Drug delivery member insertion sensing assemblies, drug delivery devices, and related methods

Abstract

To provide drug delivery member insertion depth sensing assemblies, drug delivery devices, and methods for determining an insertion depth of a drug delivery member.SOLUTION: The sensing assemblies can include electrical sensing assemblies 100 with direct or indirect measurement components or optical sensing assemblies with one or more light sources and one or more photodiodes. A controller 28, 70 of the sensing assemblies can receive data associated with the drug delivery member 20, 62 in an insertion position. The data can then be correlated with an insertion depth of the drug delivery member.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 62 / 990,133, filed on March 16, 2020, the entire contents of which are hereby expressly incorporated by reference herein.

[0002] The present disclosure relates to drug delivery devices, and more particularly to drug delivery devices with electronic control.

Background Art

[0003] Drugs can be administered by use of drug delivery devices such as auto - injectors or on - body injectors. Auto - injectors and on - body injectors can be used to assist in automating the injection and delivery or administration process, thereby simplifying the process for certain patient groups or subgroups for whom the use of a syringe / vial combination or pre - filled syringe system is disadvantageous, regardless of whether the reason is a physical or psychological impairment.

[0004] However, even after receiving the designated training, there are patients and / or caregivers who experience difficulties during the use of auto - injectors and / or on - body injectors. Such difficulties may be related to the placement of the device on the person and / or the activation of the device. The user may be unsure whether the device is properly placed prior to the operation. The user may accidentally move the device before the full dose can be administered, or may administer the drug at a sub - optimal depth. The user may also be unsure whether the drug delivery device has operated correctly due to their own series of actions.

Summary of the Invention

Means for Solving the Problems

[0005] According to a first aspect, there is disclosed a drug delivery device including a housing, a primary container disposed within the housing, a drug delivery member fluidly coupled to the primary container and movable between a retracted position disposed within the housing and an injection position extending at least partially from the housing, and a wire having a first end and a second end, the second end being electrically connected at a connection point adjacent to the drug delivery member, the connection point being fixed so as not to move relative to the housing. The drug delivery device further includes a controller in communication with the first end of the wire. The controller is configured to receive capacitance information related to the drug delivery member in the injection position from the wire.

[0006] According to some forms, the controller may be configured to associate the capacitance information with the depth to which the drug delivery member is inserted into a patient. In a further form, the drug delivery device may include a needle insertion mechanism. In these forms, the drug delivery member has an elongate configuration having a proximal end extending from the primary container and fixed so as not to move relative to the housing, an intermediate curvature, and a distal end. The needle insertion mechanism is configured to move at least a portion of the distal end between the retracted position and the injection position, and the second end of the wire is fixed to the connection point at the proximal end of the drug delivery member. In other further forms, the drug delivery device may include a pair of capacitor plates disposed within the housing and spaced from the drug delivery member, the drug delivery member extending between the pair of capacitor plates. In these forms, the connection point is located on the pair of capacitor plates, and the controller communicates with the capacitor plates to receive capacitance information related to the drug delivery member in the injection position. In a further form, the drug delivery device includes one or more dielectric members disposed between the capacitor plates and the drug delivery member, the one or more dielectric members being spaced outwardly from the drug delivery member.

[0007] In any of the above embodiments, the drug delivery member can include a cannula having a conductive portion, and the connection point can be adjacent to the conductive portion of the cannula. Further, in some embodiments, the conductive portion of the cannula can be a conductive coating extending over at least a portion of the outer surface of the cannula.

[0008] According to a second aspect, there is provided a method for determining the insertion depth of a drug delivery member, the method including moving the drug delivery member from a retracted position disposed within a housing of a drug delivery device to an injection position at least partially extending out of the housing; monitoring capacitance information associated with the drug delivery member at the injection position by a controller of the drug delivery device via a wire electrically connected to a connection point adjacent to the drug delivery member, the connection point being fixed so as not to move relative to the housing; and associating, by the controller, the capacitance information with the depth to which the drug delivery member is inserted into a patient.

[0009] In some embodiments, the drug delivery member can have an elongate configuration having a proximal end fixed so as not to move relative to the housing, an intermediate curved portion, and a distal end, and monitoring, by the controller, capacitance information associated with the drug delivery member at the injection position can include monitoring, by the controller, capacitance information associated with the drug delivery member via a wire electrically connected to a connection point at the proximal end of the drug delivery member.

[0010] According to some embodiments, moving the drug delivery member from a retracted position disposed within the housing of the drug delivery device to an injection position that at least partially extends from the housing may include moving the drug delivery member between a pair of capacitor plates disposed within the housing and spaced apart from the drug delivery member. Monitoring capacitance information of the drug delivery member at the injection position by the controller may include monitoring capacitance information of the drug delivery member as it moves from the retracted position to the injection position by the controller via a wire electrically connected at a connection point adjacent to the pair of capacitor plates. In a further embodiment, the method may include separating the capacitor plates from the drug delivery member by one or more dielectric members.

[0011] In any of the above embodiments, monitoring capacitance information related to the drug delivery member at the injection position by the controller of the drug delivery device may include monitoring capacitance information related to the cannula by the controller via a wire electrically connected at a connection point adjacent to the conductive portion of the cannula.

[0012] According to a third aspect, there is disclosed a drug delivery device including a housing, a hub movably disposed within the housing, a drug delivery member extending within the hub and having a portion connected to the hub, a needle insertion mechanism operatively coupled to the hub and configured to move the hub to drive the drug delivery member between a retracted position disposed within the housing and an injection position that at least partially extends from the housing, and a wire having a first end and a second end. At least a portion of the second end of the wire is fixed to the hub and is electrically connected to a portion of the drug delivery member extending within the hub. The drug delivery device further includes a controller in communication with the wire to receive capacitance information related to the drug delivery member at the injection position.

[0013] According to some forms, the controller can be configured to associate capacitance information with the depth at which the drug delivery member is inserted into the patient. In a further form, the drug delivery member can include a cannula having a conductive portion, and the wire is electrically connected to the conductive portion of the cannula. Optionally, the conductive portion of the cannula can be a conductive coating extending over at least a portion of the outer surface of the cannula.

[0014] According to a fourth aspect, it is to move a hub disposed within the housing of the drug delivery device by a needle insertion mechanism, whereby the drug delivery member is driven from a retracted position disposed within the housing of the drug delivery device to an injection position extending at least partially out of the housing, the drug delivery member extending into the hub and having a portion connected to the hub, and monitoring capacitance information associated with the drug delivery member at the injection position by a controller of the drug delivery device via a wire having a first end and a second end, at least a portion of the second end being fixed to the hub and electrically connected to the portion of the drug delivery member extending into the hub, and optionally associating, by the controller, the capacitance information with the depth at which the drug delivery member is inserted into the patient. A method for determining the insertion depth of the drug delivery member is disclosed.

[0015] According to some forms, monitoring capacitance information associated with the drug delivery member at the injection position by a controller of the drug delivery device can include monitoring capacitance information associated with the cannula by the controller via a wire fixed to the hub and electrically connected to the conductive portion of the cannula.

[0016] According to a fifth aspect, there is disclosed a drug delivery device including a hub and a drug delivery member fixed to the hub and having a proximal opening and a distal opening. The proximal opening is disposed within the hub and communicates with the distal opening. The drug delivery device further includes a light source directed to project light that enters the proximal opening of the drug delivery member, exits the distal opening of the drug delivery member, and enters the patient's tissue, with the drug delivery member in an injection position, and a photodiode directed to receive light radiated through the patient's tissue adjacent to the drug delivery member when the drug delivery member is in the injection position. A controller communicates with the photodiode to receive data associated with the received light.

[0017] In some forms, the controller may be configured to associate the data with the depth at which the drug delivery member is inserted into the patient's tissue. In a further form, the drug delivery device may include a housing, a primary container disposed within the housing, and a flow path fluidly coupling the primary container to the drug delivery member. In a first form, the drug delivery member extends within the hub and includes a curved portion disposed within the hub by virtue of the proximal opening extending within the hub, and a distal end extending from the curved portion through the bottom surface of the hub. In a second form, the drug delivery device includes an inlet conduit attached to the hub, the hub includes an internal cavity, the inlet conduit fluidly couples the flow path to the internal cavity of the hub, the drug delivery member extends from the internal cavity through the bottom surface of the hub, and the proximal opening of the drug delivery member fluidly couples the drug delivery member to the internal cavity. In either form, the photodiode may be attached to the upper surface of the hub and / or attached to the bottom wall of the housing adjacent to a drug delivery member opening extending through the bottom wall of the housing. In other further forms, the drug delivery device may include a primary container. In these forms, the drug delivery member may be a needle, the hub may be fixedly attached to the distal end of the primary container, the light source may be an array of light sources supported by the hub, and the photodiode may be an array of photodiodes extending around and adjacent to the distal end of the primary container. The array of light sources and the array of photodiodes are misaligned to provide a path that is generally unobstructed toward the distal end of the needle.

[0018] According to a sixth aspect, inserting a drug delivery member into a patient's tissue, the drug delivery member having a proximal end fixed to a hub and a distal end opposite the proximal end, and light from a light source supported by a drug delivery device enters a proximal opening at the proximal end of the drug delivery member, exits a distal opening at the distal end of the drug delivery member, and emits light into the patient's tissue. A method for determining the insertion depth of the drug delivery member of a drug delivery device is disclosed. The method further includes receiving, by a photodiode, light radiated through the patient's tissue adjacent to the drug delivery member, receiving, by a controller, data regarding the light received by the photodiode, and optionally associating, by the controller, the data received by the controller with the depth at which the drug delivery member is inserted into the patient's tissue.

[0019] In a first form, inserting a drug delivery member fixed to the hub of a drug delivery device into a patient's tissue may include moving, by a needle insertion mechanism, a hub having a drug delivery member extending therein. In a second form, inserting a drug delivery member fixed to the hub of a drug delivery device into a patient's tissue may include moving, by a needle insertion mechanism, a hub having an internal cavity and a drug delivery member extending from the internal cavity through the bottom surface of the hub, and the proximal opening of the drug delivery member fluidly couples the drug delivery member to the internal cavity. In any form, receiving, by a photodiode, light passing through the patient's tissue may include receiving, by a photodiode attached to the upper surface of the hub, light passing through the patient's tissue, or receiving, by a photodiode attached to the bottom wall of the housing of the drug delivery device, light passing through the patient's tissue.

[0020] According to some forms, inserting a drug delivery member fixed to the hub of a drug delivery device into a patient's tissue can include inserting a needle fixed to a hub fixedly attached to the distal end of a primary container into the patient's tissue, emitting light from a light source can include emitting light from an array of light sources supported by the hub, and receiving light passing through the patient's tissue by a photodiode can include receiving light passing through the patient's tissue by an array of photodiodes extending around the distal end of the primary container and adjacent to the distal end of the primary container. The array of light sources and the array of photodiodes are misaligned to provide a path that is generally unblocked towards the distal end of the needle.

Brief Description of the Drawings

[0021]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Modes for Carrying Out the Invention

[0022] A concept of a detection system for measuring the insertion depth of a drug delivery member, such as a needle or a soft cannula of a drug delivery device, into a patient's skin by taking measurement values and executing an algorithm to process the data has been proposed. However, it is difficult to couple the detection system with the drug delivery member of the drug delivery device. Accordingly, exemplary configurations for coupling and / or integrating a detection system to a drug delivery member of a drug delivery device, such as an autoinjector or an on-body injector, are provided herein.

[0023] Before providing details of the exemplary detection system, exemplary drug delivery devices are shown in FIGS. 1 and 2. In some forms as shown in FIG. 1, a drug delivery device 10, such as an autoinjector, can have a vertically oriented configuration in which some or all of the drug delivery components, including the injection assembly, are arranged in a stacked relationship along the longitudinal axis L within the housing 11 of the device 10. As a more specific example, the device 10 can be configured to operate with the device 10 oriented substantially perpendicular to the user's skin surface and to inject the user. The drug delivery components can include a primary container 12, such as a reservoir containing a drug 14 therein, a stopper 16 disposed within the primary container 12 and slidably movable along the longitudinal axis L within the primary container 12, a needle 20 having a distal end oriented along the longitudinal axis L, and a flow path 22 fluidly coupling the primary container 12 to the needle 20. The components can further include an injection assembly including a drive mechanism 18 coupled to a plunger 19 and configured to drive the stopper 16 through the primary container 12 and a needle insertion mechanism (NIM) 24 configured to insert the needle 20 to a desired subcutaneous depth within the user. In some approaches, the NIM 24 can be a retractable needle guard for exposing the needle 20 or a drive mechanism for moving the needle longitudinally a desired distance. For example, the drive mechanism 18 can be configured to drive the movement of both the stopper 16 and the needle 20 by moving some or all of the primary container 12, the flow path 22, and the needle 20. As generally configured, one or more of the components of the device 10, such as the drive mechanism 18 and the NIM 24, can operate in response to the actuation of a user input device 26 accessible outside the housing 11. Suitable drive mechanisms include, but are not limited to, springs, gas sources, phase change materials, motors, or other electromechanical systems. Accordingly, the device 10 can include electronic components, such as a controller 28, to control the operation of one or more of the drug delivery components.FIG. 1 shows components arranged centrally along the longitudinal axis L, although one or more of the components can be arranged eccentrically from the longitudinal axis L within the housing 11 and still be considered to be in a stacked relationship. In one example, an autoinjector drug delivery device having stacked drug delivery components corresponds to a primary container 12 that is coaxially aligned with the needle 20. In some forms, the device 10 can include a cap assembly that includes a cap housing and a remover. The device 10 can further include a needle shield that is disposed to cover at least a portion of the distal end of the needle 20 in the stored state, in which case the needle shield engages and is held by the remover. The needle shield can then be removable by removing the cap assembly from the device 10. An exemplary autoinjector device is described in U.S. Provisional Patent Application No. 62 / 447,174, filed Jan. 17, 2017, which is incorporated herein by reference.

[0024] In other forms such as shown in FIG. 2, a drug delivery device 50, such as an on-body injector, may have a horizontally oriented configuration in which the drug delivery components are disposed generally along a horizontal plane P within the housing 51 of the device 50. In these devices 50, since the housing 51 is thin with a width greater than its height, when the user places the housing 51 on the skin, the components spread over an area of the skin rather than being stacked as in the above embodiment. The drug delivery components may include a primary container 52, such as a reservoir, having a drug 54 contained therein and removably disposed within the housing 51; a stopper 56 disposed within the primary container 52 and slidably movable therein along the horizontal plane P; a drive mechanism 58 for driving the stopper 56 within the primary container 52 and coupled to a plunger 60; a needle and / or a soft cannula 62 oriented along an axis X extending generally transverse to the horizontal plane P, such as perpendicular or angled to the horizontal plane P; a flow path 64 fluidly coupling the primary container 52 to the needle 62; and a NIM 66 configured to insert the needle 62 to a desired subcutaneous depth within the user. As generally configured, one or more of the components of the device 50, such as the drive mechanism 58 and the NIM 66, can operate in response to actuation of a user input device 68 accessible outside the housing 51. Accordingly, the device 50 may include an electronic component, such as a controller 70, to control the operation of one or more of the drug delivery components. As described above, the device 50 of this form may also include a cap assembly including a cap housing and a remover. The device 50 may further include a needle shield disposed to at least cover a portion of the distal end of the needle 62 in a stored state, where the needle shield engages and is held thereby by the remover. The needle shield may be removable by removing the cap assembly from the device 50. Of course, it will be understood that some components can be disposed above or below the horizontal plane P extending generally through the center of the housing 51, either partially or entirely, and still be considered to have a horizontally oriented configuration.Suitable drive mechanisms include, but are not limited to, springs, gas sources, phase change materials, motors, or other electromechanical systems. Exemplary on-body injector devices are described in U.S. Provisional Patent Application No. 62 / 536,911, filed July 25, 2017, which is incorporated herein by reference.

[0025] The sensing systems for the drug delivery devices 10, 50 can electrically or optically measure the insertion depth of the drug delivery members 20, 52. In one form, the electrical sensing system 100 measures the insertion depth by measuring the capacitance between the inserted drug delivery members 20, 52 and the electrodes 102 in contact with the patient's skin 104. The sensing system 100 uses an algorithm to associate the measured mutual capacitance with the insertion depth of the drug delivery members 20, 52, either locally or remotely. Alternatively, the electrical sensing system 100 can measure the impedance (self-capacitance) as a function of the depth of the drug delivery members 20, 52 without using electrodes in contact with the patient's skin. In another form, the optical sensing system 200 illuminates the patient's tissue with a light source 202 through the penetrating drug delivery members 20, 52 and receives the backscattered light emitted through the patient's tissue by one or more photodiodes 206 on or adjacent to the patient's skin 204 to measure the insertion depth of the drug delivery members 20, 52. For example, the photodiodes 206 measure the intensity of the light and transmit data related to the intensity of the light. The sensing system 200 uses an algorithm to associate the insertion depth of the drug delivery members 20, 52 with the intensity of the received backscattered light, either locally or remotely.

[0026] A first exemplary electrical sensing assembly 100 for drug delivery devices 10, 50 is shown in FIG. 3. In this configuration, the drug delivery members 20, 62 are needles that are fluidly coupled to the primary containers 12, 52 by flexible tubes or rigid flow paths 22, 64 as shown. Further, the needles 20, 62 extend into a hub 108 received within the devices 10, 50 and include a portion 106 connected to the hub 108. The hub 108 is operated by the NIMs 24, 66 to move the needles 20, 62 from a retracted storage position disposed within the housings 11, 51 to an injection position that at least partially extends out of the housings 11, 51. The needles 20, 62 can have a curved configuration as shown in FIG. 3 where the needles 20, 62 enter the hub 108 from the side and exit the hub 108 through the bottom, or the needles 20, 62 can have a straight configuration where the needles 20, 62 enter the hub 108 from the top and exit through the bottom. It will be appreciated that either configuration can be utilized in the autoinjector 10 or the on-body injector 50.

[0027] Advantageously, the portions 106 of the needles 20, 62 disposed within the hub 108 are fixed relative to the hub 108. With this configuration, the wire 110 can have a first end 112 that is directly electrically connected to the portions 106 of the needles 20, 62 extending within the hub 108 and is fixed to the hub 108 at a fixed point 114 so that the connection is not loosened by the movement of the hub 108 and the needles 20, 62 during the injection operation. In one form, the first end 112 of the wire 110 can be directly fixed to the needles 20, 62. The second end 116 of the wire 110 can communicate with the controllers 28, 70, which analyze the capacitance information provided by the wire 110 associated with the needles 20, 62 at the injection location and can associate the capacitance information with the depth to which the needles 20, 62 penetrate the patient's skin 104. Alternatively or additionally, the capacitance information can be sent to a remote controller for analysis and association. The wire 110 can be flexible to accommodate the movement of the hub 108 and the needles 20, 62 relative to the controllers 28, 70 during operation of the devices 10, 50. The direct electrical connection between the needles 20, 62 and the controllers 28, 70 provides a reliable source of capacitance information without the risk of providing a failed or intermittent connection between the wire 110 and the needles 20, 62. In one form, the needles 20, 62 can be made of stainless steel.

[0028] A second exemplary electrical sensing assembly 100 for a drug delivery device 50 is shown in FIG. 4. In this configuration, the needle 62 is in direct fluid communication with the primary container 52. Thus, the needle 62 provides a fluid path 64. The needle 62 in this configuration has an elongated, extending configuration having a fixed proximal end 120 extending from the primary container 52, an intermediate bend 122, and a movable distal end 124. For example, the proximal end 120 can extend generally parallel to the horizontal plane P, e.g., within 5 degrees or within 10 degrees, and the bend 122 can be a 180-degree bend such that at least a portion 126 of the distal end 124 extends rearwardly generally parallel to the horizontal plane P. The distal end 124 can also include an angled portion 128 configured to move outside of the housing 51 during the injection operation. The angled portion 128 can extend at an angle generally transverse to the plane P, such as 30 degrees to 45 degrees, 45 degrees to 60 degrees, 60 degrees to 90 degrees, etc. In this configuration, the NIM 66 can operate the distal end 124 of the needle 62 to move the angled portion 128 from a retracted storage position disposed within the housing 51 to an injection position extending at least partially out of the housing 51. The bend 122 allows the distal end 124 to move relative to the fixed proximal end 120.

[0029] Advantageously, wire 130 can have a first end 132 and a second end 136. The second end 136 can be electrically connected to the needle 62 at a connection point 134 adjacent to the proximal end 120 of the needle 62. Advantageously, the connection point 134 is fixed so as not to move relative to the housing 51 due to the fixed configuration of the proximal end 120 of the needle 62. In one form, the first end 132 can be directly fixed to the needle 62 so that the connection is not loosened by the movement of the distal end 124 of the needle 62 during the injection operation. The second end 136 of the wire 130 can communicate with the controller 70, and the controller 70 can analyze the capacitance information related to the needle 62 at the injection position provided by the wire 130 and associate the capacitance information with the depth at which the needle 62 penetrates the patient's skin 104. Alternatively or additionally, the capacitance information can be sent to a remote controller for analysis and association. Assuming that the proximal end 120 of the needle 62 and the controller 70 are fixed to each other, the wire 130 can have a rigid or fixed configuration within the housing 51. Of course, the wire 130 can have a flexible configuration as needed. The direct electrical connection between the needle 62 and the controller 70 provides a reliable capacitance information source without the risk of providing a failed or intermittent result of the connection between the wire 130 and the needle 62. In one form, the needle 62 can be made of stainless steel.

[0030] A third exemplary electrical sensing assembly 100 for drug delivery devices 10, 50 is shown in FIG. 5. This configuration is shown in FIG. 5 with reference to the autoinjector 10, but it will be understood that the assembly 100 can be readily incorporated into the on-body injector 50. In this configuration, the NIMs 24, 66 move the needles 20, 62 between a retracted storage position disposed within the housings 11, 51 and an injection position where the distal ends of the needles 20, 62 extend at least partially out of the housings 11, 51. The electrical sensing assembly 100 of this configuration performs non-contact monitoring of the needles 20, 62. As shown, the sensing assembly 100 includes a pair of capacitor plates 140 spaced apart from each other, with the needles 20, 62 extending between the pair of capacitor plates 140. Optionally, the assembly 100 may further include one or more dielectric members 142 disposed between the capacitor plates 140 and the needles 20, 62. The dielectric members 142 are spaced from the needles 20, 62 to allow the needles 20, 62 to move freely during the injection operation, while also spacing the capacitor plates 140 a fixed distance from the needles 20, 62 to ensure consistent readings during operation.

[0031] As shown, the assembly 100 may further include one or more wires 144 that are electrically connected to the capacitor plate 140 and communicate with the controllers 28, 70. The controllers 28, 70 can analyze the capacitance information related to the needles 20, 62 at the injection positions provided by the wires 144 and the capacitor 140. For example, the wire 144 can have a first end that communicates with the controllers 28, 70 and a second end that is electrically connected at a connection point adjacent to the needles 20, 62, i.e., the connection point to the capacitor plate 140. Advantageously, the connection point is fixed so as not to move relative to the housings 11, 51 due to the fixed configuration of the capacitor plate 140. The controllers 28, 70, or optionally a remote controller, can then associate the capacitance information with the depth to which the needles 20, 62 penetrate the patient's skin 104. Assuming that the capacitor plate 140 and the controller 70 are fixed to each other, the wiring 144 can have a rigid or fixed configuration within the housings 11, 51. Of course, the wiring 144 can have a flexible configuration as needed. The non-contact monitoring of the needles 20, 62 provided by the capacitor plate 140 allows the needles to move without compromising the electrical connection of the sensing assembly 100. By being attached at a certain distance from the needles 20, 62, the capacitor plate 140 provides a reliable source of capacitance information without interfering with the operation and movement of the needles 20, 62. This form of sensing assembly 100 is particularly advantageous in an autoinjector 10 or an on-body injector 50 that has a short needle length and also requires movement of the needle for the injection operation. In one form, the needle 62 can be made of stainless steel.

[0032] In any of the above embodiments, the drug delivery members 20, 62 may include or be a cannula such as a soft cannula. The cannulas 20, 62 can be made conductive by coating their outer surface 150 with a conductive material. For example, the conductive material can be gold or platinum. The conductive material can be coated on the outer surface 150 of the cannulas 20, 62 by any suitable method such as physical vapor deposition (PVD) or atomic layer deposition (ALD). In another embodiment, the cannulas 20, 62 can be made of a polymer nanocomposite with carbon nanotubes or metal nanoparticles added to make the cannulas 20, 62 conductive. With any of these configurations, as described above, the capacitor plate 140 can monitor the cannulas 20, 62 when the cannulas 20, 62 move between the capacitor plates 140.

[0033] A first exemplary optical sensing assembly 200 for the drug delivery devices 10, 50 is shown in FIG. 6. In this embodiment, the drug delivery members 20, 62 are needles fluidly coupled to the primary containers 12, 52 by flow paths 22, 64 that can be flexible tubes as shown. Further, the needles 20, 62 extend into and are fixed to a hub 210 received within the devices 10, 50, and the hub 210 is configured to be operated by the NIMs 24, 66 to move the needles 20, 62 from a retracted storage position disposed within the housings 11, 51 to an injection position extending at least partially out of the housings 11, 51. As shown, the needles 20, 62 include a proximal end 212 that enters the hub 210 through a side surface 214, a curved portion 216 disposed within the hub 210, and a distal end 218 that exits the hub 210 through a bottom 220. In one example, the curved portion 216 of the needles 20, 62 can be a curved portion of approximately 90 degrees (e.g., within 5 degrees or within 10 degrees). In one embodiment, the needles 20, 62 can be stainless steel.

[0034] As shown, the sensing assembly 200 further includes a light source 202 that is directed and configured to project light through the proximal openings 222 of the needles 20, 62 and the distal openings 223 that communicate with the proximal openings 222 to project light onto the patient's tissue after the distal ends 218 of the needles 20, 62 are inserted into the patient's tissue. In this configuration, the proximal opening 222 is provided within the upper surface 224 of the curved portion 212 that is aligned on the distal end 218 of the needle. Further, the hub 210 can be configured to provide access to light to the opening 222 such that light can be projected onto the distal ends 218 of the needles 20, 62 through the hub 210 and the opening 222. For example, the hub 210 can be made of a transparent material, such as plastic, or an opaque material having a bore aligned with the needle opening 222 while maintaining the fluid tight properties of the needles 20, 62 with a transparent cover or shield. In one configuration, the light source 202 is attached to the hub 210 and can move with the hub 210. In such a configuration, the wire 228 electrically connected to the light source 202 can be flexible to allow the light source 202 to move freely with the hub 210. In another configuration, the light source 202 can be fixedly attached within the housings 11, 51 and the wire 228 can be fixed / rigid or flexible as needed. In another configuration, the drug delivery members 20, 62 can include a soft cannula having a needle that functions as a trocar. With this configuration, the light projected by the light source 202 can pass through the needles 20, 62 and toward the cannula. It will be understood that the above configuration can be utilized in the autoinjector 10 or the on-body injector 50.

[0035] In some configurations, the assembly 200 can further include a light focusing component to guide the light through the needles 20, 62 and avoid scattering. For example, one or more lenses, for instance, attached to or within the hub 210 and / or attached to or within the housings 11, 51, can be disposed within the path of the light projected from the light source 202. A reflective material can be disposed in front of the light source 202, such as within the bore of the hub 210.

[0036] As described above, the optical sensing assembly 200 receives backscattered light that is radiated through the patient's tissue adjacent to the needles 20, 62 at the injection site by one or more photodiodes 206 on or adjacent to the patient's skin 204. The photodiodes 206 are electrically connected to and communicate with the controllers 28, 70 to provide data related to the received light. The controllers 28, 70 or optionally a remote controller can then associate the data with the depth at which the needles 20, 62 penetrate the patient's skin 204. In a first configuration, the photodiodes 206 can be disposed adjacent to the light source 202 with the light source 202 generally centered relative to the photodiodes 206. The photodiodes 206 can be coupled to the hub 210 and move with the hub 210 or can be mounted at a fixed position within the housings 11, 51. With this configuration, the photodiodes 206 detect backscattered light passing through the hub 210. The hub 210 can be made of a transparent material as described above or can have one or more bores extending into the hub 210 that are aligned with the photodiodes 206. In a second configuration, the photodiodes 206 can be coupled to the bottom wall 230 of the housings 11, 51 adjacent to a drug delivery member opening 232 extending through the bottom wall 230 of the housings 11, 51. For example, the bottom wall 230 can include a transparent portion 234 extending around the opening 232 and the photodiodes 206 can be mounted within an external optically transparent case 236 of the housings 11, 51 with the hub 210 received therein or the photodiodes 206 can be mounted within an opening 238 in the bottom wall 230 that will be directly adjacent to the patient's skin 204.

[0037] A second exemplary optical sensing assembly 200 for drug delivery devices 10, 50 is shown in FIG. 7. In this form, the drug delivery members 20, 62 are needles fluidly coupled to the primary containers 12, 52 by flexible tubes or rigid flow paths 22, 64 as shown. The assembly 200 of this form includes a separate inlet conduit 252 that enters the hub 250 through the side 254, rather than a needle extending into the hub 250 within the hub 250 as in the above form, and the needles 20, 62 exit the hub 250 through the bottom 256. Further, the hub 250 defines an internal cavity 258 that fluidly connects the inlet conduit 252 to the needles 20, 62. Similar to the above form, the hub 250 is configured to be operated by the NIMs 24, 66 to move the needles 20, 62 from a retracted storage position within the housings 11, 51 to an injection position that extends at least partially out of the housings 11, 51. In one form, the needles 20, 62 can be stainless steel.

[0038] As shown, the sensing assembly 200 further includes a light source 202 that is directed and configured to project light through proximal openings 259 of needles 20, 62 and distal openings 261 that communicate with the proximal openings 259 into the needles 20, 62 and thus into the patient's tissue after the needles 20, 62 have been inserted into the patient's tissue. In this configuration, the needles 20, 62 extend along a longitudinal axis such that light can be projected through the hub 250 into the needles 20, 62, and the hub 250 can be configured to provide access of light to the needles 20, 62. For example, the hub 250 can be made of a transparent material, such as plastic, or an opaque material having a bore aligned with the needle opening 259 while maintaining the fluid tightness of the needles 20, 62 with a transparent cover or shield. As shown, after the needles 20, 62 have been inserted into the patient's tissue, the light source 202 is aligned with the proximal openings 259 of the needles 20, 62 such that light projected by the light source 202 enters the needles 20, 62 and travels into the patient's tissue. In one configuration, the light source 202 can be attached to the hub 250 and move with the hub 250. In such a configuration, the wire 262 electrically connected to the light source 202 can be flexible to allow the light source 202 to move freely with the hub 250. In another configuration, the light source 202 can be fixedly attached within the housings 11, 51, and the wiring 262 can be fixed, rigid, or flexible as needed. In another configuration, the drug delivery members 20, 62 can include a soft cannula having a needle that functions as a trocar. With this configuration, light projected by the light source 202 can pass through the needles 20, 62 and into the cannula. It will be appreciated that the above-described configurations can be utilized in the autoinjector 10 or the on-body injector 50.

[0039] In some forms, the assembly 200 may further include an optical focusing component for guiding light to the needles 20, 62 and avoiding scattering. For example, one or more lenses, for example, mounted on or in the hub 250 and / or on or in the housings 11, 51, may be disposed within the path of light projected from the light source 202. A reflective material may be disposed in front of the light source 202, for example, within the bore of the hub 250.

[0040] As described above, the optical sensing assembly 200 receives or measures backscattered light that is radiated through the patient's tissue when the needles 20, 62 are in the injection position, by one or more photodiodes 206 on or adjacent to the patient's skin 204. The photodiodes 206 are electrically connected to and communicate with the controllers 28, 70 to provide data related to the light received by the photodiodes 206. The controllers 28, 70 or optionally a remote controller can then associate the data with the depth at which the needles 20, 62 penetrated the patient's skin 204. In a first form, the photodiodes 206 can be arranged adjacent to the light source 202 with the light source 202 being generally centered relative to the photodiodes 206. The photodiodes 206 can be coupled to the hub 250 and move with the hub 250, or can be mounted at a fixed position within the housings 11, 51. With this configuration, the photodiodes 206 detect backscattered light passing through the hub 250. The hub 250 can be made of a transparent material as described above, or can have one or more bores extending therein that are aligned with the photodiodes 206. In a second form, the photodiodes 206 can be coupled to the bottom walls 264 of the housings 11, 51 adjacent to a drug delivery member opening 266 that extends through the bottom walls 264 of the housings 11, 51. For example, the bottom wall 264 can include a transparent portion 268 extending around the opening 266, and the photodiodes 206 can be mounted within the housings 11, 51, for example, embedded within an external optically transparent case 270 within which the hub 250 is received, or the photodiodes 206 can be mounted within an opening 272 in the bottom wall 230 that will be directly adjacent to the patient's skin 204.

[0041] A third exemplary optical sensing assembly 200 for a prefilled syringe 300 is shown in FIG. 8. The syringe 300 includes a primary container in the form of a barrel or reservoir 302 that houses a fluid treatment product. The barrel 302 has an annular sidewall 304 that extends between a dispensing opening 306 at the distal end 308 and an open proximal end 310. The syringe 300 includes a needle 312 fixed to a hub 314 coupled to the barrel 302 at the distal end 308 of the barrel 302 such that the needle 312 is in fluid communication with the interior 316 of the barrel 302.

[0042] As shown, the sensing assembly 200 further includes an array of light sources 202 that are directed and configured to project light through proximal opening 317 of needles 20, 62 disposed within hub 314 and distal opening 319 that communicates with proximal opening 317 to project light onto the patient's tissue after the needle 312 has been inserted into the patient's tissue. In this configuration, the needle 312 extends along a longitudinal axis such that light can be projected through the hub 314 and / or the barrel distal end 308 to the needle 312, and the hub 314 and / or the barrel distal end 308 can be configured to provide access to light to the needle 312. For example, the hub 314 and / or the barrel distal end 308 can be made of a transparent material, such as plastic, or an opaque material having a bore aligned with the needle opening 317 while maintaining the fluid tightness of the needle 312 and the barrel interior 316 with a transparent cover or shield. The array of light sources 202 can extend around or within the hub 314 or the barrel distal end 308.

[0043] The photodiodes 206 of the assembly 200 can be arranged in an array that extends around or within the needle hub 314 or the barrel distal end 308. The light source 202 and the photodiodes 206 can be arranged such that individual photodiodes 206 do not block the light projected from the light source 202 and such that individual light sources 202 do not block the light radiated through the patient's tissue that will be received by the photodiodes 206. For example, the light source 202 and the photodiodes 206 can be arranged in an alternating pattern around the syringe 300. The photodiodes 206 are electrically connected to and in communication with a controller 320 of the syringe 300 to provide data related to the light received by the photodiodes 206 when the drug delivery member is in the injection position. The controller 320 or optionally a remote controller can then associate the data with the depth at which the needle 312 penetrates the patient's skin 320. It will be understood that the detection assembly 200 can be incorporated into an auto-injector device 10 having an array of light sources 202 and photodiodes 206 arranged with respect to the primary container 12 and the needle 20.

[0044] In the above-described embodiments, the controllers 28, 70, 320 can refer to the expected values and determine the depth of the drug delivery members 20, 62, 312 based on the provided measurement values, thereby enabling the depth of the drug delivery members 20, 62, 312 to be confirmed and recorded during the drug dispensing operation. In some cases, the depth of drug delivery, such as an intradermal site, a subcutaneous site, an intramuscular site, or an intravenous site, can, for example, affect pharmacokinetics and can lead to a therapeutic difference for a particular drug. By using the devices described herein, interested parties can confirm with data that the devices 10, 50, 300 are correctly positioned and that the drug delivery members 20, 62, 312 are inserted to the target depth.

[0045] The term "controller" generally refers broadly to any processor-based device, memory, and programmable input / output peripherals with any microcontroller, computer, or processor designed to control the operation of other components and devices. It is further understood to include common attached accessory devices including a power supply, memory, and a transceiver for communication with other components and devices, etc. These structural options are well-known and understood in the art and need not be further described here. The controller may be configured to perform one or more of the steps, acts, and / or functions described herein (e.g., by using corresponding programming stored in memory, as will be well understood by those skilled in the art).

[0046] The elements in the figures are drawn for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions and / or relative positions of some of the elements in the figures may be exaggerated relative to other elements to improve the understanding of the various embodiments of the present invention. Also, commonly understood elements that are useful or necessary in commercially realizable embodiments are often not shown so as not to unduly obscure the figures of these various embodiments. The same reference numerals may be used to describe similar or like parts. Further, although several examples have been disclosed herein, any feature of any example may be combined with or substituted for any other feature of any other example. Further, although several examples have been disclosed herein, modifications may be made to the disclosed examples without departing from the scope of the claims.

[0047] In the above description, various devices, assemblies, components, subsystems, and methods related to drug delivery devices have been described. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used with, drugs including, but not limited to, the drugs specified below, as well as their generic and biosimilar equivalents. As used herein, the term "drug" can be used interchangeably with other similar terms and refers to any kind of agent or therapeutic substance, including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biological agents, biologically active agents and compositions, macromolecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic pharmaceuticals. Non-therapeutic injectable materials are also included. The drug may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0048] The drug is contained within a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the drug for treatment. The primary container can be a vial, cartridge, or pre-filled syringe.

[0049] In some embodiments, the reservoir of the drug delivery device may be filled with, or the device can be used with, colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0050] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA) formulation that can be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means, for example, any protein that binds to a receptor and directly or indirectly causes activation of the erythropoietin receptor by causing dimerization of the receptor. Examples of erythropoiesis stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor, antibodies that bind to and activate the erythropoietin receptor, or peptides that bind to and activate the erythropoietin receptor. Examples of erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, 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 iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules or variants or analogs.

[0051] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof. OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully human monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., particularly those that suppress activities mediated by binding to the receptors for IL-4 and / or IL-13; interleukin 1-receptor 1 (“IL1-R1”)-specific antibodies, peptibodies, related proteins, etc.; Ang2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., particularly humanized and fully human monoclonal antibodies, including but not limited to humanized and fully human antibodies, such as human CD22-specific IgG antibodies, including but not limited to the dimer of human-mouse monoclonal hLL2γ chain disulfide bound to the human-mouse monoclonal hLL2κ chain, for example, the human CD22-specific fully humanized antibody of epratuzumab (CAS registration number 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies, and related proteins, etc., including but not limited to anti-IGF-1R antibodies; B-7 related protein 1-specific antibodies, peptibodies, related proteins, etc. (also referred to as “B7RP-1,” “B7H2,” “ICOSL,” “B7h,” and “CD275”), including but not limited to fully human IgG2 monoclonal antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1, including but not limited to those that suppress the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1 on activated T cells; IL-15-specific antibodies, peptibodies, related proteins, etc., including but not limited to humanized monoclonal antibodies, such as HuMax IL-15 antibody and related proteins, including but not limited to those such as 145c7.IFN γ-specific antibodies, including but not limited to human IFN γ-specific antibodies, and fully human anti-IFN γ antibodies, peptibodies, related proteins, etc.; TALL-1-specific antibodies, peptibodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone (''PTH'')-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor (''TPO-R'')-specific antibodies, peptibodies, related proteins, etc.; hepatocyte growth factor (''HGF'')-specific antibodies, peptibodies, related proteins, etc., including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF); TRAIL-R2-specific antibodies, peptibodies, related proteins, etc.; activin A-specific antibodies, peptibodies, proteins, etc.; TGF-beta-specific antibodies, peptibodies, related proteins, etc.; amyloid beta protein-specific antibodies, peptibodies, related proteins, etc.; c-Kit-specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L-specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel hematopoietic stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel (registered trademark) (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex (registered trademark) (epoetin alpha); Erbitux (registered trademark) (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin (registered trademark) (somatropin, human growth hormone); Herceptin (registered trademark) (trastuzumab, anti-HER2 / neu (erbB2) receptor mAb); Kanjinti (trademark) (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar of Herceptin (registered trademark), or another product containing trastuzumab for the treatment of breast cancer or gastric cancer; Humatrope (registered trademark) (somatropin, human growth hormone); Humira (registered trademark) (adalimumab); Vectibix (registered trademark) (panitumumab), Xgeva (registered trademark) (denosumab), Prolia (registered trademark) (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel (registered trademark) (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate (registered trademark) (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen (registered trademark) (interferon alfa-con-1); Natrecor (registered trademark) (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret (registered trademark) (anakinra); Leukine (registered trademark) (sargramostim, rhuGM-CSF); LymphoCide (registered trademark) (epratuzumab, anti-CD22 mAb); Benlysta (trademark) (lynphosphostat B, belimumab, anti-BlyS mAb); Metalyse (registered trademark) (tenecteplase, t-PA analog); Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta); Mylotarg (registered trademark) (gemtuzumab ozogamicin); Raptiva (registered trademark) (efalizumab); Cimzia (registered trademark) (certolizumab pegol, CDP 870); Soliris (trademark) (eculizumab); pexelizumab (anti-complement C5); Numax (registered trademark) (MEDI-524); Lucentis (registered trademark) (ranibizumab);Panorex (registered trademark) (17-1A, edrecolomab); Trabio (registered trademark) (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem (registered trademark) (IDM-1); OvaRex (registered trademark) (B43.13); Nuvion (registered trademark) (visilizumab); Cantuzumab mertansine (huC242-DM1); NeoRecormon (registered trademark) (epoetin beta); Neumega (registered trademark) (oprelvekin, human interleukin-11); Orthoclone OKT3 (registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit (registered trademark) (epoetin alpha); Remicade (registered trademark) (infliximab, anti-TNFα monoclonal antibody); Reopro (registered trademark) (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); Actemra (registered trademark) (anti-IL6 receptor mAb); Avastin (registered trademark) (bevacizumab), HuMax-CD4 (zanilimumab); Mvasi (trademark) (bevacizumab-awwb); Rituxan (registered trademark) (rituximab, anti-CD20 mAb); Tarceva (registered trademark) (erlotinib); Roferon-A (registered trademark) (interferon alpha-2a); Simulect (registered trademark) (basiliximab); Prexige (registered trademark) (lumiracoxib); Synagis (registered trademark) (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri (registered trademark) (natalizumab, anti-α4 integrin mAb); Valortim (registered trademark) (MDX-1303, anti-Bacillus anthracis protective antigen mAb); ABthrax (trademark); Xolair (registered trademark) (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (Fc portion of human IgG1 and extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (Ig domain of VEGFR1 fused to IgG1 Fc); Zenapax (registered trademark) (daclizumab); Zenapax (registered trademark) (daclizumab, anti-IL-2Rα mAb);Zevalin (registered trademark) (ibritumomab tiuxetan); Zetia (registered trademark) (ezetimibe); Orencia (registered trademark) (abatacept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (cetuximab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-C. difficile toxin A and toxin B C mAb MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis phase 1 fibrinogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513;Anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-; 1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0052] In some embodiments, the drug delivery device is a sclerostin antibody such as romosozumab, blosozumab, BPS804 (Novartis), Evenity™ (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, among others. In other embodiments, the drug delivery device may contain or may be used with a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or may be used with rilotumumab, vismodegib, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to, OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042, or the device may be used with these. In some embodiments, the drug delivery device may contain or may be used with an endogenous tissue inhibitor of metalloproteinase (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain or may be used with Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product containing erenumab for the treatment of migraine. Antagonistic antibodies to the human CGRP receptor, such as erenumab, as well as bispecific antibody molecules that target the CGRP receptor and other migraine targets, among others, may also be delivered using the drug delivery devices of the present disclosure.In addition, bispecific T cell engager (BiTE®) antibodies, such as but not limited to BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ macro-agonist, such as but not limited to apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.) or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxirane-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamide)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used with Parsabiv (trademark) (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT) in patients with chronic kidney disease (KD) during hemodialysis. In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate for Rituxan (registered trademark) / MabThera (trademark), or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist such as a non-antibody VEGF antagonist and / or a VEGF trap such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate for Soliris (registered trademark), or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rozanolixizumab alpha (previously known as AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOS-L and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtiv mecarbil, a small molecule selective myocardial myosin activator, or myotrope, that directly targets the contractile mechanism of the heart, or another product containing a small molecule selective myocardial myosin activator. In some embodiments, the drug delivery device may contain sotorasib (previously known as AMG 510), KRAS. G12C a small molecule inhibitor, or KRAS G12CAnother product containing a small molecule inhibitor may be contained or used together therewith. In some embodiments, the drug delivery device may contain or be used together with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used together with another product containing AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used together with another product containing AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used together with another product containing ABP 654 (human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or a human IgG1 kappa antibody and / or that binds to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used together with another product containing Amjevita™ or Amgevita™ (previously ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or a human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used together with another product containing AMG 160, or a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used together with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing delta-like ligand 3 (DLL3) chimeric antigen receptor T (CAR T) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133, or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171, or another product containing a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176, or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199, or another product containing a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256, or another product containing an anti-PD-1×IL21 mutein and / or an IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330, or another product containing an anti-CD33×anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody that is being investigated as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 427, or a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 430 or an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 506, or a multispecific FAP × 4-1BB-targeted DARPin® biologic being studied as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 509, or a bivalent T cell engager designed using the XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 562, or a half-life extended (HL. E) Another product containing a CD19×anti-CD3 BiTE® (bispecific T cell engager) construct may be contained in, or used together with, the drug delivery device. In some embodiments, the drug delivery device may contain, or be used together with, another product containing efalizumab alpha (formerly AMG 592) or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain, or be used together with, another product containing AMG 596, or a CD3×epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain, or be used together with, another product containing AMG 673, or a half-life extended (HLE) anti-human CD33×anti-anti-human CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used together with, another product containing AMG 701, or a half-life extended (HLE) anti-B cell maturation antigen (BCMA)×anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used together with, another product containing AMG 757, or a half-life extended (HLE) anti-delta-like ligand 3 (DLL3)×anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used together with, another product containing AMG 910, or a half-life extended (HLE) epithelial tight junction constituent protein claudin 18.2×anti-CD3 BiTE® (bispecific T cell engager) construct.

[0053] Drug delivery devices, assemblies, components, subsystems, and methods have been described from the perspective of exemplary embodiments, but are not limited thereto. This detailed description should be construed as illustrative only and does not describe all possible embodiments of the present disclosure. Various alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments are still within the scope of the claims that define the invention disclosed herein.

[0054] Those skilled in the art will understand that various modifications, variations, and combinations to the above embodiments can be made without departing from the spirit and scope of the invention disclosed herein, and such modifications, variations, and combinations should be construed as being within the scope of the invention.

Claims

1. Housing and a primary container disposed within the housing; a drug delivery member fluidly coupled to the primary container, the drug delivery member movable between a retracted position disposed within the housing and an injection position extending at least partially from the housing; a wire having a first end and a second end, the second end being electrically connected to a connection point adjacent the drug delivery member, the connection point being fixed against movement relative to the housing; a controller in communication with the first end of the wire, the controller being configured to receive capacitance information from the wire relating to the drug delivery member at the injection position; 13. A drug delivery device comprising:

2. The drug delivery device of claim 1 , wherein the controller is further configured to associate the capacitance information with a depth to which the drug delivery member is inserted into a patient.

3. Further comprising a needle insertion mechanism; 3. The drug delivery device of claim 1 or 2, wherein the drug delivery member has an elongated configuration having a proximal end extending from the primary container and fixed relative to the housing, an intermediate curved portion, and a distal end, the needle insertion mechanism is configured to move at least a portion of the distal end between the retracted position and the injection position, and the second end of the wire is fixed to the connection point at the proximal end of the drug delivery member.

4. a pair of capacitor plates disposed within the housing and spaced apart from the drug delivery member, the drug delivery member extending between the pair of capacitor plates; 3. The drug delivery device of claim 1 or 2, wherein the connection points are located on the pair of capacitor plates, and the controller is in communication with the capacitor plates to receive capacitance information associated with the drug delivery member in the injection position.

5. 5. The drug delivery device of claim 4, further comprising one or more dielectric members disposed between the capacitor plate and the drug delivery member, the one or more dielectric members being spaced outwardly from the drug delivery member.

6. A drug delivery device according to any one of claims 1 to 5, wherein the drug delivery member comprises a cannula having a conductive portion, and the connection point is adjacent to the conductive portion of the cannula.

7. The drug delivery device of claim 6 , wherein the conductive portion of the cannula includes a conductive coating extending over at least a portion of an outer surface of the cannula.

8. 1. A method for determining an insertion depth of a drug delivery member, comprising: moving a drug delivery member from a retracted position disposed within a housing of the drug delivery device to an injection position at least partially extending from said housing; monitoring capacitance information associated with the drug delivery member in the injection position by a controller of the drug delivery device via a wire electrically connected to the drug delivery member at a connection point adjacent the drug delivery member, the connection point being fixed against movement relative to the housing; correlating, by the controller, the capacitance information with the depth to which the drug delivery member is inserted into the patient; A method comprising:

9. the drug delivery member has an elongate configuration having a proximal end fixed against movement relative to the housing, an intermediate curved portion, and a distal end; 9. The method of claim 8, wherein monitoring the capacitance information associated with the drug delivery member at the injection position by the controller comprises monitoring the capacitance information associated with the drug delivery member by the controller via a wire electrically connected at the connection point at the proximal end of the drug delivery member.

10. moving the drug delivery member from the retracted position disposed within the housing of the drug delivery device to the injection position at least partially extending from the housing comprises moving the drug delivery member between a pair of capacitor plates disposed within the housing and spaced apart from the drug delivery member; 9. The method of claim 8, wherein monitoring the capacitance information of the drug delivery member in the injection position by the controller includes monitoring the capacitance information of the drug delivery member as the drug delivery member moves from the retracted position to the injection position via the wires electrically connected at the connection points adjacent to the pair of capacitor plates by the controller.

11. 11. The method of claim 10, further comprising separating the capacitor plates from the drug delivery member by one or more dielectric members.

12. A method according to any one of claims 8 to 11, wherein monitoring the capacitance information associated with the drug delivery member in the injection position by the controller of the drug delivery device comprises monitoring capacitance information associated with a cannula by the controller via the wire electrically connected at the connection point adjacent to a conductive portion of the cannula.

13. Housing and a hub movably disposed within the housing; a drug delivery member having a portion extending into and connected to the hub; a needle insertion mechanism operatively coupled to the hub and configured to move the hub to drive the drug delivery member between a retracted position disposed within the housing and an injection position at least partially extending from the housing; a wire having a first end and a second end, at least a portion of the second end of the wire being secured to the hub and electrically connected to the portion of the drug delivery member that extends into the hub; a controller in communication with the wires for receiving capacitance information associated with the drug delivery member at the injection position; 13. A drug delivery device comprising:

14. The drug delivery device of claim 13 , wherein the controller is configured to associate the capacitance information with the depth to which the drug delivery member is inserted into a patient.

15. 15. The drug delivery device of claim 13 or 14, wherein the drug delivery member includes a cannula having an electrically conductive portion, and the wire is electrically connected to the electrically conductive portion of the cannula.

16. The drug delivery device of claim 15 , wherein the conductive portion of the cannula includes a conductive coating extending over at least a portion of an outer surface of the cannula.

17. 1. A method for determining an insertion depth of a drug delivery member, comprising: moving a hub disposed within a housing of a drug delivery device with a needle insertion mechanism, thereby driving a drug delivery member from a retracted position disposed within the housing of the drug delivery device to an injection position at least partially extending from the housing, the drug delivery member having a portion extending into and connected to the hub; monitoring capacitance information associated with the drug delivery member at the injection position by a controller of the drug delivery device via a wire having a first end and a second end, at least a portion of the second end being fixed to the hub and electrically connected to the portion of the drug delivery member that extends into the hub; correlating said capacitance information with the depth to which said drug delivery member is inserted into a patient; A method comprising:

18. 18. The method of claim 17, wherein associating the capacitance information with the depth to which the drug delivery member is inserted into the patient comprises associating, by the controller, the capacitance information with the depth to which the drug delivery member is inserted into the patient.

19. The method of claim 17 or 18, wherein monitoring the capacitance information associated with the drug delivery member in the injection position by the controller of the drug delivery device includes monitoring capacitance information associated with a cannula by the controller via a wire fixed to the hub and electrically connected to a conductive portion of the cannula.

20. Hub and a drug delivery member secured to the hub and having a proximal opening and a distal opening, the proximal opening being disposed within the hub and in communication with the distal opening; a light source oriented to project light into the proximal opening of the drug delivery member, out of the distal opening of the drug delivery member, and into tissue of a patient, with the drug delivery member in an injection position; a photodiode oriented to receive light emitted through the tissue of the patient adjacent the drug delivery member when the drug delivery member is in the injection position; a controller in communication with the photodiode for receiving data associated with the received light; 13. A drug delivery device comprising:

21. The drug delivery device of claim 20 , wherein the controller is configured to associate the data with the depth to which the drug delivery member is inserted into the tissue of the patient.

22. Housing and a primary container disposed within the housing; a flow path fluidly coupling the primary container to the drug delivery member; Further comprising: the drug delivery member extends into the hub, the drug delivery member including a curved portion disposed within the hub with the proximal opening extending into the hub, and a distal end extending from the curved portion through a bottom surface of the hub.

22. A drug delivery device according to claim 20 or 21.

23. Housing and a primary container disposed within the housing; a flow path fluidly coupled to the primary container; an inlet conduit attached to the hub; Further comprising: the hub includes an internal cavity, the inlet conduit fluidly couples the flow path to the internal cavity of the hub, the drug delivery member extends from the internal cavity through a bottom surface of the hub, and the proximal opening of the drug delivery member fluidly couples the drug delivery member to the internal cavity.

22. A drug delivery device according to claim 20 or 21.

24. 24. The drug delivery device of claim 22 or 23, wherein the photodiode is mounted on an upper surface of the hub.

25. 24. A drug delivery device according to claim 22 or 23, wherein the photodiode is mounted to a bottom wall of the housing adjacent a drug delivery member opening extending through the bottom wall of the housing.

26. 22. The drug delivery device of claim 20 or 21, further comprising a primary container, the drug delivery member comprising a needle, the hub fixedly attached to a distal end of the primary container, the light source comprising an array of light sources supported by the hub, the photodiodes extending around and adjacent the distal end of the primary container, the array of light sources and the array of photodiodes being misaligned to provide a generally unobstructed path toward the distal end of the needle.

27. 1. A method for determining an insertion depth of a drug delivery member of a drug delivery device, comprising: inserting a drug delivery member into tissue of a patient, the drug delivery member having a proximal end secured to a hub and a distal end opposite the proximal end; emitting light from a light source carried by the drug delivery device, into a proximal opening at the proximal end of the drug delivery member, out a distal opening at the distal end of the drug delivery member, and into the tissue of the patient; receiving, by a photodiode, light emitted through the tissue of the patient adjacent the drug delivery member; receiving data at a controller regarding the light received by the photodiode; correlating the data received by the controller with a depth to which the drug delivery member has been inserted into the tissue of the patient; A method comprising:

28. 28. The method of claim 27, wherein associating the data received at the controller with the depth to which the drug delivery member has been inserted into the tissue of the patient comprises associating, by the controller, the data received at the controller with the depth to which the drug delivery member has been inserted into the patient.

29. 29. The method of claim 27 or 28, wherein inserting the drug delivery member secured to the hub of the drug delivery device into the tissue of the patient comprises moving the hub with the drug delivery member extending therein by a needle insertion mechanism.

30. 29. The method of claim 27 or 28, wherein inserting the drug delivery member secured to the hub of the drug delivery device into the tissue of the patient includes moving a hub having an internal cavity and the drug delivery member extending from the internal cavity through a bottom surface of the hub with a needle insertion mechanism, the proximal opening of the drug delivery member fluidly coupling the drug delivery member to the internal cavity.

31. 31. The method of claim 29 or 30, wherein receiving the light passing through the tissue of the patient with the photodiode comprises receiving the light passing through the tissue of the patient with a photodiode mounted on a top surface of the hub.

32. 31. The method of claim 29 or 30, wherein receiving the light passing through the tissue of the patient by the photodiode comprises receiving the light passing through the tissue of the patient by a photodiode attached to a bottom wall of a housing of the drug delivery device.

33. inserting the drug delivery member secured to the hub of the drug delivery device into the tissue of the patient includes inserting a needle secured to the hub fixedly attached to a distal end of a primary container into the tissue of the patient; emitting light from the light sources includes emitting light from an array of light sources supported by the hub; receiving the light passing through the tissue of the patient with the photodiodes includes receiving the light passing through the tissue of the patient with an array of photodiodes extending around and adjacent the distal end of the primary container, the array of light sources and the array of photodiodes being unaligned to provide a generally unobstructed path toward the distal end of the needle.

29. The method of claim 27 or 28.

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