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WO2025058976A1 - Dispositif d'administration d'agent thérapeutique à commandes - Google Patents

Dispositif d'administration d'agent thérapeutique à commandes Download PDF

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Publication number
WO2025058976A1
WO2025058976A1 PCT/US2024/045796 US2024045796W WO2025058976A1 WO 2025058976 A1 WO2025058976 A1 WO 2025058976A1 US 2024045796 W US2024045796 W US 2024045796W WO 2025058976 A1 WO2025058976 A1 WO 2025058976A1
Authority
WO
WIPO (PCT)
Prior art keywords
therapeutic agent
reusable portion
syringe carrier
delivery device
sensing element
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/045796
Other languages
English (en)
Inventor
Adam Taylor FARWICK
Andrew Mark SCHIMMOELLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eli Lilly and Co
Original Assignee
Eli Lilly and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eli Lilly and Co filed Critical Eli Lilly and Co
Publication of WO2025058976A1 publication Critical patent/WO2025058976A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • A61M2205/103—General characteristics of the apparatus with powered movement mechanisms rotating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6009—General characteristics of the apparatus with identification means for matching patient with his treatment, e.g. to improve transfusion security
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A61M2205/8212—Internal energy supply devices battery-operated with means or measures taken for minimising energy consumption

Definitions

  • the present disclosure pertains to therapeutic agent delivery devices, and, in particular, to a portable therapeutic agent delivery device such as an injector pen.
  • injector pens Patients suffering from a number of different diseases frequently must inject themselves with medication.
  • injector pens a variety of devices broadly known as injector pens have been developed. Generally, these devices are equipped with a cartridge including a piston and one or more doses of liquid medication.
  • a drive member extending from within a base of the injector pen and operably connected with typically more rearward mechanisms of the pen that control drive member motion, is movable forward to advance the piston in the cartridge in such a manner to dispense the contained medication from an outlet at the opposite cartridge end, typically through a needle that penetrates a stopper at that opposite end.
  • a therapeutic agent delivery device includes a reusable portion that has a housing having a distal end.
  • a cam ring is rotatably movable in the housing by a drive mechanism.
  • a printed circuit board assembly includes a printed circuit board disposed adjacent the distal end of the housing, a first sensing element, a second sensing element and a controller in operable communication with the first and second sensing elements and the drive mechanism.
  • At least one indicator is mounted to the housing.
  • the device includes a syringe carrier that includes a base cap removably connected to a syringe assembly containing a therapeutic agent.
  • a third sensing element is located to substantially align with the first sensing element upon insertion of the syringe carrier into the reusable portion.
  • the third sensing element includes a memory device containing identification information about at least one of the therapeutic agent and a user associated with the reusable portion.
  • the first sensing element Upon insertion of the syringe carrier into the reusable portion, the first sensing element provides the identification information received from the third sensing element to the controller.
  • the controller upon verification of the identification information, activates the drive mechanism to rotate the cam ring to lock the syringe carrier 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 in contact with the user’s skin.
  • the second sensing element Upon placement of the distal end of the housing in contact with the user’s skin, the 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 acceptable contact, activates the at least one indicator to inform the user that the therapeutic agent delivery device is ready for injecting the therapeutic agent.
  • a method for controlling operation of a therapeutic agent delivery device including a reusable portion and a syringe carrier, including one or more of the following steps.
  • a reusable portion of a therapeutic agent delivery device is disclosed.
  • the device includes a housing including a lower wall at a distal end of the reusable portion.
  • the lower wall surrounds a cylindrical opening configured to receive a syringe carrier.
  • a ring is rotatably movable in the housing by 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 to the housing.
  • the NFC coil reader Upon insertion of the syringe carrier into the cylindrical opening, the NFC coil reader is configured to detect the presence of an NFC tag mounted to the syringe carrier and to provide a presence signal to the controller, which in turn is configured to activate the drive mechanism to rotate the ring, thereby locking the syringe carrier to the reusable portion.
  • the controller is further configured to activate the at least one indicator to instruct a user to remove a base cap of the syringe carrier and place the distal end of the housing in contact with the user’s skin.
  • the capacitive skin sensor Upon placement of the distal end in contact with the user’s skin, the capacitive skin sensor provides at least one contact signal to the controller, which, upon a determination of that the at least one contact signal indicates acceptable contact, is configured to activate the at least one indicator to inform the user that the therapeutic agent delivery device is ready to inject a therapeutic agent.
  • FIG. 1 is a top perspective view of a therapeutic agent delivery device according to an embodiment of the present disclosure
  • FIG. 2 is a bottom perspective view of the therapeutic agent delivery device of FIG. 1 with a disposable portion is shown detached from a reusable portion;
  • FIG. 3 is a transverse sectional view of the therapeutic agent delivery device along line 3-3 of FIG. 1 with a syringe assembly is shown in a stowed configuration;
  • FIG. 4 is a transverse sectional view of a distal end of the therapeutic agent delivery device of FIG. 1 with the syringe assembly is shown in a deployed configuration
  • FIG. 6 is a detail transverse sectional view of a proximal end of the therapeutic agent delivery device within line 6 of FIG. 3;
  • FIG. 7 is a cross sectional view of the proximal end of the therapeutic agent delivery device along line 7-7 of FIG. 1;
  • FIG. 8 is a cross sectional view of the proximal end of the therapeutic agent delivery device along line 8-8 of FIG. 1;
  • FIG. 10 is a detail transverse sectional view of the therapeutic agent delivery device within line 10 of FIG. 3;
  • FIG. 11 is a perspective view of a therapeutic agent delivery device according to another embodiment of the present disclosure.
  • FIG. 12 is a side view of the therapeutic agent delivery device of FIG. 11;
  • FIG. 13 is a side view of the therapeutic agent delivery device of FIG. 11 with a disposable portion removed from the reusable portion;
  • FIG. 14 is an exploded perspective view of the disposable portion of FIG. 13;
  • FIGS. 15 through 18 are side views of the therapeutic agent delivery device of FIG. 11 in various configurations
  • FIG. 19 is a perspective view of portions of the therapeutic agent delivery device of FIG. 11 and corresponding to the configuration depicted in FIG. 15;
  • FIG. 20 is a perspective view of portions of the therapeutic agent delivery device of FIG. 11 and corresponding to the configuration depicted in FIG. 16;
  • FIG. 21 is an exploded side view of a therapeutic agent delivery device according to another embodiment of the present disclosure.
  • FIG. 22 is a perspective view of certain components of the therapeutic agent delivery device of FIG. 21;
  • FIGS. 23 and 24 are a detailed perspective views of certain components of the therapeutic agent delivery device of FIG. 21;
  • FIGS. 25 through 33 are side views of the therapeutic agent delivery device of FIG. 21 in various configurations.
  • FIG. 34 is a side view of a therapeutic agent delivery device according to another embodiment of the present disclosure.
  • FIG. 35 is a schematic view of components of the therapeutic agent delivery device of FIG. 34;
  • FIG. 36 is a bottom plan view of a printed circuit board assembly including a skin sensor for use with the therapeutic agent delivery device of FIG. 34;
  • FIG. 37 is a schematic view of a therapeutic agent delivery device and base station according to one embodiment of the present disclosure.
  • FIG. 38 is a side view of the therapeutic agent delivery device and base station of FIG. 37;
  • FIG. 39 is a side view of a therapeutic agent delivery device according to another embodiment of the present disclosure.
  • FIGs. 40A and 40B are schematic views of components of a system for monitoring and communicating temperature information regarding a therapeutic agent.
  • Therapeutic agent delivery devices carry and dispense one or more therapeutic agents, which may also be referred to as medications or drugs.
  • therapeutic agents may include, for example, epinephrine, anaesthetics, analgesics, steroids, insulins, 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 polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP/GLP-1 agonists such as tirzepatide, basal insulins, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies including but not limited to IL -23 antibody analogs or derivatives, such as mirikizumab, IL-17 antibody analogs or derivatives, such as ixekizumab, therapeutic agents for pain-related treatments, such as galcanzeum
  • FIGS. 1-4 illustrate a therapeutic agent delivery device 100 according to an exemplary embodiment of the present disclosure.
  • the therapeutic agent delivery device 100 has an injector pen-like shape, although other shapes may alternatively be used.
  • the therapeutic agent delivery device 100 generally includes a reusable portion 102, which may also be referred to as a drive portion or a durable portion, and a disposable portion 104, which may also be referred to as a drug carrying portion, a cartridge or a syringe carrier.
  • the reusable portion 102 facilitates delivery of a therapeutic agent 106 (FIGS. 3 and 4) from the disposable portion 104.
  • the disposable portion 104 detachably couples to the reusable portion 102 such that after the therapeutic agent 106 has been delivered from the disposable portion 104, the disposable portion 104 may be detached from the reusable portion 102 and discarded.
  • Another disposable portion (not shown - for example, having the same or different features than the disposable portion 104) may then be attached to the reusable portion 102, and the therapeutic agent delivery device 100 is thereby ready for subsequent use.
  • the therapeutic agent delivery device 100 includes a proximal end 108 and an opposite distal end 110. During use of the therapeutic agent delivery device 100, the proximal end 108 would be further from the patient and configured to be actuated by the user, and the distal end 110 would be 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.
  • the reusable portion 102 includes a housing 112 that movably carries a user input 114 and a drive mechanism 116 (both shown in FIG. 3).
  • the user input 114 is actuatable (for example, depressible) by a user to actuate the drive mechanism 116.
  • the drive mechanism 116 thereby translates distally to drive a syringe assembly 118 of the disposable portion 104. More specifically, the drive mechanism 116 translatably drives the syringe assembly 118 from a stowed configuration (FIG. 3) to a deployed configuration (FIG.
  • a needle 120 of the syringe assembly 118 is disposed proximally relative to a distal end 122 of the disposable portion 104. Stated another way, in the stowed configuration the needle 120 is retracted within the device 100. In the deployed configuration (FIG. 4), the needle 120 at least partially extends distally from the distal end 122 of the disposable portion 104. As a result, in the deployed configuration the needle 120 is configured to pierce the skin of a patient.
  • the drive mechanism 116 of the reusable portion 102 also includes a plunger mechanism or therapeutic agent delivery mechanism 124.
  • the therapeutic agent delivery mechanism 124 is actuatable to discharge the therapeutic agent 106 from the syringe assembly 118. More specifically, when the syringe assembly 118 is in the deployed configuration, the therapeutic agent delivery mechanism 124 is actuatable to distally translate a shaft or plunger 126 of the syringe assembly 118.
  • the plunger 126 distally drives a piston 128 carried in a therapeutic agent-carrying passageway 130 of the syringe assembly 118, which causes the therapeutic agent 106 to be discharged via the needle 120.
  • the therapeutic agent delivery device 100 also includes an electronics assembly 134 that facilitates operating the device 100 in the manners described herein.
  • the electronics assembly 134 includes an electronic controller 136 that is operatively coupled to and receives power from a power source or supply 138, such as a battery.
  • the electronic controller 136 also operatively couples to the user input 114 and one or more sensors 140.
  • the sensors 140 may sense, for example, actuation of components of the device 100, positions of components of the device 100 relative to each other, and/or the position of the device 100 relative to a patient.
  • the controller 136 further operatively couples to the drive mechanism 116 (FIG. 3), the therapeutic agent delivery mechanism 124 (FIG. 3), and the securing mechanism 132 (FIG. 4).
  • the disposable portion 104 may include a tag 142 such as a Near Field Communication (NFC) tag installed in the base cap of the disposable portion 104 as is further described below.
  • NFC Near Field Communication
  • the tag 142 facilitates providing properties of the therapeutic agent 106 and/or the patient to an NFC coil reader (described below) of the reusable portion 102.
  • properties may include, for example, the type, volume, lot number, and/or concentration of the therapeutic agent 106 carried by the syringe assembly 118, and/or the position of the plunger 126.
  • the reusable portion 102 may use the properties of the therapeutic agent 106 to determine, for example, if a patient associated with the reusable portion 102 is authorized to use, or has been prescribed, the therapeutic agent 106.
  • logic or “control logic” or “application” as used herein may 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 logic, or combinations thereof. Therefore, in accordance with the embodiments, various logic may be implemented in any appropriate fashion and would remain in accordance with the embodiments herein disclosed.
  • ASICs application-specific integrated circuits
  • FPGAs field-programmable gate arrays
  • DSPs digital signal processors
  • the devices described herein may be connected (wired or wirelessly) to a computing device (not shown), which may include a mobile device, such as a smartphone.
  • a computing device may include a mobile device, such as a smartphone.
  • any suitable computing device may be used, including but not limited to a laptop, desktop, tablet, or server computer, for example.
  • the device/system/electronic electronics assembly 134 includes at least one processor that executes software and/or firmware stored in memory (not shown) of device.
  • the software/firmware code contains instructions that, when executed by processor, causes device/system/controller 136 to perform the functions described herein.
  • the at least one processor illustratively includes control logic/application operative to perform the functions described in detail later.
  • Memory is any suitable computer readable medium that is accessible by 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 memory includes random-access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, a magnetic storage device, optical disk storage, or any other suitable medium which is configured to store data and which is accessible by the processor.
  • Electronic electronics assembly 134 may include a communications module (not shown) that is used to transmit data to the computing device wirelessly, such as, for example, cellular, WIFI, Bluetooh, NFC or other suitable kinds of protocols.
  • Computing device/ smartphone includes a user interface in communication with a computing device processor and operative to provide user input data to the system and to receive and display data, information, and prompts generated by the system.
  • User interface includes at least one input device for receiving user input and providing the user input to the system.
  • the user interface may be a graphical user interface (GUI) including a touchscreen display operative to display data and receive user inputs.
  • GUI graphical user interface
  • the touchscreen display allows the user to interact with presented information, menus, buttons, and other data to receive information from the system and to provide user input into the system.
  • a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.
  • a disposable portion 104 may include a securing device 144 that is operably coupled to the controller 136.
  • the securing device 144 may initially inhibit the syringe assembly 118 from moving from the stowed configuration to the deployed configuration, and the controller 136 may actuate the securing device 144 to permit the syringe assembly 118 to move from the stowed configuration to the deployed configuration as is further described below.
  • each of the components of the electronics assembly 134 is carried by the reusable portion 102.
  • the controller 136 is operatively coupled to one or more of the other components of the electronics assembly 134 by a wired connection.
  • the controller 136 is operatively coupled to one or more of the other components of the electronics assembly 134 by a wireless connection.
  • the drive mechanism 116 includes a carriage 146 (FIG. 6) that is translatably carried in the housing 112 of the reusable portion 102.
  • the carriage 146 carries a first actuator 148 that operatively couples to the electronic controller 136 (FIG. 5).
  • the first actuator 148 may be a rotary actuator, more specifically an electric motor, that drivably couples to a transmission or speed reducer.
  • the actuator 148 drivably couples to a gear train 150, more specifically a first gear 152 that drivably couples to a second gear 154.
  • the second gear 154 is fixed relative to a follower 156, and the follower 156 is rotatably carried by the carriage 146.
  • the carriage 146, the actuator 148, the gear train 150, and the follower 156 are translatable together within the housing 112 of the reusable portion 102.
  • the carriage 146, the actuator 148, the gear train 150, and the follower 156 are translatable in a drive direction 158 (FIG. 6) that is substantially parallel to the longitudinal axis A of the device 100 (that is, parallel ⁇ 10 degrees).
  • the follower 156 movably couples to a guide 160, and the guide 160 is fixed relative to the housing 112 of the reusable portion 102.
  • a compression spring 162 urges the follower 156 distally and into engagement with the guide 160.
  • the follower 156 and the guide 160 include features that facilitate translating the follower 156 relative to the guide 160 as the follower 156 rotates relative to the guide 160 about a rotation axis R1 that is substantially parallel to the longitudinal axis A of the device 100 (that is, parallel ⁇ 10 degrees).
  • the follower 156 includes two radially-outwardly extending protrusions 164 that move along an angular track 166, or generally proximally-facing wall, defined by the guide 160 as the follower 156 is rotated by the actuator 148.
  • the protrusions 164 simultaneously move along two similar sections, or halves, of the track 166.
  • each half of the track 166 includes a plateau portion 168 that couples to a cliff portion 170 at an edge 172, a valley portion 174 coupled to the cliff portion 170 opposite the plateau portion 168, and a slope portion 176 coupled to the valley portion 174 opposite the cliff portion 170.
  • Each slope portion 176 also couples to the plateau portion 168 of the other half of the track 166.
  • the various portions of the track 166 are as follows.
  • the cliff portions 170 are substantially parallel to the longitudinal axis A of the device 100 (that is, parallel ⁇ 10 degrees).
  • the plateau portions 168 and the valley portions 174 are substantially perpendicular to the longitudinal axis A of the device 100 (that is, perpendicular ⁇ 10 degrees).
  • the slope portions 176 extend helically relative to the longitudinal axis A of the device 100.
  • the follower 156 and/or the guide 160 may have different forms.
  • the track 166 could have a different shape. More specifically, the track could include additional slope portions (not shown) instead of the cliff portions 170, and such slope portions could extend helically in the opposite directions as the slope portions 176.
  • the follower 156 could include a different number of protrusions 164 and/or the guide 160 could include a track 166 with a different number of similar sections.
  • the follower 156 could include a track 166 that movably receives one or more protrusions 164 formed on the guide 160.
  • the proximal end 108 of the device 100 also includes features for selectively inhibiting motion of the user input 114 relative to the housing 112 of the reusable portion 102 and, as a result, actuation of the user input 114.
  • the user input 114 includes snap hooks 178 that extend through openings 180 formed in the guide 160. The hooks 178 engage the guide 160 and hold the user input 114 in a depressed configuration relative to the housing 112.
  • the follower 156 includes legs 182 (FIG. 8) that engage and release the hooks 178 from the guide 160 as the follower 156 rotates relative to the guide 160.
  • a compression spring 184 expands and pushes the user input 114 to an elevated configuration relative to the housing 112. Further details regarding the motion and several configurations of the various components at the proximal end 108 of the device 100 are described in U.S. Provisional Application No. 63/234,955, Attorney Docket No. ELC-P22867-01-US, entitled THERAPEUTIC AGENT DELIVERY DEVICE INCLUDING DISPOSABLE AND REUSABLE PORTIONS, the entire contents of which are expressly incorporated herein by reference. Additionally, as described below, controller 136 may be coupled to electronics associated with the user input 114 to provide an indication of when the user input 114 is actuatable.
  • FIGS. 9 and 10 illustrate the therapeutic agent delivery mechanism 124 of the device 100.
  • the therapeutic agent delivery mechanism 124 is also illustrated adjacent other components of the device 100, such as the carriage 146, a syringe chamber 186, the piston 128.
  • the therapeutic agent delivery mechanism 124 is carried by and translates with the carriage 146 relative to the housing 112 of the reusable portion 102.
  • the therapeutic agent delivery mechanism 124 includes a second actuator 188 that operatively couples to the electronic controller 136 (FIG. 5) and may include a position sensor for indicating the axial position of the syringe assembly 118 as is further described below.
  • the second actuator 188 may be a rotary actuator, more specifically an electric motor, that drivably couples to a transmission or speed reducer.
  • the actuator 188 drivably couples to a gear train 190, more specifically a first gear 192 that drivably couples to a second gear 194.
  • the second gear 194 includes internal threads 196 (FIG. 10) that couple to external threads 198 of the plunger 126.
  • the plunger 126 is rotatably fixed but translatable relative to the carriage 146 (FIG. 10). Specifically, the plunger 126 couples to the carriage 146 via a key and slot interface, more specifically the plunger 126 includes external slots 200 that receive keys 202 (FIG. 10) formed on the carriage 146.
  • the plunger 126 also includes a ram 204 for engaging the piston 128 of the syringe assembly 118.
  • motion 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 carriage 146.
  • the plunger 126 thereby translates relative to the second gear 194 and the carriage 146.
  • the plunger 126 distally pushes the piston 128 in the syringe chamber 186.
  • such motion of the piston 128 causes the syringe assembly 118 to deliver the therapeutic agent from the needle 120.
  • the controller 136 may actuate the drive mechanism 116 and the therapeutic agent delivery mechanism 124 sequentially upon detecting one or more conditions. More specifically, in some embodiments the drive mechanism 116 is actuated to move the syringe assembly 118 from the stowed configuration to the deployed configuration, and thereafter the therapeutic agent delivery mechanism 124 is actuated to drive the plunger 126 and the piston 128 and thereby deliver the therapeutic agent 106 from the needle 120.
  • the sensors 140 of the electronics assembly 134 may include a position sensor 147, such as an encoder (not shown) coupled to the actuator 148, for determining if the syringe assembly 118 is in the stowed configuration or the deployed configuration as is further described below.
  • the therapeutic agent delivery mechanism 124 may be actuated to deliver the therapeutic agent 106 from the needle 120.
  • the drive mechanism 116 is actuated again to permit the syringe assembly 118 to move from the deployed configuration to the stowed configuration, and then the therapeutic agent delivery mechanism 124 is actuated again to retract the plunger 126 from the syringe assembly 118. More specifically, upon detecting that the syringe assembly 118 has returned to the stowed configuration, the therapeutic agent delivery mechanism 124 is actuated to retract the plunger 126 from the syringe assembly 118.
  • a therapeutic agent delivery device 300 generally includes a reusable portion 302, which may also be referred to as a drive portion or a durable portion, and a disposable portion 304, which may also be referred to as a drug carrying portion, a cartridge, or a syringe carrier.
  • the reusable portion 302 facilitates delivery of a therapeutic agent from the disposable portion 304 in a manner substantially as that described above with reference to reusable portion 102.
  • the disposable portion 304 detachably couples 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) may then be attached to the reusable portion 302, and the therapeutic agent delivery device 300 is then ready for a subsequent use.
  • the therapeutic agent delivery device 300 includes a proximal end 306 and an opposite distal end 308. During use of the therapeutic agent delivery device 300, the proximal end 306 is farther from the patient and configured to be actuated by a user, and the distal end 308 is 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.
  • the reusable portion 302 includes a housing 310 including a user input 312 and a drive mechanism 314.
  • the user input 312 is actuatable (for example, depressible) by a user to actuate the drive mechanism 314.
  • the drive mechanism 314 and the user input 312 of the reusable portion 302 may include components configured in a manner described above with reference to device 100 to cause a therapeutic agent to be forced through the needle into the patient.
  • the therapeutic agent delivery device 300 may also include an electronics assembly such as that described above with reference to device 100 to facilitate the operation of the various functions of the therapeutic agent delivery device 300 described herein.
  • the drive mechanism 314 of the reusable portion 302 further includes an actuator 316 that operably couples to a controller 136 (FIG.
  • the actuator 316 may be a rotary actuator, more specifically an electric motor, that drivably couples to a transmission or speed reducer (not shown).
  • the actuator 316 is coupled to a drive gear 318 that drivably engages a driven gear 320.
  • the driven gear 320 is fixed relative to a cam ring 322, which is rotatably disposed within the housing 310 of reusable portion 302.
  • the cam ring 322 rotates relative to the housing 310 of the reusable portion 302 about a rotation axis R that is substantially parallel to the longitudinal axis A of the therapeutic agent delivery device 300 (i.e., parallel ⁇ 10 degrees).
  • rotation of the cam ring 322 controls configurations of the disposable portion 304 throughout the process of delivering the therapeutic agent to the patient, from loading the disposable portion 304 into the reusable portion 302 to ejecting the used disposable portion 304 from the reusable portion 302.
  • the syringe carrier or disposable portion 304 which is depicted throughout this embodiment in simplified form omitting a variety of components, generally includes a base cap 324 coupled to a rigid needle shield (“RNS”) puller 326 which extends from the base cap 324, an outer housing 328 and a locking clip 330 (also referred to herein as “a first portion”).
  • RNS rigid needle shield
  • the base cap 324 and the outer housing 328 are configured to not rotate relative to one another at a first configuration.
  • one of the base cap 324 and the outer housing 328 includes one or more tabs, and the other includes a corresponding key to receive the tab.
  • the base cap 324 includes a pair of tabs 332 which engage keys 334 formed into outer housing 328 when disposable portion 304 is assembled, thereby preventing rotation of base cap 324 and RNS puller 326 relative to the outer housing 328.
  • the base cap 324 and the outer housing 328 are configured to have a locked configuration.
  • the locking clip 330 is configured to engage the RNS puller 326 through the wall of the outer housing 328 in a manner to lock the components together, and then capable of being released from engagement to permit the unlocking of the RNS puller 326.
  • the RNS puller 326 includes a pair of recess 336 (only one shown in FIG. 14) which each form an arm 338 which receives an inner protrusion 340 of the locking clip 330 to lock the base cap 324 and the RNS puller 326 to the outer housing 328 until the locking clip 330 is rotated in the manner described below.
  • the outer housing 328 includes a cylindrical body 342 formed by a wall 344 with an inner diameter that is larger than an outer diameter of the RNS puller 326 such that the RNS puller 326 can be positioned within the outer housing 328.
  • the outer housing 328 may include guide features to facilitate alignment and positioning of the disposable portion 304 relative to the reusable portion 304.
  • the outer housing 328 further may include one or more protrusions, such as, for example, a pair of upper protrusions 346 (only one shown in FIG. 14) formed on an outer surface 348 of outer housing 328 and a pair of lower protrusions 350 (only one shown in FIG. 14) formed on the outer surface 348.
  • Each upper protrusion 346 is aligned with a lower protrusion 350 in the direction of the longitudinal axis A of the device 300.
  • the upper protrusions 346 and the lower protrusions 350 interact with tracks formed on components of the reusable portion 302 to control movement of the disposable portion 304 from its insertion into and its ejection from the resuable portion 302. It is 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 further can include a clip location feature, such as, for example, a recess 352 formed into the outer surface 348 of the outer housing 328 which extends at least partially around the periphery of the outer housing 328.
  • a pair of slots 354 are formed within the recess 352 and extend through the wall 344 of the outer housing 328.
  • Each slot 354 includes a first end 356 disposed adjacent an end 358 of the recess 352 and second end 360 opposite the first end 356.
  • the locking clip 330 is formed in the shape of a semi-circle and includes an inner surface 362, an outer surface 364, a first end 366 and a second end 368.
  • protrusions may be defined along the interior and exterior of the body of the clip 330.
  • a pair of inner protrusions 340 extend from the inner surface 362 of the locking clip 330 adjacent the first end 366 and the second end 368.
  • a pair of outer protrusions 372 extend from the outer surface 364 of the locking clip 330 adjacent the first end 366 and the second end 368.
  • the width of the locking clip 330 corresponds substantially to the width of the recess 352 formed into the outer housing 328.
  • the first end 366 of the locking clip 330 is radially spaced from the second end 368 by more than 180 degrees.
  • the locking clip 330 is attached to the outer housing 328 after the base cap 324 and RNS puller 326 are inserted into outer housing 328.
  • the locking clip 330 is somewhat resilient such that the ends 366, 368 of the clip 330 flex away from one another as the clip 330 is inserted over the outer diameter of the recess 352 of the outer housing 328 and flex back toward one another when the clip 330 is fully seated within the recess 352. In other words, the locking clip 330 snaps over the outer housing 328 and into the recess 352.
  • the inner protrusions 340 extend through the slots 354 formed through the wall 344 of the outer housing 328 and into the recesses 336 of the RNS puller 326. Specifically, the inner protrusions 340 are positioned under the arms 338 of the RNS puller 326 to prevent the RNS puller 326 from being removed from the outer housing 328.
  • the locking clip 330 is movable relative to the outer housing 328 and the RNS puller 326 to define an unlocked configuration. As is further described below, the locking clip 330 is rotatable about the rotation axis R within recess 352 of the outer housing 328 to cause the inner protrusions 340 of the locking clip 330 to rotate out from under the arms 338 of the RNS puller 326 to “unlock” the RNS puller 326 and permit its removal (along with the RNS (not shown) of the syringe assembly (not shown)) from the reusable portion 302.
  • ends 356 of the slots 354 formed through the wall 344 of the outer housing 328 and the ends 358 of the recess 352 formed into the wall 344 are spaced apart from one another by substantially more than 180 degrees to permit rotational movement of the locking clip 330 about the rotatation axis R within the recess 352.
  • an internal surface 380 of the cam ring 322 includes one or more securing tracks 382 (illustratively, two securing tracks 382 - only one securing track 382 is shown in FIGS. 13 though 18), or slots, for receiving the upper protrusions 346 of the disposable portion 304.
  • the cam ring 322 rotates relative to the distal cylinder 374 to selectively align and misalign the securing tracks 382 with the leading tracks 378.
  • the rotation permits and inhibits, respectively, the upper protrusions 346 of the disposable portion 304 to move between the leading tracks 378 and the securing tracks 382, which facilitates selectively securing the disposable portion 304 to the resuable portion 302 and ejecting the disposable portion 304 from the reusable portion 302.
  • the proximal portion 386 of each leading track 378 may have a width that is slightly larger than the width of the upper protrusions 346.
  • the proximal portion 386 of each leading track 378 may be substantially parallel to the longitudinal axis A (i.e., parallel ⁇ 10 degrees).
  • each securing track 382 of the cam ring 322 includes an entry portion 390, a securing portion 392, and an egress portion 394.
  • the entry portion 390 of each securing track 382 is selectively alignable with one the leading tracks 378 to facilitate receiving the upper protrusions 346 of the disposable portion 304 therefrom.
  • the entry portion 390 of each securing track 382 may be substantially parallel to the longitudinal axis A (i.e., parallel ⁇ 10 degrees). As such, the entry portion 390 may be referred to as a longitudinal portion. Opposite the leading tracks 378, the entry portion 390 of each securing track 382 couples to the securing portion 392.
  • the securing portion 392 may be substantially perpendicular to the longitudinal axis A (i.e., perpendicular ⁇ 10 degrees). As such, the securing portion 392 may be referred to as a transverse portion. Opposite the entry portion 390, the securing portion 392 of each securing track 382 couples to the egress portion 394.
  • the egress portion 394 of each securing track 382 may extend helically relative to the longitudinal axis A and away from the securing portion 392. As such, the egress portion 394 may be referred to as a helical portion.
  • the egress portion 394 is selectively alignable with one of the leading tracks 378 to facilitate transferring the upper protrusions 346 of the disposable portion 304 thereto.
  • FIGS. 13 through 18 the motion and several configurations of the insertion and ejection of the disposable portion 304 into and from the reusable portion 302 are described below.
  • the disposable portion 304 may remain in some of the configurations for certain periods of time, other configurations are shown for illustrative purposes, and the disposable portion 304 may simply transition through those configurations without remaining in them for a period of time.
  • FIG. 13 illustrates a first or initial configuration of the disposable portion 304 wherein the disposable portion 304 is detached from the resuable portion 302 prior to use.
  • the disposable portion 304 is advanced proximally and toward the reusable portion 302 to arrive in a second configuration, as shown in FIG. 15.
  • the outer housing 328 of the disposable portion 304 is received in the distal cylinder 374 and the cam ring 322.
  • the upper protrusions 346 of the disposable portion 304 have passed through the leading tracks 378 of the distal cylinder 374 (one leading track 378 being visible in FIG. 15) and entered the entry portions 390 of the securing tracks 382 of the cam ring 322.
  • the outer protrusions 372 of the locking clip 330 have also entered the entry portions 390 of the securing tracks 382 of the cam ring 322.
  • the leading tracks 378 of the distal cylinder 374 are aligned with the entry portions 390 of the securing tracks 382 of the cam ring 322 (one entry portion 390 being visible in FIG. 15).
  • the base cap 324 of the disposable portion 304 may abut the distal end 308 of the therapeutic agent delivery device 300.
  • the lower protrusions 350 of the outer housing 328 of the disposable portion 304 (one lower protrusion 350 being visible in FIG. 15) have entered the proximal portions 386 of the leading tracks 378 of the distal cylinder 374.
  • the inner protrusions 340 of the locking clip 330 remain positioned under the arms 338 of the RNS puller 326.
  • 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., not mechanically retained within the reusable portion 302).
  • This second configuration is illustrated in both FIG. 15 and 19.
  • a patient may press and hold (e g., for five seconds) a button (not shown) which may provide a signal to controller 136 through mechanical actuation of a switch or electrical actuation using capacitance detection or other suitable means.
  • the patient may be identified through voice identification or biometrics such as finger print identification. In other embodiments, no patient identification is required. It should be noted that if the patient is never identified or if the disposable portion 304 is determined not to match the expected identification, the patient may be prompted to remove the disposable portion 304 from the reusable portion 302 via a display screen and/or an audible indicator or other type of indicator (not shown). In such an event, the RNS puller 326 remains locked to the disposable portion 304.
  • the actuator 316 is energized to lock the disposable portion 304 to the reusable portion 302 and unlock the RNS puller 326 from the disposable portion 304 to permit its removal from the reusable portion 302, placing the disposable portion 304 in a third configuration. More specifically, the actuator 316 through gears 318 and 320 causes the cam ring 322 to rotate relative to the distal cylinder 374 (illustratively, in a counter-clockwise direction as viewed from the proximal end 306 of the device 300).
  • the entry portions 390 of the securing tracks 382 of the cam ring 322 engage the outer protrusions 372 of the locking clip 330, which causes the locking clip 330 to rotate within the recess 352 (FIG. 14) of the outer housing 328 of the disposable portion 304.
  • Engagement between the leading tracks 378 of the distal cylinder 374 and the lower protrusions 350 of the outer housing 328 of the disposable portion 304 prevents rotation of the outer housing 328. As best shown in FIG.
  • the rotation of the locking clip 330 described above may be performed manually 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 locking clip 330 may be used, such as, for example, an outer ring may be movable on reusable portion 302 and configured to engage and rotate outer protrusions 372 of the locking clip as the outer ring is rotated.
  • the outer protrusions 372 may be accessible and manually movable by the user, or configured to engage a lever, slider or other mechanism that cooperates with the outer protrusions 372 to rotate the locking clip 330.
  • the upper protrusions 346 of the disposable portion 304 are positioned in the securing portions 392 of the securing tracks 382 of the cam ring 322 (one securing portion 392 and one securing track 382 being visible in FIG. 16). This inhibits axial detachment of the disposable portion 304 from the reusable portion 302 due to the securing portion 392 being engageable with the upper protrusion 392 and physically blocking the upper protrusion 346 from distal movement.
  • rotation of the cam ring 322 places disposable portion 304 in the third configuration wherein the disposable portion 304 is locked in place within the reusable portion 302 by the securing portions 392 of the cam ring 322 and the RNS puller 326 is unlocked.
  • 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 protrusions 346 of the disposable portion 304 within the securing portions 392 of the securing tracks 382 of the cam ring 322 to lock the disposable portion 304, and a second rotation of the cam ring 322 rotates the outer protrusions 372 of the locking clip 330 out from under the arms 338 of the RNS puller 326 to unlock the RNS puller 326 for removal.
  • the disposable portion 304 may remain in the third configuration until a user removes the RNS puller 326 and the base cap 324 of the disposable portion 304 from the reusable portion 302. This removal may be sensed by one of the sensors 140 of the reusable portion 302 and communicated to the controller 136.
  • the sensor 140 may be the NFC coil reader on the reusable portion 302 which senses the presence of the NFC tag on the disposable portion 304 as discussed herein.
  • the senor 140 may be an electromechanical switch, a capacitance or magnetic field sensor, such as a Hall effect sensor, positioned in proximity to a corresponding metal or magnetic surface on the RNS puller 326 or the base cap 324 when the disposable portion 304 is fully inserted into the reusable portion 302.
  • the signal sensed by the sensor 140 changes in a manner that is interpreted by the controller 136 as corresponding to removal of the RNS puller 326 and the base cap 324.
  • the controller 136 may reverse the rotation direction of the actuator 316, thereby causing the cam ring 322 to return to the second configuration and indicate to the user that the disposable portion 304 should be removed by a message on a display or an audible message or otherwise of the device 100 and/or an external device, such as a smartphone.
  • the controller 136 waits for a contact signal indicating that the distal end 308 of the reusable portion 302 is in contact with the skin of the patient.
  • This signal may be provided by one or more sensors 140 disposed adjacent a lower surface of the distal end 308 of the reusable portion 302.
  • a skin sensor 140 may be a capacitance or other sensor configured to detect contact with the skin of the patient and provide a sensed contact signal to the controller 136 that changes with contact to indicate such contact as is further described below.
  • the user input 312 is enabled in the manner described herein.
  • the drive mechanism 314 of the reusable portion 302 causes delivery of the therapeutic agent in the manner described herein.
  • the actuator 316 may cause the cam ring 322 to rotate to the fifth configuration described below to eject the disposable portion 304 containing therapeutic agent, but without the RNS puller 326 or the base cap 324 connected.
  • the cam ring 322 then rotates relative to the distal cylinder 374 (in the same direction - illustratively, in the counterclockwise direction as viewed from the proximal end 306) such that the cam ring 322 moves to a fifth configuration depicted in FIG. 18.
  • the upper protrusions 346 of the outer housing 328 are disposed in the egress portions 394 of the securing tracks 382 of the cam ring 322 (one egress portion 394 and one securing track 382 being visible in FIG. 18).
  • the cam ring 322 pushes the upper protrusions 346 and thus the disposable portion 304 distally relative to the reusable portion 302 to eject the disposable portion 304.
  • the egress portions 394 of the securing tracks 382 of the cam ring 322 are aligned with the leading tracks 378 of the distal cylinder 374 (one leading track 378 being visible in FIG. 18).
  • the upper protrusions 346 and the lower protrusions 350 of the disposable portion 304 are disposed in the leading tracks 378 of the distal cylinder 374.
  • the user may be required to provide input such as by actuating a capacitive slider (not shown) to initiate the ejection sequence described above.
  • the user may pull the disposable portion 304 distally to detach the disposable portion 304 from the reusable portion 302.
  • the controller 136 may 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.
  • the one or more sensors 140 disposed in the reusable portion 302 may detect the absence of the disposable portion 304 and provide an absence signal to the controller 136 indicating that the disposable portion 304 has been removed.
  • the presence and/or absence of the disposable portion 304 may be sensed using an electromechancial switch, a capacitance or magnetic field sensor, such as a Hall effect sensor, an RF ID tag, NFC sensing elements as described herein, or any other suitable sensing configuration.
  • the disposable portion 304 may be configured to simply fall from the reusable portion 302 after the cam ring 322 is moved into the fifth configuration.
  • the controller 136 may transition the cam ring 322 from the fourth configuration to the fifth configuration after a predetermined time period following actuation of the user input 312, if required.
  • the predetermined time period may be, for example, based on the typical time period for delivering the therapeutic agent to a patient.
  • the controller 136 causes the actuator 316 to rotate the cam ring 322 back to the first configuration illustrated in FIG. 13.
  • the actuator 316 may rotate the cam ring 322 in the counter-clockwise direction (as viewed from the proximal end 306 of the reusable portion 302) back to the first configuration or in the clockwise direction.
  • the cam ring 322 is returned to the first configuration, the reusable portion 302 is ready to receive a new disposable portion 304 to repeat the above-described process to inject a subsequent dose of the therapeutic agent.
  • the syringe carrier 404 may be used with a reusable portion such as reusable portion 302 described above.
  • the syringe carrier 404 includes a base cap 406, an RNS puller 408, a bottom housing 410, an inject stop 412 (also referred to herein as “a first portion”), a retraction spring 414, a lockout spacer 416, a syringe assembly 418, a top housing 420, and a spacer 422.
  • the bottom housing 410 and the top housing 420 generally make up the housing body of the syringe carrier 404.
  • the syringe carrier 404 may be configured to accommodate different syringe assemblies 418 containing different dosages of therapeutic agent, such as 1 mL, 2 mL, etc.
  • the syringe assemblies 418 may be different sizes, which may require modifications to the lockout spacer 416, the inject stop 412 and the base cap 406.
  • the spacer 422 may be omitted.
  • the base cap 406 receives the RNS puller 408, which engages the needle shield 424 of the syringe assembly 418 to disconnect the needle shield 424 from the syringe assembly 418, thereby exposing the needle 426 (FIG. 28), after the base cap 406 has been unlocked as described below.
  • the base cap 406 includes a disk shaped body 428, a central opening 430 for receiving the RNS puller 408, and a pair of arms 432 extending upwardly from the central opening 430.
  • Each arm 432 includes a tab 434 which engages a notch 436 formed in the distal end 438 of the inject stop 412 as is further described below.
  • the bottom housing 410 includes a substantially cylindrical body 440 with an inner diameter that is slightly larger than an outer diameter of the inject stop 412, thereby permitting the inject stop 412 to be received 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 carrier 404 is assembled. When the base cap 406 is removed from the syringe carrier 404, the lower flange 442 of the bottom housing 410 is used to engage the skin of the patient to provide the proper distance for piercing the skin of the patient by needle 426 of the syringe assembly 418 as described herein.
  • a notch 444 is formed in the bottom housing 410 and sized to receive a key 446 extending upwardly from the base cap body 428 to prevent twisting or rotation of the base cap body 428 as the inject 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 leading tracks 378 and the securing tracks 382 of the reusable portion 302 (FIG. 13) as is further described below.
  • the lower protrusions 450 are elongated along the longitudinal axis A of the syringe carrier 404 to provide extended engagement with the leading tracks 378 of the distal cylinder 374 of the reusable portion 302.
  • the bottom housing 410 also includes a pair of engagement arms 452 which are slightly resilient and include locking tabs 454 which engage with locking recesses 456 (FIG. 21) formed in the top housing 420 when the syringe carrier 404 is assembled, thereby securing the bottom housing 410 to the top housing 420.
  • the inject stop 412 generally includes a substantially cylindrical body 458 with a pair of distal arms 460, a pair of driven tabs 462, a proximal collar 464, and a pair of control recesses 466 to permit and guide movement of lockout spacer 416 in the manner described below.
  • Each of the control recesses 466 includes a lower stop surface 468, a side stop surface 470, and an upper stop surface 472.
  • the distal arms 460 include extensions 474 extending radially that form notches 436 which receive the tabs 434 of the base cap arms 432 to retain the base cap 406 in position until the inject stop 412 is rotated in the manner described below.
  • the proximal collar 464 of the inject stop 412 includes a retention notch 478 formed into the outer surface 480 of the proximal collar 464 and configured to receive a first end 482 of the retraction spring 414.
  • the retraction spring 414 is a helical torsion spring that, upon assembly of syringe carrier 404, biases lockout spacer 416 toward counterclockwise rotation relative to inject stop 412.
  • the retraction spring 414 extends between the first end 482 (FIG. 23) which engages the retention notch 478 of the proximal collar 464 of inject stop 412 and the second end 502 which engages the retention notch 498 of the proximal flange 492 of the lockout spacer 416.
  • the retraction spring 414 Upon assembly of syringe carrier 404, the retraction spring 414 is stretched in a clockwise direction and the ends 482, 502 are inserted into retention notches 478, 498, respectively, such that the lockout spacer 416 would rotate in a counter-clockwise direction and the inject stop 412 would rotate in a clockwise direction if the parts were not prevented from rotation by other components of the syringe carrier 404 as described herein.
  • the retraction spring 414 overlays the cylindrical body 484 of the lockout spacer 416 and has an outer diameter that is smaller than an inner diameter of top housing 420.
  • the syringe assembly 418 includes a barrel 504 which contains the therapeutic agent 506, a hollow needle 426 (FIG. 28) for injection of the therapeutic agent 506, an upper flange 507, and a needle shield 424 detachably connected to barrel 504 and configured to enclose the needle 426 to prevent accidental contact of the needle 426 with skin.
  • the needle 426 and the syringe assembly 418 are moveable from a stowed configuration wherein the needle 426 is retracted within syringe carrier 404 to a deployed configuration wherein the needle 426 extends at least partially below the lower flange 442 of the bottom housing 410 to pierce the skin of the patient.
  • the drive mechanism 314 and the user input 312 of the reusable portion 302 described above with reference to device 300 cause the therapeutic agent 506 to be forced through the needle 426 into the patient.
  • the spacer 422 of the syringe carrier 404 is positioned on top of the upper flange 507 of the syringe assembly 418, which is positioned on top of the proximal flange 492 of the lockout spacer 416.
  • the spacer 422 has a height that accommodates the difference in length of the 1 mb syringe assembly and the 2 mL syringe assembly 418 to permit use of the same bottom housing 410, top housing 420 and retraction spring 414 for each syringe carrier design.
  • the spacer 422 locates the tip of the needle 426 of the 2 mL syringe assembly 418 at the same distance from the skin of the patient as the distance between the tip of the needle of the 1 mL syringe assembly when assembled into the 1 mL syringe carrier as described below.
  • the spacer 422 permits use of the same drive mechanism of the reusable portion 302 (i.e., the same distance of travel) with both 1 mL syringe assemblies and shorter 2 mL syringe assemblies.
  • the top housing 420 includes a substantially cylindrical body 508 with an inner diameter that is slightly larger than an outer diameter of the inject stop 412, thereby permitting the inject stop 412 to be partially received within the top housing 420.
  • the top housing 420 also includes a pair of protrusions 510 which engage the leading tracks 378 and securing tracks 382 of the reusable portion 302 (FIG. 13) as is further described herein.
  • the top housing 420 also includes an upper wall 512 which compresses the spacer 422, the lockout spacer 416, the retraction spring 414 and the inject stop 412 within the top housing 420 and the bottom housing 410 when the top housing 420 is connected to the bottom housing 410 by engaging the locking tabs 454 of the engagement arms 452 of the bottom housing 410 with the locking recesses 456 (FIG. 21) formed on the inner surface 514 of the body 508 of the top housing 420.
  • the top housing 420 also includes a pair of lockout spacer control tracks 516 formed as recesses in the distal end 518 of the top housing 420. These lockout spacer control tracks 516 control the travel of the lockout spacer 416 during needle insertion in the manner described below.
  • Each lockout spacer control track 516 includes a retaining notch 520 formed by a control finger 522.
  • the retaining notches 520 receive the protrusions 494 of the distal arms 490 of the lockout spacer 416 when the syringe carrier 404 is assembled.
  • the control fingers 522 prevents counter-clockwise rotation of the lockout spacer 416 by preventing movement of the protrusions 494 as is further described below.
  • the lockout spacer control tracks 516 further include retention recesses 526 which cooperate with the control recesses 466 of the inject stop 412 to prevent subsequent needle insertion in the manner described below.
  • syringe carrier 404 is assembled as shown in FIG. 25, it is inserted into the reusable portion 302 for use in a manner that is substantially similar to that described above with reference to device 300.
  • the syringe carrier 404 is inserted into the reusable portion 302 in a manner similar to that depicted in FIG. 15 such that the protrusions 510 of the top housing 420 are passed through the leading tracks 378 of the distal cylinder 374 and into the securing tracks 382 of the cam ring 322.
  • the upper protrusions 448 of bottom housing 410 and the lower protrusions 450 of the bottom housing 410 are positioned within the leading tracks 378 of the distal cylinder 374.
  • the protrusions 494 of the distal arms 490 of the lockout spacer 416 are positioned within the lockout spacer control tracks 516, and more specifically within the retaining notches 520 formed by the control fingers 522 of the top housing 420.
  • the control fingers 522 prevent the protrusions 494 (and the lockout spacer 416 generally) from rotating counter-clockwise as a result of the biasing force of the retraction spring 414.
  • the protrusions 494 are positioned above the upper stop surfaces 472 of the control recesses 466 of the inject stop 412. In this position, the lockout spacer 416 is in an initial state.
  • the tabs 434 of the base cap arms 432 are positioned within the notches 476 formed by the extensions 474 of the distal arms 460 of inject stop 412. When in this first configuration, the base cap 406 and the RNS puller 408 cannot be removed from the syringe carrier 404.
  • the controller 136 waits for a signal from a sensor 140 disposed in the reusable portion 302 adjacent the base cap 406 of syringe carrier 404 indicating the detection and identification of the syringe carrier 404, the therapeutic agent, and/or the patient as is further described below.
  • a first rotation of the cam ring 322 positions the protrusions 510 of the top housing 420 in the securing portions 392 of the securing tracks 382 of the cam ring 322, thereby locking the syringe carrier 404 to the reusable portion 302 in a manner similar to that depicted in FIG. 16.
  • the above-described rotation of the cam ring 322 also causes the cam ring 322 to engage the driven tabs 462 of the inject stop 412 and rotate the inject stop 412 relative to the housing body of the syringe carrier 404 such that the notches 476 formed by the extensions 474 of the distal arms 460 of the inject stop 412 move out of engagement with the tabs 434 of the base cap arms 432, thereby unlocking the base cap 406.
  • This rotation also causes the control recesses 466 (FIG. 22) of the inject stop 412 to rotate such that the protrusions 494 of the distal arms 490 of the lockout spacer 416 are positioned in substantial alignment with the side stop surfaces 470 of the control recesses 466.
  • the base cap 406 and RNS puller 408 may be pulled downwardly out of the reusable portion 302 to remove the needle shield 424 of the syringe assembly 418.
  • This pulling force on the syringe assembly 418 cannot, however, result in movement of the syringe assembly 418 because the distal surfaces 496 of the distal arms 490 of the lockout spacer 416 are still engaged with the upper stop surfaces 472 of the control recesses 466.
  • FIG. 27 depicts base cap 406 and RNS puller 408 after removal from the reusable portion 302.
  • the controller 136 waits for detection of contact with the patient’s skin. More specifically, the controller 136 waits for one or more contact signals from a sensor 140 positioned in the reusable portion 302 adjacent the lower flange 442 of bottom housing 410 (i.e., at the distal end of the reusable portion 302).
  • a skin sensor 140 may be a capacitance or other sensor configured to detect contact with the skin of the patient and provide a sensed contact signal to the controller 136 that changes with contact to indicate such contact as is further described below.
  • the controller 136 may wait for a signal from another sensor 140 operatively coupled to an unlock input (not shown), such as a slider or wiper, that is actuated by the user.
  • an unlock input such as a slider or wiper
  • the reusable portion 302 may provide an indication to the user that the device is enabled for needle injection.
  • the indication may be visual (e.g., activation of an indicator, illumination of the user input 312 and/or displaying a message to the user on a display) or audible (e.g., playing a message over a speaker to the user) as is further described below.
  • the drive mechanism 314 causes the cam ring 322 to rotate further in the counter-clockwise direction, thereby further engaging the driven tabs 462 of the inject stop 412 and causing the inject stop 412 to rotate to the position shown in FIG. 28.
  • the lockout spacer 416 is no longer engaged with the upper stop surfaces 472 of the control recesses 466 of the inject stop 412.
  • the drive mechanism 314 of the reusable portion 302 moves the lockout spacer 416 and the syringe assembly 418 downwardly such that the needle 426 of the syringe assembly 418 pierces the skin of the patient.
  • the drive mechanism 314 then further causes the delivery of the therapeutic agent 506 through the needle 426 in the manner described herein.
  • the actuator 316 may cause the cam ring 322 to rotate to eject the syringe carrier 404.
  • the skin sensor 140 described above may continue monitoring contact the patient’s skin during the needle insertion and dose delivery processes.
  • lockout spacer 416 is free to rotate in the counter-clockwise direction under the biasing force of retraction spring 414 to begin the movement to the single-use lockout state described below.
  • the needle 426 and the syringe assembly 418 are shown in the deployed configuration to pierce the skin of a patient for delivery of the therapeutic agent 506.
  • FIG. 30 depicts the first segment of rotation of the lockout spacer 416.
  • the protrusions 494 of the distal arms 490 of the lockout spacer 416 have rotated into engagement with the side stop surfaces 470 of the control recesses 466 of the inject stop 412.
  • the syringe assembly 418 and the inject stop 412 are moved proximally relative to the housing body of the syringe carrier 404 by force supplied by the retraction spring 414.
  • the inject stop 412 continues to rotate relative to the housing body of the syringe carrier 404 in the counter-clockwise direction by torque force supplied by the retraction spring 414.
  • FIG. 31 depicts the lockout spacer 416 and the syringe assembly 418 approximately mid-way through the proximal movement described above.
  • FIG. 32 depicts the syringe carrier 404 in a fifth configuration.
  • the lockout spacer 416 has been retracted proximally relative to the housing body of the syringe carrier 414 by the retraction spring 414 and rotated counter-clockwise under the biasing force of the retraction spring 414 such that the protrusions 494 of the distal arms 490 of the lockout spacer 416 are positioned in the control recesses 466 of the inject stop 412 in contact with the upper stop surfaces 472.
  • the syringe assembly 418 is fully retracted and in the stowed configuration. In this position, the syringe carrier 404 is in the single-use lockout state.
  • the lockout spacer 416 (and therefore the syringe assembly 418 and the needle 426) cannot be moved downwardly again because of the engagement between the protrusions 494 and the upper stop surfaces of the inject stop 412.
  • the retraction spring 414 biases the lockout spacer 416 in the lockout state.
  • the cam ring 322 rotates relative to the distal cylinder 374 (in the same direction - illustratively, in the counter-clockwise direction as viewed from the proximal end 306 of the reusable portion 302) such that the protrusions 510 of the top housing 420 are disposed in the egress portions 394 of the securing tracks 382 of the cam ring 322 in a manner substantially as described above with reference to FIG. 18.
  • the cam ring 322 pushes the protrusions 510 and the syringe carrier 404 distally to position the syringe carrier 404 for ejection.
  • FIG 33 depicts the syringe carrier 404 after the cam ring 322 has rotated the syringe carrier 404 as described above. It should be noted the syringe carrier 404 remains in the single-use lockout state because the distal surfaces 496 of the distal arms 490 of the lockout spacer 416 remain engaged with the upper stop surfaces 472 of the control recesses 466.
  • FIG. 34 one example embodiment of a therapeutic agent delivery device 600 is shown which is similar to delivery devices 100 and 300 described above.
  • the device 600 generally includes a reusable portion 602 (similar to reusable portion 302) and a syringe carrier 604 (similar to syringe carrier 404). Many of the components of the device 600 are omitted for simplicity of description. It should be noted, however, that reference to various mechanical components of the device 600 in the description below use the numeric designations used above with reference to the reusable portion 302 and the syringe carrier 404. It should be understood that the features described below with reference to the device 600 may be implemented on the other embodiments of the reusable portion and the syringe carrier as described herein.
  • the device 600 of FIG. 34 includes components for sensing the presence and absence of the base cap 406 of the syringe carrier 604 and for identification of the syringe carrier 604, the therapeutic agent 106, and/or the patient. More specifically, a first sensing element such as an NFC coil reader 608 is disposed adjacent a lower wall 609 at the distal end 308 of the reusable portion 602 in a cavity 610 formed between an outer wall 612 and an inner wall 614 of the reusable portion 602. The inner wall 614 and the lower wall 609 form a cylindrical opening 611 for receiving the syringe carrier 406.
  • the base cap 406 can include a third sensing element such as an NFC tag 142 (shown in dashed lines) attached to an upper wall 606 of the base cap 406 in vertical alignment with the NFC coil reader 608.
  • the NFC tag 142 is substantially parallel to and axially under, preferably centered, and in vertical alignment with the NFC coil reader 608.
  • the NFC tag 142 is an adhesive label.
  • the NFC tag 142 includes a small, embedded antenna and has overall dimensions of approximately 4 mm by 4 mm.
  • the NFC tag 142 (shown in dashed lines) is alternatively located on an outer wall 616 of the syringe carrier 604 in at least one of a perpendicular and coplanar orientation relative to the NFC coil reader 608.
  • the NFC coil reader 608 is disposed on a printed circuit board (PCB) 613 of a printed circuit board assembly (PCBA) 618.
  • the PCB 613 is in the shape of an annulus, and extends substantially around the cylindrical opening 611 or 360 degrees around the inner wall 614 of the reusable portion 602. In other embodiments, the PCB 613 extends less than 360 degrees around the inner wall 614.
  • the NFC tag 142 is configured to provide identification information relating to the therapeutic agent 106 and/or the patient prescribed the agent 106.
  • 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 regarding the therapeutic agent 106 such as the type, volume, lot number, concentration, and/or expiration date.
  • the memory device 720 may further include identification information regarding the patient such as the patient’s name and prescription information.
  • the antenna 722 may be a conductive deposit in plastic or a label such as the labels available from Avery Dennison.
  • the controller 136 waits for a presence signal from the NFC coil reader 608 indicating that the NFC tag 142 has been detected and the identification information regarding the syringe carrier 604 and/or the patient has been received from the NFC tag 142. As indicated above, upon receiving and verifying the identification information, the controller 136 activates the actuator 316 (FIGs.
  • the NFC coil reader 608 When the base cap 406 is removed, the NFC coil reader 608 is no longer in communication with the NFC tag 142 and generates an absence signal.
  • the controller 136 determines from the absence signal that the base cap 406 has been removed.
  • the base cap includes the NFC tag 142 as described, which may be for charging, and the syringe carrier includes another NFC tag 142 as described, which may be for identification, or vice versa.
  • one of the arranged NFC tags is utilized for at least one of charging and identification.
  • the controller 136 may provide a signal to illuminate an indicator 621 (such as an LED) associated with the user input 114 (FIG. 6) to inform the user that the device 600 is ready to inject the therapeutic agent 106.
  • controller 136 provides one of a plurality of signals to the indicator 621 to provide the user with information regarding whether the base cap 406 is sensed by the controller 136 and/or whether the base cap 406 is unlocked, in addition to whether the identification information is verified.
  • the controller may provide a signal to the indicator 621 causing it to illuminate yellow when the base cap 604 is sensed, blue when the base cap is unlocked, and green when the identification information is verified and the device 600 is ready for injection.
  • multiple indicators 621 are provided and controlled by the controller 136.
  • the controller 136 actuates a motor or other device (not shown) that mechanically causes the user input 114 to move (or pop up) to an actuable position as described above.
  • the indicator 621 or multiple indicators 621 may be controlled to provide information to the user regarding the status of the injection of the therapeutic agent 106.
  • the indicator 621 may flash or change colors and/or brightness when the user input 114 is actuated by the user, then illuminate continuously, flash at a different speed, and/or change color during the injection of the therapeutic agent. Additionally, upon completion of delivery of the dose, the indicator 621 or multiple indicators 621 may change state yet again to indicate that delivery is complete.
  • a sensor 140 on the reusable portion 602 may provide a signal to the controller 136 indicating that the base cap 406 has been removed.
  • the sensor 140 may be an electromechanical switch, a capacitance or magnetic field sensor, such as a Hall effect sensor, positioned in proximity to a corresponding metal or magnetic surface on the RNS puller 408 or the base cap 406 when the syringe carrier 604 is fully inserted into the reusable portion 602.
  • the signal sensed by the sensor 140 changes in a manner that is interpreted by the controller 136 as corresponding to removal of the RNS puller 408 and the base cap 406.
  • the controller 136 waits for a contact signal indicating that the distal end 308 of the reusable portion 602 is in contact with the skin of the patient.
  • This contact signal may be provided by a second sensing element such as a capacitive skin sensor 620 as described below.
  • the skin sensor 620 is mounted on the PCB 613 and configured to detect when the distal end 308 of the reusable portion 602 is in contact (or within a maximum allowed offset such as 1 mm) with the patient’s skin.
  • the skin sensor 620 also facilitates detection of an acceptable tilt angle between the distal end 308 and the patient’s skin, such as a tilt of no more than five degrees, as is further described below.
  • the skin sensor 620 is a Semtech SX9325 sensor.
  • the 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.
  • the controller 136 may control the color and/or brightness of the indicator 621 to inform the user that contact with the patient’s skin has been sensed and the tilt angle of the distal end 308 of the reusable portion 602 relative to the patient’s skin is within an acceptable range.
  • the sensor 620 includes three sensing pads 626, 628 and 630 of substantially equal size and shape, arranged on the PCB 613 in a 120 degree symmetrical layout.
  • the sensing pads 626, 628 and 630 are spaced apart from one another and disposed adjacent an outer periphery 627 of PCB 613.
  • the outer radial placement of the sensing pads 626, 628 and 630 improves the sensitivity of the skin sensor to 620 tilt.
  • One of the sensing pads 630 is positioned on the PCB 613 adjacent a sensor chip 632 of the sensor 620 and is connected to ground, as well as to a shield layer 634 formed on one or more layers of the PCB 613 (see FIG. 34) over the other two sensing pads 626 and 628.
  • the sensing pads 626 and 628 provide contact sensing input signals to the sensor chip 632 to indicate contact (or near contact) with the patient’s skin.
  • the reusable portion 602 may include shielding (not shown) in addition to the shield layer 634 formed on the PCB 613.
  • the skin sensor 620 provides tilt detection with the goal of enabling the user to orient the needle 426 perpendicular to the skin of the patient, thereby ensuring the desired depth of penetration into the patient’s skin and reducing the chance of relative movement between the needle 426 and the skin during the injection process. Tilt detection is accomplished by the controller 136 receiving the contact signals from the skin sensor 620 (i.e., signals from the sensor chip 632 received from the sensing pads 626 and 628) and verifying that the signals are within an expected range which indicates skin contact. Additionally, the signals must match within a given tolerance to indicate an acceptable tilt.
  • the controller 136 determines acceptable contact has been made with the patient’s skin (i.e., that the distal end 308 of the reusable portion 602 is in contact with the skin of the patient and within an acceptable tilt range relative to the skin of the patient).
  • the NFC coil reader 608 is disposed on the 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 the sensing pads 626, 628 and 630 as shown and coils with reduced diameter to a last section connected to the second terminal 635 and extending adjacent an inner diameter 637 of the PCB 613.
  • the inner diameter 637 of the PCB 613 is approximately 20 mm
  • the diameter of the outer periphery 627 is approximately 40 mm
  • the transition between the sensing pads 626, 628 and 630 and the NFC coil reader 608 is located spanning across from a region defined between the inner diameter 637 to a diameter of approximately 30 mm.
  • a region of the PCB 613 may include a separation region 639 between the outer extent of the NFC coil reader 608 and the inner diameter of the sensing pads 626, 628 and 630.
  • the NFC coil reader 608 may be used for NFC wireless power transfer for charging the power source 138 of the reusable portion 602.
  • the power source 138 includes a power storage device 139 such as a battery and, in one embodiment, a power sensor 141.
  • the power sensor 141 is configured to sense a state-of-charge of the power storage device 139 and communicate the state-of-charge to the controller 136.
  • the controller 136 may then provide an indication of the state-of-charge of the power storage device 139 by activating an indicator, such as indicator 621, or providing a message on a display of the reusable portion 602.
  • a charging circuit 636 includes a tuning circuit 638 and passive recitification circuit 640 mounted to the PCB 613 of the reusable portion 602.
  • the tuning circuit 638 is connected to the NFC coil reader 608 and the passive recitification circuit 640.
  • the passive rectification circuit 640 is connected to a battery charging circuit 642 which is configured to charge the power storage device 139.
  • charging power is provided to the NFC coil reader 608 by a base station 644 as depicted in FIG. 38.
  • the base station 644 includes a housing 646 with an NFC transmitter chip 648 coupled to a tuning circuit 650, which in turn is coupled to an NFC coil 652.
  • the base station 644 further includes a ferrite rod 654 mounted within the housing 646 in a vertical orientation within a protrusion 656 that is substantially the same diameter as the syringe carrier 604. As shown in FIG. 38, 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 for enhanced coupling. Power from a power supply 658 (FIG.
  • the base station 644 is supplied to the base station 644 from, for example, a wall receptacle through a USB cable, and transmitted through the NFC transmitter chip 648 and tuning circuit 650 to the NFC coil 652, which in turn transmits the power through the ferrite rod 654 to provide power through wireless inductive coupling to the NFC coil reader 608.
  • the power is provided to the tuning circuit 638 of the reusable portion 602 and to the passive recitification circuit 640, which delivers the power to the battery charging circuit 642.
  • the power source 138 of the reusable portion 602 may be wirelessly charged by the base station 644.
  • Other charging mechanisms may be included including respective components for QI charging and/or capacitive charging.
  • PCB 613 includes the skin sensor 620 for sensing contact with and tilt relative to a patient’s skin, the NFC coil reader 608 and associated circuitry for sensing the presence and absence of the base cap 406 of the syringe carrier 604 and identifying the syringe carrier 604, the therapeutic agent 106 and/or the patient, and the charging circuit 636 which uses the NFC coil reader 608 to receive power from the base station 644 to charge the power source [0120]
  • all of the electronics to provide skin sensing, identification and wireless charging are provided on the PCB 613.
  • identification of the syringe carrier 604 may be provided using an RFID device, a memory card, a barcode, or an electrical contact.
  • a serial interface may also be provided with a transceiver that permits communications with external devices such as a smart phone or other devices used in a pharmacy or by a health care provider.
  • the device 600 includes the capability of sensing the temperature of the therapeutic agent 106 to inform the user when the therapeutic agent 106 has reached a temperature suitable for injection. As some drugs are refrigerated for storage, a warmup period is sometimes desirable to ensure that the drug has reached a sufficient temperature for injection. Moreover, in certain embodiments the therapeutic agent delivery device 600 is capable of sensing and tracking the temperature of the therapeutic agent 106 during storage, transport and use to identify temperature excursions that may degrade the therapeutic agent 106. In certain embodiments, the temperature of the therapeutic agent 106 is inferred from the temperature of the glass container or barrel holding the therapeutic agent 106 within the syringe carrier 604. In certain embodiments, the accuracy of the temperature measurements described herein is within 1 degree Celsius of the actual temperature of the therapeutic agent 106.
  • a variety of different configurations for temperature sensing include an Infrared (“IR”) sensor in the reusable portion 602, a thermistor in the reusable portion 602, a wireless sensor (e.g., an NFC and digital temperature sensor) in the syringe carrier 604, a contact -based sensor (e.g., a digital or NTC analog temperature sensor, an EEPROM and NTC analog temperature sensor, an EEPROM and digital temperature sensor, etc.) in the syringe carrier 604, and a thermochromic label in the syringe carrier 604 that is read by the reusable portion 602 or the user.
  • IR sensor 660 mounted within the reusable portion 602 adjacent inner wall 614 to detect the temperature of the barrel 504 of the syringe assembly. Signals indicating the temperature of the barrel 504 are provided by the IR sensor 660 to the controller 136 which infers the temperature of the therapeutic agent 506. In this manner, the reusable portion 602 can instantly determine the temperature of the therapeutic agent 506 upon insertion of the syringe carrier 604 into the reusable portion 602.
  • IR transmissive material is used to seal the surface of the IR sensor 660.
  • the NFC tag 142 includes an inter-integrated circuit (“I2C”) digital temperature sensor 662 and has I2C communication capabilities that are powered by energy harvesting functionality in the NFC tag 142.
  • the NFC tag 142 includes an I2C interface chip such as an NXP NTP53321G0JHKZ and an I2C temperature sensor 662 such as a Maxim MAX31875R1TZS+T.
  • the syringe carrier 604 includes a temperature sensor 664 and a memory device 666 in the NFC tag 142 to log the temperature of the therapeutic agent 506 within the syringe carrier 604 from the time of initial packaging and shipment to the time of injection.
  • the temperature history of the therapeutic agent 506 is communicated via an NFC antenna 668 on the syringe carrier 604 and an NFC antenna 670 in the syringe carrier packaging 672 to an NFC reader 674 in the packaging 672.
  • the data may be processed by a microcontroller 676 in the packaging 672.
  • Power for the components within the packaging 672 is provided by a power storage device such as a battery 678 through power management circuitry 680.
  • the temperature data is provided via wireless communications to the reusable portion 602 or a remote device such as the user’s phone 682 to indicate whether the therapeutic agent 506 is safe for use (i.e., has not undergone unacceptable temperature conditions prior to use).
  • the temperature sensor 664 may be part of the syringe carrier packaging 672 instead of the syringe carrier 604 [0127]
  • the reusable portion 602 includes a sleep/wake-up function.
  • the controller 136 may be connected to a timer 663 and a use sensor 664 on the reusable portion 602.
  • the use sensor 664 may be an accelerometer, a contact sensor, a mechanical sensor or other suitable sensor that is triggered (i.e., activated) when the reusable portion 602 is moved, such as when the reusable portion 602 is picked up by a user.
  • the use sensor 664 When the use sensor 664 is activated, it provides a “wake-up” or use signal to the controller 136 which causes the controller 136 to transition from a low-power sleep mode to an in-use mode. This in turn causes the controller 136 to communicate with the power source 138 to supply power to the other components of the reusable portion 602.
  • the use sensor 664 also provides signals to the timer 663 when use of the reusable portion 602 is detected. 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 time. If the timer 663 receives a signal from the use sensor 664 during the countdown time, the timer 663 resets the countdown time. If the countdown time is reached without a signal from the use sensor 664, then the timer 663 provides a sleep signal to the controller 136 which the controller 136 interprets as a command to enter the sleep mode. The controller 136 responds by communicating with the power source 138 and causing it to enter the low- power sleep mode.
  • a therapeutic agent delivery device including: a reusable portion, including: housing having a distal end; a cam ring rotatably movable in the housing by a drive mechanism; a printed circuit board assembly including a printed circuit board disposed adjacent the distal end of the housing, a first sensing element, a second sensing element and a controller in operable communication with the first and second sensing elements and the drive mechanism; and at least one indicator mounted to the housing; and a syringe carrier, including: a base cap removably connected to a syringe assembly configured to contain a therapeutic agent; and a third sensing element located to substantially align with the first sensing element upon insertion of the syringe carrier into the reusable portion, the 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; wherein upon insertion of the syringe carrier into the reusable portion, the first sensing element provides the identification information received from the third sensing
  • the therapeutic agent delivery device of any one of aspects 1-2 wherein the second sensing element includes a plurality of capacitive sensing pads disposed on the printed circuit board radially outward of the first sensing element.
  • the therapeutic agent delivery device of any one of aspects 1-3 wherein the third sensing element is attached to an upper wall of the base cap, the third sensing element being substantially parallel to and in vertical alignment with the first sensing element upon insertion of the syringe carrier into the reusable portion.
  • the therapeutic agent delivery device of any one of aspects 1-5 wherein upon removal of the base cap, the first sensing element provides an absence signal to the controller indicating the absence of the base cap, and the controller activates the at least one indicator to inform the user that the therapeutic agent delivery device is ready for injecting the therapeutic agent upon receiving the absence signal and determining that the at least one contact signal indicates acceptable contact.
  • the housing includes an inner wall, an outer wall and a lower wall that at least partially define a cavity, the printed circuit board being mounted on the lower wall within the cavity.
  • the therapeutic agent delivery device of any one of aspects 1-10 wherein the third sensing element includes an antenna configured to transmit the identification information.
  • acceptable contact as indicated by the at least one contact signal indicates that the distal end of the reusable portion is in contact with or within a maximum allowed offset from the user’s skin and a tilt angle between the distal end and the user’s skin is within an acceptable range of tilt angles.
  • the temperature sensor is an infrared sensor.
  • the therapeutic agent delivery device of any one of aspects 1-15 wherein 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.
  • the reusable portion further includes a use sensor that provides a use signal to the controller in response to detection of movement of the reusable portion, the controller configured to transition from a low-power sleep mode to an in-use mode in response to receipt of the use signal.
  • the resuable portion further includes a timer in communication with the use sensor to receive the use signal, the timer configured to provide a sleep signal to the controller when a countdown time is reached after receiving the use signal, the controller transitioning from the in-use mode to the low- power sleep mode in response to receipt of the sleep signal.
  • a method for controlling operation of a therapeutic agent delivery device including a reusable portion and a syringe carrier including: receiving, upon insertion of the syringe carrier into the reusable portion, by a first sensing element disposed in the reusable portion from a third sensing element disposed in the syringe carrier, identification information about at least one of a therapeutic agent contained within the syringe carrier and a user associated with the reusable portion; responding to verification of the identification information by rotating a cam ring of the reusable portion to lock the syringe carrier to the reusable portion and activating at least one indicator to instruct a user to remove a base cap of the syringe carrier and place a distal end of the reusable portion in contact with the user’s skin; determining from at least one contact signal received from a second sensing element disposed in the reusable portion whether the distal end of the reusable portion is in acceptable contact with the user’s skin; and responding to a determination of acceptable contact by activating the at least
  • 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
  • a reusable portion of a therapeutic agent delivery device including: a housing including a lower wall at a distal end of the reusable portion, the lower wall surrounding a cylindrical opening configured to receive a syringe carrier; a ring rotatably movable in the housing by a drive mechanism; a printed circuit board assembly including a printed circuit board attached to the lower wall, the printed circuit board assembly including 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 to the housing; wherein upon insertion of the syringe carrier into the cylindrical opening, the NFC coil reader is configured to detect the presence of an NFC tag mounted to the syringe carrier and to provide a presence signal to the controller, which in turn is configured to activate the drive mechanism to rotate the ring, thereby locking the syringe carrier to the reusable portion, the controller further configured to activate the at least one indicator to instruct a user to remove a base cap of the s
  • the housing further includes an inner wall and an outer wall which, together with the lower wall at least partially define a cavity, the printed circuit board being mounted on the lower wall within the cavity.
  • the NFC coil reader upon insertion of the syringe carrier into the cylindrical opening, the NFC coil reader is configured to receive identification information about at least one of the therapeutic agent and the user from the NFC tag, and the controller verifies the identification information before activation of the drive mechanism.
  • the reusable portion of any one of aspects 23-36 further including a use sensor that provides a use signal to the controller upon detection of movement of the reusable portion, the controller is configured to transition from a low-power sleep mode to an in-use mode in response to receipt of the use signal.
  • the reusable portion of aspect 37 further including a timer in communication with the use sensor to receive the use signal, the timer configured to provide a sleep signal to the controller when a countdown time is reached after receipt of the use signal, the controller is configured to transition from the in-use mode to the low-power sleep mode in response to receipt of the sleep signal.
  • the printed circuit board is an annulus printed circuit board that extends substantially around the cylindrical opening
  • the capacitive skin sensor includes three sensing pads disposed adjacent an outer periphery of the annulus printed circuit board in a substantially symmetric arrangement, wherein the NFC coil reader is located along an inner region of the annulus printed circuit board, the inner region disposed radially inward from the outer periphery.
  • the reusable portion of aspect 39 wherein the NFC coil reader is radially separated from the three sensing pads by a separation region.
  • the reusable portion of aspect 40 further including a power source, and wherein the NFC coil reader is configured to receive identification information in response to an insertion of the syringe carrier into the cylinrdral opening, and in response to removal of the syringe carrier from the cyrlindical opening and mounting of the reusable portion to a base station, the NFC coil reader is configured to wirelessly receive power from the base station that includes an NFC transmitter chip to charge the power source.
  • a therapeutic agent delivery device including: the reusable portion of any one of aspects 23-41; and a syringe carrier insertable within the cylindrical opening, the syringe carrier including a passageway holding a therapeutic agent, and an NFC tag located to substantially align with the NFC coil reader upon insertion of the syringe carrier into the reusable portion, the 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.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un dispositif d'administration d'agent thérapeutique comprend une partie réutilisable et un support de seringue. La partie réutilisable comprend un boîtier, un anneau de came, un ensemble PCB comprenant des premier et deuxième éléments de détection et un dispositif de commande, et un indicateur. Le support de seringue comprend un capuchon de base relié à un ensemble seringue contenant un agent thérapeutique et un troisième élément de détection qui s'aligne avec le premier élément de détection lors de l'insertion du support de seringue dans la partie réutilisable. Le premier élément de détection reçoit des informations d'identification provenant du troisième élément de détection, que le dispositif de commande vérifie avant d'amener l'anneau de came à verrouiller le support de seringue. L'indicateur ordonne à l'utilisateur de retirer le capuchon de base et de placer l'extrémité distale de la partie réutilisable en contact avec la peau de l'utilisateur. Le deuxième élément de détection détecte un contact, et si le contact est acceptable, l'indicateur informe l'utilisateur que le dispositif est prêt à injecter.
PCT/US2024/045796 2023-09-12 2024-09-09 Dispositif d'administration d'agent thérapeutique à commandes Pending WO2025058976A1 (fr)

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US63/582,039 2023-09-12

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150165135A1 (en) * 2012-07-30 2015-06-18 Ucb Biopharma Sprl Auto-injector
US20190046735A1 (en) * 2016-02-25 2019-02-14 Novo Nordisk A/S A medical injection device with a axially movable shield
WO2021254744A1 (fr) * 2020-06-16 2021-12-23 Shl Medical Ag Cassette et dispositif d'administration de médicament comprenant une cassette
WO2022010726A1 (fr) * 2020-07-09 2022-01-13 Eli Lilly And Company Dispositif d'injection automatique à partie réutilisable
WO2022178207A1 (fr) * 2021-02-19 2022-08-25 Eli Lilly And Company Systèmes de détection d'état pour dispositif d'injection connecté
WO2024123637A1 (fr) * 2022-12-07 2024-06-13 Eli Lilly And Company Dispositif d'administration d'agent thérapeutique à support de seringue

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150165135A1 (en) * 2012-07-30 2015-06-18 Ucb Biopharma Sprl Auto-injector
US20190046735A1 (en) * 2016-02-25 2019-02-14 Novo Nordisk A/S A medical injection device with a axially movable shield
WO2021254744A1 (fr) * 2020-06-16 2021-12-23 Shl Medical Ag Cassette et dispositif d'administration de médicament comprenant une cassette
WO2022010726A1 (fr) * 2020-07-09 2022-01-13 Eli Lilly And Company Dispositif d'injection automatique à partie réutilisable
WO2022178207A1 (fr) * 2021-02-19 2022-08-25 Eli Lilly And Company Systèmes de détection d'état pour dispositif d'injection connecté
WO2024123637A1 (fr) * 2022-12-07 2024-06-13 Eli Lilly And Company Dispositif d'administration d'agent thérapeutique à support de seringue

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