Drug delivery member insertion sensing assembly, drug delivery device, and related methods

Abstract

Drug delivery member insertion depth sensing assemblies, drug delivery devices, and methods for determining the insertion depth of drug delivery members are disclosed. These sensing assemblies may include electrical sensing assemblies with direct or indirect measurement components or optical sensing assemblies with one or more light sources and one or more photodiodes. The controller of these sensing assemblies may receive data associated with the drug delivery member in the insertion position. The data may then be associated with the insertion depth of the drug delivery member.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Priority is claimed to U.S. Provisional Patent Application No. 62 / 990,133, filed on March 16, 2020, the entire contents of which are hereby expressly incorporated herein by reference. Technical Field

[0003] The present disclosure relates to drug delivery devices, and more particularly to drug delivery devices with electronic controls. Background Art

[0004] The drug may be administered using a drug delivery device such as an auto-injector or a portable syringe. Auto-injectors and portable syringes may be used to help automate the injection and delivery or administration process, thereby simplifying the process for certain patient groups or subgroups that would be uncomfortable using a syringe / vial combination or pre-filled syringe system, whether due to physical or psychological barriers.

[0005] However, even after receiving specific training, some patients and / or caregivers may experience challenges when using an autoinjector and / or a portable syringe. Such challenges may be related to placement of the device on the person and / or activation of the device. The user may be unsure whether the device is properly placed prior to operation. The user may inadvertently move the device before a full dose can be dispensed, or may dispense the drug at a depth that is not optimal. The user may also be unsure whether his / her sequence of actions is correct for operating the drug delivery device. Summary of the invention

[0006] According to a first aspect, a drug delivery device is disclosed, the drug delivery device comprising: a housing; a main container, the main container is disposed in the housing; a drug delivery member, the drug delivery member is fluidly connected to the main container, wherein the drug delivery member can be moved between a retracted position disposed in the housing and an injection position extending at least partially outside the housing; and a wire having a first end and a second end, wherein the second end is electrically connected at a connection point adjacent to the drug delivery member, and the connection point is fixed to prevent movement relative to the housing. The drug delivery device further includes a controller, the controller communicating with the first end of the wire. The controller is configured to receive capacitance information associated with the drug delivery member at the injection position from the wire.

[0007] According to some forms, the controller can be configured to associate the capacitance information with the depth that the drug delivery member has been inserted into the patient's body. In other forms, the drug delivery device can include a needle insertion mechanism. In these forms, the drug delivery member has an elongated configuration, which has a proximal end, an intermediate bend and a distal end extending from the main container and fixed to prevent movement relative to the housing. 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 other forms, the drug delivery device can include a pair of capacitor plates, which are arranged in the housing and spaced apart from the drug delivery member, wherein the drug delivery member extends 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 the capacitance information associated with the drug delivery member at the injection position. In further forms, the drug delivery device includes one or more dielectric members disposed between the capacitor plate and the drug delivery member, wherein the one or more dielectric members are spaced outwardly from the drug delivery member.

[0008] In any of the above forms, 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. Additionally, in some versions, the conductive portion of the cannula may be a conductive coating extending over at least a portion of the outer surface of the cannula.

[0009] According to a second aspect, a method for determining an insertion depth of a drug delivery member is disclosed, the method comprising: moving the drug delivery member from a retracted position disposed in a housing of a drug delivery device to an injection position extending at least partially outside the housing; monitoring, by a controller of the drug delivery device, capacitance information associated with the drug delivery member at the injection position via a wire electrically connected at a connection point adjacent to the drug delivery member, wherein the connection point is fixed to prevent movement relative to the housing; and associating, by the controller, the capacitance information with a depth to which the drug delivery member has been inserted into a patient's body.

[0010] According to some forms, the drug delivery member can have an elongated configuration having a proximal end, an intermediate bend, and a distal end that are fixed to prevent movement relative to the housing, and monitoring capacitance information associated with the drug delivery member at the injection position with the controller can include monitoring capacitance information associated with the drug delivery member with the controller via a wire electrically connected at a connection point at the proximal end of the drug delivery member.

[0011] According to some forms, moving the drug delivery member from a retracted position disposed in the housing of the drug delivery device to an injection position extending at least partially outside 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, and monitoring capacitance information of the drug delivery member at the injection position with the controller may include monitoring capacitance information of the drug delivery member as the drug delivery member moves from the retracted position to the injection position with the controller via wires electrically connected at connection points adjacent to the pair of capacitor plates. In other forms, the method may include spacing the capacitor plates from the drug delivery member with one or more dielectric members.

[0012] In any of the above forms, monitoring capacitance information associated with the drug delivery member at the injection site with a controller of the drug delivery device may include monitoring capacitance information associated with the cannula with the controller via a wire electrically connected at a connection point adjacent to a conductive portion of the cannula.

[0013] According to a third aspect, a drug delivery device is disclosed, the drug delivery device comprising: a housing; a seat, the seat being movably disposed within the housing; a drug delivery member, a portion of which extends through and is connected to the seat; a needle insertion mechanism, the needle insertion mechanism being operably connected to the seat and configured to move the seat to drive the drug delivery member between a retracted position disposed in the housing and an injection position extending at least partially outside 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 seat and electrically connected to the portion of the drug delivery member extending through the seat. The drug delivery device further comprises a controller, the controller communicating with the wire to receive capacitance information associated with the drug delivery member at the injection position.

[0014] According to some forms, the controller may be configured to correlate the capacitance information with the depth to which the drug delivery member has been inserted into the patient. In other forms, the drug delivery member may include a cannula having a conductive portion, and the lead is electrically connected to the conductive portion of the cannula. If desired, the conductive portion of the cannula may be a conductive coating extending over at least a portion of the outer surface of the cannula.

[0015] According to a fourth aspect, a method for determining an insertion depth of a drug delivery member is disclosed, the method comprising: moving a seat disposed within a housing of a drug delivery device with a needle insertion mechanism, thereby driving the drug delivery member from a retracted position disposed in the housing of the drug delivery device to an injection position extending at least partially outside the housing, a portion of the drug delivery member extending through and connected to the seat; monitoring capacitance information associated with the drug delivery member at the injection position via a wire having a first end and a second end with a controller of the drug delivery device, wherein at least a portion of the second end is fixed to the seat and electrically connected to a portion of the drug delivery member extending through the seat; and optionally associating the capacitance information with a depth to which the drug delivery member has been inserted into a patient's body with the controller.

[0016] According to some forms, monitoring with a controller of the drug delivery device capacitance information associated with the drug delivery member at the injection site may include monitoring with the controller capacitance information associated with the cannula via a wire secured to the seat and electrically connected to a conductive portion of the cannula.

[0017] According to a fifth aspect, a drug delivery device is disclosed, comprising: a seat; and a drug delivery member, the drug delivery member being fixed to the seat and having a proximal opening and a distal opening. The proximal opening is disposed within the seat and communicates with the distal opening. The drug delivery device further comprises 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 the patient's tissue when the drug delivery member is in an injection position, and a photodiode oriented to receive light irradiated through the patient's tissue adjacent to the drug delivery member when the drug delivery member is in the injection position. The controller communicates with the photodiode to receive data associated with the received light.

[0018] According to some forms, the controller can be configured to associate the data with the depth to which the drug delivery member has been inserted into the patient's tissue. In other forms, the drug delivery device can include: a housing; a main container, the main container is disposed within the housing; and a flow path, the flow path fluidly coupling the main container to the drug delivery member. In a first version, the drug delivery member extends through the seat and includes a curved portion disposed within the seat, wherein the proximal opening extends through it and the distal end extends from the curved portion through the bottom surface of the seat. In a second version, the drug delivery device includes an inlet conduit mounted to the seat, wherein the seat includes an inner cavity, the inlet conduit fluidically couples the flow path to the inner cavity of the seat, and the drug delivery member extends from the inner cavity through the bottom surface of the seat so that the proximal opening of the drug delivery member fluidly couples the drug delivery member to the inner cavity. In either version, the photodiode can be mounted to the upper surface of the seat and / or can be mounted to the bottom wall of the housing, adjacent to the drug delivery member opening extending through the bottom wall. In other further forms, the drug delivery device may include a main container. In these forms, the drug delivery member may be a needle, the seat may be fixedly mounted to the distal end of the main container, the light source may be an array of light sources carried by the seat, and the photodiode may be an array of photodiodes extending around and adjacent to the distal end of the main container. The array of light sources and the array of photodiodes are not aligned to provide a generally clear path toward the distal end of the needle.

[0019] According to a sixth aspect, a method for determining the insertion depth of a drug delivery member of a drug delivery device is disclosed, the method comprising: inserting the drug delivery member into the tissue of a patient, wherein the drug delivery member has a proximal end fixed to a seat and a distal end opposite the proximal end; and 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, emitting from a distal opening at the distal end of the drug delivery member, and emitting into the tissue of the patient. The method further comprises: receiving light irradiated through the tissue of the patient adjacent to the drug delivery member with a photodiode; receiving data about the light received by the photodiode at a controller; and optionally 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 with the controller.

[0020] In a first version, inserting a drug delivery member secured to a seat of the drug delivery device into the patient's tissue may include moving a seat having a drug delivery member extending therethrough with a needle insertion mechanism. In a second version, inserting a drug delivery member secured to a seat of the drug delivery device into the patient's tissue may include moving a seat having an inner cavity and a drug delivery member extending from the inner cavity through a bottom surface of the seat with a needle insertion mechanism, wherein a proximal opening of the drug delivery member fluidly couples the drug delivery member to the inner cavity. In either version, receiving light passing through the patient's tissue with the photodiode may include receiving light passing through the patient's tissue with a photodiode mounted to an upper surface of the seat or receiving light passing through the patient's tissue with a photodiode mounted to a bottom wall of a housing of the drug delivery device.

[0021] According to some forms, inserting a drug delivery member secured to a seat of the drug delivery device into the patient's tissue may include inserting a needle secured to the seat into the patient's tissue, the seat being fixedly mounted to the distal end of the main container, emitting light from the light source may include emitting light from an array of light sources carried by the seat, and receiving light passing through the patient's tissue with the photodiode may include receiving light passing through the patient's tissue with a photodiode array extending around and adjacent to the distal end of the main container, wherein the array of light sources and the array of photodiodes are not aligned to provide a generally clear path toward the distal end of the needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is a schematic diagram of an auto-injector drug delivery device according to an embodiment of the present disclosure.

[0023] Figure 2 is a schematic diagram of an on-body drug delivery device according to an embodiment of the present disclosure.

[0024] Figure 3 is a cross-sectional view of a first example electrical sensing assembly for a drug delivery device according to an embodiment of the present disclosure.

[0025] Figure 4 is a cross-sectional view of a second example electrical sensing assembly for a drug delivery device according to an embodiment of the present disclosure.

[0026] Figure 5 is a cross-sectional view of a third example electrical sensing assembly for a drug delivery device according to an embodiment of the present disclosure.

[0027] Figure 6 is a cross-sectional view of a first exemplary light sensing assembly for a drug delivery device according to an embodiment of the present disclosure.

[0028] Figure 7is a cross-sectional view of a second exemplary light sensing assembly for a drug delivery device according to an embodiment of the present disclosure.

[0029] Figure 8 is a cross-sectional view of a third exemplary light sensing assembly for a drug delivery device according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0030] Concepts of sensing systems for measuring the insertion depth of a drug delivery member (such as a needle or soft cannula) of a drug delivery device in a patient's skin by taking measurements and running algorithms to process the data have been proposed. However, the coupling between the sensing system and the drug delivery member of the drug delivery device is challenging. Therefore, example configurations for coupling and / or integrating a sensing system into or with a drug delivery member of a drug delivery device (such as an autoinjector or a portable syringe) are provided herein.

[0031] Before providing details of an example sensing system, Figure 1 and Figure 2 An exemplary drug delivery device is shown in FIG. Figure 1In some versions shown, the 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 disposed in a stacked relationship within a housing 11 in the device 10 along a longitudinal axis L. As a more specific example, the device 10 can be configured to operate and inject a user with the device 10 oriented generally perpendicular to the skin surface of the user. The drug delivery components can include a main container 12 (such as a reservoir) containing a drug 14 therein, a plug 16 disposed within the main container 12 and slidably movable therein along the longitudinal axis L, a needle 20 having a distal end oriented along the longitudinal axis L, and a flow path 22 fluidly coupling the main container 12 to the needle 20. The components can further include an injection assembly including a drive mechanism 18 coupled to a plunger 19 to drive the plug 16 through the main container 12 and a needle insertion mechanism (NIM) 24 configured to insert the needle 20 to a desired subcutaneous depth in the user's body. By some approaches, the NIM 24 can be a retractable needle shield that exposes the needle 20 or a drive mechanism that moves the needle longitudinally a desired distance. For example, the drive mechanism 18 can be configured to drive both the stopper 16 and the needle 20 to move by moving some or all of the main 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 be operable in response to actuation of a user input device 26 accessible on the exterior of 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 may include electronic components, such as a controller 28, for controlling the operation of one or more of the drug delivery components. It will be understood that although Figure 1 Components are shown centered along the longitudinal axis L, but one or more of these components may be disposed off-center relative to the longitudinal axis L within the housing 11 and still be considered a stacked relationship. In one example, an auto-injector drug delivery device having drug delivery components in a stacked relationship corresponds to a primary container 12 coaxially aligned with a needle 20. In some versions, the device 10 may include a cap assembly comprising a cap housing and a remover. The device 10 may further include a needle shield disposed over at least a portion of the distal end of the needle 20 in a stored state, wherein the needle shield is engaged and retained by the remover. The needle shield may then be removed by removing the cap assembly from the device 10. An exemplary auto-injector device is described in U.S. Serial No. 62 / 447,174 filed on January 17, 2017, which is incorporated herein by reference.

[0032] In such Figure 2In other versions shown, the drug delivery device 50 (such as a portable syringe) can have a horizontally oriented configuration, wherein the drug delivery components are generally disposed within the housing 51 of the device 50 along a horizontal plane P. In the case of these devices 50, the housing 51 has a low profile, with a width greater than a height, so that when the user positions the housing 51 on the skin, the components are dispersed over an area of ​​the skin rather than being stacked as in the above embodiments. The drug delivery components may include: a main container 52 (such as a reservoir) containing a drug 54 therein, which can be removably disposed within the housing 51; a plug 56 disposed within the main container 52 and slidably movable in the main container along a horizontal plane P; a drive mechanism 58 coupled to a plunger 60 to drive the plug 56 through the main container 52; a needle and / or soft cannula 62 oriented along an axis X extending generally transverse to the horizontal plane P (such as perpendicular to the horizontal plane or at an angle relative to the horizontal plane); a flow path 64 fluidly coupling the main container 52 to the needle 62; and a NIM 66 configured to insert the needle 62 to a desired subcutaneous depth within the user's body. As generally configured, one or more of the components of the device 50 (such as the drive mechanism 58 and the NIM 66) may be operable in response to actuation of a user input device 68 accessible on the exterior of the housing 51. Accordingly, the device 50 may include an electronic component, such as a controller 70, for controlling the operation of one or more of the drug delivery components. As described above, this form of the device 50 may also include a cap assembly, which includes a cap housing and a remover. The device 50 may further include a needle shield, which is disposed at least on a portion of the distal end of the needle 62 in a storage state, wherein the needle shield is engaged and retained by the remover. The needle shield can be removed by removing the cap assembly from the device 50. Of course, it will be understood that some components may be partially or entirely disposed above or below a horizontal plane P that extends generally centrally through 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 example portable syringe device is described in U.S. Serial No. 62 / 536,911 filed on July 25, 2017, which is incorporated herein by reference.

[0033] The sensing system for the drug delivery device 10, 50 can electrically or optically measure the insertion depth of the drug delivery member 20, 52. In one form, the electrical sensing system 100 measures the insertion depth by measuring the capacitance between the inserted drug delivery member 20, 52 and the electrode 102 in contact with the patient's skin 104. Using an algorithm, the sensing system 100 locally or remotely associates the measured mutual capacitance with the insertion depth of the drug delivery member 20, 52. Alternatively, the electrical sensing system 100 can measure the impedance (self-capacitance) that varies with the depth of the drug delivery member 20, 52 without using electrodes against the patient's skin. In another form, the optical sensing system 200 measures the insertion depth of the drug delivery member 20, 52 by irradiating light through the penetrating drug delivery member 20, 52 with a light source 202 and receiving the backscattered light radiated 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 intensity of the light and transmits data associated with the intensity of the light. Using an algorithm, the sensing system 200 locally or remotely correlates the insertion depth of the drug delivery member 20, 52 to the intensity of the received backscattered light.

[0034] Figure 3 A first example electrical sensing assembly 100 for a drug delivery device 10, 50 is shown in FIG. In this form, the drug delivery member 20, 62 is a needle that is fluidly coupled to the main container 12, 52 via a flow path 22, 64, which can be a flexible tube as shown, or rigid. In addition, the needle 20, 62 includes a portion 106 that extends through and connects to a seat 108 received within the device 10, 50. The seat 108 is manipulated by the NIM 24, 66 to move the needle 20, 62 from a retracted storage position disposed in the housing 11, 51 to an injection position that extends at least partially outside the housing 11, 51. The needle 20, 62 can have a curved configuration, such as Figure 3 As shown, where the needle 20, 62 enters the seat 108 from the side and exits the seat 108 through the bottom, or can have a straight configuration, where the needle 20, 62 enters the seat 108 from the top and exits through the bottom. It will be understood that either configuration can be used in the automatic injector 10 or the portable syringe 50.

[0035] Advantageously, the portion 106 of the needle 20, 62 disposed within the seat 108 is fixed relative to the seat 108. With this configuration, the wire 110 can have a first end 112 that is directly electrically connected to the portion 106 of the needle 20, 62 that extends through the seat 108 and is fixed to the seat 108 at a fixing point 114, so that movement of the seat 108 and the needle 20, 62 during the injection operation does not loosen the connection. In one version, the first end 112 of the wire 110 can be directly fixed to the needle 20, 62. The second end 116 of the wire 110 can communicate with the controller 28, 70, which can analyze the capacitance information provided by the wire 110 associated with the needle 20, 62 in 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 can be sent to a remote controller for analysis and correlation. The wire 110 may be flexible to accommodate movement of the hub 108 and needle 20, 62 during operation of the device 10, 50 relative to the controller 28, 70. The direct electrical connection between the needle 20, 62 and the controller 28, 70 provides a reliable source of capacitance information without the risk of the connection of the wire 110 to the needle 20, 62 failing or providing intermittent results. In one version, the needle 20, 62 may be made of stainless steel.

[0036] Figure 4 , a second example electrical sensing assembly 100 for a drug delivery device 50 is shown in FIG. In this form, a needle 62 is directly fluidly connected to the main container 52. Thus, the needle 62 provides a flow path 64. The needle 62 in this form has an extended elongated configuration having a fixed proximal end 120 extending from the main container 52, an intermediate bend 122, and a movable distal end 124. For example, the proximal end 120 may extend generally parallel to the horizontal plane P (e.g., within 5 degrees or within 10 degrees), and the bend 122 may be a 180 degree bend, so that at least a portion 126 of the distal end 124 extends rearwardly generally parallel to the horizontal plane P. The distal end 124 may also include an angled portion 128 configured to move to the exterior of the housing 51 during an injection operation. The angled portion 128 may extend generally transverse to the plane P at an angle such as between 30 and 45 degrees, between 45 and 60 degrees, or between 60 and 90 degrees. In this form, NIM 66 can manipulate distal end 124 of needle 62 to move angled portion 128 from a retracted storage position disposed within housing 51 to an injection position extending at least partially outside housing 51. Bend 122 allows distal end 124 to move relative to fixed proximal end 120.

[0037] Advantageously, the lead 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, due to the fixed configuration of the proximal end 120 of the needle 62, the connection point 134 is fixed to prevent movement relative to the housing 51. In one version, the second end 136 may be directly fixed to the needle 62 so that movement of the distal end 124 of the needle 62 during the injection operation does not loosen the connection. The first end 136 of the lead 130 may communicate with the controller 70, which may analyze the capacitance information provided by the lead 130 associated with the needle 62 in 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 relative to each other, the lead 130 may have a rigid or fixed configuration within the housing 51. Of course, if desired, the wire 130 can have a flexible configuration. The direct electrical connection between the needle 62 and the controller 70 provides a reliable source of capacitance information without the risk of the wire 130 failing to connect to the needle 62 or providing intermittent results. In one version, the needle 62 can be made of stainless steel.

[0038] Figure 5 A third example electrical sensing assembly 100 for use with a drug delivery device 10, 50 is shown in FIG. Figure 5 1, 51, 52. The form is shown with reference to the automatic injector 10, but it will be understood that the assembly 100 can be easily incorporated into the portable syringe 50. In this form, the NIM 24, 66 moves the needle 20, 62 between a retracted storage position disposed in the housing 11, 51 and an injection position in which the distal end of the needle 20, 62 at least partially extends outside the housing 11, 51. This form of the electrical sensing assembly 100 provides non-contact monitoring of the needle 20, 62. As shown, the sensing assembly 100 includes a pair of capacitor plates 140 spaced apart from each other, wherein the needle 20, 62 extends between the pair of capacitor plates. If desired, the assembly 100 may further include one or more dielectric members 142, which are disposed between the capacitor plates 140 and the needle 20, 62. The dielectric member 142 is spaced apart from the needle 20, 62 to allow the needle 20, 62 to move freely during an injection operation, while also spacing the capacitor plate 140 a fixed distance from the needle 20, 62 to ensure consistent readings during operation.

[0039] As shown, the assembly 100 may further include one or more wires 144 electrically coupled to the capacitor plate 140 and in communication with the controller 28, 70, which may analyze the capacitance information associated with the needle 20, 62 at the injection position provided by the wire 144 and the capacitor 140. For example, the wire 144 may have a first end in communication with the controller 28, 70 and a second end electrically connected at a connection point adjacent to the needle 20, 62 (i.e., the connection point to the capacitor plate 140). Advantageously, due to the fixed configuration of the capacitor plate 140, the connection point is fixed to prevent movement relative to the housing 11, 51. The controller 28, 70 or optionally a remote controller may then associate the capacitance information with the depth to which the needle 20, 62 has penetrated the patient's skin 104. Assuming that the capacitor plate 140 and the controller 70 are fixed relative to each other, the wiring 144 may have a rigid or fixed configuration within the housing 11, 51. Of course, if desired, the wiring 144 may have a flexible configuration. The non-contact monitoring of the needle 20, 62 provided by the capacitor plate 140 allows the needle to move without damaging the electrical connections of the sensing assembly 100. By being mounted at a fixed distance from the needle 20, 62, the capacitor plate 140 provides a reliable source of capacitance information without interfering with the operation and movement of the needle 20, 62. This form of the sensing assembly 100 is particularly advantageous for auto-injectors 10 or portable syringes 50 having a short needle length, while still requiring needle movement for injection operations. In one version, the needle 62 can be made of stainless steel.

[0040] In any of the above forms, the drug delivery member 20, 62 may include or may be a cannula, such as a soft cannula. The cannula 20, 62 may be made conductive by coating its outer surface 150 with a conductive material. For example, the conductive material may be gold or platinum. The conductive material may be coated on the outer surface 150 of the cannula 20, 62 by any suitable method, such as physical vapor deposition (PVD) or atomic layer deposition (ALD). In another version, the cannula 20, 62 may be made of a polymer nanocomposite doped with carbon nanotubes or metal nanoparticles to make the cannula 20, 62 conductive. In any of these configurations, the capacitor plate 140 may monitor the cannula 20, 62 as it moves between the capacitor plates, as described above.

[0041] Figure 6, a first exemplary optical sensing assembly 200 for a drug delivery device 10, 50 is shown. In this form, the drug delivery member 20, 62 is a needle that is fluidly coupled to the main container 12, 52 through a flow path 22, 64, which can be a flexible tube as shown. In addition, the needle 20, 62 extends through a seat 210 received in the device 10, 50 and is fixed to the seat, and the seat 210 is configured to be manipulated by the NIM 24, 66 to move the needle 20, 62 from a retracted storage position disposed in the housing 11, 51 to an injection position that extends at least partially outside the housing 11, 51. As shown, the needle 20, 62 includes a proximal end 212 that enters the seat 210 through a side 214, a curved portion 216 disposed in the seat 210, and a distal end 218 that leaves the seat 210 through a bottom 220. In one example, bend 216 of needle 20, 62 may be a substantially (eg, within 5 degrees or within 10 degrees) 90 degree bend. In one version, needle 20, 62 may be stainless steel.

[0042] As shown, the sensing assembly 200 further includes a light source 202, which is oriented and configured to project light into the needle 20, 62 through the proximal opening 222 of the needle 20, 62 and through the distal opening 223 communicating with the proximal opening 222, so as to project light into the tissue of the patient after the distal end 218 of the needle 20, 62 has been inserted into the tissue of the patient. In this form, the proximal opening 222 is arranged to pass through the upper surface 224 of the curved portion 212, which is aligned above the distal end 218 of the curved portion. In addition, the seat 210 can be configured to provide a light path to the opening 222, so that light can be projected through the seat 210 and the opening 222 and projected into the distal end 218 of the needle 20, 62. For example, the seat 210 can be made of a transparent material (e.g., plastic) or an opaque material that is aligned with the needle opening 222, while maintaining the liquid-tight nature of the needle 20, 62 with a transparent cover or shield. In one version, the light source 202 can be mounted to the seat 210 to move with it. In this 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 seat 210. In another version, the light source 202 can be fixedly mounted in the housing 11, 51, and the wire 228 can be fixed / rigid or flexible as needed. In another form, the drug delivery member 20, 62 can include a soft cannula, in which the needle acts as a cannula needle. In the case of this configuration, the light projected by the light source 202 can pass through the needle 20, 62 to reach the cannula. It will be understood that the above configuration can be used in an automatic injector 10 or a portable injector 50.

[0043] In some versions, assembly 200 may further include a light focusing component to direct light into needle 20, 62 and avoid scattering. For example, one or more lenses may be disposed in the path of light projected from light source 202, such as mounted to or within seat 210 and / or mounted to or within housing 11, 51, a reflective material may be disposed in front of light source 202, such as within a hole in seat 210, etc.

[0044] As discussed above, the light sensing assembly 200 receives backscattered light irradiated through the patient's tissue adjacent to the needle 20, 62 at the injection site by means of one or more photodiodes 206 on or adjacent to the patient's skin 204. The photodiode 206 is electrically coupled to the controller 28, 70 and communicates with the controller to provide data associated with the received light. The controller 28, 70 or optionally a remote controller can then associate the data with the depth to which the needle 20, 62 has penetrated the patient's skin 204. In a first form, the photodiode 206 can be disposed adjacent to the light source 202, wherein the light source 202 is located at a substantially central position relative to it. The photodiode 206 can be coupled to the seat 210 to move with it or mounted in a fixed position within the housing 11, 51. In the case of this configuration, the photodiode 206 detects backscattered light passing through the seat 210, which can be made of a transparent material or have one or more holes extending therethrough, which are aligned with the photodiode 206, as discussed above. In a second form, the photodiode 206 can be coupled to the bottom wall 230 of the housing 11, 51, adjacent to a drug delivery member opening 232 extending through the bottom wall. For example, the bottom wall 230 can include a transparent portion 234 extending around the opening 232, and the photodiode 206 can be mounted within the housing 11, 51, i.e., within an outer optically transparent housing 236 in which the seat 210 is received, or the photodiode 206 can be mounted within an opening 238 of the bottom wall 230 to be directly adjacent to the patient's skin 204.

[0045] Figure 7A second exemplary optical sensing assembly 200 for a drug delivery device 10, 50 is shown in FIG. In this form, the drug delivery member 20, 62 is a needle that is fluidly coupled to the main container 12, 52 through a flow path 22, 64, which can be a flexible tube as shown, or rigid. As in the above form, a separate inlet conduit 252 is included in the assembly 200 of this form, which enters the seat 250 through the side 254 and the needle 20, 62 leaves the seat 250 through the bottom 256, rather than the needle extending through the seat 250. In addition, the seat 250 defines an inner cavity 258 that fluidly connects the inlet conduit 252 to the needle 20, 62. As in the above form, the seat 250 is configured to be manipulated by the NIM 24, 66 to move the needle 20, 62 from a retracted storage position in the housing 11, 51 to an injection position that extends at least partially outside the housing 11, 51. In one version, the needle 20, 62 can be stainless steel.

[0046] As shown, the sensing assembly 200 further includes a light source 202 that is oriented and configured to project light into the needle 20, 62 through a proximal opening 259 of the needle 20, 62 and through a distal opening 261 that communicates with the proximal opening 259 to project light into the patient's tissue after the needle 20, 62 has been inserted into the patient's tissue. In this form, the needle 20, 62 extends along a longitudinal axis, and the seat 250 can be configured to provide a light path thereto so that light can pass through the seat 250 and project into the needle 20, 62. For example, the seat 210 can be made of a transparent material (e.g., plastic) or an opaque material that is aligned with the needle opening 259, while maintaining the liquid-tight nature of the needle 20, 62 with a transparent cover or shield. As shown, the light source 202 is aligned with the proximal opening 259 of the needle 20, 62, so that the light projected by the light source 202 enters the needle 20, 62 and is delivered to the patient's tissue after the needle 20, 62 has been inserted into the patient's tissue. In one form, the light source 202 can be mounted to the seat 250 to move with it. In this 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 seat 250. In another form, as required, the light source 202 can be fixedly mounted in the housing 11, 51, and the wiring 262 can be fixed / rigid or flexible. In another form, the drug delivery member 20, 62 can include a soft cannula, wherein the needle acts as a cannula needle. In the case of this configuration, the light projected by the light source 202 can pass through the needle 20, 62 to reach the cannula. It will be understood that the above configuration can be used in an automatic injector 10 or a portable injector 50.

[0047] In some versions, assembly 200 may further include a light focusing component to direct light into needle 20, 62 and avoid scattering. For example, one or more lenses may be disposed in the path of light projected from light source 202, such as mounted to or within seat 250 and / or mounted to or within housing 11, 51, a reflective material may be disposed in front of light source 202, such as within a hole in seat 250, etc.

[0048] As discussed above, the light sensing assembly 200 receives or measures the backscattered light radiated through the patient's tissue when the needle 20, 62 is in the injection position by means of one or more photodiodes 206 on or adjacent to the patient's skin 204. The photodiode 206 is electrically coupled to the controller 28, 70 and communicates with the controller to provide data associated with the received light. The controller 28, 70 or optionally a remote controller can then associate the data with the depth to which the needle 20, 62 has penetrated the patient's skin 204. In a first form, the photodiode 206 can be disposed adjacent to the light source 202, wherein the light source 202 is located at a substantially central position relative to it. The photodiode 206 can be coupled to the seat 250 to move with it or be mounted in a fixed position within the housing 11, 51. In the case of this configuration, the photodiode 206 detects the backscattered light passing through the seat 250, which can be made of a transparent material or have one or more holes extending therethrough, which are aligned with the photodiode 206, as discussed above. In a second form, the photodiode 206 can be coupled to the bottom wall 264 of the housing 11, 51, adjacent to a drug delivery member opening 266 extending through the bottom wall. For example, the bottom wall 264 can include a transparent portion 268 extending around the opening 266, and the photodiode 206 can be mounted within the housing 11, 51, such as embedded within an outer optically transparent housing 270 in which the seat 250 is received, or the photodiode 206 can be mounted within an opening 272 of the bottom wall 230 to be directly adjacent to the patient's skin 204.

[0049] Figure 8 , a third exemplary optical sensing assembly 200 for a prefilled syringe 300 is shown. The syringe 300 includes a primary container in the form of a barrel or reservoir 302 that contains a fluid therapeutic product. The barrel 302 has an annular sidewall 304 extending between a dispensing opening 306 at a distal end 308 and an open proximal end 310. At the distal end 308 of the barrel 302, the syringe 300 includes a needle 312 fixed to a seat 314 coupled to the barrel 302, such that the needle 312 is fluidly coupled to an interior 316 of the barrel 302.

[0050] As shown, the sensing assembly 200 further includes an array of light sources 202 that are oriented and configured to project light into the needle 312 through a proximal opening 317 of the needle 20, 62 disposed within the seat 314 and through a distal opening 319 that communicates with the proximal opening 317 to project light into the patient's tissue after the needle 312 has been inserted into the patient's tissue. In this form, the needle 312 extends along a longitudinal axis, and the seat 314 and / or the barrel distal end 308 can be configured to provide a light path thereto so that light can pass through the seat 314 and / or the barrel distal end 308 and project into the needle 312. For example, the seat 314 and / or the barrel distal end 308 can be made of a transparent material (e.g., plastic) or an opaque material that is aligned with the needle opening 317, while maintaining the liquid-tight nature of the needle 312 and the barrel interior 316 with a transparent cover or shield. The array of light sources 202 may extend around or within the seat 314 or the barrel distal end 308 .

[0051] The photodiode 206 of the assembly 200 can be arranged in an array extending around the needle seat 314 or the distal end 308 of the barrel or in the needle seat or the distal end of the barrel. The light source 202 and the photodiode 206 can be positioned so that the individual photodiode 206 does not block the light projected from the light source 202 and the individual light source 202 does not block the light irradiated through the patient's tissue to be received by the photodiode 206. For example, the light source 202 and the photodiode 206 can be arranged in an alternating pattern around the syringe 300. The photodiode 206 is electrically connected to the controller 320 of the syringe 300 and communicates with the controller to provide data associated with the light received when the drug delivery member is in its injection position. Then, the controller 320 or optionally a remote controller can 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 sensing assembly 200 can be incorporated into the automatic injector device 10, wherein the array of light sources 202 and the photodiode 206 are positioned relative to the main container 12 and the needle 20.

[0052] In the above form, the controller 28, 70, 320 can determine the depth of the drug delivery member 20, 62, 312 based on the provided measurement reference expected value, thereby confirming and recording the depth of the drug delivery member 20, 62, 312 during the drug dispensing operation. In some cases, the delivery depth of the drug, such as to the intradermal, subcutaneous, intramuscular or intravenous site, may affect the pharmacokinetics, which may lead to therapeutic differences in a particular drug. Using the device as described herein, the relevant party can confirm with data that the device 10, 50, 300 is correctly positioned and the drug delivery member 20, 62, 312 is inserted into the target depth.

[0053] The term controller refers broadly to any microcontroller, computer, or processor-based device having a processor, memory, and programmable input / output peripherals, typically designed to manage the operation of other components and devices. This is further understood to include common accompanying accessory devices, including power supplies, memory, transceivers for communicating with other components and devices, etc. These architectural options are well known and understood in the art and do not require further description here. The controller can be configured (e.g., by using a corresponding program stored in the memory, as will be readily understood by those skilled in the art) to perform one or more of the steps, actions, and / or functions described herein.

[0054] It will be understood that the elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the size and / or relative position of some elements in the figure may be enlarged relative to other elements to help improve the understanding of various embodiments of the present invention. Moreover, commonly used but easy-to-understand elements that are available or necessary in commercially feasible embodiments are usually not drawn to facilitate viewing these various embodiments with less obstruction. The same reference numerals may be used to describe the same or similar parts. Further, although several examples have been disclosed herein, any feature from any example can be combined with other features from other examples or replaced by other features. In addition, although several examples have been disclosed herein, the disclosed examples may be changed without departing from the scope of the claims.

[0055] The above description describes various devices, assemblies, parts, subsystems and methods used in relation to drug delivery devices. Devices, assemblies, parts, subsystems, methods or drug delivery devices may further include drugs or be used together with drugs, including but not limited to those drugs identified below and their generic counterparts and biosimilar counterparts. As used herein, the term drug can be used interchangeably with other similar terms, and can be used to refer to any type of medicament or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, supplements, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also included. The drug can be in liquid form, in lyophilized form or in a form that can be reconstructed by lyophilized form. The following exemplary drug list should not be considered to include all or restrictive.

[0056] The drug will be contained in 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, a cartridge, or a pre-filled syringe.

[0057] In some embodiments, the reservoir of the drug delivery device can be filled with a colony stimulating factor, such as granulocyte colony stimulating factor (G-CSF), or the device can be used with a colony stimulating factor. 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).

[0058] 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. ESA is any molecule that stimulates erythropoiesis. In some embodiments, ESA is an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis stimulating proteins include erythropoietin and variants, analogs or derivatives thereof that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alpha), Aranesp® (darbepoetin alpha), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alpha), 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 molecules thereof or variants or analogs thereof.

[0059] Specific illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies, peptibodies, related proteins, etc. (also referred to as RANKL-specific antibodies, peptibodies, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, particularly fully humanized 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 inhibit the production of IL-4 and / or IL -13 and receptor-mediated activities; 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., in particular human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, in particular including but not limited to human CD22 specific IgG antibodies, such as human-mouse monoclonal hLL2 Dimers of a γ-chain and a human-mouse monoclonal hLL2 κ chain that are disulfide-linked, for example, the human CD22-specific fully humanized antibody in Epratuzumab, CAS Registry No. 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. ("B7RP-1", also known as B7H2, ICOSL, B7h, and CD275), 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 epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor ICOS on activated T cells; IL-15-specific antibodies, peptibodies, related proteins, etc., such as, in particular, humanized monoclonal antibodies, including but not limited to HuMaxIL-15 antibodies and related proteins, such as 145c7; IFN γ-specific antibodies, peptibodies, related proteins, etc., including but not limited to human IFNγ-specific antibodies, and including but not limited to fully human anti-IFNγ antibodies; 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 (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; amyloid-β 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 OX40 receptors other ligands of activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-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-α4ß7 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, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab);Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody to RANK ligand, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP)); Kineret® (anakinra); Leukine® (sargramostim, rhuGM-CSF); LymphoCide® (epatuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (viciluzumab); cantuzumabmertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (meromob-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab); HuMax-CD4 (zanolimumab); Mvasi; TM(bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon α-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (Fc portion of human IgG1 and extracellular domain of IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (IgG1 Fc-fused Ig domain of VEGFR1); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (ruximab); 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 (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-Clostridium difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (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 stage I 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-TGFß 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). ;

[0060] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product for the treatment of postmenopausal osteoporosis and / or fracture healing containing romosozumab, and in other embodiments, a monoclonal antibody (IgG) that binds 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 be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or be used 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. In some embodiments, the drug delivery device may contain or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (Anovimab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product for treating migraine containing Anovimab. Antagonistic antibodies to human calcitonin gene-related peptide (CGRP) receptors (such as but not limited to Anovimab) and bispecific antibody molecules targeting CGRP receptors and other headache targets may also be delivered using the drug delivery device of the present disclosure. Additionally, bispecific T cell engager (BiTE®) antibodies (such as but not limited to BLINCYTO® (blinatumomab)) may be used in or used with the drug delivery device of the present disclosure.In some embodiments, the drug delivery device may contain or be used with an APJ macromolecular agonist, such as, but not limited to, apelin or its analogs. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain Avsola for the treatment of autoimmune diseases. TM (infliximab-axxq), an anti-TNF alpha monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab or used together with it. In some embodiments, the drug delivery device may contain Kyprolis® (carfilzomib) for the treatment of multiple myeloma, (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutyramido)-4-methylpentanamide, or another product containing carfilzomib or used together with it. 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 Parsabiv® for the treatment of secondary hyperparathyroidism (sHPT), such as in chronic kidney disease (KD) dialysis patients. TM(vecositriptyline HCl, KAI-4169) or another product comprising vecositriptyline HCl or used with it. In some embodiments, the drug delivery device may comprise or be used with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product comprising an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may comprise 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 of VEGFR1 and Ig domain 3 of VEGFR2 fused to the Fc domain of IgG1)). In some embodiments, the drug delivery device may comprise or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product comprising a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly 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 with omecadimecarb (a small molecule selective cardiac myosin activator), or a myotrope that directly targets the cardiac contractile machinery, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotolacib (formerly AMG 510), KRAS G12C Small molecule inhibitors, or KRAS G12CIn some embodiments, the drug delivery device may contain or be used with another product that is a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product that contains a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product that contains a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein (a) (also known as Lp(a)), or another product that contains a small interfering RNA (siRNA) that lowers lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 κ antibody), a biosimilar candidate to Stelara®, or another product containing a human IgG1 κ antibody and / or binding to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain Amjevita TM or Amgevita TM(formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product comprising human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may comprise or be used with AMG 160, or another product comprising a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 119, or another product comprising a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may comprise or be used with AMG 119, or another product comprising a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may comprise or be used with AMG 133, or another product comprising a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG171 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 x IL21 mutein and / or an IL-21 receptor agonist) designed to selectively turn on 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 x 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 comprising a human anti-programmed cell death-1 (PD-1) monoclonal antibody that is being studied for the treatment of patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product comprising a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x 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 x 4-1BB-targeting DARPin® biologic) being studied for solid tumor treatment. 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 is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Efavaleukin alpha (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596 or another product containing a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with AMG 673 or another product containing a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, a drug delivery device may contain AMG 910 or another product containing a half-life extended (HLE) claudin 18.2 xCD3 BiTE® (bispecific T cell engager) construct for use therewith.

[0061] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments may be implemented using current technology or technology developed after the filing date of this patent application, which still fall within the scope of the claims defining the invention disclosed herein.

[0062] Those skilled in the art will appreciate that various modifications, changes and combinations may be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and such modifications, changes and combinations should be deemed to be within the scope of the inventive concept.

Claims

1. A drug delivery device, comprising: case; a main 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 at least partially extended outside of the housing; a lead having a first end and a second end, the second end being electrically connected at a connection point adjacent the drug delivery member, the connection point being secured against movement relative to the housing; and a controller in communication with the first end of the lead, the controller configured to receive capacitance information associated with the drug delivery member at the injection site from the lead, further comprising a pair of capacitor plates disposed entirely within the housing and spaced apart from the drug delivery member, the drug delivery member extending between the pair of capacitor plates; and Wherein the connection point is located on the pair of capacitor plates and the controller communicates with the capacitor plates to receive capacitance information associated with the drug delivery member at the injection site.

2. The drug delivery device of claim 1, wherein: The controller is further configured to correlate the capacitance information to a depth to which the drug delivery member has been inserted into the patient's body.

3. The drug delivery device of claim 1 or 2, further comprising a needle insertion mechanism; and in, The drug delivery member has an elongated configuration having a proximal end extending from the main container and fixed to prevent movement relative to the housing, an intermediate bend and a distal end, the needle insertion mechanism being configured to move at least a portion of the distal end between the retracted position and the injection position.

4. The drug delivery device of claim 1, further comprising 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.

5. The drug delivery device of claim 1, 2 or 4, wherein: The drug delivery member includes a cannula having a conductive portion.

6. The drug delivery device of claim 5, wherein: The conductive portion of the cannula includes a conductive coating extending over at least a portion of an outer surface of the cannula.

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