Patent Application
20190046396
Specific embodiments of this disclosure relate to reservoirs, particularly reservoirs containing a medicament. More particularly, the present disclosure is generally directed to a collapsible drug reservoir, which may beneficially prevent reservoir use with an incorrect drug delivery device and which may be provided with certain coding features. As just one example, such medicament reservoirs may comprise a collapsible ampoule, cartridge, vial, or pouch, and may be used with a suitable 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.
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 may load 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 may be disconnected from the drug delivery device and the empty cartridge may be 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 reloading of empty cartridges have certain limitations. For example, in certain generally known systems, a user may simply load a new cartridge into the delivery system without the drug delivery device or without the cartridge having any mechanism of preventing cross use of an incorrect cartridge. That is, the drug delivery device does not have a mechanism for determining if the medicament contained in the cartridge is indeed the correct type of medicament to be administered by the patient. Alternatively, certain known drug delivery devices do not present a mechanism for determining if the correct type of medicament within the cartridge should be used with that particular drug delivery system. This potential problem could be exacerbated given that certain elderly patients, such as those suffering from diabetes, may have limited manual dexterity. Identifying an incorrect medicament is quite important, since the administration of a potentially incorrect dose of a medicament such as a short-acting insulin in lieu of a long-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. This is 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 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. However, these cartridges 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, mechanically code, or electronically code a cartridge to its drug type and to design an injection device that 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 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.
The problem to be solved by the present invention is to provide a drug reservoir and a drug delivery system where the safety for the user is improved.
One aspect of the present disclosure relates to a drug reservoir. The drug reservoir may be adapted for use with a drug delivery device. The drug reservoir may be collapsible. In particular, the drug reservoir may comprise a collapsible housing. This collapsible housing preferably stores a medicament, in particular one or a plurality of doses of the medicament. The medicament may have at least one drug agent. For example, the collapsible housing may be deformed when force is exerted on it, e.g. when the medicament is forced out of the housing. This may facilitate delivering the medicament from the reservoir. The collapsible drug reservoir may comprise a coding feature. The coding feature may be disposed on, along or in the reservoir, for example. The coding feature may be configured to code information related to the drug reservoir such that reading the code may help to identify the specific drug reservoir, in particular information related to the drug reservoir. In particular, the coding feature may serve for identifying the drug reservoir and, therefore, the medicament contained in the reservoir. The coding feature may prevent use of the drug reservoir with an incorrect drug delivery device.
According to an embodiment, a shape of the reservoir is configured to act as the coding feature. In particular, the shape of the collapsible housing may be configured to act as a coding feature identifying the medicament contained in the reservoir. According to an embodiment, the collapsible housing comprises a generally cylindrical structure. Alternatively, the collapsible housing may comprise a generally oval-shaped structure. Alternatively, the collapsible housing may comprise a triangular-shaped structure. Alternatively, the collapsible housing may comprise a trapezoidal-shaped top surface. A given shape or structure of the collapsible housing and/or its surface may identify a predetermined medicament held in the collapsible housing, for example. Furthermore, the given shape or structure may prevent the reservoir from being inserted into an incorrect device.
According to an embodiment, the drug reservoir further includes a port. The port may be adapted and arranged for fluid communication with the collapsible housing. In particular, this port may serve as an exit port from which the medicament stored in the collapsible housing may exit the housing. The coding feature may be located on the port, for example. The coding feature may comprise at least one of an indentation or a protrusion on the port.
The port may comprise a hub for attaching a needle, for example. Alternatively, the port may comprise a septum. The septum may be adapted and arranged to seal the port fluid-tightly. In particular, the septum may be configured to prevent flow of the medicament out of the collapsible housing. Alternatively, the port may comprise a tube. The tube may be configured to attach to at least one of a septum and a needle hub, for example. In particular, the tube may connect the port with one of the needle hub and the septum. Additionally or alternatively, the port may comprise a support ring. The support ring may be arranged circumferentially around the port. The support ring may comprise a stiff element. In particular, the support ring may be stiffer than the flexible housing and/or the port. The support ring may be configured to prevent the port from collapsing. The support ring may comprise the coding feature, for example.
According to an embodiment, the coding feature comprises a mechanical coding feature. The mechanical coding feature may be configured to cooperate with a corresponding, in particular mating, coding feature provided by the drug delivery device using the reservoir. The coding feature of the reservoir may comprise at least one of a recessed or raised feature. In particular, the coding feature may comprise an embossed feature, a hole or an indentation of the reservoir. For example, the coding feature may comprise a protrusion. In this case, the mating coding feature may comprise an indentation. For example, the mating coding feature may be arranged on an inner surface of a reservoir holder or a housing part of the device. Mechanical cooperation of the coding feature and the mating coding feature may help to prevent insertion of a reservoir having the wrong coding feature and, thus, as an example, holding a wrong type of medicament into the device. User safety may be increased in this way.
According to an embodiment, the coding feature is a coding feature configured to be electronically detectable. The electronically detectable coding feature may be detected when the reservoir is inserted into the drug delivery device, for example. In this way, a user may realize at once which medicament is contained in the reservoir.
According to an embodiment, the reservoir comprises a non-collapsible feature. The non-collapsible feature may be connected to the collapsible housing. The non-collapsible feature may comprise the coding feature. The non-collapsible feature may be a stiff element, for example. In particular, the non-collapsible feature may be stiffer than the collapsible housing. The coding element may comprise a coding plate, for example, or the previously mentioned support ring. The coding plate may be fixed to the reservoir. The coding plate may be preferably a stiff element. The coding plate may comprise one or a plurality of coding features.
According to an embodiment, the coding feature is provided on an outer edge of the reservoir. The outer edge may comprise a sealing means of the reservoir. In particular, the sealing means may seal the reservoir fluid-tightly such that medicament is prevented to leak from the outer edge of the reservoir.
According to an embodiment, the collapsible housing comprises a plurality of sheets of sheet material. The sheet material may be adapted to form the collapsible housing. The plurality of sheets may be sealed together. Preferably, the sheet material comprises several layers of material. The sheet material may comprise laminated material. The sheet material may provide at least one of a long-term chemical compatibility with a given drug or medicament and a barrier to air.
According to an embodiment, the collapsible housing is constructed from a single sheet of sheet material. The sheet material may be folded and crimped together to form the collapsible housing.
A further aspect relates to a drug delivery system. The drug delivery system may comprise a drug delivery device, e.g. a pen-type device, for example a pen-type injector. The drug delivery system may be configured to deliver a medicament. The drug delivery system may comprise a housing. The housing may receive the previously described drug reservoir. The housing may contain a dose setter. The dose setter may be operably connected to the reservoir. The drug delivery system may further include a dose button. The dose button may be operably connected to the reservoir of medicament. The dose button may be capable of being depressed by a user of the drug delivery system. A user may use the drug delivery system to deliver (e.g., by injecting) medicament that is stored in the coded collapsible drug reservoir.
According to an embodiment, the drug delivery system may comprise a dispensing mechanism. The dispensing mechanism may be configured for dispensing the medicament from the reservoir. In particular, the dispensing mechanism may be activated when the user depresses the dose button. The dispensing mechanism may provide at least one of a suction force, a compression force, and a sacrificial fluid in order to dispense medicament from the reservoir. For example, upon activating the dispensing mechanism, a compression force may be applied onto the collapsible housing such that medicament is forced out of the housing.
According to an embodiment, the device comprises a device coding feature. The device coding feature may be adapted and arranged to mechanically or electrically cooperate with the coding feature of the reservoir when the reservoir is connected to the device. Cooperation of the coding feature of the reservoir and the device coding feature may be configured to prevent use of the device with a non-mating reservoir. In particular, mechanical cooperation of the coding feature and the device coding feature may prevent that a reservoir holding a wrong medicament is inserted into the device. Thus, dispensing of a wrong type of medicament from the device may be prevented.
According to a preferred embodiment, a drug reservoir is provided which is adapted for use with a drug delivery device, the drug reservoir comprising a collapsible housing and a coding feature, wherein said coding feature is configured to code information related to the drug reservoir.
According to a preferred embodiment, a drug reservoir is provided comprising a collapsible housing, a port in communication with the collapsible housing, and a coding feature disposed on the drug reservoir, wherein said coding feature identifies the drug reservoir.
According to a preferred embodiment, a drug delivery system is provided to deliver medicament, the drug delivery system comprising a housing containing a dose setter operably connected to a reservoir of medicament containing at least one drug agent, wherein the reservoir comprises a collapsible housing, a port in communication with the collapsible housing, and a coding feature disposed on the drug reservoir, wherein said coding feature identifies the drug reservoir. The drug delivery system further comprises a dose button operably connected to the reservoir of medicament, wherein the dose button is capable of being depressed by a user of the drug delivery system.
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.
Exemplary embodiments are described herein with reference to the drawings, in which:
Referring first to
A reservoir from which a number of doses of a medicinal product may be dispensed is provided in the reservoir retaining part 102. Preferably, the reservoir contains a type of medicament that must be administered often, such as once or more times a day. One such medicament may be insulin, for example.
Drug delivery device 100 also includes a dose setting mechanism 110. This dose setting mechanism may include a dose button 112. A user of the drug delivery device 100 may use the dose setting mechanism 110 in order to set and deliver a dose of medicament from the reservoir provided in the reservoir retaining part 102. The dose setting mechanism 110 may operate in ways known in the art or later developed. 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 or reservoir retaining part 102 and the dose setting mechanism 110 may be removably coupled together. In a disposable device, they may be permanently coupled together.
The disclosed drug reservoir (see, for example, drug reservoir 200 in
The coded collapsible drug reservoir may offer numerous advantages over typical drug reservoirs. For example, the proposed collapsible reservoirs may be less expensive, more compact, and/or less fragile than typical drug reservoirs such as those typical drug reservoirs comprising a glass cartridge. Further, the coding may ensure that particular drugs are only used in the correct drug delivery device.
The coded collapsible drug reservoir may include a collapsible housing, and this collapsible housing preferably stores a medicament, preferably a plurality of doses of the medicament. The coded collapsible drug reservoir may further include a port that may be in fluid communication with the collapsible housing and hence the medicament contained within this housing. This port may serve as an exit port from which the medicament stored in the collapsible housing may exit the housing. Still further, the coded collapsible drug reservoir may include a coding feature disposed on, along, or in the drug reservoir. Among other things, this coding feature may serve to identify the drug reservoir and, hence, the medicament contained within the drug reservoir.
Beneficially, this coding feature may ensure that drugs are only used in the correct drug delivery device and/or that drug delivery devices can react to a drug in a correct or intended manner. Specifically, the disclosed reservoir and drug delivery system can help a user distinguish between medicaments, thereby ensuring that a delivery device can only be used with a medicament for which it is intended. Therefore, with the coded collapsible drug reservoir, a user may be prevented from loading an incorrect drug reservoir into a given delivery device due to a coding feature of the incorrect reservoir that is not intended for the given device. Accordingly, the user may be prevented from completing one or more of the following actions: fully inserting an incorrect reservoir into a reservoir holder, or attaching an incorrect reservoir and/or reservoir holder into a medical delivery device or medical delivery system.
Coded collapsible drug reservoirs in accordance with exemplary embodiments will be further described with reference to
As shown, each of these drug reservoirs includes a collapsible housing portion and a port in communication with the collapsible housing. Specifically, as shown in
The collapsible housings depicted in these figures may be composed of various materials that result in a collapsible structure. Examples of possible materials include polymers such as PET, PE, PVC, or PP, or foils such as aluminium. These housings may be formed from, for example, sheet material. The sheet material may be manipulated as necessary (e.g., folded and crimped (i.e., sealed at the edges)) in order to form a collapsible housing of a desired shape and size. The sheet material may comprise several layers or be of a laminated construction in order to meet various desired requirements. For example, desired requirements may include long-term chemical compatibility with a particular drug, a barrier to air, desired strength, and desired sealing capability.
Returning to
In an embodiment, the coding feature on a coded collapsible drug reservoir may be a mechanical coding feature. For instance, the coding may be coding by number of features, size, shape, position, asymmetry, coding by more than one dimension/feature, and/or color. Such a mechanical coding feature may cooperate with a corresponding coding feature on a drug delivery device, such as drug delivery device 100. Preferably, the mechanical coding feature is disposed on the drug reservoir. Such mechanical coding features will be described in greater detail below, with particular reference to
In addition to various possible types of features, these coding features for a collapsible drug reservoir may be located at various positions on or along the drug reservoir. For instance, the coding feature may be located on the port of the drug reservoir, a sidewall of the reservoir, a sealing means of the reservoir, the collapsible housing, an edge of the collapsible housing, and/or other locations. Various possible locations will be described with reference to
As particular examples, the coding features may be embossed or debossed features, holes, or indentations on an outer edge of the drug reservoir. Such features are depicted in
In an alternative arrangement, the coding features may comprise indentations and/or protrusions on the port of the coded collapsible drug reservoir. These indentations or protrusions may be orientated in practically any direction. For example, such indentations and/or protrusions may be oriented in the axial and/or traverse direction. The particular indentations or protrusions may depend on how the reservoir is intended to be attached to an intended drug delivery device. An example of such coding features is shown in
As another example, the coding feature for the collapsible reservoir may comprise a coding plate that is fixed to some point on the reservoir. An example of a coding plate is shown in
In an alternative arrangement, the collapsible drug reservoir may include a non-collapsible feature that is connected to the collapsible housing. In such an arrangement, the coding feature may be disposed on such a non-collapsible feature. Certain exemplary arrangements of possible coding features disposed along a non-collapsible feature of a collapsible reservoir are depicted in
As shown in
In additional embodiments, as mentioned above, the coding feature on a coded collapsible drug reservoir could be a coding feature that may be electronically detected. Reservoir 290 depicted in
The collapsible housing may be formed in various ways. In addition, the collapsible housing may have a variety of shapes and sizes. For example, the collapsible housing may have a generally cylindrical shape, a generally oval shape, a generally triangular shape, or a generally trapezoidal shape. Other shapes and reservoir geometries are possible as well. Further, various examples of different shapes and sizes of collapsible housings and how to form such housings are discussed with reference to
For example,
In other embodiments, the collapsible housing may be formed from a single sheet of sheet material. As just one example,
The shape and size of the coded collapsible drug reservoir may depend on the type of drug delivery device for which the reservoir is intended. For instance,
As described above, the coded collapsible reservoir may include a port that allows for the drug stored in the collapsible housing to exit the housing. This port may take various forms and may be different depending on the type of drug delivery device the reservoir is intended to be used with. For example, the port may include a hub for attaching a needle. For instance, with reference to
The port of the coded collapsible drug reservoir may be disposed on a sidewall of the reservoir, as shown in
As mentioned above, the proposed coded collapsible drug reservoir may be used in conjunction with a suitable and intended drug delivery device. Accordingly, the drug delivery system to deliver medicament may comprise a housing containing a dose setter operably connected to a coded collapsible drug reservoir of medicament containing at least one drug agent. This reservoir is preferably the coded collapsible drug reservoir discussed above. The drug delivery system further includes a dose button operably connected to the reservoir of medicament, wherein the dose button may be capable of being depressed by a user of the drug delivery system.
The drug delivery system may further include a dispensing mechanism for dispensing medicament from the collapsible reservoir. This dispensing mechanism is preferably operably connected to the dose button and the reservoir. The dispensing mechanism preferably operates to dispense the medicament stored in the collapsible housing when a user compresses the dose button to deliver a dose. The dispensing mechanism may operate in various ways to compress the collapsible reservoir and, thus, force the medicament out through the port of the reservoir.
For example, the dispensing mechanism may use a suction force to dispense the drug. For instance, the dispensing mechanism may comprise a peristaltic pump acting on a tube. As another example, the dispensing mechanism may use a compression force to dispense the drug. For instance, the dispensing mechanism may comprise a screw mechanism that advances a platen or a roller, which may compress the collapsible reservoir and force medicament through the port. As yet another example, the dispensing mechanism may displace the collapsible housing by a sacrificial fluid. For instance, the coded collapsible drug reservoir may be placed in a non-collapsible housing, and liquid and/or gas may be pumped into the non-collapsible housing. This sacrificial fluid may compress the collapsible housing and thereby force medicament to flow out of the collapsible reservoir.
Other mechanisms for dispensing medicament from a collapsible reservoir are possible as well. For example, medicament may be dispensed from the proposed coded collapsible reservoirs by osmotic pressure or the force of gravity.
As mentioned above, the disclosed concepts result in a number of advantages. For example, as mentioned above, the coded collapsible reservoirs may be less expensive, more compact, and less fragile than typical standard drug reservoirs. Further, there are quite a large number of coding features that can be used. Consequently, with the disclosed coding features, a large number of medicaments can be distinguished from one another. Moreover, with the disclosed coded reservoirs, if a user attempts to load an incorrect reservoir, the user may be alerted at an early stage of assembling the reservoir into a delivery device that the user is attempting to load an incorrect reservoir, and hence attempting to possibly use a wrong medicament.
Exemplary embodiments of the present invention 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 invention, which is defined by the claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10160871.9 | Apr 2010 | EP | regional |
The present application is a continuation of U.S. patent application Ser. No. 13/519,233, filed Dec. 7, 2012, which is a 35 U.S.C. 371 National Application of PCT/EP2011/050798 filed Jan. 21, 2011, which claims priority to U.S. Provisional Patent Application No. 61/297,608 filed Jan. 22, 2010 and European Patent Application No. 10160871.9 filed Apr. 23, 2010. The entire contents of each are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61297608 | Jan 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13519233 | Dec 2012 | US |
| Child | 16162141 | US |
