Method and system for determining information related to a drug reservoir

A method and system for detecting information related to a drug reservoir. The method includes transmitting energy at a coded material disposed on a drug reservoir, where the energy has at least one predefined characteristic. The coded material identifies information related to the drug reservoir. The coded material modifies the energy and emits the modified energy to a receiver. The method further includes receiving at the receiver the modified energy. The method further includes determining information related to the drug reservoir based on the modified energy as the drug reservoir is loaded into a drug delivery device.

FIELD OF THE INVENTION

The present disclosure is generally directed to a method and system for determining information related to a drug reservoir, particularly a drug reservoir containing a medicament. As just one example, such medicament reservoirs may comprise an ampoule, a cartridge, or a vial and may be used with a medical delivery device. Such exemplary medical delivery devices could comprise a syringe, a pen type syringe, a pump, or other similar device that requires a reservoir containing at least one medicament.

BACKGROUND

The present disclosure is generally directed to reservoirs, particularly reservoirs containing a medicament. More particularly, the present disclosure is generally directed to determining information related to a drug reservoir, which may help ensure that a drug delivery device can only be used with a drug reservoir for which it is 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.

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 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 dispose of the empty cartridges properly. Where the drug delivery device comprises a disposable device, once the cartridge is empty, the user is recommended to dispose of the entire device.

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

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 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.

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.

SUMMARY

According to an exemplary embodiment, a method of determining information related to a drug reservoir may comprise receiving energy, for example electromagnetic radiation, from a coded material. The coded material may be disposed on a drug reservoir and may identify information related to the drug reservoir. As an example, the information may be selected from the group comprising drug type, drug concentration, a manufacturing date of the reservoir, an expiration of the drug and a storage condition of the drug. Electronic means for determining the information may be provided. The electronic means may comprise a receiver for receiving the energy emitted by the coded material. The receiver may comprise at least one photosensor. Based on the received energy, as an example based on the received electromagnetic radiation, the information identified by the coded material may be determined. Furthermore, the electronic means may comprise a transmitter for transmitting electromagnetic radiation to the coded material. The transmitter may comprise an LED.

The method may comprise, before receiving energy emitted by the coded material, the step of transmitting energy at the coded material. The coded material, which identifies information related to the drug reservoir, may modify the energy, for example the electromagnetic radiation, and then emit the modified energy, for example the modified electromagnetic radiation, to the receiver. The transmitted energy may have at least one predefined characteristic, which may be modified by the coded material. In particular, the coded material may modifiy the energy, for example the electromagnetic radiation, by at least one of (i) shifting the frequency of the transmitted radiation, (ii) filtering the radiation, (iii) absorbing the transmitted radiation followed by gradually releasing the radiation, (iv) absorbing the transmitted radiation followed by releasing the radiation after a given delay, and (v) shifting the phase of the transmitted radiation. The method may further include receiving the modified energy at the receiver and, based on this modified energy, for example based on the modified characteristic, determine information related to the drug reservoir.

According to a first specific embodiment, a method of determining information related to a drug reservoir comprises an electronic means detecting light energy from a coded material. The coded material is disposed on the drug reservoir, and this coded material comprises material having at least one color. The method may further include determining the color of the detected light or light energy. Based on the color of the detected light or light energy, information related to the drug reservoir may be determined.

According to a second specific embodiment, a method of determining information related to a drug reservoir comprises transmitting energy at a coded material disposed on a drug reservoir, wherein the energy has at least one predefined characteristic and wherein the coded material identifies information related to the drug reservoir. The coded material modifies the energy and emits the modified energy to a receiver. Based on the modified energy, information related to the drug reservoir is determined.

According to a further specific embodiment, a method of determining information related to a drug reservoir comprises providing a drug reservoir comprising a coded material, wherein the coded material identifies information related to the drug reservoir. The method further comprises providing electronic means for determining the information, wherein the electronic means comprise a receiver and receiving by the receiver electromagnetic radiation emitted from the coded material. Based on the received electromagnetic radiation, information identified by the coded material is determined.

As an example, the step of determining information may be performed as the drug reservoir is loaded into the drug delivery device. Here, it may be determined that the drug reservoir is not intended for use with the drug delivery device. Then, an insertion of the drug reservoir into the drug delivery device may be prevented, for example by activating an electronic latch. Additionally or alternatively, an indication that the drug reservoir is not intended for use with the rug delivery device may be displayed.

According to another exemplary embodiment, a medical delivery device may comprise a drug reservoir holder operable to receive a drug reservoir. The delivery device may further comprise electronic means, for example an electronic device, for detecting information related to the drug reservoir. The electronic means may comprise a transmitter configured to transmit energy. Furthermore, the electronic means may comprise a receiver configured to receive energy. Moreover, the delivery device may comprise a processor and data storage. The processor may be configured to execute or trigger steps of determining information and execute or trigger actions based on the determined information. The data storage may comprise instructions executable by the processor to based upon the received electromagnetic radiation determine the information related to the drug reservoir. Additionally or alternatively, the data storage may comprise instructions executable by the processor to transmit energy via the transmitter. The received energy may be emitted by a coded material disposed on a drug reservoir, wherein the coded material identifies information related to the drug reservoir. The transmitted energy may be directed at the coded material. The coded material may modify the energy and emit the energy to the receiver of the electronic means. The device may further comprise a display configured to display at least a portion of the information related to the drug reservoir.

According to a first specific embodiment of the drug delivery device, the drug delivery device comprises a drug reservoir holder operable to receive a drug reservoir, electronic means for detecting information related to the drug reservoir. The electronic means comprise a receiver configured to receive electromagnetic radiation emitted from a coded material disposed on the drug reservoir, a processor and data storage. The data storage comprises instructions executable by the processor to determine the information identified by the coded material based upon the received electromagnetic radiation.

According to a further specific embodiment of the drug delivery device, the drug delivery device comprises a drug reservoir holder operable to receive a drug reservoir and an electronic device for detecting information related to the drug reservoir. The electronic device comprises a transmitter configured to transmit energy, a receiver configured to receive energy, a processor and data storage. The data storage comprises instructions executable by the processor to transmit energy via the transmitter, wherein the transmitted energy is directed at the coded material disposed on a drug container, and wherein the coded material modifies the energy and emits the energy to a receiver. Based upon the modified energy received at the receiver, information related to the drug reservoir is determined.

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.

DETAILED DESCRIPTION

The proposed method and system allows for identifying information related to a drug reservoir by an electronic means. The proposed system and method may help a user to distinguish between medicament reservoirs, thereby ensuring that a medical delivery device can only be used with a medicament reservoir for which it is intended. In an arrangement, a given drug delivery device may be intended to only be used with a single drug reservoir. Thus, the proposed system and method may help a user ensure that only the single given drug reservoir is used with the given drug delivery device. However, in other arrangements, a given drug delivery device may be intended for use with multiple drug reservoirs. Thus, the proposed system and method may help a user ensure that only the intended reservoirs are used with the drug delivery device. In addition to allowing a user to identify whether a given drug reservoir is intended to be used with a drug delivery device, the proposed system and method may also inform a user of other useful information regarding a drug reservoir, such as required storage conditions for the reservoir and/or expiration date of the reservoir.

In a first embodiment, information regarding a drug reservoir may be determined by optical detection of a coded material by an electronic means. In a second embodiment, information regarding a drug reservoir may be determined by detecting color of a coded material by an electronic means. These embodiments for identifying information related to a drug reservoir are described in greater detail below.

Exemplary Method and System for Identifying Information Related to a Drug Reservoir

An Exemplary Architecture

FIG. 1depicts a system100for optical detection of a coded material. This system100may determine information related to a drug reservoir. System100includes transmitter102, at least one receiver107, and processor112. The system may also comprise data storage130comprising instructions132executable by the processor112to carry out the functions described herein. The processor112may comprise a single processor such as a general purpose microprocessor or multiple (e.g., parallel) processors. The data storage130may take various forms, in one or more parts, such as a non-volatile storage block and/or a removable storage medium, and may include program instructions132executable by processor112for carrying out the system functions described herein. Data storage130may also include data134, which may be used for carrying out the functions described herein.

An Exemplary Operation

The system100may operate to identify information related to a drug reservoir. Specifically, system100may operate to identify information related to a drug reservoir by first identifying a coded material, such as coded material120. As described in greater detail below, the coded material120can be applied to a reservoir such as a cartridge, vial, ampoule, pouch, or container. This coded material120may serve to indicate information about the drug reservoir the coded material120is disposed on. In a preferred embodiment, coded material120is disposed on a drug reservoir, such as drug reservoir400depicted inFIG. 4.

FIG. 9is a flowchart of an exemplary method that may be carried out by system100, in accordance with an exemplary embodiment. As shown inFIG. 9, method900begins at step902, where system100transmits energy at coded material120, which is preferably disposed on a drug reservoir. The coded material120modifies the energy and emits the modified energy to receiver107. At step904, receiver107receives the modified energy. Then, at step906, based on the modified energy, system100determines information related to the drug reservoir. These steps are further explained in the following subsections.

(a) Transmitting Energy at the Coded Material

In accordance with the proposed method and system, instructions132executable by the processor112may first cause the transmitter102to transmit energy103. The energy103is preferably transmitted at coded material120, which as described above is preferably disposed on a drug reservoir, such as drug reservoir400depicted inFIG. 4. For example, the coded material120may be on the reservoir, ferrule, bung, label, connector or an adaptor. However, in other given embodiments, the coded material120may be disposed elsewhere, such as on the box of a drug reservoir(s).

The transmitted energy103may be any type of energy, such as electromagnetic radiation, and the transmitter may be an LED. The transmitted energy103is preferably electromagnetic radiation in the ultra-violet (UV) range. However, the transmitted energy103may be electromagnetic energy in other ranges, such as the visible range or infra-red (IR) range. This energy preferably has at least one predefined characteristic, such as a known frequency, duration, and/or known intensity. By having a known predefined characteristic, system100will be able to identify a type of coded material120based on how the coded material120modifies this transmitted energy having a known, predefined characteristic.

(b) Receiving the Modified Energy at the Receiver

After the energy is transmitted at coded material120, the coded material120modifies the energy103and emits the modified energy105to a receiver107. This material120may be composed of material specifically selected to modify energy in a highly predictable way. As such, the coded material120may be composed of various materials or combinations of various materials. For example, coded material120may be in the form of volatile chemicals, particles to be identified microscopically, magnetic particles, and/or energy emitting particles, such as fluorescent or phosphorescent materials. At step904, the receiver107receives the modified energy105.

The receiver107may be a single receiver or may include a plurality of receivers, such as sensors104,106,108,110. The sensors may be, for example, photosensors. For instance, the sensors may be a PIN diode, a phototransistor, a Complementary Metal Oxide Semiconductor (CMOS) sensor (also known as an Active Pixel Sensor (APS)), or a Charge Coupled Device (CCD). Other types of sensors are possible as well.

The receiver107may be specifically configured to receive or detect certain information or signals. For example, sensors104,106,108, and110may each be configured to detect different information. Further, to aid in detecting different information, other components such as filters114,116, and118may be placed before certain sensors, such as sensors106,108, and110, respectively.

In an example, sensor104may be configured to receive the intensity of modified emitted energy105, sensor106may be configured to receive any light from a first color, sensor108may be configured to receive any light from a second color, and sensor110may be configured to receive any light from a third color. For example, there may be three filters to detect the colors red, green, and blue light. Color would then be identified by calculating the ratio of light from each sensor. The fourth sensor without a filter could measure the total intensity.

As mentioned above, the coded material120may modify the transmitted energy103in a variety of ways.FIGS. 2(A)-(B) depict examples of how coded material120may modify the transmitted energy. However, it should be understood that these figures are intended to serve as examples of energy modification, and the coded material120may modify the energy in additional ways.

With reference toFIG. 2(A), the coded material120may cause a frequency shift in the transmitted energy. As depicted in theFIG. 2(A), the energy emission (i.e., the modified energy105) from the coded material120may be at a lower frequency than the absorbed energy (i.e., the transmitted energy103). This change in frequency is commonly referred to as “down-converting” or a “Stokes shift.” In alternative embodiments, the energy emission from the coded material120may be at a higher frequency than the absorbed (i.e., transmitted) energy (not depicted). This change in frequency is commonly referred to as “up-converting” or an “anti-Stokes shift.” Different types of coded material120may cause different frequency shifts.

In other embodiments, the coded material120may act as a filter, as depicted byFIG. 2(B). As shown, a narrow band of energy105may be returned when the coded material120is excited with energy103of a broad spectrum. Other examples of filtering are also possible. For instance, a broad spectrum may be returned when the coded material120is excited with a narrow band of transmitted energy. Different types of coded material120may filter the energy in different ways.

In other embodiments, the coded material120may modify the transmitted energy103by absorbing the energy103and then gradually releasing the energy (e.g., phosphorescence or persistence) with a given rate of decay. An example of such absorption and emission is shown for a plurality of coded materials120inFIG. 2(C). Certain coded materials120may have a given rate of decay, and decay rates may be chosen from a wide range of rates. For instance, the half-life of a material may vary from nanoseconds to hours. Different types of coded material120may have different rates of decay. For example, as depicted, the coded materials120for drugs1-3have a different rate of decay. Thus, when the receiver107detects energy emission at a given rate, the system100may determine the type of coded material120disposed on the drug reservoir. A mix of phosphorescent materials may be used to control the decay rate of the coded material120. The materials may preferably be mixed onto the same area of the container; however, each phosphorescent material may be located on a separate area than the other phosphorescent materials.

In other embodiments, the coded material120may modify the transmitted energy by causing a time shift, as depicted inFIG. 2(D). Coded material120may absorb transmitted energy at a give time and emit the energy only after a given delay. Different types of coded material120may cause different time shifts. For example, coded material for drug1may absorb transmitted energy at t=0 and emit the energy at t=1, coded material for drug2may absorb transmitted energy at t=0 and emit the energy at t=2, and coded material for drug3may absorb transmitted energy at t=0 and emit the energy at t=3.

Further, the coded material120may modify the transmitted energy by causing a phase shift, as depicted inFIG. 2(E). Different types of coded material120may cause different phase shifts. Other types of energy modification by the coded material120are possible as well.

In order to accurately identify the coded material120, the receiver107must be able to distinguish between the transmitted energy103(illumination) and the energy105modified by the coded material120. For various reasons (e.g. losses in the material, or scattering of light), the receiver107may detect the illumination103with higher intensity than the modified energy105, so the modified energy105may be difficult to detect. To alleviate this problem, in one embodiment, optical filters may be used to filter out the illumination. Alternatively, if the coded material120delays the release of energy (phosphoresence), the illumination103may be applied for a pulse, and then the response detected after the illumination103is switched off. In another embodiment, if the coded material120uses a frequency shift (fluorescence), down-converting the frequency makes it easier to distinguish the modified energy105from the illumination103. Optical sensors are generally most sensitive to IR, and the response reduces through higher frequencies (visible and then UV). So, in a system such as system100that uses high frequency illumination (e.g., UV) and when lower frequencies emitted by the coding material120(e.g., visible), the coding is easy to distinguish from the illumination103.

In another embodiment, the effects of ambient light may be filtered out electronically. For example, the system100may be programmed to read for ambient light before the illumination103(i.e., transmitted energy) is turned on. Additionally or alternatively, the system100may be programmed to read for ambient light after the response has decayed sufficiently.

Since the coded material120may modify the transmitted energy103in a predictable way, system100may determine what type of coded material120is disposed on the drug reservoir400based on the received energy105. Different coded materials120will modify the transmitted energy103in different ways. Therefore, based on the modified energy105, system100may identify the coded material120.

(c) Determining Information Related to the Drug Reservoir

Based on this modified energy105, the system100determines information related to the drug reservoir. As described above, the system100is able to determine information related to the drug reservoir based on modified energy105because the coded material120may modify the transmitted energy103in a predictable way. Based on the identified coded material120, system100may identify information related to the drug reservoir. For instance, coded material120may vary for different types of drug reservoirs. As a particular example, a first given coded material120may be associated with a first drug reservoir and may modify the transmitted energy103in a first way. A second given coded material120may be associated with a second drug and may modify the transmitted energy103in a second way. Further, a third coded material120may be associated with a third drug reservoir, and so forth.

As a particular example, if the received modified energy105detected by system100indicates that the energy103was modified in the first way, system100may determine that the drug reservoir is the first drug reservoir. However, if the received modified energy indicates that the energy was modified in the second way, the system may determine that the drug reservoir is the second drug reservoir.

As discussed above, system100may comprise data storage130that includes data134. This data134may comprise a database of information that links a plurality of coded materials120to respective information regarding a given drug reservoir. For example, the database may include information that links a given coded material120to a type of drug the drug reservoir contains. In addition to identifying a type of drug or drug reservoir, the coded material120may serve to identify other information about a drug reservoir. For example, the information related to the drug reservoir may be information related to drug type, a drug concentration, a manufacturing date of the reservoir, an expiration date of the drug, and a storage condition of the drug (e.g., required storage temperature). Other types of information about a drug reservoir are possible as well.

In accordance with the proposed method and system, a large amount of information may be coded (e.g., distinguishing a large number of medicament reservoirs) by varying the coded material or coding features disposed on the drug reservoir. For instance, multiple materials may be provided in order to provide coding for drug reservoirs. The multiple materials may be configured to emit energy, for example electromagnetic radiation, wherein the energy from the multiple materials may differ in at least one predefined characteristic. The determined information may comprise information based on the differing predefined characteristics. For example, three coded materials may be provided that each fluoresce to a different color. Based on these three different materials, there may be eight (2^3) possible combinations that may each define given information about a drug reservoir (e.g., eight different types of drug reservoirs). An example of eight possible combinations301-308using three different materials is shown inFIG. 3(A). As shown, each combination may serve to identify a different drug (i.e., Drug Nos.1-8). It should be understood that many more combinations are possible by, for instance, using four or more coded materials. In the above example, it is assumed that the sensors can only detect the presence (or absence) of each color. If the sensors can detect the ratio of each color, far more combinations could be distinguished.

In some embodiments, the position of the coded material120may also be used for identification purposes. For example, position of the coded material120relative to a standard feature may be used to identify information about the drug reservoir. As such, system100may be further configured to detect the position of the coded material120. As an example, with reference toFIG. 4(A), system100may be configured to detect the position of the coded material120relative to the axial length from the distal end402of the drug reservoir400. For instance, coded material120at position410may indicate to system100that the drug reservoir is reservoir400; coded material120at position420may indicate to system100that the drug reservoir is reservoir404; and coded material120at position430may indicate to system100that the drug reservoir is reservoir406. If position is used for the coding, the position on different drugs is preferably far enough apart (e.g., 10 millimeters (mm)) so that the drugs may be accurately distinguished from one another.

In alternative embodiments, the system100may identify a coded material120based on the size (e.g., the axial, circumferential, and/or radial extent of the coded material120) or orientation (e.g., axial strips, circumferential rings, or 2D pattern) of the coded material120.

The coded material120is preferably non-visible, e.g. UV or IR radiation. Therefore, the coded material120may not aesthetically affect the drug reservoir, and allow for covert coding; however, the system100would still be capable of identifying the drug reservoir based on the non-visible coded material120. It should be understood, however, that the coded material120may be visible.

An Exemplary Drug Delivery Device

In accordance with the disclosed system and method, system100may be provided on or in a drug delivery device, such as syringes, pen-type injection syringes, credit-card-shaped injection devices, pumps, inhalers, or other similar injection or infusing devices that require at least one reservoir containing at least one medicament. For example, system100may be provided in pen type drug delivery device600shown inFIG. 6. The drug delivery device600comprises a housing602having a first cartridge retaining part604, and second main (exterior) housing part606that includes a dose setting mechanism. A first end of the cartridge retaining means604and a second end of the main housing606are secured together by retaining features608. In this illustrated arrangement, the cartridge retaining means604is secured within the second end of the main housing606. 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 holder604and the dose setting mechanism are removably coupled together. In a disposable device, they may be permanently coupled together.

A drug reservoir such as drug reservoir400, from which a number of doses of a medicinal product may be dispensed, may be inserted in the cartridge retaining part604. Preferably, the drug reservoir400contains a type of medicament that must be administered often, such as once or more times a day. One such medicament is insulin.

In an embodiment, the system100is provided at or near the interface between the cartridge retaining part604, and main housing part606. Thus, when a drug reservoir400is inserted in the drug delivery device600, the system100may detect information related to the reservoir400being inserted.

Since information regarding the drug reservoir400may be detected during or after a drug reservoir400is inserted into a drug delivery device600, the method and system may react to the identified information at various stages in an operating sequence of the drug delivery device600. Specifically, system100may be configured to take certain actions when a drug reservoir400is identified. For instance, the system100may react to the information and take an appropriate action during (i) loading of the device, (ii) dose selection, and (iii) dispensing of the drug. Other stages are possible as well. Beneficially, during these steps, the system100may help a user identify whether the drug reservoir400being loaded or that is loaded is intended for the drug delivery device600.

The step of determining information related to the drug reservoir400may be performed as a user loads the drug reservoir400in drug delivery device600. System100may identify the coded material120and then may determine, based on the coded material120, whether the drug reservoir400is intended for use with the drug delivery device600.

In an embodiment, when the drug reservoir400is not intended for use with the drug delivery device600, the system100may display an indication that the drug reservoir400is not intended for use with the drug delivery device600. For instance, as shown inFIG. 1, the system100may comprise a display feature140that is in communication with the processor112. This display feature140could indicate that the drug reservoir400is incorrect. For example, the display feature may display a red dot or red “X” when an incorrect drug reservoir is loaded. The display feature400may also operate to indicate when a correct drug reservoir400is loaded. For example, the display feature140may display a green dot when a correct drug reservoir400is loaded. Other types of indications are possible as well, such as an audible indication.

If a user attempts to insert an incorrect reservoir400into the drug delivery device600, the system100may operate to prevent the insertion of the drug reservoir400into the drug delivery device600. For instance, preventing insertion of the drug reservoir400may comprise activating an electronically-controlled latch, such as latch150shown inFIG. 1, which prevents insertion of the drug reservoir400. System100may also be configured to prevent the reset of a piston rod of the drug delivery device600with an incorrect drug container400.

In an embodiment, system100may be configured to block the insertion of all drug reservoirs other than a given drug reservoir for which the drug delivery device is intended. In another embodiment, the system may be configured to only block drugs that are considered dangerous for using with the device (e.g., a short-acting drug could be fitted into a device intended for long-acting insulin, or a low-concentration drug could be fitted into a device intended for a high-concentration drug, but not vice versa).

The method and system may also react to an identified drug reservoir and take an appropriate action during a dose selection phase (i.e., when a user is selecting a dose). For instance, system100may be configured to control dose selection based on the identified drug reservoir. Similar to preventing loading of an incorrect drug reservoir, system100may be configured to prevent dose selection when the identified drug reservoir is not intended for use with the drug delivery device. System100may, for instance, trigger a latch, such as latch150that prevents a user from setting a dose when an incorrect reservoir is loaded in the drug delivery device.

Other examples of controlling dose selection are possible as well. For instance, system100may control dose selection based on the identified drug reservoir by setting or enforcing a maximum dose. The drug reservoir may contain a drug that should only be dosed in small increments (e.g., 20 units or less). Thus, the system100may be configured to prevent a user from setting a dose greater than20units when such a drug reservoir is inserted in the drug delivery device. As another example, system100may control dose selection based on the identified drug reservoir by setting or enforcing a minimum dose.

As yet another example, system100may control dose selection based on the identified drug reservoir by controlling the dosing frequency. For instance, if a drug should not be dosed more than once a day, after a user injects a dose, the system100may be configured to lock the drug delivery dose setting mechanism out for a 24-hour period. For example, the system100may activate the electronic latch150to prevent dose setting for the 24-hour period.

The method and system may also react and take an appropriate action during the dispensing phase (i.e., when a user dispenses the drug). The system100may be configured to control dispensing of the drug based on the identified drug reservoir. For example, similar to preventing loading of an incorrect drug reservoir and dose selection with an incorrect reservoir, system100may be configured to prevent dispensing when the identified drug reservoir is not intended for use with the drug delivery device.

As another example, controlling dispensing of the drug based on the identified drug reservoir may include controlling a dispense speed and/or a required dispense force. Controlling a dispense speed and/or a required dispense force may be beneficial for various reasons. For example, certain drugs may require an increased dispense force due to crystallizing on the bung and/or high viscosity. In such a case, it may be beneficial to inject the drug slowly in order to reduce the force needed by a motorized drive. Further, in such a case, injecting such a drug may be painful for the user, so slower injection may reduce any pain. As another example, one other reason to control speed/force is to detect abuse loads, e.g. to detect blockages it is necessary to know what force is ‘normal’ for a given drug at a given speed.

As yet another example of identifying information related to a drug reservoir, system100may be used to identify the time that has elapsed since a drug reservoir was loaded into a drug delivery device. For example, the time at which the cartridge holder latch was last operated could be recorded into memory in the device, or on the drug reservoir.

Alternatively, rather than system100being disposed in or on a drug delivery device, system100may be a stand-alone device, such as a scan gun or used for identifying information related to drug reservoirs or a drug-identification base station. The stand-alone system may be used by, for example, a patient or medical staff personnel, or a drug manufacturer in order to identify information related to drug reservoirs. Such a stand-alone device may be used for a variety of reasons. For example, the stand-alone system may be used to aid with storage or shipping of drug reservoirs. As a particular example, the system100may be used to identify the expiration date of the drug reservoir. As another example, system100may be used to identify required storage conditions for the drug reservoir. It may also be possible to record storage conditions experienced by a cartridge, e.g. with a temperature sensitive label, and for this information to be read by the device.

The transmitter102and receiver107of system100may be arranged in various ways in order to transmit the energy103at a coded material120and receive the emitted energy105at the receiver107. For instance, transmitter102and receiver107may be adjacent to one another. For example, the transmitter102and receiver107may be arranged as shown inFIG. 5(A). The transmitter102and receiver107may be at any angle in a transverse or longitudinal plane, but the receiver107would preferably be normal to the surface of the container. Alternatively, the transmitter102and receiver107may be on opposite sides of the drug reservoir400, as shown inFIG. 5(B). If the coded material120is located on a curved surface, and if the surface is misaligned relative to the transmitter102and receiver107, the modified energy105might not be transmitted towards the receiver107. To resolve this potential issue, the coded material120may be provided on a flat surface of the drug reservoir400, such as on an adaptor.

In an embodiment, the coded material120may be applied around the full circumference of the drug reservoir400. For example, as shown inFIG. 4(A), coded material120is applied around the full circumference of drug reservoir400. In such an embodiment, the orientation of the drug reservoir400as it is loaded is not important. In other arrangements, the coded material120may be a discrete area, (e.g. a strip) of material that is not disposed around the full circumference of a reservoir400, such as the strips of coded material120shown inFIG. 4(B).

In an alternative embodiment, the coded material120may be aligned with the receiver(s) of system100when a drug reservoir400is loaded. Alignment may be accomplished in various manners, such as aligning the coded material120with the receiver of system100using a mechanical protrusion or indentation in the drug reservoir400to force alignment.

In an embodiment, where multiple areas of coding are applied, the multiple areas of coding may be read during insertion into the reading apparatus, so that only one receiver107is needed. For example, a reservoir400may have three areas of coding, such as a coded area indicating a storage condition, a coded area indicating the type of drug, and a coded area indicating expiration date. These coded areas may be displaced vertically 5 mm apart from one another. As a drug reservoir is inserted into the system, the system may scan the coded areas at each 5 mm interval and may identify all three coded materials120.

It should be understood that the functional and structural properties described above are not limited to the system as shown inFIGS. 1 and 9. In particular, any of the disclosed methods and drug delivery devices may comprise any of these properties and any combination of these properties.

Another Exemplary Method and System for Identifying Information Related to a Drug Reservoir

As mentioned above, in another embodiment, information regarding a drug reservoir may be determined by detecting color of a coded material120by an electronic means.FIG. 7illustrates a system700for detecting color of a coded material120. Thereby, this system700may determine information related to a drug reservoir. System700includes at least one receiver707and processor712. The system may also comprise data storage730comprising instructions732executable by the processor712to carry out the identification functions described herein. The data storage730may take various forms, in one or more parts, such as a non-volatile storage block and/or a removable storage medium, and may include (a) program instructions732executable by processor712for carrying out the system functions described herein and (b) data734. In an embodiment, to improve accuracy of system700, the system700may include a transmitter that illuminates the colored areas by light of a known frequency or intensity.

This system700detects colors in a similar fashion to system100as described above. Furthermore, system700is related in some respects to system100, and thus is not described in as great of detail. It should be explicitly noted, however, that many possibilities and permutations described above with respect to system100may equally apply to system700. However, rather than transmitting energy at the coded material120and detecting emitted energy, the system700is configured to detect the color of the coded material120. In certain embodiments, however, a transmitter, such as the transmitter102illustrated inFIG. 1and described above, may be used to illuminate the coded material120.

Further,FIG. 10is a flowchart of an exemplary method that may be carried out by system700, in accordance with an exemplary embodiment. As shown inFIG. 10, method1000begins at step1002, where system700detects light energy from a coded material, such as coded material120, which is preferably disposed on a drug reservoir. The coded material120comprises a material having at least one color. At step1004, the color of the detected light energy is determined. Then, at step1006, based on the color of the detected light energy, information related to the drug reservoir is determined by system700.

Beneficially, a large amount of information may be distinguished by using color codes. For example, referring toFIG. 3(B), if there are two colored areas on a drug reservoir and each colored area can be one of three colors, there are nine possible combinations,310-318. It should be appreciated that more combinations of color codes are possible by increasing the number of colored areas and/or the number of possible colors. Further, given that many drug reservoirs are already color-coded reservoirs, this proposed method1000and system700beneficially avoids the need for additional coding on a drug delivery device. That is, system700may be used for drug reservoirs as currently manufactured, without the need to add an additional coding material to the reservoirs.

It should be understood that the functional and structural properties described above are not limited to the system and method as shown inFIGS. 7 and 10. In particular, any of the disclosed methods and drug delivery devices may comprise any of these properties and any combination of these properties.

The disclosed concepts result in a number of advantages. For example, the disclosed concept may result in a user-friendly system that identifies information related to a drug reservoir automatically by electronic means. More, there are quite a large number of different coding materials that may be used. Consequently, with the disclosed coding scheme, a large number of medicaments can be distinguished from one another. Moreover, with the disclosed coding scheme, if a user attempts to load an incorrect reservoir, the user may be alerted at an early stage of the assembly step that the user is attempting to load in incorrect reservoir, and hence attempting to possibly use a wrong medicament.

Additionally, the proposed system and method may make drug reservoirs difficult to counterfeit. The proposed system and method may beneficially reduce tampering and/or counterfeiting of drug reservoirs. Because such reservoirs with coded materials 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.

An additional benefit is that an electrical connection is not needed to the drug delivery device, making it easy to use and portable, etc.

Although aimed primarily at the insulin market, the invention may apply to other drugs. The disclosed method and system may apply to various devices, including the following examples; an injector pen with a cartridge (e.g. 3 ml cylindrical glass cartridge) and a separate holder as illustrated inFIG. 6. Applicant's present application may also apply to 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, and to an injector pen where the primary pack attaches directly to the pen, e.g. an injection moulded polymer cartridge.

In other applications, the disclosed method and concept may apply to any drug delivery device, with any type of primary pack, e.g. inhaler, pouch. For example, coding features such as a coded material120may be added to a pouch, such as the pouch800illustrated inFIG. 8. In an embodiment, coding features are added to port802. However, coded material120may also be added to the body804of the pouch800.

Another example of a device that may include system100or system700is shown inFIG. 11. System100or system700may be provided in drug delivery device1100shown inFIG. 11. Referring toFIG. 11, there is shown a drug delivery device1100, which is a credit-card-shaped drug delivery device. Drug delivery device1100comprises a body1102. Body1102includes a cartridge retaining portion1104into which a cartridge1106may be inserted. When cartridge1106is inserted, system100may detect information related to the cartridge. Device1100also includes a screen1108, which may display information related to the cartridge1106to the user of the device1100. It should be understood that systems100and700may be used in various other devices as well.

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.