Patent Description:
The disclosure relates generally to a drug delivery device and, in particular, to a valve 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. A medicament device is disclosed in <CIT>.

In one aspect or embodiment, it is provided a valve assembly for a drug delivery device, according to claim <NUM>.

The piercing member may be entirely spaced from the valve boot. The second end of the body of the piercing member is engaged with the valve sleeve. The second end of the body of the piercing member may received by a recessed area defined by the valve sleeve.

The second end of the body of the piercing member may be received by a recessed area defined by the second portion of the valve sleeve. The first cylindrical portion of the valve sleeve may be positioned between the first end and the second end of the body of the piercing member. The body of the piercing member may be cylindrical.

The body of the piercing member may define a central passageway, with the central passageway receiving a portion of the valve sleeve. The valve sleeve may be formed from an elastomeric material. The second portion of the valve sleeve may include a frustoconical section and a cylindrical section. The third portion of the valve sleeve may include at least one recessed portion configured to facilitate a collapse and deformation of the valve sleeve. The valve boot may be formed from an elastomeric material. The piercing member may be formed from metal.

In further aspect or embodiment, 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 within 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 patient's skin, and a valve assembly as described in any of the aspects or embodiments discussed above.

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. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the scope of the present invention.

Referring to <FIG>, a drug delivery system <NUM> 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 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 system <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 system <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 system <NUM> may deliver the medicament at a fixed pressure to the user with the rate being variable. The general operation of the system <NUM> is described below in reference to <FIG>.

Referring again to <FIG>, the system <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 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 operation of the system <NUM> is also shown and described in <CIT>. The housing <NUM> of the system <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 system <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 system <NUM> to indicate a pre-use status, use status, and post-use status of the system <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 system <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 system <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 system <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 system <NUM>.

During the use position of the system <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 system <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>.

Referring to <FIG>, as discussed above, the valve assembly <NUM> operates to facilitate fluid communication between the container <NUM> and the needle actuator assembly <NUM>. The valve assembly <NUM> includes a valve housing <NUM>, a cannula <NUM>, a piercing member <NUM>, and a valve boot <NUM>. The valve assembly <NUM> also includes a valve sleeve <NUM>. The valve housing <NUM> has a first side <NUM> and a second side <NUM> positioned opposite from the first side <NUM>. The valve housing <NUM> may be formed integrally with the housing <NUM> of the system <NUM> or may be formed as a separate component. The cannula <NUM> has a first end <NUM> and a second end <NUM> positioned opposite from the first end <NUM>. The cannula <NUM> defines a central passageway <NUM>. The first end <NUM> of the cannula <NUM> is sharp and configured to pierce a septum of the container <NUM>. The second end <NUM> of the cannula <NUM> is received by and secured to the valve housing <NUM>. The valve housing <NUM> is in fluid communication with the needle actuator assembly <NUM> via tubing (not shown) to form a fluid flow path from the cannula <NUM> to the needle actuator assembly <NUM>.

Referring again to <FIG>, the piercing member <NUM> includes a body <NUM> with a piercing tip <NUM> extending from the body <NUM>. The body <NUM> of the piercing member <NUM> has a first end <NUM> and a second end <NUM> positioned opposite the first end <NUM>. The piercing tip <NUM> extends from the first end <NUM> of the body <NUM>. The piercing member <NUM> is engaged with the valve sleeve <NUM>. The piercing member <NUM> is entirely spaced from the valve boot <NUM>. In one aspect or embodiment, the piercing member <NUM> is not directly or indirectly in contact with the valve boot <NUM>. The second end <NUM> of the body <NUM> of the piercing member <NUM> is engaged with the valve sleeve <NUM>. In one aspect or embodiment, the second end <NUM> of the body <NUM> is received by a recessed area <NUM> defined by the valve sleeve <NUM>. The body <NUM> of the piercing member <NUM> is cylindrical, although other suitable shapes and configurations may be utilized. The body <NUM> of the piercing member <NUM> defines a central passageway <NUM> that receives a portion of the valve sleeve <NUM>. In one aspect or embodiment, the piercing member <NUM> is snugly positioned over the valve sleeve <NUM> with the piercing member <NUM> in contact with the valve sleeve <NUM> from the first end <NUM> of the body <NUM> to the second end <NUM> of the body <NUM>. The piercing member <NUM> is formed from metal, although other suitable materials may be utilized. The piercing member <NUM> may be manufactured using a stamping, rolling, and/or forming process.

The valve boot <NUM> is connected to the valve housing <NUM> and defines an interior space <NUM>. The valve boot <NUM> may be formed from an elastomeric material, although other suitable materials or combination of materials may be utilized. The valve boot <NUM> is configured to move from a pre-use position where the first end <NUM> of the cannula <NUM> and the piercing tip <NUM> of the piercing member <NUM> are received within the interior space <NUM> to a use position where the piercing tip <NUM> of the piercing member <NUM> and the first end <NUM> of the cannula <NUM> extend outside of the valve boot <NUM> and the interior space <NUM>. The pre-use position of the valve boot <NUM> and the valve assembly <NUM> is shown in <FIG>. The use position of the valve boot <NUM> and the valve assembly <NUM> is shown in <FIG>. In the use position, the piercing tip <NUM> pierces the valve boot <NUM> and a foil seal (not shown) on the container <NUM> and the cannula <NUM> pierces a septum of the container <NUM> to provide fluid communication with the interior of the container <NUM> and the piercing member <NUM> moving toward the valve housing <NUM>.

Referring to <FIG>, the valve sleeve <NUM> is positioned within the interior space <NUM> defined by the valve boot <NUM>. The valve sleeve <NUM> defines a cannula space <NUM> and is configured to move from a pre-use position where the first end <NUM> of the cannula <NUM> is received within the cannula space <NUM> to a use position where the first end <NUM> of the cannula <NUM> extends outside of the valve sleeve <NUM> and the cannula space <NUM>. The valve sleeve <NUM> may be formed from an elastomeric material, such as a rubber material, although other suitable materials or combination of materials may also be utilized. The valve sleeve <NUM> includes a first cylindrical portion <NUM> having a convex tip <NUM>, a second portion <NUM> extending from the first portion <NUM>, and a third frustoconical portion <NUM> extending from the second portion <NUM>. The second portion <NUM> is frustoconical and cylindrical. The third portion <NUM> of the valve sleeve <NUM> may include one or more recessed portions <NUM> to facilitate the collapse and deformation of the valve sleeve <NUM>. Upon engagement of the valve assembly <NUM> with the container <NUM>, the valve sleeve <NUM> will retract with the first end <NUM> of the cannula <NUM> extending through the valve sleeve <NUM>.

The valve sleeve <NUM> is configured to ensure the cannula <NUM> and flow path of the system <NUM> remain free from contamination during operation of the system <NUM>. During operation of the system <NUM>, as discussed above, the container <NUM> is moved into engagement with the valve boot <NUM> to collapse the valve boot <NUM> with the piercing tip <NUM> of the piercing member <NUM> puncturing the foil seal of the container <NUM> and the valve boot <NUM> to form respective chads or flaps (not shown). The valve sleeve <NUM> prevents any contamination present on the container <NUM> and valve boot <NUM> from being discharged or flung from the container <NUM> or valve boot <NUM> onto or into the cannula <NUM>. The valve sleeve <NUM> also shields the cannula <NUM> from contact with the chads or flaps formed by the piercing member <NUM> and minimizes the surface area of the closure <NUM> of the container <NUM> through which the cannula <NUM> must pass through. The valve sleeve <NUM> is also configured to prevent contamination caused by the depressurization of the valve boot <NUM> when the valve boot <NUM> is compressed and subsequently pierced by the piercing member <NUM> by preventing the settling of entrained contamination onto the external and internal surfaces of the cannula <NUM>.

In one aspect or embodiment, the second end <NUM> of the body <NUM> of the piercing member <NUM> may be flared to allow the piercing member <NUM> to more easily slide over the first cylindrical portion <NUM> of the valve sleeve <NUM>.

In one aspect or embodiment, a thickness of the valve sleeve <NUM> as well as angles of the first cylindrical portion <NUM>, second portion <NUM>, and third portion <NUM> may be varied to optimize a force required to move the valve sleeve from the pre-use position to the use position. The valve sleeve <NUM> may be configured to fully pierce the valve boot <NUM>, as discussed above, before the valve sleeve <NUM> collapses or moves from the pre-use position to the use position.

Referring to <FIG>, the second end <NUM> of the body <NUM> of the piercing member <NUM> is received in the recessed area <NUM> defined by the second portion <NUM> of the valve sleeve <NUM>. The first cylindrical portion <NUM> of the valve sleeve <NUM> is positioned between the first end <NUM> and the second end <NUM> of the body <NUM> of the piercing member <NUM>.

Elements of one disclosed aspect can be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of the present invention.

Claim 1:
A valve assembly (<NUM>) for a drug delivery device (<NUM>), the valve assembly (<NUM>) comprising:
a valve housing (<NUM>) having a first side (<NUM>) and a second side (<NUM>) positioned opposite from the first side (<NUM>);
a cannula (<NUM>) having a first end (<NUM>) and a second end (<NUM>) positioned opposite the first end (<NUM>), the cannula (<NUM>) defining a central passageway (<NUM>);
a valve boot (<NUM>) connected to the valve housing (<NUM>) and defining an interior space (<NUM>), the valve boot (<NUM>) is configured to move from a pre-use position where the first end (<NUM>) of the cannula (<NUM>) is received within the interior space (<NUM>) to a use position where the first end (<NUM>) of the cannula (<NUM>) extends outside of the valve boot (<NUM>) and the interior space (<NUM>);
a valve sleeve (<NUM>) defining a cannula space (<NUM>), the valve sleeve (<NUM>) is positioned within the interior space (<NUM>) defined by the valve boot (<NUM>), the valve sleeve (<NUM>) is configured to move from a pre-use position where the first end (<NUM>) of the cannula (<NUM>) is received within the cannula space (<NUM>) to a use position where the first end (<NUM>) of the cannula (<NUM>) extends outside of the valve sleeve (<NUM>) and the cannula space (<NUM>); and
a piercing member (<NUM>) having a body (<NUM>) with a piercing tip (<NUM>), the body (<NUM>) of the piercing member (<NUM>) having a first end (<NUM>) and a second end (<NUM>) positioned opposite the first end (<NUM>), the piercing member (<NUM>) engaged with the valve sleeve (<NUM>), the body (<NUM>) of the piercing member (<NUM>) defining a central passageway (<NUM>) that receives a portion of the valve sleeve (<NUM>),
characterized in that the valve sleeve comprises a first cylindrical portion having a convex tip, a second portion extending from the first cylindrical portion, and a third frustoconical portion extending from the second portion.