Patent Description:
According to the invention it is disclosed an example of a system that includes an on-body pump device and a secondary unit. The on-body pump device includes a reservoir and a fluid pathway. The reservoir is configured to hold a liquid drug. The secondary unit is removably coupled to the on-body pump device. The secondary unit includes a fill needle, a cartridge stop, and an opening which is configured to receive a prefilled cartridge containing a liquid drug. The secondary unit is configured to receive the prefilled cartridge, pierce with the fill needle a movable plunger in the prefilled cartridge to access the liquid drug, expel the liquid drug from the prefilled cartridge via the fill needle, and deliver the liquid drug to the reservoir of the on-body pump device via the fluid pathway.

Disclosed is an on-body pump device including a first reservoir, a second reservoir, a first pump mechanism, a second pump mechanism, a flow regulator valve and a cannula. The first reservoir may be configured to hold a first fluid. The second reservoir configured to hold a second fluid. The first pump mechanism may be fluidly coupled to the first reservoir and may be operable to pump the first fluid from the first reservoir at a first preset rate. The second pump mechanism may be fluidly coupled to the second reservoir and may be operable to pump the second fluid from the second reservoir at a second preset rate. The flow regulator valve may be fluidly coupled to the first pump mechanism and the second pump mechanism. The flow regulator valve may comprise a first flow channel and a second flow channel. The cannula may be fluidly coupled to the flow regulator valve.

According to the invention it is disclosed is a secondary unit including an opening, a needle insertion mechanism and a settings dial. The opening is configured to receive a prefilled cartridge containing a liquid drug. A fill needle and a cartridge stop are within the opening. The needle insertion mechanism is configured to actuate an introducing needle device of an on-body pump device. The settings dial is configured to set or adjust an amount of the liquid drug for delivery into the on-body pump device. The fill needle has one end configured to pierce a septum of the on-body pump device to deliver the liquid drug to the on-body pump device and another end configured to a pierce a movable plunger of the prefilled cartridge when in the opening to access the liquid drug.

Examples disclosed herein provide techniques and a drug insertion delivery apparatus usable in a drug delivery system. Example of a disclosed drug delivery system include an on-body pump device and a removable secondary unit/assembly. The disclosed secondary unit may be configured to include various components typically maintained in a housing of prior on-body pump devices, and, as a result, the disclosed on-body pump device of the drug delivery system described herein may be made to be smaller, more lightweight, and have fewer internal components.

As shown in <FIG>, an example of a drug delivery system <NUM> may include an on-body pump device (or drug delivery device) <NUM> and a secondary unit <NUM> or assembly coupled to the on-body pump device <NUM>. The secondary unit <NUM> may include a settings dial <NUM>, a needle insertion mechanism button <NUM>, and a release button <NUM>. The on-body pump device <NUM> may be a wearable device and may be disposable. For example, the on-body pump device <NUM> may be affixed to the body (typically, the skin) of a user via an adhesive pad <NUM>. Of course, methods other than adhesive pad <NUM> may be used to affix the on-body pump device <NUM> to the body of the user. As an alternative, adhesive pad <NUM> may be a base a semi-permanently attached to the body of the user and the on-body pump device <NUM> may be configured to removably couple to the semi-permanently attached base, or the like.

The secondary unit <NUM> may include internal components (shown in other examples) for expelling a liquid drug from a liquid drug source, such as a prefilled cartridge <NUM>, and delivering the liquid drug to a reservoir (shown in other examples) in the on-body pump device <NUM>. The prefilled cartridge <NUM> is shown inserted into an opening (shown in other examples) of the secondary unit <NUM>. After filling the reservoir of the on-body pump device <NUM>, the secondary unit <NUM> may be removed/decoupled from the on-body pump device <NUM>. The settings dial <NUM> of the secondary unit <NUM> may be operable to set or adjust operation of the on-body pump device (e.g., set or adjust dosages and/or flow rates of the liquid drug from the reservoir of the on-body pump device <NUM>). In addition, the insertion mechanism button <NUM> of the secondary unit <NUM> may actuate a needle insertion mechanism that operates to cause an introducing needle device (shown in the example of <FIG>) to insert a needle coupled to the reservoir into the skin of a user (i.e., a wearer) of the on-body pump device <NUM>. The configuration of the secondary unit <NUM> is beneficial and advantageous because it enables the on-body pump device <NUM> to be smaller and include fewer components than prior pump devices.

In an example, the on-body pump device <NUM> may include a reservoir for the liquid drug, a fluid path to a user, and/or a drive mechanism for delivering the liquid drug from the reservoir to the user through the fluid path. The on-body pump device may be mechanically operated or may include one or more electromechanical systems.

Various examples described herein provide a smaller on-body pump device (e.g., a wearable drug delivery device including a drug pump) that may be filled by a prefilled cartridge <NUM>. In various examples, the secondary unit <NUM> may be removable from the on-body pump device <NUM> and may be configured to operate with either a mechanical or electromechanical on-body pump device <NUM>. The removable secondary unit <NUM> may be attached to the top of the on-body pump device <NUM>. In some instances, the removable secondary unit <NUM> may be removed after the pump device is filled with a liquid drug from the prefilled cartridge and a needle insertion mechanism is deployed. This arrangement (e.g., on-body pump device <NUM> and removable secondary unit <NUM>) may enable the needle insertion mechanism to be moved to the secondary unit <NUM> to further reduce the size of the on-body pump device <NUM> as compared to prior wearable pumps.

The secondary unit <NUM> may also incorporate a fill mechanism (described with reference to another example) to allow for variable filling of the on-body device from a prefilled cartridge. The drug delivery system <NUM> may also allow for selecting customizable drug delivery parameters such as a basal rate and/or a bolus increment size. The on-body pump device <NUM> may include a bolus button that delivers a bolus of fluid (e.g., liquid drug) per each button push. The amount of fluid provided per each button push may be selected or adjusted by the system (e.g., as set during manufacture or by the patient/user).

The secondary unit <NUM> may, for example, be used for any combination of filling the on-body pump device <NUM>, housing or triggering a needle insertion mechanism, setting adjustable parameters such as basal rates or bolus increments, and/or activating the on-body pump device <NUM> either mechanically or electronically.

As described with reference to other examples, the secondary unit <NUM> may have multiple interlocks that require the reservoir of the on-body pump device to be filled before the needle insertion mechanism may be triggered and/or require the needle insertion mechanism be deployed before the secondary unit may be removed from the on-body pump device. In other examples, the secondary unit is removable from the on-body pump device and may include a number of mechanisms and/or components for filling a reservoir of the on-body pump device.

In addition, the secondary unit may include a number of mechanisms and/or components configured to manage operation of the on-body pump device. As shown in the example of <FIG>, the secondary unit <NUM> may include one or more setting dials, such as setting dial <NUM>, that may be used to set a combination of variable settings. For example, a first dial, such as setting dial <NUM>, may be operable to select a basal rate, and a second dial (not shown in the example of <FIG>) may be operable to select bolus increments. In the example, the first and second dials may interact with the on-body pump device <NUM> through a common septum or respective individual septa in the surface of the on-body pump device <NUM>.

<FIG> illustrates an example of an on-body pump device. In the example, a first individual septum <NUM> and a second individual septum <NUM>, both of which may be self-sealing, for example, when the secondary unit <NUM> is removed from the on-body pump device <NUM> are shown. The on-body pump device <NUM> is held in place by adhesive pad <NUM>. The respective septa <NUM> and <NUM> may interact or interface with components of the secondary unit <NUM> as described in more detail below.

<FIG> illustrates a side view of an example of a drug delivery system <NUM>. The drug delivery system <NUM> includes an on-body pump device <NUM> and a secondary unit <NUM>. The on-body pump device <NUM> and the secondary unit <NUM> are shown coupled together.

The on-body pump device <NUM> may include a reservoir <NUM>, an introducing needle device <NUM>, a fill septum <NUM>, a septum <NUM>, a fluid pathway <NUM>, a drive or pump mechanism <NUM> and an activation component <NUM>.

The secondary unit <NUM> may include, for example, an opening <NUM>, an activation switch <NUM>, a needle insertion mechanism <NUM>, and other components.

The activation switch <NUM> may interact with the activation component <NUM> of the on-body pump device <NUM> to provide electronic or mechanical activation of the secondary unit <NUM> and the on-body pump device <NUM>. For example, the activation switch <NUM>, which may be a mechanical switch or a reed switch, may be triggered by an insertion mechanism, a filling process, attachment of the secondary unit <NUM> from the on-body pump device <NUM>, or removal of the secondary unit <NUM> from the on-body pump device <NUM>.

The opening <NUM>, for example, may be configured to receive a prefilled cartridge such as <NUM> containing a liquid drug (not shown). In the example, the opening <NUM> may include a fill needle <NUM> and a cartridge stop <NUM>.

The needle insertion mechanism <NUM> may be configured to actuate the introducing needle device <NUM> of the on-body pump device <NUM>. The needle insertion mechanism <NUM> may include an insertion mechanism button <NUM>, an insertion spring <NUM> and a member <NUM> coupled to the insertion spring <NUM>.

In an example, filling of a reservoir <NUM> of the on-body pump device <NUM> may be performed by placing a prefilled cartridge <NUM> into an opening <NUM> of the secondary unit <NUM>. The prefilled cartridge <NUM> may contain a liquid drug or other medicinal fluid. When the prefilled cartridge <NUM> is placed into the secondary unit <NUM>, at first end of the fill needle <NUM> may pierce a plunger <NUM> of the cartridge <NUM>. An opposite end of the fill needle <NUM> may be configured to pierce the fill septum <NUM> of the on-body pump device <NUM> to fill the reservoir <NUM>. In an alternative example, the fill needle <NUM> may be fluidly coupled to another needle that is configured to pierce the fill septum <NUM>. As the cartridge <NUM> is pushed further into the opening <NUM> of the secondary unit <NUM>, the cartridge plunger <NUM> contacts a stop <NUM>, preventing the cartridge plunger <NUM> from moving further into the opening <NUM> while pushing the liquid drug in the cartridge <NUM> through the fill needle <NUM>. As the prefilled cartridge is pushed further into the stroke is completed, interlock <NUM> (e.g., detent(s) or other mechanisms) in the opening <NUM> of the secondary unit <NUM> may interact and lock with the cartridge <NUM> within the opening <NUM>, giving the user positive feedback of full fill (i.e., of the reservoir <NUM>) and may prevent removal of the cartridge <NUM> from the secondary unit <NUM>. This may also allow for no sharps to be exposed after fill is complete or prevent reuse of secondary unit <NUM>.

In addition, the secondary unit <NUM> may include a settings dial <NUM> and an insertion mechanism button <NUM> that are located at the surface <NUM> of the secondary unit <NUM>. The settings dial <NUM> may be configured to set or adjust an amount of liquid drug for delivery from the cartridge <NUM> into the reservoir <NUM> of the on-body pump device <NUM>.

The drive or pump mechanism <NUM> may be operable to pump the liquid drug or fluid from the reservoir <NUM> to the fluid pathway <NUM> to the cannula <NUM> for delivery of the liquid drug or fluid according to the settings provided via the settings dial <NUM>. For ease of illustration, the couplings of the pump mechanism <NUM> to the fluid pathway 313or the reservoir <NUM>, and the introducing needle device <NUM> are not shown. The fill volume of the liquid drug or fluid that is delivered to the reservoir <NUM> may be set based on a setting of the setting dial <NUM>. The pump mechanism <NUM> may be a mechanical pump or an electromechanical device. The pump mechanism <NUM> may be powered by batteries or another power source. The pump mechanism <NUM> may be a component as known in the art.

In a further example, the interlock <NUM> may prevent the needle insertion mechanism <NUM> from being actuated until the cartridge is locked in the opening <NUM> by the interlock <NUM>. The introducing needle device <NUM> of the on-body pump device <NUM> may not function until the activation component <NUM> is actuated by proper placement of actuation activation switch <NUM> in or near activation component <NUM>. In the example, the interlock <NUM> when actuated by the cartridge <NUM> may enable the needle insertion mechanism <NUM> to operate. The interlock <NUM> may also actuate activation switch <NUM>, which, in turn, actuates activation component <NUM> of the on-body pump device <NUM>. Actuation of the activation component <NUM> may enable the introducing needle device <NUM> to operate as well. For example, introducing needle device <NUM> may be operable to insert a needle coupled to the reservoir into the skin of a user (i.e., a wearer) of the on-body pump device <NUM>.

The fill needle <NUM> may be coupled to a reservoir <NUM> (e.g., a bag reservoir) positioned in the on-body pump device <NUM>. As the cartridge <NUM> is pushed into the secondary unit <NUM>, the liquid drug (not shown) stored in the cartridge <NUM> may be expelled and delivered to the reservoir <NUM> through the fill needle <NUM>.

Activation of the on-body pump device <NUM> may be prevented during the filling process. For example, activation of the needle insertion mechanism <NUM> may be prevented until after the filling process is complete. In various examples, after the reservoir <NUM> has been filled and the cartridge <NUM> has been emptied, the interlock <NUM> may be triggered allowing the insertion mechanism button <NUM> to be unlocked and allow the user to press an activation button when ready. For example, prior to completing the filling process, the interlock <NUM> may remain in a locked state preventing the insertion mechanism from firing. The interlock <NUM> may also be used to activate one or more electrical components of the on-body pump device through, for example, a mechanical switch or a reed switch. In various examples, a device removal interlock, such as <NUM>, may be triggered by the fill action if the secondary unit does not incorporate the insertion mechanism. For example, the device removal interlock <NUM> may be a spring plunger-like mechanism or the like.

In various examples, deployment or activation of the insertion mechanism <NUM> may be regulated by one or more interlocks. For example, the respective interlocks <NUM> and <NUM> as well as once the fill interlock <NUM> has been actuated or released and the user has placed the on-body pump device onto her body, the insertion mechanism <NUM> may be triggered by the insertion mechanism button <NUM>. In addition, before the insertion mechanism button <NUM> may be pressed, the device removal interlock <NUM> may be used that requires the on-body pump device to be on the user's body. In various examples, the device removal interlock <NUM> may be housed in the secondary unit <NUM> coupled to a member <NUM> or component passing through the waterproof seal (e.g., septum) <NUM>. The member <NUM> may move the cannula <NUM> (also referred to as a cannula/needle) into the skin <NUM> of the user and may retract the needle, leaving the cannula <NUM> in the skin <NUM> to provide access to the user for delivery of the liquid drug. In various examples, the cannula/needle <NUM> may be inserted from the introducing needle mechanism <NUM> that remains in the skin.

In various examples, one or more of the components of the insertion mechanism <NUM> may be housed in the secondary unit. Alternatively, one or more of the insertion mechanism <NUM> components may be housed in the on-body pump device <NUM> and the secondary unit <NUM> may house the corresponding components for providing mechanical energy, such as spring <NUM>, for activating the needle insertion mechanism <NUM>. For example, the on-body pump device <NUM> may house the needle and cannula <NUM> while the secondary unit <NUM> houses one or more components (e.g., a spring <NUM>) for firing the needle and cannula. After access to the user is provided by puncturing the skin <NUM>, the needle insertion mechanism <NUM> may trigger the device removal interlock <NUM> that may activate a drive mechanism (not shown in this example) for expelling the liquid drug from the <NUM> reservoir for delivery into the skin <NUM> of the user. The drive mechanism may be a mechanical system or an electromechanical system (e.g., a pump system). The device removal interlock <NUM> may also enable the secondary unit <NUM> to be removed from the on-body pump device <NUM> or may allow the secondary unit <NUM> to be removed by engaging a release button <NUM> (not shown in this example). In various examples, activation of the mechanical or electromechanical drive system (not shown in this example) may be triggered (or allowed to be triggered) after completion of the filling process, after completion of a needle/cannula insertion process, and/or removal of the secondary unit <NUM> from the on-body pump device <NUM>(or any combination thereof).

In various examples, the drug delivery system <NUM> described in the example of <FIG> may provide for variably filling the reservoir of the on-body pump device via a variable fill mechanism. <FIG> illustrates an example of a mechanism that enables variable filling of an example of an on-body pump device.

In the example of <FIG>, the variable fill mechanism <NUM> enables a user to variably fill the reservoir, such as <NUM> of <FIG>, of an on-body pump device, such as <NUM>, to a desired volume and to not necessarily have all of the liquid drug contained in the prefilled cartridge transferred to the reservoir. Variable fill also allows a user to use one or more cartridges to fill the on-body pump device. In such an example, the interlock <NUM> described with reference to <FIG> does not prevent the cartridge from being removed from the opening <NUM>.

In an example, a first on-body pump containing insulin, for example, may be filled with <NUM> units of a <NUM>-unit cartridge. When removed, the cartridge may have <NUM> units remaining in the cartridge. A second on-body pump device may be filled with the remaining <NUM> units of the same <NUM>-unit cartridge and may be filled further with additional units (e.g., <NUM> units) from a <NUM>-unit second cartridge. The second <NUM>-unit cartridge would then have <NUM> units remaining and could be used to partially fill a third on-body pump device. In another example, the same on-body pump device may be filled on separate occasions.

<FIG> illustrates examples of components that may enable variably filling an on-body pump. As an example, a user may set a required or desired fill volume using a dial, such as dial <NUM> of <FIG> or dial <NUM> of <FIG>, on the secondary unit connected to a gear <NUM> operable to move a visual indicator <NUM> to the desired volume shown on a visual amount indicator component <NUM>. The visual amount indicator component <NUM> may include a volume scale (e.g., "units") that shows a volume range of liquid drug that may be output by the variable fill mechanism <NUM>. The visual indicator <NUM> shows an amount on the visual amount indicator component <NUM> that has been output by the variable fill mechanism <NUM>. A needle <NUM> may be provided and is operable to pierce the movable plunger <NUM>. For example, a user may push the prefilled cartridge <NUM> into the opening of the secondary unit (shown in previous examples) and the needle <NUM> pierces the movable plunger <NUM>. The needle <NUM> may be supported or stabilized by a stabilizer component <NUM>. The body of the prefilled cartridge <NUM> may contact a variable fill rod <NUM> which moves along with the prefilled cartridge <NUM>. While the prefilled cartridge <NUM> is being pushed into the opening of the secondary unit, the movable plunger <NUM> pushes a travel pin <NUM> into a travel stop <NUM> having an inclined plane. The contact with the inclined plane of the travel stop <NUM> directs the travel pin <NUM> to contact the indicator rod <NUM>. As a result of the contact, the travel pin <NUM> pushes the indicator rod <NUM> into contact with the variable fill rod <NUM>. The variable fill rod <NUM> and the indicator rod <NUM> may, for example, have toothed edges as shown in <FIG> that are configured to mess together. Of course, mechanical structures or mechanisms other than toothed edges may be used. As the cartridge <NUM> pushes the variable fill rod <NUM>, the indicator rod <NUM> moves along with the cartridge <NUM>. Once the cartridge stops being pushed into the opening in the secondary unit and the cartridge <NUM> is pulled out of the opening, a component <NUM> prevents the indicator rod <NUM> from being pulled back. For example, the component <NUM> may be spring-loaded or otherwise configured to prevent the indicator rod <NUM> from being pulled back.

If there is more fluid in the cartridge <NUM> than the requested volume shown on the visual indicator <NUM>, then the indicator rod <NUM> may hit the hard stop <NUM> of the visual indicator <NUM> and prevent further fill. As the cartridge is pulled out, a spring-loaded travel pin <NUM> releases the connection between the spring-loaded variable fill rod <NUM> and the indicator rod <NUM>. The spring-loaded variable fill rod <NUM> will return to its original position, ready for an additional cartridge to be inserted (if applicable). If the volume in the first cartridge is lower than the volume set by the user, a second cartridge may be inserted. Because the variable fill rod <NUM> may be spring-loaded, the variable fill rod <NUM> returns to its original position and the indicator rod <NUM> remains in place. Accordingly, the secondary unit <NUM> may be adjustable for any position of the plunger <NUM> within the cartridge <NUM>.

In various examples, the secondary unit <NUM> may include an energy storage system (e.g., a spring system) that may be used for aiding the filling process. For example, in lieu of the user having to push the prefilled cartridge into the opening of the secondary unit <NUM>, the user may place the prefilled cartridge into the secondary unit and actuate a button or the like to trigger the energy storage system which pushes the prefilled cartridge into the opening. The energy storage system may provide a force on the plunger within the prefilled cartridge to expel the liquid drug without the user needing to continue to push the prefilled cartridge. In the example of <FIG>, the interlock <NUM> in the example of <FIG> may not be present or may not prevent removal of a cartridge.

<FIG> illustrates another example of a drug delivery system. As shown in <FIG>, the drug delivery system <NUM> may include a removable secondary unit <NUM> and an on-body pump device <NUM>. The secondary unit <NUM> may be configured differently than secondary unit <NUM> of previous examples. In the drug delivery system <NUM>, the removable secondary unit <NUM> may have components like those of secondary unit <NUM> of <FIG>, such as adhesive pad <NUM>, setting dial <NUM>, release button <NUM> and the like (some of which are not shown in this example), but may be further configured to accept two pre-filled cartridge vials for different types of fluid (e.g., insulin and glucagon, or some other combination of fluids). The first fluid cartridge <NUM> may be inserted into a first opening <NUM> and the second fluid cartridge <NUM> may be inserted into opening <NUM>. Each cartridge <NUM> and <NUM> may fill separate reservoirs, for example, reservoirs <NUM> and <NUM>, inside the on-body pump device <NUM> to be delivered to the patient in combination or at separate times. As an example, a first reservoir <NUM> may be configured for storing and delivering insulin and a second reservoir <NUM> would be configured for storing and delivering glucagon.

<FIG> illustrates a third example of a drug delivery system. The drug delivery system depicted in <FIG> may include a dual fluid delivery mechanism <NUM> that provides stored fluids to a user in one or more insertions/insertion sites. The on-body pump device may have two separate reservoirs <NUM> and <NUM>. These reservoirs <NUM> and <NUM> may hold different fluids or the same type of fluid. The flow rates may be controlled by pump mechanisms <NUM> and <NUM> and/or by the flow regulator valve <NUM>. The fluids may be delivered through separate cannulas (not shown) or through one insertion site via a multi-lumen cannula <NUM>. The multi-lumen cannula <NUM> may have two or more ports (shown and described further with referent to the example of <FIG>).

In one or more examples, the multi-lumen cannula <NUM> may deliver the fluid through the needle within the lumen, as shown in more detail with respect to <FIG>. In <FIG>, example configurations of multi-lumen cannula <NUM> are shown as viewed from either cross-section A-A or cross section B-B. As shown in the example of <FIG>, the multi-lumen cannula <NUM> may have two ports where a first fluid is provided through a first port and a second fluid is provided through a second port. One of the two ports may also contain an introducing needle <NUM> used to pierce and lead the cannula into the skin of a user's body. In various examples, the multi-lumen cannula may include three lumens where the two fluids are delivered through two separate lumens and the introducing or piercing needle <NUM> may be housed in a third lumen. The cannula <NUM> may have a nail head design <NUM> that functions as a seal interface to the fluid path as well as the needle <NUM>.

<FIG> illustrates cross-sections of various exemplary multi-lumen cannulas that may be used with the drug delivery system depicted in <FIG>. As shown, cross-section A-A option <NUM> may illustrate a cannula having two larger circular openings while cross-section BB, option <NUM> illustrates the cross-section farther along the cannula in which the cross-section has two half-circular openings for delivering the liquid drug. Similarly, cross-section A-A option <NUM> illustrates a cannula having three larger circular openings while cross-section BB, option <NUM> illustrates the cross-section farther along the cannula in which the cross-section is three smaller circular openings for delivering the liquid drug. Of course, the illustrated cross-sections are examples and other cross-sections may be used to deliver the liquid drug.

<FIG> illustrates an exemplary example of a flow regulator valve suitable for use in the example of <FIG>. An on-body pump device as described herein may include reservoirs for two fluids as described above. The pump system may deliver two different fluids at different times (e.g., insulin and glucagon), two different fluids at the same time that are mixed (e.g., drug mixing), or the same fluid at different times with different rates (e.g., insulin bolus and basal).

As shown in <FIG>, the flow regulator valve <NUM> may embody two flow channels. For example, the flow regulator valve <NUM> may include a first flow channel <NUM> and a second flow channel <NUM>. The two flow channels may be independently set or changed relative to one another via a gear system <NUM> (e.g., a planetary gear). For example, the gear system <NUM> may be configured to independently set a flow rate of the first fluid output from the first pump mechanism relative to a flow rate of the second fluid output from the second pump mechanism. As shown in <FIG>, an inner valve <NUM> may have a separate flow channel <NUM> to deliver a first stored fluid (stored in a first reservoir, such as <NUM> of <FIG>) at a first rate and the outer valve <NUM> may have separate flow channel <NUM> to deliver a second stored fluid (stored in a second reservoir, such as <NUM> of <FIG>) at a second rate, independent of the first rate.

The following components may be included with example of the drug delivery system described herein (e.g., as shown in reference to <FIG>):.

Various examples described include a wearable drug delivery device capable of delivering one more liquid drugs (or any other fluid or therapeutic agent) to a user.

Certain examples of the present example were described above. It is, however, expressly noted that the present example is not limited to those examples, but rather the intention is that additions and modifications to what was expressly described herein are also included within the scope of the example. Moreover, it is to be understood that the features of the various examples described herein were not mutually exclusive and may exist in various combinations and permutations, even if such combinations or permutations were not made express herein, without departing from the scope of the example. In fact, variations, modifications, and other implementations of what was described herein will occur to those of ordinary skill in the art without departing from the scope of the example. As such, the example is not to be defined only by the preceding illustrative description.

Various examples also relate to apparatus or systems for performing these operations. The suitable structure for a variety of these machines will appear from the description given.

It is emphasized that the Abstract of the Disclosure is provided to allow a reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features are grouped together in a single example for streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed examples require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate example. In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein," respectively. Moreover, the terms "first," "second," "third," and so forth, are used merely as labels and are not intended to impose numerical requirements on their objects.

Claim 1:
A system, comprising:
an on-body pump device (<NUM>; <NUM>) comprising a reservoir (<NUM>) and a fluid pathway (<NUM>), wherein the reservoir (<NUM>) is configured to hold fluid; and
a secondary unit (<NUM>; <NUM>) removably coupled to the on-body pump device (<NUM>; <NUM>) and including a fill needle (<NUM>), a cartridge stop (<NUM>), and an opening (<NUM>) configured to receive a prefilled cartridge (<NUM>; <NUM>) containing a liquid drug, wherein the secondary unit is configured to:
receive the prefilled cartridge (<NUM>),
pierce with the fill needle (<NUM>) a movable plunger (<NUM>; <NUM>) in the prefilled cartridge (<NUM>; <NUM>),
expel the liquid drug from the prefilled cartridge (<NUM>; <NUM>), and
deliver the liquid drug to the reservoir (<NUM>) of the on-body pump device via the fill needle (<NUM>).