Patent Description:
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 drug delivery system having the features defined within the preamble of claim <NUM> is described in <CIT>. <CIT>, <CIT> and <CIT> show further background art for the present invention.

A drug delivery system according to the invention is defined by the features of claim <NUM>. Preferred embodiments are defined by the features of the dependent claims.

The drug delivery system for injecting a medicament according to the invention includes a housing defining a cavity, a container received within the cavity and configured to receive a medicament with the container including a closure, a valve assembly received within the cavity and including a piercing configured to pierce the closure of the container, and a connector arrangement provided between the container and the valve assembly, the connector arrangement movable between a first, pre-use position maintaining sterility between the closure of the container and the valve assembly and a second, use position permitting fluid communication between the container and the valve assembly.

In another aspect, the connector arrangement may include at least one membrane held between the container and the valve assembly. The connector arrangement may include two membranes held between the container and the valve assembly. The at least membrane may include flashspun high-density polyethylene fibers. At least a portion of the connector arrangement may extend through and outside of the housing. The connector arrangement may be pulled out of the housing to move the connector arrangement from the first position to 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. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

Referring to <FIG>, a drug delivery system <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 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 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>. 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>, in one aspect, a connector arrangement <NUM> is provided between two mating components to provide a sterile connection between the two components during fluid transfer. In one aspect, the connector arrangement <NUM> is provided between a syringe barrel or container <NUM> and a cannula arrangement <NUM>. The cannula arrangement <NUM> includes a cannula <NUM> surrounded by a housing <NUM> with a flange <NUM>. The container <NUM> also includes a corresponding flange <NUM>. The container <NUM> and the housing <NUM> each include a membrane <NUM>, <NUM> to provide a sterile seal of the mating portions of the container <NUM> and the housing <NUM>. The membranes <NUM>, <NUM> are made of any suitable material, such as a foil, rubber, or polymer, to maintain sterility of the container <NUM>, the cannula <NUM>, and the housing <NUM> while allowing the membranes <NUM>, <NUM> to be removed.

Referring again to <FIG>, during assembly of the connector arrangement <NUM>, a clip <NUM> or other similar type of connector is fitted to engage the respective flanges <NUM>, <NUM> of the container <NUM> and the housing <NUM> such that the membranes <NUM>, <NUM> are brought into contact with one another. In one aspect, a single clip <NUM> is provided to clamp the flanges <NUM>, <NUM> together with one another. In another aspect, two clips <NUM> are provided to clamp the flanges <NUM>, <NUM> together with one another. The membranes <NUM>, <NUM> may extend through one of the clips <NUM> once the connector arrangement <NUM> has been assembled. Prior to use of the cannula arrangement <NUM>, the membranes <NUM>, <NUM> are removed from the connector arrangement <NUM> to permit fluid communication between the container <NUM> and the cannula <NUM>. The membranes <NUM>, <NUM> may be pulled away from the connector arrangement <NUM> to permit the container <NUM> and the housing <NUM> to move into engagement with one another. In one aspect, a distal end of the container <NUM> and a proximal end of the housing <NUM> may include joints <NUM>, <NUM> to facilitate engagement between the container <NUM> and the housing <NUM>. The joints <NUM>, <NUM> may be any type of engagement and locking mechanism that connects the distal end of the container <NUM> with the proximal end of the housing <NUM>.

Referring to <FIG>, the connector arrangement <NUM> is shown in use with the drug delivery system <NUM> shown in <FIG>. The connector arrangement <NUM> is provided between the container <NUM> and the valve assembly <NUM>. In particular, the membranes <NUM>, <NUM> are held between a distal end of the container <NUM> and a proximal end of a valve member <NUM> of the valve assembly <NUM>. In this aspect, the membranes <NUM>, <NUM> form a pull tab that extends through and outside of the housing <NUM> of the system <NUM>. The valve assembly <NUM> is configured to pierce a septum <NUM> held in the closure <NUM> of the container <NUM>. During the drug delivery process of the system <NUM>, the container <NUM> is pressed against the valve member <NUM> to expose a piercing member <NUM> housed in the valve member <NUM>. The piercing member <NUM> pierces the septum <NUM> of the container <NUM> to establish fluid communication between the container <NUM> and the valve assembly <NUM>. Prior to use of the system <NUM>, however, the membranes <NUM>, <NUM> are positioned between the container <NUM> and the valve assembly <NUM> to maintain the sterility of the components before use of the system <NUM>. A portion of the membranes <NUM>, <NUM> may extend out of the housing <NUM> of the system <NUM> to allow a user to grasp the membranes <NUM>, <NUM>. Before use of the system <NUM>, the membranes <NUM>, <NUM> are pulled from the housing <NUM> to allow the container <NUM> and the valve assembly <NUM> to move towards one another during the drug delivery process of the system <NUM>. In this aspect, the membranes <NUM>, <NUM> are made of flashspun high-density polyethylene fibers to allow pulling of the membranes <NUM>, <NUM> without breaking or tearing the membranes <NUM>, <NUM>. It is contemplated, however, that other suitable materials may also be used for the membranes <NUM>, <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 drug delivery system (<NUM>) for injecting a medicament, the system comprising:
a housing (<NUM>) defining a cavity;
a container (<NUM>) received within the cavity and configured to receive a medicament, the container (<NUM>) comprising a closure (<NUM>);
a valve assembly (<NUM>) received within the cavity and comprising a piercing member (<NUM>) configured to pierce the closure (<NUM>) of the container (<NUM>);
wherein the drug delivery system (<NUM>) is transitionable between a first, pre-use position in which the valve assembly (<NUM>) is spaced apart from the container (<NUM>) thereby maintaining sterility between the closure (<NUM>) of the container (<NUM>) and the valve assembly (<NUM>) and a second, use position in which the container (<NUM>) is advanced within the housing (<NUM>), such that the piercing member (<NUM>) pierces the closure (<NUM>) thereby permitting fluid communication between the container (<NUM>) and the valve assembly (<NUM>); and
characterized by:
a connector arrangement (<NUM>) provided between the container (<NUM>) and the valve assembly (<NUM>), the connector arrangement (<NUM>) configured to be removable from between the container (<NUM>) and the valve assembly (<NUM>);
wherein removal of the connector arrangement (<NUM>) allows the container (<NUM>) to move towards the valve assembly (<NUM>).