Patent Application
20130096511
The present patent application may be generally directed to reservoirs, particularly reservoirs containing a medicament. More particularly, the present application may be generally directed to a coding for identifying a type of drug for use with a reservoir and reservoir housing so as to prevent unwanted reservoir cross use. As just one example, such medicament reservoirs may comprise an ampoule, a cartridge assembly, 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 syringes, pumps, inhalers, or other similar injection or infusing devices that require at least one reservoir containing at least one medicament.
Medicament reservoirs such as ampoules, cartridge assemblies, 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 housing. After the cartridge assembly 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 assembly. Where the drug delivery device comprises a reusable device, once the cartridge assembly is empty, the cartridge housing 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 assembly 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 assembly 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 acting 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 manufactured to 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 a 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 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 object of the present disclosure to facilitate provision of a drug delivery device with increased user safety.
This object is achieved, for example, by the subject matter of the independent claims. Advantageous embodiments and refinements are subject matter of the dependent claims.
According to an exemplary arrangement, a tactile identification coding for use with a drug cartridge is provided. The tactile identification coding includes a cartridge containing a drug and an identification coding located on the cartridge, the identification coding including a, preferably logical, symbol to visually and/or tactilely indicate to a user the type of drug contained in the cartridge.
In another arrangement, a drug delivery device is provided. The drug delivery device has a cartridge having an identification coding including a, preferably logical, symbol to visually and/or tactilely indicate to a user the type of drug contained in the cartridge. The drug delivery device furthermore has a cartridge holder to receive the cartridge. The cartridge may be retained in the cartridge holder. The cartridge holder includes a second tactile and/or visual identification coding that preferably corresponds to the, e.g. tactile, identification coding on the cartridge.
One aspect relates to a tactile identification system, comprising a cartridge containing a drug and an identification coding located on the cartridge. The, preferably tactile, identification coding may include a symbol, preferably a logical symbol, to visually and/or tactilely indicate to a user information about the drug, e.g. to indicate to the user the type of drug, contained in the cartridge.
A user may get information about the drug contained in the cartridge via the symbol. The user may gain the information tactilely and/or visually. Thus, the identification coding increases user safety as it provides information to the user about the drug. The symbol may be easily interpreted by the user, preferably tactilely and/or visually. The symbol is expediently visible from outside of the cartridge.
Preferably, the symbol indicates a drug action rate information, the drug action rate information including one of at least two different drug action rates. At least, the drug action rate information includes the information whether the drug action rate is “slow” or “fast”.
It is preferred that the drug action rate information is provided by the outer shape of the symbol. In this way, the drug action rate information may be derived directly by the user without any need for analyzing different aspects of the symbol. Preferably, the drug action rate information is provided by the outer shape alone.
Preferably, the symbol represents an animal. This enables the user to quickly read the code by recognizing the type of animal. Here, no detailed analysis of the outer shape is required, since animals are widely known by the users and as such the symbol will quickly be related an accordingly known representation of the animal.
Furthermore, it is preferred when the type of animal is typical for a drug action rate, i.e. at least typical for a fast or a slow drug action rate. In this case, the user may recognize the drug action rate without the need for the step of decoding a code since the representation of the code leads directly to the information that has to be indicated. This may enhance the comfort of the user when operating the device.
The symbol, particularly its shape, may be intuitively indicative for a characteristic of the drug, e.g. whether the cartridge contains a slow acting drug or a fast acting drug such as slow acting or fast acting insulin. Pictograms or other representations, e.g. pictograms or representations of animals, may be used as symbols for this purpose. If the drug is a fast acting drug, an animal which is known to move at high speed may be used. If the drug is a slow acting drug, an animal which is known to move at low speed may be used. For example, the identification coding, particularly the symbol, may comprise a turtle to indicate that the cartridge contains slow acting insulin or a hare to indicate that the cartridge contains fast acting insulin. The identification coding, in particular the symbol, may comprise a color. Preferably, the identification coding is distinguished and/or highlighted by the color from its surroundings.
The tactile identification system or coding may further comprise a cartridge holder, which is preferably configured to receive the cartridge or in which the cartridge is received. The cartridge holder may include or comprise a second tactile and/or visual identification coding. The second identification coding may correspond, e.g. in color, in shape and/or in the information it transports to the user, to the identification coding on the cartridge. The second identification coding may comprise a color. The identification coding and the second identification coding may comprise the same color. The identification coding may comprise a green turtle and the second identification coding may comprise the color green to indicate that the cartridge contains slow acting insulin, or the identification coding may comprise a pink hare and the second identification coding may comprise the color pink to indicate that the cartridge contains fast acting insulin.
The identification coding may comprise only one coding feature, e.g. the symbol, or a plurality of coding features, e.g. the symbol and one or more other features.
The identification coding may be secured to the cartridge by a fastener. The identification coding may be located on an outer surface of the cartridge.
The cartridge may be intended to be used with a drug delivery device. The device may be a reusable device or a disposable device.
A drug delivery device preferably comprises the tactile identification system or coding as described above. The drug delivery device may comprise a reusable drug delivery device or a disposable drug delivery device. Expediently, a cartridge holder is provided in the device to retain the cartridge.
In the following text, a set of further aspects of this disclosure is described. The aspects are denoted by numbers, which facilitates referencing the features contained in specific aspects by the respective number. These aspects are:
1. A tactile identification coding for use with a drug cartridge comprising:
a cartridge containing a drug;
an identification coding located on the cartridge, the identification coding including a logical symbol to visually indicate to a user the type of drug contained in the cartridge.
2. The tactile identification coding of aspect 1 wherein the identification coding comprises a turtle to indicate that a cartridge contains slow acting insulin.
3. The tactile identification coding of aspect 1 wherein the identification coding comprises a hare to indicate that a cartridge contains fast acting insulin.
4. The tactile identification coding of aspect 1 further comprising a cartridge holder configured to receive the cartridge.
5. The tactile identification coding of aspect 4 wherein the cartridge holder includes a second tactile identification coding that corresponds to the tactile identification coding on the cartridge.
6. The tactile identification coding of aspect 5 wherein the second tactile identification coding comprises a color.
7. The tactile identification coding of aspect 5 wherein the identification coding comprises a green turtle and the second tactile identification coding comprises the color green to indicate that a cartridge contains slow acting insulin.
8. The tactile identification coding of aspect 5 wherein the identification coding comprises a pink hare and the second tactile identification coding comprises the color pink to indicate that a cartridge contains fast acting insulin.
9. The tactile identification coding of aspect 1 wherein the identification coding comprises only one coding feature.
10. The tactile identification coding of aspect 1 wherein the identification coding comprises a plurality of coding features.
11. The tactile identification coding of aspect 1 wherein the identification coding is secured to the cartridge by a fastener.
12. The tactile identification coding of aspect 1 wherein the identification coding is located on an outer surface of the cartridge.
13. The tactile identification coding of aspect 1 wherein the drug cartridge is intended for use with a drug delivery device.
14. The tactile identification coding of aspect 13 wherein the drug delivery device comprises a reusable drug delivery device.
15. A drug delivery device comprising:
a cartridge having an identification coding including a logical symbol to visually indicate to a user the type of drug contained in the cartridge;
a cartridge holder to receive the cartridge, the cartridge holder including a second tactile identification coding that corresponds to the tactile identification coding on the cartridge.
16. The drug delivery device of aspect 15 wherein the identification coding comprises a turtle to indicate that a cartridge contains slow acting insulin.
17. The drug delivery device of aspect 15 wherein the identification coding comprises a hare to indicate that a cartridge contains fast acting insulin.
18. The drug delivery device of aspect 15 wherein the second tactile identification coding comprises a color.
19. The drug delivery device of aspect 18 wherein the identification coding comprises a green turtle and the second tactile identification coding comprises the color green to indicate that a cartridge contains slow acting insulin.
20. The drug delivery device of aspect 18 wherein the identification coding comprises a pink hare and the second tactile identification coding comprises the color pink to indicate that a cartridge contains fast acting insulin.
21. The drug delivery device of aspect 15 wherein the identification coding is secured to the cartridge by a fastener.
22. The drug delivery device of aspect 15 wherein the identification coding is located on an outer surface of the cartridge.
23. The drug delivery device of aspect 15 wherein the drug delivery device comprises a reusable drug delivery device
24. The drug delivery device of aspect 15 wherein the drug delivery device comprises a disposable drug delivery device.
Features, which are described above and below in connection with different aspects, arrangements or embodiments, may be combined with each other even if the combination is not explicitly described herein.
These as well as other features and 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.
Exemplary embodiments are described herein with reference to the drawings, in which:
a illustrates an exemplary pen type drug delivery device;
b illustrates an exemplary drug cartridge;
For purposes of the present application, a tactile identification coding is provided on a cartridge to provide a tactile and visual indication of the type of drug contained in the cartridge. The color or symbol used as the coding provides a logical and intuitive explanation to a user as to the type of drug. Thus, this coding ensures that the appropriate cartridge and drug can be correctly identified by the patient.
Such a cartridge may be used with any type of drug delivery device that utilizes a reservoir or cartridge, such as, for example, a reusable pen type drug delivery device, a disposable pen type delivery device, a prefilled syringe or any auto-injector.
Referring to
To inject a previously set dose, a double ended needle assembly (not shown) is attached to a distal end 108 of the cartridge holder. Preferably, the distal end of the holder 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 of the holder. When the drug delivery device is not in use, the removable cap 106 can be releasably retained over the cartridge holder 104.
An inner cartridge cavity 111 defined by the cartridge holder 104 is dimensioned and configured to securely receive and retain a cartridge, such as glass cartridge 120.
At the distal end 130, the cartridge 120 includes a smaller diameter neck 126 and this neck projects distally from the shoulder 131 of the barrel 122. Preferably, the smaller diameter neck 126 is provided with a large diameter annular bead 124 which extends circumferentially thereabout at the extreme distal end of the neck 126 and defines an opening 127. A pierceable seal or septum 133 is securely held across the opening 127 by a metallic sleeve or a ferrule.
Medicament 125 is pre-filled into the cartridge 120 and is retained within this cartridge, in part, by the pierceable seal 133, a ferrule, and a 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 urge the medication 125 from the cartridge 120 though a double ended needle mounted onto the distal end 130 of the cartridge holder 104 and into the injection site. Such axially forces may be provided by the piston rod 109 working in unison with the dose setting member 102.
A portion of the cartridge holder 104 defining the cartridge holder cavity 111 is of substantially uniform diameter represented in
A number of doses of a medicament 125 may be dispensed from the cartridge 120. Preferably, the cartridge 120 contains a type of medicament that must be administered often, such as one or more times a day. One such medicament is insulin.
The dose setting mechanism 102 comprises a dose setter 117 at the proximal end of the dose setting mechanism 102. In one preferred arrangement, the dose setter 117 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 of the cartridge holder. In this manner, the needle assembly pierces the seal 133 of the cartridge 120 and is therefore in liquid communication with the medicament 125. The user pushes on the dose setter 117 to inject the set dose. The same dose setting and dose administration procedure is followed until the medicament 125 in the cartridge is expended and then a new cartridge must be loaded in the drug delivery device. To exchange an empty cartridge, the user is called upon to remove the cartridge holder 104 from the dose setting mechanism 102.
In accordance with exemplary embodiments, a cartridge, such as cartridge 120, or cartridge holder, such as cartridge holder 104, may be coded to a delivery device, so that given cartridges and cartridge holders may only be connected with intended drug delivery devices and vice versa.
The coded cartridge 200 may include a visual and tactile identification coding 204. The coding includes a logical symbol to visually indicate to a user the type of drug contained in the cartridge. For example, as shown in
The visual and tactile identification coding 204 may comprise a number of different coding features, either alone or in combination. For example, the coding feature may comprise anything that represents a characteristic of the drug contained by the cartridge, such as an animal or object. The coding feature may also include a particular color. Further, the coding feature may comprise a specific texture, such as a rough or smooth surface, or a hard or flexible surface. The hard surface may be made of polycarbonate and the flexible surface may be made of PVC, for example.
Additional features which may be included as characteristics of the visual or tactile identification coding 204 are the size, shape, and orientation of the coding. For example, the coding may be large or small, and may be axial, circumferential, or radial protrusions, or ribs. Further, the coding feature may include protrusions or some other distinguishing feature to indicate differences in the drug compared to other drugs. The orientation of the coding may also be used to identify the type of drug in the cartridge. For example, the coding may project radially from the cartridge axis, in a transverse direction, or in an axial direction.
Turning now to
In operation, where the cartridge is used with a reusable drug delivery device, when a user needs to take a drug, they simply locate the tactile identification coding 204 on the cartridge 200 to determine which type of drug is contained in the cartridge. Next, the user identifies the appropriate cartridge holder 208 that matches up with the coding 204 located on the cartridge 200. The cartridge and holder may then be inserted into a drug delivery device, such as drug delivery device 100, modified to receive cartridge 200, and then be administered. Provided that the correct coding 204 is present and matched up with the correct second coding 208 on the cartridge holder, the user can be confident that they have administered the appropriate drug.
One advantage of the coded cartridge and cartridge holder system is that it may include more than one coding feature, thereby providing additional vigilance for preventing the accidental intake of the wrong type of drug by a patient.
The coded cartridge 300 may include a visual and tactile identification coding 304 that includes a logical symbol to visually indicate to a user the type of drug contained in the cartridge. For example, as shown in
Although shown as a single feature in
Turning now to
In operation, where the cartridge is for use with a reusable pen type delivery device, such as the delivery device illustrated in
Although aimed primarily at the insulin market, the presently proposed coded cartridge or cartridge holder may apply to other drugs. The proposed coding system may apply to various devices, including the following examples:
a. An injector pen with a cartridge (e.g. 3 ml cylindrical glass cartridge) and a separate holder. (reusable or disposable)
b. An injector pen with a cartridge (e.g. 3 ml cylindrical glass cartridge) non-removably retained in a holder, so that the holder will be disposed of with the primary pack.
c. An injector pen where the primary pack attaches directly to the pen, e.g. an injection-moulded polymer cartridge.
d. Any drug delivery device, with any type of primary pack, e.g. inhaler, pouch.
The proposed coding system results in a number of advantages. For example, the proposed coded cartridge holder arrangements assist a user to distinguish between medicaments, thereby helping to ensure that a delivery device is used with a medicament for which the device is intended. Therefore, with the system applied to a cartridge to form a cartridge assembly, the cartridge assembly is prevented from being loaded into any other drug by loading a cartridge with an incorrect fastening mechanism. The coded cartridge or cartridge holder prevents a user from completing one or more of the following actions: fully inserting the cartridge assembly into an incorrect cartridge holder or attaching the cartridge and/or cartridge holder onto an incorrect dose setting mechanism.
The coded cartridge or cartridge holder also results in a low cost coding mechanism since the proposed cartridge holders do 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 cartridge coding configurations between the cartridge, the cartridge holder, and the drug delivery device that may be used. Consequently, with proposed coding schemes, a large number of medicaments can be distinguished from one another. In addition, with the disclosed coding schemes, if a user attempts to load an incorrect cartridge assembly into a cartridge holder designed for a different cartridge assembly, the user will be alerted at an early stage of the assembly process.
In addition, the disclosed system can be used to prevent errors during manufacturing, when inserting cartridge assemblies into disposable cartridge holders or disposable devices. With an incorrect drug (and hence incorrectly coded cartridge), the user is alerted at an early stage of assembly.
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10171171.1 | Jul 2010 | EP | regional |
The present application is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2011/057039 filed May 3, 2011, which claims priority to U.S. Provisional Patent Application No. 61/331,096 filed May 4, 2010 and European Patent Application No. 10171171.1 filed Jul. 29, 2010. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP2011/057039 | 5/3/2011 | WO | 00 | 12/27/2012 |
| Number | Date | Country | |
|---|---|---|---|
| 61331096 | May 2010 | US |
