WO2012020088A2

WO2012020088A2 - Coded cartridge assembly

Info

Publication number: WO2012020088A2
Application number: PCT/EP2011/063846
Authority: WO
Inventors: Christopher Nigel Langley; Richard James Vincent Avery
Original assignee: Sanofi-Aventis Deutschland Gmbh
Priority date: 2010-08-13
Filing date: 2011-08-11
Publication date: 2012-02-16
Also published as: WO2012020088A3

Abstract

A cartridge assembly for use with a drug delivery device (100). The cartridge assembly comprises a cartridge (120) and a cartridge holder (104). The cartridge (120) is configured to attach to the cartridge holder (104) and comprises a coding feature disposed along a portion of the cartridge (120). The coding feature is configured to pass through a corresponding coding feature provided by the drug delivery device (100).

Description

CODED CARTRIDGE ASSEMBLY

FIELD OF DISCLOSURE The present disclosure is generally directed to reservoirs, particularly reservoirs containing a medicament. More particularly, it is generally directed to a coding mechanism for use with a reservoir and a reservoir holder so as to ensure the reservoir and reservoir holders are only used with the drug for which they are intended. 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 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 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 medicament 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 a cartridge to its drug type and design an injection device with a coding feature to prevent unwanted 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 cartridge assembly which comprises a cartridge holder; a cartridge; and a coding feature; wherein said coding feature is configured to affix to the exterior surface of said cartridge and pass through a corresponding coding feature provided by the cartridge holder. The coding feature of the cartridge may be a mechanical coding feature. The coding feature provided by the cartridge holder may be a mating mechanical coding feature.

In an alternative embodiment, the coding feature may comprise a bar code or an RFID coding. The cartridge assembly is provided for use with a drug delivery device. In one embodiment the cartridge assembly is configured to attach to a drug delivery device, more precisely to a dose setting mechanism of the drug delivery device. According to an exemplary arrangement, a coding feature configured to be affixed to the exterior surface of a cartridge and pass through a corresponding coding feature is provided by the cartridge holder. Such a coding feature may be arc-shaped.

One embodiment of the cartridge assembly comprises a cartridge and a cartridge holder. The cartridge is configured to attach to the cartridge holder and comprises a coding feature disposed along a portion of the cartridge. The coding feature is configured to pass through a corresponding coding feature provided by the drug delivery device. In one embodiment the coding feature comprises a deformable arc, so that the cartridge assembly for use with a drug delivery device is configured to attach to the drug delivery device, the cartridge assembly comprising a cartridge holder, a cartridge; and a coding feature. Said coding feature comprises a deformable arc configured to affix to the exterior surface of said cartridge and pass through a corresponding coding feature provided by the cartridge holder.

In one embodiment the deformable arc comprises a first end and a second end which are separated so as to define a gap in a first position. The first end and the second end may transition from said first position to a second position, wherein in said second position the distance between said first end and said second end is greater than in said first position, such that said gap is widened.

In one embodiment the deformable arc extends less than 360°. The deformable arc may comprise an interior surface, wherein said interior surface comprises an adhesive. In one embodiment the coding feature comprises an exterior surface, and at least one protrusion on said exterior surface. In one embodiment the coding feature comprises an exterior surface, and at least one indentation on said exterior surface. The coding feature may comprise an exterior surface with a plurality of protrusions and indentations.

In one embodiment the coding feature further comprises a main body with an aperture extending through the center of said main body.

In an alternative arrangement, a cartridge assembly is provided, comprising a cartridge holder, a cartridge, and a coding feature. The coding feature comprises a first section, a second section, and a hinge, which may be a living hinge, connecting the first section to the second section. The coding feature is configured so as to affix to the exterior surface of the cartridge and pass through a corresponding coding feature provided by the cartridge holder.

In one embodiment the coding feature comprises a first section and a second section. The coding feature may form a multi-part ring around the exterior of the cartridge.

In one embodiment the coding feature comprises an interior surface, wherein said interior surface comprises an adhesive. In one embodiment the coding feature extends less than 360°. The coding feature may comprise an exterior surface, and at least one protrusion on said exterior surface. The coding feature may comprise an exterior surface, and at least one indentation on said exterior surface. In one embodiment the coding feature comprises an exterior surface with a plurality of protrusions and indentations. In one embodiment the cartridge assembly comprises a coding mechanism comprising a plurality of coding features, wherein the coding mechanism is provided on the exterior of said cartridge.

In one embodiment the cartridge holder is configured to attach to the coding features on the cartridge. In yet another alternative arrangement, a dose setting mechanism for use with a cartridge assembly is provided, the cartridge assembly including a plurality of coding mechanisms with a plurality of coding features provided on the cartridge. The cartridge holder is configured to attach to the coding features on the cartridge.

In one embodiment the dose setting mechanism may be provided for use with a cartridge assembly, wherein the cartridge assembly comprises a cartridge, a plurality of coding mechanisms comprising a plurality of coding features, and a cartridge holder, wherein said plurality of coding mechanisms are provided on the exterior of said cartridge, and wherein said cartridge holder is configured to attach to the coding features on the cartridge. The plurality of coding mechanisms may form a multi-part ring around the exterior of said cartridge.

The terms "medicament" and "drug", as used herein, preferably mean 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, 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; Β29-Ν-(ω- 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.

These as well as other advantages of various aspects of the present invention 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.

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 of the pen type drug delivery device illustrated in Figure 1 ;

Figure 3 is a perspective view of an exemplary cartridge and an exemplary coding mechanism;

Figure 4 is a perspective view of the exemplary cartridge and coding mechanism of Figure 3;

Figures 5A, 5B, and 5C illustrate end views of the cartridge and coding mechanism of Figure 3; Figure 6 illustrates an alternative arrangement of a coding mechanism;

Figure 7 illustrates a perspective view of the coding mechanism of Figure 6 affixed to an exemplary cartridge holder; Figure 8 illustrates the coding mechanism of Figure 7; and

Figure 9 illustrates an alternative arrangement of a coding mechanism.

DETAILED DESCRIPTION

Referring to Figure 1 , there is shown a drug delivery device 100 in the form of a pen type syringe. This drug delivery device 100 comprises a dose setting mechanism 102, a cartridge holder 104, 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. 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 holder 104 and the dose setting mechanism 102 are removably coupled together. In a disposable device, they may be permanently coupled together. In Figure 1 , the dose setting mechanism 102 comprises a piston rod 109, 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 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 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 explicitly 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. The diameter of ferrule 124 is shown by D2 136. The medicament 125 is pre-filled into the cartridge 120 and is retained within the cartridge 120, in part, by the pierceable seal 127, the metallic sleeve or ferrule 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 medicament 125 from the cartridge 120 though 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 piston rod 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 D1 134. This diameter D1 is preferably slightly greater than the diameter D2 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 mechanism 102, the cartridge 120 will be securely held within the cartridge cavity 1 1 1 . More particularly, the neck 126 and 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 ferrule 124 eventually passing entirely into the cartridge holder 104. With the cartridge 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 mechanism 102. A number of doses of a 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 125 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 piston rod 109 of the dose setting mechanism 102.

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 a dose. To administer this 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 pushes on the dose setter 1 17 to inject the set dose. The same dose setting and dose administration procedure is followed until the medicament 125 in the cartridge 120 is expended, at which time a new cartridge 120 may be loaded in the drug delivery device 100. To exchange an empty cartridge 120, the user is called upon to remove the cartridge holder 104 from the dose setting mechanism 102.

Figures 3 and 4 illustrate a first arrangement of a coded cartridge assembly. A coding mechanism 200 is shown for use with a cartridge 120 that may be used with a cartridge holder 104 in a pen type drug delivery device 100, such as the cartridge 120 illustrated in Figure 2. More specifically, the coding mechanism 200 is fitted around the exterior surface of cartridge 120. In this manner, and as explained in greater detail below, coding mechanism 200 can provide a coding feature to the cartridge 120 to allow for assembly with a corresponding cartridge holder 104. The coding feature is a mechanical coding feature. In an alternative embodiment (not explicitly shown in the Figures) the coding feature may comprise a bar code or an RFID coding.

Figure 3 shows the coding mechanism 200 before placement on cartridge 120. The coding mechanism 200 shown in Figure 3 comprises an arc shaped main body 201 that defines a centrally located aperture 203. This aperture 203 extends through the entire length of main body 201 . Main body 201 comprises an exterior surface 202 with a plurality of coding features such as protrusions 204 and indents 205. Main body 201 also comprises an interior surface 206. The plurality of protrusions 204 and indents 205 (shown in Figures 5A, 5B, and 5C) may correspond to coding features present in cartridge holder 104. The coding features in the cartridge holder 104 are mating mechanical coding features. According to the alternative embodiment as mentioned above, the coding features of the cartridge holder 104 may comprise any elements cooperating with the coding feature of the cartridge, e.g. a bar code reader. Main body 201 does not extend 360°, but instead is broken up by a first end 208 and a second end 210 that define a gap 214.

In use, coding mechanism 200 is affixed to proximal end 132 of cartridge holder 104, as shown in Figure 4. Gap 214 may be used to properly align the coding mechanism 200 with the coding on the cartridge holder 104. A ridge made to correspond with gap 214 may be present on the inside of the cartridge holder 104, providing for proper alignment of the coding mechanism within the cartridge holder 104. Gap 214 may also provide for the reduction in radial play.

To transition coding mechanism 200 from its position off of the cartridge 120 in Figure 3 to its position on the cartridge 120 in Figure 4, the main body 201 of coding mechanism 200 is deformed. Figures 5A-5C are end view illustrations of main body 201 that show the deformation process of the main body 201 so as to place coding mechanism 200 around cartridge 120. In Figure 5A, main body 201 is in its rest or relaxed first position. Figure 5B shows that each of the first and second ends 208, 210 are pulled away from each other such that gap 214 expands. This expanded gap 214, shown in Figure 5B, allows for first end 208 and second end 210 to be placed around the exterior surface of cartridge 120. Coding mechanism 200 then slides against the exterior surface of cartridge 120 as the mechanism 200 is pressed toward the distal end 130 of cartridge 120. Coding mechanism 200 may continue to be pushed in this direction until the entire interior surface 206 of main body 201 abuts the exterior surface of cartridge 120.

In a preferred embodiment, coding mechanism 200 would be non-detachable once assembled on cartridge 120. Interior surface 206 may comprise an adhesive or glue to secure coding mechanism 200 to cartridge 120. In the alternative, other methods of retaining coding mechanism 200 may be used. Interior surface 206 is preferably shaped such that the angle of curvature corresponds with the curvature of the exterior of the cartridge 120, allowing for the interior surface 206 and the exterior of the cartridge 120 to be flush when mated.

Coding mechanism 200 may be manufactured in a number of ways. Coding

mechanism 200 may be a molding. In this instance, coding mechanism 200 may be molded to have a smaller diameter than the cartridge 120 on which it will be affixed, so that after it has stretched to pass over the cartridge 120, radial play is minimized. In the alternative, coding mechanism 200 may be a label, such as the identifier described in U.S. Application Serial No. 61/297,602, entitled "A Multi-Dimensional Identifier," the contents of which are fully incorporated herein. Figure 6 illustrates an alternative exemplary coding mechanism 300. In this

arrangement, the coding mechanism 300 comprises a first arced section 302 and a second arced section 304. First arced section 302 and second arced section 304 are attached to each other with a living hinge portion 305, and may be molded as an integral piece. First arced section 302 and second arced section 304 each comprise an interior surface 306 and an exterior surface 308. A plurality of coding features such as protrusions 310 may be present on exterior surface 308 and may correspond to coding features present in a cartridge holder 104. Indents may also be present on exterior surface 308. Figure 7 shows the coding mechanism 300 partially attached to a cartridge 120, such as the cartridge 120 from Figure 1 . As can be seen in Figure 7, first arced section 302 is affixed to the curved exterior of cartridge 120 such that the interior surface 306 mates with the exterior. In Figure 7, second arced section 304 is not attached to cartridge 120.

Second arced section 304 may be rotated on living hinge 305 from the position in Figure 7 toward the cartridge 120, such that the interior surface 306 moves toward the exterior of the cartridge 120. Figure 8 illustrates the coding mechanism 300 once interior surface 306 has rotated toward and mated with the exterior of cartridge 120. First end 312 and second end 314 may not touch when both sections 304, 306 are affixed to the cartridge, but instead may leave a gap between the ends 312, 314. In an alternative arrangement, shown in Figure 9, first arced section 302 and second arced section 304 may comprise separate pieces that are arranged around cartridge 120 so as to form a multi-part ring. Each arced section 302, 304 may comprise a plurality of coding features, such as protrusions and indents, to allow for a cartridge holder 104 with corresponding coding features to pass over the arced sections 302, 304. Those of skill in the art will recognize alternative geometries of these coding features may also be used. For example, the thickness or length of the coding mechanisms 200, 300 may be altered, and the gap 214 may range in size as well. A change in any of these features may alter the force applied required to deform the coding mechanisms 200, 300 to affix them to the cartridge 120. More than one coding mechanism 200, 300 around the cartridge 120 may be provided.

Although primarily aimed at the insulin market, the proposed coding schemes may apply to other drugs. In fact, the coding mechanism 200, 300 may apply to any drug delivery device 100, with any type of reservoir or primary pack, e.g. inhaler, pouch. Standard parts may be used on devices for dispensing all drugs, and the coding applied. One advantage of the proposed coding mechanism 200, 300 allows for a coding method to the cartridge holder 104 to prevent insertion of a cartridge 120 into the incorrect cartridge holder 104. The coding mechanism results in a number of advantages. The coding mechanism 200, 300 assists a user to distinguish between medicaments 125, thereby helping to ensure that a drug delivery device 100 can only be used with a medicament 125 for which the drug delivery device 100 is intended. Therefore, with the coding system applied to the cartridge 120, the cartridge 120 is prevented from being confused with any other drug by loading a cartridge 120 with an incorrect or unwanted interface. The coded system prevents a user from fully attaching the cartridge assembly onto an incorrect dose setting mechanism 102. In addition, with the coding schemes, if a user attempts to load an incorrect cartridge assembly, the user will be alerted at an early stage of the assembly process.

The coding mechanism 200, 300 also results in a low cost coding mechanism 200, 300 since the coding mechanisms 200, 300 do not require a large number of parts and can be manufactured in a cost effective manner. Moreover, because of the ease of alteration of the coding features, there are quite a large number of different coding configurations between the cartridge holder 104 and cartridge 120 that may be used. Consequently, a large number of medicaments 125 can be distinguished from one another.

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.

Reference numerals

100 drug delivery device

102 dose setting mechanism

103 distal end

104 cartridge holder

105 proximal end

106 cap

108 distal end

109 piston rod

1 1 1 cavity

1 17 dose setter

20 cartridge

121 thread

122 barrel

124 ferrule

125 medicament

126 neck

127 seal

128 stopper

130 distal end

131 shoulder

132 proximal end

134 D1

36 D₂

200 coding mechanism

201 main body

202 exterior surface

203 aperture

204 protrusion

205 indent

206 interior surface first end second end gap

coding mechanism first section second section hinge

interior surface exterior surface protrusion first end second end

Claims

1 . A cartridge assembly comprising:

a cartridge holder (104);

a cartridge (120); and

a coding feature;

wherein said coding feature is configured to affix to the exterior surface of said cartridge (120) and pass through a corresponding coding feature provided by the cartridge holder (104).

2. The cartridge assembly of claim 1 wherein the coding feature comprises a deformable arc.

3. The cartridge assembly of claim 2 wherein said deformable arc comprises a first end (208) and a second end (210) which are separated so as to define a gap (214) in a first position.

4. The cartridge assembly of claim 3 wherein said first end (208) and said second end (210) transition from said first position to a second position, wherein in said second position the distance between said first end(208) and said second end (210) is greater than in said first position, such that said gap (214) is widened.

5. The cartridge assembly of one of the claims 1 to 4 wherein said coding feature further comprises a main body (201 ) with an aperture (203) extending through the center of said main body (201 ).

6. The cartridge assembly of claim 1 wherein said coding feature comprises a first section (302) and a second section (304).

7. The cartridge assembly of claim 6 further comprising a hinge (305) connecting said first section (302) to said second section (304).

8. The cartridge assembly of claim 7 wherein said hinge (305) is a living hinge.

9. The cartridge assembly of claim 6 wherein the coding feature forms a multi-part ring around the exterior of said cartridge (120).

10. The cartridge assembly of one of the claims 1 to 9, wherein said coding feature comprises an interior surface (206, 306), and wherein said interior surface (206, 306) comprises an adhesive.

1 1 . The cartridge assembly of one of the claims 1 to 10 wherein said coding feature extends less than 360°.

12. The cartridge assembly of one of the claims 1 to 1 1 wherein said coding feature comprises an exterior surface (202, 308), and at least one protrusion (204, 310) on said exterior surface (202, 308).

13. The cartridge assembly of one of the claims 1 to 12 wherein said coding feature comprises an exterior surface (202, 308), and at least one indentation (205) on said exterior surface (202, 308).

14. The cartridge assembly of one of the claims 1 to 13 wherein said coding feature comprises an exterior surface (202, 308) with a plurality of protrusions (204, 310) and indentations (205).

15. The cartridge assembly of one of the claims 1 to 14 wherein the cartridge assembly comprises a coding mechanism (200, 300) comprising a plurality of coding features, wherein the coding mechanism (200, 300) is provided on the exterior of said cartridge (120).

16. The cartridge assembly of one of the claims 1 to 15 wherein said cartridge holder (104) is configured to attach to the coding features on the cartridge (120).

PAGE INTENTIONALLY LEFT BLANK