number of doses of the medicament 125 may be dispensed from the cartridge 120. Preferably, the cartridge 120 contains a type of medicament 125 that must be administered often, such as one or more times a day. One such medicament is insulin. The stopper 128 is retained in a first end or proximal end 132 of the cartridge 120 and receives an axial force created by the spindle 109 of the dose setting mechanism 102.

To administer a set dose, the user attaches the needle assembly comprising a double ended needle on the distal end 108 of the cartridge holder 104. In this manner, the needle assembly pierces the seal 127 of the cartridge 120 and is therefore in liquid communication with the medicament 125. The user may push on the dose setter 1 17 to inject the afore-set dose. The same dose setting and dose administration procedure is followed until the medicament 125 in the cartridge is expended, at which time a new cartridge 120 may be loaded in the device 100, i.e. in the cartridge holder 104. To exchange an empty cartridge 120, the user is called upon to remove the cartridge holder 104 from the dose setting mechanism 102. The cartridge holder 104 may be attached and secured to the dose setting mechanism 102 of the device 100 via a rotating mechanism. In particular, this rotating mechanism may comprise at least one coding feature that may interact with another coding feature, especially a cartridge coding feature, provided on the cartridge holder 104. According to one aspect, the interaction of the coding feature of the rotating mechanism with the coding feature of the cartridge holder 104 may act as a fastening mechanism in order to affix the cartridge holder 104 to the dose setting mechanism via the rotating mechanism. Rotation of the rotating mechanism causes the coding feature of the cartridge holder 104 to affix to the coding feature of the rotating mechanism. In this way, the cartridge holder 104 may be secured and fastened to the dose setting mechanism 102. According to another aspect, the interaction of the coding feature of the rotating mechanism with the coding feature of the cartridge holder 104 may provide a certain coding functionality and may prevent unwanted cross use of a cartridge holder 104 retaining an incorrect cartridge 120 containing an incorrect medicament 125. Because providing coding features on the rotating mechanism and on the cartridge holder 104 only allows a cartridge holder 104 providing an appropriate coding feature to be attached and secured to the dose setting mechanism 102 of the device 100. Hence, only coding features of the rotating mechanism and the cartridge holder 104 fitting together may lead to an operational combination of a cartridge holder 104 with the dose setting mechanism 102 of the device 100.

Figure 3 illustrates a first arrangement of an exemplary embodiment of a rotating mechanism or rotatable member. The rotating mechanism comprises a rotating collar 310 with a coding mechanism, especially at least one collar coding feature, used to connect a cartridge holder or cartridge assembly with a device body or dose setting mechanism, such as the cartridge holder 104 and dose setting mechanism 102 in the pen type drug delivery device 100 illustrated in Figure 1 .

More specifically according to Figure 3, the rotating collar 310 is present on a dose setting mechanism 300. The rotating collar 310 is preferably located at the distal end 303 of the dose setting mechanism 300. In this manner, and as explained in greater detail below, rotating collar 310 can fit around a cartridge holder 304 so as to provide a releasable or a non-releasable locking mechanism to the drug delivery device corresponding to the dose setting mechanism 300, e.g. a drug delivery device 100 of Figure 1. As such, the arrangement of the rotating collar 310 and the cartridge holder 304 may be used with either re-usable or non-reusable drug delivery devices. The rotating collar 310 shown in Figure 3 comprises a cylindrically shaped main body 312 defining a centrally located aperture 314. Preferably, aperture 314 has a diameter that is slightly larger than the diameter of the cartridge holder 304. The exterior surface of main body 312 may comprise a plurality of grips 316 to aid a user in maintaining hold on the collar 310. Grips 316 may be channels or extrusions along the surface of main body 312, and may comprise a number of shapes and sizes to aid in the ergonomic handling of main body 312.

Cartridge holder or cartridge assembly 304 may contain a 3 ml cartridge. The cartridge holder 304 may be either detachable or non-detachable. In an alternative configuration, cartridge holder 304 may comprise a molded cartridge. Cartridge holder 304 comprises a plurality of cartridge coding features 306. Each coding feature 306 may comprise an axial extension 307 with a notch, groove, or channel 308, as shown in Figure 3. Channel 308 extends substantially horizontally through a portion of axial extension 307. Alternatively, coding features 306 may comprise a number of sizes, shapes, and/or positions that may differ from the sizes, shapes, and/or positions of coding features 306 of another cartridge holder 304 in order to provide coding features unique to the corresponding cartridge holders 304. In a further alternative arrangement, the body of the cartridge holder 304 may be extended in a proximal direction so as to the end of the axial extensions, so that the channels 308 are formed as grooves. In use, aperture 314 may be placed over the proximal end 305 of the cartridge holder 304, or the cartridge holder 304 may be axially inserted into aperture 314. Assembling the components 304 and 314 may only be successful, if the coding features 306 of the cartridge holder 304 fit with the collar coding features of the coding mechanism of the rotating collar 310. This may prevent unwanted cross use of an incorrect cartridge holder 304. The axial direction of insertion of the cartridge assembly 304 is shown by arrow 320. Once cartridge holder 304 is axially inserted into the aperture 314, the dose setting mechanism 300 and cartridge holder 304 are in the second or assembled position, shown in Figure 4.

After the cartridge holder 304 and the dose setting mechanism 300 are in the assembled position according to Figure 4, rotating collar 310 may be rotated in the radial direction shown by arrow 330. This may only be successful, if the coding features 306 of the cartridge holder 304 fit with the collar coding features of the coding mechanism of the rotating collar 310. This may also prevent unwanted cross use of an incorrect cartridge holder 304. The direction of rotation shown by arrow 330 may be in a clockwise direction as viewed from the proximal end or top of dose setting mechanism 300. Although the direction of radial rotation is shown as moving in the direction of arrow 330, the direction of rotation may be counter-clockwise as viewed from the top or proximal end of the dose setting mechanism 300. A visual indicator may be present on any of the cartridge holder 304, rotating collar 310, and/or the dose setting mechanism 300 to show when the collar is fully rotated and fastened in a final second position. As illustrated in Figure 4, the cartridge holder 304 may now be permanently or non-permanently attached and secured to the dose setting mechanism 300.

Figure 5 illustrates a cross-sectional view of the assembled dose setting mechanism 300 and cartridge holder 304 of Figure 4. In Figure 5, the interior, especially the interior surface 313 of rotating collar 310 may comprise collar coding features 309 that correspond and may interact with the cartridge coding features 306 of cartridge holder 304. Thus, as collar 310 is rotated in the direction of arrow 330, each collar coding feature 309 may be pressed into each channel 308 of each axial extension 307 of each cartridge coding feature 306. Each collar coding feature 309 may be shaped like a hook such that after being pressed into a channel 308, if collar 310 is attempted to be rotated in the direction opposite that of the direction shown by arrow 330, the hook on the respective collar coding feature 309 does not permit collar coding feature 309 from being removed from its position within channel 308.

The collar 310, when locked to cartridge holder 304, may interact with, e.g. engage a drive mechanism, at least the threaded spindle 109 (see Figure 1) in the dose setting mechanism 300, allowing a dose to be set and/or delivered.

In an alternative configuration, the rotating collar 310 may be sprung such that its free position is either open or closed. Thus, if sprung open, it would be more apparent to a user if an incorrect cartridge was fitted. And if sprung closed, there would be less risk of accidental opening. In this configuration, an over-center mechanism may allow the rotating collar 310 to be sprung either open or closed, depending on which side of the central position the user selects.

One advantage of using the dose setting mechanism 300 with a rotating collar 310 is that the fit of collar coding feature 309 within channel 308 may prevent the dose setting mechanism 300 from being affixed to the wrong cartridge holder 304. That is, the collar coding features 309 within rotating collar 310 and the cartridge coding features 306 on cartridge holder 304 may prevent unwanted attachment of the dose setting mechanism 300 from an incorrect cartridge holder 304 because the collar coding features 309 within collar 310 may be designed so as to be attachable only with one or more corresponding cartridge coding features 306 in a cartridge holder 304. In another alternate configuration, the rotating collar 310 may be located on the cartridge holder 304 instead of on the dose setting mechanism 300. The attachment of the cartridge holder 304 to the dose setting mechanism 300 would operate in the same way as described for Figures 3-5, except that the rotating collar 310 would be on the cartridge holder 304 instead of on the dose setting mechanism 300. Nevertheless, in this configuration coding features may also be provided on the dose setting mechanism for interacting with collar coding features of the rotating collar 310 on the cartridge holder 304.

Those of skill in the art will recognize that alternative geometries of the rotating collar and its at least one collar coding feature as well as the cartridge holder and its at least one cartridge coding feature may also be used. For example, the thickness, width, or length of any of the axial extension 307, or channel 308 may be altered. As another example, the curvature of collar coding feature 309 may be increased or decreased. A change in any of these features may alter the force applied required to rotate collar 310 once dose setting mechanism 300 is affixed to cartridge holder 304.

The proposed rotating collar with coding features may apply to any drug delivery device, e.g. pen type drug delivery devices, syringes, and inhalers, with any type of reservoir or primary pack, e.g. inhaler, cartridge, vial or pouch. The proposed rotating collar with at least one coding feature comprises a coding method to both the dose setting mechanism and cartridge holder to prevent insertion of a cartridge assembly into the incorrect dose setting mechanism. The rotating collar with coding feature may comprise a color that distinguishes the cap to be used for a specific drug.

The proposed rotating collar with coding feature results in a number of advantages. For example, the proposed rotating collar with coding feature helps to ensure that a delivery device can only be used with a medicament for which the device is intended. The rotating collar with coding feature prevents a user from affixing a dose setting mechanism to the wrong cartridge holder or cartridge assembly. The action of inserting the cartridge holder axially, followed by rotating the collar to lock the components, allows utilisation of coding features both axially and rotationally, thereby offering a large number of codes.

The rotating collar with coding feature also results in a low cost mechanism since the interface does not require a large number of parts and can be manufactured in a cost effective manner.

Exemplary embodiments of the present disclosure have been described. 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 disclosure, which is defined by the claims.

The term "drug" or "medicament", as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, 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.

Insulin analogues are for example Gly(A21), Arg(B31 ), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl- des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N- myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N- myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N- palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(u-carboxyheptadecanoyl)-des(B30) human insulin and Β29-Ν-(ω- carboxyhepta-'decanoyl) human insulin.

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-lle-Glu-Trp-Leu-Lys-Asn-

Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following list of compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,

H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,

des Pro36 [Asp28] Exendin-4(1-39),

des Pro36 [lsoAsp28] Exendin-4(1-39), des Pro36 [Met(0)14, Asp28] Exendin-4(1-39),

des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1-39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1-39); or des Pro36 [Asp28] Exendin-4(1-39),

des Pro36 [lsoAsp28] Exendin-4(1-39),

des Pro36 [Met(0)14, Asp28] Exendin-4(1-39),

des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1-39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1-39),

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

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,

des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Met(0)14, Asp28] Exendin-4(1-39)-Lys6-NH2,

des Met(0)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-Lys6-des Pro36 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25] Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative. Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin. A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates. REFERENCE NUMERALS

100 drug delivery device

102 dose setting mechanism

103 distal end

104 cartridge holder

105 proximal end

106 removable cap

108 distal end

109 spindle

1 1 1 inner cartridge cavity

1 17 dose setter

120 cartridge

121 thread

122 generally tubular barrel

124 metallic sleeve or ferrule

125 medicament 125

126 smaller diameter neck

127 pierceable seal or septum

128 stopper

130 distal end

131 converging shoulder

132 proximal end

134 diameter D1

136 diameter D2

300 dose setting mechanism

303 distal end

304 cartridge holder, cartridge assembly 306 plurality of coding features

307 portion of axial extension

308 notch, groove, or channel

309 collar coding feature

310 rotating collar

312 main body

313 interior aperture plurality of grips arrow

Claims

1. A rotating member for attaching a cartridge holder (104, 304) and/or a cartridge (120) to a dose setting mechanism (102, 300), the rotating member comprising:

- a main body (312) with an exterior surface, and an interior surface (313) defining an aperture (314); and

- at least one coding feature (309) provided on the interior surface (313) of the main body (312), wherein the aperture (314) of the rotating member is designed to receive at least a portion of the cartridge holder (104, 304) and/or the cartridge (120), and

wherein the rotating member is rotatable between a first position and a second position, and wherein the rotating member is designed such that in the second position at least a portion of the coding feature (309) is arranged to interact with at least a portion of the cartridge holder (104, 304) and/or the cartridge (120), when the cartridge holder (104, 304) and/or the cartridge (120) is at least partially inserted into the aperture (314) of the rotating member, to lock the cartridge holder (104, 304) and/or the cartridge (120) within the rotating member,

wherein the coding feature (309) comprises a hook-shaped feature designed to slide into a channel (308) of an extension (307) on the cartridge holder (104, 304) and/or the cartridge (120) and to be secured to the extension (307) when the rotating member is rotated from the first position into the second position, the hook-shaped feature being designed to prevent the rotating member from being removed from the second position within the channel (308).

2. The rotating member of claim 1 , wherein the rotating member is part of a dose setting mechanism (102, 300) of a drug delivery system.

3. The rotating member of claim 1 or 2, wherein the exterior surface of the main body (312) comprises a plurality of grips (316).

4. The rotating member of one of claims 1 to 3, wherein the rotating member is configured to be manually rotated from the first position to the second position by a user.

5. The rotating member of one of claims 1 to 4, wherein the rotating member comprises a rotating collar (310).

6. Assembly of a rotating member of one of claims 1 to 5 and a cartridge holder (104, 304) and/or a cartridge (120), wherein the cartridge holder (104, 304) and/or cartridge (120) is at least partially inserted into the aperture (314) of the rotating member, and wherein at least a portion of the coding feature (309) of the rotating member interacts with at least a portion of the cartridge holder (104, 304) and/or a portion of the cartridge (120), thereby locking the cartridge holder (104, 304) and/or cartridge (120) within the rotating member.

7. The assembly of claim 6, wherein the cartridge holder (104, 304) and/or the cartridge (120) comprises a cartridge coding feature (306) which is designed to code the cartridge holder (104, 304) and/or the cartridge (120) and to fit to the coding feature (309) of the rotating member, and wherein the coding feature (309) of the rotating member is affixed to the cartridge coding feature (306).

8. The assembly of claim 7, wherein the cartridge holder (104, 304) and/or the cartridge (120) comprises at least one axial extension (307), and wherein the cartridge coding feature (306) comprises at least one channel (308) within the extension (307).

9. The assembly of claim 8, wherein the hook-shaped feature of the coding feature (309) of the rotating member is secured within the channel (308) of the extension (307) on the cartridge holder (104, 304) and/or the cartridge (120), the hook-shaped feature preventing the rotating member from being removed from the channel (308).

10. A drug delivery system comprising:

a drug delivery device (100) comprising

- a dose setting mechanism (102, 300), and

- an assembly of one of claims 6 to 8, wherein the assembly is secured to

the dose setting mechanism (102, 300).

1 1. The drug delivery system of claim 10, wherein the drug delivery device (100) comprises a reusable drug delivery device.