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.

In treating certain chronic illnesses, such as cancer requiring chemotherapy, an implanted port is inserted under the skin the patient. The port is covered by the skin of the patient. One end of the port has a rubber septum facing the skin surface via which a delivery needle is inserted. The other end of the port is a catheter that is inserted into a vein for intravenous delivery of medicament. Typically, an infusion set with a needle is used to deliver medicament through the port, which is usually accomplished in a clinical setting by a heath care provider. Conventional ports <NUM>, <NUM>, <NUM> are shown in <FIG> and include a triangular port <NUM> (<FIG>), an oval port <NUM> (<FIG>), and a round port <NUM> (<FIG>), although other shaped ports may be utilized. <CIT>, <CIT> and <CIT> represent prior art to the invention.

In one aspect, a drug delivery device is as defined in claim <NUM>.

The housing includes a main body and an interface plate secured to the main body, with the interface plate defining the bottom surface of the housing. The interface plate may be detachably secured to the main body via a connection arrangement. The connection arrangement may include corresponding snap members provided on the main body of the housing and the interface plate. The interface plate includes an opening having a shape corresponding to a shape of an implanted injection port.

In a further aspect, a port interface plate for a drug delivery device including a housing, a cartridge received within the housing, a drive assembly received within the housing and configured to engage the cartridge and dispense medicament from the cartridge, and a needle actuator assembly received within the housing, includes a plate body having a first side and a second side positioned opposite from the first side, and a port interface configured to receive an implanted injection port.

The port interface is an opening having a shape corresponding to a shape of an implanted injection port. The shape of the opening may be one of triangular, oval, and circular. The port interface plate may include a connection arrangement configured to secure the port interface plate to the housing the drug delivery device. The connection arrangement may include snap members provided on the plate body of the interface plate.

The drug delivery device includes a housing including a bottom surface defining a port recess, 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 comprising a patient needle configured to pierce a patient's skin, and a port interface plate configured to be secured to the bottom surface of the housing. The port interface plate includes a port interface configured to be aligned with the port recess of the housing when the port interface plate is secured to the housing.

The port interface plate may include a connection arrangement configured to secure the port interface plate to the housing the drug delivery device.

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 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 port interface <NUM> for receiving an implanted injection port <NUM>, such as the ports <NUM>, <NUM>, <NUM> shown in <FIG>, is provided. The port interface <NUM> is configured for receiving the port <NUM>, <NUM>, <NUM> such that a needle of a drug delivery device, such as the needle <NUM> of drug delivery device <NUM>, is aligned with a septum <NUM> of the port. The port interface <NUM> may be provided with the drug delivery device <NUM> described above and shown in <FIG>, although the port interface <NUM> may be provided on other suitable drug delivery devices.

Referring to <FIG>, which disclose devices not covered by the claims, a bottom surface <NUM> of the housing <NUM> of the drug delivery device <NUM> defines the port interface <NUM>. The port interface <NUM> is a recess having a shape corresponding to a shape of the implanted injection port <NUM>, <NUM>, <NUM>. The shape of the recess may be triangular (<FIG>), oval (<FIG>), or circular (<FIG>), although other suitable shapes may be utilized to receive any other size and shape of port. The port interfaces <NUM> shown in <FIG> are configured to receive the ports <NUM>, <NUM>, <NUM> shown in <FIG>, respectively. The size and shape of the recess may be configured to partially or entirely receive a portion of the port <NUM>, <NUM>, <NUM> that extends from a skin surface <NUM> of a patient to ensure the needle <NUM> is aligned with the septum <NUM> of the port <NUM>, <NUM>, <NUM>. The bottom surface <NUM> of the housing <NUM> may include an adhesive material (not shown) to secure the device <NUM> to the skin surface <NUM> of the patient, although other suitable arrangements for securing the device <NUM> to the patient may be utilized.

Referring to <FIG> which disclose a device not covered by the claims, the port interface <NUM> is aligned with the port <NUM>, <NUM>, <NUM> and the housing <NUM> is engaged with the skin surface <NUM> of the patient. The port interface <NUM> receives the port <NUM>, <NUM>, <NUM> such that the needle <NUM> is aligned with the septum <NUM> of the port <NUM>, <NUM>, <NUM>. During injection, the needle <NUM> pierces the septum <NUM> of the port <NUM>, <NUM>, <NUM> to deliver medicament from the device <NUM> to the patient via the port <NUM>, <NUM>, <NUM>.

Referring to <FIG>, rather than providing the port interface <NUM> as an integral part of the housing of the device <NUM>, the port interface <NUM> is provide via a port interface plate <NUM>. The port interface plate <NUM> is detachably secured to a main body <NUM> of the housing <NUM> of the device <NUM> via a connection arrangement <NUM>. The port interface plate <NUM> includes a plate body <NUM> having a first side <NUM> and a second side <NUM> positioned opposite the first side <NUM>. The plate body <NUM> defines the port interface <NUM>. In one aspect, the port interface <NUM> may be an opening extending from the first side <NUM> of the plate body <NUM> to the second side <NUM> of the plate body <NUM>. The port interface <NUM> of the port interface plate <NUM> may be triangular (<FIG>), oval (<FIG>), or circular (<FIG>), although other suitable shapes may be utilized to receive any other size and shape of port. The port interfaces <NUM> shown in <FIG> are configured to receive the ports <NUM>, <NUM>, <NUM> shown in <FIG>, respectively. The connection arrangement <NUM> of the port interface plate <NUM> may be snap members <NUM> provided on the plate body, which cooperate with and engagement corresponding snap members <NUM> provided on the main body of the device <NUM>, although any other suitable securing arrangement may be provided.

Referring to <FIG>, the main body <NUM> of the device <NUM> includes a port recess <NUM> configured to accommodate any one of the port interfaces <NUM> shown in <FIG>. The port interface plate <NUM> is secured to the main body <NUM> of the housing <NUM> such that the port interface <NUM> is aligned with the port recess <NUM> of the housing <NUM>. In other words, the port recess <NUM> of the main body <NUM> has sufficient clearance to accommodate any port shape. One of the port interface plates <NUM> may be selected and secured to the main body <NUM> depending on the size and shape of the implanted injection port <NUM>, <NUM>, <NUM>.

Referring to <FIG>, one of the port interface plates <NUM> is connected to the main body <NUM> of the device <NUM> with the port interface plate <NUM> secured to the skin surface <NUM> of the patient. The port interface plate <NUM> may include an adhesive material (not shown) to secure the plate <NUM> and device <NUM> to the skin surface <NUM> of the patient, although other suitable arrangements for securing the plate <NUM> and device <NUM> to the patient may be utilized. The port interface <NUM> of the plate <NUM> is aligned with the septum <NUM> of the port <NUM>, <NUM>, <NUM>. During injection, the needle <NUM> pierces the septum <NUM> of the port <NUM>, <NUM>, <NUM> to deliver medicament from the device <NUM> to the patient via the port <NUM>, <NUM>, <NUM>.

Claim 1:
A drug delivery device (<NUM>) comprising:
a housing (<NUM>) including a bottom surface (<NUM>);
a cartridge (<NUM>) received within the housing (<NUM>), the cartridge (<NUM>) configured to receive a medicament;
a drive assembly (<NUM>) received within the housing (<NUM>) and configured to engage the cartridge (<NUM>) and dispense medicament from the cartridge (<NUM>);
a needle actuator assembly (<NUM>) received within the housing (<NUM>), the needle actuator assembly (<NUM>) comprising a patient needle (<NUM>) configured to pierce a patient's skin (<NUM>),
characterised in that
the bottom surface (<NUM>) of the housing (<NUM>) defines a port recess (<NUM>);
in that the drug delivery device (<NUM>) further comprises
a port interface plate (<NUM>) configured to be secured to the bottom surface (<NUM>) of the housing (<NUM>), the port interface plate (<NUM>) comprising a port interface (<NUM>) configured to be aligned with the port recess (<NUM>) of the housing (<NUM>) when the port interface plate (<NUM>) is secured to the housing (<NUM>);
in that the port interface plate (<NUM>) includes a plate body (<NUM>) having a first side (<NUM>) and a second side (<NUM>) positioned opposite the first side <NUM>;
in that the port interface (<NUM>) is an opening extending from the first side (<NUM>) of the plate body (<NUM>) to the second side (<NUM>) of the plate body (<NUM>);
and in that the port interface plate (<NUM>) is selected and secured to a main body (<NUM>) of the housing (<NUM>) depending on the size and shape of an implanted injection port (<NUM>, <NUM>, <NUM>), such that the opening has a shape corresponding to a shape of the implanted injection port (<NUM>, <NUM>, <NUM>).