Patent Description:
Drugs can be administered through the use of drug delivery devices such as autoinjectors or on-body injectors, which are also referred to as wearable injectors. Autoinjectors and on-body injectors may be used to help automate the injection and delivery or administration process, thereby simplifying the process for certain patient groups or sub-groups for which use of the syringe/vial combination or pre-filled syringe systems would be disadvantageous, whether because of physiological or psychological impediments.

Subcutaneous injection is one method for a gradual release of drug product into the blood stream and is the injection type in most autoinjector and on-body injector drug delivery devices. The limited amount of blood vessels and fluid paths within the subcutaneous tissue, however, can cause a pressure build up at the point of injection. This pressure can resist the injection, can cause significant variability in the injection time, and may cause pain for the patients. <CIT> discloses a device for providing substantially painless injection of medication. <CIT> discloses a device for transdermal injection of drugs. <CIT> discloses a device for automatic injection of drugs into or beneath the skin.

In accordance with a first aspect, a drug delivery device is disclosed according to claim <NUM>.

According to some versions, the drug delivery device can further include one or more of the following aspects: the force sensor can be disposed between the plunger rod and the plunger stopper; the controller can be configured to continuously monitor the force data and direct power to the magnetic actuator based on the force data to control an onset, rate, and extent of retraction of the drug delivery member to maintain a desired tissue resistive pressure in the injection cavity; the controller can be in communication with the drive of the drug dispensing assembly and configured to control operation of the drive and magnetic actuator to maintain a desired drug dispensing force; the magnetic actuator can be the insertion drive; the primary container assembly can include a cannula coaxially disposed over the drug delivery member and fluidly coupled to the reservoir by the flow path and components of the primary container assembly and drug dispensing assembly can be disposed in a generally horizontal plane and the drug delivery member and cannula can extend along an axis generally perpendicular to the horizontal plane; components of the primary container assembly and drug dispensing assembly can be disposed along a longitudinal axis and the flow path can be a hub rigidly coupling the drug delivery member to the reservoir; the drug delivery device can further include a limit stop that is disposed in a path of the shaft of the magnetic actuator to provide a movement limit for the shaft in the second direction; the drug delivery device can further include a lock that is selectively securable to the shaft of the magnetic actuator to retain the shaft and hold the drug delivery member in a retracted position; or the controller can be configured to direct power to the magnetic actuator to retract the drug delivery member after the drug delivery member is inserted to the subcutaneous location.

The above needs are at least partially met through provision of the embodiments described in the following detailed description, particularly when studied in conjunction with the drawings, wherein:.

Methods, devices, and components are provided to reduce tissue resistive pressure during a subcutaneous drug delivery operation by increasing the size of the injection cavity by partially retracting a drug delivery member (e.g., a rigid needle or soft cannula) after inserting the same to a subcutaneous position. An injection cavity refers to the cavity at the tip of the drug delivery member inside the patient tissue. The drug delivery devices described herein include a magnetic actuator coupled to the drug delivery member and controlled by a controller. A force sensor is coupled to drug dispensing components of the devices so that the controller can selectively supply power to the magnetic actuator to retract the drug delivery member based on force data from the sensor. If desired, the controller can vary the amount of power supplied to the magnetic actuator based on the magnitude of the force data to control the extent of drug delivery member retraction. The drug delivery devices can include locks and/or hard stops to contain movement of the drug delivery member.

In some versions, as illustrated in <FIG>, drug delivery devices <NUM>, such as on body injectors, can have a horizontally oriented configuration with drug delivery components disposed generally along a horizontal plane P within a low profile housing <NUM> of the devices <NUM>. The drug delivery components can include a reservoir <NUM> having a drug <NUM> contained therein, a plunger stopper <NUM> disposed within the reservoir <NUM> and sildably movable therein along the horizontal plane P, a drive mechanism <NUM> coupled to a plunger rod <NUM> to drive the plunger stopper <NUM> through the reservoir <NUM>, a trocar <NUM> and drug delivery member <NUM> which in the depicted version includes a soft cannula oriented along an axis X that extends generally perpendicular to the horizontal plane P, a flow path <NUM> fluidly coupling the reservoir <NUM> to the drug delivery member <NUM>, and an insertion mechanism <NUM> configured to insert the trocar <NUM> and drug delivery member <NUM> into a subcutaneous injection region within the user. Thereafter, the insertion mechanism <NUM> can fully retract the trocar <NUM> to leave the drug delivery member <NUM> within the patient at the subcutaneous injection region.

As commonly configured, one or more of the components of the device <NUM>, such as the drive mechanism <NUM> and insertion mechanism <NUM>, can be operable in response to actuation of a user input device <NUM> accessible on an exterior of the housing <NUM>. Suitable drive/insertion mechanisms include, but are not limited to, springs, gas sources, phase changing materials, motors, or other electromechanical systems. The device <NUM> can also include electronic components, such as a controller <NUM>, to control operation of one or more of the drug delivery components. As used herein, a controller will be understood to include a processor and a memory storing logic that is executable by the processor. More specifically, the memory may include one or more tangible non-transitory readable memories having logic (e.g., executable instructions) stored thereon, which instructions when executed by the processor may cause the at least one processor to carry out the actions that the controller is adapted to perform. Additionally, the controller may include other circuitry for carrying out certain actions in accordance with the principles of the present disclosure. Example on body injector devices are described in <CIT>.

It has been found through simulations based on a developed de novo model of the flow of drug product within the subcutaneous tissue, that the magnitude of the tissue resistive pressure, in addition to drug product viscosity and injection rate, depends on the volume of the injection cavity at the point of injection. Simulation results for the variation of the steady state tissue resistive pressure as a function of the injection cavity radius is shown in <FIG>. The simulation utilized a drug product viscosity of 10cP and an injection rate of <NUM>/min. The horizontal axis is the diameter of the injection cavity in mm and the vertical axis is the tissue resistive pressure in psi. As shown, the simulation results demonstrate that increasing the size of the injection cavity increase the size of the injection cavity and therefore reduces the tissue resistive pressure against the injection.

An example assembly <NUM> for implementing a partial retraction to reduce the tissue resistive pressure within a patient is shown in <FIG> with a retraction drive. The assembly <NUM> is shown in a diagrammatic form for simplicity and ease of showing interacting components configured to cause the partial retraction. As shown, similar to the above form, each assembly <NUM> includes a reservoir <NUM> containing a drug <NUM>, a plunger stopper <NUM> disposed within the reservoir <NUM>, a drive mechanism <NUM>, a plunger rod/piston <NUM>, and a flow path <NUM> fluidly coupling the reservoir <NUM> to a drug delivery member <NUM>. In this form, the insertion mechanism <NUM> includes a drive <NUM>, a spring in the illustrated form, and a magnetic actuator <NUM>. As shown, the magnetic actuator <NUM> includes a shaft <NUM> and an electrical circuit <NUM> with a coil <NUM> encircling the shaft <NUM>. The spring <NUM> and the shaft <NUM> are coupled or mounted to one or more hubs <NUM> having the trocar <NUM> and drug delivery member <NUM> coupled thereto along with the flow path <NUM>. If desired, the spring <NUM> can coaxially extend around the shaft <NUM>. In addition to providing a drive for inserting the trocar <NUM> and drug delivery member <NUM> to a subcutaneous location, the spring <NUM> can act as a dampener for movement of the shaft <NUM> while retracting the trocar <NUM> and/or drug delivery member <NUM>. In an alternative form, the magnetic actuator <NUM> can act as the drive for the insertion mechanism <NUM>. In other forms, the drive <NUM> can be a gas source, phase changing materials, a motor, or other electromechanical system.

The controller <NUM> is in communication with the drive <NUM> to selectively cause the spring to be released from a compressed state to drive movement of the trocar <NUM> and cannula <NUM> along the x axis to a subcutaneous position within a patient. The controller can also be in communication with the circuit <NUM> to direct power therethrough to cause the shaft <NUM> to translate linearly with respect to the coil <NUM>. The assembly <NUM> can further include a circuit board <NUM> in communication with a force sensor <NUM> disposed between the plunger rod <NUM> and the plunger stopper <NUM>.

As discussed above, when a user actuates the user input <NUM>, the controller <NUM> directs the drive <NUM> to drive movement of the trocar <NUM> and drug delivery member <NUM> along the x axis to drive the trocar <NUM> and drug delivery member <NUM> to a subcutaneous injection region within a patient. In an alternative form, the controller can direct a current to the circuit <NUM> and through the coil <NUM>, which causes the shaft <NUM> to translate along the x axis and drive the trocar <NUM> and drug delivery member <NUM> to the subcutaneous injection region.

After the insertion operation, in a first retraction operation, the controller <NUM> can operate the drive <NUM>, if capable of causing the trocar <NUM> and/or drug delivery member <NUM> to move in a second, opposite direction, or can direct a current through the circuit <NUM> to cause the shaft <NUM> to translate in the second direction along the x axis to partially retract the trocar <NUM> and/or drug delivery member <NUM> to reduce tissue resistive pressure in the injection cavity due to the initial insertion. Although the same drive <NUM> is shown performing the insertion and, optionally, the retraction, a separate retraction drive, having any of the above forms, can be coupled to one or more of the syringe components.

The retraction operation can be performed automatically by the controller <NUM>. In another approach, the retraction operation can be performed in response to reception of a signal in response to a sensed event. The signal can be provided by the user input <NUM> in response to a user actuation to relieve pressure in the injection cavity, or by a sensor coupled to one or more components of the device <NUM>. For example, the sensor can be a pressure sensor coupled to the flow path <NUM>, a force sensor coupled to a drive, an optical or capacitance sensor to ensure proper location of the device <NUM> on the patient, an accelerometer to ensure proper orientation of the device <NUM>, and so forth. In an alternative approach, the controller <NUM> can operate after a predetermined delay from an event. In some examples, the event can be the initial actuation or subsequent actuation of the user input <NUM>, the insertion mechanism <NUM> starting or finishing the insertion, or the drive mechanism <NUM> starting the drug dispensing operation.

Thereafter, the controller <NUM> can operate the drive mechanism <NUM> or cause the drive mechanism <NUM> to be released to drive movement of the plunger <NUM> and plunger stopper <NUM> to thereby dispense the drug <NUM> through the trocar <NUM> and drug delivery member <NUM>. The controller <NUM> is in communication with the force sensor <NUM> to receive data regarding the force required to push the plunger stopper <NUM> through the reservoir <NUM> to dispense the drug <NUM> into the injection cavity. In some versions, the controller <NUM> can estimate a tissue resistive pressure based on the insertion force and determine a predetermined distance for the retraction based on the tissue resistive pressure and direct power to the magnetic actuator accordingly.

Advantageously, if desired, the controller <NUM> can monitor the force data for a predetermined threshold corresponding to an undesirable tissue resistive pressure within the injection cavity. In response to determining that the force data indicates that the tissue resistive pressure is equal to or greater than the predetermined threshold, the control <NUM> can direct a current to the circuit <NUM> to shift the shaft <NUM> in the second direction to partially retract the trocar <NUM> and/or drug delivery member <NUM> to thereby reduce the tissue resistive pressure in the injection cavity. The force feedback can be a dynamic feedback loop, such that the controller <NUM> can continuously monitor the force and control the onset, rate, and/or extent of the retraction to maintain a desired tissue resistive pressure in the injection cavity.

As shown in <FIG>, the assembly <NUM> can include structure to limit or stop undesirable movement of the shaft <NUM>. For example, the assembly <NUM> can include one or more locks <NUM>, which can be mechanical, to engage and hold the shaft <NUM>, and therefore the trocar <NUM> and/or drug delivery member <NUM>, in the retracted position. The locks <NUM> can be configured to automatically engage in response to the shaft <NUM> translating a predetermined distance, in response to a signal from the controller <NUM>, or combinations thereof. The assembly <NUM> can also include an upper limit <NUM> provided by a lock or stationary surface to prevent further movement of the shaft <NUM> in the second direction to ensure that the trocar <NUM> and/or drug delivery member <NUM> is retained within the injection cavity.

In other versions as illustrated in <FIG>, autoinjector drug delivery devices <NUM> can have a vertically oriented configuration with some or all drug delivery components disposed in stacked relation along a longitudinal axis L within a housing <NUM> of the devices <NUM>. More specifically, the devices <NUM> can be configured to operate and inject a user with the device <NUM> oriented generally perpendicular to a skin surface of the user. The drug delivery components can include a primary container assembly such as a syringe with a reservoir <NUM> having a drug <NUM> contained therein, a plunger stopper <NUM> disposed within the reservoir <NUM> and sildably movable therein along the longitudinal axis L, a drug delivery member <NUM> oriented along the longitudinal axis L, and a flow path or hub <NUM> fluidly coupling the reservoir <NUM> to the drug delivery member <NUM>. In some versions, the drug delivery member <NUM> of the autoinjector of <FIG> include a rigid hollow needle. The drug delivery components further include a drive mechanism <NUM>, such as one or more springs, gas sources, phase changing materials, motors, or other electromechanical systems, coupled to a plunger rod <NUM> to drive the plunger stopper <NUM> through the reservoir <NUM> and a needle insertion mechanism <NUM> configured to insert the drug delivery member <NUM> to a desired subcutaneous depth within the user. The needle insertion mechanism <NUM> can be secured to any one of the syringe components.

The device <NUM> can include electronic components, such as a controller <NUM>, to control operation of one or more of the drug delivery components. Example autoinjector devices are described in <CIT>. If desired, the drive mechanisms <NUM>, <NUM> can be a single mechanism configured to drive both movement of the plunger stopper <NUM> and the drug delivery member <NUM> by moving some or all of the reservoir <NUM>, hub <NUM>, and drug delivery member <NUM>. As commonly configured, one or more of the components of the device <NUM>, such as the drive mechanism <NUM> and needle insertion mechanism <NUM>, can be operable in response to actuation of a user input device <NUM> accessible on an exterior of the housing <NUM>.

The above described retraction assembly <NUM> can also be utilized in these autoinjector devices <NUM>. As shown in <FIG>, the drug delivery device <NUM> can include the force sensor <NUM> disposed between the plunger <NUM> and the plunger stopper <NUM> and the controller <NUM> is in communication with the force sensor <NUM> and drive mechanisms <NUM>, <NUM> through the circuit board <NUM>. Similar to the above form, the insertion mechanism <NUM> can include a drive and the magnetic actuator <NUM>. So configured, when a user actuates the user input <NUM>, the controller <NUM> operates the drive or directs a current to the circuit <NUM> to cause the shaft <NUM> to shift along the longitudinal axis L to drive the drug delivery member <NUM> to a subcutaneous injection region within a patient. After the insertion operation, in a first retraction operation, the controller <NUM> can direct a current to the circuit <NUM> to shift the shaft <NUM> in the second direction along the longitudinal axis L to partially retract the drug delivery member <NUM> to reduce tissue resistive pressure in the injection cavity due to the initial insertion. The retraction operation can be performed automatically by the controller <NUM> or in response to a signal, such as from the user input <NUM>.

Thereafter, the controller <NUM> can operate the drive mechanism <NUM> or cause the drive mechanism <NUM> to be released to drive movement of the plunger rod <NUM> and plunger stopper <NUM> to thereby dispense the drug <NUM> through the drug delivery member <NUM>. The controller <NUM> is in communication with the force sensor <NUM> to receive data regarding the force required to push the plunger stopper <NUM> through the reservoir <NUM> to dispense the drug <NUM> into the injection cavity. In some versions, the controller <NUM> can estimate a tissue resistive pressure based on the insertion force and determine a predetermined distance for the retraction based on the tissue resistive pressure and direct power to the magnetic actuator <NUM> accordingly.

Advantageously, if desired, the controller <NUM> can monitor the force data for a predetermined threshold corresponding to an undesirable tissue resistive pressure within the injection cavity. In response to determining that the force data indicates that the tissue resistive pressure is equal to or greater than the predetermined threshold, the control <NUM> can direct a current to the circuit <NUM> to cause the shaft <NUM> to move in the second direction to partially retract the drug delivery member <NUM> to thereby reduce the tissue resistive pressure in the injection cavity. The force feedback can be a dynamic feedback loop, such that the controller <NUM> can continuously monitor the force and control the onset, rate, and/or extent of the retraction to maintain a desired tissue resistive pressure in the injection cavity.

The above description describes various assemblies, devices, and methods for use with a drug delivery device. It should be clear that the assemblies, drug delivery devices, or methods can further comprise use of a medicament listed below with the caveat that the following list should neither be considered to be all inclusive nor limiting. The medicament will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the medicament. The primary container can be a cartridge or a pre-filled syringe.

For example, the drug delivery device or more specifically the reservoir of the device may be filled with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). In various other embodiments, the drug delivery device may be used with various pharmaceutical products, such as an erythropoiesis stimulating agent (ESA), which may be in a liquid or a lyophilized form. An ESA is any molecule that stimulates erythropoiesis, such as Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-<NUM>, INS-<NUM>, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, as well as the molecules or variants or analogs thereof as disclosed in the following patents or patent applications: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; and <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

An ESA can be an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, epoetin alfa, epoetin beta, epoetin delta, epoetin omega, epoetin iota, epoetin zeta, and analogs thereof, pegylated erythropoietin, carbamylated erythropoietin, mimetic peptides (including EMP1/hematide), and mimetic antibodies. Exemplary erythropoiesis stimulating proteins include erythropoietin, darbepoetin, erythropoietin agonist variants, and peptides or antibodies that bind and activate erythropoietin receptor (and include compounds reported in <CIT> and <CIT>) as well as erythropoietin molecules or variants or analogs thereof as disclosed in the following patents or patent applications: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; and <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

Examples of other pharmaceutical products for use with the device may include, but are not limited to, antibodies such as Vectibix® (panitumumab), Xgeva™ (denosumab) and Prolia™ (denosamab); other biological agents such as Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF), Neupogen® (filgrastim , G-CSF, hu-MetG-CSF), and Nplate® (romiplostim); small molecule drugs such as Sensipar® (cinacalcet). The device may also be used with a therapeutic antibody, a polypeptide, a protein or other chemical, such as an iron, for example, ferumoxytol, iron dextrans, ferric glyconate, and iron sucrose. The pharmaceutical product may be in liquid form, or reconstituted from lyophilized form.

Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof:.

Also included can be a sclerostin antibody, such as but not limited to romosozumab, blosozumab, or BPS <NUM> (Novartis). Further included can be therapeutics such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX or XGEVA. Additionally, included in the device can be a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin/Kexin Type <NUM> (PCSK9). Such PCSK9 specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab), as well as molecules, variants, analogs or derivatives thereof as disclosed in the following patents or patent applications: <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

Also included can be talimogene laherparepvec or another oncolytic HSV for the treatment of melanoma or other cancers. Examples of oncolytic HSV include, but are not limited to talimogene laherparepvec (<CIT> and <CIT>); OncoVEXGALV/CD (<CIT>); OrienX010 (<NPL>); G207, <NUM>; NV1020; NV12023; NV1034 and NV1042 (<NPL>).

Also included are TIMPs. TIMPs are endogenous tissue inhibitors of metalloproteinases (TIMPs) and are important in many natural processes. TIMP-<NUM> is expressed by various cells or and is present in the extracellular matrix; it inhibits all the major cartilage-degrading metalloproteases, and may play a role in role in many degradative diseases of connective tissue, including rheumatoid arthritis and osteoarthritis, as well as in cancer and cardiovascular conditions. The amino acid sequence of TIMP-<NUM>, and the nucleic acid sequence of a DNA that encodes TIMP-<NUM>, are disclosed in <CIT>. Description of TIMP mutations can be found in <CIT> and <CIT>.

Also included are antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor and bispecific antibody molecule that target the CGRP receptor and other headache targets. Further information concerning these molecules can be found in <CIT>.

Additionally, bispecific T cell engager (BiTE®) antibodies, e.g. BLINCYTO® (blinatumomab), can be used in the device. Alternatively, included can be an APJ large molecule agonist e.g., apelin or analogues thereof in the device. Information relating to such molecules can be found in <CIT>.

In certain embodiments, the medicament comprises a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody. Examples of anti-TSLP antibodies that may be used in such embodiments include, but are not limited to, those described in <CIT>, and <CIT>, and <CIT>. Examples of anti-TSLP receptor antibodies include, but are not limited to, those described in <CIT>. In particularly preferred embodiments, the medicament comprises a therapeutically effective amount of the anti-TSLP antibody designated as A5 within <CIT>.

Although the drug delivery devices, methods, and components thereof, have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention because describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention. For example, components described herein with reference to certain kinds of drug delivery devices, such as on-body injector drug delivery devices or other kinds of drug delivery devices, can also be utilized in other kinds of drug delivery devices, such as autoinjector drug delivery devices.

Claim 1:
A drug delivery device (<NUM>) comprising:
a primary container assembly including a reservoir (<NUM>), a plunger stopper (<NUM>) disposed within the reservoir (<NUM>), and a drug delivery member (<NUM>) fluidly coupled to the reservoir by a flow path;
an insertion drive (<NUM>) operably coupled to the primary container assembly to insert the drug delivery member (<NUM>) in a first direction to a subcutaneous location in an insertion operation;
a magnetic actuator (<NUM>) coupled to the primary container assembly and including a shaft (<NUM>) and a circuit (<NUM>) with a coil (<NUM>) encircling the shaft; and
a drug dispensing assembly including a plunger rod (<NUM>) and a drive (<NUM>) operably coupled to the plunger rod (<NUM>) to drive the plunger stopper (<NUM>) through the reservoir with the plunger rod (<NUM>) in a drug dispensing operation;
characterized in that the drug delivery device (<NUM>) further comprises:
a force sensor (<NUM>) coupled to the drug dispensing assembly and configured to measure force data associated with dispensing a drug from the reservoir (<NUM>) through the drug delivery member (<NUM>) to an injection cavity at the subcutaneous location; and
a controller (<NUM>) in communication with the force sensor (<NUM>) and the magnetic actuator (<NUM>), the controller (<NUM>) configured to direct power to the magnetic actuator (<NUM>) to translate the shaft (<NUM>) linearly through the coil (<NUM>) in a second direction to partially retract the drug delivery member (<NUM>) in response to determining that the force data indicates a force greater than or equal to a predetermined threshold.