Patent Description:
Automatic drug delivery devices, such as autoinjectors, are designed with removable shields to maintain sterility of the needle and to prevent inadvertent contact between the needle and a user. Many of these needle shields are elastomeric, and ensuring accurate placement and a firm grip between the needle shield and caps or other removal devices can be difficult, resulting in a need for excess force to remove the shield or slippage and an inability to remove the shield at all. Accordingly, a need exists in the art for a needle shield remover that can reliably be positioned for quick and easy removal of the needle shield when the autoinjector is to be used. Related art includes documents <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

Provided herein is a shield removal assembly for an autoinjector including a syringe barrel, a needle, and a needle shield at least partially surrounding the needle. The shield removal assembly is as defined in claim <NUM> to <NUM>.

Also provided herein is an autoinjector as defined in claims <NUM> and <NUM>.

Also provided herein is a method of assembling an autoinjector as defined in claims <NUM>-<NUM>.

Further embodiments and aspects are set forth below:.

The autoinjector as defined in the claims, wherein the cap remover at least partially surrounds the open distal end of the housing.

The method as defined in the claims, wherein the retainer comprises at least one radially-extending protrusion.

The method described above, wherein the cap remover comprises a shoulder in a sidewall thereof between the proximal end and the distal end of the cap remover.

The autoinjector as defined in the claims, wherein the retainer and the cap remover are arranged to provide lag between initiation of longitudinal movement of the cap remover and initiation of longitudinal movement of the retainer.

The autoinjector described above, wherein the proximal end of the retainer comprises at least one grasping feature.

The autoinjector described above, wherein, in the first position, the proximal end of the needle shield is longitudinally spaced from the at least one grasping feature and in the second position the proximal end of the needle shield abuts the at least one grasping feature.

The autoinjector described above, wherein the retainer comprises at least one member extending proximally from the distal end of the retainer, the at least one member comprising a radially-extending protrusion.

The autoinjector described above, wherein the cap remover is rotatably fixed relative to the housing.

A method of assembling an autoinjector as defined in the claims, wherein the step of inserting a syringe comprises moving the syringe towards the distal end of the lower housing along the longitudinal axis such that: the proximal end of the retainer contacts the syringe barrel proximal to the distal end of the syringe barrel; and the distal end of the needle shield abuts the distal end of the retainer.

The method described above, wherein the retainer comprises at least one member extending proximally from the distal end of the retainer, the at least one member comprising a radially-extending protrusion.

The method described above, wherein the cap remover comprises an opening in a sidewall thereof between the proximal end and the distal end of the cap remover.

A shield removal assembly for an autoinjector as defined in the claims, wherein the proximal end of the retainer is configured to engage the needle shield between the proximal end of the needle shield and the distal end of the syringe barrel, and the distal end comprising an opening therethrough and configured to abut the distal end of the cap remover.

The shield removal assembly described above, wherein the retainer and the cap remover are arranged to provide lag between initiation of longitudinal movement of the cap remover and initiation of longitudinal movement of the retainer.

The shield removal assembly described above, wherein the retainer comprises at least one member extending proximally from the distal end of the retainer, the at least one member comprising a radially-extending protrusion.

The shield removal assembly described above, wherein the lag-providing arrangement defines a longitudinal distance between the radially-extending protrusion of the retainer and a shoulder of the cap remover, such that the cap remover is moved longitudinally away from the syringe a set distance before the radially extending protrusion of the retainer engages the shoulder of the cap remover.

The shield removal assembly described above, wherein the proximal end of the retainer comprises at least one grasping feature.

The shield removal assembly described above, wherein, in the first position, the proximal end of the needle shield is longitudinally spaced from the at least one grasping feature and, in the second position, the proximal end of the needle shield abuts the at least one grasping feature.

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.

Provided herein is a shield removal assembly for a drug delivery device including a needle. In non-limiting embodiments or aspects, the drug delivery device is an autoinjector or other similar device for automatic or manual delivery of a substance to a user. With reference to <FIG>, shown is a shield removal assembly (<NUM>) including a retainer (<NUM>) and a cap remover (<NUM>). Retainer (<NUM>) is nested within cap remover (<NUM>). In non-limiting embodiments or aspects, cap remover (<NUM>) is flared at a distal end thereof to form an ergonomic gripping surface to allow a user to firmly grip the cap remover. Retainer (<NUM>) and cap remover (<NUM>) can be formed of any rigid material, for example, and without limitation, plastics and the like.

<FIG>, <FIG>, and <FIG>-5C show exploded views of a non-limiting embodiment or aspect of the shield removal assembly described herein. Cap remover (<NUM>) includes proximal end (<NUM>), which is configured to be closest to the housing, and a distal end (<NUM>). In non-limiting embodiments or aspects, proximal end (<NUM>) of cap remover (<NUM>) includes two or more arms that engage with a housing (not shown) of an autoinjector. In such non-limiting embodiments or aspects, the arms of the cap remover (<NUM>) include at least one projection or shoulder to allow secure, releasable engagement with the housing of the autoinjector. The distal end (<NUM>) of cap remover (<NUM>) includes at least one opening (<NUM>) therethrough. In non-limiting embodiments or aspects, cap remover (<NUM>) includes in a sidewall thereof at least one opening (<NUM>). In non-limiting embodiments or aspects, cap remover (<NUM>) includes two openings (<NUM>). In non-limiting embodiments or aspects, cap remover (<NUM>) includes two openings (<NUM>) that are located on opposite sides of the cap remover (<NUM>).

With continued reference to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, retainer (<NUM>) includes proximal (<NUM>, closest to the housing) and distal (<NUM>) ends. In non-limiting embodiments or aspects, proximal end (<NUM>) of retainer (<NUM>) includes two or more arms that engage with the needle shield (not shown) of an autoinjector. In such non-limiting embodiments or aspects, the arms of the retainer (<NUM>) include at least one projection to allow secure engagement with the needle shield. The distal end (<NUM>) of retainer (<NUM>) includes at least one opening (<NUM>) therethrough. In non-limiting embodiments, the distal end (<NUM>) of the retainer (<NUM>) is configured to abut the distal end (<NUM>) of the cap remover (<NUM>). In non-limiting embodiments or aspects, the opening (<NUM>) in the distal end (<NUM>) of the cap remover (<NUM>) is of a larger diameter than the opening (<NUM>) in the distal end (<NUM>) of the retainer (<NUM>). In non-limiting embodiments or aspects, this difference in diameter allows the retainer (<NUM>) to be introduced into the cap remover (<NUM>) through the opening (<NUM>) in the distal end (<NUM>) of the cap remover (<NUM>).

As described previously, proximal end (<NUM>) of retainer (<NUM>) can include at least one grasping feature, such as a projection, to allow secure engagement with a needle shield. Turning to <FIG> and <FIG>, shown is a shield removal assembly according to a non-limiting embodiment or aspect, where the retainer (<NUM>) includes at least one grasping feature (<NUM>) at a proximal end (<NUM>) thereof. The at least one grasping feature can be at least one protrusion (<NUM>), and can be configured such that it is capable of gripping a needle shield by a flange thereof.

In non-limiting embodiments or aspects, the retainer (<NUM>) and cap remover (<NUM>) of the shield removal assembly (<NUM>) are configured or arranged such that the needle shield and/or syringe of an autoinjector (not shown) can be shifted relative to the retainer by introducing a device, such as a tool, through the openings (<NUM>, <NUM>) in the distal ends (<NUM>, <NUM>) of the retainer (<NUM>) and cap remover (<NUM>), respectively. Placing a tool through the openings in the cap remover and retainer allows the needle shield and syringe to be displaced proximally, and thus allows for adjustment of the positioning of the projections (<NUM>) relative to the needle shield to ensure a secure grip between the retainer (<NUM>) and the needle shield.

With continued reference to <FIG> and <FIG>, as described above in non-limiting embodiments or aspects the cap remover (<NUM>) includes at least one opening (<NUM>) in a sidewall thereof. The at least one opening (<NUM>) is configured to allow at least one radially-extending protrusion (<NUM>) on retainer (<NUM>) to extend therethrough. In the non-limiting embodiment or aspect shown in <FIG> and <FIG>, at least one radially-extending protrusion (<NUM>) extends from an arm that extends proximally from the distal end (<NUM>) of the retainer (<NUM>). In other non-limiting embodiments or aspects (not shown), the at least one radially-extending protrusion (<NUM>) is positioned on a main body of the retainer (<NUM>).

With reference to <FIG> and <FIG>, a lag arrangement is provided between the cap remover (<NUM>) and the retainer (<NUM>) during removal of the shield removal assembly (<NUM>). Retainer (<NUM>) is received within cap remover (<NUM>) such that at least one protrusion (<NUM>) is arranged proximally of at least one shoulder (<NUM>) of cap remover (<NUM>). In non-limiting embodiments or aspects, the at least one protrusion (<NUM>) prevents the retainer (<NUM>) from being displaced distally out of the cap remover (<NUM>), by virtue of engagement with a proximal surface of the at least one shoulder (<NUM>). In non-limiting embodiments or aspects, the retainer (<NUM>) further includes at least one flange (<NUM>), arranged distally of the at least one shoulder (<NUM>) of the cap remover (<NUM>). In this way, the retainer (<NUM>) is prevented from being displaced proximally out of the cap remover (<NUM>) by virtue of engagement of a proximal surface of the at least one flange (<NUM>) with a distal surface of the at least one shoulder (<NUM>). The longitudinal space between the at least one protrusion (<NUM>) and the at least one flange (<NUM>) on the retainer (<NUM>) results in a predetermined amount of "play" between these components. Accordingly, in non-limiting embodiments or aspects, when the cap remover (<NUM>) is pulled distally to remove the shield removal assembly (<NUM>) from a drug delivery device to which it is attached, cap remover (<NUM>) is pulled a certain distance before the at least one shoulder (<NUM>) engages the at least one protrusion (<NUM>) of the retainer (<NUM>). This results in a lag between the initiation of movement of the cap remover (<NUM>) and initiation of movement of the retainer (<NUM>). When cap remover (<NUM>) moves sufficiently such that the at least one shoulder (<NUM>) engages with the at least one protrusion (<NUM>), the retainer (<NUM>) begins to be pulled away from the drug delivery device, and, because of the positioning of the at least one projection (<NUM>) relative to the needle shield, the needle shield begins to be pulled away from the syringe and needle.

Also provided herein is an autoinjector including a housing, a syringe having a barrel, a needle, and a needle shield, and a shield removal assembly. Turning to <FIG>, shown is an autoinjector having a housing, a syringe (<NUM>) having a barrel (<NUM>) and a needle (<NUM>) attached thereto, a removable needle shield (<NUM>) configured to at least partially surround the needle (<NUM>), and a shield removal assembly (<NUM>). The autoinjector housing (a lower housing (<NUM>) is shown, though it should be understood that autoinjector can include an upper housing, as described below) includes a proximal end and a distal end, where the distal end is open to permit the needle (<NUM>) to pass therethrough to allow a substance to be delivered to a user.

Removable needle shield (<NUM>) can include proximal (<NUM>) and distal (<NUM>) ends. In non-limiting embodiments or aspects, removable needle shield (<NUM>) is a two-piece needle shield, including an elastomeric inner portion and a rigid outer portion. In non-limiting embodiments or aspects, the rigid outer portion at least partially surrounds the elastomeric inner portion of the needle shield (<NUM>). In non-limiting embodiments or aspects, needle shield (<NUM>) includes at least one flange or shoulder (<NUM>). In non-limiting embodiments or aspects, the at least one flange or shoulder (<NUM>) is located on the elastomeric inner portion, for engaging the rigid outer portion. In non-limiting embodiments or aspects, needle shield (<NUM>) includes at least one complementary grasping feature (<NUM>) on the proximal end (<NUM>) thereof. In non-limiting embodiments or aspects, the at least one complementary grasping feature (<NUM>) is configured to be complementary to, and engageable with, the at least one grasping feature (<NUM>) of the retainer. In non-limiting embodiments or aspects, the at least one complementary grasping feature (<NUM>) is the proximal edge of the needle shield (<NUM>).

In non-limiting embodiments or aspects, the elastomeric portion of the needle shield (<NUM>) is formed of one or more natural or synthetic rubbers and/or of thermoplastic elastomer, or combinations thereof. In non-limiting embodiments or aspects, the rigid outer portion of the needle shield (<NUM>) is formed of a rigid plastic. In non-limiting embodiments or aspects, the rigid outer portion is formed of polypropylene.

Shield removal assembly (<NUM>) includes, as described previously, cap remover (<NUM>) and retainer (<NUM>). In non-limiting embodiments or aspects, the cap remover (<NUM>) and/or retainer (<NUM>) include one or more of the features described above. In non-limiting embodiments or aspects, cap remover (<NUM>) at least partially surrounds the open distal end of the housing. In non-limiting embodiments or aspects, cap remover (<NUM>) is not rotatable relative to the housing. Autoinjector housing and/or cap remover (<NUM>) can include suitable features to prevent rotation of the cap remover (<NUM>), and, accordingly, retainer (<NUM>) and needle shield (<NUM>), relative to the housing and the needle (<NUM>), during needle shield (<NUM>) removal. In non-limiting embodiments or aspects, suitable anti-rotation features include one or more projections, guide channels, and/or shoulders on cap remover (<NUM>) and/or housing.

Also provided herein is a method of assembling an autoinjector including a shield removal assembly, including the steps of providing a lower housing assembly of an autoinjector, inserting a syringe into the lower assembly, and placing an upper assembly on the lower assembly. In a first step, a lower housing assembly (<NUM>), including shield removal assembly (<NUM>) engaged therewith, is provided. The lower housing assembly (<NUM>) includes lower housing (<NUM>). In non-limiting embodiments or aspects, lower assembly (<NUM>) includes a ring (<NUM>) at a proximal end thereof. The lower housing assembly (<NUM>) includes a proximal end and a distal end, the distal end being open to allow a needle of a syringe to pass therethrough, and the proximal end of the lower housing (<NUM>) being open to allow a syringe to be inserted into the housing. Housing may be formed of any suitable material, including, for example and without limitation, a rigid plastic. Lower assembly (<NUM>) also includes a shield removal assembly (<NUM>). Shield removal assembly (<NUM>) includes, as described previously, cap remover (<NUM>) and retainer (<NUM>), each having distal ends (<NUM>, <NUM>) having an opening (<NUM>, <NUM>) therethrough. In non-limiting embodiments or aspects, the cap remover (<NUM>) and/or retainer (<NUM>) include one or more of the features described above. In an initial configuration (e.g., when shield removal assembly (<NUM>) is positioned on lower housing (<NUM>)), the distal end (<NUM>) of the retainer (<NUM>) is spaced from the distal end (<NUM>) of the cap remover (<NUM>).

With reference to <FIG>, in non-limiting embodiments or aspects, in a second step of the method, a syringe (<NUM>) is inserted into the lower housing (<NUM>). The syringe (<NUM>) can include a barrel (<NUM>) to hold a medicament or other substance therein, a needle (<NUM>) arranged at a distal end of the barrel (<NUM>), and a removable needle shield (<NUM>). Syringe (<NUM>), barrel (<NUM>), needle (<NUM>), and needle shield (<NUM>) can include one or more of the features described above. Syringe barrel (<NUM>) can be of any useful size, and can be formed of any useful material, such as glass or plastic. In non-limiting embodiments or aspects, syringe (<NUM>) is a unitary syringe, and the needle (<NUM>) is formed with the syringe barrel (<NUM>). In non-limiting embodiments or aspects, syringe barrel (<NUM>) is not formed with needle (<NUM>) therein and, instead, a needle hub (not shown) holds needle (<NUM>). Syringe needle (<NUM>) can be formed of any useful material, and can be of any suitable gauge. Needle shield (<NUM>) can be a one-piece needle shield formed of an elastomeric material, or a two-piece needle shield having an inner portion formed of an elastomeric material and an outer portion formed of a rigid material. The needle shield (<NUM>) at least partially surrounds the needle (<NUM>). In non-limiting embodiments or aspects, syringe (<NUM>) includes a flange (<NUM>) at a proximal end thereof. At the conclusion of the second step, the distal end (<NUM>) of the retainer (<NUM>) remains longitudinally spaced from the distal end (<NUM>) of the cap remover (<NUM>).

In non-limiting embodiments or aspects, the step of inserting the syringe (<NUM>) includes moving the syringe (<NUM>) towards the distal end of the housing (<NUM>), preferably such that the at least one grasping feature (<NUM>) is spaced longitudinally from the proximal end of the needle shield. In other words, the at least one grasping feature (<NUM>) is more proximal than in its final position (shown in <FIG>). In this position, the distal end (<NUM>) of the syringe flange abuts the ring (<NUM>). In this position, the proximal end (<NUM>) of the retainer (<NUM>) contacts the syringe barrel (<NUM>).

As described above, at the conclusion of this step, the distal end (<NUM>) of the retainer (<NUM>) is maintained proximally with respect to the distal end (<NUM>) of the cap remover (<NUM>), such that the distal end (<NUM>) of the retainer (<NUM>) is longitudinally spaced from the distal end (<NUM>) of the cap remover (<NUM>). In non-limiting embodiments or aspects, a tool (not shown) is inserted within the opening (<NUM>) of the cap remover (<NUM>). This tool can be used to push the retainer (<NUM>) proximally, such that the distal end (<NUM>) of the retainer (<NUM>) is longitudinally spaced from the distal end (<NUM>) of the cap remover (<NUM>).

In non-limiting embodiments or aspects, the proximal end (<NUM>) of the retainer (<NUM>) includes at least one grasping feature, such as projections (<NUM>), and the projections (<NUM>) contact the syringe barrel (<NUM>) proximally of the distal end of the syringe barrel (<NUM>). In this way, the retainer (<NUM>) is in an "overstroked" position, where the at least one grasping feature (<NUM>) is located too far proximally of the needle shield (<NUM>) (<FIG>). In non-limiting embodiments or aspects, the needle shield (<NUM>) includes at least one flange or shoulder (<NUM>), and the proximal end (<NUM>) of the retainer (<NUM>) includes at least one grasping feature (<NUM>), and the at least one grasping feature (<NUM>) contacts the syringe barrel (<NUM>) proximally of the at least one flange or shoulder (<NUM>).

With reference to <FIG>, in non-limiting embodiments or aspects, a third step of the method of assembling the syringe includes, after inserting the syringe (<NUM>) into the lower housing (<NUM>), moving the syringe (<NUM>) proximally. In non-limiting embodiments or aspects, moving the syringe (<NUM>) proximally within the lower housing (<NUM>) is achieved by inserting a device through the at least one opening (<NUM>, <NUM>) in the distal ends (<NUM>, <NUM>) of the cap remover (<NUM>) and retainer (<NUM>), and applying pressure to urge the syringe (<NUM>) proximally. In non-limiting embodiments or aspects, and as shown in <FIG>, when the syringe (<NUM>) is urged proximally, the at least one grasping feature (<NUM>) of the retainer (<NUM>) engages the needle shield at a proximal-most end thereof. In non-limiting embodiments or aspects, the at least one grasping feature (<NUM>) engages at least one corresponding, complementary grasping feature (<NUM>) on the needle shield (<NUM>). In non-limiting embodiments or aspects, after the syringe (<NUM>) is urged proximally, the syringe flange (<NUM>) is longitudinally spaced from the ring (<NUM>) of the lower assembly (<NUM>). At the end of this step the at least one grasping feature (<NUM>) engages the at least one complementary grasping feature (<NUM>) of the needle shield (<NUM>), the distal end (<NUM>) of the retainer (<NUM>) is longitudinally spaced from the distal end (<NUM>) of the cap remover (<NUM>), and the syringe flange (<NUM>) is longitudinally spaced from the ring (<NUM>).

In non-limiting embodiments or aspects, the method includes a fourth step of placing an upper assembly (not shown), including an upper housing, on the lower assembly. As with lower assembly and lower housing, upper assembly and upper housing can be formed of any suitable material, including, for example and without limitation, a rigid plastic. In non-limiting embodiments or aspects, the step of placing the upper assembly on the lower assembly causes the syringe to move distally, such that the syringe flange (<NUM>) abuts the ring (<NUM>).

With reference to <FIG>, after assembly, distal end (<NUM>) of retainer (<NUM>) falls or is otherwise displaced towards the distal end (<NUM>) of the cap remover (<NUM>), such that the distal end (<NUM>) of the retainer (<NUM>) abuts the distal end (<NUM>) of the cap remover (<NUM>).

Once a final user wants to remove the needle shield, he/she pulls the cap remover. As described above, the gap between the at least one protrusion (<NUM>) of the retainer (<NUM>) and the at least one shoulder (<NUM>) of the cap remover (<NUM>) causes a lag between the initiation of longitudinal movement of the cap remover (<NUM>) away from the lower housing assembly (<NUM>) and the initiation of longitudinal movement of the retainer (<NUM>) away from the lower housing assembly (<NUM>).

Claim 1:
A shield removal assembly (<NUM>) for an autoinjector comprising a syringe barrel, a needle, and a needle shield at least partially surrounding the needle, the shield removal assembly comprising:
a cap remover (<NUM>) configured to be grasped by a user and having a proximal end (<NUM>) and a distal end (<NUM>), the distal end (<NUM>) of the cap remover (<NUM>) comprising at least one opening (<NUM>) therethrough; and
a retainer (<NUM>) received within the cap remover (<NUM>) and having a proximal end (<NUM>) and a distal end (<NUM>), the retainer (<NUM>) comprising at least one grasping feature (<NUM>) configured to engage at least one complementary grasping feature of the needle shield, and the distal end (<NUM>) comprising an opening (<NUM>) therethrough;
wherein the shield removal assembly (<NUM>) is configured such that the needle shield of the autoinjector can be advanced through the shield removal assembly (<NUM>) from a first position in which the at least one grasping feature (<NUM>) is spaced longitudinally and located proximally of the at least one complementary grasping feature of the needle shield to a second position in which the at least one grasping feature (<NUM>) engages the at least one complementary grasping feature of the needle shield;
wherein the retainer (<NUM>) comprises at least one radially-extending protrusion (<NUM>), and the cap remover (<NUM>) comprises at least one window (<NUM>) configured to receive the radially-extending protrusion (<NUM>), and
characterized in that the retainer is axially moveable with respect to the cap remover,
and in that the retainer comprises at least one protrusion (<NUM>); and the cap remover (<NUM>) comprises at least one shoulder (<NUM>) longitudinally spaced from the at least one protrusion (<NUM>) of the retainer (<NUM>), such that the cap remover (<NUM>) is moved longitudinally away from the syringe a set distance before the at least one shoulder (<NUM>) engages the at least one protrusion (<NUM>).