Patent Description:
The present disclosure relates generally to a drug delivery device and, in particular, to a priming assembly for a drug delivery device.

Various types of automatic injection or drug delivery devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered by untrained personnel or to be self-injected. Generally, these devices include a reservoir that is pre-filled with the liquid therapeutic preparation, and some type of automatic needle-injection mechanism that can be triggered by the user. When the volume of fluid or drug to be administered is generally below a certain volume, such as <NUM>, an auto-injector is typically used, which typically has an injection time of about <NUM> to <NUM> seconds. When the volume of fluid or drug to be administered is above <NUM>, the injection time generally becomes longer resulting in difficulties for the patient to maintain contact between the device and the target area of the patient's skin. Further, as the volume of drug to be administered becomes larger, increasing the time period for injection becomes desirable. The traditional method for a drug to be injected slowly into a patient is to initiate an IV and inject the drug into the patient's body slowly. Such a procedure is typically performed in a hospital or outpatient setting.

Certain devices allow for self-injection in a home setting and are capable of gradually injecting a liquid therapeutic preparation into the skin of a patient. In some cases, these devices are small enough (both in height and in overall size) to allow them to be "worn" by a patient while the liquid therapeutic preparation is being infused into the patient. These devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic preparation to flow out of a reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism to cause the liquid therapeutic preparation to begin to flow at the proper time and a triggering mechanism to initiate the injection.

<CIT>, <CIT>, <CIT> and <CIT> describe relevant background art for the present invention.

The present invention is defined in claims <NUM> and <NUM>.

In one aspect, a priming assembly for a drug delivery device includes a hub, a base connected to the hub and moveable relative to the hub between a first position and a second position, with the base defining a passageway, a cap defining an interior chamber and a passageway in fluid communication with the interior chamber, and a needle connected to the hub and positioned within the interior chamber of the cap. The passageway of the base is in fluid communication with the passageway of the cap when the base is in the first position, and the passageway of the base is isolated from the passageway of the cap when the base is in the second position.

The cap and the base form a sealed interface between the cap and the base. The cap includes a closed first end and an open second end, with the open second end secured to the hub. The cap may be manufactured from an elastomeric material. The cap is configured to deform from a first position where an end of the needle is positioned within the cap and a second position where the end of the needle is positioned outside of the cap. One of the hub and the base may define a slot and the other of the hub and the base may include a projection received within the slot, with the slot having a first end and a second end, and where, when the projection is at the first end of the slot, the base is in the first position, and, when the projection is at the second end of the slot, the base is in the second position. The assembly may further include a priming fluid tube in fluid communication with the passageway of the base. The assembly may further include a delivery tube connected to the hub and in fluid communication with the needle.

In a further aspect, a drug delivery device includes a housing, a cartridge received within the housing with the cartridge configured to receive a medicament, a drive assembly received with the housing and configured to engage the cartridge and dispense medicament from the cartridge, a needle actuator assembly received within the housing with the needle actuator assembly including a patient needle configured to pierce a user's skin, and a priming system. The priming system includes a cartridge priming assembly including a hub, a base connected to the hub and moveable relative to the hub between a first position and a second position, a cap defining an interior chamber and a passageway in fluid communication with the interior chamber, and a needle connected to the hub and positioned within the interior chamber of the cap. The base defines a passageway. The priming system further includes a needle actuator priming assembly including a hub, a base connected to the hub and moveable relative to the hub between a first position and a second position, a cap defining an interior chamber and a passageway in fluid communication with the interior chamber, and a needle connected to the hub and positioned within the interior chamber of the cap, with the base defining a passageway. The priming system also includes a delivery tube in fluid communication with the hub of the cartridge priming assembly and the hub of the needle actuator priming assembly. The passageway of the base of the cartridge priming assembly is in fluid communication with the passageway of the cap of the cartridge priming assembly when the base is in the first position, and the passageway of the base of the cartridge priming assembly is isolated from the passageway of the cap when the base is in the second position.

The passageway of the base of the needle actuator priming assembly may be in fluid communication with the passageway of the cap of the needle actuator priming assembly when the base is in the first position, and the passageway of the base cartridge of the needle actuator priming assembly may be isolated from the passageway of the cap when the base is in the second position. The device may further include an inflow tube in fluid communication with the passageway of the base of the cartridge priming assembly. The device may further include an outflow tube in fluid communication with the passageway of the base of the needle actuator priming assembly. The cap and the base of the cartridge priming assembly and the needle actuator priming assembly each form a sealed interface between the cap and the base. The caps of the cartridge priming assembly and the needle actuator priming assembly each include a closed first end and an open second end, with the open second ends secured to the respective hubs. The caps of the cartridge priming assembly and the needle actuator priming assembly may each comprise an elastomeric material. The caps of the cartridge priming assembly and the needle actuator priming assembly may each be configured to deform from a first position where an end of the needle is positioned within the cap and a second position where the end of the needle is positioned outside of the cap. One of the hub and the base of the cartridge priming assembly may define a slot and the other of the hub and the base may include a projection received within the slot, with the slot having a first end and a second end, and where, when the projection is at the first end of the slot, the base is in the first position, and, when the projection is at the second end of the slot, the base is in the second position.

The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art.

Referring to <FIG>, a drug delivery device <NUM> according to one aspect of the present disclosure includes a drive assembly <NUM>, a container <NUM>, a valve assembly <NUM>, and a needle actuator assembly <NUM>. The drive assembly <NUM>, the container <NUM>, the valve assembly <NUM>, and the needle actuator assembly <NUM> are at least partially positioned within a cavity defined by a housing <NUM>. The housing <NUM> includes a top portion <NUM> and a bottom portion <NUM>, although other suitable arrangements for the housing <NUM> may be utilized. In one aspect, the drug delivery device <NUM> is an injector device configured to be worn or secured to a user and to deliver a predetermined dose of a medicament provided within the container <NUM> via injection into the user. The device <NUM> may be utilized to deliver a "bolus injection" where a medicament is delivered within a set time period. The medicament may be delivered over a time period of up to <NUM> minutes, although other suitable injection amounts and durations may be utilized. A bolus administration or delivery can be carried out with rate controlling or have no specific rate controlling. The device <NUM> may deliver the medicament at a fixed pressure to the user with the rate being variable. The general operation of the device <NUM> is described below in reference to <FIG>.

Referring again to <FIG>, the device <NUM> is configured to operate through the engagement of an actuation button <NUM> by a user, which results in a needle <NUM> of the needle actuator assembly <NUM> piercing the skin of a user, the actuation of the drive assembly <NUM> to place the needle <NUM> in fluid communication with the container <NUM> and to expel fluid or medicament from the container <NUM>, and the withdrawal of the needle <NUM> after injection of the medicament is complete. The general operation of a drug delivery system is shown and described in International Publication Nos. <CIT> and<CIT>.

The housing <NUM> of the device <NUM> includes an indicator window <NUM> for viewing an indicator arrangement <NUM> configured to provide an indication to a user on the status of the device <NUM> and a container window <NUM> for viewing the container <NUM>. The indicator window <NUM> may be a magnifying lens for providing a clear view of the indicator arrangement <NUM>. The indicator arrangement <NUM> moves along with the needle actuator assembly <NUM> during use of the device <NUM> to indicate a pre-use status, use status, and post-use status of the device <NUM>. The indicator arrangement <NUM> provides visual indicia regarding the status, although other suitable indicia, such an auditory or tactile, may be provided as an alternative or additional indicia.

Referring to <FIG>, during a pre-use position of the device <NUM>, the container <NUM> is spaced from the drive assembly <NUM> and the valve assembly <NUM> and the needle <NUM> is in a retracted position. During the initial actuation of the device <NUM>, as shown in <FIG>, the drive assembly <NUM> engages the container <NUM> to move the container <NUM> toward the valve assembly <NUM>, which is configured to pierce a closure <NUM> of the container <NUM> and place the medicament within the container <NUM> in fluid communication with the needle <NUM> via a tube (not shown) or other suitable arrangement. The drive assembly <NUM> is configured to engage a stopper <NUM> of the container <NUM>, which will initially move the entire container <NUM> into engagement with the valve assembly <NUM> due to the incompressibility of the fluid or medicament within the container <NUM>. The initial actuation of the device <NUM> is caused by engagement of the actuation button <NUM> by a user, which releases the needle actuator assembly <NUM> and the drive assembly <NUM> as discussed below in more detail. During the initial actuation, the needle <NUM> is still in the retracted position and about to move to the extended position to inject the user of the device <NUM>.

During the use position of the device <NUM>, as shown in <FIG>, the needle <NUM> is in the extended position at least partially outside of the housing <NUM> with the drive assembly <NUM> moving the stopper <NUM> within the container <NUM> to deliver the medicament from the container <NUM>, through the needle <NUM>, and to the user. In the use position, the valve assembly <NUM> has already pierced a closure <NUM> of the container <NUM> to place the container <NUM> in fluid communication with the needle <NUM>, which also allows the drive assembly <NUM> to move the stopper <NUM> relative to the container <NUM> since fluid is able to be dispensed from the container <NUM>. At the post-use position of the device <NUM>, shown in <FIG>, the needle <NUM> is in the retracted position and engaged with a pad <NUM> to seal the needle <NUM> and prevent any residual flow of fluid or medicament from the container <NUM>. The container <NUM> and valve assembly <NUM> may be the container <NUM> and valve assembly <NUM> shown and described in International Publication No. <CIT>.

Referring to <FIG>, a priming system <NUM> for use in connection with the drug delivery device <NUM> is shown. Although the priming system <NUM> is shown in connection with the delivery device <NUM>, the priming system <NUM> may also be incorporated into any other suitable device or system for delivering medicament to patient. The priming system <NUM> includes a cartridge priming assembly <NUM>, a needle actuator priming assembly <NUM>, and a delivery tube <NUM> extending between the cartridge priming assembly <NUM> and the needle actuator priming assembly <NUM>.

Referring to <FIG>, each of the priming assemblies <NUM>, <NUM> includes a hub <NUM>, <NUM>, a base <NUM>, <NUM> connected to the hub <NUM>, <NUM> and defining a passageway <NUM>, <NUM>, a cap <NUM>, <NUM> defining an interior chamber <NUM>, <NUM> and a passageway <NUM>, <NUM> in fluid communication with the interior chamber <NUM>, <NUM>, and a needle <NUM>, <NUM> connected to the hub <NUM>, <NUM> and positioned within the interior chamber <NUM>, <NUM> of the cap <NUM>, <NUM>. The base <NUM>, <NUM> is moveable relative to the hub <NUM>, <NUM> between a first positon and a second position. In particular, the base <NUM>, <NUM> is rotatable relative to the cap <NUM>, <NUM> and the hub <NUM>, <NUM> between the first and second positions. The delivery tube <NUM> is in fluid communication with the hub <NUM> of the cartridge priming assembly <NUM> and the hub <NUM> of the needle actuator priming assembly <NUM>. For each assembly <NUM>, <NUM>, the passageway <NUM>, <NUM> of the base <NUM>, <NUM> is in fluid communication with the passageway <NUM>, <NUM> of the cap <NUM>, <NUM> when the base <NUM>, <NUM> is in the first position, and the passageway <NUM>, <NUM> of the base <NUM>, <NUM> is isolated from the passageway <NUM>, <NUM> of the cap <NUM>, <NUM> when the base <NUM>, <NUM> is in the second position. The cap <NUM>, <NUM> and the base <NUM>, <NUM> of the priming assemblies <NUM>, <NUM> each form a sealed interface between the cap <NUM>, <NUM> and the base <NUM>, <NUM>. The sealed interface prevents any leakage from the passageway <NUM>, <NUM> of the cap <NUM>, <NUM> during movement of the base <NUM>, <NUM> between the first and second positions. The sealed interface may be provided by the engagement between the cap <NUM>, <NUM> and the base <NUM>, <NUM>. In particular, the cap <NUM>, <NUM> may be manufactured from an elastomeric material that forms a seal with the base <NUM>, <NUM> and the hub <NUM>, <NUM>. The cap <NUM>, <NUM> includes a closed first end <NUM>, <NUM> and an open second end <NUM>, <NUM>, with the open second end <NUM>, <NUM> positioned over and secured to the hub <NUM>, <NUM>. The open second end <NUM>, <NUM> is engaged with the base <NUM>, <NUM>.

Referring again to <FIG>, the needle <NUM>, <NUM> includes a first end <NUM>, <NUM> secured to and in fluid communication with the hub <NUM>, <NUM> and a second end <NUM>, <NUM> positioned within the interior chamber <NUM>, <NUM> of the cap <NUM>, <NUM>. The second end <NUM>, <NUM> of the needle <NUM>, <NUM> may be sharpened and configured to pierce the cap <NUM>, <NUM> and a closure <NUM> of the cartridge <NUM>. For each of the priming assemblies <NUM>, <NUM>, the cap <NUM>, <NUM> is configured to deform from a first, pre-use position where the second end <NUM>, <NUM> of the needle <NUM>, <NUM> is positioned within the cap <NUM>, <NUM> and a second, use position where the second end <NUM>, <NUM> of the needle <NUM>, <NUM> is positioned outside of the cap <NUM>, <NUM>.

Referring again to <FIG>, the cartridge priming assembly <NUM> includes an inflow tube <NUM> in fluid communication with the passageway <NUM> of the base <NUM> of the cartridge priming assembly <NUM>. The needle actuator priming assembly <NUM> includes an outflow tube <NUM> in fluid communication with the passageway <NUM> of the base <NUM> of the needle actuator priming assembly <NUM>.

Referring to <FIG>, prior to use of the priming system <NUM>, the priming assemblies <NUM>, <NUM> and the delivery tube <NUM> are filled with air and are ready for filling. The priming system <NUM> is primed by delivering priming fluid through the inflow tube <NUM> of the cartridge priming assembly <NUM> with the base <NUM> in the first position such that fluid flows through the inflow tube <NUM>, through the passageway <NUM> of the base <NUM>, through the passageway <NUM> of the cap <NUM>, and into the interior chamber <NUM> of the cap <NUM>. From the interior chamber <NUM> of the cap <NUM>, the fluid continues to flow through the needle <NUM>, through the hub, and into the delivery tube <NUM>. With the base <NUM> of the needle actuator priming assembly <NUM> in the first position, the fluid flows through the hub <NUM> of the needle actuator priming assembly <NUM>, through the needle <NUM>, into the interior chamber <NUM> of the cap <NUM> of the needle actuator priming assembly <NUM>, and into the outflow tube <NUM> of the needle actuator priming assembly <NUM>. Once the priming system <NUM> is fully primed and all air is removed from the system <NUM>, the bases <NUM>, <NUM> of the cartridge priming assembly <NUM> and the needle actuator priming assembly <NUM> are each rotated from the first position to the second position to seal the primed fluid with the priming system <NUM>. When the bases <NUM>, <NUM> are in the second position, the passageways <NUM>, <NUM> of the bases <NUM>, <NUM> are isolated from and are sealed from the passageways <NUM>, <NUM> of the cap. The priming fluid may be buffered saline, heparin, or any other suitable priming fluid.

Referring to <FIG>, the priming system <NUM> is configured to be primed and assembled into the drug delivery device <NUM>. In one aspect, the cartridge priming assembly <NUM> replaces the valve assembly <NUM> and the needle actuator priming assembly <NUM> replaces the needle <NUM> while functioning the same as the valve assembly <NUM> and needle <NUM>. As shown in <FIG>, the cartridge priming assembly <NUM> and the needle actuator priming assembly <NUM> include interfaces <NUM>, <NUM> for cooperating with the device <NUM> in the same manner as the valve assembly <NUM> and needle <NUM>. As shown in <FIG>, in a pre-use state, the priming system <NUM> is primed and filled with priming fluid. As shown in <FIG>, during an injection, the cartridge <NUM> engages the cap <NUM> of the cartridge priming assembly <NUM> and deforms the cap <NUM> to the second position with the needle <NUM> being placed in fluid communication with the medicament in the cartridge <NUM>. The priming fluid is pushed out by the medicament from the cartridge <NUM>, which flows from the cartridge <NUM> through the cartridge priming system <NUM>, through the delivery tube <NUM>, and through the needle actuator priming assembly <NUM> and into a patient. As shown in <FIG>, during injection, all of the priming fluid has been injected and the medicament from the cartridge <NUM> is being injected.

Referring to <FIG>, in one aspect, the hub <NUM>, <NUM> of the priming assemblies <NUM>, <NUM> defines a slot <NUM>, <NUM> and the base <NUM>, <NUM> includes a projection <NUM>, <NUM> received within the slot <NUM>, <NUM>. The slot <NUM>, <NUM> has a first end <NUM>, <NUM> and a second end <NUM>, <NUM>. When the projection <NUM>, <NUM> is at the first end <NUM>, <NUM> of the slot <NUM>, <NUM>, as shown in <FIG>, the base <NUM>, <NUM> is in the first position and, when the projection <NUM>, <NUM> is at the second end of the slot <NUM>, <NUM>, as shown in <FIG>, the base <NUM>, <NUM> is in the second position. Accordingly, the base <NUM>, <NUM> is rotatable between the first and second positions and movement of the base <NUM>, <NUM> may be restricted to movement between the first and second positions. The slots <NUM>, <NUM> may include bumps or other structures to retain the projections <NUM>, <NUM> in the first and second ends <NUM>, <NUM>, <NUM>, <NUM> of the slots <NUM>, <NUM>. Further, the slot <NUM>, <NUM> and projection <NUM>, <NUM> may provide a visual and/or tactile feedback regarding whether the base <NUM>, <NUM> is in the first position or the second position. Although the slot <NUM>, <NUM> is provided on the hub <NUM>, <NUM> and the projection <NUM>, <NUM> is provided on the base <NUM>, <NUM>, the position of the slot <NUM>, <NUM> and the projection <NUM>, <NUM> may be reversed with the base <NUM>, <NUM> defining the slot <NUM>, <NUM> and the hub <NUM>, <NUM> including the projection <NUM>, <NUM>. As shown in <FIG>, the inflow and outflow tubes <NUM>, <NUM> may be removed after the priming system <NUM> is primed and sealed.

Elements of one disclosed aspect can be combined with elements of one or more other disclosed aspects to form different combinations.

Claim 1:
A priming assembly (<NUM>, <NUM>) for a drug delivery device comprising:
a hub (<NUM>, <NUM>);
a base (<NUM>, <NUM>) connected to the hub (<NUM>, <NUM>) and rotatable relative to the hub (<NUM>, <NUM>) between a first position and a second position, the base (<NUM>, <NUM>) defining a passageway (<NUM>, <NUM>);
a cap (<NUM>, <NUM>) comprising a closed first end (<NUM>, <NUM>) and an open second end (<NUM>, <NUM>), the open second end (<NUM>, <NUM>) secured to the hub (<NUM>, <NUM>), the cap (<NUM>, <NUM>) defining an interior chamber (<NUM>, <NUM>) and a passageway (<NUM>, <NUM>) in fluid communication with the interior chamber (<NUM>, <NUM>), wherein the cap (<NUM>, <NUM>) and the base (<NUM>, <NUM>) form a sealed interface between the cap (<NUM>, <NUM>) and the base (<NUM>, <NUM>); and
a needle (<NUM>, <NUM>) connected to the hub (<NUM>, <NUM>) and positioned within the interior chamber (<NUM>, <NUM>) of the cap (<NUM>, <NUM>),
characterized in that the passageway (<NUM>, <NUM>) of the base (<NUM>, <NUM>) is in fluid communication with the passageway (<NUM>, <NUM>) of the cap (<NUM>, <NUM>) when the base (<NUM>, <NUM>) is in the first position, and wherein the passageway (<NUM>, <NUM>) of the base (<NUM>, <NUM>) is isolated from the passageway (<NUM>, <NUM>) of the cap (<NUM>, <NUM>) when the base (<NUM>, <NUM>) is in the second position.