Patent Description:
Parenteral delivery of various drugs, i.e., delivery by means other than through the digestive tract, has become a desired method of drug delivery for a number of reasons. This form of drug delivery by injection may enhance the effect of the substance being delivered and ensure that the unaltered medicine reaches its intended site at a significant concentration. Similarly, it is also possible with parenteral delivery to avoid undesirable side effects such as systemic toxicity associated with other routes of delivery. By bypassing the digestive system of a mammalian patient, one can avoid degradation of the active ingredients caused by the catalytic enzymes in the digestive tract and liver and ensure that a necessary amount of drug, at a desired concentration, reaches the targeted site.

Traditionally, manual syringes and injection pens have been employed for delivering parenteral drugs to a patient. More recently, parenteral delivery of liquid medicines into the body has been accomplished by administering bolus injections using a needle and reservoir, continuously by gravity driven dispensers, or via transdermal patch technologies. Bolus injections can require large individual doses. Continuous delivery of medicine through gravity-feed systems can compromise the patient's mobility and lifestyle, and limit therapy to simplistic flow rates and profiles. Transdermal patches often require specific molecular drug structures for efficacy, and the control of the drug administration through a transdermal patch can be severely limited.

In recent years, wearable drug delivery devices, which are sometimes referred to as on-body injectors, have grown in applicability and preference. Like syringes, these wearable devices deliver drug by inserting a needle or cannula into the patient. But, unlike conventional syringes and pens, the patient or caregiver is not required to interact with the device after it is placed onto the patient's skin and activated. For some patients, this removes the fear associated with manually inserting a needle or depressing a syringe plunger. Regardless, for those devices that include externally located and manually operable activator mechanisms, the process of placing the device on the patient's skin must be performed with a certain level of care to avoid inadvertent activation.

<CIT> discloses a needle insertion mechanism for a drug delivery pump. <CIT> discloses a fluid dispensing device having a needle.

One aspect of the present disclosure provides a wearable drug delivery device including a housing, a reservoir, a needle or cannula, a drive mechanism, an activator mechanism, and an activation prevention mechanism. The reservoir is adapted to store a drug product. The needle or cannula is in fluid communication with the reservoir. The drive mechanism is for selectively urging the drug product out of the reservoir, through the needle or cannula and to a patient. The activator mechanism is disposed on an external surface of the housing for enabling a user to activate the drive mechanism. Finally, the activation prevention mechanism is removably coupled to the housing and/or the activator mechanism to prevent inadvertent actuation of the activator mechanism.

In some aspects, the activator mechanism includes a manually depressible activator button operably coupled to the drive mechanism, and the activation prevention mechanism includes a coupling portion that is removably coupled to the activator button between the activator button and the housing to prevent the activator button from being depressed to activate the drive mechanism.

In some aspects, the activator mechanism further includes an activator stem connected between the button and the drive mechanism. And the activation prevention mechanism includes a plurality of forks defining a gap dimensioned to accommodate the stem such that the forks reside between the button and the housing to prevent actuation.

In some aspects, the activation prevention mechanism includes a securing portion engaging the housing for proper positioning of the activation prevention mechanism and/or for securing the activation prevention mechanism to the housing.

In some aspects, the securing portion includes a tab with a surface contoured to corresponding with a corresponding surface of the housing.

In some aspects, the activator mechanism includes a manually depressible activator button operably coupled to the drive mechanism, and the activation prevention mechanism includes a shell portion at least partially enclosing the activator button to prevent inadvertent manipulation of the activator mechanism.

In some aspects, shell portion of the activation prevention mechanism is at least one of: (a) transparent, (b) translucent, (c) opaque, (d) rigid, and (e) more rigid than the remainder of the activation prevention mechanism.

In some aspects, the activator mechanism includes an adhesive removably securing the activation prevention mechanism to the housing.

In some aspects, the shell portion is dimensioned to frictionally engage the activator button.

The activation prevention mechanism comprises a gripping portion for selectively removing the activation prevention mechanism from the injector housing.

In some aspects, the gripping portion of the activation prevention mechanism includes an integral tab comprising either (a) a rigid tab, or (b) a flexible tab.

In some aspects, the activation prevention mechanism includes a gripping portion for selectively removing the activation prevention mechanism from the injector housing and a connecting portion disposed between the shell portion and the gripping portion.

In some aspects, the activator mechanism includes a manually depressible activator button operably coupled to the drive mechanism, and the activation prevention mechanism includes a frame portion at least partially enclosing the activator button to prevent inadvertent manipulation of the activator mechanism. In further aspects, the frame portion can include a front wall portion and lateral side prongs that define a chamber sized to receive the activator button therein. In yet further aspects, at least one of the front wall portion or the lateral side portions can include catches that extend along opposite sides of the activator button to hold the frame portion on the activator button.

In some aspects, the activator mechanism further includes an activator stem connected between the activator button and the drive mechanism, and the activation prevention mechanism includes an opening extending therethrough with an insertion portion and coupling portion. The insertion portion is sized to receive the activator button therethrough and the coupling portion is sized so that the activator stem can pass, but has a dimension smaller than the activator button.

In some aspects, the activator mechanism further includes an activator stem connected between the activator button and the drive mechanism, where the activator stem including an opening extending therethrough, and the activation prevention mechanism includes an insertion portion sized to be inserted into the opening of the activator stem. In further aspects, the activation prevention mechanism can include a flexible intermediate portion adjacent to the insertion portion.

Another aspect of the present disclosure provides a wearable drug delivery device, including a housing, a reservoir, a needle or cannula, a drive mechanism, an activator mechanism and an activation prevention mechanism. The reservoir is adapted to store a drug product. The needle or cannula is in fluid communication with the reservoir. The drive mechanism is for selectively urging the drug product out of the reservoir, through the needle or cannula and to a patient. The activator mechanism is disposed on an external surface of the housing for enabling a user to activate the drive mechanism. The activator mechanism includes a manually depressible activator button operably coupled to the drive mechanism. Finally, the activation prevention mechanism is removably coupled to the activator mechanism between the activator button and the housing to prevent the activator button from being depressed to activate the drive mechanism.

In some aspects, the activator mechanism further includes an activator stem connected between the button and the drive mechanism, and the activation prevention mechanism includes a plurality of forks defining a gap dimensioned to accommodate the stem such that the forks are adapted to reside between the button and the housing to prevent actuation.

In some aspects, the activation prevention mechanism includes a securing portion adapted to engage the housing for proper positioning of the activation prevention mechanism and/or for securing the activation prevention mechanism to the housing.

In some aspects, the securing portion includes a tab with a surface contoured to engage a corresponding surface of the housing.

In some aspects, the activation prevention mechanism comprises a gripping portion for selectively removing the activation prevention mechanism from the injector housing.

In some aspects, the gripping portion of the activation prevention mechanism includes a rigid integral tab.

Yet another aspect of the present disclosure provides a wearable drug delivery device, including a housing, a reservoir, a needle or cannula, a drive mechanism, an activator mechanism, and an activation prevention mechanism. The reservoir is adapted to store a drug product. The needle or cannula is in fluid communication with the reservoir. The drive mechanism is for selectively urging the drug product out of the reservoir, through the needle or cannula and to a patient. The activator mechanism disposed on an external surface of the housing for enabling a user to activate the drive mechanism and including a manually depressible activator button operably coupled to the drive mechanism. Finally, the activation prevention mechanism is removably coupled to the housing to prevent inadvertent actuation of the activator mechanism, the activation prevention mechanism comprising a shell portion at least partially enclosing the activator button.

In some aspects, the shell portion of the activation prevention mechanism is at least one of: (a) transparent, (b) translucent, (c) opaque, (d) rigid, and (e) more rigid than the remainder of the activation prevention mechanism.

In some aspects, the gripping portion of the activation prevention mechanism includes an integral flexible tab.

In some aspects, the activation prevention mechanism includes a connecting portion disposed between the shell portion and the gripping portion.

In some aspects, the reservoir of the wearable drug delivery device of the present disclosure is filled with a drug product.

The present disclosure also provides a method for allowing operation of a drug delivery device that includes grasping a gripping portion of an activation prevention mechanism that is removably coupled to a housing of the drug delivery device and/or an activator mechanism of the drug delivery device disposed on an external surface of the housing, where the activator mechanism prevents inadvertent actuation of the activator mechanism. The method further includes pulling the activation prevention mechanism away from the housing and/or activator mechanism to decouple the activation prevention mechanism therefrom.

In some aspects, pulling the activation prevention mechanism away from the housing and/or activator mechanism can include one or more of: pulling the activation prevention mechanism away from the activator mechanism so that forks of the activation prevent mechanism resiliently deform and allow a stem of the activator mechanism to pass between the forks; pulling the activation prevention mechanism away from the activator mechanism to pull an insertion portion of the activation prevention mechanism out of an opening extending through a stem of the activation prevention mechanism; sliding the activation prevention mechanism along a surface of the housing so that an activator button of the activator mechanism aligns with an insertion portion of an opening of the activation prevention mechanism and pulling the activation prevention mechanism away from the activator mechanism so that the activator button pass through the insertion portion of the opening; pulling a shell portion of the activation prevention mechanism that at least partially encloses an activator button of the activator mechanism away from the activator mechanism; or pulling a frame portion of the activation prevention mechanism that includes a front wall and lateral side prongs that at least partially enclose an activator button of the activator mechanism away from the activator mechanism.

In some aspects, pulling the activation prevention mechanism away from the housing and/or activator mechanism can include peeling an adhesive disposed between the activation prevention mechanism and the housing.

In some aspects, the method can further include actuating the activator mechanism to operate the drug delivery device.

The present disclosure further provides a method for preventing operation of a drug delivery device that includes grasping a gripping portion of an activation prevention mechanism and coupling the activation prevention mechanism to a housing of the drug delivery device and/or an activator mechanism of the drug delivery device disposed on an external surface of the housing, so that the activation prevention mechanism prevents inadvertent actuation of the activator mechanism.

In some aspects, coupling the activation prevention mechanism to the housing of the drug delivery device and/or the activator mechanism of the drug delivery can include one or more of: pushing the activation prevention mechanism toward the activator mechanism so that forks of the activation prevent mechanism resiliently deform and allow a stem of the activator mechanism to pass between the forks; inserting a portion of the activation prevention mechanism into an opening extending through a stem of the activation prevention mechanism; inserting an activator button of the activator mechanism through an insertion portion of an opening extending through the activation prevention mechanism and sliding the activation prevention mechanism along a surface of the housing so that a stem of the activator mechanism slides into a coupling portion of the opening, the coupling portion of the opening having a dimension smaller than a corresponding dimension of the activator button; mounting a shell portion of the activation prevention mechanism to the housing and/or activator mechanism so that the shell portion at least partially encloses an activator button of the activator mechanism; or mounting a frame portion of the activation prevention mechanism that includes a front wall and lateral side prongs to an activator button of the activator mechanism so that the frame portion at least partially encloses the activator button.

In some aspects, the method can further include adhering a portion of the activation prevention mechanism to the housing and/or activator mechanism.

The drug delivery device of the present disclosure will be understood in view of the following detailed description, particularly when studied in conjunction with the drawings, wherein:.

For example, the dimensions and/or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments. It will further be appreciated that certain actions and/or steps may be described or depicted in a particular order of occurrence while those skilled in the art will understand that such specificity with respect to sequence is not actually required. It will also be understood that the terms and expressions used herein have the ordinary technical meaning as is accorded to such terms and expressions by persons skilled in the technical field as set forth above except where different specific meanings have otherwise been set forth herein. The eighth, tenth and eleventh embodiments are embodiments useful for understanding the invention.

Wearable injectors, which are often referred to as on-body injectors, can be applied to a patient's skin with an adhesive applicator. Selecting the configuration of the applicator requires consideration of at least the following two events: (<NUM>) applying the injector to the patient's skin and (<NUM>) removing the injector from the patient's skin. Each event includes different circumstances. For example, application may require a user to remove an adhesive backing layer to expose the adhesive layer, and then subsequently place the device against the skin with sufficient force to ensure a strong bond. Additionally, during application, it is important that the adhesive layer does not fold onto itself thereby rendering a portion of the adhesive layer unusable. This can be critical in situations where the injector includes a pre-filled injector because if the adhesive layer becomes unusable, the entire injector including the drug product in the injector may have to be discarded. Alternatively, the removal process requires some level of strength and dexterity to break the adhesive bond with the patient's skin. Moreover, a patient may wish to first affix the device to their skin and administer the drug at a later time. During the application process and/or during the period between affixing the injector and administering the drug, the patient may accidentally come into contact with the device (e.g., by accidentally bumping the device), which may in turn accidentally activate the device and administer the drug prior to the desired time. As such, disclosed herein are various novel arrangements for preventing inadvertent activation of the device.

<FIG> depict a first embodiment of an on-body drug delivery device <NUM> including an injector <NUM>, an adhesive applicator <NUM>, an activator mechanism <NUM>, and an activation prevention mechanism <NUM>. The injector <NUM> can include a pre-filled, pre-loaded drug delivery device having an external housing <NUM> that includes a number of sidewalls 108a, 108b, 108c, 108d and a generally planar outer or top surface <NUM>. As is generally known, the housing can contain, for example, a drug reservoir filled (or adapted to be filled) with a drug, a needle and/or a cannula for insertion into a patient, and a drive mechanism for urging the drug out of the reservoir and into the patient as is generally known in the art. As shown, the injector <NUM> of this embodiment can include any number of additional features such as side grips molded into a side wall <NUM> of the housing <NUM> for assisting a user with grasping the device <NUM> for placement and/or removal. As an example, side grips can include elongated recesses molded into the housing <NUM> at a location between the bottom and the top surface <NUM> of the housing <NUM>. The adhesive applicator <NUM> of this embodiment can include a non-woven material fixed to a bottom surface of the injector <NUM> and includes a dimension that is larger than the injector <NUM>. So configured, the adhesive applicator <NUM> includes a perimeter portion 104a that encircles the injector <NUM>. A bottom surface of the adhesive applicator <NUM> includes a layer of an adhesive (not shown) and an adhesive backing material (not shown).

So configured, to apply and use the device <NUM>, a user must first remove the adhesive backing layer to expose the adhesive layer. Then, the entire device can be placed against a patient's injector site such that exposed adhesive on the adhesive applicator <NUM> adheres to the patient's skin. The user then activates the activator mechanism <NUM>, which causes the drive mechanism to urge the drug product out of the reservoir, through the needle or cannula, and to the patient. After injection, a user can simply peel the perimeter portion 104a of the adhesive applicator <NUM> away from the skin with one hand, while grasping the injector <NUM> at the side grips with the other hand and pulling away from the patient.

The activator mechanism <NUM> includes a manually operable activator button <NUM> and an activator stem (not shown) is coupled and/or fixed to the activator button <NUM>. The activator stem is disposed through an opening (not shown) of the sidewall 108c and is operably coupled to the drive mechanism. A portion of the activator stem extends outwardly beyond the sidewall 108c in order to allow the activator button <NUM> to be depressed inwardly toward the housing <NUM> in order to actuate the device.

The activation prevention mechanism <NUM> of this embodiment is operably coupled to the housing <NUM> and/or the activator mechanism <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated (e.g., depressed). The activation prevention mechanism <NUM> includes a body <NUM> having a gripping portion <NUM> for selectively handling the activation prevention mechanism <NUM>, e.g., for removing the mechanism <NUM> from the housing <NUM> and for coupling the activation prevention mechanism <NUM> to the injector housing <NUM>. The gripping portion <NUM> may include a first surface 134a, a second surface 134b, and a third surface 134c. In the illustrated example, the first surface 134a is a generally flat surface, and the second and third surfaces 134b, 134c are both generally curved surfaces. The third surface 134c may be curved and/or shaped to correspond to the shape of the sidewall <NUM>. When the activation prevention mechanism <NUM> is coupled to the housing <NUM>, the gripping portion <NUM> protrudes outwardly from the top surface <NUM> to allow a user to grasp the gripping surfaces 134a, 134b, 134c in order to remove the activation prevention mechanism <NUM> from the device <NUM>.

The activation prevention mechanism <NUM> further includes a coupling portion <NUM> that includes forks <NUM> and gap or opening <NUM>. The forks <NUM> may be of any shape and/or dimension that generally correspond to a cross sectional shape and dimension of the activator stem. The coupling portion <NUM> (as well as the entirety of the activation prevention mechanism <NUM>) may be constructed from a resilient material capable of slightly deforming when a force is applied thereto, or may be completely rigid. As illustrated in <FIG>, the forks <NUM> are generally symmetrical about axis L and include catches <NUM> that protrude inwardly towards axis L. These catches <NUM> engage the activator stem in order to increase the force required to remove the activation prevention mechanism <NUM> from the device <NUM>.

The device <NUM> may be provided to patients with the activation prevention mechanism <NUM> already coupled thereto. However, to couple the activation prevention mechanism <NUM> to the device, a user may align the gap <NUM> with the activator stem and press downwardly on the first surface 134a. In one version, the forks <NUM> may slightly deform outwardly (i.e., in a direction away from axis L) until the activator stem has cleared the catches <NUM> and is nested in the gap <NUM>. In other versions, forks <NUM> do not deform but the user applied force must merely overcome a frictional force between the catches <NUM> and the stem. Upon the activator stem clearing the catches <NUM>, the forks <NUM> may return to an original resting configuration.

So configured, the legs <NUM> at least partially surround the activator stem, and the legs <NUM> remain in contact with the activator button <NUM>. Also, the forks <NUM> reside between the button <NUM> and the housing <NUM> thereby acting as an interference that prevents the button <NUM> from being depressed and moving toward the housing <NUM>. Said another way, when the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device because the motion of travel is obstructed by the forks <NUM>.

To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion and pull the activation prevention mechanism <NUM> upwardly and away from the device <NUM>. As illustrated in <FIG>, the activation prevention mechanism <NUM> may include an indicator <NUM> (e.g., an arrow formed in the body <NUM>) to assist in identifying the direction to pull the activation prevention mechanism <NUM>. Upon pulling the activation prevention mechanism <NUM>, the forks <NUM> may again slightly deform to allow the activator stem to clear the catches <NUM>.

In some examples, and as illustrated in <FIG>, the activation prevention mechanism <NUM> may also include a securing portion <NUM> to secure the activation prevention mechanism <NUM> to the housing <NUM>. In the illustrated example, the securing portion <NUM> is a tab that engages the sidewall 108c or in some versions a groove (not shown) formed by and/or disposed on the sidewall 108c. An upper surface 144a of the tab may engage a surface of the groove to further restrict the activation prevention mechanism <NUM> from being removed from the device <NUM>. Other examples of securing portions <NUM> are possible.

Another embodiment is shown in <FIG> that includes an activation prevention mechanism <NUM>' with a form similar to the mechanism <NUM> of <FIG> without an outwardly projecting gripping portion <NUM>. Instead, as illustrated, the mechanism <NUM> includes a planar tab gripping portion <NUM>'. The mechanism <NUM>' includes a body <NUM>' with a coupling portion <NUM>' having forks <NUM>' configured similarly to the above form. The body <NUM>' further includes an indicator <NUM>' that may be a through opening as shown, a recess, or a projection providing tactile edges or surfaces. With this configuration, a user can press the mechanism <NUM>' downwardly onto the activator stem and the forks <NUM>' at least partially surround the activator stem and remain in contact with the activator button <NUM>. Also, the forks <NUM>' reside between the button <NUM> and the housing <NUM> thereby acting as an interference that prevents the button <NUM> from being depressed and moving toward the housing <NUM>. Said another way, when the activation prevention mechanism <NUM>' is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device because the motion of travel is obstructed by the forks <NUM>'. Further, when activation is desired, a user can grip the body <NUM>' and pull upwardly to deflect the forks <NUM>' and disengage the mechanism <NUM>' from the activator stem. The tactile edges and/or opening of the indicator <NUM>' can provide gripping surfaces for the user to easily remove the mechanism <NUM>' from the device <NUM>.

A third embodiment is shown in <FIG>. In this form, an activation prevention mechanism <NUM> operably couples to the activator mechanism <NUM> of the device <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated (e.g., depressed). The activation prevention mechanism <NUM> includes a body <NUM> with a planar configuration. The body <NUM> includes an upper gripping portion <NUM> for selectively handling the activation prevention mechanism <NUM>, e.g., for removing the mechanism <NUM> from the housing <NUM> and for coupling the mechanism <NUM> to the housing <NUM>. The gripping portion <NUM> includes opposite first and second surfaces 154a, 154b. When the activation prevention mechanism <NUM> is coupled to the housing <NUM>, the gripping portion <NUM> protrudes outwardly from the top surface <NUM> to allow a user to grasp the gripping surfaces 154a, 154b in order to remove the activation prevention mechanism <NUM> from the device <NUM>. The gripping portion <NUM> can further include an indicator <NUM> (e.g., an arrow formed in the body <NUM>) to assist in identifying the direction to pull the activation prevention mechanism <NUM>. The indicator <NUM> may be a through opening as shown, a recess, or a projection providing tactile edges or surfaces for a user to get a better grip on the gripping portion <NUM>.

The activation prevention mechanism <NUM> further includes a coupling portion <NUM> that includes prongs <NUM> defining a coupling area <NUM> therebetween and a gap or opening <NUM> at a bottom thereof. The coupling area <NUM> may be of any shape and/or dimension that generally corresponds to a cross sectional shape and dimension of the activator stem. The coupling portion <NUM> (as well as the entirety of the activation prevention mechanism <NUM>) may be constructed from a resilient material capable of slightly deforming when a force is applied thereto, or may be completely rigid.

As illustrated in <FIG>, the prongs <NUM> are generally symmetrical about axis L and have an outwardly curved configuration with bottom catch portions <NUM> that protrude inwardly towards axis L. The catches <NUM> protrude underneath the activator stem in order to increase the force required to remove the activation prevention mechanism <NUM> from the device <NUM>.

The device <NUM> may be provided to patients with the activation prevention mechanism <NUM> already coupled thereto. However, to couple the activation prevention mechanism <NUM> to the device <NUM>, a user may align the gap <NUM> with the activator stem and press downwardly. The prongs <NUM> may deform outwardly (i.e., in a direction away from axis L) until the activator stem has cleared the catches <NUM> and is nested in the coupling area <NUM>. To provide a greater flexibility for the prongs <NUM>, the mechanism <NUM> can include an additional gap or opening <NUM> between the prongs <NUM> above the coupling area <NUM>. Upon the activator stem clearing the catches <NUM>, the prongs <NUM> may resiliently return to an original resting configuration extending around the stem.

So configured, the prongs <NUM> at least partially surround the activator stem and remain in contact with the activator button <NUM>. Also, the prongs <NUM> reside between the button <NUM> and the housing <NUM> thereby acting as an interference that prevents the button <NUM> from being depressed and moving toward the housing <NUM>. Said another way, when the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device because the motion of travel is obstructed by the prongs <NUM>.

To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion <NUM> and pull the activation prevention mechanism <NUM> upwardly and away from the device <NUM>. Upon pulling the activation prevention mechanism <NUM>, the prongs <NUM> may again slightly deform to allow the activator stem to clear the catches <NUM>.

<FIG> depict a fourth embodiment of an on-body drug delivery device <NUM>. It is understood that the device <NUM> includes similar features and components as the device <NUM> described with reference to <FIG>, thus reference numerals having identical two-digit suffixes (e.g., injector <NUM>, adhesive applicator <NUM>, and the like) have similar construction and operation as corresponding components in the device <NUM>. It is understood that features described with regard to the device <NUM> and/or <NUM> can be used interchangeably in either of these embodiments. The device <NUM> includes an activator mechanism <NUM> and an activation prevention mechanism <NUM>. The injector <NUM> can include a pre-filled, pre-loaded drug delivery device having an external housing <NUM> that includes a number of sidewalls 208a, 208b, 208c, 208d and a generally planar outer or top surface <NUM>. The housing can contain, for example, a drug reservoir filled (or adapted to be filled) with a drug, a needle and/or a cannula for insertion into a patient, and a drive mechanism for urging the drug out of the reservoir and into the patient as is generally known in the art. The adhesive applicator <NUM> of this embodiment can include a non-woven material fixed to a bottom surface of the injector <NUM> and includes a dimension that is larger than the injector <NUM>. So configured, the adhesive applicator <NUM> includes a perimeter portion 204a that encircles the injector <NUM>. A bottom surface of the adhesive applicator <NUM> includes a layer of an adhesive (not shown) and an adhesive backing material (not shown).

In this example, the activator mechanism <NUM> includes an activator button <NUM> and an activator stem (not shown) coupled to the activator button <NUM>. The activator stem is disposed through an opening (not shown) of the top surface <NUM> and is operably coupled to the drive mechanism. A portion of the activator stem extends outwardly beyond the top surface <NUM> in order to allow the activator button <NUM> to be depressed inwardly toward the housing <NUM> in order to administer the drug.

The activation prevention mechanism <NUM> is operably coupled to the housing <NUM> and/or the activator mechanism <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated. The activation prevention mechanism <NUM> includes a body <NUM> having a gripping portion <NUM> for selectively removing the activation prevention mechanism <NUM> from the housing <NUM> and for coupling the activation prevention mechanism <NUM> to the injector housing <NUM>. The gripping portion <NUM> may include a first surface 234a, and a second surface 234b. In the illustrated example, the first and second surfaces 234a, 234b are generally flat and include gripping features <NUM> in the form of bumps or protrusions to assist in removing the activation prevention mechanism <NUM>. Similar gripping features <NUM> can be utilized in any of the embodiments described herein. The body <NUM> includes a curved region 232a that is curved and/or shaped to correspond to the shape of the sidewall <NUM>. When the activation prevention mechanism <NUM> is coupled to the housing <NUM>, the gripping portion <NUM> protrudes outwardly from the housing <NUM> to allow a user to grasp the gripping surfaces 234a, 234b in order to remove the activation prevention mechanism <NUM> from the device <NUM>.

The activation prevention mechanism <NUM> further includes a coupling portion <NUM> that includes forks <NUM> that define a gap or opening <NUM> therebetween. The forks <NUM> may be of any shape and/or dimension so that the gap <NUM> generally corresponds to a cross sectional shape and dimension of the activator stem. In the illustrated form, the gap <NUM> has a generally rectangular configuration with a curved end to be complementary to a curved activator stem. The coupling portion <NUM> (as well as the entirety of the activation prevention mechanism <NUM>) may be constructed from a resilient material capable of slightly deforming when a force is applied thereto. As illustrated in <FIG>, the forks <NUM> are generally symmetrical about axis L and include catches <NUM> that protrude inwardly towards axis L. These catches <NUM> engage the activator stem in order to increase the force required to remove the activation prevention mechanism <NUM> from the device <NUM>.

The device <NUM> may be provided to patients with the activation prevention mechanism <NUM> already coupled thereto. However, to couple the activation prevention mechanism <NUM> to the device, a user may align the gap <NUM> with the activator stem and press downwardly on the first surface 234a. The forks <NUM> may slightly deform outwardly (i.e., in a direction away from axis L) until the activator stem has cleared the catches <NUM> and is nested in the gap <NUM>. Upon the activator stem clearing the catches <NUM>, the forks <NUM> may return to an original resting configuration. Similar to the first embodiment, in other versions the forks <NUM> may not be deformable but rather a user applied force must merely overcome frictional resistance between the catches <NUM> and the stem of the activator mechanism <NUM>.

So configured, the forks <NUM> at least partially surround the activator stem and reside at a location between the button <NUM> and the housing, and the forks <NUM> remain in contact with the activator button <NUM>. When the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device because the motion of travel is obstructed by the forks <NUM>.

To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion and pull the activation prevention mechanism <NUM> away from the device <NUM>. As illustrated in <FIG>, the activation prevention mechanism <NUM> may include an indicator <NUM> (e.g., an arrow formed in the body <NUM>) to assist in identifying the direction to pull the activation prevention mechanism <NUM>. Upon pulling the activation prevention mechanism <NUM>, the forks <NUM> may again slightly deform (or friction must be overcome) to allow the activator stem to clear the catches <NUM>.

A fifth embodiment is shown in <FIG> that includes an activation prevention mechanism <NUM>' with a form similar to the mechanism <NUM> of <FIG> without an outwardly projecting gripping portion <NUM>. Instead, as shown, the activation prevention mechanism <NUM>' includes a body <NUM>' with a curved region 232a' that is shaped to generally correspond to the curvature or shape of the sidewall <NUM>. If desired, the body <NUM>' can further include gripping portions <NUM>' that project laterally outwardly from the curved region 232a'. The gripping portions <NUM>' can curve or otherwise slant forwardly of the curved region 232a'. With this configuration, the gripping portions <NUM>' project away from the housing <NUM> of the device <NUM> when the mechanism <NUM>' is coupled thereto to allow a user to grasp the gripping portions <NUM>' in order to remove the activation prevention mechanism <NUM>' from the device <NUM>.

The activation prevention mechanism <NUM>' further includes a coupling portion <NUM>' that includes forks <NUM>' and a gap or opening <NUM>' configured as described above. The forks <NUM>' may be of any shape and/or dimension that generally corresponds to a cross sectional shape and dimension of the activator stem. The forks <NUM>' can be generally symmetrical about axis L and include catches <NUM>' that protrude inwardly towards axis L. Further, installation and removal of the activation prevention mechanism <NUM>' can be performed similar to the above form <NUM>, except that a user can grip the lateral gripping portions <NUM>' rather than the gripping portion <NUM>.

A sixth embodiment of an activation prevention mechanism <NUM> is shown in <FIG> that operably couples to the activator mechanism <NUM> of the device <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated (e.g., depressed). In this form, the mechanism <NUM> includes a body <NUM> that is configured to extend along the top surface <NUM> of the device <NUM> when installed to prevent activation of the device <NUM>. The body <NUM> includes a gripping portion <NUM> that projects away from the top surface <NUM> so that the gripping portion <NUM> can be easily grasped by a user for selectively removing the activation prevention mechanism <NUM> from the housing <NUM> and for coupling the activation prevention mechanism <NUM> to the injector housing <NUM>. The gripping portion <NUM> of the illustrated form includes opposing first and second surfaces 254a, 254b with a curved transition <NUM> from the remaining portion of the body <NUM> and a distal tab portion <NUM> that projects away from the remaining portion of the body <NUM>.

The activation prevention mechanism <NUM> further includes a coupling portion <NUM> that includes forks <NUM> with a gap or opening <NUM> defined therebetween. The forks <NUM> may be of any shape and/or dimension that generally corresponds to a cross sectional shape and dimension of the activator stem. In the illustrated form, the gap <NUM> has a generally rectangular configuration with a curved end to be complementary to the activator stem. The coupling portion <NUM> (as well as the entirety of the activation prevention mechanism <NUM>) may be constructed from a resilient material capable of slightly deforming when a force is applied thereto. As illustrated in <FIG>, the forks <NUM> are generally symmetrical about axis L and include catches <NUM> that protrude inwardly towards axis L. These catches <NUM> engage the activator stem in order to increase the force required to remove the activation prevention mechanism <NUM> from the device <NUM>.

The device <NUM> may be provided to patients with the activation prevention mechanism <NUM> already coupled thereto. However, to couple the activation prevention mechanism <NUM> to the device, a user may align the gap <NUM> with the activator stem and slide the mechanism <NUM> across the top surface <NUM>. The user can then press the gripping portion <NUM> in a direction generally parallel to the top surface <NUM> and the forks <NUM> may slightly deform outwardly (i.e., in a direction away from axis L) until the activator stem has cleared the catches <NUM> and is nested in the gap <NUM> between the forks <NUM>. Upon the activator stem clearing the catches <NUM>, the forks <NUM> may return to an original resting configuration. Similar to the first embodiment, in other versions the forks <NUM> may not be deformable but rather a user applied force must merely overcome frictional resistance between the catches <NUM> and the stem of the activator mechanism <NUM>.

So configured, the forks <NUM> at least partially surround the activator stem and reside at a location between the activator button <NUM> and the housing <NUM>, and the forks <NUM> remain in contact with the activator button <NUM>. When the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device <NUM> because the motion of travel is obstructed by the forks <NUM>.

To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion <NUM> and pull the activation prevention mechanism <NUM> along the top surface <NUM> of the device <NUM> away from the activator button <NUM>. As illustrated in <FIG>, the activation prevention mechanism <NUM> may include an indicator <NUM> (e.g., an arrow formed in the body <NUM>) to assist in identifying the direction to pull the activation prevention mechanism <NUM>. Upon pulling the activation prevention mechanism <NUM>, the forks <NUM> may again slightly deform (or friction must be overcome) to allow the activator stem to clear the catches <NUM>.

A seventh embodiment is shown in <FIG> that includes an activation prevention mechanism <NUM>' with a form similar to the mechanism <NUM> of <FIG>. As illustrated, the mechanism <NUM>' includes a body <NUM>' that is configured to extend along the top surface <NUM> of the device <NUM> when installed to prevent activation of the device <NUM>. The body <NUM>' includes a gripping portion <NUM>', which in this form may have a planar configuration with opposing first and second surfaces 254a', 254b' that project away from a remaining portion of the body <NUM>' at angle, such as between about <NUM> degrees to about <NUM> degrees, preferably between about <NUM> degrees to about <NUM> degrees, and more preferably about <NUM> degrees. So configured, the gripping portion <NUM>'can be easily grasped by a user for selectively removing the activation prevention mechanism <NUM>' from the housing <NUM> and for coupling the activation prevention mechanism <NUM>' to the injector housing <NUM>.

As shown in <FIG>, the mechanism <NUM>' further includes a coupling portion <NUM>' that includes forks <NUM>' with a gap or opening <NUM>' defined therebetween. The gap <NUM>' of this form has a keyhole shape with catches <NUM>' and outwardly angled sides extending to the opening to the gap <NUM>'. The relatively wider width at the opening of the gap <NUM>' provides an easy location for a user to install the mechanism <NUM>' on the device <NUM>. The forks <NUM>' may be of any shape and/or dimension that generally corresponds to a cross sectional shape and dimension of the activator stem. In the illustrated form, the forks <NUM>' are generally symmetrical about axis L and include catches <NUM>' that protrude inwardly towards axis L. These catches <NUM>' engage the activator stem in order to increase the force required to remove the activation prevention mechanism <NUM>' from the device <NUM>. The coupling portion <NUM>' (as well as the entirety of the activation prevention mechanism <NUM>) may be constructed from a resilient material capable of slightly deforming when a force is applied thereto.

The body <NUM>' can further includes an indicator <NUM>' that may be a through opening as shown, a recess, or a projection providing tactile edges or surfaces. With this configuration, a user can slide the mechanism <NUM>' across the device top surface <NUM> and press the gripping portion <NUM>' in a direction generally parallel to the top surface <NUM> and the forks <NUM>' may slightly deform outwardly (i.e., in a direction away from axis L) until the activator stem has cleared the catches <NUM>' and is nested in the gap <NUM>' between the forks <NUM>'. Upon the activator stem clearing the catches <NUM>', the forks <NUM>' may return to an original resting configuration. Similar to the first embodiment, in other versions the forks <NUM>' may not be deformable but rather a user applied force must merely overcome frictional resistance between the catches <NUM>' and the stem of the activator mechanism <NUM>. So configured, the forks <NUM>' at least partially surround the activator stem and reside at a location between the activator button <NUM> and the housing <NUM> so that a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device <NUM> because the motion of travel is obstructed by the forks <NUM>'. The mechanism <NUM>' of this form can be installed and removed similarly to the above mechanism <NUM>.

<FIG> depict an eighth embodiment of an activation prevention mechanism <NUM> for an on-body drug delivery device <NUM>. It is understood that the device <NUM> includes similar features and components as the devices <NUM> and <NUM> described with reference to <FIG>, thus reference numerals having identical two-digit suffixes (e.g., injector <NUM>, adhesive applicator <NUM>, and the like) have similar construction and operation as corresponding components in the devices <NUM>, <NUM>. Accordingly, these features and components will not be discussed in substantial detail. It is understood that features described with regard to the devices <NUM>, <NUM>, and/or <NUM> can be used interchangeably in any of these embodiments.

In this embodiment, the device <NUM> includes an activator mechanism <NUM> and an activation prevention mechanism <NUM>. The activator mechanism <NUM> includes an activator button <NUM> and an activator stem (not shown) coupled to the activator button <NUM>. The activator stem is disposed through an opening (not shown) of the sidewall 308c and is operably coupled to the drive mechanism. In some examples, a portion of the activator stem may extend outwardly beyond the sidewall 308c, and in other examples, the activator button <NUM> may be mounted flush with the sidewall 308c via a recess or other opening in order to allow the activator button <NUM> to be depressed inwardly toward the housing <NUM> in order to administer the drug.

The activation prevention mechanism <NUM> is operably coupled to the housing <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated. The activation prevention mechanism <NUM> includes a body <NUM> that connects a gripping portion <NUM> to a shell portion <NUM>. The gripping portion <NUM> is used to selectively remove the activation prevention mechanism <NUM> from the housing <NUM> and for coupling the activation prevention mechanism <NUM> to the injector housing <NUM>. The gripping portion <NUM> may include a first surface 334a and a second surface 334b, which may include any number of gripping features <NUM> (e.g., texturing, surface treatment, etching, dimpling, etc.). The body <NUM> may be curved, shaped and/or contoured to correspond to the shape of the sidewall <NUM>. When the activation prevention mechanism <NUM> is coupled to the housing <NUM>, the gripping portion <NUM> protrudes outwardly from the housing <NUM> to allow a user to grasp the gripping surfaces 334a, 334b in order to remove the activation prevention mechanism <NUM> from the device <NUM>.

The shell portion <NUM> includes a protrusion <NUM> which may be of any shape and/or dimension that generally corresponds to a shape and/or dimension of the activator button <NUM>. In some examples, the protrusion <NUM> is slightly larger than the activator button <NUM>; in other examples, the protrusion <NUM> is dimensioned to be substantially larger than the activator button <NUM>. The shell portion <NUM> (as well as the entirety of the activation prevention mechanism <NUM>) may be constructed from a rigid material capable of withstanding a force exerted in the direction indicated by line L, which represents the direction in which the activator button <NUM> is depressed to cause the drive mechanism to administer the drug. In some examples, the shell portion <NUM> has a rigidity that is greater than a force required to depress the activator button <NUM>. In some examples, the rigidity of the shell portion <NUM> is greater than a rigidity of the remainder of the activation prevention mechanism <NUM>.

So configured, the protrusion <NUM> at least partially surrounds the activator button <NUM>. In some examples, the protrusion <NUM> is dimensioned so that it frictionally engages the activator button <NUM> and thus remains affixed to the device. In other examples, the protrusion <NUM> is substantially larger than the activator button <NUM>, thus an alternative and/or additional securing device is needed. In either example, an adhesive may be applied to the body <NUM> to releasably secure the activation prevention mechanism <NUM> to the housing <NUM>. Upon applying the adhesive, the curved portion of the body <NUM> may be pressed against the sidewall 308c, thereby securing the activation prevention mechanism <NUM> to the device <NUM>. When the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device because the activator button <NUM> is encapsulated by the protrusion <NUM>.

In some versions, the shell portion <NUM> can be constructed of a material that is clear, transparent, translucent, or opaque depending on the demands of the particular application and overall design of the injector.

To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion <NUM> and pull the activation prevention mechanism <NUM> away from the device <NUM>.

A ninth embodiment of an activation prevention mechanism <NUM> is shown in <FIG>. The activation prevention mechanism <NUM> of this embodiment is operably coupled to the housing <NUM> and/or the activator mechanism <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated (e.g., depressed). The activation prevention mechanism <NUM> includes a body <NUM> with a gripping portion <NUM> and a frame portion <NUM>. The gripping portion <NUM> is used to selectively remove the activation prevention mechanism <NUM> from the housing <NUM> and for coupling the activation prevention mechanism <NUM> to the injector housing <NUM>. The gripping portion <NUM> may include a top first surface 354a, a front second surface 354b, and a rear third surface 354c. In the illustrated example, the first surface 354a is a generally flat surface, and the second and third surfaces 354b, 354c are both curved surfaces, such that the gripping portion <NUM> has a generally T-shaped configuration. Further, the third surface 354c may be curved and/or shaped to correspond to the shape of the sidewall <NUM>. If desired, the gripping portion <NUM> can also include side surfaces 354d that curve outwardly traveling from the frame portion <NUM> up to the first surface 354a. So configured, a user can grasp the gripping portion <NUM> between the second and third surfaces 354b, 354c and/or the side surfaces 354d. When the activation prevention mechanism <NUM> is coupled to the housing <NUM>, the gripping portion <NUM> protrudes outwardly from the top surface <NUM> to allow a user to grasp the gripping portion <NUM> in order to remove the activation prevention mechanism <NUM> from the device <NUM>.

The frame portion <NUM> includes a front wall <NUM> and lateral side prongs <NUM> that define a chamber <NUM> therebetween which may be of any shape and/or dimension that generally corresponds to a shape and/or dimension of the activator button <NUM>. Preferably, the side prongs <NUM> have a depth larger than the activator button <NUM> so that the prongs <NUM> abut the device housing <NUM> preventing the button <NUM> from being actuated. In some examples, the frame portion <NUM> can further include a top wall <NUM> and a bottom wall or catch <NUM> that project above and below the activator button <NUM>, respectively, with the mechanism <NUM> mounted to the device <NUM>. So configured, the frame portion <NUM> is configured to enclose the button <NUM>. Additionally, the button <NUM> can include a flange and the frame portion <NUM> can include inwardly projecting protrusions or lips configured to snap-fit the mechanism <NUM> to the button <NUM>. For example, the top and bottom walls <NUM>, <NUM> can both include protrusions so that the mechanism <NUM> is coupled to the button <NUM> on opposite sides thereof. Additionally, or alternatively, the side prongs <NUM> can include similarly configured protrusions. In other examples, the frame portion <NUM> is dimensioned so that it frictionally engages the activator button <NUM> and thus remains affixed to the device.

The frame portion <NUM> (as well as the entirety of the activation prevention mechanism <NUM>) may be constructed from a rigid material capable of withstanding forces exerted in the direction indicated by line L, which represents the direction in which the activator button <NUM> is depressed to cause the drive mechanism to administer the drug. In some examples, the frame portion <NUM> has a rigidity that is greater than a force required to depress the activator button <NUM>. In some examples, the rigidity of the frame portion <NUM> is greater than a rigidity of the remainder of the activation prevention mechanism <NUM>.

So configured, the frame portion <NUM> at least partially surrounds the activator button <NUM>. When the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device because the activator button <NUM> is encapsulated by the frame portion <NUM>. To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion <NUM> and pull the activation prevention mechanism <NUM> away from the device <NUM>, such as by pulling the gripping portion <NUM> forwardly.

<FIG> depict a tenth embodiment of an activator mechanism <NUM> for an on-body drug delivery device <NUM>. It is understood that the device <NUM> includes similar features and components as the devices <NUM>, <NUM>, and <NUM> described with reference to <FIG>, thus reference numerals having identical two-digit suffixes (e.g., injector <NUM>, adhesive applicator <NUM>, and the like) have similar construction and operation as corresponding components in the devices <NUM>, <NUM>, <NUM>. Accordingly, these features and components will not be discussed in substantial detail. It is understood that features described with regard to the devices <NUM>, <NUM>, <NUM>, and/or <NUM> can be used interchangeably in any of these embodiments.

Like the device <NUM> of <FIG>, the device <NUM> includes an activator mechanism <NUM> having an activator button <NUM> and an activator stem (not shown) coupled to the activator button <NUM>. The activator stem is disposed through an opening (not shown) of the top surface <NUM> and is operably coupled to the drive mechanism. Similar to the device <NUM> of <FIG>, a portion of the activator stem may extend outwardly beyond the top surface <NUM>, and in other examples, the activator button <NUM> may be mounted flush with the top surface <NUM> via a recess or other opening in order to allow the activator button <NUM> to be depressed inwardly toward the housing <NUM> in order to administer the drug.

The activation prevention mechanism <NUM> is operably coupled to the housing <NUM> to prevent the activator mechanism <NUM> from being inadvertently activated. The activation prevention mechanism <NUM> includes a body <NUM> that connects a gripping portion <NUM> to a shell portion <NUM>. The gripping portion <NUM> is used to selectively remove the activation prevention mechanism <NUM> from the housing <NUM> and for coupling the activation prevention mechanism <NUM> to the injector housing <NUM>. The gripping portion <NUM> may include a first surface 434a and a second surface 434b, which may include any number of gripping features <NUM>. The body <NUM> may be curved and/or shaped to correspond to the shape of the top surface <NUM> and/or the sidewall <NUM>. When the activation prevention mechanism <NUM> is coupled to the housing <NUM>, the gripping portion <NUM> protrudes outwardly from the housing <NUM> to allow a user to grasp the gripping surfaces 434a, 434b in order to remove the activation prevention mechanism <NUM> from the device <NUM>.

The shell portion <NUM> includes a protrusion <NUM> which may be of any shape and/or dimension that generally corresponds to a shape and/or dimension of the activator button <NUM>. In some examples, the protrusion <NUM> is slightly larger than the activator button <NUM>; in other examples, the protrusion <NUM> is dimensioned to be substantially larger than the activator button <NUM>. The shell portion <NUM> (as well as the entirety of the activation prevention mechanism <NUM>) may be constructed from a rigid material capable of withstanding a force exerted in the direction indicated by line L, which represents the direction in which the activator button <NUM> is depressed to cause the drive mechanism to administer the drug. In some examples, the shell portion <NUM> has a rigidity that is greater than a force required to depress the activator button <NUM>, and may include a rigidity that is greater than a rigidity of the remainder of the activation prevention mechanism. In some versions, the shell portion <NUM> can be constructed of a material that is clear, transparent, translucent, or opaque depending on the demands of the particular application and overall design of the injector.

So configured, the protrusion <NUM> at least partially surrounds the activator button <NUM>. In some examples, the protrusion <NUM> is dimensioned so that it frictionally engages the activator button <NUM> and thus remains affixed to the device. In other examples, the protrusion <NUM> is substantially larger than the activator button <NUM>, thus an alternative and/or additional securing device is needed. In either example, an adhesive may be applied to the body <NUM> to releasably secure the activation prevention mechanism <NUM> to the housing <NUM>. Upon applying the adhesive, the body <NUM> may be pressed against the sidewall 408c, thereby securing the activation prevention mechanism <NUM> to the device <NUM>. When the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device because the activator button <NUM> is encapsulated by the protrusion <NUM>.

While the embodiments described in <FIG> show the respective shell portions as fully encapsulating or enclosing the activator mechanisms, it should be appreciated that in other versions the shell portions may less than fully encapsulate or enclose the activator mechanisms. That is, in some versions, the shell portion may simply provide one or more bars or ribs that reduce access to the activator mechanism but do not necessarily fully prevent access.

<FIG> depict an eleventh embodiment of an activation prevention mechanism <NUM> for an on-body drug delivery device <NUM>. It is understood that the device <NUM> includes similar features and components as the devices <NUM>, <NUM>, <NUM>, <NUM> described with reference to <FIG>, thus reference numerals having identical two-digit suffixes (e.g., injector <NUM>, adhesive applicator <NUM>, and the like) have similar construction and operation as corresponding components in the devices <NUM>, <NUM>, <NUM>, <NUM>. Accordingly, these features and components will not be discussed in substantial detail. It is understood that features described with regard to the devices <NUM>, <NUM>, <NUM>, <NUM>, and/or <NUM> can be used interchangeably in any of these embodiments.

Like the device <NUM> of <FIG>, the device <NUM> includes an activator mechanism <NUM> having an activator button <NUM> and an activator stem <NUM> coupled to the activator button <NUM>. The activator stem <NUM> is disposed through an opening <NUM> of the top surface <NUM> and is operably coupled to the drive mechanism. Similar to the device <NUM> of <FIG>, a portion of the activator stem <NUM> may extend outwardly beyond the top surface <NUM> in order to allow the activator button <NUM> to be depressed inwardly toward the housing <NUM> in order to administer the drug.

The activation prevention mechanism <NUM> is operably coupled to the housing <NUM> to prevent the activator mechanism <NUM> from being inadvertently activated. The activation prevention mechanism <NUM> includes a body <NUM> that is configured to extend along the top surface <NUM> of the device <NUM> when installed to prevent activation of the device <NUM>. The body <NUM> includes a gripping portion <NUM> that projects away from the top surface <NUM> so that the gripping portion <NUM> can be easily grasped by a user for selectively removing the activation prevention mechanism <NUM> from the housing <NUM> and for coupling the activation prevention mechanism <NUM> to the injector housing <NUM>. The gripping portion <NUM> projects away from the remaining portion of the body <NUM> and includes opposing first and second surfaces 534a, 534b. In the illustrated form, the gripping portion <NUM> has a curvature, which can be convex as shown or concave, as desired. Alternatively, the gripping portion <NUM> can have a generally planar configuration.

The activation prevention mechanism <NUM> further includes a coupling portion <NUM> that includes an opening <NUM> extending therethrough. The opening <NUM> includes an insertion portion <NUM> and a retention portion <NUM>. The insertion portion <NUM> has dimensions larger than the activator button <NUM> so that the activator button <NUM> can pass therethrough and the retention portion <NUM> has a width smaller than the activator button <NUM>, but larger than the activator stem <NUM>. So configured, the activation prevention mechanism <NUM> can be coupled to the device <NUM> by inserting the button <NUM> through the insertion portion <NUM> and sliding the mechanism <NUM> along the top surface <NUM> of the device <NUM> so that the activator stem <NUM> slides into the retention portion <NUM>. If desired, the retention portion <NUM> can be sized to frictionally engage the activator stem <NUM> in order to increase the force required to remove the activation prevention mechanism <NUM> from the device <NUM>. When the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device <NUM> because the motion of travel is obstructed by the coupling portion <NUM>.

To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion <NUM> and push the gripping portion <NUM> along the top surface <NUM> of the device <NUM> towards the activator button <NUM> to align the activator button <NUM> with the insertion portion <NUM>. Thereafter, the user can lift the mechanism <NUM> off the device <NUM> or depress the activator button <NUM> through the insertion portion <NUM>.

<FIG> depict a twelfth embodiment of an activation prevention mechanism <NUM> for an on-body drug delivery device <NUM>. It is understood that the device <NUM> includes similar features and components as the devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM> described with reference to <FIG>, thus reference numerals having identical two-digit suffixes (e.g., injector <NUM>, adhesive applicator <NUM>, and the like) have similar construction and operation as corresponding components in the devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. Accordingly, these features and components will not be discussed in substantial detail. It is understood that features described with regard to the devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and/or <NUM> can be used interchangeably in any of these embodiments.

Like the device <NUM> of <FIG>, the device <NUM> includes an activator mechanism <NUM> having an activator button <NUM> and an activator stem <NUM> coupled to the activator button <NUM>. The activator stem is disposed through an opening <NUM> of the top surface <NUM> and is operably coupled to the drive mechanism. Similar to the device <NUM> of <FIG>, a portion of the activator stem may extend outwardly beyond the top surface <NUM> in order to allow the activator button <NUM> to be depressed inwardly toward the housing <NUM> in order to administer the drug.

The activation prevention mechanism <NUM> is operably coupled to the activator mechanism <NUM> to prevent the activator mechanism <NUM> from being inadvertently activated. The activation prevention mechanism <NUM> includes a body <NUM> that is configured to extend along the top surface <NUM> of the device <NUM> when installed to prevent activation of the device <NUM>. The body <NUM> includes a gripping portion <NUM> that projects away from the top surface <NUM> so that the gripping portion <NUM> can be easily grasped by a user for selectively removing the activation prevention mechanism <NUM> from the housing <NUM> and for coupling the activation prevention mechanism <NUM> to the activator mechanism <NUM>. The gripping portion <NUM> projects away from the remaining portion of the body <NUM> and includes opposing first and second surfaces 634a, 634b. In the illustrated form, the gripping portion <NUM> has a planar configuration projecting away from the top surface <NUM> at an angle with respect thereto. Alternatively, the gripping portion <NUM> can have a curvature, which can be convex or concave, as desired.

The activation prevention mechanism <NUM> further includes a coupling portion <NUM> that has an elongate configuration. The activator stem <NUM> includes an opening <NUM> that extends therethrough that is sized and configured to receive the coupling portion <NUM> of the activation prevention mechanism <NUM> therethrough. So configured, the activation prevention mechanism <NUM> can be coupled to the device <NUM> by inserting coupling portion <NUM> through the opening <NUM> in the activator stem <NUM>. If desired, the coupling portion <NUM> and opening <NUM> can be sized so that the coupling portion <NUM> frictionally engages the sides of the opening <NUM> in order to increase the force required to remove the activation prevention mechanism <NUM> from the device <NUM>. When the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device <NUM> because the motion of travel is obstructed by the coupling portion <NUM>.

In the illustrated form, the coupling portion <NUM> has a flat configuration with a rectangular cross-section and the opening <NUM> has a corresponding shape. Of course, other shapes and sizes can also be utilized, such as circular, triangular, other polygons, curvilinear portions, and combinations thereof. In such cases, the opening <NUM> can have shapes corresponding or sized to receive the coupling portion <NUM> therethrough.

To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion <NUM> and push the body <NUM> along the top surface <NUM> to remove the coupling portion <NUM> from the stem opening <NUM>. Further, as illustrated in <FIG>, the activation prevention mechanism <NUM> may include an indicator <NUM> (e.g., an arrow formed in the body <NUM>) to assist in identifying the direction to pull the activation prevention mechanism <NUM>.

A thirteenth embodiment of an activation prevention mechanism <NUM> is shown in <FIG> that operably couples to the activator mechanism <NUM> of the device <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated (e.g., depressed). The activation prevention mechanism <NUM> includes a body <NUM> with a gripping portion <NUM> and a coupling portion <NUM>. The mechanism <NUM> of this form is similar to the above mechanism <NUM> except that the gripping portion <NUM> is configured to extend forwardly of the device <NUM> and the coupling portion <NUM> is configured to be inserted into the stem opening <NUM> from a position forwardly of the device <NUM>. The gripping portion <NUM> of the illustrated form has a planar, tab configuration with opposing first and second surfaces 654a, 654b. The gripping portion <NUM> can include an edge <NUM> that is generally complementary to an edge <NUM> of the top surface <NUM>. The gripping portion <NUM> can be easily grasped by a user for selectively removing the activation prevention mechanism <NUM> from the activator stem <NUM> and for coupling the activation prevention mechanism <NUM> to the activator stem <NUM>.

<FIG> depict a fourteenth embodiment of an activation prevention mechanism <NUM> for an on-body drug delivery device <NUM>. It is understood that the device <NUM> includes similar features and components as the devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> described with reference to <FIG>, thus reference numerals having identical two-digit suffixes (e.g., injector <NUM>, adhesive applicator <NUM>, and the like) have similar construction and operation as corresponding components in the devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. Accordingly, these features and components will not be discussed in substantial detail. It is understood that features described with regard to the devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and/or <NUM> can be used interchangeably in any of these embodiments.

In this embodiment, the device <NUM> includes an activator mechanism <NUM> with an activator button <NUM> and an activator stem <NUM> coupled to the activator button <NUM>. The activator stem <NUM> is disposed through a front opening <NUM> of the housing <NUM> and is operably coupled to the drive mechanism. The activator stem <NUM> extends outwardly beyond a front portion of the housing <NUM>.

The activation prevention mechanism <NUM> operably couples to the activator mechanism <NUM> of the device <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated (e.g., depressed). The activation prevention mechanism <NUM> includes a body <NUM> with a generally planar configuration. The body <NUM> includes an upper gripping portion <NUM> for selectively handling the activation prevention mechanism <NUM>, e.g., for removing the mechanism <NUM> from the housing <NUM> and for coupling the mechanism <NUM> to the housing <NUM>. The gripping portion <NUM> has a generally planar configuration with opposite first and second surfaces 734a, 734b. When the activation prevention mechanism <NUM> is coupled to the housing <NUM>, the gripping portion <NUM> protrudes outwardly from the top surface <NUM> to allow a user to grasp the gripping surfaces 734a, 734b in order to remove the activation prevention mechanism <NUM> from the device <NUM>. The gripping portion <NUM> can further include an indicator <NUM> (e.g., an arrow formed in the body <NUM>) to assist in identifying the direction to pull the activation prevention mechanism <NUM>. The indicator <NUM> may be a through opening as shown, a recess, or a projection providing tactile edges or surfaces for a user to get a better grip on the gripping portion <NUM>.

As shown in <FIG>, the body <NUM> can include a rear projection <NUM> having a curved and/or shaped surface 737a that is configured to correspond to the shape of the sidewall <NUM> along the front thereof adjacent to the opening <NUM> so that the body <NUM> can nest along the housing <NUM> when the mechanism <NUM> is installed on the device <NUM>. If desired, the rear projection <NUM> can have a peaked profile with a second curved and/or shaped surface 737b extending away from the sidewall <NUM> toward the gripping portion <NUM>.

The activation prevention mechanism <NUM> further includes a coupling portion <NUM> that has an elongate or tab configuration. The activator stem <NUM> includes an opening <NUM> that extends therethrough that is sized and configured to receive the coupling portion <NUM> of the activation prevention mechanism <NUM> therethrough. So configured, the activation prevention mechanism <NUM> can be coupled to the device <NUM> by inserting coupling portion <NUM> through the opening <NUM> in the activator stem <NUM>. If desired, the coupling portion <NUM> and opening <NUM> can be sized so that the coupling portion <NUM> frictionally engages the sides of the opening <NUM> in order to increase the force required to remove the activation prevention mechanism <NUM> from the device <NUM>. When the activation prevention mechanism <NUM> is coupled to the device <NUM>, a patient will not be able to intentionally or unintentionally depress the activator button <NUM> to actuate the device <NUM> because the motion of travel is obstructed by the coupling portion <NUM> abutting the activator stem <NUM> and device housing <NUM>.

The device <NUM> may be provided to patients with the activation prevention mechanism <NUM> already coupled thereto. However, to couple the activation prevention mechanism <NUM> to the device, a user may align the coupling portion <NUM> with the opening <NUM> of the activator stem <NUM> and insert the coupling portion <NUM> therein. The coupling portion <NUM> can be sized to extend entirely therethrough. To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion <NUM> and pull the body <NUM> upwardly away from the activator stem <NUM> until the coupling portion <NUM> clears the opening <NUM>.

A fifteenth embodiment of an activation prevention mechanism <NUM> is shown in <FIG> that operably couples to the activator mechanism <NUM> of the device <NUM> to prevent the activator mechanism <NUM> from being inadvertently actuated (e.g., depressed). The activation prevention mechanism <NUM> includes a body <NUM> with a gripping portion <NUM> and a coupling portion <NUM>. The mechanism <NUM> of this form is similar to the above mechanism <NUM> except that the body <NUM> further includes a flexible intermediate portion <NUM> so that with the coupling portion <NUM> inserted into the stem opening <NUM>, the flexible intermediate portion <NUM> can curve along the device housing <NUM> and the gripping portion <NUM> can extend along the device top surface <NUM>. The gripping portion <NUM> can be substantially rigid or can be flexible similar to the intermediate portion <NUM>. If desired, the gripping portion <NUM> can be adhered to the device top wall <NUM> to further secure the mechanism <NUM> to the device <NUM>. The adhesive can be applied to the gripping portion <NUM>, housing <NUM>, or both. Moreover, the adhesive can be disposed to as to leave an adhesive-free gripping tab of the gripping portion <NUM> so that a user can easily grasp the gripping portion <NUM> to overcome the adhesive and remove the mechanism <NUM> from the device <NUM>.

The device <NUM> may be provided to patients with the activation prevention mechanism <NUM> already coupled thereto. However, to couple the activation prevention mechanism <NUM> to the device, a user may align the coupling portion <NUM> with the opening <NUM> of the activator stem <NUM> and insert the coupling portion <NUM> therein. The coupling portion <NUM> can be sized to extend entirely therethrough. To remove the activation prevention mechanism <NUM> from the device <NUM>, a user may grasp the gripping portion <NUM>, pull the gripping portion <NUM> to overcome the adhesive, and pull the coupling portion <NUM> upwardly away from the activator stem <NUM> until the coupling portion <NUM> clears the opening <NUM>.

Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described embodiments without departing from the scope of the invention, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept.

The above description describes various systems and methods for a drug delivery device having an activation prevention feature. It should be clear that the system, drug delivery device, or activation prevention features or methods can further comprise use of a drug product or medicament listed below with the caveat that the following list should neither be considered to be all inclusive nor limiting. The drug product or medicament will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug product or medicament. The primary container can be a cartridge or a pre-filled syringe.

For example, the drug delivery device or more specifically the reservoir of the device may be filled with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). In various other embodiments, the drug delivery device may be used with various pharmaceutical products, such as an erythropoiesis stimulating agent (ESA), which may be in a liquid or a lyophilized form. An ESA is any molecule that stimulates erythropoiesis, such as Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-<NUM>, INS-<NUM>, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, as well as the molecules or variants or analogs thereof as disclosed in the following patents or patent applications: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; and <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

An ESA can be an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, epoetin alfa, epoetin beta, epoetin delta, epoetin omega, epoetin iota, epoetin zeta, and analogs thereof, pegylated erythropoietin, carbamylated erythropoietin, mimetic peptides (including EMP1/hematide), and mimetic antibodies. Exemplary erythropoiesis stimulating proteins include erythropoietin, darbepoetin, erythropoietin agonist variants, and peptides or antibodies that bind and activate erythropoietin receptor (and include compounds reported in <CIT> and <CIT>) as well as erythropoietin molecules or variants or analogs thereof as disclosed in the following patents or patent applications: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; and <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

Examples of other pharmaceutical products for use with the device may include, but are not limited to, antibodies such as Vectibix® (panitumumab), Xgeva™ (denosumab) and Prolia™ (denosamab); other biological agents such as Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF), Neupogen® (filgrastim , G-CSF, hu-MetG-CSF), and Nplate® (romiplostim); small molecule drugs such as Sensipar® (cinacalcet). The device may also be used with a therapeutic antibody, a polypeptide, a protein or other chemical, such as an iron, for example, ferumoxytol, iron dextrans, ferric glyconate, and iron sucrose. The pharmaceutical product may be in liquid form, or reconstituted from lyophilized form.

Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof:.

Also included can be a sclerostin antibody, such as but not limited to romosozumab, blosozumab, or BPS <NUM> (Novartis). Further included can be therapeutics such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX or XGEVA. Additionally, included in the device can be a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin/Kexin Type <NUM> (PCSK9). Such PCSK9 specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab), as well as molecules, variants, analogs or derivatives thereof as disclosed in the following patents or patent applications: <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

Also included can be talimogene laherparepvec or another oncolytic HSV for the treatment of melanoma or other cancers. Examples of oncolytic HSV include, but are not limited to talimogene laherparepvec (<CIT> and <CIT>); OncoVEXGALV/CD (<CIT>); OrienX010 (<NPL>); G207, <NUM>; NV1020; NV12023; NV1034 and NV1042 (<NPL>).

Also included are TIMPs. TIMPs are endogenous tissue inhibitors of metalloproteinases (TIMPs) and are important in many natural processes. TIMP-<NUM> is expressed by various cells or and is present in the extracellular matrix; it inhibits all the major cartilage-degrading metalloproteases, and may play a role in role in many degradative diseases of connective tissue, including rheumatoid arthritis and osteoarthritis, as well as in cancer and cardiovascular conditions. The amino acid sequence of TIMP-<NUM>, and the nucleic acid sequence of a DNA that encodes TIMP-<NUM>, are disclosed in <CIT>. Description of TIMP mutations can be found in <CIT> and <CIT>.

Also included are antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor and bispecific antibody molecule that target the CGRP receptor and other headache targets. Further information concerning these molecules can be found in <CIT>.

Additionally, bispecific T cell engager (BiTE®) antibodies, e.g. BLINCYTO® (blinatumomab), can be used in the device. Alternatively, included can be an APJ large molecule agonist e.g., apelin or analogues thereof in the device. Information relating to such molecules can be found in <CIT>.

In certain embodiments, the medicament comprises a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody. Examples of anti-TSLP antibodies that may be used in such embodiments include, but are not limited to, those described in <CIT>, and <CIT>, and <CIT>. Examples of anti-TSLP receptor antibodies include, but are not limited to, those described in <CIT>. In particularly preferred embodiments, the medicament comprises a therapeutically effective amount of the anti-TSLP antibody designated as A5 within <CIT>.

Although the drug injection device, activation prevention features and/or mechanisms, methods, and elements thereof, have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention because describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention.

Claim 1:
A wearable drug delivery device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), comprising:
a housing (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>);
a reservoir adapted to store a drug product;
a needle or cannula in fluid communication with the reservoir;
a drive mechanism for selectively urging the drug product out of the reservoir, through the needle or cannula and to a patient;
an activator mechanism (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) disposed on an external surface of the housing for enabling a user to activate the drive mechanism; and
an activation prevention mechanism (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) removably coupled to the housing and/or the activator mechanism to prevent inadvertent actuation of the activator mechanism, the activation prevention mechanism comprising a body having a gripping portion, and one of:
a) a plurality of forks (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>, <NUM>') defining a gap dimensioned to accommodate an activator stem of the activator mechanism at least one of the forks including a catch protruding inwardly;
b) prongs (<NUM>, <NUM>) to define a coupling area or a chamber to receive the activator mechanism, the gripping portion protruding outwardly from a top surface of the housing; and
c) a coupling portion (<NUM>, <NUM>, <NUM>) configured to be inserted into an opening extending through a stem of the activator mechanism.