Therapeutic agent delivery device with control

Abstract

A therapeutic agent delivery device includes a reusable portion and a syringe mount. The reusable portion includes a housing, a cam ring, a printed circuit board assembly including first and second sensing elements and a controller, and an indicator. The syringe holder includes a base cover connected to a syringe assembly containing a therapeutic agent and a third sensing element aligned with the first sensing element when the syringe holder is inserted into the reusable portion. The first sensing element receives identification information from the third sensing element, and the controller verifies the identification information prior to locking the cam ring to the syringe holder. The indicator instructs a user to remove the base cover and contact the distal end of the reusable portion with the user's skin. A second sensing element senses the contact, and if the contact is permissible, an indicator notifies the user that the device is ready for injection.

Description

Technical Field

[0001] This invention relates to therapeutic agent delivery devices, and more particularly to portable therapeutic agent delivery devices, such as pen syringes / injection pens. Background Technology

[0002] Patients with various illnesses often need to self-administer medications. To allow individuals to conveniently and accurately administer medication themselves, various devices widely known as pen injectors have been developed. Typically, these devices are equipped with a cartridge containing a piston and one or more doses of liquid medication. An actuator, extending from the base of the pen injector and operably connected to a mechanism that controls the movement of a drive member (usually further back), can move forward to advance the piston in the cartridge, thereby dispensing the contained medication, typically through a needle that penetrates a stopper / stop at the opposite end of the cartridge, from the outlet at that end. In disposable pens, after the pen has been used and the medication supply in the cartridge has been exhausted, the entire pen is discarded by the user, who can then begin using a replacement pen. In reusable pens, after the pen has been used and the medication supply in the cartridge has been exhausted, the pen is disassembled, the used cartridge is replaced with a new one, and the pen is reassembled for subsequent use.

[0003] The aim is to provide an injection pen with improved features, such as cartridge, syringe assembly within the cartridge, and / or patient proximity sensing and recognition to ensure proper drug delivery, skin sensing to facilitate accurate and safe drug delivery, and other automated functions to control the operation of the injection pen. Summary of the Invention

[0004] In one embodiment, a therapeutic agent delivery device is disclosed. The device includes a reusable portion comprising a housing having a distal end. A cam ring is rotatably movable within the housing by means of a drive mechanism. A printed circuit board assembly includes a printed circuit board disposed adjacent to the distal end of the housing, a first sensing element, a second sensing element, and a controller operatively communicating with the first and second sensing elements and the drive mechanism. At least one indicator is mounted on the housing. The device includes a syringe holder / carrier / carrier, the syringe holder including a base cap removably connected to a syringe assembly containing a therapeutic agent. A third sensing element is positioned substantially aligned with the first sensing element when the syringe holder is inserted into the reusable portion. The third sensing element includes a storage device containing identification information about the therapeutic agent and at least one of the users associated with the reusable portion. When the syringe holder is inserted into the reusable portion, the first sensing element provides the identification information received from the third sensing element to the controller. Upon verification of the identification information, the controller activates the drive mechanism to rotate the cam ring, thereby locking the syringe holder into the reusable portion and activating at least one indicator to instruct the user to remove the base cap and position the distal end of the housing in contact with the user's skin. While the distal end of the housing is in contact with the user's skin, a second sensing element provides at least one contact signal to the controller, and the controller, upon determining that at least one contact signal indicates acceptable / permissible contact, activates at least one indicator to notify the user that the therapeutic delivery device is ready to administer the therapeutic agent.

[0005] In another embodiment, a method for controlling the operation of a therapeutic agent delivery device including a reusable portion and a syringe holder includes one or more of the following steps: When the syringe holder is inserted into the reusable portion, identification information regarding at least one of the therapeutic agent contained within the syringe holder and a user associated with the reusable portion is received from a third sensing element disposed in the syringe holder via a first sensing element disposed in the reusable portion. Verification of the identification information is responded to by rotating a cam ring of the reusable portion to lock the syringe holder into the reusable portion and activating at least one indicator to instruct the user to remove the base cap of the syringe holder and position the distal end of the reusable portion in contact with the user's skin. Based on at least one contact signal received from a second sensing element disposed in the reusable portion, it is determined whether the distal end of the reusable portion is in permissible contact with the user's skin. Activation of at least one indicator in response to the determination of permissible contact notifies the user that the therapeutic agent delivery device is ready to inject the therapeutic agent.

[0006] In another embodiment, a reusable portion of a therapeutic agent delivery device is disclosed. The device includes a housing with a lower wall located at the distal end of the reusable portion. The lower wall surrounds a cylindrical opening configured to receive a syringe holder. A ring is rotatably movable within the housing by means of a drive mechanism. A printed circuit board assembly includes a printed circuit board attached to the lower wall. The printed circuit board assembly includes an NFC coil reader mounted on the printed circuit board, a capacitive skin sensor mounted on the printed circuit board, and a controller; and at least one indicator mounted on the housing. When the syringe holder is inserted into the cylindrical opening, the NFC coil reader is configured to detect the presence of an NFC tag attached to the syringe holder and provide a presence signal to the controller, which is then configured to activate the drive mechanism to rotate the ring, thereby locking the syringe holder into the reusable portion. The controller is also configured to activate the at least one indicator to instruct a user to remove the base cap of the syringe holder and position the distal end of the housing in contact with the user's skin. When the distal end is placed in contact with the user's skin, the capacitive skin sensor provides at least one contact signal to the controller. Upon determining that at least one contact signal indicates permissible contact, the controller is configured to activate at least one indicator to notify the user that the therapeutic delivery device is ready to inject the therapeutic agent. Attached Figure Description

[0007] The above and other advantages and objects of this disclosure, as well as the ways in which they are realized, will become more apparent from the following description of embodiments of the invention, taken in conjunction with the accompanying drawings, and the disclosure itself will be more readily understood, wherein: Figure 1 This is a top perspective view of a therapeutic agent delivery device according to an embodiment of the present disclosure; Figure 2 for Figure 1 The therapeutic agent delivery device shown is a bottom perspective view, in which the single-use / disposable portion is separated from the reusable portion; Figure 3 For along Figure 1 A transverse sectional view of the therapeutic agent delivery device taken along the midline 3-3, showing the syringe assembly in a retracted configuration; Figure 4 for Figure 1 A transverse sectional view of the distal end of the therapeutic agent delivery device shown, in which the syringe assembly is shown in an unfolded configuration; Figure 5 for Figure 1 A schematic diagram of the electronic components of the therapeutic agent delivery device shown. Figure 6 for Figure 3 Detailed transverse sectional view of the proximal end of the therapeutic agent delivery device within midline 6; Figure 7 For along Figure 1 A cross-sectional view of the proximal end of the therapeutic agent delivery device, taken along midline 7-7; Figure 8 For along Figure 1 A cross-sectional view of the proximal end of the therapeutic agent delivery device, taken along midline 8-8; Figure 9 for Figure 1 A perspective view of the therapeutic agent delivery mechanism of the therapeutic agent delivery device shown; Figure 10 for Figure 3 Detailed transverse sectional view of the therapeutic agent delivery device within the midline 10; Figure 11 A perspective view of a therapeutic agent delivery device according to another embodiment of this disclosure; Figure 12 for Figure 11 Side view of the therapeutic agent delivery device shown; Figure 13 for Figure 11 The side view of the therapeutic agent delivery device shown indicates that the disposable portion has been removed from the reusable portion; Figure 14 for Figure 13 Exploded perspective view of the single-use portion; Figures 15 to 18 for Figure 11 Side views of the therapeutic agent delivery device shown in different configurations; Figure 19 for Figure 11 The perspective view of the therapeutic agent delivery device shown corresponds to... Figure 15 The configuration shown; Figure 20 for Figure 11 The perspective view of the therapeutic agent delivery device shown corresponds to... Figure 16 The configuration shown; Figure 21 An exploded side view of a therapeutic agent delivery device according to another embodiment of this disclosure; Figure 22 for Figure 21 A perspective view of certain components of the therapeutic agent delivery device shown; Figure 23 and Figure 24 for Figure 21 Detailed perspective view of certain components of the therapeutic agent delivery device shown; Figures 25 to 33 for Figure 21 Side views of the therapeutic agent delivery device shown in different configurations.

[0008] Figure 34 A side view of a therapeutic agent delivery device according to another embodiment of the present invention; Figure 35for Figure 34 A schematic diagram of the components of the therapeutic agent delivery device shown; Figure 36 This is a bottom view of a printed circuit board assembly, which includes... Figure 34 The skin sensor shown is used in conjunction with the therapeutic agent delivery device. Figure 37 This is a schematic diagram of a therapeutic agent delivery device and a base station / base according to an embodiment of the present disclosure; Figure 38 for Figure 37 Side view of the therapeutic agent delivery device and base station shown; Figure 39 A side view of a therapeutic agent delivery device according to another embodiment of the present invention; and Figure 40A and Figure 40B A schematic diagram of system components used to monitor and transmit temperature information related to therapeutic agents.

[0009] In several views, corresponding reference numerals denote corresponding parts. Although the drawings represent embodiments of the invention, they are not drawn to scale, and some features may be exaggerated or omitted in some drawings for better illustration and explanation of this disclosure. Detailed Implementation

[0010] The therapeutic agent delivery device according to this disclosure can carry and dispense one or more therapeutic agents, which may also be referred to as drugs or pharmaceuticals. For example, such therapeutic agents may include adrenaline, anesthetics, analgesics, steroids, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory peptides (GIPs), GIP analogs, GIP derivatives, GIP / GLP-1 combined agonists such as tezepamide, basal insulin, gastrin analogs, gastrin derivatives, therapeutic antibodies—including but not limited to IL-23 antibody analogs or derivatives such as migelizumab, IL-17 antibody analogs or derivatives such as ixekizumab, therapeutic agents for pain-related treatments such as ganezumab, lamiditan, or lerizumab for the treatment of Alzheimer's disease, and any therapeutic agent capable of being delivered via the device described herein. The device according to this disclosure can be operated by a user (e.g., a healthcare professional, caregiver, or other person) in a manner generally as described herein to deliver one or more medications to a patient (e.g., another person or user).

[0011] Any directional references used in any of the accompanying drawings, such as right or left, top or bottom, are intended for descriptive purposes and are not intended to limit the invention or any component thereof to any particular location or spatial orientation. Furthermore, any references to clockwise or counterclockwise rotation are merely illustrative. Any such rotation can be achieved in the opposite direction to that described herein.

[0012] Figure 1-4 A therapeutic agent delivery device 100 according to an exemplary embodiment of the present disclosure is shown. Exemplarily, the therapeutic agent delivery device 100 has the shape of an injection pen, although other shapes may be used alternatively. The therapeutic agent delivery device 100 generally includes a reusable portion 102 and a disposable portion 104, the reusable portion 102 also referred to as a drive portion or a durable portion, and the disposable portion 104 also referred to as a drug carrying portion, cartridge, or syringe holder. The reusable portion 102 facilitates the delivery of therapeutic agent 106 from the disposable portion 104. Figure 3 and Figure 4 Furthermore, the disposable portion 104 is detachably coupled to the reusable portion 102, such that after the therapeutic agent 106 has been delivered from the disposable portion 104, the disposable portion 104 can be removed from the reusable portion 102 and discarded. Another disposable portion (not shown, for example, having the same or different features as the disposable portion 104) can then be attached to the reusable portion 102, thereby preparing the therapeutic agent delivery device 100 for subsequent use.

[0013] The therapeutic agent delivery device 100 includes a proximal end 108 and an opposing distal end 110. During use of the therapeutic agent delivery device 100, the proximal end 108 is positioned away from the patient and configured to be actuated by the user, while the distal end 110 is positioned closer to the patient and configured to deliver the therapeutic agent 106 to the patient. The therapeutic agent delivery device 100 also includes a longitudinal axis A extending between the proximal end 108 and the distal end 110. These and other features of the therapeutic agent delivery device 100 will be described in further detail below.

[0014] For details, please refer to the following: Figure 3 and Figure 4 A cross-sectional view showing the internal components and other features of the reusable portion 102 and the disposable portion 104. Typically, the reusable portion 102 includes a housing 112 that movably carries the user input device 114 and the drive mechanism 116 (both within...). Figure 3 (As shown in the diagram). The user input device 114 can be actuated by the user (e.g., pressed) to actuate the drive mechanism 116. The drive mechanism 116 is thus translated distally to drive the syringe assembly 118 of the disposable portion 104. More specifically, the drive mechanism 116 moves the syringe assembly 118 from a retracted configuration ( Figure 3 Translation-driven to unfolded configuration Figure 4 In the retracted configuration, the needle 120 of the syringe assembly 118 is positioned proximally relative to the distal end 122 of the disposable portion 104. In other words, in the retracted configuration, the needle 120 retracts into the device 100. In the unfolded configuration ( Figure 4 The needle 120 extends distally, at least partially, from the distal end 122 of the disposable portion 104. As a result, in the unfolded configuration, the needle 120 is configured to pierce the patient's skin.

[0015] See details Figure 3 The drive mechanism 116 of the reusable portion 102 also includes a plunger mechanism or a therapeutic agent delivery mechanism 124. The therapeutic agent delivery mechanism 124 is actuable to dispense therapeutic agent 106 from the syringe assembly 118. More specifically, when the syringe assembly 118 is in an deployed configuration, the therapeutic agent delivery mechanism 124 can be actuated to distally translate the shaft or plunger 126 of the syringe assembly 118. The plunger 126 distally drives a piston 128, which is carried in a therapeutic agent carrying channel 130 of the syringe assembly 118, thereby dispensing the therapeutic agent 106 via the needle 120.

[0016] refer to Figure 5 In addition to the components described above, the therapeutic agent delivery device 100 also includes an electronic component 134 to facilitate operation of the device 100 in the manner described herein. The electronic component 134 includes an electronic controller 136, which is operatively coupled to / coupled to a power source or power supply 138 (e.g., a battery) and receives power from the power source or power supply 138. The electronic controller 136 is also operatively coupled to a user input device 114 and one or more sensors 140. As described in further detail below, the sensors 140 can sense, for example, actuation of components of the device 100, the position of components of the device 100 relative to each other, and / or the position of the device 100 relative to the patient. The controller 136 is also operatively coupled to a drive mechanism 116 (… Figure 3 ), therapeutic agent delivery mechanism 124 ( Figure 3 ) and holding mechanism 132 ( Figure 4 ).

[0017] In some embodiments, as described below, some components of electronic component 134 are carried by reusable portion 102 and some components are carried by disposable portion 104 (both within... Figure 1 and Figure 4(As shown in the diagram). For example, the single-use portion 104 may include a tag 142, such as a near-field communication (NFC) tag mounted in the base cover of the single-use portion 104, as further described below. The tag 142 facilitates the provision of attributes of the therapeutic agent 106 and / or the patient to the NFC coil reader of the reusable portion 102 (as described below). Such attributes may include, for example, the type, volume, batch number, and / or concentration of the therapeutic agent 106 carried on the syringe assembly 118, and / or the location of the plunger 126. For example, the reusable portion 102 may use the characteristics of the therapeutic agent 106 to determine whether the patient associated with the reusable portion 102 is authorized to use or has been prescribed the therapeutic agent 106.

[0018] As used herein, the terms "logic" or "control logic" or "application" can include software and / or firmware executing on one or more programmable processors, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), digital signal processors (DSPs), hardwired / hardwired logic, or combinations thereof. Therefore, various logics can be implemented in any suitable manner, depending on the embodiment, and will remain consistent with the embodiments disclosed herein.

[0019] The device described herein can be connected (wired or wirelessly) to a computing device (not shown), which may include a mobile device (e.g., a smartphone). Alternatively, any suitable computing device may be used, including but not limited to, a laptop, desktop computer, tablet, or server computer.

[0020] Device / system / electronic component 134 includes at least one processor that executes software and / or firmware stored in device memory (not shown). The software / firmware code contains instructions that, when executed by the processor, cause device / system / controller 136 to perform the functions described herein. The at least one processor illustratively includes control logic / application for performing the functions described in the following detailed description. Memory is any suitable computer-readable medium accessible to the processor. Memory may be a single storage device or multiple storage devices, may be located internally or externally to the processor, and may include both volatile and non-volatile media. Exemplary memories include random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, magnetic storage devices, optical disc storage, or any other suitable medium configured to store data and accessible by the processor. Electronic component 134 may include a communication module (not shown) for wirelessly transmitting data to a computing device, such as cellular communication, Wi-Fi, Bluetooth, NFC, or other suitable protocols.

[0021] A computing device / smartphone includes a user interface that communicates with the computing device's processor to provide user input data to the system and to receive and display data, information, and prompts generated by the system. The user interface includes at least one input device for receiving and providing user input to the system. The user interface may be a graphical user interface (GUI) including a touchscreen display for displaying data and receiving user input. The touchscreen display allows the user to interact with presented information, menus, buttons, and other data to receive information from the system and provide user input to the system. Alternatively, a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.

[0022] As another example, the disposable portion 104 may include a holding device 144 operatively coupled to the controller 136. The holding device 144 may initially prevent the syringe assembly 118 from moving from a retracted configuration to an extended configuration, and the controller 136 may actuate the holding device 144 to allow the syringe assembly 118 to move from the retracted configuration to the extended configuration, as further described below. In other embodiments, each component of the electronic assembly 134 is carried by a reusable portion 102. In some embodiments, the controller 136 is operatively coupled to one or more other components of the electronic assembly 134 via a wired connection. In some embodiments, the controller 136 is operatively coupled to one or more other components of the electronic assembly 134 via a wireless connection.

[0023] For reference Figure 6-8 The proximal end 108 of the device 100 is shown in more detail, particularly the proximal portion of the user input device 114 and the drive mechanism 116. The drive mechanism 116 includes a support 146. Figure 6 The support 146 is translatably supported within the housing 112 of the reusable portion 102. The support 146 carries a first actuator 148, which is operatively coupled to an electronic controller 136. Figure 5 The first actuator 148 may be a rotary actuator, more specifically an electric motor, which is drivably coupled to a transmission or reducer. The actuator 148 is drivably coupled to a gear train 150, more specifically a first gear 152, which is drivably coupled to a second gear 154. The second gear 154 is fixed relative to a follower 156, and the follower 156 is rotatably supported by a support 146. Therefore, the support 146, actuator 148, gear train 150, and follower 156 can translate together within the housing 112 of the reusable portion 102. Exemplarily, the support 146, actuator 148, gear train 150, and follower 156 can be in the driving direction 158 (…). Figure 6The drive direction 158 is basically parallel to the longitudinal axis A of the device 100 (i.e., parallel ±10 degrees).

[0024] Follower 156 is movably coupled to guide 160, which is fixed relative to housing 112 of reusable portion 102. Compression spring 162 pushes follower 156 distally and engages follower 156 with guide 160. Typically, follower 156 and guide 160 include features that facilitate translation of follower 156 relative to guide 160 when follower 156 rotates relative to guide 160 about a rotation axis R1 that is substantially parallel (i.e., ±10 degrees) to longitudinal axis A of device 100. More specifically, follower 156 includes two radially outwardly extending protrusions 164 that move along an inclined track 166 defined by guide 160 or a wall generally facing proximal when follower 156 is driven to rotate by actuator 148. Protrusions 164 move simultaneously along two similar segments or halves of track 166. See details. Figure 7 and Figure 8 Each half of track 166 includes a raised platform-shaped portion 168 connected at edge 172 to the cliff-shaped portion 170, a valley-shaped portion 174 connected to the cliff-shaped portion 170 opposite to the raised platform-shaped portion 168, and a sloping portion 176 connected to the valley-shaped portion 174 opposite to the cliff-shaped portion 170. Each sloping portion 176 is also connected to the raised platform-shaped portion 168 of the other half of track 166.

[0025] In the illustrated embodiment, the various portions of track 166 are described below. The cliff-shaped portion 170 is substantially parallel to the longitudinal axis A of device 100 (i.e., parallel ±10 degrees). The platform-shaped portion 168 and the valley-shaped portion 174 are substantially perpendicular to the longitudinal axis A of device 100 (i.e., perpendicular ±10 degrees). The ramp-shaped portion 176 extends spirally relative to the longitudinal axis A of device 100.

[0026] In other embodiments, the follower 156 and / or guide 160 may take different forms. For example, the track 166 may have different shapes. More specifically, the track may include an additional ramp-shaped portion (not shown) instead of the cliff-shaped portion 170, and this ramp-shaped portion may extend spirally in the direction opposite to the ramp-shaped portion 176. As another example, the follower 156 may include a different number of protrusions 164 and / or the guide 160 may include a track 166 with a different number of similar segments. As yet another example, the follower 156 may include a track 166 that movably receives one or more protrusions 164 formed on the guide 160.

[0027] Now for specific reference Figure 6The proximal end 108 of the device 100 also includes a feature structure for selectively preventing / inhibiting movement of the user input device 114 relative to the housing 112 of the reusable portion 102, and thus preventing actuation of the user input device 114. More specifically, the user input device 114 includes a spring-loaded hook 178 extending through an opening 180 formed in the guide 160. The hook 178 engages the guide 160 and holds the user input device 114 in a press-fit configuration relative to the housing 112. Referring now specifically... Figure 6 and Figure 8 Follower 156 includes support leg 182 ( Figure 8 When the follower 156 rotates relative to the guide 160, the outrigger 182 engages and releases the hook 178 from the guide 160. When the hook 178 disengages from the guide 160, the compression spring 184 extends and pushes the user input device 114 into a raised configuration relative to the housing 112. Further details regarding the movement of various components and several configurations at the proximal end 108 of the device 100 are described in U.S. Provisional Application No. 63 / 234,955 (Agent's File No. ELC-P22867-01-US, entitled "Therapeutic Agent Delivery Device Including Disposable and Reusable Parts"), the entire contents of which are expressly incorporated herein by reference. Furthermore, as described below, the controller 136 may be coupled to electronics associated with the user input device 114 to provide indication of when the user input device 114 can be actuated.

[0028] Figure 9 and Figure 10 The therapeutic agent delivery mechanism 124 of the device 100 is shown. Figure 10 In the cross-sectional view, the therapeutic agent delivery mechanism 124 is also shown as other components adjacent to the device 100, such as the support 146, the syringe chamber 186, and the piston 128.

[0029] Continue to refer to Figure 9 and Figure 10 The therapeutic agent delivery mechanism 124 is supported by a support 146 and translates with the support 146 relative to the housing 112 of the reusable portion 102. The therapeutic agent delivery mechanism 124 includes components operably coupled to an electronic controller 136. Figure 5 The second actuator 188 may include a position sensor for indicating the axial position of the syringe assembly 118, as further described below. The second actuator 188 may be a rotary actuator, more specifically an electric motor, drivably coupled to a transmission or reducer. The actuator 188 is drivably coupled to a gear train 190, more specifically a first gear 192, which is drivably coupled to a second gear 194. The second gear 194 includes an internal thread 196 (…). Figure 10The internal thread connects to the external thread 198 of the plunger 126. The plunger 126 is fixed in rotation relative to the support 146 but is capable of translation. Figure 10 Specifically, plunger 126 is connected to support 146 via a keyway interface structure; more specifically, plunger 126 includes an external slot 200 that receives a key structure 202 formed on support 146. Figure 10 The plunger 126 also includes a pusher / impact head 204 for engaging the piston 128 of the syringe assembly 118.

[0030] Further reference Figure 9 and Figure 10 The movement of the various components of the therapeutic agent delivery mechanism 124 is as follows: The actuator 188 is energized to rotatably drive the gear train 190 relative to the support 146. The plunger 126 thereby translates relative to the second gear 194 and the support 146. The plunger 126 pushes the piston 128 distally within the syringe chamber 186. As described above, this movement of the piston 128 causes the syringe assembly 118 to deliver the therapeutic agent from the needle 120.

[0031] General Reference Figures 1-10 Controller 136 ( Figure 5 The drive mechanism 116 and the therapeutic agent delivery mechanism 124 can be sequentially actuated upon detection of one or more conditions. More specifically, in some embodiments, the drive mechanism 116 is actuated to move the syringe assembly 118 from a retracted configuration to an deployed configuration, and thereafter the therapeutic agent delivery mechanism 124 is actuated to drive the plunger 126 and piston 128, thereby delivering therapeutic agent 106 from the needle 120. In these embodiments, the sensor 140 of the electronic component 134 may include a position sensor 147, such as an encoder (not shown) coupled to the actuator 148, for determining whether the syringe assembly 118 is in a retracted or deployed configuration, as further described below. When the syringe assembly 118 is detected to be in a deployed configuration, the therapeutic agent delivery mechanism 124 can be actuated to deliver therapeutic agent 106 from the needle 120. After the delivery of the therapeutic agent 106, the drive mechanism 116 is actuated again to allow the syringe assembly 118 to move from an deployed configuration to a retracted configuration, and then the therapeutic agent delivery mechanism 124 is actuated again to retract the plunger 126 from the syringe assembly 118. More specifically, the therapeutic agent delivery mechanism 124 is actuated to retract the plunger 126 from the syringe assembly 118 upon detecting that the syringe assembly 118 has returned to the retracted configuration.

[0032] like Figure 11As shown, a therapeutic agent delivery device 300 according to another exemplary embodiment of this disclosure generally includes a reusable portion 302 (also referred to as a drive portion or durable portion) and a disposable portion 304 (also referred to as a drug carrier portion, cartridge, or syringe holder). The reusable portion 302 facilitates the delivery of therapeutic agent from the disposable portion 304 in a manner substantially as described above with reference to the reusable portion 102. The disposable portion 304 is detachably coupled to the reusable portion 302 such that, after the therapeutic agent has been delivered, the used disposable portion 304 is automatically ejected from the reusable portion 302. Another disposable portion (not shown, for example, having the same or different features as the disposable portion 304) can then be attached to the reusable portion 302, and the therapeutic agent delivery device 300 is then ready for subsequent use.

[0033] The therapeutic agent delivery device 300 includes a proximal end 306 and an opposing distal end 308. During use of the therapeutic agent delivery device 300, the proximal end 306 is located away from the patient and configured to be actuated by the user, while the distal end 308 is located closer to the patient and configured to deliver the therapeutic agent to the patient. The therapeutic agent delivery device 300 also includes a longitudinal axis A extending between the proximal end 306 and the distal end 308. These and other features of the therapeutic agent delivery device 300 will be described in further detail below.

[0034] like Figure 11 and Figure 12 As shown, the reusable portion 302 includes a housing 310, which includes a user input device 312 and a drive mechanism 314. The user input device 312 can be actuated by a user (e.g., pressed) to actuate the drive mechanism 314. Typically, the drive mechanism 314 and the user input device 312 of the reusable portion 302 may include components constructed in the manner described in the above-described reference device 100 to facilitate the delivery of a therapeutic agent through a needle into the patient's body. Furthermore, the therapeutic agent delivery device 300 may also include electronic components, such as those described in the above-described reference device 100, to facilitate the operation of the various functions of the therapeutic agent delivery device 300 described herein.

[0035] Return to reference Figure 11 and Figure 12 The drive mechanism 314 of the reusable portion 302 also includes an actuator 316 operably coupled to the controller 136. Figure 5Actuator 316 may be a rotary actuator, more specifically an electric motor, which is drivably coupled to a transmission or reducer (not shown). Actuator 316 is coupled to drive gear 318, which drivably engages driven gear 320. Driven gear 320 is fixed relative to cam ring 322, which is rotatably disposed within housing 310 of reusable portion 302. Typically, cam ring 322 rotates relative to housing 310 of reusable portion 302 about a rotation axis R, which is substantially parallel (i.e., ±10 degrees) to longitudinal axis A of therapeutic delivery device 300. As further described below, rotation of cam ring 322 controls the configuration of disposable portion 304 throughout the delivery of therapeutic agent to the patient, from loading disposable portion 304 into reusable portion 302 to ejecting used disposable portion 304 from reusable portion 302.

[0036] Now for reference Figure 13 and Figure 14 The syringe holder or disposable portion 304 (shown in a simplified form in this embodiment, with various components omitted) typically includes a base cover 324 coupled to a rigid needle guard (“RNS”) extractor 326, which extends from the base cover 324, the outer housing 328, and the locking clip 330 (also referred to herein as the “first portion”). The base cover 324 and the outer housing 328 are configured not to rotate relative to each other in the first configuration. In one example, one of the base cover 324 and the outer housing 328 includes one or more tabs, and the other includes a corresponding key structure for receiving the tabs. In one embodiment, the base cover 324 includes a pair of tabs 332 that, when the disposable portion 304 is assembled, engage the key structure 334 formed in the outer housing 328, thereby preventing the base cover 324 and the RNS extractor 326 from rotating relative to the outer housing 328. The base cover 324 and the outer housing 328 are configured to have a locking configuration. In one example, the locking clip 330 is configured to engage the RNS puller 326 via the wall of the outer housing 328 to lock the components together, and can then be released from the engagement to allow the RNS puller 326 to unlock. In one embodiment, the RNS puller 326 includes a pair of recesses 336 ( Figure 14 (Only one is shown in the image), each groove 336 forms an arm 338 that receives an internal protrusion 340 of the locking clip 330 to lock the base cover 324 and the RNS puller 326 onto the outer housing 328 until the locking clip 330 is rotated as described below.

[0037] The outer housing 328 includes a cylindrical body 342 formed by walls 344, the inner diameter of which is larger than the outer diameter of the RNS puller 326, thus allowing the RNS puller 326 to be positioned within the outer housing 328. The outer housing 328 may include guiding features to facilitate the alignment and positioning of the disposable portion 304 relative to the reusable portion 304. In one embodiment, the outer housing 328 may also include one or more protrusions, such as a pair of upper protrusions 346 formed on the outer surface 348 of the outer housing 328. Figure 14 Only one is shown in the image) and a pair of lower protrusions 350 formed on the outer surface 348. Figure 14 (Only one is shown in the diagram). Each upper protrusion 346 is aligned with the lower protrusion 350 in the direction of the longitudinal axis A of the device 300. As described in detail below, the upper protrusions 346 and the lower protrusions 350 interact with tracks formed on the components of the reusable portion 302 to control the movement of the disposable portion 304 from its insertion into the reusable portion 302 and its ejection from the reusable portion 302. It should be understood that in other embodiments, the tracks are formed along the disposable portion 304, and the protrusions are defined by the reusable portion 302. The outer housing 328 may also include clamping / clamping positioning features, such as a groove 352 formed in the outer surface 348 of the outer housing 328, which extends at least partially around the outer periphery of the outer housing 328. A pair of slots 354 are formed within the grooves 352 and extend through the wall 344 of the outer housing 328. Each slot 354 includes a first end 356 disposed adjacent to the end 358 of the recess 352 and a second end 360 opposite to the first end 356.

[0038] The locking clip 330 is semi-circular and includes an inner surface 362, an outer surface 364, a first end 366, and a second end 368. In one embodiment of the locking clip 330, protrusions may be defined along the interior and exterior of the body of the locking clip 330. For example, a pair of inner protrusions 340 ( Figure 14 Only one is shown in the image. It extends from the inner surface 362 of the locking clip 330 adjacent to the first end 366 and the second end 368. A pair of external protrusions 372 (… Figure 14 (Only one is shown in the image) It extends from the outer surface 364 of the locking clip 330 adjacent to the first end 366 and the second end 368. The width of the locking clip 330 substantially corresponds to the width of the groove 352 formed in the outer housing 328. The first end 366 and the second end 368 of the locking clip 330 are radially / circumferentially spaced by more than 180 degrees.

[0039] After the base cover 324 and the RNS puller 326 are inserted into the outer housing 328, the locking clip 330 is attached to the outer housing 328. The locking clip 330 is somewhat flexible, such that when the locking clip 330 is inserted into the outer diameter of the recess 352 of the outer housing 328, the ends 366 and 368 of the locking clip 330 bend away from each other, and when the locking clip 330 is fully within the recess 352, the ends 366 and 368 bend toward each other. In other words, the locking clip 330 snaps onto the outer housing 328 and enters the recess 352. When the locking clip 330 is installed in the recess 352 of the outer housing 328, the inner protrusion 340 extends through the slot 354 formed by the wall 344 of the outer housing 328 and enters the recess 336 of the RNS puller 326. Specifically, the internal protrusion 340 is positioned below the arm 338 of the RNS puller 326 to prevent the RNS puller 326 from being removed from the outer housing 328.

[0040] The locking clip 330 is movable relative to the outer housing 328 and the RNS extractor 326 to determine an unlocking configuration. As further described below, the locking clip 330 is rotatable within a recess 352 of the outer housing 328 about a rotation axis R, causing an internal protrusion 340 of the locking clip 330 to rotate out from under the arm 338 of the RNS extractor 326 to "unlock" the RNS extractor 326 and allow it (along with the RNS (not shown) of the syringe assembly (not shown)) to be removed from the reusable portion 302. It should be understood that the end 356 of the slot 354 formed through the wall 344 of the outer housing 328 and the end 358 of the recess 352 formed in the wall 344 are spaced apart from each other by substantially more than 180 degrees to allow the locking clip 330 to rotate within the recess 352 about the rotation axis R.

[0041] Now for reference Figures 13 to 18 A cam ring 322 is mounted within the housing 310 of the reusable portion 302, close to the distal cylinder 374 fixed within the housing 310. Thus, the cam ring 322 rotates relative to the distal cylinder 374 about a rotation axis R. Both the cam ring 322 and the distal cylinder 374 include features that facilitate selective fastening of the disposable portion 304 to the reusable portion 302. More specifically, the inner surface 376 of the distal cylinder 374 includes one or more guide rails 378 (schematically, two guide rails 378—in... Figures 13 to 18Only one guide rail 378 is visible in the middle, or a slot, for receiving an upper protrusion 346 and a lower protrusion 350 formed on the outer housing 328 of the disposable portion 304. The guide rail 378 is configured to align the disposable portion 304 within the reusable portion 302 with respect to each other at a predetermined angular position. Similarly, the inner surface 380 of the cam ring 322 includes one or more retaining rails 382 (schematically, two retaining rails 382—in the middle). Figures 13 to 18 Only one retaining track 382, ​​or slot, is shown for receiving the upper protrusion 346 of the disposable portion 304. As described in further detail below, the cam ring 322 rotates relative to the distal cylinder 374 to selectively align and misalign the retaining track 382 with the guide track 378. This rotation allows and prevents the upper protrusion 346 of the disposable portion 304 from moving between the guide track 378 and the retaining track 382, ​​which facilitates selectively securing the disposable portion 304 to the reusable portion 302 and ejecting the disposable portion 304 from the reusable portion 302.

[0042] Further reference Figures 13 to 18 Each guide rail 378 of the distal cylindrical body 374 is an inverted funnel shape. Each guide rail 378 includes a tapered / tapered distal portion 384 and a relatively narrow proximal portion 386. The width of each distal portion 384 gradually tapers towards the proximal side. More specifically, each distal portion 384 includes two opposing spirally extending walls 388 that connect to the proximal portion 386. As a result, when the disposable portion 304 is connected to the reusable portion 302, the walls 388 are configured to guide the upper protrusion 346 of the disposable portion 304 to the proximal portion 386. The width of the proximal portion 386 of each guide rail 378 may be slightly larger than the width of the upper protrusion 346. The proximal portion 386 of each guide rail 378 may be substantially parallel to the longitudinal axis A (i.e., parallel ±10 degrees).

[0043] For details, please refer to the following: Figure 13Each retaining track 382 of the cam ring 322 includes an inlet portion 390, a retaining portion 392, and an outlet portion 394. The inlet portion 390 of each retaining track 382 is selectively aligned with a guide track 378 to receive the upper protrusion 346 of the disposable portion 304 from there. The inlet portion 390 of each retaining track 382 may be substantially parallel to the longitudinal axis A (i.e., parallel ±10 degrees). Thus, the inlet portion 390 may be referred to as the longitudinal portion. Opposite to the guide track 378, the inlet portion 390 of each retaining track 382 is coupled to the retaining portion 392. The retaining portion 392 may be substantially perpendicular to the longitudinal axis A (i.e., perpendicular ±10 degrees). Thus, the retaining portion 392 may be referred to as the transverse portion. Opposite to the inlet portion 390, the retaining portion 392 of each retaining track 382 is coupled to the outlet portion 394. The exit portion 394 of each retaining track 382 may extend spirally relative to the longitudinal axis A and away from the retaining portion 392. Thus, the exit portion 394 may be referred to as the spiral portion. The exit portion 394 may be selectively aligned with a guide track 378 to facilitate the transfer of the upper protrusion 346 of the disposable portion 304 there.

[0044] Still referencing Figures 13 to 18 The movement and several configurations of the single-use portion 304 inserting into and ejecting from the reusable portion 302 are described below. Although the single-use portion 304 can be retained for a period of time in some configurations, other configurations are shown for illustrative purposes, and the single-use portion 304 can be easily switched between those configurations without being retained in them for a period of time. Figure 13 A first configuration or initial configuration of the single-use portion 304 is shown, in which the single-use portion 304 is separated from the reusable portion 302 before use.

[0045] The disposable portion 304 is proximal to the reusable portion 302, forming a second configuration, such as... Figure 15 As shown. In the second configuration, the outer housing 328 of the disposable portion 304 is received within the distal cylinder 374 and the cam ring 322. In the second configuration, the upper protrusion 346 of the disposable portion 304 (an upper protrusion 346 in...) Figure 15 (As can be seen in the image) has passed through the guide rail 378 of the distal cylinder 374 (one guide rail 378 in...) Figure 15(As can be seen in the image) and enters the inlet portion 390 of the retaining track 382 of the cam ring 322. Furthermore, the outer protrusion 372 of the locking clip 330 has also entered the inlet portion 390 of the retaining track 382 of the cam ring 322. In the second configuration, the guide track 378 of the distal cylinder 374 is aligned with the inlet portion 390 of the retaining track 382 of the cam ring 322 (one inlet portion 390 is in...). Figure 15 (See in the middle).

[0046] In the second configuration, the base cover 324 of the disposable portion 304 may be adjacent to the distal end 308 of the therapeutic agent delivery device 300. The lower protrusion 350 of the outer housing 328 of the disposable portion 304 (a lower protrusion 350 in...) Figure 15 (As can be seen in the middle) It has entered the proximal part 386 of the guide track 378 of the distal cylinder 374.

[0047] In addition, such as Figure 19 As shown, when the disposable portion 304 is inserted into the reusable portion 302, the internal protrusion 340 of the locking clip 330 remains positioned below the arm 338 of the RNS puller 326. Therefore, in this configuration, the RNS puller 326 is locked to the disposable portion 304, and the disposable portion 304 is unlocked relative to the reusable portion 302 (i.e., it is not mechanically held within the reusable portion 302). Figure 15 and Figure 19 The second configuration is shown in both.

[0048] When the cam ring 322 is in the second configuration, further movement of the cam ring 322 is paused until the controller 136 recognizes the disposable portion 304, for example, by reading the NFC tag 142 attached to the disposable portion 304 via an NFC coil reader on the reusable portion 302, as further described below. This disclosure contemplates other identification methods, such as using magnetic sensing to detect the loading of the disposable portion 304 within the reusable portion 302, as further described below. After the disposable portion 304 is recognized, the controller 136 waits until the patient is identified. More specifically, the patient may press and hold (e.g., for up to five seconds) a button (not shown), which may signal the controller 136 via mechanical actuation of a switch or electro-actuation using capacitive detection or other suitable means. Alternatively, the patient may be identified via voice / voiceprint recognition or biometrics such as fingerprint recognition. In other embodiments, patient identification is not required at all. It should be noted that if a patient is never identified or if the disposable part 304 is determined not to match the expected identification, the patient may be prompted to remove the disposable part 304 from the reusable part 302 via a display screen and / or an auditory indicator or other type of indicator (not shown). In this case, the RNS pull-out device 326 remains locked on the disposable part 304.

[0049] refer to Figure 12 and Figure 16 After the disposable part 304 and the patient are identified and confirmed as valid or verified by the controller 136, the actuator 316 is energized to lock the disposable part 304 to the reusable part 302 and unlock the RNS puller 326 from the disposable part 304 to allow it to be removed from the reusable part 302, thereby placing the disposable part 304 in the third configuration. More specifically, the actuator 316 rotates the cam ring 322 relative to the distal cylinder 374 via gears 318 and 320 (exemplarily, viewed from the proximal end 306 of the device 300, in a counterclockwise direction). As the cam ring 322 rotates, the inlet portion 390 of the retaining track 382 of the cam ring 322 engages with the outer protrusion 372 of the locking clip 330, which causes the locking clip 330 to engage in the groove 352 of the outer housing 328 of the disposable part 304. Figure 14 Rotation within the outer casing 328 is prevented by the engagement between the guide rail 378 of the distal cylinder 374 and the lower protrusion 350 of the outer casing 328 of the disposable portion 304. Figure 20As shown in the best view, as a result of the rotation of the cam ring 322, the rotation of the locking clip 330 causes the inner protrusion 340 of the locking clip 330 to rotate out from under the arm 338 of the RNS puller 326, thereby unlocking the RNS puller 326 from the outer housing 328 of the disposable part 304.

[0050] In an alternative embodiment, the locking clip 330 can be manually rotated to unlock the RNS puller 326 from the outer housing 328 of the disposable portion 304. Any of a variety of different mechanisms for rotating the locking clip 330 can be used; for example, an outer ring may be movable on the reusable portion 302 and configured to engage and rotate the outer protrusion 372 of the locking clip when the outer ring is rotated. In other examples, the outer protrusion 372 may be accessible and manually moved by a user, or configured as an engaging lever, slider, or other mechanism that cooperates with the outer protrusion 372 to rotate the locking clip 330.

[0051] Furthermore, when the cam ring 322 rotates, the upper protrusion 346 of the disposable portion 304 (an upper protrusion 346 in) Figure 16 (As can be seen in the image) positioned in the retaining portion 392 of the retaining rail 382 of the cam ring 322 (one retaining portion 392 and one retaining rail 382 in...) Figure 16 (See image). This prevents the disposable portion 304 from axially separating from the reusable portion 302 because the retaining portion 392 engages with the upper protrusion 392 and physically / concretely prevents the upper protrusion 346 from moving distally. Therefore, rotation of the cam ring 322 positions the disposable portion 304 in the third configuration, where the disposable portion 304 is locked in place within the reusable portion 302 by the retaining portion 392 of the cam ring 322, and unlocks the RNS puller 326.

[0052] However, it should be understood that in alternative embodiments, the rotation of the cam ring 322 and the configuration of the disposable portion 304 may be modified such that a first rotation of the cam ring 322 positions the upper protrusion 346 of the disposable portion 304 within the retaining portion 392 of the retaining track 382 of the cam ring 322 to lock the disposable portion 304, and a second rotation of the cam ring 322 rotates the outer protrusion 372 of the locking clip 330 out from under the arm 338 of the RNS puller 326 to unlock the RNS puller 326 for removal.

[0053] In some embodiments, the disposable portion 304 may remain in a third configuration until the user removes the RNS pull-out 326 and base cover 324 of the disposable portion 304 from the reusable portion 302. This removal may be sensed by one of the sensors 140 on the reusable portion 302 and transmitted to the controller 136. For example, sensor 140 may be an NFC coil reader on the reusable portion 302 that senses the presence of an NFC tag on the disposable portion 304, as described herein. Alternatively, sensor 140 may be an electromechanical switch, capacitive or magnetic field sensor (e.g., a Hall effect sensor) positioned near a corresponding metallic or magnetic surface on the RNS pull-out 326 or base cover 324 when the disposable portion 304 is fully inserted into the reusable portion 302. When the RNS puller 326 and the base cover 324 are removed from the reusable portion 302, the signal sensed by the sensor 140 is interpreted by the controller 136 as changing in a manner corresponding to the removal of the RNS puller 326 and the base cover 324. If the RNS puller 326 is not removed from the reusable portion 302, the controller 136 can cause the actuator 316 to rotate in the reverse direction, thereby causing the cam ring 322 to return to the second configuration, and instructing the user, via a message on the display of the device 100 and / or an external device (e.g., a smartphone), an auditory message, or other means, that the disposable portion 304 should be removed.

[0054] After the RNS puller 326 and base cover 324 are removed from the reusable portion 302, the outer housing 328 (and internal components not shown) of the disposable portion 304 remains in place. This fourth configuration... Figure 17As shown herein. When the disposable portion 304 is in the fourth configuration, the controller 136 awaits a contact signal indicating that the distal end 308 of the reusable portion 302 is in contact with the patient's skin. This signal may be provided by one or more sensors 140 disposed adjacent to the lower surface of the distal end 308 of the reusable portion 302. For example, the skin sensor 140 may be a capacitive or other sensor configured to detect contact with the patient's skin and provide the controller 136 with a sensed contact signal that varies with contact to indicate such contact, as further described below. After detecting contact with the patient's skin, the user input device 312 is actuated in the manner described herein. When the user actuates the user input device 312, the drive mechanism 314 of the reusable portion 302 delivers the therapeutic agent in the manner described herein. If the user input device 312 is not actuated, or is not actuated within a predetermined time limit (i.e., a dose of treatment is not delivered to the patient within a predetermined time limit), the actuator 316 may rotate the cam ring 322 to the fifth configuration described below to eject the single-use portion 304 containing the treatment, but without connecting the RNS pull-out device 326 or the base cover 324.

[0055] After the therapeutic agent is delivered to the patient, the cam ring 322 rotates relative to the distal cylinder 374 (rotating in the same direction—exemplarily, counterclockwise when viewed from the proximal end 306), causing the cam ring 322 to move to Figure 18 The fifth configuration is shown. In the fifth configuration, the upper protrusion 346 of the outer shell 328 (an upper protrusion 346 in...) Figure 18 (As can be seen in the image) is disposed in the outlet portion 394 of the retaining rail 382 of the cam ring 322 (an outlet portion 394 and a retaining rail 382 are located in the image). Figure 18 (As can be seen in the image). As a result, the cam ring 322 pushes the upper protrusion 346 distally relative to the reusable portion 302, thereby pushing the disposable portion 304 to eject it. In this fifth configuration, the exit portion 394 of the retaining rail 382 of the cam ring 322 (an exit portion 394 and a retaining rail 382 in...) Figure 18 (visible in the middle) and the guide rail 378 of the distal cylinder 374 (one guide rail 378 in Figure 18(See image) Alignment. Furthermore, the upper protrusion 346 and lower protrusion 350 of the disposable portion 304 are disposed in the guide rail 378 of the distal cylinder 374. In some embodiments, user input may be required, for example, by actuating a capacitive slider (not shown) to initiate the aforementioned ejection sequence. In either case, the user can pull the disposable portion 304 distally to detach it from the reusable portion 302. At this stage, the controller 136 can wait for a signal from one or more sensors 140 indicating that the user has removed the disposable portion 304 from the reusable portion 302. One or more sensors 140 disposed in the reusable portion 302 can detect the absence of the disposable portion 304 and provide a missing signal to the controller 136, indicating that the disposable portion 304 has been removed. The presence and / or absence of the disposable portion 304 can be sensed using electromechanical switches, capacitive or magnetic field sensors (e.g., Hall effect sensors), RFID (Radio Frequency Identification) tags, NFC sensing elements described herein, or any other suitable sensing configuration. In an alternative embodiment, the single-use portion 304 may be configured to simply fall from the reusable portion 302 after the cam ring 322 has moved into the fifth configuration. In another alternative embodiment, if desired, the controller 136 may switch the cam ring 322 from the fourth configuration to the fifth configuration after a predetermined time period following actuation of the user input device 312. This predetermined time period may be based, for example, on a typical time period for delivering a therapeutic agent to a patient.

[0056] In any case, when the disposable portion 304 is no longer located within the reusable portion 302, the controller 136 causes the actuator 316 to rotate the cam ring 322 back. Figure 13 The first configuration is shown. Actuator 316 can rotate cam ring 322 back to the first configuration counterclockwise (viewed from the proximal end 306 of reusable portion 302) or clockwise. When cam ring 322 returns to the first configuration, reusable portion 302 is ready to receive new disposable portion 304 to repeat the above process for injecting subsequent doses of therapeutic agent.

[0057] Now for reference Figures 21 to 33 This illustrates another embodiment of a disposable portion or syringe holder 404 for use with a motor-driven therapeutic agent delivery device. The syringe holder 404 can be used with a reusable portion, such as the reusable portion 302 described above. First, refer to... Figure 21In one embodiment, the syringe holder 404 includes a base cover 406, an RNS puller 408, a bottom housing 410, an injection stop 412 (also referred to herein as the "first part"), a return spring 414, a locking spacer 416, a syringe assembly 418, a top housing 420, and a spacer 422. The bottom housing 410 and the top housing 420 generally constitute the housing of the syringe holder 404. In some embodiments, the syringe holder 404 may be configured to accommodate different syringe assemblies 418 containing different doses of therapeutic agent, such as 1 ml, 2 ml, etc. In such embodiments, the syringe assemblies 418 may be of different sizes, which may require modifications to the locking spacer 416, the injection stop 412, and the base cover 406. For example, in an embodiment using a 1 ml syringe assembly 418, the spacer 422 may be omitted.

[0058] The base cover 406 accommodates an RNS puller 408 that engages with a needle shield 424 of the syringe assembly 418 to separate the needle shield 424 from the syringe assembly 418, thereby exposing the needle 426 after the base cover 406 is unlocked as described below. Figure 28 ).like Figure 22 As best shown, the base cover 406 includes a disc-shaped body 428, a central opening 430 for receiving the RNS puller 408, and a pair of arms 432 extending upward from the central opening 430. Each arm 432 includes a tab 434 that engages a recess 436 formed in the distal end 438 of the injection stop 412, as further described below.

[0059] The bottom housing 410 includes a generally cylindrical body 440 with an inner diameter slightly larger than the outer diameter of the injection stop 412, thereby allowing the injection stop 412 to be accommodated within the bottom housing 410. The bottom housing 410 also includes a lower flange 442 that engages the base cap body 428 when the syringe support 404 is assembled. When the base cap 406 is removed from the syringe support 404, the lower flange 442 of the bottom housing 410 engages with the patient's skin to provide an appropriate distance for the needle 426 of the syringe assembly 418 to pierce the patient's skin, as described herein. A notch 444 is formed in the bottom housing 410, sized to accommodate a key structure 446 extending upward from the base cap body 428 to prevent the base cap body 428 from twisting or rotating when the injection stop 412 is rotated in the manner described below. The bottom housing 410 also includes a pair of upper protrusions 448 and a pair of lower protrusions 450, which engage the reusable portion 302. Figure 13The guide rail 378 and retaining rail 382 of the syringe support 404 are further described below. The lower protrusion 450 extends along the longitudinal axis A of the syringe support 404 to provide extended engagement with the guide rail 378 of the distal barrel 374 of the reusable portion 302. Finally, the bottom housing 410 also includes a pair of engagement arms 452, which are slightly resilient and include locking tabs 454 that, when the syringe support 404 is assembled, engage with locking recesses 456 formed in the top housing 420. Figure 21 The bottom housing 410 is fastened to the top housing 420 by engaging the bottom housing 410.

[0060] The injection stop 412 typically includes a generally cylindrical body 458 having a pair of distal arms 460, a pair of driven tabs 462, a proximal annulus 464, and a pair of control grooves 466 to allow and guide movement of the locking spacer 416 as described below. Each control groove 466 includes a lower stop surface 468, a side stop surface 470, and an upper stop surface 472. The distal arms 460 include radially extending extensions 474 forming notches 436 that receive tabs 434 of the base cap arms 432 to hold the base cap 406 in place until the injection stop 412 rotates as described below. Figure 23 As shown in the best view, the proximal ring 464 of the injection stop 412 includes a retention / stop recess 478 formed in the outer surface 480 of the proximal ring 464 and configured to receive the first end 482 of the retraction spring 414.

[0061] Return to reference Figure 22 The locking spacer 416 includes a cylindrical body 484 defining a central opening 488, a pair of distal arms 490 extending from the cylindrical body 484, and a proximal flange 492. Each distal arm 490 includes a protrusion 494 extending radially outward from the distal arm 490. Each distal arm 490 also includes a distal surface 496 that interacts with a portion of the injection stop control recess 466 in a manner described below. Figure 24 As shown in the best view, the proximal flange 492 includes a retention recess 498 formed in the outer surface 500 of the proximal flange 492 and configured to receive the second end 502 of the retraction spring 414.

[0062] Still referencing Figure 24 The return spring 414 is a helical torsion spring. When assembling the syringe support 404, the locking spacer 416 is biased in a counterclockwise direction relative to the injection stop 412. The return spring 414 is located at the first end 482 ( Figure 23Extending between the first end 482 and the second end 502, the first end 482 engages the retention recess 478 of the proximal ring 464 of the injection stop 412, and the second end 502 engages the retention recess 498 of the proximal flange 492 of the locking spacer 416. When assembling the syringe support 404, the return spring 414 is stretched clockwise, and the ends 482 and 502 are inserted into the retention recesses 478 and 498, respectively, such that if these components are not prevented from rotating by other components of the syringe support 404, the locking spacer 416 will rotate counterclockwise, and the injection stop 412 will rotate clockwise, as described herein. The return spring 414 covers the cylindrical body 484 of the locking spacer 416 and has an outer diameter smaller than the inner diameter of the top housing 420.

[0063] Return to reference Figure 21 The syringe assembly 418 includes a cylindrical part / tube 504 containing a therapeutic agent 506 and a hollow needle 426 for injecting the therapeutic agent 506. Figure 28 The upper flange 507 and needle guard 424 are detachably connected to the cylindrical member 504 and configured to enclose the needle 426 to prevent accidental contact between the needle 426 and the skin. As described above with reference to device 100, the needle 426 and syringe assembly 418 can move from a retracted configuration where the needle 426 is retracted into the syringe support 404 to an extended configuration where the needle 426 extends at least partially below the lower flange 442 of the bottom housing 410 to pierce the patient's skin. Typically, during operation as described below, the drive mechanism 314 of the reusable portion 302 and the user input device 312 of the reference device 300 cause the therapeutic agent 506 to enter the patient through the needle 426.

[0064] Still referencing Figure 21 The spacer 422 of the syringe holder 404 is positioned on top of the upper flange 507 of the syringe assembly 418, which in turn is positioned on top of the proximal flange 492 of the locking spacer 416. The spacer 422 has a height that accommodates the length difference between the 1 ml syringe assembly and the 2 ml syringe assembly 418, allowing the use of the same bottom housing 410, top housing 420, and retraction spring 414 for each syringe holder design. In this way, the spacer 422 positions the tip of the needle 426 of the 2 ml syringe assembly 418 at the same distance from the patient's skin as the distance between the tips of the needles of the 1 ml syringe assembly when assembled into the 1 ml syringe holder as described below. Those skilled in the art will understand that the use of the spacer 422 allows the same drive mechanism (i.e., the same travel distance) of the reusable portion 302 for both the 1 ml syringe assembly and the shorter 2 ml syringe assembly.

[0065] For reference Figure 21 and Figure 22 The top housing 420 includes a generally cylindrical body 508 with an inner diameter slightly larger than the outer diameter of the injection stop 412, thereby allowing the injection stop 412 to be partially accommodated within the top housing 420. The top housing 420 also includes a pair of protrusions 510 that engage the reusable portion 302. Figure 13 The top housing 420 also includes a guide rail 378 and a retaining rail 382, ​​as further described herein. The top housing 420 also includes an upper wall 512, which, when the top housing 420 engages with the locking tab 454 of the engaging arm 452 of the bottom housing 410, forms a locking groove 456 on the inner surface 514 of the body 508 of the top housing 410. Figure 21 When engaged and connected to the bottom housing 410, the upper wall 512 compresses the spacer 422, locking spacer 416, return spring 414, and injection stop 412 within the top housing 420 and the bottom housing 410. Finally, the top housing 420 also includes a pair of locking spacer control tracks 516 formed as recesses in the distal end 518 of the top housing 420. These locking spacer control tracks 516 control the movement of the locking spacer 416 during needle insertion in a manner described below. Each locking spacer control track 516 includes a retaining recess 520 formed by control fingers 522. When the syringe support 404 is assembled, the retaining recess 520 receives a protrusion 494 on the distal arm 490 of the locking spacer 416. The control fingers 522 prevent counterclockwise rotation of the locking spacer 416 by preventing movement of the protrusion 494, as further described below. The locking spacer control track 516 also includes a retaining groove 526 that cooperates with the control groove 466 of the injection stop 412 to prevent subsequent needle insertion as described below.

[0066] like Figure 25 After assembling the syringe holder 404 as shown, it is inserted into the reusable portion 302 for use in a manner substantially similar to that described in the reference device 300 above. Figure 15The reusable portion 302 is inserted in the manner shown, such that the protrusion 510 of the top housing 420 passes through the guide rail 378 of the distal barrel 374 and enters the retaining rail 382 of the cam ring 322. The upper protrusion 448 and the lower protrusion 450 of the bottom housing 410 are located within the guide rail 378 of the distal barrel 374. As shown, the protrusion 494 of the distal arm 490 of the locking spacer 416 is positioned within the locking spacer control rail 516, and more specifically, within the retaining recess 520 formed by the control finger 522 of the top housing 420. The control finger 522 prevents the protrusion 494 (and the locking spacer 416) from rotating counterclockwise due to the biasing force of the return spring 414. Furthermore, the protrusion 494 is located above the upper stop surface 472 of the control groove 466 of the injection stop 412. In this position, the locking spacer 416 is in its initial state. Furthermore, the tab 434 of the base cover arm 432 is positioned within a notch 476 formed by the extension 474 of the distal arm 460 of the injection stop 412. In this first configuration, the base cover 406 and the RNS puller 408 cannot be removed from the syringe holder 404.

[0067] In this configuration, the controller 136 awaits a signal from the sensor 140, which is located in the reusable portion 302 adjacent to the base cover 406 of the syringe holder 404, indicating the detection and identification of the syringe holder 404, the therapeutic agent, and / or the patient, as described below. After the syringe holder 404 is identified and verified, a first rotation of the cam ring 322 positions the protrusion 510 of the top housing 420 in the retaining portion 392 of the retaining track 382 of the cam ring 322, thereby achieving a position similar to... Figure 16 The syringe holder 404 is locked to the reusable portion 302 in the manner shown.

[0068] Now for reference Figure 26 The aforementioned rotation of the cam ring 322 also causes the cam ring 322 to engage with the driven tab 462 of the injection stop 412, and causes the injection stop 412 to rotate relative to the housing body of the syringe support 404. This causes the notch 476 formed by the extension 474 of the distal arm 460 of the injection stop 412 to disengage from the tab 434 of the base cover arm 432, thereby unlocking the base cover 406. This rotation also causes the control groove 466 of the injection stop 412 ( Figure 22 The rotation causes the protrusion 494 of the distal arm 490 of the locking spacer 416 to be positioned substantially aligned with the side stop surface 470 of the control groove 466. However, it should be noted that the distal surface 496 of the distal arm 490 remains engaged with the upper stop surface 472 of the control groove 466 of the injection stop 412. Therefore, when in... Figure 26In the second configuration shown, the base cover 406 and RNS puller 408 can be pulled downwards to extend the reusable portion 302 to remove the needle guard 424 of the syringe assembly 418. However, this pull on the syringe assembly 418 does not cause movement of the syringe assembly 418 because the distal surface 496 of the distal arm 490 of the locking spacer 416 remains engaged with the upper stop surface 472 of the control groove 466. In other words, the syringe assembly 418 cannot move downwards because the locking spacer 416 cannot move downwards. Because the locking spacer 416 cannot move downwards, this design prevents the single-use lock described below from being triggered when the base cover 406 is removed. Figure 27 The base cover 406 and RNS puller 408 are depicted after being removed from the reusable part 302.

[0069] Now for reference Figure 28 After removing the base cover 406 and the RNS puller 408, the controller 136 awaits detection of contact with the patient's skin. More specifically, the controller 136 awaits one or more contact signals from sensors 140 located adjacent to the lower flange 442 of the bottom housing 410 within the reusable portion 302 (i.e., at the distal end of the reusable portion 302). For example, the skin sensor 140 may be a capacitive or other sensor configured to detect contact with the patient's skin and provide the controller 136 with a sensed contact signal that varies with contact to indicate such contact, as further described below. As an optional next step, the controller 136 may await a signal from another sensor 140 operatively coupled to an unlock input device (not shown), such as a slider or scraper actuated by the user. When contact with the patient's skin is detected (and optionally, when the user has already actuated the unlock input device), the reusable portion 302 may provide the user with an indication that the device can be used for needle injection. The indication may be visual (e.g., activating an indicator, illuminating the user input device 312 and / or displaying a message to the user on a display) or auditory (e.g., playing a message to the user through a speaker), as further described below.

[0070] Furthermore, when patient skin is detected (optionally, when the user actuates the unlock input device), the drive mechanism 314 causes the cam ring 322 to rotate further counterclockwise, thereby further engaging the driven tab 462 of the injection stop 412 and rotating the injection stop 412 to... Figure 28 The position shown. In this third configuration, the locking spacer 416 no longer engages with the upper stop surface 472 of the control groove 466 of the injection stop 412.

[0071] When the user actuates the user input device 312, the drive mechanism 314 of the reusable portion 302 moves downwards the locking spacer 416 and the syringe assembly 418, causing the needle 426 of the syringe assembly 418 to pierce the patient's skin. The drive mechanism 314 then further causes the therapeutic agent 506 to be delivered through the needle 426 in the manner described herein. If the user input device 312 is not actuated, or is not actuated within a predetermined time limit (i.e., a dose of therapeutic agent 506 is not delivered to the patient within a predetermined time limit), the actuator 316 can cause the cam ring 322 to rotate to eject the syringe holder 404. The skin sensor 140 described above can continue to monitor contact with the patient's skin during needle insertion and dose delivery.

[0072] When the drive mechanism 314 causes the locking spacer 416 and the syringe assembly 418 to move distally relative to the housing body of the syringe support 404, the protrusion 494 of the distal arm 490 of the locking spacer 416 moves to... Figure 29 The position is shown. In this fourth configuration, the return spring 414 is compressed, and the protrusion 494 of the distal arm 490 has moved out of the retaining recess 520 and is located below the control finger 522 of the locking spacer control track 516 of the top housing 420. When loaded, the return spring 414 can be configured to provide axial force and torsional force. Thus, the locking spacer 416 rotates freely counterclockwise under the biasing force of the return spring 414 to begin moving toward the single-use locking state described below. In this fourth configuration, the needle 426 and syringe assembly 418 are shown in an unfolded configuration to pierce the patient's skin for delivery of the therapeutic agent 506.

[0073] Figure 30 The first segment of the rotation process of the locking spacer 416 is depicted. As shown, the protrusion 494 of the distal arm 490 of the locking spacer 416 has rotated to engage with the side stop surface 470 of the control groove 466 of the injection stop 412. After the delivery of the therapeutic agent 506 is completed, the syringe assembly 418 and the injection stop 412 move proximally relative to the housing of the syringe support 404 by the force provided by the return spring 414. During this process, the injection stop 412 continues to rotate counterclockwise relative to the housing body of the syringe support 404 by the torque provided by the return spring 414.

[0074] Figure 31 The locking spacer 416 and the syringe assembly 418 are depicted approximately midway through the aforementioned proximal movement. Figure 32The syringe holder 404 in the fifth configuration is depicted. In this fifth configuration, the locking spacer 416 has been retracted proximally relative to the housing body of the syringe holder 404 by means of a return spring 414, and rotated counterclockwise under the biasing force of the return spring 414, such that the protrusion 494 of the distal arm 490 of the locking spacer 416 is positioned in the control groove 466 of the injection stop 412, contacting the upper stop surface 472. Furthermore, the syringe assembly 418 is fully retracted and in a stowed configuration. In this position, the syringe holder 404 is in a single-use locked state. Due to the engagement between the protrusion 494 and the upper stop surface of the injection stop 412, the locking spacer 416 (and therefore the syringe assembly 418 and needle 426) cannot move downwards again. In the locked state, the return spring 414 biases the locking spacer 416.

[0075] When the user actuates the pop-out slider or other input device (not shown), the cam ring 322 rotates relative to the distal cylinder 374 (rotating in the same direction—exemplarily, counterclockwise when viewed from the proximal end 306 of the reusable portion 302), causing the protrusion 510 of the top housing 420 to rotate substantially as referenced above. Figure 18 The aforementioned arrangement is set in the outlet portion 394 of the retaining track 382 of the cam ring 322. As a result, the cam ring 322 pushes the protrusion 510 and the syringe support 404 distally to position the syringe support 404 for injection. Figure 33 The syringe support 404 is depicted after the cam ring 322 has rotated the syringe support 404 as described above. It should be noted that the syringe support 404 remains in a single-use locked state because the distal surface 496 of the distal arm 490 of the locking spacer 416 remains engaged with the upper stop surface 472 of the control groove 466.

[0076] Now for reference Figure 34 This illustration shows an exemplary embodiment of a therapeutic agent delivery device 600, similar to the delivery devices 100 and 300 described above. Device 600 generally includes a reusable portion 602 (similar to reusable portion 302) and a syringe holder 604 (similar to syringe holder 404). For simplicity, many components of device 600 are omitted. However, it should be noted that in the following description, references to various mechanical parts of device 600 use the reference numerals used above with reference to reusable portion 302 and syringe holder 404. It should be understood that the features described below with reference to device 600 can be implemented in other embodiments of the reusable portion and syringe holder described herein.

[0077] Figure 34The device 600 includes components for detecting the presence and absence of a base cover 406 for a syringe holder 604, and for identifying the syringe holder 604, the therapeutic agent 106, and / or the patient. More specifically, a first sensing element, such as an NFC coil reader 608, is disposed in a cavity 610 formed between an outer wall 612 and an inner wall 614 of the reusable portion 602, near the distal end 308 of the reusable portion 602. The inner wall 614 and the lower wall 609 form a cylindrical opening 611 for receiving the syringe holder 406. The base cover 406 may include a third sensing element, such as an NFC tag 142 (shown in dashed lines), attached to the upper wall 606 of the base cover 406, vertically aligned with the NFC coil reader 608.

[0078] As shown, the NFC tag 142 is substantially parallel to and axially positioned below the NFC coil reader 608—preferably centered relative to the NFC coil reader 608—and vertically aligned with the NFC coil reader 608. In one embodiment, the NFC tag 142 is an adhesive label. In another embodiment, the NFC tag 142 includes a small embedded antenna and has an overall size of approximately 4mm × 4mm. In still other embodiments, as an alternative, the NFC tag 142 (shown in dashed lines) is positioned on the outer wall 616 of the syringe holder 604 with at least one of a vertical and coplanar orientation relative to the NFC coil reader 608. In the depicted embodiment, the NFC coil reader 608 is disposed on the printed circuit board (PCB) 613 of the printed circuit board assembly (PCBA) 618. In some embodiments, the PCB 613 is annular in shape and extends substantially around the cylindrical opening 611, or extends 360 degrees around the inner wall 614 of the reusable portion 602. In other embodiments, the PCB613 extends less than 360 degrees around the inner wall 614.

[0079] In one embodiment, the NFC tag 142 is configured to provide identification information associated with the therapeutic agent 106 and / or the patient for whom the agent 106 was prescribed. Figure 35 As shown, in some embodiments, the NFC tag 142 may include a memory device 720 such as an EEPROM, an antenna 722, and a power source 724 such as a battery. The memory device 720 is programmed with identification information about the therapeutic agent 106, such as type, volume, batch number, concentration, and / or expiration date. The memory device 720 may also include identification information about the patient, such as the patient's name and prescription information. The antenna 722 may be a conductive plating in plastic or a label (e.g., a sticker available from Avery Dennison).

[0080] When the reusable device 602 and the syringe support 604 are constructed according to the reusable portion 302 and the syringe support 404 as described above, respectively, and the syringe support 604 is inserted into the reusable portion 602 in the first configuration (see...) Figure 25 The controller 136 awaits a presence signal from the NFC coil reader 608, indicating that the NFC tag 142 has been detected and identification information regarding the syringe holder 604 and / or the patient has been received from the NFC. As described above, upon receiving and verifying the identification information, the controller 136 activates the actuator 316. Figure 12 and Figure 16 This causes the cam ring 322 to rotate, thereby locking the syringe holder 604 to the reusable portion 602 in the manner described above. This rotation of the cam ring 322 also causes it to engage the driven tab 462 of the injection stop 412 and rotate the injection stop 412 relative to the housing body of the syringe holder 604, causing the notch 476 formed by the extension 474 of the distal arm 460 of the injection stop 412 to disengage from the tab 434 of the base cover arm 432, thereby unlocking the base cover 406. Therefore, the base cover 406 and the RNS puller 408 can be removed from the reusable portion 602, thereby removing the needle shield 424 of the syringe assembly 418. When the base cover 406 is removed, the NFC coil reader 608 ceases communication with the NFC tag 142 and generates a missing signal. The controller 136 determines that the base cover 406 has been removed based on the missing signal. In some embodiments, the base cover includes an NFC tag 142 as described above that can be used for charging, and the syringe holder includes another NFC tag 142 as described above that can be used for identification, and vice versa. In other embodiments, one of the deployed NFC tags is used for at least one of charging and identification.

[0081] In some embodiments, after verifying the identification information and identifying the removal of the base cover 406, the controller 136 can provide a signal to the user input device 114 ( Figure 5An associated indicator 621 (e.g., an LED) illuminates to notify the user that the device 600 is ready to inject the therapeutic agent 106. In other embodiments, the controller 136 provides the indicator 621 with one of a plurality of signals to provide the user with information about whether the controller 136 has sensed the base cover 406 and / or whether the base cover 406 is unlocked, and whether the identification information has been verified. For example, the controller may provide the indicator 621 with a signal to emit a yellow light when the base cover 604 is sensed, a blue light when the base cover is unlocked, and a green light when the identification information is verified and the device 600 is ready to inject. In other variations, the controller 136 sets and controls a plurality of indicators 621. In other embodiments, when the identification information is verified, the controller 136 actuates a motor or other device (not shown) that mechanically moves (or pops out) the user input device 114 to an actuable position as described above.

[0082] It should be understood that indicator 621 or multiple indicators 621 can be controlled to provide the user with information about the injection status of therapeutic agent 106. For example, when the user actuates user input device 114, indicator 621 may flash or change color and / or brightness, then emit light continuously, flash at different speeds, and / or change color during the injection of therapeutic agent. Furthermore, when the dose delivery is completed, indicator 621 or multiple indicators 621 may change state again to indicate that delivery is complete.

[0083] In an alternative embodiment, instead of using the NFC tag 142 and NFC coil reader 608, a sensor 140 on the reusable portion 602, as described above, provides a signal to the controller 136 indicating that the base cover 406 has been removed. For example, the sensor 140 may be an electromechanical switch, a capacitive or magnetic field sensor, such as a Hall effect sensor, positioned near the corresponding metallic or magnetic surface on the RNS puller 408 or the base cover 406 when the syringe holder 604 is fully inserted into the reusable portion 602. When the RNS puller 408 and the base cover 406 are removed from the reusable portion 602, the signal sensed by the sensor 140 changes in a manner interpreted by the controller 136 corresponding to the removal of the RNS puller 408 and the base cover 406.

[0084] As described above, after removing the RNS puller 408 and the base cover 406, the controller 136 awaits a contact signal indicating that the distal end 308 of the reusable portion 602 is in contact with the patient's skin. This contact signal can be provided by a second sensing element, such as the capacitive skin sensor 620 described below. Figure 34As shown, skin sensor 620 is mounted on PCB 613 and configured to detect when the distal end 308 of reusable portion 602 comes into contact with patient skin (or within a maximum permissible offset, such as 1 mm). Skin sensor 620 also facilitates the detection of permissible tilt angles (e.g., tilts not exceeding 5 degrees) between distal end 308 and patient skin, as further described below. In one embodiment, skin sensor 620 is a Semtech SX9325 sensor.

[0085] In some embodiments, controller 136 is connected to one or more indicators (such as indicator 621 described above) and configured to provide feedback to the user regarding the placement of the reusable portion 602 relative to the patient's skin. For example, controller 136 may control the color and / or brightness of indicator 621 to notify the user that contact with the patient's skin has been sensed and that the tilt angle of the distal end 308 of the reusable portion 602 relative to the patient's skin is within an acceptable range.

[0086] Now for reference Figure 36 An example embodiment of PCBA 618 is shown, featuring a skin sensor 620 and an NFC coil reader 608 mounted on a PCB 613. Sensor 620 includes three sensing pads 626, 628, and 630 of substantially the same size and shape, arranged symmetrically at 120 degrees on the PCB 613. Sensing pads 626, 628, and 630 are spaced apart from each other and positioned adjacent to the outer periphery 627 of the PCB 613. As those skilled in the art will understand, the circumferential placement of sensing pads 626, 628, and 630 improves the sensitivity of the skin sensor 620 to tilt. One of the sensing pads, sensing pad 630, is positioned adjacent to the sensor chip 632 of sensor 620 on the PCB 613. This sensing pad is grounded and connected to a shielding layer 634 formed on one or more layers of the PCB 613 above the other two sensing pads 626 and 628 (see [link to relevant documentation]). Figure 34 The sensor pads 626 and 628 provide contact sensing input signals to the sensor chip 632 to indicate contact (or proximity) with the patient's skin.

[0087] To reduce capacitive sensing of the user's hand holding the reusable portion 602 and to improve the sensing accuracy of the patient's injection site, the reusable portion 602 may also include a shielding structure (not shown) in addition to the shielding layer 634 formed on the printed circuit board 613.

[0088] Skin sensor 620 provides tilt detection to enable the user to orient needle 426 perpendicular to the patient's skin, thereby ensuring the desired depth of penetration and reducing the chance of relative movement between needle 426 and the skin during injection. Tilt detection is achieved by controller 136 receiving contact signals from skin sensor 620 (i.e., signals from sensor chip 632 received from sensing pads 626 and 628) and verifying that the signals are within the expected range—which indicates skin contact. Furthermore, the signals must match within a given tolerance to indicate permissible tilt. When the signals from skin sensor 620 are within the expected range and within each other's given tolerances, controller 136 determines that permissible contact has been made with the patient's skin (i.e., the distal end 308 of reusable portion 602 is in contact with the patient's skin and within the permissible tilt range relative to the patient's skin).

[0089] An NFC coil reader 608 is disposed on a PCB 613, radially inward of the sensing pads 626, 628, and 630 of the skin sensor 620. The NFC coil reader 608 includes a first terminal 631, a coil body 633, and a second terminal 635. The coil body 633 extends from the first terminal 631 adjacent to the sensing pads 626, 628, and 630, as shown, and extends with a decreasing circumference until its final section connects to the second terminal 635, extending adjacent to the inner perimeter 637 of the PCB 613. In one embodiment of this disclosure, the inner perimeter 637 of the PCB 613 has a diameter of approximately 20 mm, the outer perimeter 627 has a diameter of approximately 40 mm, and a transition region between the sensing pads 626, 628, and 630 and the NFC coil reader 608 is positioned across a region defined between the inner perimeters 637 to a diameter of approximately 30 mm. As shown in the figure, the area of ​​PCB 613 may include the outer range of NFC coil reader 608 and the separation area 639 between the inner diameters of sensing pads 626, 628 and 630.

[0090] Now for reference Figure 37 and 38In one embodiment of the invention, the NFC coil reader 608 can be used for NFC wireless power transfer to charge a power source 138 of the reusable portion 602. The power source 138 includes an energy storage device 139 (e.g., a battery) and, in one embodiment, includes a power sensor 141. The power sensor 141 is configured to sense the charging state of the energy storage device 139 and transmit the charging state to a controller 136. The controller 136 can then provide an indication of the charging state of the energy storage device 139 by activating an indicator (e.g., indicator 621) or by providing a message on a display of the reusable portion 602. As shown, the charging circuit 636 includes a tuning circuit 638 and a passive rectifier circuit 640 mounted on a PCB 613 of the reusable portion 602. The tuning circuit 638 is connected to the NFC coil reader 608 and the passive rectifier circuit 640. The passive rectifier circuit 640 is connected to a battery charging circuit 642 configured to charge the energy storage device 139.

[0091] In some embodiments, the base station / base station 644 provides charging power to the NFC coil reader 608, such as Figure 38 As shown. Base station 644 includes a housing 646, which has an NFC transmitter chip 648 connected to a tuning circuit 650, which in turn is connected to an NFC coil 652. Base station 644 also includes a ferrite rod 654, which is vertically mounted within a protrusion 656 within the housing 646. The diameter of the protrusion 656 is substantially the same as the diameter of the syringe holder 604. Figure 38 As shown, the protrusion 656 is sized to fit within the reusable portion 602 and is substantially centered between the NFC coil 652 and the NFC coil reader 608 to enhance coupling. (Source: Power supply 658) Figure 37 Power is supplied to base station 644 via a USB cable from, for example, a wall socket, and then transmitted to NFC coil 652 via NFC transmitter chip 648 and tuning circuit 650. NFC coil 652, in turn, transmits power via ferrite rod 654 to power NFC coil reader 608 via wireless inductive coupling. This power is provided to tuning circuit 638 and passive rectifier circuit 640 of reusable portion 602, which delivers power to battery charging circuit 642. In this way, power source 138 of reusable portion 602 can be wirelessly charged by base station 644. Other charging mechanisms may also be included, including corresponding components for Q1 charging and / or capacitive charging.

[0092] As described above, in one embodiment of the reusable portion 602, the electronic device mounted on the printed circuit board 613 provides three main functions. Specifically, the PCB 613 includes a skin sensor 620 for sensing contact with and tilt relative to the patient's skin, an NFC coil reader 608 for sensing the presence and absence of the base cover 406 of the syringe holder 604 and identifying the syringe holder 604, the therapeutic agent 106, and / or the patient, and a charging circuit 636 that uses the NFC coil reader 608 to receive power from the base station 644 to charge the power supply 138 of the reusable portion 602.

[0093] In one embodiment, all the electronics providing skin sensing, recognition, and wireless charging are housed on PCB 613. One advantage of arranging syringe holder recognition, system recharging, and skin sensing detection on PCB 613 is to avoid supporting all three functions with their own separate circuitry on the same PCB.

[0094] It should be understood that identification of the syringe holder 604 (and the treatment agent 106 and the patient) can be provided using an RFID device, memory card, barcode, or electrical contacts, rather than the NFC tag 142 described above. In embodiments using a memory card, the serial interface may also be provided with a transceiver that allows communication with an external device, such as a smartphone or other device used in a pharmacy or by a healthcare provider.

[0095] In other embodiments of the therapeutic agent delivery device 600, the device 600 has the function of sensing the temperature of the therapeutic agent 106 and notifying the user when the therapeutic agent 106 reaches a suitable injection temperature. Since some medications require refrigerated storage, a preheating time is sometimes necessary to ensure the medication reaches a sufficient injection temperature. Furthermore, in some embodiments, the therapeutic agent delivery device 600 is able to sense and track the temperature of the therapeutic agent 106 during storage, transport, and use to identify temperature deviations that may degrade the quality of the therapeutic agent 106. In some embodiments, the temperature of the therapeutic agent 106 is inferred from the temperature of the glass container or tubular part holding the therapeutic agent 106 within the syringe holder 604. In some embodiments, the temperature measurements described herein are accurate to within 1 degree Celsius of the actual temperature of the therapeutic agent 106.

[0096] Various configurations of temperature sensing include an infrared (“IR”) sensor in the reusable portion 602 or a user-readable reusable portion 602, a thermistor in the reusable portion 602, a wireless sensor (e.g., NFC and digital temperature sensor) in the syringe holder 604, a contact-based sensor (e.g., digital or NTC analog temperature sensor, EEPROM and NTC analog temperature sensor, EEPROM and digital temperature sensor, etc.) in the syringe holder 604, and a thermochromic label in the syringe holder 604.

[0097] Figure 39 An example of an infrared sensor 660 is shown, mounted within the reusable portion 602 adjacent to the inner wall 614, for detecting the temperature of the syringe assembly's cylindrical member 504. The infrared sensor 660 provides a signal indicative of the temperature of the cylindrical member 504 to a controller 136, which infers the temperature of the therapeutic agent 506. In this way, the reusable portion 602 can immediately determine the temperature of the therapeutic agent 506 when the syringe holder 604 is inserted into it. In some embodiments, an infrared-transmitting material is used to seal the surface of the infrared sensor 660.

[0098] In another embodiment, the NFC tag 142 includes an internal integrated circuit (“I2C”) digital temperature sensor 662 and has I2C communication capability powered by energy harvesting functionality within the NFC tag 142. In one example, the NFC tag 142 includes an I2C interface chip (such as NXP NTP53321G0JHKZ) and an I2C temperature sensor 662 (such as Maxim MAX31875R1TZS+T).

[0099] In yet another embodiment and reference Figure 40A The syringe holder 604 includes a temperature sensor 664 and a storage device 666 in an NFC tag 142 to record the temperature of the therapeutic agent 506 within the syringe holder 604 from initial packaging / packaging and shipping to the time of injection. The temperature history of the therapeutic agent 506 is transmitted via an NFC antenna 668 on the syringe holder 604 and an NFC antenna 670 in the syringe holder packaging 672 to an NFC reader 674 in the packaging 672. This data can be processed by a microcontroller 676 in the packaging 672. Power for the components within the packaging 672 is provided by an energy storage device such as a battery 678 via a power management circuit 680. When using or nearing use of the syringe holder 604, the temperature data is provided wirelessly to a reusable portion 602 or a remote device such as a user telephone 682 to indicate whether the therapeutic agent 506 is safe to use (i.e., it has not experienced unacceptable temperature conditions prior to use). Alternatively, as... Figure 40BAs shown, temperature sensor 664 may be part of syringe support package 672, rather than part of syringe support 604.

[0100] In another embodiment of the therapeutic agent delivery device 600, the reusable portion 602 includes a sleep / wake function. (Return to Reference) Figure 35 In some embodiments, controller 136 may be connected to timer 663 and usage sensor 664 on reusable portion 602. Usage sensor 664 may be an accelerometer, contact sensor, mechanical sensor, or other suitable sensor that is triggered (i.e., activated) when reusable portion 602 is moved (e.g., when reusable portion 602 is picked up by a user). When usage sensor 664 is activated, it provides a “wake-up” or usage signal to controller 136, causing controller 136 to transition from a low-power sleep mode to a usage mode. This, in turn, causes controller 136 to communicate with power supply 138 to power other components of reusable portion 602.

[0101] When use of the reusable portion 602 is detected, the use sensor 664 also signals the timer 663. When the timer 663 no longer receives a signal from the use sensor 664 indicating use of the reusable portion 602, the timer 663 begins a countdown. If the timer 663 receives a signal from the use sensor 664 during the countdown, the timer 663 resets the countdown. If the countdown time is reached without a signal from the use sensor 664, the timer 663 provides a sleep signal to the controller 136, which interprets this signal as a command to enter sleep mode. The controller 136 responds by communicating with the power supply 138 and putting it into a low-power sleep mode.

[0102] While the invention has been shown and described with preferred embodiments, modifications may be made to the invention within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or modifications of the invention using its general principles. Furthermore, this application is intended to cover deviations from this disclosure in known or conventional practice within the art to which this invention pertains.

[0103] This invention specification describes several aspects, including but not limited to the following: A therapeutic agent delivery device includes: a reusable portion comprising: a housing having a distal end; a cam ring rotatably movable within the housing by means of a drive mechanism; a printed circuit board assembly comprising: a printed circuit board disposed adjacent to the distal end of the housing, a first sensing element, a second sensing element, and a controller operatively communicating with the first sensing element, the second sensing element, and the drive mechanism; and at least one indicator mounted on the housing; and a syringe holder comprising: a base cover removably connected to the syringe assembly, the syringe assembly being configured to receive a therapeutic agent; and a third sensing element positioned substantially aligned with the first sensing element when the syringe holder is inserted into the reusable portion, the third sensing element including a memory device. The memory device contains identification information about at least one of the therapeutic agent and the user associated with the reusable portion; wherein, when the syringe holder is inserted into the reusable portion, a first sensing element provides the identification information received from a third sensing element to a controller, and the controller, upon verifying the identification information, activates a drive mechanism to rotate a cam ring, thereby locking the syringe holder to the reusable portion, and activates the at least one indicator to instruct the user to remove the base cap and place the distal end of the housing into contact with the user's skin; and wherein, when the distal end of the housing is placed into contact with the user's skin, a second sensing element provides at least one contact signal to the controller, and the controller, upon determining that the at least one contact signal indicates permissible contact, activates at least one indicator to notify the user that the therapeutic agent delivery device is ready to inject the therapeutic agent.

[0104] According to aspect 1, the therapeutic agent delivery device, wherein the first sensing element is an NFC coil reader and the third sensing element is an NFC tag.

[0105] According to any one of aspects 1-2, the therapeutic agent delivery device includes a second sensing element comprising a plurality of capacitive sensing pads disposed on a printed circuit board radially outside the first sensing element.

[0106] According to any one of aspects 1-3, in the therapeutic agent delivery device, a third sensing element is attached to the upper wall of the base cover, and when the syringe holder is inserted into the reusable portion, the third sensing element is substantially parallel to and vertically aligned with the first sensing element.

[0107] According to any one of aspects 1-4, in the therapeutic agent delivery device, when the syringe holder is inserted into the reusable portion, the third sensing element is attached to the outer wall of the syringe holder in an orientation substantially perpendicular and coplanar with respect to the first sensing element.

[0108] According to any one of aspects 1-5, in the therapeutic agent delivery device, when the base cover is removed, a first sensing element provides a missing signal to the controller indicating the absence of the base cover, and when the controller receives the missing signal and determines that the at least one contact signal indicates permissible contact, it activates the at least one indicator to notify the user that the therapeutic agent delivery device is ready to inject a therapeutic agent.

[0109] According to any one of aspects 1-6, the therapeutic agent delivery device includes an inner wall, an outer wall, and a lower wall, the inner wall, the outer wall, and the lower wall at least partially defining a cavity, and a printed circuit board mounted on the lower wall within the cavity.

[0110] According to aspect 7, the therapeutic agent delivery device comprises an inner wall and a lower wall forming a cylindrical opening for receiving a syringe holder, the printed circuit board extending substantially around the cylindrical opening.

[0111] According to aspect 8, the therapeutic agent delivery device includes three capacitive sensing pads arranged symmetrically at 120 degrees to the outer periphery of the printed circuit board.

[0112] According to any one of aspects 1-9, the therapeutic agent delivery device, wherein the identification information includes at least one of the type, volume, batch number, concentration and expiration date of the therapeutic agent.

[0113] According to any one of aspects 1-10, in a therapeutic agent delivery device, the third sensing element includes an antenna configured to transmit the identification information.

[0114] According to any one of aspects 1-11, in a therapeutic agent delivery device, the distal end of a permissible contact indication reusable portion indicated by the at least one contact signal is in contact with the user's skin or at a distance from the user's skin within a maximum permissible offset range, and the tilt angle between the distal end and the user's skin is within a permissible tilt angle range.

[0115] According to aspect 2, the therapeutic agent delivery device wherein the NFC coil reader is configured to wirelessly receive power from a base station including an NFC transmitter chip to charge the power supply of the reusable portion.

[0116] According to any one of aspects 1-13, the therapeutic agent delivery device further includes a temperature sensor mounted on the housing to detect the temperature of the therapeutic agent-containing cylindrical part of the syringe assembly.

[0117] According to aspect 14, the therapeutic agent delivery device, wherein the temperature sensor is an infrared sensor.

[0118] According to any one of aspects 1-15, in a therapeutic agent delivery device, the third sensing element includes a temperature sensor and an interface chip to provide temperature information about the therapeutic agent to the first sensing element.

[0119] According to any one of aspects 1-16, the therapeutic agent delivery device further includes a temperature sensor and an antenna to transmit temperature information about the therapeutic agent to at least one of a reusable portion and a remote device.

[0120] According to aspect 17, the therapeutic agent delivery device includes a third sensing element comprising a temperature sensor, an antenna, and a memory device connected to the temperature sensor to store temperature information.

[0121] According to any one of aspects 1-18, the therapeutic agent delivery device further includes a reusable portion that provides a usage sensor to a controller in response to detecting movement of the reusable portion, the controller being configured to switch from a low-power sleep mode to a usage mode in response to receiving the usage signal.

[0122] According to aspect 19, the therapeutic agent delivery device further includes a reusable portion that communicates with the usage sensor to receive a usage signal, the timer being configured to provide a sleep signal to a controller when a countdown time is reached after receiving the usage signal, the controller switching from the usage mode to the low-power sleep mode in response to receiving the sleep signal.

[0123] A method for controlling the operation of a therapeutic agent delivery device, the therapeutic agent delivery device including a reusable portion and a syringe holder, the method comprising: receiving identification information via a first sensing element disposed in the reusable portion and a third sensing element disposed in the syringe holder, the identification information relating to at least one of a therapeutic agent contained within the syringe holder and a user associated with the reusable portion, upon insertion of the syringe holder into the reusable portion; verifying the identification information in response to rotating a cam ring of the reusable portion, wherein rotating the cam ring locks the syringe holder to the reusable portion and activates at least one indicator to instruct a user to remove a base cap of the syringe holder and position the distal end of the reusable portion in contact with the user's skin; determining whether the distal end of the reusable portion is in permissible contact with the user's skin based on at least one contact signal received from a second sensing element disposed in the reusable portion; and responding to the determination of permissible contact by activating at least one indicator, wherein activating at least one indicator notifies the user that the therapeutic agent delivery device is ready to inject a therapeutic agent.

[0124] According to the method of aspect 21, the first sensing element is an NFC coil reader, the second sensing element includes a plurality of capacitive sensing pads, the third sensing element is an NFC tag, and the first and second sensing elements are disposed on a printed circuit board remotely positioned adjacent to the reusable portion.

[0125] A reusable portion of a therapeutic agent delivery device includes: a housing having a lower wall located at a distal end of the reusable portion, the lower wall surrounding a cylindrical opening configured to receive a syringe holder; a ring rotatably movable within the housing by means of a drive mechanism; a printed circuit board assembly including a printed circuit board attached to the lower wall, the printed circuit board assembly including a controller, an NFC coil reader mounted on the printed circuit board, and a capacitive skin sensor mounted on the printed circuit board; and at least one indicator mounted on the housing; wherein the NFC coil reader is configured to receive a syringe holder when inserted into the cylindrical opening. The system detects the presence of an NFC tag attached to the syringe holder and provides a presence signal to the controller, which is then configured to activate a drive mechanism to rotate a ring, thereby locking the syringe holder to the reusable portion. The controller is also configured to activate at least one indicator to instruct the user to remove the base cover of the syringe holder and place the distal end of the housing into contact with the user's skin. Furthermore, when the distal end is placed into contact with the user's skin, a capacitive skin sensor provides at least one contact signal to the controller. Upon determining that the at least one contact signal indicates permissible contact, the controller is configured to activate the at least one indicator to notify the user that the therapeutic delivery device is ready to inject a therapeutic agent.

[0126] According to aspect 23, the reusable portion includes a plurality of capacitive sensing pads disposed on the printed circuit board radially outside the NFC coil reader.

[0127] According to any of aspects 23-24, the reusable portion wherein the NFC coil reader is positioned within the housing such that, when the syringe holder is inserted into the cylindrical opening, the NFC coil reader is substantially parallel to and vertically aligned with the NFC tag.

[0128] According to any of aspects 23-25, the reusable portion wherein the NFC coil reader is positioned within the housing such that, when the syringe holder is inserted into the cylindrical opening, the NFC coil reader is substantially perpendicular to and coplanar with the NFC tag.

[0129] According to any of aspects 23-26, the reusable portion wherein, upon removal of the base cover, the NFC coil reader provides a missing signal to the controller, which is then configured to activate the at least one indicator to instruct the user to place the distal end of the housing into contact with the user's skin.

[0130] According to any of aspects 23-27, the reusable portion further includes an inner wall and an outer wall that, together with the lower wall, at least partially define a cavity, in which the printed circuit board is mounted on the lower wall.

[0131] According to any of aspects 23-28, the reusable portion wherein the printed circuit board is a ring-shaped printed circuit board extending substantially around a cylindrical opening.

[0132] According to any of aspects 23-29, the reusable portion includes a capacitive skin sensor comprising three sensing pads arranged in a substantially symmetrical manner adjacent to the outer periphery of a printed circuit board.

[0133] According to any of aspects 23-30, in the reusable portion, when the syringe holder is inserted into the cylindrical opening, the NFC coil reader is configured to receive identification information from the NFC tag regarding at least one of the therapeutic agent and the user, and the controller verifies the identification information before activating the drive mechanism.

[0134] According to aspect 31, the reusable portion includes at least one of the following: type, volume, batch number, concentration, and expiration date of the therapeutic agent.

[0135] According to any one of aspects 23-32, the reusable portion is wherein the permissible contact indication indicated by the at least one contact signal is that the distal end of the housing is in contact with the user's skin or the distance to the user's skin is within the maximum permissible offset range, and the tilt angle between the distal end and the user's skin is within the permissible tilt angle range.

[0136] The reusable portion according to any one of aspects 23-33 also includes a power source, and the NFC coil reader is configured to wirelessly receive power from a base station including an NFC transmitter chip to charge the power source.

[0137] The reusable portion according to any one of aspects 23-34 also includes a temperature sensor mounted on the housing to detect the temperature of the cylindrical portion containing the therapeutic agent in the syringe holder.

[0138] According to aspect 35, the reusable portion wherein the temperature sensor is an infrared sensor.

[0139] The reusable portion according to any one of aspects 23-36 further includes a usage sensor that provides a usage signal to a controller when it detects movement of the reusable portion, the controller being configured to switch from a low-power sleep mode to a usage mode in response to receiving the usage signal.

[0140] The reusable portion according to aspect 37 further includes a timer that communicates with the usage sensor to receive a usage signal, the timer being configured to provide a sleep signal to the controller when a countdown time is reached after receiving the usage signal, the controller being configured to switch from the usage mode to the low-power sleep mode in response to receiving the sleep signal.

[0141] According to any of aspects 23-38, the reusable portion is wherein the printed circuit board is an annular printed circuit board extending substantially around a cylindrical opening, wherein the capacitive skin sensor includes three sensing pads arranged in a substantially symmetrical manner adjacent to the outer periphery of the annular printed circuit board, wherein the NFC coil reader is positioned along an inner region of the annular printed circuit board, the inner region being arranged radially inward relative to the outer periphery.

[0142] According to aspect 39, the reusable portion wherein the NFC coil reader is radially separated from the three sensing pads by a separation region.

[0143] The reusable portion according to aspect 40 further includes a power source, wherein the NFC coil reader is configured to receive identification information in response to inserting a syringe holder into a cylindrical opening, and the NFC coil reader is configured to wirelessly receive power from a base station including an NFC transmitter chip to charge the power source in response to removing the syringe holder from the cylindrical opening and mounting the reusable portion to a base station.

[0144] A therapeutic agent delivery device includes: a reusable portion according to any one of aspects 23-41; and a syringe holder insertable into the cylindrical opening, the syringe holder including a channel for holding the therapeutic agent and an NFC tag positioned substantially aligned with an NFC coil reader when the syringe holder is inserted into the reusable portion; a third sensing element including a memory device containing identification information about at least one of the therapeutic agent and a user associated with the reusable portion.

[0145] According to aspect 1 or 42, the therapeutic agent delivery device includes a syringe holder that holds the therapeutic agent.

Claims

1. A therapeutic agent delivery device, the therapeutic agent delivery device comprising: The reusable portion includes: A housing with a distal end; A cam ring, which can be rotatably moved within a housing by means of a drive mechanism; A printed circuit board assembly, the printed circuit board assembly comprising: a printed circuit board disposed distal to a housing, a first sensing element, a second sensing element, and a controller operably in communication with the first sensing element, the second sensing element, and a drive mechanism; and At least one indicator mounted on the housing; and Syringe support, the syringe support comprising: A base cap removably connected to a syringe assembly configured to contain a therapeutic agent; and A third sensing element, positioned substantially aligned with a first sensing element when the syringe holder is inserted into the reusable portion, includes a memory device containing identification information about the therapeutic agent and at least one of the users associated with the reusable portion. When the syringe holder is inserted into the reusable portion, the first sensing element provides identification information received from the third sensing element to the controller. Upon verification of the identification information, the controller activates a drive mechanism to rotate the cam ring, thereby locking the syringe holder into the reusable portion and activating at least one indicator to instruct the user to remove the base cap and position the distal end of the housing in contact with the user's skin. When the distal end of the housing is placed in contact with the user's skin, the second sensing element provides at least one contact signal to the controller, and the controller activates at least one indicator when it determines that the at least one contact signal indicates permissible contact to notify the user that the therapeutic delivery device is ready to inject the therapeutic agent.

2. The therapeutic agent delivery device according to claim 1, wherein, The first sensing element is an NFC coil reader, and the third sensing element is an NFC tag.

3. The therapeutic agent delivery device according to claim 1 or 2, wherein, The second sensing element includes multiple capacitive sensing pads disposed on a printed circuit board on the radially outer side of the first sensing element.

4. The therapeutic agent delivery device according to any one of claims 1-3, wherein, The third sensing element is attached to the upper wall of the base cover, and when the syringe support is inserted into the reusable part, the third sensing element is substantially parallel to and vertically aligned with the first sensing element.

5. The therapeutic agent delivery device according to any one of claims 1-4, wherein, When the syringe holder is inserted into the reusable portion, the third sensing element is attached to the outer wall of the syringe holder in a substantially perpendicular and coplanar orientation relative to the first sensing element.

6. The therapeutic agent delivery device according to any one of claims 1-5, wherein, When the base cover is removed, the first sensing element provides a missing signal to the controller indicating the absence of the base cover, and when the controller receives the missing signal and determines that the at least one contact signal indicates permissible contact, it activates the at least one indicator to notify the user that the therapeutic delivery device is ready to inject the therapeutic agent.

7. The therapeutic agent delivery device according to any one of claims 1-6, wherein, The housing includes an inner wall, an outer wall, and a lower wall, which at least partially define a cavity in which a printed circuit board is mounted on the lower wall.

8. The therapeutic agent delivery device according to claim 7, wherein, The inner wall and the lower wall form a cylindrical opening for receiving a syringe support, and the printed circuit board extends substantially around the cylindrical opening.

9. The therapeutic agent delivery device according to claim 8, wherein, The second sensing element includes three capacitive sensing pads arranged symmetrically at 120 degrees to the outer periphery of the printed circuit board.

10. The therapeutic agent delivery device according to any one of claims 1-9, wherein, The identification information includes at least one of the following: type, volume, batch number, concentration, and expiration date of the therapeutic agent.

11. The therapeutic agent delivery device according to any one of claims 1-10, wherein, The third sensing element includes an antenna configured to transmit the identification information.

12. The therapeutic agent delivery device according to any one of claims 1-11, wherein, The distal end of the reusable portion of the permissible contact indication, indicated by the at least one contact signal, is in contact with the user's skin or at a distance from the user's skin within the maximum permissible offset range, and the tilt angle between the distal end and the user's skin is within the permissible tilt angle range.

13. The therapeutic agent delivery device according to claim 2, wherein, The NFC coil reader is configured to wirelessly receive power from a base station that includes an NFC transmitter chip to charge the power supply of the reusable portion.

14. The therapeutic agent delivery device according to any one of claims 1-13, wherein, The reusable portion also includes a temperature sensor mounted to the housing to detect the temperature of the syringe assembly's tubular portion containing the therapeutic agent.

15. The therapeutic agent delivery device according to claim 14, wherein, The temperature sensor is an infrared sensor.

16. The therapeutic agent delivery device according to any one of claims 1-15, wherein, The third sensing element includes a temperature sensor and an interface chip to provide the first sensing element with temperature information about the therapeutic agent.

17. The therapeutic agent delivery device according to any one of claims 1-16, wherein, The syringe holder also includes a temperature sensor and an antenna to transmit temperature information about the therapeutic agent to at least one of the reusable portion and the remote device.

18. The therapeutic agent delivery device according to claim 17, wherein, The third sensing element includes a temperature sensor, an antenna, and a memory device connected to the temperature sensor to store temperature information.

19. The therapeutic agent delivery device according to any one of claims 1-18, wherein, The reusable portion also includes a usage sensor that provides a usage signal to a controller in response to detecting movement of the reusable portion. The controller is configured to switch from a low-power sleep mode to a usage mode in response to receiving the usage signal.

20. The therapeutic agent delivery device according to claim 19, wherein, The reusable portion also includes a timer that communicates with the usage sensor to receive a usage signal, the timer being configured to provide a sleep signal to the controller when a countdown time is reached after receiving the usage signal, the controller switching from the usage mode to the low-power sleep mode in response to receiving the sleep signal.

21. A method for controlling the operation of a therapeutic agent delivery device, the therapeutic agent delivery device comprising a reusable portion and a syringe holder, the method comprising: When the syringe holder is inserted into the reusable portion, identification information is received from a third sensing element disposed in the syringe holder via a first sensing element disposed in the reusable portion. The identification information relates to at least one of the therapeutic agent contained in the syringe holder and the user associated with the reusable portion. The verification of identification information is responded to by rotating the cam ring of the reusable part, wherein rotating the cam ring locks the syringe holder to the reusable part and activates at least one indicator to instruct the user to remove the base cover of the syringe holder and place the distal end of the reusable part into contact with the user's skin. Based on at least one contact signal received from a second sensing element disposed in the reusable portion, it is determined whether the distal end of the reusable portion is in permissible contact with the user's skin. and The determination of permissible contact is responded to by activating at least one indicator, wherein activation of at least one indicator notifies the user that the therapeutic agent delivery device is ready to inject the therapeutic agent.

22. The method according to claim 21, wherein, The first sensing element is an NFC coil reader, the second sensing element includes multiple capacitive sensing pads, and the third sensing element is an NFC tag. The first and second sensing elements are disposed on a printed circuit board remotely positioned adjacent to the reusable portion.

23. A reusable portion of a therapeutic agent delivery device, comprising: A housing, the housing including a lower wall located at the distal end of the reusable portion, the lower wall surrounding a cylindrical opening configured to receive a syringe support; A ring, which can rotate within the housing by means of a drive mechanism; A printed circuit board assembly, the printed circuit board assembly including a printed circuit board attached to the lower wall, the printed circuit board assembly including a controller, an NFC coil reader mounted on the printed circuit board, and a capacitive skin sensor mounted on the printed circuit board; and At least one indicator mounted on the housing; Specifically, when the syringe holder is inserted into the cylindrical opening, the NFC coil reader is configured to detect the presence of an NFC tag attached to the syringe holder and provide a presence signal to the controller. The controller is then configured to activate a drive mechanism to rotate a ring, thereby locking the syringe holder into the reusable portion. The controller is also configured to activate at least one indicator to instruct the user to remove the base cover of the syringe holder and position the distal end of the housing in contact with the user's skin. When the distal end is placed in contact with the user's skin, the capacitive skin sensor provides at least one contact signal to the controller. When the controller determines that the at least one contact signal indicates permissible contact, it is configured to activate the at least one indicator to notify the user that the therapeutic delivery device is ready to inject the therapeutic agent.

24. The reusable portion according to claim 23, wherein, The capacitive skin sensor includes multiple capacitive sensing pads disposed on a printed circuit board on the radially outer side of the NFC coil reader.

25. The reusable portion according to claim 23 or 24, wherein, The NFC coil reader is positioned within the housing such that when the syringe holder is inserted into the cylindrical opening, the NFC coil reader is substantially parallel to and vertically aligned with the NFC tag.

26. The reusable portion according to any one of claims 23-25, wherein, The NFC coil reader is positioned within the housing such that, when the syringe holder is inserted into the cylindrical opening, the NFC coil reader is substantially perpendicular to and coplanar with the NFC tag.

27. The reusable portion according to any one of claims 23-26, wherein, When the base cover is removed, the NFC coil reader provides a missing signal to the controller, which is then configured to activate the at least one indicator to instruct the user to place the distal end of the housing into contact with the user's skin.

28. The reusable portion according to any one of claims 23-27, wherein, The housing also includes an inner wall and an outer wall, which together with the lower wall at least partially define a cavity, within which the printed circuit board is mounted on the lower wall.

29. The reusable portion according to any one of claims 23-28, wherein, A printed circuit board is a ring-shaped printed circuit board that extends essentially around a cylindrical opening.

30. The reusable portion according to any one of claims 23-29, wherein, The capacitive skin sensor includes three sensing pads arranged in a substantially symmetrical manner adjacent to the outer periphery of a printed circuit board.

31. The reusable portion according to any one of claims 23-30, wherein, When the syringe holder is inserted into the cylindrical opening, the NFC coil reader is configured to receive identification information from the NFC tag about at least one of the therapeutic agent and the user, and the controller verifies the identification information before activating the drive mechanism.

32. The reusable portion according to claim 31, wherein, Identification information includes at least one of the following: type of therapeutic agent, volume, batch number, concentration, and expiration date.

33. The reusable portion according to any one of claims 23-32, wherein, The permissible contact indication indicated by the at least one contact signal is that the distal end of the housing is in contact with the user's skin or the distance to the user's skin is within the maximum permissible offset range, and the tilt angle between the distal end and the user's skin is within the permissible tilt angle range.

34. The reusable portion according to any one of claims 23-33 further includes a power source, wherein the NFC coil reader is configured to wirelessly receive power from a base station including an NFC transmitter chip to charge the power source.

35. The reusable portion according to any one of claims 23-34 further includes a temperature sensor mounted to the housing to detect the temperature of the syringe holder containing the therapeutic agent.

36. The reusable portion according to claim 35, wherein, The temperature sensor is an infrared sensor.

37. The reusable portion according to any one of claims 23-36, further comprising a usage sensor that provides a usage signal to a controller upon detecting movement of the reusable portion, the controller being configured to switch from a low-power sleep mode to a usage mode in response to receiving the usage signal.

38. The reusable portion of claim 37 further includes a timer communicating with the usage sensor to receive a usage signal, the timer being configured to provide a sleep signal to the controller when a countdown time is reached after receiving the usage signal, the controller being configured to switch from the usage mode to the low-power sleep mode in response to receiving the sleep signal.

39. The reusable portion according to any one of claims 23-38, wherein, The printed circuit board is a ring-shaped printed circuit board that extends substantially around a cylindrical opening. The capacitive skin sensor includes three sensing pads arranged in a substantially symmetrical manner adjacent to the outer periphery of the ring-shaped printed circuit board. An NFC coil reader is positioned along an inner region of the ring-shaped printed circuit board, which is radially inward relative to the outer periphery.

40. The reusable portion according to claim 39, wherein, The NFC coil reader is radially separated from the three sensing pads by a separation region.

41. The reusable portion of claim 40 further includes a power supply, wherein, The NFC coil reader is configured to receive identification information in response to inserting a syringe holder into a cylindrical opening, and the NFC coil reader is configured to wirelessly receive power from a base station including an NFC transmitter chip to charge the power source in response to removing the syringe holder from the cylindrical opening and mounting the reusable portion to a base station.

42. A therapeutic agent delivery device, comprising: The reusable portion according to any one of claims 23-41; as well as A syringe holder that can be inserted into the cylindrical opening includes a channel for holding therapeutic agents and an NFC tag, the NFC tag being positioned substantially aligned with an NFC coil reader when the syringe holder is inserted into the reusable portion; The third sensing element includes a memory device containing identification information about at least one of the therapeutic agent and the user associated with the reusable portion.

43. The therapeutic agent delivery device according to claim 1 or 42, wherein, The syringe support includes a channel for holding the therapeutic agent.

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