Drug delivery component insertion detection assembly, drug delivery device, and related method

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 content of which is hereby expressly incorporated by reference herein. 【0002】 This 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 physiological or psychological. 【0004】 However, even after receiving designated training, some patients and / or caregivers 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 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 embodiment, a drug delivery device is disclosed, comprising a housing; a primary container disposed within the housing; a drug delivery member fluidly coupled to the primary container, the drug delivery member being movable between a retracted position located 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 relative to the housing so as not to move. The drug delivery device further comprises a controller communicating with the first end of the wire. The controller is configured to receive capacitance information from the wire relating to the drug delivery member at the injection position. 【0006】 In some embodiments, the controller may be configured to associate capacitance information with the depth to which the drug delivery member is inserted into the patient. In further embodiments, the drug delivery device may include a needle insertion mechanism. In these embodiments, the drug delivery member has an elongated configuration having a proximal end extending from a primary container and fixed to the housing so as not to move, 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 a retracted position and an injection position, and the second end of the wire is fixed to a connection point at the proximal end of the drug delivery member. In other further embodiments, the drug delivery device may include a pair of capacitor plates disposed within a housing and spaced apart from the drug delivery member, with the drug delivery member extending between the pair of capacitor plates. In these embodiments, 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 at the injection position. In a further embodiment, the drug delivery device includes one or more dielectric members positioned between a capacitor plate and a drug delivery member, wherein the one or more dielectric members are spaced outward from the drug delivery member. 【0007】 In any of the above embodiments, the drug delivery member may include a cannula having a conductive portion, and the connection point may be adjacent to the conductive portion of the cannula. Furthermore, in some embodiments, the conductive portion of the cannula may be a conductive coating extending over at least a portion of the outer surface of the cannula. 【0008】 A second embodiment discloses a method for determining the insertion depth of a drug delivery member, comprising: moving the drug delivery member from a retracted position located within the housing of a drug delivery device to an injection position extending at least partially from 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 at a connection point adjacent to the drug delivery member, wherein the connection point is fixed so as not to move relative to the housing; and associating the capacitance information with the depth to which the drug delivery member is inserted into the patient. 【0009】 In some embodiments, the drug delivery member may have an elongated configuration having a proximal end fixed to the housing so as not to move, an intermediate curved portion, and a distal end, and monitoring capacitance information related to the drug delivery member at the injection position by the controller may include monitoring capacitance information related to the drug delivery member by the controller via a wire electrically connected at a connection point at the proximal end of the drug delivery member. 【0010】 In some embodiments, moving a drug delivery member from a retracted position located within the housing of a drug delivery device to an injection position extending at least partially from the housing may include moving the drug delivery member between a pair of capacitor plates located within the housing and spaced apart from the drug delivery member, and monitoring the capacitance information of the drug delivery member at the injection position by a controller may include monitoring the capacitance information of the drug delivery member as it moves from the retracted position to the injection position by a controller via wires electrically connected at connection points adjacent to the pair of capacitor plates. In further embodiments, 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 a drug delivery member at the injection site by the drug delivery device controller may include monitoring capacitance information related to a cannula by the controller via a wire electrically connected at a connection point adjacent to the conductive portion of the cannula. 【0012】 A drug delivery device is disclosed, comprising a housing; a hub movably disposed within the housing; a drug delivery member having a portion extending into the hub and connected to the hub; a needle insertion mechanism operationally coupled to the hub and configured to move the hub to drive the drug delivery member between a retracted position located within the housing and an injection position at least partially extending 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 electrically connected to the portion of the drug delivery member extending into the hub. The drug delivery device further comprises a controller communicating with the wire to receive capacitance information related to the drug delivery member at the injection position. 【0013】 In some embodiments, the controller may be configured to associate capacitance information with the depth to which the drug delivery member is inserted into the patient. In further embodiments, the drug delivery member may include a cannula having a conductive portion, and the wire is electrically connected to the conductive portion of the cannula. If necessary, the conductive portion of the cannula may be a conductive coating extending over at least a portion of the outer surface of the cannula. 【0014】 A fourth aspect discloses a method for determining the insertion depth of a drug delivery member, comprising: moving a hub located within the housing of a drug delivery device by a needle insertion mechanism, thereby driving a drug delivery member from a retracted position located within the housing of the drug delivery device to an injection position where it extends at least partially from the housing, the drug delivery member having a portion that extends into and is connected to the hub; monitoring capacitance information related to 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, the portion of which at least a portion of the second end is fixed to the hub and electrically connected to the portion of the drug delivery member extending into the hub; and optionally associating the capacitance information with the depth to which the drug delivery member is inserted into the patient. 【0015】 In some embodiments, monitoring capacitance information related to a drug delivery component at the injection site by a drug delivery device controller may include monitoring capacitance information related to a cannula by the controller via a wire fixed to a hub and electrically connected to the conductive portion of the cannula. 【0016】 According to a fifth aspect, a drug delivery device is disclosed, comprising a hub and a drug delivery member fixed to the hub and having a proximal opening and a distal opening. The proximal opening is located within the hub and communicates with the distal opening. The drug delivery device further includes a light source directed to project light into the proximal opening of the drug delivery member, out of the distal opening of the drug delivery member, and into patient tissue when the drug delivery member is in the injection position, and a photodiode is directed to receive the light emitted through patient 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 the received light and associated data. 【0017】 In some embodiments, the controller may be configured to associate data with the depth to which the drug delivery member is inserted into the patient's tissue. In further embodiments, the drug delivery device may include a housing, a primary container disposed within the housing, and a flow path that fluidly connects the primary container to the drug delivery member. In a first embodiment, the drug delivery member extends into a hub and includes a curved portion disposed within the hub, with a proximal opening extending into the hub, and a distal end extending from the curved portion through the bottom surface of the hub. In a second embodiment, the drug delivery device includes an inlet conduit attached to the hub, the hub includes an internal cavity, the inlet conduit fluidly connects 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 connects the drug delivery member to the internal cavity. In any embodiment, a photodiode may be attached to the top surface of the hub and / or to the bottom wall of the housing adjacent to the drug delivery member opening that extends through the bottom wall of the housing. In other further embodiments, the drug delivery device may include a primary container. In these configurations, 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 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 not aligned to provide a generally unobstructed path toward the distal end of the needle. 【0018】 A sixth aspect discloses a method for determining the insertion depth of a drug delivery member of a drug delivery device, comprising inserting the drug delivery member into patient tissue, wherein the drug delivery member has a proximal end fixed to a hub and a distal end opposite to the proximal end, and emitting light from a light source supported by the drug delivery device so that it enters a proximal opening at the proximal end of the drug delivery member and exits a distal opening at the distal end of the drug delivery member and enters patient tissue. The method further comprises receiving light emitted through patient tissue adjacent to the drug delivery member with a photodiode, receiving data relating to the light received by the photodiode with a controller, and optionally relating the data received by the controller to the depth to which the drug delivery member is inserted into patient tissue. 【0019】 In the first embodiment, inserting a drug delivery member fixed to the hub of a drug delivery device into the patient's tissue may include moving the hub, which has the drug delivery member extending into the hub, by a needle insertion mechanism. In the second embodiment, inserting a drug delivery member fixed to the hub of a drug delivery device into the patient's tissue may include moving the hub, which has an internal cavity, and the drug delivery member extending from the internal cavity through the bottom surface of the hub, by a needle insertion mechanism, wherein the proximal opening of the drug delivery member fluidly connects the drug delivery member to the internal cavity. In either embodiment, receiving light passing through the patient's tissue with a photodiode may include receiving light passing through the patient's tissue with a photodiode mounted on the top surface of the hub, or receiving light passing through the patient's tissue with a photodiode mounted on the bottom wall of the housing of the drug delivery device. 【0020】 According to some embodiments, inserting a drug delivery member fixed to the hub of a drug delivery device into a patient's tissue may 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 may 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 may 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 toward the distal end of the needle. 【Brief Description of the Drawings】 【0021】 [Figure 1] A diagram of an autoinjector drug delivery device according to an embodiment of the present disclosure. [Figure 2] A diagram of an on-body drug delivery device according to an embodiment of the present disclosure. [Figure 3] A cross-sectional view of a first exemplary electrical sensing assembly for a drug delivery device according to an embodiment of the present disclosure. [Figure 4] A cross-sectional view of a second exemplary electrical sensing assembly for a drug delivery device according to an embodiment of the present disclosure. [Figure 5] A cross-sectional view of a third exemplary electrical sensing assembly for a drug delivery device according to an embodiment of the present disclosure. [Figure 6] A cross-sectional view of a first exemplary optical sensing assembly for a drug delivery device according to an embodiment of the present disclosure. [Figure 7] A cross-sectional view of a second exemplary optical sensing assembly for a drug delivery device according to an embodiment of the present disclosure. [Figure 8] A cross-sectional view of a third exemplary optical sensing assembly for a drug delivery device according to an embodiment of the present disclosure. 【Mode 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. Therefore, 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 an exemplary detection system, exemplary drug delivery devices are shown in Figures 1 and 2. In some embodiments, such as shown in Figure 1, the drug delivery device 10, such as an autoinjector, may 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. In a more specific example, the device 10 may be configured to operate with the device 10 oriented substantially perpendicular to the user's skin surface and to inject into the user. The drug delivery components may include a primary container 12, such as a reservoir containing a drug 14 inside; 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 that fluidly connects the primary container 12 to the needle 20. The components may further include an injection assembly comprising a drive mechanism 18 coupled to a plunger 19 and driving a stopper 16 through a primary vessel 12, and a needle insertion mechanism (NIM) 24 configured to insert a needle 20 to a desired subcutaneous depth within the user. In some methods, the NIM 24 may be a retractable needle guard for exposing the needle 20, or a drive mechanism for moving the needle longitudinally by a desired distance. For example, the drive mechanism 18 may be configured to drive the movement of both the stopper 16 and the needle 20 by moving some or all of the primary vessel 12, the flow path 22, and the needle 20. As is commonly configured, one or more components of the device 10, such as the drive mechanism 18 and the NIM 24, may be operated in response to the operation of a user input device 26 accessible from 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, device 10 may include electronic components such as a controller 28 to control the operation of one or more of the drug delivery components.Figure 1 shows components centrally positioned along the longitudinal axis L, but it will be understood that one or more components may be positioned eccentrically with respect to 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 relationship drug delivery components corresponds to a needle 20 and a primary container 12 coaxially aligned. In some embodiments, the device 10 may include a cap assembly including a cap housing and a remover. The device 10 may further include a needle shield positioned to cover at least a portion of the distal end of the needle 20 in the stowed state, in which case the needle shield engages with and is held by the remover. The needle shield may 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 January 17, 2017, which is incorporated herein by reference. 【0024】 In other embodiments, such as those shown in Figure 2, the drug delivery device 50, including an on-body injector, may have a horizontally oriented configuration in which the drug delivery components are arranged generally along a horizontal plane P within the housing 51 of the device 50. In these devices 50, the housing 51 is thin, with a width greater than its height, so that when the user places the housing 51 on their skin, the components spread out over an area of ​​skin rather than being stacked as in the embodiments described above. The drug delivery component may include a primary container 52, such as a reservoir, having a drug 54 contained within it, which may be removably disposed within a housing 51; a stopper 56 disposed within the primary container 52 and slidably movable along a horizontal plane P within it; a drive mechanism 58 coupled to a plunger 60 for driving the stopper 56 within the primary container 52; a needle and / or soft cannula 62 oriented along an axis X extending substantially transversely to the horizontal plane P, such as perpendicular or at an angle to the horizontal plane P; a flow path 64 that fluidly connects 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 is commonly configured, one or more components of the device 50, such as the drive mechanism 58 and the NIM 66, may be operated in response to the operation of a user input device 68 accessible from outside the housing 51. Accordingly, the device 50 may include electronic components, such as a controller 70, to control the operation of one or more of the drug delivery components. As described above, this embodiment of the device 50 may also include a cap assembly comprising a cap housing and a remover. The device 50 may further include a needle shield positioned to cover at least a portion of the distal end of the needle 62 in the stowed state, in which case the needle shield engages with and is held by the remover. The needle shield may be removable by removing the cap assembly from the device 50. Naturally, it will be understood that some components may be positioned partially or entirely above or below the horizontal plane P extending approximately to the center of the housing 51, 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. An exemplary on-body injector device is described in U.S. Provisional Patent Application No. 62 / 536,911, filed on 25 July 2017, which is incorporated herein by reference. 【0025】 A detection system for drug delivery devices 10, 50 can electrically or optically measure the insertion depth of the drug delivery members 20, 52. In one embodiment, an electrical detection system 100 measures the insertion depth by measuring the capacitance between the inserted drug delivery member 20, 52 and an electrode 102 in contact with the patient's skin 104. The detection system 100 uses an algorithm to correlate the measured mutual capacitance, either locally or remotely, with the insertion depth of the drug delivery member 20, 52. Alternatively, the electrical detection system 100 can measure impedance (self-capacitance) as a function of the depth of the drug delivery member 20, 52 without using an electrode in contact with the patient's skin. In another embodiment, an optical detection system 200 measures the insertion depth of the drug delivery member 20, 52 by illuminating the patient's tissue through the penetrating drug delivery member 20, 52 with a light source 202 and receiving the backscattered light emitted through the patient's tissue with one or more photodiodes 206 on or adjacent to the patient's skin 204. For example, the photodiode 206 measures the light intensity and transmits data related to the light intensity. The detection system 200 uses an algorithm to correlate 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 electrosensing assembly 100 for drug delivery devices 10, 50 is shown in Figure 3. In this embodiment, the drug delivery member 20, 62 is a needle fluidly coupled to a primary container 12, 52 by a channel 22, 64 which may be a flexible tube or rigid, as shown. Furthermore, the needle 20, 62 includes a portion 106 that extends into and is connected to a hub 108 received within the device 10, 50. The hub 108 is operated by NIM 24, 66 to move the needle 20, 62 from a retracted storage position located within the housing 11, 51 to an injection position that extends at least partially from the housing 11, 51. The needle 20, 62 may have a curved configuration, as shown in Figure 3, where the needle 20, 62 enters the hub 108 from the side and exits the hub 108 through the bottom, or it may have a straight configuration, where the needle 20, 62 enters the hub 108 from the top and exits through the bottom. It will be understood that either configuration can be used in the auto-injector 10 or the on-body injector 50. 【0027】 Advantageously, portion 106 of the needle 20,62 positioned within the hub 108 is fixed to the hub 108. This configuration allows the wire 110 to have a first end 112, which is directly electrically connected to portion 106 of the needle 20,62 extending into the hub 108 and fixed to the hub 108 at a fixing point 114 to prevent the connection from loosening due to the movement of the hub 108 and needle 20,62 during the injection operation. In one embodiment, the first end 112 of the wire 110 may be directly fixed to the needle 20,62. A second end 116 of the wire 110 may communicate with controllers 28,70, which can analyze capacitance information provided by the wire 110 related to the needle 20,62 at the injection position and correlate the capacitance information with the depth to which the needle 20,62 has penetrated the patient's skin 104. Alternatively or additionally, the capacitance information may be sent to a remote controller for analysis and correlation. Wire 110 may be flexible to accommodate the movement of the hub 108 and needles 20, 62 relative to the controllers 28, 70 during the operation of devices 10, 50. Direct electrical connection between needles 20, 62 and controllers 28, 70 provides a reliable capacitive information source without the risk of connection failure or intermittent results from wire 110 and needles 20, 62. In one embodiment, needles 20, 62 may be made from stainless steel. 【0028】 A second exemplary electrosensing assembly 100 for a drug delivery device 50 is shown in Figure 4. In this embodiment, the needle 62 is directly fluid-connected to the primary container 52. Thus, the needle 62 provides a flow path 64. The needle 62 in this embodiment has an elongated configuration having a fixed proximal end 120 extending from the primary container 52, an intermediate curved section 122, and a movable distal end 124. For example, the proximal end 120 may extend substantially parallel to the horizontal plane P, for example, within 5 degrees or within 10 degrees, and the curved section 122 may be a 180-degree curve such that at least a portion 126 of the distal end 124 extends backward substantially parallel to the horizontal plane P. The distal end 124 may also include an angled section 128 configured to move out of the housing 51 during the injection operation. The angled portion 128 can extend at angles that are generally transverse to the plane P, such as 30 to 45 degrees, 45 to 60 degrees, or 60 to 90 degrees. In this embodiment, the NIM 66 can move the angled portion 128 from a retracted storage position located within the housing 51 to an injection position that extends at least partially from the housing 51 by manipulating the distal end 124 of the needle 62. The curved portion 122 allows the distal end 124 to move relative to the fixed proximal end 120. 【0029】 Advantageously, the wire 130 may have a first end 132 and a second end 136. The second end 136 may 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 to the housing 51 by the fixed configuration of the proximal end 120 of the needle 62 so as not to move. In one embodiment, the first end 132 may be directly attached to the needle 62 so as not to loosen due to the movement of the distal end 124 of the needle 62 during the injection operation. The second end 136 of the wire 130 may communicate with a controller 70, which can analyze capacitance information provided by the wire 130 related to the needle 62 at the injection position and correlate the capacitance information with the depth to which the needle 62 has penetrated the patient's skin 104. Alternatively or additionally, the capacitance information may be sent to a remote controller for analysis and correlation. 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. Naturally, the wire 130 can also have a flexible configuration if necessary. A direct electrical connection between the needle 62 and the controller 70 provides a reliable capacitive information source without the risk of connection failure or intermittent results from the wire 130 and the needle 62. In one embodiment, the needle 62 may be made from stainless steel. 【0030】 A third exemplary electrosensing assembly 100 for drug delivery devices 10, 50 is shown in Figure 5. This embodiment is shown in Figure 5 with reference to an autoinjector 10, but it will be understood that the assembly 100 can be readily incorporated into an on-body injector 50. In this embodiment, the NIM 24, 66 moves the needles 20, 62 between a retracted storage position located within the housing 11, 51 and an injection position in which the distal ends of the needles 20, 62 extend at least partially from the housing 11, 51. The electrosensing assembly 100 in this embodiment provides 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 positioned between the capacitor plates 140 and the needles 20, 62. The dielectric member 142 is positioned at a distance from the needles 20 and 62 to allow the needles 20 and 62 to move freely during the injection operation, while the capacitor plate 140 is also positioned at a certain distance from the needles 20 and 62 to ensure consistent readings during operation. 【0031】 As shown in the figure, the assembly 100 may further include one or more wires 144 electrically connected to the capacitor plate 140 and communicating with controllers 28, 70. Controllers 28, 70 can analyze capacitance information provided by the wires 144 and the capacitor 140, relating to the needles 20, 62 at the injection site. For example, the wire 144 may have a first end communicating with controllers 28, 70 and a second end electrically connected at a connection point adjacent to the needles 20, 62, i.e., a connection point to the capacitor plate 140. Advantageously, the connection point is fixed to the housings 11, 51 so as not to move due to the fixed configuration of the capacitor plate 140. Controllers 28, 70, or optionally a remote controller, can then relate the capacitance information to the depth to which the needles 20, 62 have penetrated the patient's skin 104. Assuming that the capacitor plate 140 and controller 70 are fixed to each other, the wires 144 may have a rigid or fixed configuration within the housings 11, 51. Naturally, the wiring 144 can have a flexible configuration if necessary. Non-contact monitoring of the needles 20, 62 provided by the capacitor plate 140 allows the needles to move without compromising the electrical connections of the sensing assembly 100. By being mounted at a certain distance from the needles 20, 62, the capacitor plate 140 provides a reliable capacitive information source without interfering with the operation and movement of the needles 20, 62. This form of sensing assembly 100 is particularly advantageous in an auto-injector 10 or on-body injector 50 that has a short needle length and also requires the movement of the needle for injection operation. In one embodiment, the needle 62 may be made of stainless steel. 【0032】 In any of the above embodiments, the drug delivery members 20, 62 may include or be cannulas such as soft cannulas. The cannulas 20, 62 can be made conductive by coating their outer surface 150 with a conductive material. For example, the conductive material may be gold or platinum. The conductive material can be coated onto 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 from a polymer nanocomposite to which carbon nanotubes or metal nanoparticles are added to make the cannulas 20, 62 conductive. With any of these configurations, as described above, the condenser plate 140 can monitor the cannulas 20, 62 as they move between the condenser plates 140. 【0033】 A first exemplary optical sensing assembly 200 for drug delivery devices 10, 50 is shown in Figure 6. In this embodiment, the drug delivery member 20, 62 is a needle fluidly coupled to the primary container 12, 52 by a channel 22, 64 which may be a flexible tube as shown. Furthermore, the needle 20, 62 extends into and is fixed to a hub 210 received within the device 10, 50, the hub 210 is configured to be operated by NIM 24, 66 to move the needle 20, 62 from a retracted storage position located within the housing 11, 51 to an injection position that extends at least partially from the housing 11, 51. As shown, the needle 20, 62 includes a proximal end 212 that enters the hub 210 through a side 214, a curved portion 216 located 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 may be a curve of approximately 90 degrees (for example, within 5 degrees or 10 degrees). In one embodiment, the needles 20, 62 may be made of stainless steel. 【0034】 As illustrated, the sensing assembly 200 further includes a light source 202 that is directed and configured to project light onto the patient's tissue by projecting light onto the needle 20, 62 through a proximal opening 222 and a distal opening 223 communicating with the proximal opening 222, after the distal end 218 of the needle 20, 62 has been inserted into the patient's tissue. In this embodiment, the proximal opening 222 is located within the upper surface 224 of the curved portion 212, aligned with the distal end 218 of the needle. Furthermore, the hub 210 may be configured to provide light access to the opening 222 so that light can be projected onto the distal end 218 of the needle 20, 62 through the hub 210 and the opening 222. For example, the hub 210 may be made from 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 needle 20, 62 by a transparent cover or shield. In one configuration, the light source 202 is mounted on a hub 210 and can move with the hub 210. In such a configuration, the wire 228 electrically connected to the light source 202 may be flexible to allow the light source 202 to move freely with the hub 210. In another configuration, the light source 202 may be fixedly mounted within a housing 11, 51, and the wire 228 may be fixed / rigid or flexible as needed. In yet another configuration, the drug delivery member 20, 62 may include a soft cannula with a needle that functions as a trocar. In this configuration, light projected by the light source 202 can pass through the needle 20, 62 and be directed towards the cannula. It will be understood that the above configurations can be utilized in an auto-injector 10 or an on-body injector 50. 【0035】 In some forms, the assembly 200 may further include light focusing components to guide light to the needles 20, 62 and avoid scattering. For example, one or more lenses, mounted on or within the hub 210 and / or in or within the housings 11, 51, may be positioned in the path of light projected from the light source 202. Reflective material may be positioned in front of the light source 202, for example, within the bore of the hub 210. 【0036】 As described above, the optical sensing assembly 200 receives backscattered light emitted 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 controllers 28, 70 to provide the received light and associated data. The controllers 28, 70, or optionally a remote controller, can then associate the data with the depth to which the needles 20, 62 have penetrated the patient's skin 204. In the first embodiment, the photodiode 206 may be positioned adjacent to the light source 202, with the light source 202 in a generally central position relative to the photodiode 206. The photodiode 206 may be coupled to a hub 210 and move with the hub 210, or it may be mounted in a fixed position within the housing 11, 51. In this configuration, the photodiode 206 detects backscattered light passing through the hub 210. The hub 210 may be made from a transparent material as described above, or may have one or more bores extending within the hub 210 that are matched with the photodiode 206. In a second embodiment, the photodiode 206 may be coupled to the bottom wall 230 of the housing 11, 51 adjacent to a drug delivery member opening 232 that extends through the bottom wall 230 of the housing 11, 51. For example, the bottom wall 230 may include a transparent portion 234 extending around the opening 232, and the photodiode 206 may be mounted in an external optically transparent case 236 of the housing 11, 51 into which the hub 210 is received, or the photodiode 206 may be mounted in an opening 238 in the bottom wall 230 that is 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 Figure 7. In this embodiment, the drug delivery member 20, 62 is a needle fluidly coupled to the primary container 12, 52 by a channel 22, 64 which may be a flexible tube or rigid, as shown. The assembly 200 in this embodiment includes a separate inlet conduit 252 that enters the hub 250 through a side 254, rather than a needle extending into the hub 250 as in the above embodiment, and the needle 20, 62 exits the hub 250 through a bottom 256. Furthermore, the hub 250 defines an internal cavity 258 that fluidly connects the inlet conduit 252 to the needle 20, 62. Similar to the above embodiment, the hub 250 is configured to be operated by NIM 24, 66 to move the needle 20, 62 from a retracted storage position within the housing 11, 51 to an injection position that extends at least partially from the housing 11, 51. In one configuration, the needles 20 and 62 may be made of stainless steel. 【0038】 As illustrated, the sensing assembly 200 further includes a light source 202 that is directed and configured to project light onto the patient's tissue by projecting light onto the needles 20, 62 through a proximal opening 259 and a distal opening 261 communicating with the proximal opening 259 after the needles 20, 62 have been inserted into the patient's tissue. In this embodiment, the needles 20, 62 extend along their longitudinal axis so that light can be projected onto the needles 20, 62 through a hub 250, and the hub 250 may be configured to provide light access to the needles 20, 62. For example, the hub 250 may be made from a transparent material, such as plastic, or an opaque material having a bore matched with the needle opening 259, while maintaining the fluid-tight properties of the needles 20, 62 by a transparent cover or shield. As illustrated, after the needles 20, 62 are inserted into the patient's tissue, the light source 202 is aligned with the proximal opening 259 of the needles 20, 62 so that light projected by the light source 202 enters the needles 20, 62 and travels to the patient's tissue. In one embodiment, the light source 202 is mounted on a hub 250 and can move with the hub 250. In such a configuration, the wire 262 electrically connected to the light source 202 may be flexible to allow the light source 202 to move freely with the hub 250. In another embodiment, the light source 202 may be fixedly mounted within a housing 11, 51, and the wiring 262 may be fixed / rigid or flexible as needed. In yet another embodiment, the drug delivery member 20, 62 may include a soft cannula with a needle that functions as a trocar. In this configuration, light projected by the light source 202 can pass through the needles 20, 62 and travel towards the cannula. It will be understood that the above configuration can be used in an auto-injector 10 or an on-body injector 50. 【0039】 In some forms, the assembly 200 may further include light focusing components to guide light to the needles 20, 62 and avoid scattering. For example, one or more lenses, mounted on or within the hub 250 and / or in or within the housings 11, 51, may be positioned in the path of light projected from the light source 202. Reflective material may be positioned 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 emitted through the patient's tissue when the needles 20, 62 are in the injection position, using one or more photodiodes 206 on or adjacent to the patient's skin 204. The photodiodes 206 are electrically connected to and communicate with controllers 28, 70 to provide data associated with the light received by the photodiodes 206. The controllers 28, 70, or optionally a remote controller, can then associate the data with the depth to which the needles 20, 62 have penetrated the patient's skin 204. In the first embodiment, the photodiode 206 may be positioned adjacent to the light source 202, with the light source 202 in a generally central position relative to the photodiode 206. The photodiode 206 may be coupled to a hub 250 and move with the hub 250, or it may be mounted in a fixed position within the housing 11, 51. In this configuration, the photodiode 206 detects backscattered light passing through the hub 250. The hub 250 may be made from a transparent material as described above, or it may have one or more bores extending within the hub 250 that are matched with the photodiode 206. In a second embodiment, the photodiode 206 may be coupled to the bottom wall 264 of the housing 11, 51, adjacent to a drug delivery member opening 266 that extends through the bottom wall 264 of the housing 11, 51. For example, the bottom wall 264 may include a transparent portion 268 extending around the opening 266, and the photodiode 206 may be mounted within the housing 11, 51, for example, embedded in an external optically transparent case 270 into which the hub 250 is received, or the photodiode 206 may be mounted in an opening 272 in the bottom wall 230 that is directly adjacent to the patient's skin 204. 【0041】 A third exemplary optical detection assembly 200 for a pre-filled syringe 300 is shown in Figure 8. The syringe 300 includes a primary container in the form of a barrel or reservoir 302 for containing a fluid therapeutic product. The barrel 302 has an annular side wall 304 extending 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 fluidly coupled to the interior 316 of the barrel 302. 【0042】 As illustrated, the sensing assembly 200 further includes an array of light sources 202 that are directed and configured to project light onto the patient's tissue by projecting light onto the needle 312 through the proximal opening 317 of the needle 20, 62 located within the hub 314 and the distal opening 319 communicating with the proximal opening 317, after the needle 312 has been inserted into the patient's tissue. In this embodiment, the needle 312 extends along its longitudinal axis so that light can be projected onto the needle 312 through the hub 314 and / or the distal end 308 of the barrel, and the hub 314 and / or the distal end 308 of the barrel may be configured to provide light access to the needle 312. For example, the hub 314 and / or the distal end 308 of the barrel may be made from a transparent material, such as plastic, or an opaque material having a bore matched with the needle opening 317, while maintaining the fluid-tight properties of the needle 312 and the inside of the barrel 316 by a transparent cover or shield. The array of light sources 202 may extend around or into the hub 314 or the distal end 308 of the barrel. 【0043】 The photodiodes 206 of assembly 200 may be arranged in an array extending around or into the needle hub 314 or the distal end 308 of the barrel. The light sources 202 and photodiodes 206 may be arranged such that individual photodiodes 206 do not block the light projected from the light sources 202, and individual light sources 202 do not block the light emitted through the patient's tissue, which will be received by the photodiodes 206. For example, the light sources 202 and photodiodes 206 may be arranged in an alternating pattern around the syringe 300. The photodiodes 206 are electrically connected to and communicate with the controller 320 of the syringe 300 to provide data associated with 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 to which the needle 312 has penetrated the patient's skin 320. It will be understood that the above detection assembly 200 can be incorporated into an autoinjector device 10 having an array of light sources 202 and photodiodes 206 positioned relative to the primary container 12 and the needle 20. 【0044】 In the above configuration, controllers 28, 70, and 320 refer to expected values ​​and determine the depth of drug delivery members 20, 62, and 312 based on provided measurements, thereby allowing the depth of drug delivery members 20, 62, and 312 to be confirmed and recorded during drug dispensing operations. In some cases, the depth of drug delivery, such as intracutaneous, subcutaneous, intramuscular, or intravenous, can affect pharmacokinetics, for example, and may lead to differences in the therapeutic effects of certain drugs. Using the devices described herein, the parties concerned can verify through data that devices 10, 50, and 300 are correctly positioned and that drug delivery members 20, 62, and 312 are inserted to the target depth. 【0045】 The term "controller" broadly refers to any microcontroller, computer, or processor-based device with a processor, memory, and programmable input / output peripherals that are generally designed to control the operation of other components and devices. It is further understood that it also includes common accompanying accessory devices, including transceivers for communication with power supplies, memory, other components and devices, etc. These structural options are well known and understood in the art and do not need to be described further here. A controller may be configured to perform one or more of the steps, operations, and / or functions described herein (for example, by using corresponding programming stored in memory, as will be well understood by those skilled in the art). 【0046】 Elements in the figures are depicted for simplification and clarity and should be understood not necessarily to a consistent scale. For example, the dimensions and / or relative positions of some elements in the figures may be exaggerated relative to others to improve the understanding of various embodiments of the invention. Also, common but well-understood elements that are useful or necessary in commercially viable embodiments are often omitted so as not to interfere too much with the illustrations of these various embodiments. The same reference numerals may be used to describe similar or analogous parts. Furthermore, although several examples have been disclosed herein, any feature of any example may be combined with or substituted for other features of other examples. Furthermore, although several examples have been disclosed herein, modifications may be made to the disclosed examples without departing from the scope of the claims. 【0047】 The above description relates to various devices, assemblies, components, subsystems, and methods of use associated with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used in conjunction with, the drugs specified below, and their generic and biosimilar equivalents, but not limited to those drugs. As used herein, the term "drug" is interchangeable with other similar terms and may be used to refer to any type of drug or therapeutic substance, including traditional and non-traditional medicines, dietary supplements, supplements, biological preparations, biological activators and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or restrictive. 【0048】 The drug is contained within a reservoir. In some cases, the reservoir is a primary container into which the drug is filled or pre-filled for therapeutic purposes. The primary container may be a vial, cartridge, or pre-filled syringe. 【0049】 In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF), or the device may be used with such factors. Examples of such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgastrim, 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), which may be in liquid or lyophilized form. The ESA is any molecule that stimulates erythrocyte production. In some embodiments, the ESA is an erythrocyte-stimulating protein. As used herein, “erythrocyte-stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Examples of erythrocyte-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 red blood cell production stimulating proteins include 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), and Binocrit® (epoetin alfa). Examples include, but are not limited to, epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues. 【0051】 Certain exemplary proteins, including their fusions, fragments, analogues, variants, or derivatives, are described below: fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies (also referred to as RANKL-specific antibodies, peptide bodies, etc.), OPGL-specific antibodies, peptide bodies, and related proteins; myostatin-binding proteins, peptide bodies, and related proteins, particularly myostatin-specific peptide bodies; and IL-4 receptor-specific antibodies, peptide bodies, and related proteins that suppress the activity mediated by the binding of IL-4 and / or IL-13 to their receptors. Interleukin-1 receptor 1 ("IL1-R1") specific antibodies, peptide bodies, and related proteins; Ang2 specific antibodies, peptide bodies, and related proteins; NGF specific antibodies, peptide bodies, and related proteins; CD22 specific antibodies, peptide bodies, and related proteins, etc., in particular, dimers of human-mouse monoclonal hLL2γ chain disulfide bound to human-mouse monoclonal hLL2κ chain, for example, epratuzumab (CAS registry number 501423-23-0) Human CD22-specific antibodies, including but not limited to human CD22-specific IgG antibodies such as human CD22-specific fully humanized antibodies; including but not limited to humanized and fully human monoclonal antibodies; including but not limited to anti-IGF-1R antibodies; IGF-1 receptor-specific antibodies, peptide bodies, and related proteins; including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies; 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 antibodies that suppress the interaction between B7RP-1 and ICOS, the innate receptor of B7RP-1 on activated T cells; B-7-related protein 1-specific antibodies, peptide bodies, and related proteins (also referred to as "B7RP-1", B7H2, ICOSL, B7h, and CD275); e.g., HuMax, such as 145c7; IL-15 specific antibodies, peptide bodies, and related proteins, including but not limited to IL-15 antibodies and related proteins, particularly humanized monoclonal antibodies;This includes, but is not limited to, human IFN-γ specific antibodies, and, but is not limited to, fully human anti-IFN-γ antibodies, such as IFN-γ specific antibodies, peptide bodies, and related proteins; TALL-1 specific antibodies, peptide bodies, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptide bodies, and related proteins; thrombopotiene receptor ("TPO-R") specific antibodies, peptide bodies, and related proteins; and antibodies targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersion factor (HGF / SF). , hepatocyte growth factor ("HGF") specific antibodies, peptide bodies, and related proteins; TRAIL-R2 specific antibodies, peptide bodies, and related proteins; activin A specific antibodies, peptide bodies, and proteins; TGF-beta specific antibodies, peptide bodies, and related proteins; amyloid-beta protein specific antibodies, peptide bodies, and related proteins; c-Kit specific antibodies, peptide bodies, and related proteins, including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors. Proteins, etc.; OX40L-specific antibodies, peptide bodies, 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 (Registered Trademark) (Epoetin Alpha, or Erythropoietin); GLP-1, Avonex (Registered Trademark) (Interferon Beta-1a); Bexxar (Registered Trademark) (Tositumomab, anti-CD22 monoclonal antibody); Betaseron (Registered Trademark) (Interferon-Beta); Campath (Registered Trademark) (Alemtuzumab, anti-CD52 monoclonal antibody); Dynepo (Registered Trademark) (Epoetin Delta); Velcade (Registered Trademark) (Bortezomib); MLN0002 (Anti-α4β7 mAb); MLN1202 (Anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti® (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar of Herceptin®, or other products containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix® (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, Ganitumumab, Conatumumab, Brodalumab, Insulin in Solution; Infergen (Registered Trademark) (Interferon Alphacon-1); Natrecor (Registered Trademark) (Nesiritide; Recombinant Human Type B Natriuretic Peptide (hBNP); Kineret (Registered Trademark) (Anakinra); Leukine (Registered Trademark) (Sargamostim, rhuGM-CSF); LymphoCide (Registered Trademark) (Epratuzumab, Anti-CD22 mAb); Benlysta (trademark) (lymphostat 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); pexerizumab (anti-complement C5); Numax (registered trademark) (MEDI-524); Lucentis (registered trademark) (ranibizumab);Panorex(registered trademark) (17-1A, edrecolomab); Trabio(registered trademark) (reldelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem(registered trademark) (IDM-1); OvaRex(registered trademark) (B43.13); Nuvion(registered trademark) (vizilizumab); Cantuzumab meltansine (huC242-DM1); NeoRecormon(registered trademark) (epoetin beta); Neumega(registered trademark) (oprelbequin, human interleukin-11); Orthoclone OKT3(registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit(registered trademark) (epoetin alfa); Remicade(registered trademark) (infliximab, anti-TNFα monoclonal antibody); Reopro(registered trademark) (absiximab, anti-GP) Ib / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanorimumab); Mvasi® (bevacizumab-awwb); Rituxan® (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-anthrax (B. anthracis) protective antigen mAb); ABthrax(trademark); Xolair(registered trademark) (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domains of the Fc portion of human IgG1 and both IL-1 receptor components (type I receptor and receptor co-protein)); VEGF trap (IgG1 VEGFR1 Ig domain fused with Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimabe); Orencia® (atacicept, 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 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (saltumumab); M200 (boroxiximab, 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 BC 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); Adekatumumab; 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 stage 1 fibrogen (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 may contain, or be used in conjunction with, sclerostin antibodies such as romosozumab, brosozumab, BPS804 (Novartis), Evenity® (romosozumab-aqqg), or other products containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing. In other embodiments, it may contain, or be used in conjunction with, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Examples of 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 be used in conjunction with, rilotumumab, bixalomer, trevananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the drug delivery device reservoir may be filled with IMLYGIC® (Tarimogene Laharpa Lepbec) 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 them. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors (TIMPs) of metalloproteinases, including but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (Erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraine. Erenumab, as well as bispecific antibody molecules targeting the calcitonin gene-related peptide (CGRP) receptor and other headache targets, and antagonistic antibodies to the human CGRP receptor, may also be delivered using the drug delivery device of this disclosure.In addition, bispecific T-cell activator (BiTE®) antibodies, such as but not limited to BLINCYTO® (blinatumomab), may be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with APJ macromolecule agonists, such as but not limited to Apelin or its analogues. In some embodiments, therapeutically effective amounts of anti-thymocrine interstitial lymphocyte generating factor (TSLP) or TSLP receptor antibodies may be used in or with the drug delivery device of this 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 in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamide)-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 in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindole-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 in conjunction with, Parsabiv® (ethelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT) in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain, or be used in conjunction with, another product containing ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera®, or an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain, or be used in conjunction 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 condensed to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, ABP 959 (eculizumab), a biosimilar candidate of Soliris®, 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 in conjunction with, rozibafusp alfa (formerly known as AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain, or be used in conjunction with, omecamutib mecarbir, small molecule selective cardiac myosin activator, or myotrope, or another product containing small molecule selective cardiac myosin activator that directly targets the cardiac contractile mechanism. In some embodiments, the drug delivery device may contain sotrasib (formerly known as AMG 510), KRAS. G12C Small molecule inhibitors, or KRAS G12CAnother product containing a small molecule inhibitor may be contained or used in conjunction with it. In some embodiments, the drug delivery device may contain or use in conjunction with it tezeperumab, a human monoclonal antibody, or another product containing a human monoclonal antibody that inhibits the action of thymic interstitial lymphocyte necrosis factor (TSLP). In some embodiments, the drug delivery device may contain or use in conjunction with it AMG 714 that binds to interleukin-15 (IL-15), a human monoclonal antibody, or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or use in conjunction with it AMG 890 that reduces lipoprotein (a), also known as Lp(a), a small interfering RNA (siRNA), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain, or be used in conjunction with, ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stellara®, or another product containing human IgG1 kappa antibody and / or binding 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 in conjunction with, another product containing Amjevita® or Amgevita® (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 160, or another product containing the half-life extension (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 in conjunction with, AMG 119 or another product containing delta-like ligand 3 (DLL3)CAR T (chimeric antigen receptor T cell) therapy.In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 119, or another product containing 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 in conjunction with, AMG 133, or another product containing a gastric suppressor polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 171, or another product containing a growth and differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 176, or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 199, or another product containing a half-life extension (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 256, or another product containing anti-PD-1 × IL-21 mutaine 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 in conjunction with, AMG 330, or another product containing the anti-CD33 × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain, or be used with, AMG 427, or another product containing an extended half-life (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, AMG 430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain, or be used with, AMG 506, or another product containing a multispecific FAP × 4-1 BB-targeted DARPin® biologic being studied as a treatment for solid tumors. In some embodiments, the drug delivery device may contain, or be used with, AMG 509, or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain, or be used with, AMG 562, or an extended half-life (HL. E) Another product containing the CD19 × anti-CD3 BiTE® (bispecific T cell engager) construct may be contained or used in conjunction with it. In some embodiments, the drug delivery device may contain or use in conjunction with it another product containing efavavaluquin alfa (formerly AMG 592) or IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or use in conjunction with it another product containing AMG 596 or the CD3 × epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or use in conjunction with it another product containing AMG 673 or the 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 in conjunction with, AMG 701, or another product containing the HLE (Hyperlife-Extended Epithelial) 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 in conjunction with, AMG 757, or another product containing the HLE (Hyperlife-Extended Epithelial Tissue-Like Ligand 3 (DLL3) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 910, or another product containing the HLE (Hyperlife-Extended 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 in terms 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 Disclosure. Various alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but such embodiments are still included within the claims defining the invention disclosed herein. 【0054】 Those skilled in the art will understand that a variety of modifications, changes, and combinations of the above embodiments can be made without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes, and combinations should be construed as falling within the scope of the invention.

Claims

[Claim 1] Housing and A primary container placed inside the housing, A drug delivery member fluidly coupled to the primary container, the drug delivery member being movable between a retracted position located within the housing and an injection position extending at least partially from the housing, A wire having a first end and a second end, wherein the first end is electrically connected to a connection point adjacent to the drug delivery member, and the connection point is fixed relative to the housing so as not to move, and A controller communicating with the second end of the wire, configured to receive capacitance information from the wire related to the drug delivery member at the injection position, A drug delivery device including, The housing further includes 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, A drug delivery device wherein 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 at the injection position. [Claim 2] The drug delivery device according to claim 1, wherein the controller is further configured to associate the capacitance information with the depth to which the drug delivery member is inserted into the patient. [Claim 3] It further includes a needle insertion mechanism, The drug delivery member has an elongated configuration having a proximal end extending from the primary container and fixed to the housing, an intermediate curved portion, and a distal end, and the needle insertion mechanism is configured to move at least a portion of the distal end between the retracted position and the injection position, according to claim 1 or 2. [Claim 4] The drug delivery device according to claim 1, further comprising one or more dielectric members disposed between the capacitor plate and the drug delivery member, wherein the one or more dielectric members are spaced outward from the drug delivery member. [Claim 5] The drug delivery device according to any one of claims 1 to 4, wherein the drug delivery member includes a cannula having a conductive portion. [Claim 6] The drug delivery device according to claim 5, wherein the conductive portion of the cannula includes a conductive coating extending over at least a portion of the outer surface of the cannula. [Claim 7] Housing and A hub movably disposed within the housing, A drug delivery member having a portion that extends into the hub and is connected to the hub, A needle insertion mechanism is operationally coupled to the hub and configured to move the hub in order to drive the drug delivery member between a retracted position located within the housing and an injection position extending at least partially from the housing, A wire having a first end and a second end, wherein at least a portion of the first end of the wire is fixed to the hub and is electrically connected to the portion of the drug delivery member extending into the hub, A controller communicating with the wire to receive capacitance information related to the drug delivery member at the injection position, Drug delivery devices, including those mentioned above. [Claim 8] The drug delivery device according to claim 7, wherein the controller is configured to associate the capacitance information with the depth to which the drug delivery member is inserted into the patient. [Claim 9] The drug delivery device according to claim 7 or 8, wherein the drug delivery member includes a cannula having a conductive portion, and the wire is electrically connected to the conductive portion of the cannula. [Claim 10] The drug delivery device according to claim 9, wherein the conductive portion of the cannula includes a conductive coating extending over at least a portion of the outer surface of the cannula.

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