Self-injection device with indicator for indicating proper connection of components

A self-injection device includes a visual indicator for visually indicating that a main body and a cartridge holder are properly connected to each other. In one embodiment, the visual indicator includes a visual marking on the cartridge holder and a visual marking on the main body, such that when the cartridge holder and the main body are properly connected, the visual markings are aligned with each other. A self-injection device that includes an indicator for a dose window is also disclosed.

FIELD OF THE INVENTION

The present invention relates generally to self-injection devices. More particularly, the present invention generally relates to a drug delivery pen having a visual indicator that alerts a user whether key components of the drug delivery pen are properly connected to each other.

BACKGROUND OF THE INVENTION

Insulin and other injectable medications are commonly administered with drug delivery pens, whereby a disposable pen needle assembly is attached to facilitate drug container access and allow fluid egress from the container through a needle into the patient.

The assembly and operation of a typical drug delivery pen are described in U.S. Patent Application Publication No. 2006/0229562 to Marsh et al., published on Oct. 12, 2006, which is hereby incorporated by reference in its entirety. Drug delivery pens typically include a dial function that can control the exact amount of dosage that is injected. However, the exactness of the dosage is based on the assumption that the main components of the drug delivery pen, namely a main body with a dosage dialing function and a medicament cartridge holder holding a liquid medicament cartridge, are connected together properly. A drive mechanism, such as a piston, extends from the main body against the medicament cartridge housed in the cartridge holder, and its movement is based on proper attachment of the main body to the cartridge holder. However, a proper connection between the main body and the cartridge holder may be lost due to user error or some form of vibration or unintended force that causes an unwanted partial separation between the main body and the cartridge holder.

Accordingly, a need exists for an improved drug delivery pen that can alert a user that key components thereof are not properly connected, which would result in an improper dosage of medicament being delivered to a user.

SUMMARY OF THE INVENTION

In accordance with an aspect of the present invention, a drug delivery pen is provided including a visual indicator for alerting a user that the main components are not properly attached together, which may result in an improper dosage of medicament being delivered to the user.

An objective of the present invention is to provide various embodiments of visual indicators that may be used for such purpose.

These and other objects are substantially achieved by providing a self-injection pen in the form of a drug delivery pen in which a main body having a dose dialing function and a cartridge holder are each provided with a marking, such that when the main body and the cartridge holder are properly connected, the respective markings align with each other to inform a user of a correct connection.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

FIGS. 1-4disclose an embodiment of the self-injection device of the present invention. The self-injection device1includes a main body2, a cartridge holder3and a cap4. The cartridge holder3houses a disposable cartridge (not shown) containing liquid medicament, such as insulin. The cartridge holder3is secured to the main body2, preferably via male and female threads on the main body2and the cartridge holder3. The main body2includes a dose setting device29, preferably in the form of a dial. The user rotates the dose setting device29to select the appropriate dosage for injection by matching the desired dosage to the corresponding measurement that is visible in a window24, and then pushes the dose setting device29which causes a drive mechanism such as a piston (not shown) to act against a cartridge connected to an injection needle so that the desired amount of liquid medicament is forced out of the injection needle into the skin of a user.

The dose setting device29is calibrated on the assumption that the cartridge holder3is properly attached to the main body2. However, if the cartridge holder3and the main body2are not properly attached, the user may not be able to receive the correct dosage of medicament. For instance, if the cartridge holder3is further apart from the main body2than it is in its nominal attachment position, a piston (not shown) actuated by the dose setting device3may travel a set distance which would not be sufficient to deliver the desired dosage due to the improper attachment of the cartridge holder3to the main body2.

FIG. 1illustrates the self-injection pen1with the cap4attached to the cartridge holder3, and the cartridge holder3being properly connected to the main body2. A proper connection between the main body2and the cartridge holder3is indicated when the indicator mark21on the main body2and the indicator mark31on the cartridge holder3are rotationally aligned with each other along the longitudinal length or axis of the self-injection device1. InFIG. 1, only a portion of the cartridge holder3is visible due to the cap4being placed on the cartridge holder3.

FIG. 2illustrates the self-injection pen1ofFIG. 1, with the cap4removed from the cartridge holder3. The cartridge holder3includes a window opening33through which the liquid medicament cartridge (not shown) is visible when present. The cartridge holder3includes an injection needle receiving portion35at an open end, allowing attachment of an injection hub containing a penetrating needle cannula for piercing the cartridge and a needle for penetrating a user's skin, prior to use. The cartridge holder3includes a protruding outer ring36and the cap4includes a protruding inner ring46. When the cap4is pushed on the cartridge holder3, the respective rings36,46engage and prevent further movement of the cap4against the cartridge holder3. The cap4may include an outer ring42which assists a user to grip the cap4for attachment to and removal from the cartridge holder3.

The self-injection pen1includes visual indicators21,22and31,32for indicating that the main body2and the cartridge holder3are properly connected together. As illustrated inFIGS. 2 and 3, the cartridge holder3includes a visual indicator in the form of indicia31, as well as a raised longitudinal bar32on which the indicia31is positioned. The raised bar32also prevents full rotation or rolling of the self-injection pen1when the injection pen1is placed on a flat surface (e.g., a table). The main body2includes a visual indicator in the form of indicia21position on a raised portion22. When the cartridge holder3and the main body2are properly attached together, preferably by being threaded onto one another, the indicia21and31, as well as the raised portion22and the raised longitudinal bar32, rotationally align in the direction of the longitudinal length or axis of the self-injection device, as illustrated inFIGS. 1-3. In the event that the cartridge holder3and the main body2are not properly attached together, the visual indicators21,22and31,32will not align properly in the manner illustrated inFIG. 2(i.e., they may be rotationally and/or axially displaced from one another). The raised bar32and the raised portion22may assist visually-impaired users in determining whether the cartridge holder3is properly attached to the main body2.

Line7, illustrated inFIGS. 1-3, exemplifies the outer connection between the cartridge holder3and the main body2. Line8, illustrated inFIGS. 1 and 3, exemplifies the outer connection between the cap4and the cartridge holder3.

FIG. 3is a close-up view of the self-injection device1in which the cap4is attached to the cartridge holder3and the cartridge holder3is properly attached to the main body2. As illustrated, the visual indicators for proper alignment in the form of the indicator marks21,31, as well as the raised portions22,32, indicate to a user, visually or by touch, that the cartridge holder3is properly attached to the main body2.

FIG. 4is a close-up view of the window24of the main body2of the self-injection device1ofFIG. 1. The window24displays the amount of dosage of liquid medicament selected by the user via the dose setting device or knob29. A window cover26surrounds the window24, to visually highlight the window24. The window cover26includes a pointer27that points in the direction of the dosage of liquid medicament corresponding to the dosage set by dialing the dose setting device29. The dose setting device29is preferably a dial or knob including indents and dimples or small protrusions that assist a user in properly gripping the device.

The window cover26, illustrated inFIG. 4, may be a separate component from the main body2, or it may be over-molded onto the main body2. Alternatively, the window cover26may be printed onto the main body2. In any case, it is preferred that the window cover26be the same color as the dose setting device29. Furthermore, it is preferred that the cover opening260in the window cover26be sized such that it is larger than the body opening200on the main body2, to reveal portion201. It is preferred that the body opening200be shaped such that the body opening200aligns with a helical path of numerals representing a dose dialed with the dose setting device29. More preferably, the body opening200is an elongated slot oriented at the same angle as the helical path of the numerals to be displayed in the body opening200.

In one embodiment of the present invention, as illustrated inFIG. 4, the opening260is a substantially circular opening, with the pointer27extending over parts of both the body opening200and the cover opening260. One advantage of such an arrangement is that the portion201can be revealed to highlight the numerals within the body opening200by providing a contrasting foreground.

FIGS. 5-8illustrate another embodiment of the self-injection device of the present invention. In this embodiment, the indicator mark on the cartridge holder3is an indicia310in the form of a cylinder, with a pointer31aextending in a longitudinal direction of the self-injection device1. When the cartridge holder3is properly attached to the main body2, the pointer31aof the cartridge holder3aligns with the indicator mark21aof the main body2, as illustrated inFIGS. 6 and 7. This embodiment also includes grip portions28,48on the main body2and the cap4, respectively, to visually highlight the self-injection device1. In a preferred embodiment, the grip portions28,48are made of a clear material. The embodiment ofFIGS. 5-8is similar to that ofFIGS. 1-4in the manner of attachment of the main body2, the cartridge holder3and the cap4.

The embodiment of the self-injection device ofFIGS. 9-12differs from that of the embodiments mentioned above in several ways. In this embodiment, the cartridge holder3is fully covered by the cap4when the cartridge holder3is properly attached to the main body2, as illustrated inFIG. 9. As illustrated inFIG. 10, the indicator mark31bon the cartridge holder3, in the form of an arrow, is aligned with the indicator mark21bon the main body2, in the form of a raised bar, to indicate that the two parts are properly connected. The cap4is made, at least partially, of a clear or translucent material so that even when the cap4is attached on the cartridge holder3, the indicator mark31bon the cartridge holder3is visible, as illustrated inFIG. 11. Line or gap9indicates the connection border between the cap4and the main body2.

In the embodiment ofFIGS. 9-12, the cap4fully covers the cartridge holder3. The window cover26of the main body2, surrounding the window24, may be a separate component from the main body2or it may be over-molded onto body2. Alternatively, the window cover26may be printed onto the main body2. In any case, it is preferred that the window cover26be the same color as the dose setting device29. Furthermore, as illustrated inFIG. 12, it is preferred that the window cover opening260in the window cover26be sized such that it is larger than the body opening200on main body2, to reveal portion201. Preferably, the body opening200is shaped such that the body opening200aligns with a helical path of numerals representing a dose dialed with dose setting device29. More preferably, and as illustrated in this embodiment, the body opening200is an elongated slot having rounded edges oriented at the same angle as the helical path of numerals to be displayed in the body opening200. In this embodiment, the cover opening260is a substantially oval opening, with the pointer27extending over parts of both the body opening200and the window cover opening260. One advantage of such an arrangement is that the portion201can be revealed to highlight the numerals within body opening200by providing a contrasting foreground.