Patent ID: 12239825

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. Therefore, specific designs and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims.

FIGS.5and6show an exemplary embodiment of a drug delivery assembly110according to the present disclosure. The assembly110includes a main body112and a cartridge114.FIG.5shows the main body112and cartridge114coupled together and ready for use.FIG.6shows the cartridge114separated from the main body112.

The body112includes a housing116having upper118and lower surfaces120and defining a recess122(FIG.6) that is configured to at least partially receive the cartridge114(FIG.5). The housing116may be made from any suitable (typically, generally rigid) material, including plastic polymers such as polyvinyl chloride (PVC), polypropylene, polycarbonate, and polystyrene. An adhesive pad126may be associated with the lower surface120of the housing116. The adhesive pad126may be configured to removably attach to a human body surface. Any suitable medical grade adhesive pad configured to be removably attached to the human body surface may be used.

The cartridge114includes (as best shown inFIG.6): a cartridge housing128, a drug reservoir130positioned within the cartridge housing128, a stopper132movably associated with the drug reservoir130, and a needle134movably associated with the drug reservoir130. The cartridge114is sized and configured to be at least partially inserted into the recess122, as shown inFIG.5. The body112also includes a rod136configured to be engaged by the stopper132when the cartridge114is inserted into the recess122. The cartridge housing128may be made from any suitable material, including (for example) plastic polymers such as PVC. The drug reservoir130may also be made from any suitable material, including (but not limited) to polyethylene terephthalate (PET). The stopper132may be any suitably sized medical grade stopper, configured to form a fluid-tight seal against the inner surface of the drug reservoir130, while also being movable along at least a portion of the length of the drug reservoir130.

In an exemplary embodiment, the cartridge housing128may include a port138(FIG.6) configured to receive a medicament. The port138may be incorporated into the cartridge housing128, for example at the bottom or underside of the housing128. The port138is configured to fluidically connect to the drug reservoir130. To maintain sterility, a pierceable seal (not shown) may cover the port138. The pierceable seal may be durable, such as a rubber septum, in order to seal the port to maintain sterility but allow for multiple refills. After entrance into the port138, the medicament flows into the reservoir130, in general accordance with the above description of the manner in which the reservoir14of the conventional device10ofFIGS.1-4is filled. In such an embodiment, the drug reservoir130may be filled by a medical professional. The medical professional injects the medicament, for example using a syringe, through the port138and the medicament flows into the drug reservoir130.

In all embodiments described herein, the medicament may be any suitable fluid medication. In an exemplary embodiment, the medicament may be pegfilgrastim, though other exemplary medications include (without limitation) one or more of the following: adalimumab, rituximab, risankizumab, etanercept, trastuzumab, ado-trastuzumab emtansine, trastuzumab deruxtecan, bevacizumab, infliximab, pegfilgrastim, filgrastim, tocilizumab, golimumab, interferon beta-1a, ranibizumab, denosumab, pembrolizumab, nivolumab, aflibercept, eculizumab, ocrelizumab, pertuzumab, secukinumab, omalizumab, ustekinumab, vedolizumab, daratumumab, dupilumab, atezolizumab, natalizumab, bortezomib, ipilimumab, durvalumab, emicizumab, palivizumab, guselkumab, mepolizumab, panitumumab, ramucirumab, belimumab, abatacept, certolizumab pegol, ixekizumab, romiplostim, benralizumab, evolocumab, canakinumab, obinutuzumab, cetuximab, erenumab, blinatumomab, romosozumab, mirikizumab, inotuzumab, sacituzumab govitecan, enfortumab vedotin, brentuximab vedotin.

The medicament is most typically injected into the drug reservoir130immediately before the assembly110is secured to the patient to ensure that the proper drug is supplied, along with the proper amount. The drug reservoir130may be refillable, such that after the drug reservoir130is emptied upon first use, it may be filled again, for example by another injection. The drug reservoir130may be filled when the cartridge114is separated from the recess122. Alternatively, the drug reservoir130may be filled when the cartridge114is attached to the recess122.

In an alternative embodiment, the drug reservoir of the cartridge is not refillable, but is instead pre-filled with a medicament, for example during manufacture of the cartridge. In such an embodiment, the cartridge housing128may omit port138, though it is also within the scope of the present disclosure for such a port138to be provided, but configured for only a single use (e.g., during manufacture to pre-fill the drug reservoir). Regardless of the particular configuration, after use, the cartridge is detached from the body and discarded. If further administration of a medicament is needed, a new pre-filled cartridge is coupled to the recess.

These pre-filled and fillable aspects allow the medicament to be stored separately from the assembly110. For example, the medical professional may need to keep a drug at a certain temperature to retain the medicament's efficacy. The drug may be stored at the needed temperature, for instance cooled in a refrigerator or freezer until it is time for use, while the assembly110including the main body112and the empty or pre-filled cartridge114may be stored, for example, at room temperature.

As the medicament fills the drug reservoir130, the stopper132moves (from right to left, in the orientation ofFIG.6) to accommodate the medicament. Movement of the stopper132into its final position (when the reservoir130has been filled with the appropriate amount of the medicament) causes an extension150of the stopper132to extend from the drug reservoir130(FIG.6), allowing or causing the rod136to engage the extension150of the stopper132. The rod136and extension150may be variously configured without departing from the scope of the present disclosure. For example, in one embodiment, the rod136may be configured as a push rod, configured to push the medicament through the reservoir130and into the needle134upon actuation of the assembly110.

Turning back now to the body112, it includes an actuator124associated with the housing116. The actuator124is movable with respect to the housing116, withFIGS.7-9showing the actuator124moving from a first position (FIG.7), through an intermediate position (FIG.8), and into a second position (FIG.9). The actuator124may be variously configured without departing from the scope of the present disclosure. In the illustrated embodiment, the actuator124includes a button portion146at least partially positioned outside of the body housing116. The illustrated actuator124also includes a cam or wedge140associated with the button portion146. In the illustrated embodiment, the cam140is integrally formed with the button portion146as a single component, but it is within the scope of the present disclosure for the two to be separate components. The button portion146and the cam140may be made from any suitable, generally rigid material including, for example, PVC or a metallic material.

The cam140is surrounded by a coil spring142that bears against a portion of the button portion146and/or the cam140to bias the button portion146and cam140to the first position ofFIG.7, in which the cam140is spaced from the recess122. The button portion146is pressed or otherwise manipulated to move it toward the housing116(in a left-to-right direction in the orientation ofFIGS.7-9), which compresses the spring142as the button portion146and cam140move toward the recess122(FIGS.8and9), with at least a portion of the cam140eventually entering into the recess122.

Before moving on to the implications of the cam140being at least partially moved into the recess122, it is noted that the present disclosure is not limited to a manually manipulable actuator124, but rather it is contemplated that the actuator124may be moved by any suitable means or mechanism. For example, rather than including a button portion146that is pressed to move the actuator124toward the recess122, the actuator124may instead be configured to be moved by electrical and/or magnetic mechanisms, withFIG.6Aillustrating an assembly having an actuator124configured to be moved by an electrical mechanism143andFIG.6Billustrating an assembly having an actuator124configured to be moved by a magnetic mechanism145.

Regardless of the particular mechanism employed to move the actuator124, when the cartridge114is at least partially received within the recess122, movement of the cam140into the recess122will cause the cam140to interact with the cartridge114. In the illustrated embodiment, the cartridge114includes a sterile seal152that is oriented so as to be positioned in the path of the cam140when the cartridge114is mounted within the recess122. The sterile seal152is configured to be pierced or otherwise broken by the actuator124when it is moved from the first position to the second position, such that it may be advantageous for the sterile seal152to be formed of a thin foil or film material that seals or overlays an opening defined in the cartridge housing128while being readily broken when contacted by the cam140.

The cam140may include an inclined surface156configured to engage the sterile seal152when the actuator124is moved from the first position to the second position. If provided, the inclined surface156may facilitate piercing of the sterile seal152, as shown inFIG.8. In the illustrated embodiment, the inclined surface156is further configured to contact and cause movement of at least a portion of the needle134when the actuator124is moved into the second position, as shown inFIG.9. In particular, the needle134is initially in a first position (which is shown inFIGS.7and8as a raised position) with respect to the drug reservoir130and the skin surface underlying the assembly110. In one embodiment, the needle134may be out of fluid communication with the drug reservoir130when the needle134is in the first position, with the needle134only being placed into fluid communication with the drug reservoir130(e.g., with an outlet of the drug reservoir130) when the needle134is moved into a second position by the inclined surface156of the cam140(FIG.9). Alternatively, the needle134may be configured to be in fluid communication with the drug reservoir130regardless of the position of the needle134, which may include the needle134being in fluid communication with the drug reservoir130before the cartridge114is mounted within the recess122, or the needle134being placed into fluid communication with the drug reservoir130by the action of mounting the cartridge114into the recess122(e.g., by breaking a seal between the needle134and the drug reservoir130).

As the inclined surface156of the cam140is pressed toward and against the needle134, the inclined surface156will force the needle134to move from its first position to a second position, which is shown inFIG.9as a lowered position, which is closer to the lower surface120of the housing116. The drug reservoir130may include a track or guide that defines the path of the needle134as the needle134is moved from the first position to the second position by the cam140(which is a vertical path, in the illustrated embodiment). In the second position, the needle134will be in fluid communication with the interior of the drug reservoir130to allow a medicament to be dispensed from the drug reservoir130via the needle134. Additionally, in the second position, the needle134will pierce or otherwise pass through a lower seal148formed of a thin film or foil or the like that seals or overlays a lower opening defined in the cartridge housing128. In embodiments in which the needle134is in fluid communication with the drug reservoir130before movement of the needle134into its second position, it may be advantageous for the lower seal148to be more substantial than a film or foil. For example, in such embodiments, the lower seal148may be configured as a rubber septum, with the end of the needle134positioned within the lower seal148when the needle134is in its first position (so as to prevent leakage of fluid from the needle134), with movement of the needle134into its second position causing the end of the needle134to pierce entirely through the lower seal148.

Regardless of the particular configuration of the lower seal148, in the second position, the lower end of the needle134will extend out of the lower surface120of the housing116to pierce the skin of a patient to which the assembly110is secured by the adhesive pad126. Thus, moving the actuator124from its first position to its second position will move the needle134from its first position to its second position, thereby creating a fluid flow path between the drug reservoir130and the patient, with the needle134defining at least a portion of the fluid flow path. While not shown in the illustrated embodiment, it should be understood that the assembly110may be provided with a cannula of the type described above with regard to the device10ofFIGS.1-4, with movement of the needle134with respect to the drug reservoir130causing deployment of a portion of the cannula into the skin of the patient, with one portion of the fluid flow path being by the needle134and another portion of the fluid flow path being defined by the cannula.

In an alternative embodiment, rather than the needle134being in fluid communication with the drug reservoir130before mounting the cartridge114into the recess122, being placed into fluid communication with the drug reservoir130upon mounting the cartridge114into the recess, or being placed into fluid communication with the drug reservoir130by moving the needle134into its second position, the needle134may instead be configured to initially remain out of fluid communication with the drug reservoir130upon moving to the second position. In such an embodiment, some additional action or event following movement of the needle134into the second position causes the needle134to be placed into fluid communication with the drug reservoir130. This subsequent action or event may comprise, for example, further movement of the actuator124or a secondary actuator to remove a seal between the needle134and the drug reservoir130(e.g., by causing an end of the needle134to pierce through a rubber septum positioned between that end of the needle134and the drug reservoir130).

Once the needle134is in position to define at least a portion of the fluid flow path between the drug reservoir130and the patient, it is advantageous for the needle134to remain in place until a drug delivery routine has been completed. As the position of the actuator124determines the position of the needle134, it may be advantageous to lock the actuator124in place during a drug delivery routine to ensure that the needle134remains properly positioned. Accordingly, the assembly110may be provided with a latch144(FIG.9) that is actuated when the actuator124has moved into its second position. The latch144(which may be variously configured without departing from the scope of the present disclosure) engages a portion of the actuator124to prevent the compressed spring142from resiliently returning the actuator124from the second position to the first position. In one embodiment, a controller154of the assembly110configured to execute a drug delivery routine may execute a subroutine in which the latch144is deployed at the appropriate time; otherwise, the latch144may be configured to be automatically deployed via a suitable mechanical mechanism without involvement of the controller154.

Locking the actuator124in place will lock the needle134in place. Locking the actuator124in place also serves to secure the cartridge114to the body112. In particular, as shown inFIG.9, when the actuator124is in its second position, the cam140will extend through the sterile seal152of the cartridge114and into an interior of the cartridge114. With the actuator124in the second position, the cartridge114cannot be removed from the recess122, due to the actuator124extending into the cartridge114and holding the cartridge114in place. Thus, locking the actuator124in place (in its second position) during a drug delivery routine will ensure the integrity of the fluid flow path during drug delivery (by holding the needle134in position) and ensure that the assembly110remains assembled during drug delivery. It should be understood that locking the actuator124in its second position is merely one possible approach to locking the cartridge114to the main body112and that additional or alternative mechanisms may be provided to lock the cartridge114in place within the recess122. Likewise, locking the needle134in place may be achieved by a separate mechanism than the mechanism that locks the cartridge114. The separate mechanism may be any appropriately configured locking mechanism, such as a latch.

While it is advantageous for the cartridge114and needle134to be locked in place during a drug delivery routine, it is advantageous for them to be moved once drug delivery has been completed. Thus, the assembly110may be configured such that the latch144will disengage the actuator124and allow the spring142to resiliently return the actuator124to its first or initial position after a drug delivery routine has been completed. The latch144may be actuated to disengage the actuator124at the appropriate time by any suitable approach, which may include the latch144being released as a result of a subroutine executed by the controller154or by the latch144being released by a suitable mechanical mechanism not requiring intervention by the controller154. In either case, disengaging the latch144allows the spring142to resiliently return the actuator124from its second position to its first position. With the actuator124in its first position, the needle134may be returned to its first position and the cartridge114may be removed from the recess122. The needle134should be removed from the skin of the patient before the cartridge114is removed from the recess122to prevent injury to the patient. To that end, it may be advantageous for the needle134to be configured to automatically move from its second position to its first position, such as by being spring-loaded, to ensure that the needle134has been removed from the patient before the cartridge114is removed from the recess122. As an additional safety measure, the assembly110may include a secondary locking mechanism between the cartridge114and the main body112to better ensure that the needle134is retracted before the cartridge114is fully unlocked and allowed to be removed from the recess122.

As for drug delivery using the assembly110, in an exemplary embodiment, the controller154is configured to execute a drug delivery routine and is incorporated into the main body112. The controller154may be variously configured without departing from the scope of the present disclosure, with the controller154being configured as a CPU or MPU of the type described above with regard to the controller of the device10ofFIGS.1-4. The controller154may be configured to be activated when the cartridge114is inserted into the recess122or when the actuator124is manipulated to move it from its first position to its second position or at any other suitable time. The exact nature of the drug delivery routine executed by the controller154may vary without departing from the scope of the present disclosure. For example, as described above, the controller154may be configured to execute a drug delivery routine in which a drug is delivered over the span of 45 minutes, with delivery beginning 27 hours after the controller154has been activated and applied to a patient (to ensure that the drug is not delivered sooner than 24 hours after a medical procedure or treatment).

Regardless of the particular steps carried out, each drug delivery routine will include at least a portion of the medicament in the drug reservoir130being conveyed out of the drug reservoir130, through a fluid flow path at least partially defined by the needle134, and into body of a patient. The flow of the medicament out of the drug reservoir130is controlled by movement of the stopper132through the drug reservoir130. As described above, the stopper132, when the cartridge114has been inserted into the recess122, is coupled to a rod136of the main body112. Movement of the rod136is controlled by the controller154, which is coupled to the rod136by any suitable linkage (e.g., a muscle wire-lever assembly of the type described above with regard to the device10ofFIGS.1-4). During a drug delivery routine, the controller154causes the rod136to manipulate the stopper132to move through the drug reservoir130toward the needle134, which dispenses medicament from the drug reservoir130via the needle134.

It will be understood that the embodiments and examples described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.