Multipurpose drug delivery device

Abstract

To provide a multi-use drug-delivery device.SOLUTION: A drug-delivery device is provided including: a drug reservoir configured to contain a fluid drug; a needle cartridge comprising a plurality of needle assemblies, a drive member, a pump, one or more springs, a loading button and a dosing button. The device is configured to use work done by the user in actuating the loading button to load the one or more springs. When the user actuates the dosing button after actuating the loading button, the device is configured to (i) release the one or more loaded springs to operate the drive member to drive a needle assembly that is in operational alignment with the drive member from a retracted position to an injection position, (ii) drive the pump to pump the fluid drug from the drug reservoir through the driven needle assembly, and (iii) retract the driven needle assembly from the injection position to the retracted position.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to devices and methods for delivering drugs. More particularly, the present disclosure relates to multi-purpose drug delivery devices. [Background technology]

[0002] Some drug delivery devices, such as auto-injectors, store potential energy in a compressed spring that is released upon device actuation. This stored energy is used to drive various functions of such drug delivery devices, such as inserting a needle into a patient and expelling liquid from a drug reservoir. However, long-term potential energy storage in a spring can be problematic because the resultant force from the compressed spring can cause deformation of the device material over the device's shelf life. Furthermore, basic physical and material properties require a suitable spring that stores enough potential energy to drive the aforementioned functions of the drug delivery device over a shelf life during which the device is a certain minimum size, which can increase the device size. Ideally, the spring should be unstressed or maintain minimal stress over the device's shelf life, and then be loaded and released in a relatively short time during device use. Summary of the Invention

[0003] Various aspects are described in this disclosure, including but not limited to the following aspects.

[0004] 1. A drug delivery device comprising: a housing; a drug reservoir within the housing configured to contain a drug fluid; a drive member; a needle assembly disposed in a retracted position within the housing; a pump in fluid communication with the drug reservoir; one or more springs; a load button coupled to the housing, the load button configured to be manually actuated to load the one or more springs using work done by actuation of the load button; and a dose button coupled to the housing, the dose button configured to be manually actuated after actuation of the load button to release the one or more loaded springs and operate the drive member to drive the needle assembly from the retracted position to an injection position, to drive the pump to pump drug fluid from the drug reservoir through the driven needle assembly, and to retract the driven needle assembly from the injection position to the retracted position.

[0005] 2. The device of embodiment 1, further comprising a drug fluid contained within the drug reservoir.

[0006] 3. The device of any of aspects 1-2, wherein the needle assembly includes a first needle assembly of a plurality of needle assemblies, the plurality of needle assemblies being disposed within a needle cartridge within the housing.

[0007] 4. The device of aspect 3, wherein actuation of the load button advances the needle cartridge such that a second needle assembly of the multiple needle assemblies is moved out of operative alignment with the drive member and a first needle assembly is moved into operative alignment with the drive member.

[0008] 5. The device of any of aspects 1-4, further comprising an unlock button configured to prevent actuation of the medication button until the unlock button is moved to the unlocked configuration.

[0009] 6. The device of any of aspects 1-5, wherein the one or more springs comprise one or more linear springs movable between an axially expanded configuration and an axially compressed configuration, wherein actuation of the load button loads the one or more linear springs by moving the one or more linear springs to the axially compressed configuration, and actuation of the dose button after actuation of the load button moves the one or more linear springs to the axially expanded configuration and releases the one or more linear springs by operating the drive member.

[0010] 7. The device of any of aspects 1-6, wherein the one or more springs comprise one or more clock springs movable between an unwound configuration and a wound configuration, and wherein actuation of the load button loads the one or more clock springs by moving the one or more clock springs to the wound configuration using work done by actuation of the load button, and actuation of the dose button after actuation of the load button releases the one or more clock springs by moving the one or more clock springs to the unwound configuration and driving the pump.

[0011] 8. The one or more springs comprise a first linear spring and a second linear spring, each movable between an axially expanded configuration and an axially compressed configuration; the device further comprises a primary slide and a secondary slide, the primary slide configured to slidably move parallel to a linear axis of the device between a first primary slide position and a second primary slide position; the secondary slide configured to slidably move parallel to the linear axis between a first secondary slide position and a second secondary slide position; the primary slide coupled to the first linear spring; the secondary slide coupled to both the first linear spring and the second linear spring; and the device configured to compress the primary slide until released. 8. The device of any of aspects 1-7, further comprising a blocker configured to prevent movement of the primary slide from the first primary slide position to the second primary slide position, wherein actuation of the load button moves the secondary slide from the first secondary slide position to the second secondary slide position and moves both the first linear spring and the second linear spring to an axially compressed configuration, wherein actuation of the dose button after actuation of the load button releases the blocker to allow the first linear spring to move to the axially expanded configuration, wherein movement of the first linear spring to the axially expanded configuration moves the primary slide from the first primary slide position to the second primary slide position, and movement of the primary slide to the second primary slide position operates the drive member.

[0012] 9. The device of aspect 8, further comprising a latch configured to prevent the secondary slide from moving from the second secondary slide position to the first secondary slide position after actuation of the load button until released, the latch configured to be released a predetermined time after the blocker is released to allow the second linear spring to move to the axially expanded configuration, wherein movement of the second linear spring to the axially expanded configuration moves the secondary slide from the second secondary slide position to the first secondary slide position.

[0013] 10. The device of aspect 9, wherein the primary slide and secondary slide are coupled such that movement of the secondary slide from the second secondary slide position to the first secondary slide position moves the primary slide from the second primary slide position to the first primary slide position, and movement of the primary slide to the first primary slide position retracts the actuated needle assembly from the injection position to the retracted position.

[0014] 11. The device of any of aspects 9-10, wherein the device is a reusable device and is configured to enable a second actuation of the load button when the primary slide returns to the first primary slide position and the secondary slide returns to the first secondary slide position, and then enable a second actuation of the dose button after the second actuation of the load button to deliver a second dose of the medication fluid.

[0015] 12. A clock spring rotatable between an unwound configuration and a wound configuration, a face gear rotationally locked with the clock spring, and a pawl configured to engage the face gear, wherein actuation of a load button loads the clock spring by rotating the face gear in a first rotational direction, and rotation of the face gear in the first rotational direction rotates the clock spring to the wound configuration, and the pawl engages the face gear after rotation of the clock spring to the wound configuration to prevent rotation of the face gear in a second rotational direction opposite the first rotational direction, and wherein the clock spring is in the unwound configuration. 12. The device of any of aspects 9-11, wherein actuation of the dose button after actuation of the load button disengages the pawl from the face gear and allows the face gear to rotate in the second rotational direction, rotating the face gear in the second rotational direction rotates the clock spring to the unwound configuration, rotation of the face gear in the second rotational direction through a predetermined rotational angle releases the latch and allows the second linear spring to move to the axially expanded configuration, and movement of the second linear spring to the axially expanded configuration moves the secondary slide from the second secondary slide position to the first secondary slide position.

[0016] 13. The device of any one of aspects 1-12, wherein the pump is a rotary plunger pump.

[0017] 14. The device of any of aspects 1-13, wherein the device is configured to use only energy released from the one or more loaded springs to operate the drive member to drive the pump and retract the driven needle assembly.

[0018] 15. A method for operating a drug delivery device, the method comprising: actuating a load button of the device to load one or more springs of the device using work done by actuating the load button; and after actuating the load button to release the one or more loaded springs, actuating a dose button of the device, wherein releasing the one or more loaded springs operates a drive member of the device to drive a needle assembly in the device from a retracted position to an injection position; actuating a pump of the device to pump drug fluid from a drug reservoir through the driven needle assembly; and actuating the driven needle assembly to retract from the injection position to the retracted position.

[0019] 16. The method of aspect 15, wherein a drug reservoir is disposed within the device and contains a drug fluid.

[0020] 17. The method of any of aspects 15-16, wherein the needle assembly is a first needle assembly of a plurality of needle assemblies, and the plurality of needle assemblies are disposed in a needle cartridge.

[0021] 18. The method of aspect 17, further comprising advancing the needle cartridge in response to a user actuation of the load button, such that a second needle assembly of the plurality of needle assemblies is moved out of operative alignment with the drive member and the first needle assembly is moved into operative alignment with the drive member.

[0022] 19. The method of any of aspects 15-18, further comprising activating an unlock button on the device to unlock the medication button for activation.

[0023] 20. The method of any of aspects 15-19, wherein only energy released from the one or more loaded springs is used to operate the drive member to drive the pump and retract the driven needle assembly.

[0024] 21. A needle insertion mechanism for a drug delivery device, comprising: a drive member; a needle assembly disposed in a retracted position within a housing of the drug delivery device; a primary linear spring; a secondary linear spring; a primary slide configured to slidably move parallel to a linear axis of the device between a first primary slide position and a second primary slide position, the primary slide coupled to the first linear spring; a secondary slide configured to slidably move parallel to a linear axis of the device between a first secondary slide position and a second secondary slide position, the secondary slide coupled to the first linear spring and the second linear spring; and a drive member configured to drive the primary slide from the first primary slide position to the second primary slide position until released. a load button configured to be manually actuated to move the secondary slide from the first secondary slide position to the second secondary slide position using work done by actuation of the load button to compress both the first linear spring and the second linear spring; and a dose button configured to be manually actuated after actuation of the load button to release the blocker and allow the primary slide to move from the first primary slide position to the second primary slide position under biasing pressure from the compressed first linear spring, wherein movement of the primary slide to the second primary slide position operates a drive member to drive the needle assembly from the retracted position to the injection position.

[0025] 22. The mechanism of aspect 21, further comprising a latch configured to prevent the secondary slide from moving from the second secondary slide position to the first secondary slide position after actuation of the load button until released, and configured to release the latch at a predetermined time after release of the blocker to allow the secondary slide to move from the second secondary slide position to the first secondary slide position under biasing pressure from the compressed second linear spring.

[0026] 23. The mechanism of aspect 22, wherein the primary slide and secondary slide are coupled such that movement of the secondary slide from the second secondary slide position to the first secondary slide position moves the primary slide from the second primary slide position to the first primary slide position, and movement of the primary slide to the first primary slide position retracts the actuated needle assembly from the injection position to the retracted position.

[0027] 24. A device further comprising a clock spring rotatable between an unwound configuration and a wound configuration, a face gear rotationally locked with the clock spring, and a pawl configured to engage the face gear, wherein actuation of a load button loads the clock spring by rotating the face gear in a first rotational direction, and rotation of the face gear in the first rotational direction rotates the clock spring to the wound configuration, and the pawl engages the face gear after rotation of the clock spring to the wound configuration to prevent the face gear from rotating in a second rotational direction opposite the first rotational direction, and 24. The mechanism of any of aspects 22-23, wherein the mechanism is configured to prevent the clock spring from rotating to the unwound configuration, wherein actuation of the dose button after actuation of the load button disengages the pawl from the face gear and allows the face gear to rotate in the second rotational direction, wherein rotation of the face gear in the second rotational direction rotates the clock spring to the unwound configuration, and wherein rotating the face gear in the second rotational direction through the predetermined rotational angle releases the latch and allows the secondary slide to move from the second secondary slide position to the first secondary slide position under biasing pressure from the compressed second linear spring.

[0028] 25. A method for operating a needle insertion mechanism for a drug delivery device, the needle insertion mechanism comprising: a primary slide coupled to a first linear spring; a secondary slide coupled to the first linear spring and a second linear spring; and a blocker configured to prevent the primary slide from moving from the first primary slide position to the second primary slide position until released, the method comprising: actuating a load button of the device to move the secondary slide from the first secondary slide position to the second secondary slide position, wherein movement of the secondary slide axially compresses both the first linear spring and the second linear spring; and after actuating the load button, actuating a dose button of the device to release the blocker and move the primary slide from the first primary slide position to the second primary slide position under biasing pressure from the compressed first linear spring, wherein movement of the primary slide to the second primary slide position operates a drive member to drive a needle assembly disposed within the device from a retracted position to an injection position.

[0029] 26. The method of embodiment 25, wherein the device further comprises a latch that prevents the secondary slide from moving from the second secondary slide position to the first secondary slide position after a user activates the load button until released, and further comprising releasing the latch at a predetermined time after release of the blocker to allow the secondary slide to move from the second secondary slide position to the first secondary slide position under biasing pressure from the compressed second linear spring.

[0030] 27. The method of embodiment 26, wherein the primary slide and secondary slide are coupled such that movement of the secondary slide from the second secondary slide position to the first secondary slide position moves the primary slide from the second primary slide position to the first primary slide position, and movement of the primary slide to the first primary slide position retracts the actuated needle assembly from the injection position to the retracted position.

[0031] 28. The method of any of aspects 25-27, wherein the needle handling mechanism further comprises a clock spring, a face gear coupled to the clock spring, and a pawl configured to engage with the face gear, and includes: during actuation of the load button, loading the clock spring by rotationally winding the face gear and clock spring in a first rotational direction using work done by actuation of the load button; preventing the clock spring from unwinding after loading the clock spring by engaging the pawl with the face gear and rotating it in a second rotational direction opposite the first rotational direction; during actuation of the medication button, allowing the clock spring to unwind by disengaging the pawl from the face gear and rotating it in the second rotational direction; and when the clock spring has unwinded by a predetermined rotational angle, releasing the latch to allow the secondary slide to move from the second secondary slide position to the first secondary slide position under biasing pressure from the compressed second linear spring.

[0032] 29. A device for storing and handling needles, comprising: a housing; a drive member; a needle cartridge holding a plurality of needle assemblies, each needle assembly disposed in a distinct retracted position within the needle cartridge; the needle cartridge; one or more springs; a load button coupled to the housing, the load button configured to be manually actuated, and wherein work done by actuation of the load button is used to load the one or more springs and advance the needle cartridge so that a first needle assembly of the plurality of needle assemblies is moved out of operative alignment with the drive member and a second needle assembly of the plurality of needle assemblies is moved into operative alignment with the drive member; and a dose button coupled to the housing, the dose button configured to be manually actuated after actuation of the load button to release the one or more loaded springs and operate the drive member to drive the second needle assembly from its retracted position within the needle cartridge to an injection position.

[0033] 30. The device of aspect 29, wherein the device is further configured to, after operating the drive member to drive the second needle assembly to the injection position, use energy released from the one or more springs to retract the second needle assembly to its retracted position.

[0034] 31. The device of any of aspects 29-30, wherein the needle cartridge includes a plurality of Geneva wheel members, and wherein the device further comprises a Geneva wheel configured to engage with the Geneva wheel members, the Geneva wheel configured to rotate in response to actuation of the load button, and wherein engagement between the Geneva wheel and the Geneva wheel members rotates the needle cartridge such that the first needle assembly is moved out of operative alignment with the drive member and the second needle assembly is moved into operative alignment with the drive member.

[0035] 32. The device of any of aspects 29-31, wherein the device further comprises a drug reservoir configured to contain a drug fluid; and a pump in fluid communication with the drug reservoir.

[0036] 33. The device of aspect 32, wherein the device is configured to operate the drive member to drive the second needle assembly to the injection position, and then drive the pump to pump drug fluid from the drug reservoir through the second needle assembly using energy released from the one or more springs.

[0037] 34. The device of any one of aspects 32-33, wherein the pump is a rotary plunger pump.

[0038] 35. The device of any of aspects 29-34, further comprising an unlock button configured to prevent actuation of the medication button until the unlock button is moved to the unlocked configuration.

[0039] 36. The device of any one of aspects 29-35, wherein the device is configured to operate the drive member using only energy released from the one or more loaded springs.

[0040] 37. The device of any of aspects 30-35, wherein the device is configured to use only energy released from the one or more loaded springs to operate the drive member and retract the second needle assembly.

[0041] 38. The device of any one of aspects 33-35, wherein the device is configured to use only energy released from one or more loaded springs to operate the drive member and drive the pump.

[0042] 39. A method for operating a drug delivery device comprising one or more springs, a load button, a dose button, a drive member, and a needle cartridge holding a plurality of needle assemblies, each needle assembly disposed in a retracted position within the needle cartridge, the method comprising: actuating the load button of the device to advance the needle assemblies using work done by the actuation of the load button to move a first needle assembly of the plurality of needle assemblies out of operative alignment with the drive member and a second needle assembly of the plurality of needle assemblies into operative alignment with the drive member, and to load the one or more springs using work done by the actuation of the load button; and actuating the dose button of the device after the actuation of the load button to release the one or more loaded springs, wherein releasing the one or more loaded springs uses energy released from the one or more loaded springs to operate the drive member to drive the second needle assembly from its retracted position within the needle cartridge to an injection position.

[0043] 40. The method of embodiment 39, wherein releasing the one or more loaded springs uses energy released from the one or more loaded springs after driving the second needle assembly to the injection position to retract the second needle assembly to its retracted position.

[0044] 41. The method of any of aspects 39-40, wherein the needle cartridge comprises a plurality of Geneva wheel members, and the device further comprises a Geneva wheel configured to engage with the Geneva wheel members, the Geneva wheel rotating in response to actuation of the load button, and engagement between the Geneva wheel and the Geneva wheel members rotating the needle cartridge, thereby moving the first needle assembly out of operative alignment with the drive member and moving the second needle assembly into operative alignment with the drive member.

[0045] 42. The method of any of aspects 39-41, wherein the device further comprises a drug reservoir configured to contain a drug fluid; and a pump in fluid communication with the drug reservoir.

[0046] 43. The method of embodiment 42, wherein releasing the one or more loaded springs drives a pump to pump drug fluid from the drug reservoir through the second needle assembly using energy released from the one or more loaded springs.

[0047] 44. The method of any one of aspects 42-43, wherein the pump is a rotary plunger pump.

[0048] 45. The method of any of aspects 39-44, further comprising actuating an unlock button to unlock the medication button.

[0049] 46. ​​The method of any one of aspects 39-45, wherein only energy released from one or more loaded springs is used to operate the drive member.

[0050] 47. The method of any of aspects 40-45, wherein only energy released from the one or more loaded springs is used to operate the drive member and retract the second needle assembly.

[0051] 48. The method of any one of aspects 43-45, wherein only the energy released from the one or more loaded springs is used to operate the drive member and drive the pump.

[0052] 49. A drug delivery device comprising: a housing; a drug reservoir within the housing configured to contain a drug fluid; a pump in fluid communication with the drug reservoir; a needle cartridge holding a plurality of needle assemblies; one or more springs; a loading button coupled to the housing, the loading button configured to be manually actuated, where work done by actuation of the loading button is used to load the one or more springs and advance the needle cartridge so that a first needle assembly of the plurality of needle assemblies is moved out of a dosing position within the device and a second needle assembly of the plurality of needle assemblies is moved to a dosing position; and a dosing button coupled to the housing configured to be manually actuated after actuation of the loading button to release the one or more loaded springs to drive a pump to pump drug fluid from the drug reservoir through the second needle assembly.

[0053] 50. The device of aspect 49, further comprising a drive member, wherein the dosing position is in operative alignment with the drive member, and wherein actuation of the dosing button after actuation of the loading button releases one or more loaded springs to operate the drive member and drive the second needle assembly to the injection position.

[0054] 51. The device of aspect 50, wherein the device is further configured to, after operating the drive member to drive the second needle assembly to the injection position, use energy released from the one or more springs to retract the second needle assembly to the dosing position.

[0055] 52. The device of any one of aspects 49-51, wherein the pump is a rotary plunger pump.

[0056] 53. The device of any of aspects 49-52, further comprising an unlock button configured to prevent actuation of the medication button until the unlock button is moved to the unlocked configuration.

[0057] 54. The device of any of aspects 49-53, wherein the one or more springs comprise one or more clock springs movable between an unwound configuration and a wound configuration, and wherein actuation of the load button loads the one or more clock springs by moving the one or more clock springs to the wound configuration using work done by actuation of the load button, and actuation of the dose button after actuation of the load button releases the one or more clock springs by moving the one or more clock springs to the unwound configuration to drive the pump.

[0058] 55. The device of any of aspects 50-54, wherein the one or more springs each comprise one or more linear springs movable between an axially expanded configuration and an axially compressed configuration, and wherein actuation of the load button moves the one or more linear springs to the axially compressed configuration using work done by actuation of the load button, and actuation of the dose button after actuation of the load button moves the one or more linear springs to the axially expanded configuration and operates the drive member, thereby releasing the one or more linear springs.

[0059] 56. The device of any one of aspects 49-55, wherein the device is configured to drive the pump using only energy released from one or more loaded springs.

[0060] 57. A device according to any of aspects 50-55, wherein the device is configured to drive the pump using only the energy released from the one or more loaded springs to operate the drive member.

[0061] 58. A device according to any of aspects 51-55, wherein the device is configured to use only energy released from the one or more loaded springs to drive the pump and operate the drive member to retract the second needle assembly.

[0062] 59. A method for operating a drug delivery device, the method comprising: actuating a load button of the device using work through the actuation of the load button to advance a needle cartridge of the device so that a first needle assembly of a plurality of needle assemblies stored in the needle cartridge is moved out of a dosing position in the device and a second needle assembly of the plurality of needle assemblies is moved to the dosing position, and to load one or more springs in the device using work done by the actuation of the load button; and actuating a dose button of the device after the actuation of the load button to release the one or more loaded springs and use energy released from the one or more loaded springs to drive a pump to pump drug fluid from a drug reservoir of the device through the second needle assembly.

[0063] 60. The method of embodiment 59, wherein the device further comprises a drive member, the dispensing position is in operative alignment with the drive member, and releasing the one or more loaded springs operates the drive member to drive the second needle assembly to the injection position.

[0064] 61. The method of embodiment 60, wherein releasing the one or more loaded springs operates the drive member to drive the second needle assembly to the injection position and then retracts the second needle assembly to the dosing position.

[0065] 62. The method of any one of aspects 59-61, wherein the pump is a rotary plunger pump.

[0066] 63. The method of any of aspects 59-62, further comprising activating an unlock button to unlock the medication button.

[0067] 64. The method of any of embodiments 59-63, wherein the one or more springs comprise one or more clock springs, loading the one or more springs comprises rotationally winding the one or more clock springs, and releasing the one or more loaded springs comprises allowing the one or more clock springs to unwind, and using energy released by the one or more unwinding clock springs to drive the pump.

[0068] 65. The method of any of embodiments 60-64, wherein the one or more springs comprise one or more linear springs, wherein loading the one or more springs comprises compressing the one or more linear springs, and wherein releasing the one or more springs comprises allowing the one or more linear springs to expand, and wherein using energy released by the one or more expanding linear springs to operate the drive member.

[0069] 66. The method of any one of aspects 59-65, wherein only the energy released from the one or more loaded springs is used to drive the pump.

[0070] 67. The method of any one of aspects 60-65, wherein only the energy released from the one or more loaded springs is used to drive the pump and to operate the drive member.

[0071] 68. The method of any of aspects 61-65, wherein only energy released from the one or more loaded springs is used to drive the pump to operate the drive member and retract the second needle assembly. [Brief explanation of the drawings]

[0072] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent and will be better understood by reference to the following description of the embodiments of the invention taken in conjunction with the accompanying drawings. [Figure 1]FIG. 1 is a block diagram providing a system-level overview of a multi-purpose drug delivery device, according to some embodiments. [Figure 2] 1 provides a top perspective view of the exterior of an exemplary drug delivery device. [Figure 3] 1 provides a bottom perspective view of the exterior of an exemplary drug delivery device. [Figure 4] 1 provides a top view of the internal components of an exemplary drug delivery device. [Figure 5] 1 provides a top perspective view of the internal components of an exemplary drug delivery device. [Figure 6] 1 provides an exploded perspective view of an exemplary drug delivery device. [Figure 7A] 1 provides a first cross-sectional perspective view of an exemplary drug delivery device. [Figure 7B] 1 provides a second cross-sectional perspective view of an exemplary drug delivery device. [Figure 8] 1 provides a first top perspective view of the internal components of an exemplary drug delivery device, with certain components omitted for simplicity and clarity; [Figure 9] 1 provides a second top perspective view of the internal components of an exemplary drug delivery device, with certain components omitted for simplicity and clarity. [Figure 10] 1 provides a bottom perspective view of the internal components of an exemplary drug delivery device. [Figure 11] 1 provides a detailed close-up view of a secondary slide component, according to some embodiments. [Figure 12] 1 provides a detailed close-up view of a primary slide component, according to some embodiments. [Figure 13A] 10 provides a detailed close-up view of a dose button lock component, according to some embodiments. [Figure 13B] 10 provides a detailed close-up view of a dose button lock component, according to some embodiments. [Figure 14A] 1 provides a detailed close-up view of a blocker component according to some embodiments. [Figure 14B]1 provides a detailed close-up view of a blocker component according to some embodiments. [Figure 15A] 10A-10C illustrate a series of states of an exemplary drug delivery device in operation when a user presses a load button. [Figure 15B] 10A-10C illustrate a series of states of an exemplary drug delivery device in operation when a user presses a load button. [Figure 15C] 10A-10C illustrate a series of states of an exemplary drug delivery device in operation when a user presses a load button. [Figure 15D] 10A-10C illustrate a series of states of an exemplary drug delivery device in operation when a user presses a load button. [Figure 16A] 10 illustrates the proximal movement of a secondary slide component caused by depression of a load button on an exemplary drug delivery device. [Figure 16B] 10 illustrates the proximal movement of a secondary slide component caused by depression of a load button on an exemplary drug delivery device. [Figure 17A] 1 illustrates the rotation of face gear components in an exemplary drug delivery device. [Figure 17B] 1 illustrates the rotation of face gear components in an exemplary drug delivery device. [Figure 18A] 10 illustrates disengagement of a side-facing slide rack component from a pinion coupler component in an exemplary drug delivery device. [Figure 18B] 10 illustrates disengagement of a side-facing slide rack component from a pinion coupler component in an exemplary drug delivery device. [Figure 18C] 10 illustrates disengagement of a side-facing slide rack component from a pinion coupler component in an exemplary drug delivery device. [Figure 19A] 10 illustrates disengagement of a downward-facing slide rack component from a gear component in an exemplary drug delivery device. [Figure 19B] 10 illustrates disengagement of a downward-facing slide rack component from a gear component in an exemplary drug delivery device. [Figure 19C]10 illustrates disengagement of a downward-facing slide rack component from a gear component in an exemplary drug delivery device. [Figure 20A] 10 illustrates how pressing an exemplary drug delivery device against a patient's body unlocks the dose button component. [Figure 20B] 10 illustrates how pressing an exemplary drug delivery device against a patient's body unlocks the dose button component. [Figure 21A] 10 illustrates how pressing the dose button component releases the primary slide component and causes it to translate proximally within an exemplary drug delivery device. [Figure 21B] 10 illustrates how pressing the dose button component releases the primary slide component and causes it to translate proximally within an exemplary drug delivery device. [Figure 22A] 10 illustrates how proximal translation of a primary slide component drives needle insertion into an exemplary drug delivery device. [Figure 22B] 10 illustrates how proximal translation of a primary slide component drives needle insertion into an exemplary drug delivery device. [Figure 23A] 1 illustrates the interaction between a dose button component, a blocker component, and a latch assembly component in an exemplary drug delivery device. [Figure 23B] 1 illustrates the interaction between a dose button component, a blocker component, and a latch assembly component in an exemplary drug delivery device. [Figure 23C] 1 illustrates the interaction between a dose button component, a blocker component, and a latch assembly component in an exemplary drug delivery device. [Figure 24A] 10 illustrates how actuation of a dose button releases the unwinding of face gear components in an exemplary drug delivery device. [Figure 24B] 10 illustrates how actuation of a dose button releases the unwinding of face gear components in an exemplary drug delivery device. [Figure 24C]10 illustrates how actuation of a dose button releases the unwinding of face gear components in an exemplary drug delivery device. [Figure 25A] 10 illustrates how unwinding of a face gear component releases a sliding latch component in an exemplary drug delivery device. [Figure 25B] 10 illustrates how unwinding of a face gear component releases a sliding latch component in an exemplary drug delivery device. [Figure 25C] 10 illustrates how unwinding of a face gear component releases a sliding latch component in an exemplary drug delivery device. [Figure 26A] 10 illustrates how release of a slide latch component releases distal movement of a secondary slide component and a primary slide component within an exemplary drug delivery device. [Figure 26B] 10 illustrates how release of a slide latch component releases distal movement of a secondary slide component and a primary slide component within an exemplary drug delivery device. [Figure 26C] 10 illustrates how release of a slide latch component releases distal movement of a secondary slide component and a primary slide component within an exemplary drug delivery device. [Figure 27A] 10 illustrates how distal movement of a primary slide component drives retraction of an inserted needle in an exemplary drug delivery device. [Figure 27B] 10 illustrates how distal movement of a primary slide component drives retraction of an inserted needle in an exemplary drug delivery device. [Figure 27C] 10 illustrates how distal movement of a primary slide component drives retraction of an inserted needle in an exemplary drug delivery device. [Figure 28] 1 shows one possible embodiment of a drug pump. [Figure 29] 1 shows an exploded view of an embodiment of a drug pump. [Figure 30A]10A-10C show different profile views of a rotary plunger component within an embodiment of a drug pump. [Figure 30B] 10A-10C show different profile views of a rotary plunger component within an embodiment of a drug pump. [Figure 30C] 10A-10C show different profile views of a rotary plunger component within an embodiment of a drug pump. [Figure 30D] 10A-10C show different profile views of a rotary plunger component within an embodiment of a drug pump. [Figure 31] 1A and 1B show perspective views of a rotary plunger component in an embodiment of a drug pump. [Figure 32] 1A and 1B show perspective views of pump housing components of an embodiment of a drug pump. [Figure 33] 1 shows a cutaway view of the drug pump housing components. [Figure 34A] 1A-1D show different cutaway views of an embodiment of a drug pump in operation. [Figure 34B] 1A-1D show different cutaway views of an embodiment of a drug pump in operation. [Figure 34C] 1A-1D show different cutaway views of an embodiment of a drug pump in operation. [Figure 34D] 1A-1D show different cutaway views of an embodiment of a drug pump in operation. [Figure 35A] 1A-1D show different top cutaway views of an embodiment of a drug pump in operation. [Figure 35B] 1A-1D show different top cutaway views of an embodiment of a drug pump in operation. [Figure 35C] 1A-1D show different top cutaway views of an embodiment of a drug pump in operation. [Figure 35D] 1A-1D show different top cutaway views of an embodiment of a drug pump in operation.

[0073] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary embodiments of the present invention, and such exemplifications should not be construed as limiting the scope of the present invention in any way. DETAILED DESCRIPTION OF THE INVENTION

[0074] The present disclosure relates to a drug delivery device that stores energy as a result of work done by a user to perform steps such as indexing a needle cartridge, inserting a needle, retracting a needle, unlocking a dose button, forming a fluid pathway from a reservoir to a patient, and pumping.

[0075] According to one aspect of the present disclosure, the device disclosed herein uses a user-initiated action (e.g., by pressing a button) in a first actuation step to load one or more springs and index the needle-retaining cartridge. A second actuation step by the user releases one or more loaded springs (e.g., linear compression springs) to drive the needle into the patient's subcutaneous / intramuscular tissue. This step also releases one or more loaded springs (e.g., one or more coiled clock springs) to drive a gear train, the output torque of which rotates a pump (e.g., a rotary plunger pump). The pump then draws fluid from the reservoir and delivers it to the patient. At the end of the dose, additional energy from the one or more loaded springs is released to retract the needle and reset the device. A locking mechanism associated with the on-body sensing button reduces the possibility of the user accidentally triggering the second actuation step by mechanically locking out the device and preventing the user from triggering the second actuation step until the device is pressed against the patient's body.

[0076] The devices disclosed herein may be configured to be filled by the user at the time of use (e.g., the user fills the drug reservoir of the device when the device is to be used), assembled at the time of use (e.g., the user assembles a pre-filled drug reservoir when the device is to be used), or pre-filled and pre-assembled (e.g., the device is provided to the user pre-filled and pre-assembled).

[0077] 1 is a block diagram providing a system-level overview of an exemplary multi-purpose drug delivery device 100, according to some embodiments. The device 100 includes a load button 102, a dose button 104, and an optional on-body sensing button 106.

[0078] Device 100 also includes a drug reservoir 150. Reservoir 150 can be a rigid or elastomeric container configured to store a drug. Device 100 can further include a drug stored in reservoir 150. In another embodiment, a system can include device 100 and one or more devices containing a drug. The term "drug" refers to one or more therapeutic agents capable of being delivered by the device, including, but not limited to, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any therapeutic agent capable of being delivered by device 100. Drugs used in the device can be formulated with one or more excipients. The device is operated by a patient, caregiver, or medical professional to deliver a drug to a person in a manner generally described herein.

[0079] Device 100 also includes pump 180. Pump 180 may comprise any suitable pump that draws fluid medication from reservoir 150 and delivers said fluid medication through a fluid pathway into the patient's body. One example of a suitable pump 180 is a rotary plunger pump. Other examples of suitable pumps include piston pumps, peristaltic pumps, diaphragm pumps, rotary vane pumps, and screw pumps.

[0080] The device 100 also includes a needle cartridge 300 that holds multiple needle assemblies. Each individual needle assembly within the cartridge 300 may include an injection needle and a support hub that holds the needle and provides a gripping and / or pushing surface that allows the needle assembly to be individually handled by an insertion / retraction mechanism. Each needle assembly may be configured for use in a single injection. After a needle assembly is used, it may be retracted within the needle cartridge 300. After all needle assemblies within the cartridge 300 have been used, the entire cartridge may be replaced and / or discarded. In some disposable embodiments of the device 100, the entire device 100 may be discarded once all needles within the cartridge 300 have been used.

[0081] Device 100 also includes a needle insertion / retraction mechanism 500 that, when activated by a user, drives individual needle assemblies within cartridge 300 in operative alignment with mechanism 500 from a retracted position to an injection position, and then retracts said individual needle assemblies from the injection position back to the retracted position after an injection is completed. Mechanism 500 can include a single hammer or arm that both drives and retracts the individual needle assemblies; alternatively, mechanism 500 can include multiple hammers / arms, one or more of which drive the needle assemblies and one or more of which retract the needle assemblies. Device 100 also includes a cartridge indexing mechanism 400 that, when activated, advances or indexes cartridge 300 to move spent or used needle assemblies out of operative alignment with mechanism 500 and position a new, unused needle assembly into operative alignment with mechanism 500.

[0082] Device 100 may be used by a user to inject a fluid medication stored in reservoir 150 into a patient's body. As used herein, "user" may refer to a person who operates device 100, for example, by pressing a button on device 100 and / or by positioning the device against the patient's body for injection. "Patient" may refer to a person receiving an injection. In some embodiments, the "user" and "patient" may be the same person, for example, when the device is used by a patient to inject themselves. In some embodiments, the "user" and "patient" may be different people, for example, when the device is used by a caregiver to inject a patient.

[0083] Device 100 may be operated by a user by first pressing load button 102 to “load” the device. When the user presses load button 102, the work done by the user in pressing button 102 is captured and / or collected by energy transfer, storage, and release mechanism 200. Mechanism 200 may include one or more mechanical components, such as gears, gear trains, sliding racks, pinion couplers, wires, and / or other mechanical linkages, that transfer the work done by the user to other parts of device 100. For example, the work done by the user may be transferred to cartridge indexing mechanism 400, which advances or indexes cartridge 300. Mechanism 200 may also include one or more springs (e.g., linear springs, torsion springs, clock springs, etc.), that store the work done by the user as potential energy that can be released at a later time to drive other components of device 100.

[0084] After the load button 102 is pressed, the user can trigger the device to begin an injection by pressing the dose button 104. However, in some embodiments, the dose button 104 is initially locked so that the user cannot depress it. The dose button 104 can be subsequently unlocked, for example, by a button or another unlocking component. In such embodiments, the user can unlock the dose button 104 by actuating the unlock button 106. For example, the user can press the unlock button 106 with their finger. Alternatively, the user can actuate the unlock button 106 (e.g., the unlock button 106 takes the form of an on-body sensing button 106) by pressing the device 100 against the patient's body in preparation for an injection. In such embodiments, the unlock button 106 is depressed when the device 100 is pressed against the patient's body, thereby unlocking the dose button 104. While the remainder of this disclosure refers to an on-body sensing button 106, it should be understood that this is but one embodiment of the device 100. The primary function of the button 106 is to unlock the medication button 104, and the button 106 need not take the form of an on-body sensing button.

[0085] When the user subsequently presses the medication button 104, potential energy stored by the energy transfer, storage, and release mechanism 200 (e.g., by one or more springs) is released to drive the needle insertion / retraction mechanism 500 to insert an individual needle assembly for injection. The energy stored by the mechanism 200 is also released to drive the pump 180 to pump liquid medication from the reservoir 150 through the inserted needle assembly and into the patient. In other embodiments, in addition to or instead of driving the needle assembly, the driven needle assembly can be retracted back into the device after the injection is completed. For example, after the injection is completed, additional energy stored by the mechanism 200 is released to drive the needle insertion / retraction mechanism 500 to retract the inserted needle assembly into the cartridge 300. In some embodiments, no means for converting or storing electrical energy (e.g., a battery, an electric motor) or chemical energy (e.g., a fuel cell, an internal combustion engine, a fuel storage reservoir, or a reaction chamber for a chemical reaction that produces heat or gas) is required. Instead, all energy required to drive the device 100, including assigning the cartridge 300, inserting and retracting the needle, and pumping the medication, is provided by the user.

[0086] 2 and 3 provide top and bottom perspective views (respectively) of the exterior of exemplary device 100. For ease of explanation only, FIGS. 2-27A, 27B, and 27C use an x, y, z directional system indicated by arrows 201.

number

number

[0087] Device 100 comprises an upper housing 101 and a lower housing 103 that house the internal components of the device. A load button 102 protrudes from the distal end of the device, a dose button 104 protrudes upward from upper housing 101, while an on-body sensing button 106 (e.g., unlock button 106) protrudes downward from lower housing 103. Lower housing 103 also defines a needle opening 108 (see FIG. 3 ) through which the needle of the needle assembly can protrude when inserted into a patient.

[0088] Figures 4, 5, and 6 show the internal components of device 100 when upper housing 101 is removed. Figure 4 provides a top view of device 100, Figure 5 provides a perspective view of device 100, and Figure 6 provides an exploded perspective view of device 100.

[0089] In the embodiment shown in FIGS. 4-6, cartridge 300 may take the form of a circular carousel having a generally planar top surface 301 and a generally planar bottom surface 303 (see FIG. 6). Cartridge 300 has a central shaft 310 extending from the top surface to the bottom surface through a central vertical axis of the cartridge. Central shaft 310 may be configured to receive a central spindle 302 extending vertically upward from the inner surface of lower housing 103 (see FIG. 6). When central spindle 302 is inserted through central shaft 310, carousel 300 is configured to rotate about central spindle 302. Carousel 300 defines a plurality of cavities 304a, b, c, etc. (collectively or individually referred to herein as "cavity" or "cavity(s)" 304, as appropriate). Each cavity 304 extends radially outward from the central shaft 310 toward the radial periphery of the cartridge and includes an opening in the top surface 301 and an opening in the bottom surface 303 .

[0090] Each cavity 304 houses a needle assembly 306a, b, c (collectively or individually referred to herein as a "needle assembly" or "needle assemblies" 306, as needed). One exemplary embodiment of a needle assembly 306 is shown in FIGS. 22A and 22B. In this embodiment, the needle assembly 306 includes a J-shaped needle or cannula 312 having a first leg segment 324 configured to pierce the drug septum 182 and withdraw a fluid drug therefrom, as described below, and a second leg segment 326 configured to be driven into the patient's body for injection. The needle 312 is held within a support hub 314 having a needle support base 316. In addition to holding and supporting the needle 312, the needle support base 316 also carries a ledge 328. The needle support base 316 also carries an upright arm member 320 having a tang 322 at its tip. Additional details regarding cartridge 300, cavity 304, and / or needle assembly 306 are further described in U.S. Patent No. 9,149,578, entitled "NEEDLE CARTRIDGE FOR MEDICATION INJECTION DEVICE," filed November 17, 2011, the entire contents of which are expressly incorporated herein by reference.

[0091] 4-6, cartridge 300 includes an intermittent rotary drive. For example, cartridge 300 includes a plurality of Geneva wheel members 308a, b, c (hereinafter collectively or individually referred to as "Geneva wheel member" or "Geneva wheel members" 308), as needed, that interact with Geneva wheel 410 to index and advance cartridge 300 one increment at a time, as described in further detail below. Each Geneva wheel member includes a substantially planar member that extends radially outward from cartridge 300 in a horizontal plane. Each Geneva wheel member may include a vertical, concave, arcuate wall 309 (see FIG. 5) at the furthest extent of each such wheel member, away from central shaft 310. When a Geneva wheel member is aligned with Geneva wheel 410, this vertical, concave wall 309 fits into the inner hub 411 of Geneva wheel 410 (see FIG. 5). The Geneva wheel 410 further includes a Geneva pin 412 that extends vertically upward from the horizontal plane of the Geneva wheel 410. Every pair of adjacent Geneva wheel members (e.g., 308a and 308b) defines a gap between said wheel members into which the Geneva pin 412 may fit.

[0092] Reservoir 150 (best seen in FIG. 6 ), which in this embodiment takes the form of an elastomeric container, is configured to contain a medication. Reservoir 150 may be provided to the user pre-filled with the medication or may be configured to be filled by the user. Pump 180 (also best seen in FIG. 6 ) in this embodiment takes the form of a rotary plunger pump. An example of a suitable rotary plunger pump is disclosed in U.S. Provisional Patent Application No. 62 / 891,600, filed August 26, 2019, entitled “ROTARY PLUNGER PUMP SUBSYSTEMS,” the entire contents of which are incorporated herein by reference. As discussed in further detail below, pump 180 can be actuated to pump liquid medication from reservoir 150 toward medication septum 182, where the medication can be forced into individual needles and, from there, into the patient.

[0093] 5-6 includes a secondary slide 202, a primary slide 210, a latch 216, a dose button lock 224, a blocker 226, a gear train including face gear 230, gears 232, 234, 235, 238, and 240, and a latch assembly 250. Each of these components will now be considered in turn.

[0094] The secondary slide 202 is attached to or mechanically coupled to the load button 102 via one or more intermediate mechanical components (e.g., gears, rods, wires, etc.). The slide 202 is configured to slidably move parallel to the x-axis of the device 100 between a secondary slide distal position and a secondary slide proximal position, as described in further detail below. FIG. 11 provides a more detailed view of one embodiment of the secondary slide 202. In this embodiment, the secondary slide 202 takes the form of a hollow, substantially rectangular-shaped member with its long axis aligned with the x-axis of the device 100. The slide 202 includes a first left wall 201, a second right wall 203, a bottom wall 205, a distal wall 207, an open-topped channel 209 defined between body portions of the left wall 201 and the right wall 203, and an open proximal channel 211 defined at the proximal end of the slide between the ends of the left wall 201 and the right wall 203. The slide 202 also includes a load button support 213 extending from the distal wall 207, which is configured to be attached to or mechanically coupled to the load button 102 via one or more intermediate components. The secondary slide 202 also includes a locking tab 206 extending horizontally outward from the left wall 201 of the slide 202 and a compression tab 208 extending horizontally outward from the right wall 203 of the slide 202. The secondary slide 202 houses a spring 204 (see FIGS. 4-6 ) within a channel 209. A distal end of the spring 204 abuts the inner surface of the distal wall 207, and a proximal end of the spring 204 abuts a tab (not shown) extending downward from the inner surface of the upper housing 101.

[0095] FIG. 8 shows a perspective view of device 100 from a different angle. For simplicity and clarity, certain components have been omitted from the view of device 100 in FIG. 8. As shown in FIG. 8, secondary slide 202 also includes one or more slide racks (two are shown): downward slide rack 241 and lateral slide rack 243. Downward slide rack 241 projects horizontally outward from left wall 201 of secondary slide 202 (i.e., toward the +y side of slide 202) and has teeth facing downward (i.e., in the -z direction) that interact with gear 232 (described in more detail below). Lateral slide rack 243 projects proximally from the proximal end of secondary slide 202 (shown coupled to a proximal end portion of left wall 201) and has teeth facing in the +y direction. As described in more detail below, the teeth from the lateral slide rack interact with teeth 408 of pinion coupler 406.

[0096] 4-6 , the primary slide 210 is configured to slidably move parallel to the x-axis of the device 100 between a primary slide distal position and a primary slide proximal position, as described in further detail below. FIG. 12 provides a more detailed view of one embodiment of the primary slide 210. In this embodiment, the primary slide 210 takes the form of a hollow, substantially rectangular-shaped member, also having a major axis aligned with the x-axis of the device 100. The primary slide 210 comprises a first left wall 215, a second right wall 217, a bottom wall 219, a distal wall 221, a proximal wall 225, and an open-topped channel 223 defined between body portions of the left wall 217 and the right wall 215. The primary slide 210 also comprises a locking tab 214 extending horizontally outward from the right wall 217 (i.e., the −y side) of the slide 210 and a pair of fins 227 extending proximally from the proximal wall 225. Left wall 215 and right wall 217 define slot 211 extending laterally (y-direction) therethrough, and fin 227 defines channel 220 extending laterally (y-direction) therethrough. When device 100 is fully assembled (see FIGS. 4-6 ), compression tab 208 of secondary slide 202 is configured to extend through slot 211 and through the interior volume of primary slide 210. Primary slide 210 also houses spring 212 within its channel 223. A distal end of spring 212 abuts a proximal face of compression tab 208 of secondary slide 202, and a proximal end of spring 212 abuts an interior surface of proximal wall 225 of primary slide 210.

[0097] Latch 216 is configured to rotate in a horizontal flat plane about axis 229 and includes latch tab 218. When latch 216 rotates counterclockwise (when viewed from above), an over-rotation prevention mechanism (shown as spring 222) prevents latch 216 from over-rotating and biases latch 216 clockwise back to a neutral position (i.e., as shown in FIGS. 4-5 ), where the long axis of latch 216 is parallel to the x-axis of device 100. The over-rotation prevention mechanism may also include a pin or plate with a spring configured to function as described above.

[0098] The dose button lock 224 interacts with other components to prevent the user from depressing the dose button 104 until the sensing button 106 on the body is depressed. The dose button lock 224 is shown in more detail in FIGS. 13A and 13B. In this embodiment, the lock 224 includes a vertical panel 232 defining a pin slot 244. The slot 244 can extend diagonally in the +x / +z direction. The lock 224 also includes a horizontal panel 237 extending from the vertical panel 232, e.g., orthogonally. The horizontal panel 237 defines another pin slot 247 extending in the +x direction. The horizontal panel 237 also includes a blocker member 236 in the form of a substantially flat tab aligned with a horizontal flat surface extending from a distal end of the horizontal panel 237 beyond the vertical panel 232. The member 236 is also shown extending laterally beyond the vertical panel 232 in the -y direction.

[0099] FIG. 7A provides a cross-sectional perspective view of device 100 taken along plane 1-1 (see FIGS. 4-5) to best illustrate how the medication button lock 224 interacts with the on-body sensing button 106 when device 100 is fully assembled. For clarity, the lower housing 103 is rendered transparent. The on-body sensing button 106 can translate up and down in and out of a sensing button cavity 120 defined within the lower housing 103. The button 106 also includes a vertical sensing button shaft 116, which is coaxially surrounded by a sensing button spring 114. The upper end of the spring 114 abuts the inner surface of cavity 120, and the lower end of the spring 114 abuts the interior upper surface of the button 106. The spring 114 biases the button 106 downward and out of the cavity 120. When a user presses the bottom side of the device 100 against their body, the user's pressing force overcomes the biasing force of the spring 114 and causes the button 106 to translate upward into the cavity 120. When the pressing force is removed, the spring force allows the button 106 to return to its biased out position. The pin 118 is configured to extend horizontally from the left side of the shaft 116. When the device 100 is assembled, the pin 118 is configured to ride in the pin slot 244 of the dose button lock 224. As discussed in more detail below, the interaction of the pin 118 with the pin slot 244 of the dose button lock 224 causes the dose button lock 224 to translate proximally (i.e., in the −x direction) as the button 106 is pressed upward into the cavity 120.

[0100] 4-6 , the blocker 226 interacts with the dose button lock 224 to prevent the user from depressing the dose button 104 until the dose button 104 is unlocked, i.e., until the on-body sensing button 106 is depressed. Once the dose button 104 is unlocked and depressed, the blocker 226 also interacts with the latch assembly 250 (described in further detail below) to release the energy stored by the mechanism 200. The blocker 226 is depicted in further detail in FIGS. 14A and 14B . In this embodiment, the blocker 226 comprises three portions: a blocking tab 242, a button seat 239, and an arm 275. The button seat 239 takes the form of a substantially planar surface or member (in this embodiment, having a circular shape, although other shapes are possible) oriented parallel to the horizontal plane of the device 100. Block tab 242 is attached to the left side (i.e., the +y side) of button seat 239 and takes the form of a substantially planar surface or member oriented parallel to the vertical plane of device 100, extending in both the +y / +z directions away from seat 239. Arm 275 is also attached to button seat 239, spaced circumferentially from tab 242, and extends generally in the +x direction. Arm 275 includes fin 232 disposed at its distal end and extending in the +y direction. Fin 232 includes top surface 260, bottom surface 262, proximal surface 266, and distal surface 268. As best seen in FIG. 14B , top surface 260 and bottom surface 262 are obliquely angled, meaning they are parallel to a plane oriented in the -x / +z directions.

[0101] Figure 7B provides a perspective cross-sectional view of device 100 as cut along plane 2-2 (see Figures 4-5). Both Figure 7B and Figure 6 best illustrate how blocker 226 interacts with dose button 104 and how it interacts with dose button lock 224 when device 100 is fully assembled. As shown in Figure 6, when a user has not yet depressed sensing button 106 on their body, blocker member 236 of dose button lock 224 is positioned below button seat 239 of blocker 226. The position of blocker member 236 below button seat 239 of blocker 226 prevents blocker 226 from translating downward. As will be discussed in further detail below, when a user presses the sensing button 106 on the body upward, the interaction between the pin 118 and the pin slot 244 of the medication button lock 224 causes the medication button lock 224 to translate proximally (i.e., in the -x direction), and the blocker member 236 disengages the button seat 239, thereby unlocking the blocker 226 and allowing it to translate downward.

[0102] The dose button 104 can translate up and down into and out of a dose button cavity 121 defined within the upper housing 101 (see FIG. 7B). The dose button 104 includes a vertical dose button shaft 112 coupled to a blocker 226 such that the button 104 and blocker 226 translate up and down together. In the embodiment shown in FIG. 7B, the dose button shaft 112 is coupled to the blocker 226 using a screw, although any suitable attachment method (e.g., heat staking, one-way snaps, etc.) can be used. A dose button spring 110 coaxially surrounds the dose button shaft 112. The upper end of the spring 110 abuts against the bottom surface of the button 104, while the lower end of the spring 110 abuts against the interior upward-facing surface of the dose button cavity 121. Spring 110 biases button 104 (and blocker 226 attached to button 104) upward. When a user presses down on button 104, shaft 112 transfers the downward force of button 104 to button seat 239 of blocker 226. When blocker 226 is unlocked as described above, the user's downward force causes button 104 and blocker 226 (including button seat 239) to translate downward.

[0103] Mechanism 200 also includes face gear 230 and a gear train including gears 232, 234, 235, 238, and 240, each of which is best seen in FIG. 6. Face gear 230 takes the form of a circular gear including a plurality of upwardly facing teeth 231. Face gear 230 is coupled to clock spring 228. Both face gear 230 and clock spring 228 are disposed parallel to a horizontal plane and configured to rotate about central axis 233. Clock spring 228 resists rotational motion of face gear 230 about central axis 233. In other words, rotating face gear 230 in a first rotational direction about central axis 233 tensions clock spring 228, thereby storing potential energy within clock spring 228. Face gear 230 interacts with drive gear 240, which in turn interacts with and drives gear 232. Gear 232 also interacts with and drives a smaller gear 234 that is rotationally coupled to gear 235, causing gear 234 and gear 235 to rotate together. Gear 235 in turn interacts with gear 238, which provides rotational torque to pump 180. The number of gears, the relative size and configuration of the gears and teeth, can be selected to provide the rotational speed and torque required to drive the pump.

[0104] 9 and 10 provide additional, more detailed views of face gear 230 and clock spring 228 and how they interact with latch 216. FIG. 9 provides a top perspective view in which certain components (e.g., slides 202, 210, blocker 226, dose button lock 224, and latch assembly 250) have been removed to expose face gear 230 and clock spring 228, and FIG. 10 provides a bottom perspective view in which bottom housing 103 has been rendered transparent to better view the underside of face gear 230. As visible in FIG. 9, the top surface of face gear 230 defines a plurality of notches 270a, b, c, d, e (referred to herein collectively or individually as a "notch" or "notches" 270, as appropriate). While the embodiment of face gear 230 depicted in FIG. 9 defines five notches (notch 270c is hidden beneath gear 240 in FIG. 9), other embodiments are possible in which face gear 230 defines fewer or more notches. The notches are shown radially spaced from one another and may be equally radially spaced. Each notch is shaped to accommodate a pawl 256, as described in further detail below with reference to FIG. 23A. As best seen in FIG. 10, face gear 230 also includes a plurality of fins 272a, b, c, d, e (collectively or individually referred to herein as “fins” or “fins” 272, as appropriate). Again, while the embodiment of face gear 230 depicted in FIGS. 9 and 10 includes five fins, other embodiments in which face gear 230 includes fewer or more fins are possible. The fins are shown radially spaced from one another and may be equally radially spaced. Each fin extends radially outward in a horizontal plane from the outer periphery of the face gear 230 and includes a sloped leading edge and a straight trailing edge. As shown, the fins may be radially offset from the notch. As best seen in FIG. 10 , the latch 216 further includes a downwardly extending arm 274 that extends downward from the horizontal plane of the latch tab 218 to the horizontal plane of the face gear 230.As discussed in more detail below, each fin 272 is sized and positioned such that when face gear 230 rotates into a position where such fin 272 is aligned with arm 274, they push and displace arm 274 radially outward.

[0105] Latch assembly 250 is visible in the distal right corner of device 100 in FIGS. 4-5 and is shown in more detail in FIGS. 23A-C. The latch assembly includes a latch support 254 that secures latch assembly 250 to bottom housing 103. Latch support 254 has a first end 255 and a second end 257. First end 255 of support 254 is attached to the inner surface of bottom housing 103, while second end 257 of support 254 supports latch pin 252 and pawl 256. Both latch pin 252 and pawl 256 can rotate in a horizontal plane about axis 264. Torsion V-spring 258 is disposed between latch pin 252 and pawl 256 and is coupled to both components such that rotation of latch pin 252 about axis 264 also imparts a rotational force to pawl 256, and vice versa. When device 100 is fully assembled, latch pin 252 is configured to interact with fin 232 of blocker 226 and pawl 256 is configured to interact with face gear 230, as described in further detail below.

[0106] The cartridge indexing mechanism 400 is depicted in FIGS. 4-5. The mechanism 400 includes a pinion coupler 406 having teeth 408 that interact with and are driven to rotate with teeth on a side-facing slide rack 243 as the rack 243 is linearly translated. The pinion coupler 406 is rotationally coupled to a Geneva wheel 410 such that rotation of the pinion coupler 406 drives rotation of the Geneva wheel 410. The Geneva wheel 410 may be shaped as a substantially planar disk having a first circumference and an inner hub 411 having a second, smaller circumference stacked on top of the planar disk. A Geneva pin 412 extends vertically upward from the top surface of the planar disk. The Geneva pin 412 interacts with the Geneva wheel members 308 of the cartridge 300 by fitting within the gap between adjacent wheel members, as best seen in FIG.

[0107] A needle insertion / retraction mechanism 500 is depicted in FIGS. 4-6 and 22A and 22B. The mechanism 500 includes a drive member or hammer 502. As discussed in further detail below, the proximal end of the hammer 502 includes a head 503 that interacts with a needle assembly 306 within the cartridge 300, which engages the hammer 502 in operative alignment. The distal end of the hammer 502 includes pins 504 and 506 (see FIGS. 22A and 22B). When the device 100 is fully assembled, the hammer 502 is configured to rotate about the pin 506, which is fixed to either the upper housing 101 or the lower housing 103 (not shown in FIGS. 22A and 22B). When the device 100 is assembled, the pin 504 of the hammer 502 is also configured to fit within a channel 220 defined in the fin 227 of the primary slide 210 (see FIG. 5). Thus, proximal or distal translation of primary slide 210 exerts a force on pin 504 of hammer 502 , thus causing hammer 502 to rotate about pin 506 .

[0108] The operation of device 100 will now be described. FIGS. 15A-15D depict a series of states of device 100 during operation, according to some embodiments. FIG. 15A shows device 100 in an initial neutral state, before a user begins to depress load button 102. While in this neutral state, spring 204 of secondary slide 202 urges slide 202 distally until it hits a stop (e.g., when a surface of secondary slide 202 hits a stop in upper housing 101 or lower housing 103, or when a distal surface of compression tab 208 hits distal wall 221 of primary slide 210). The position of secondary slide 202 in this initial neutral state of device 100 is referred to herein as the secondary slide distal position. Similarly, while in this neutral state, spring 212 of primary slide 210 urges slide 210 distally until slide 210 hits a stop in upper housing 101 or lower housing 103 (not shown). The position of the primary slide 210 in this initial neutral state of the device 100 is referred to herein as the primary slide distal position. The Geneva pin 412 is initially engaged between the two Geneva wheel members 308 of the cartridge 300, labeled 308a and 308b in FIG. 15A.

[0109] 15B depicts what happens when a user begins to apply a proximal force to the load button 102, as indicated by arrow 606. Moving the load button 102 proximally causes the secondary slide 202 to translate proximally, parallel to the x-axis of the device 100, thereby compressing the spring 204 against a tab (not shown) extending downward from the inner surface of the upper housing 101. The compression tab 208 of the secondary slide 202 also translates proximally within the primary slide 210, thereby compressing the spring 212 against the inner surface of the proximal wall 225 of the primary slide 210. In this manner, movement of the secondary slide 202 proximally compresses both the spring 204 and the spring 212. As the secondary slide 202 translates proximally, the locking tab 206 eventually presses against the latch tab 218 of the latch 216. Both the locking tab 206 and the latch tab 218 include angled surfaces that, when pressed together, cause the latch 216 to rotate counterclockwise (when viewed from above) about axis 229, as indicated by arrow 608 in FIG. 15C. Eventually, as the secondary slide 202 continues to translate proximally, the locking tab 206 clears the latch tab 218, at which point the biasing pressure of the spring 222 causes the latch 216 to rotate clockwise (when viewed from above) about axis 229, as indicated by arrow 610 in FIG. 15D. As depicted in FIG. 15D, the latch tab 218 slides into position behind (i.e., distal to) the locking tab 206, thereby preventing the secondary slide 202 from translating distally. The position of the secondary slide 202 shown in FIG. 15D is referred to herein as the secondary slide proximal position.

[0110] Proximal movement of the secondary slide 202 also translates the side-facing slide rack 243 proximally, as shown by arrow 604 in FIGURES 15B-D. Due to engagement between the teeth of the side-facing slide rack 243 and the teeth 408 of the pinion coupler 406, proximal movement of the side-facing slide rack 243 rotates the pinion coupler 406 clockwise (when viewed from above), as shown by arrow 602. Due to the rotational coupling between the pinion coupler 406 and the Geneva wheel 410, the Geneva wheel 410 also rotates in the direction of arrow 602. The rotation of the Geneva wheel 410 causes the Geneva pin 412 to disengage from the gap between the two Geneva wheel members 308a, 308b with which the pin 412 was initially engaged, as shown in FIGURE 15B. As the Geneva wheel 410 continues to rotate, the pin 412 re-engages clockwise with the next gap defined between the two Geneva wheel members (308b, 308c) of the cartridge 300, as shown in FIG. 15D. This release and re-engagement of the pin 412 within the next gap between the Geneva wheel members allows the cartridge 300 to advance or index one increment in the counterclockwise direction (as viewed from above), as indicated by arrow 612. When the pin 412 is in the re-engaged state, the pin 412 maintains its position to prevent the cartridge from rotating, and the Geneva wheel 410 cannot rotate any further because the side-facing rack 243 is disengaged from the teeth 408, as depicted in FIG. 18C.

[0111] 15A-D, the work done by the user in pressing the load button 102 has been converted into potential energy stored in the compressed springs 204 and 212. This potential energy is prevented from being released by the latch tab 218, which prevents the secondary slide 202 from translating distally and releasing the spring. This potential energy is also prevented from being released by the blocker 226, which prevents the primary slide 210 from translating proximally (as described below). The work done by the user has also been used to index or advance the cartridge 300 one increment, thereby moving one spent or used needle assembly out of operative alignment with the drive member or hammer 502 and placing a new, unused needle assembly into operative alignment with the hammer 502.

[0112] 16A and 16B illustrate the proximal movement of secondary slide 202 resulting from depression of load button 102 from the +y side of device 100. FIG. 16A illustrates the state of device 100 in a neutral state before load button 102 is pressed. FIG. 16B illustrates the proximal movement of button 102 as a user depresses button 102, as indicated by arrow 606. The proximal movement of button 102 causes secondary slide 202 to translate proximally, which in turn causes downward slide rack 241 to translate proximally as well (because slide rack 241 is attached to secondary slide 202). Due to engagement between the downward teeth of downward slide rack 241 and gear 232, the proximal movement of downward slide rack 241 causes gear 232 to rotate in the direction indicated by arrow 614.

[0113] 17A and 17B illustrate the result of rotating gear 232 in the direction of arrow 614. For clarity, certain components (e.g., primary slide 210 and drug reservoir 150) are not depicted to better illustrate the movement of other components. Due to the engagement between gears 232 and 240, the rotational movement of gear 232 in the direction of arrow 614 causes gear 240 to rotate in the direction of arrow 616. Rotation of gear 240 in the direction of arrow 616, in turn, drives face gear 230 to rotate in the direction of arrow 618. Rotation of face gear 230 in the direction of arrow 618 tensions clock spring 228. As discussed above, face gear 230 defines a plurality of notches 270 on its upper surface. As face gear 230 rotates in the direction of arrow 618, one of these notches 270 eventually aligns with pawl 256 of latch assembly 250. Once this alignment is achieved, the pawl 256 slides into the notch 270 under the biasing pressure of the torsion V-spring 258, thereby preventing the face gear 230 from rotating backward in the direction indicated by arrow 618.

[0114] 16A-B and 17A-B, the work done by the user in pressing the load button 102 has also been converted into potential energy stored in the rotational tension of the clock spring 228. This potential energy is prevented from being released by the pawl 256 interacting with one of the notches 270 in the face gear 230 to prevent the face gear 230 and clock spring 228 from unwinding.

[0115] After cartridge 300 has been advanced one increment (as described above in FIGS. 15A-D ), and face gear 230 has been rotated and locked (as described above in FIGS. 16A-B and 17A-B ), side-facing slide rack 243 can be disengaged from teeth 408 of pinion coupler 406, and downward-facing slide rack 241 can be disengaged from gear 232. Disengagement of side-facing rack 243 from teeth 408 is shown in FIGS. 18A-C , which depict a top view of device 100. For clarity, secondary slide 202 has been rendered transparent using dashed lines to reveal the components underneath. As is apparent from this view, both side-facing slide rack 243 and downward-facing slide rack 241 are mounted on a common slide rack platform 249. Slide rack platform 249 is a substantially planar structure that lies in the horizontal plane of device 100 and, in turn, is mounted below secondary slide 202. Platform 249 defines two slide rack slots 245a, 245b that extend diagonally in the +x / +y direction in the horizontal plane. Two underside pins 274a, 274b extending downward from bottom wall 205 of secondary slide 202 fit into slide rack slots 245a, 245b, respectively.

[0116] FIG. 18A shows the initial, neutral state of device 100, with secondary slide 202 positioned at its farthest distal extent (i.e., in the secondary slide distal position as in FIG. 15A). In FIG. 18B, secondary slide 202 translates proximally in the direction of arrow 604 in response to a user depressing load button 102, as previously described. As secondary slide 202 translates proximally, lower pins 274a, 274b engage the proximal edges of slide rack slots 245a, 245b, which causes platform 249, downward-facing slide rack 241, and side-facing slide rack 243 to also translate proximally. When secondary slide 202 completes its proximal translation, platform 249 can continue to slide proximally, with lower pins 274a, 274b engaging the distal ends of slide rack slots 245a, 245b, as shown in FIG. 18C. Because slide rack slots 245a, 245b extend diagonally in the +x / +y directions, this continued proximal translation of platform 249 in the −x direction also causes platform 249 to translate radially in the −y direction, away from pinion coupler 406, as indicated by arrow 607. This translation in the −y direction causes the side-facing teeth of slide rack 243 to disengage from teeth 408 of pinion coupler 406.

[0117] 19A-C show the same sequence of states of device 100 from different angles, best illustrating how downward-facing slide rack 241 disengages from gear 232. Similar to FIG. 18A, FIG. 19A shows the initial neutral state of device 100. FIG. 19B shows how downward-facing slide rack 241 translates proximally (in the −x direction, as indicated by arrow 605) in response to a user depressing load button 102, as described above. As described above and shown in FIG. 18C, when platform 249 translates in the −x / −y direction, downward-facing slide rack 241 also translates in the −x / −y direction, as indicated by arrow 609 in FIG. 19C. This causes the teeth of downward-facing slide rack 241 to disengage from the teeth of gear 232.

[0118] After device 100 is loaded by pressing load button 102 and sliding racks 241, 243 disengage from gear 232 and pinion coupler 406, respectively, device 100 is ready to be placed on a patient's body for injection. FIG. 20A shows the configuration of device 100 after it has been loaded but before it has been pressed against a patient's body. In this configuration, blocker member 236 of dose button lock 224 is positioned below blocker 226, thereby preventing blocker 226 from translating downward. This prevents the user from prematurely triggering device 100. FIG. 20B shows what happens when the user presses device 100 against a patient's body. Pressing the device 100 against the patient's body applies an upward force to the on-body sensing button 106, which overcomes the downward biasing pressure of the sensing button spring 114 and causes the button 106 to translate upward into the sensing button cavity 120 in the direction of arrow 620. As the on-body sensing button 106 moves upward, the pin 118 rides within the pin slot 244 of the dose button lock 224, as described above. Because the pin slot 244 of the vertical panel 232 extends at an angle in the +x / +z directions, moving the pin 118 upward within the pin slot 244 also causes the dose button lock 224 to translate proximally (i.e., in the −x direction), as indicated by arrow 622. As the dose button lock 224 translates proximally, the blocker member 236 clears the blocker 226, thereby allowing the blocker 226 to translate downward (i.e., in the direction of arrow 624). This unlocks the dose button 104, which prepares the device 100 for injection.

[0119] FIG. 21A shows the configuration of the device 100 after the device has been pressed against the patient's body (thus unlocking the dose button 104), but before the dose button 104 has been depressed. In this state, the blocking tab 242 of the blocker 226 is positioned in front of the locking tab 214 of the primary slide 210, thereby preventing the primary slide 210 from translating proximally in the −x direction. As discussed above, this position of the primary slide 210 is referred to herein as the primary slide distal position. FIG. 21B shows what happens when a user depresses the dose button 104. When the dose button 104 is depressed downward in the direction of arrow 624, the downward force exerted by the user overcomes the upward biasing pressure of the dose button spring 110, causing the button 104 to translate downward. The downward force on the button 104 is transmitted to the blocker 226 via the dose button shaft 112. This causes the blocker 226 to translate downward in the direction of arrow 626. As the blocker 226 translates downward, the blocking tab 242 clears the locking tab 214 of the primary slide 210, thereby allowing the primary slide 210 to translate proximally in the direction of arrow 628 (i.e., in the −x direction). Because the spring 212 was previously compressed by the proximal movement of the compression tab 208 of the secondary slide 202 (as described above), once the blocking tab 226 clears the locking tab 214, the primary slide 210 is urged proximally by the loaded spring 212. The position when the primary slide 210 has translated to its maximum proximal extent is referred to herein as the primary slide proximal position.

[0120] 22A-B provide a profile view of device 100, illustrating how proximal movement of primary slide 210 drives needle assembly 306 within cartridge 300 from a retracted position to an injection position. FIG. 22A shows the configuration of device 100 before a user presses dose button 104. In this state, needle assembly 306 is disposed in a retracted position within cavity 304 of cartridge 300. As primary slide 210 is urged forward by spring 212, primary slide 210 exerts a proximal force in the direction of arrow 630 on pin 504 of hammer 502. This proximal force rotates hammer 502 about pin 506 in the direction of arrow 631. As hammer 502 rotates in the direction of arrow 631, hammer head 503 depresses ledge 328 of needle assembly 306 within cartridge 300 in operative alignment with hammer 502, thereby driving the needle assembly downward in the direction of arrow 632 to the injection position, as shown in FIG. 22B. As needle assembly 306 translates downward, first leg segment 324 of needle 312 pierces drug septum 182 and second leg segment 326 of needle 312 protrudes downward from needle opening 108 in lower housing 103, piercing the patient's skin and into the patient's body. In this manner, when needle assembly 306 is in its injection position, needle 312 establishes a fluid pathway from drug septum 182 into the patient's body. Once the needle assembly is positioned at the injection location, the biasing force of spring 212 biases primary slide 210 proximally, causing hammer head 503 to maintain downward pressure on ledge 328 until the needle assembly is retracted (as described below), thereby ensuring that the needle assembly maintains the proper depth within the patient's body and drug septum 182.

[0121] In addition to unlocking the primary slide 210, the downward translation of the blocker 226 also drives the latch assembly 250 to unlock the face gear 230. The interaction between the blocker 226 and the latch assembly 250 is best depicted in FIGS. 23A-C. FIG. 23A shows the spatial position of the blocker 226 relative to the latch assembly 250 before the user depresses the dose button 104. In this initial position, the fin 232 of the blocker 226 is positioned directly above the latch pin 252 of the latch assembly 250. When the user depresses the button 104, the blocker 226 is driven downward so that the bottom surface 262 of the fin 232 contacts the latch pin 252. Because bottom surface 262 is angled diagonally in the -x / +z direction, downward movement of bottom surface 262 causes pin 252 to rotate horizontally about axis 264 in the direction indicated by arrow 638 (see FIGS. 23B and 23C). As pin 252 rotates in the direction of arrow 638, torsion V-spring 258 transmits a rotational torque onto pawl 256 in the direction of arrow 640 (again about axis 264).

[0122] 24A-C show different angles of the interaction between the blocker 226 and the latch assembly 250. FIG. 24A shows the state of the device 100 after a user has depressed the load button 102 to load the device, but before the user depresses the button 104. In this state, the work done by the user in depressing the load button 102 is stored in the form of potential energy in the coiled clock spring 228 coupled to the face gear 230. However, the face gear 230 and clock spring 228 are prevented from unwinding by the pawl 256, which fits into one of the notches 270 defined on the face gear 230. When the user presses the dose button 104, the button 104 translates downward in the direction of arrow 624. This downward force on button 104 also translates blocker 226 downward, causing latch pin 252 to rotate in the direction of arrow 638 and pawl 256 to rotate in the direction of arrow 640, as discussed above. Rotation of pawl 256 in the direction of arrow 640 disengages pawl 256 from notch 270, thereby allowing face gear 230 and clock spring 228 to unwind in the direction of arrow 642, as shown in FIG. 24B.

[0123] 23C , as the user continues to press downward on the load button 104 and the blocker 226 continues to translate downward, the latch pin 252 eventually leaves contact with the bottom surface 262 of the fin 232 and instead contacts the proximal surface 266 of the fin 232. At this point, the latch pin 252 stops rotating in the direction of arrow 638. As the blocker 226 continues to translate downward, the entire fin 232 slides under the latch pin 252, causing it to clear the proximal surface 266. When the user stops pressing downward on the button 104, the button 104 and blocker 226 again rise upward due to the biasing pressure of the dose button spring 110. At this point, the latch pin 252 contacts the top surface 260 of the fin 232. Because the top surface 260 of the fin 232 is also angled obliquely in the −x / +z direction, the top surface 260 now forces the latch pin 252 to rotate in the opposite direction about axis 264, i.e., in the direction of arrow 644. As the pin 252 rotates in the direction of arrow 644, the torsion V-spring transmits the rotational torque of the pawl 256 in the direction of arrow 646.

[0124] 25A-25C are views of device 100 from below, with lower housing 103 rendered transparent to better show how unwinding of face gear 230 unlatches latch 216. FIG. 25A depicts device 100 after pawl 256 disengages from one of notches 270 in face gear 230, causing face gear 230 and clock spring 228 to begin unwinding in the direction of arrow 642. While face gear 230 and clock gear 228 unwind, needle insertion / retraction mechanism 500 drives needle assembly 306 to the injection position, as discussed above and shown in FIGS. 22A-B. Also, while face gear 230 unwinds, it drives the rotation of gears 240, 232, 234, 235, and 238 (see FIG. 6). Rotation of gear 238, in turn, provides a rotational input to pump 180, causing pump 180 to pump liquid medication from reservoir 150, through septum 182 and actuated needle 312, and into the patient.

[0125] 28 through 35A-35D illustrate one possible embodiment of pump 180. Pump 180 includes a mounting frame 602, a rotary drive shaft 604, a rotary plunger 802, a pump housing 702, and a return spring 624. A first end of frame 602 supports rotary drive shaft 604, which is in turn connected to rotary plunger 802. Rotary drive shaft 604 may be connected to gear 238, which provides a rotational input to pump 180 that rotates rotary drive shaft 604 about longitudinal axis 701 in the direction of arrow 705 (e.g., clockwise), as shown in FIG.

[0126] FIGS. 30A-30D and 31 depict a rotary plunger 802 in more detail, according to some embodiments. FIGS. 30A-30D depict the plunger 802 from four separate side views, while FIG. 31 provides a perspective view. The plunger 802 comprises a substantially cylindrical, elongated body having a first end 812 and a second end 814 connected by a curved, cylindrical sidewall 820. A plunger pin 804 projects radially outward from the sidewall 820 of the plunger 802 and may be rigidly secured thereto. In some embodiments, the pin 804 and the sidewall 820 may be formed from a single, unitary piece; in other embodiments, the pin 804 may be a separate piece that is glued, bonded, inserted, or molded into the sidewall 820. As shown, the pin 804 may be disposed adjacent the first end 812 of the plunger 802. However, the pins may be arranged at any point along the length of the plunger 802. As best seen in FIG. 31 , the plunger 802 may include a portion of reduced cross-sectional area, which may be defined by a notch 810 located adjacent the second end 814. The notch 810 is defined by a substantially planar longitudinal portion 816 that is recessed below a sidewall 820 and connected to a lip 818 that steps inwardly from the cylindrical sidewall 820 of the plunger 802. The portion 816 and the lip 818 may intersect in a transverse relationship. In one embodiment, the planar portion 816 of the notch 810 faces a first radial direction, and the pin 804 extends in a second radial direction that is perpendicular to the first radial direction of the notch arrangement.

[0127] Plunger 802 is received within pump housing 702. One exemplary embodiment of housing 702 is shown in further detail in Figures 32 and 33, where Figure 32 provides a perspective view of housing 702 and Figure 33 provides a cross-sectional view of housing 202 as cut along line 3-3. Housing 702 may be constructed from any suitable and relatively rigid material, such as an olefin plastic (e.g., cyclic olefin copolymer and / or polypropylene). The interface between housing 702 and plunger 802 may be lubricated with a suitable medication container lubricant, such as silicone oil.

[0128] The housing 702 includes three sections: a first section 708, a middle section 710, and a third section 712, each aligned along a common axis 701. The first section 708 includes a sidewall 722 that defines an angled pin track 718. The pin track 718 is angled such that the plane defined by the track 718 is not perpendicular to the longitudinal axis 701, but rather is angularly offset such that a first end 754 of the track 718 is farther from the middle section 710 than an opposite second end 750 of the track 718. The second end 750 is connected to the first end 754 of the track 718 via an upwardly sloping portion 752 and a downwardly sloping portion 756. The first section 708 also includes two tabs 710a, 710b that receive and support the plunger 802.

[0129] The intermediate section 710 includes a sidewall 724 and one or more axial ridges 714 projecting radially outward from the sidewall 724. The one or more ridges 714 have a radially inward step 716 oriented toward the third section 712 of the housing 702. As best shown in FIG. 33 , the sidewall 724 defines an internal cavity 730 along an axis 701 having an open first end 760 and a closed second end 762. The sidewall 724 also defines an inlet port 726 and an outlet port 728, which are shown defined by radially extending arms. In one embodiment, the ports 726, 728 are oriented in different radial directions. In one embodiment, the ports 726, 728 are oriented to extend in opposite directions (e.g., 180 degrees apart from each other) along a transverse axis 703 extending perpendicular to the longitudinal axis 701. An inlet port 726 and an outlet port 728 pass through the side wall 724 and are in fluid communication with the cavity 730. The ducts are shown arranged in the arms with a fluid-tight seal. The inlet port 726 is fluidly connected to the inlet duct 704, while the outlet port 728 is fluidly connected to the outlet duct 706. During operation of the pump subsystem, fluid is drawn into the cavity 730 through the inlet port 726 / inlet duct 704 and expelled through the outlet port 728 / outlet duct 706.

[0130] Returning to FIG. 32 , the third section 712 of the housing 702 comprises a substantially cylindrical body having a smaller cross-sectional area compared to the first section 708 and the middle section 710. The third section 712 may also take the form of other shapes. A return spring 724 may be wrapped around the third section 712 such that a first end of the spring 624 abuts against the inwardly stepped portion 716 of one or more ridges 714 and a second end of the spring 624 abuts and / or is received within a receptacle on the mounting frame 602 (see FIG. 28 ). Mounted in this manner, the return spring 624 provides a biasing pressure against the housing 702.

[0131] When plunger 802 is received within housing 702, plunger 802 is configured to rotate about longitudinal axis 701 within cavity 730. Plunger 802 is also configured to translate longitudinally along longitudinal axis 701 within cavity 730. The biasing pressure of return spring 624 ensures that pin track 718 always abuts and / or engages the underside of plunger pin 804 while plunger 802 rotates within cavity 730. When plunger 802 is received within cavity 730, the surfaces defining notch 810 (i.e., surfaces 816, 818) and the interior wall of cavity 730 (i.e., the inner surface of side wall 724) together define a working chamber 902 (see Figures 34A-34D) which, as the plunger moves within the cavity, is fluidly out of communication with the port, then in fluid communication with the inlet port, then out of communication with the port, then in fluid communication with the outlet port, and so on, sequentially.

[0132] During operation, rotational input from gear 238 provides a rotational force to drive shaft 604. This rotational force rotates shaft 604 and plunger 802 about longitudinal axis 701 in the direction of arrow 705 (see FIG. 29 and FIGS. 34A-34D). As plunger 802 rotates within cavity 802, plunger 802 and housing 702 move sequentially through a series of configurations depicted in FIGS. 34A-34D and 35A-35D. Each of FIGS. 34A-34D shows a side cross-sectional view of pump subsystem 108 taken along line 3-3. Each of FIGS. 35A-35D shows a top cross-sectional view of pump subsystem 108 taken along line 4-4. For clarity, the location of plunger pin 804 is outlined in phantom in FIGS. 35A-35D.

[0133] 34A and 35A, the plunger 802 is rotated so that the plunger pin 804 faces left in FIGS. 34A and 35A. With the plunger pin 304 oriented in this direction, the spring 624 engages the pin 804 with the lowest portion (i.e., second end 750) of the pin track 718, thereby longitudinally translating the plunger 802 to its furthest position relative to the housing 702 within the cavity 730. While the plunger 802 is in this furthest position, the distal end 814 of the plunger 802 may come into contact with (or be located near) the closed end 762 of the cavity 730, such that the working chamber 902 has the smallest volume of any of the four configurations depicted in FIGS. 34A-34D and 35A-35D. Also, while plunger 802 is in this farthest position, notch 810 is oriented out of the page in FIG. 34A and downward in FIG. 35A . As previously described, notch 810 and the inner wall of cavity 730 (i.e., the inner surface of sidewall 724) define working chamber 902. With notch 810 so oriented, curved sidewall 820 of plunger 802 presses firmly against the inner surfaces of sidewall 724 surrounding inlet port 726 and outlet port 728, respectively, establishing a fluid-tight seal blocking both ports. As a result, working chamber 902 is not in fluid communication with either port while in this configuration.

[0134] 34B and 35B, plunger 802 is rotated so that plunger pin 804 is pointing into the page in FIG. 34B and pointing upward in FIG. 35B. With plunger pin 804 oriented in this direction, spring 624 engages pin 804 with upwardly sloping portion 752 of pin track 718. This causes plunger 802 to translate longitudinally out of housing 702 as plunger 802 rotates, thereby increasing the volume of working chamber 902. Also, in this configuration, notch 810 is oriented to the left in FIGS. 34B and 35B, thereby opening fluid communication between working chamber 902 and inlet port 726. The open fluid communication and increasing volume of working chamber 902 allows fluid to be drawn into working chamber 902 from inlet port 726 as pin 804 rotates (or allows fluid to enter working chamber 902 if fluid is stored under pressure in the drug reservoir).

[0135] 34C and 35C, the plunger 802 is rotated so that the plunger pin 804 faces right in FIGS. 34C and 35C. When the plunger pin 804 is oriented in this direction, the spring 624 causes the pin 804 to engage the highest portion of the pin track 718 (i.e., first portion 754), thereby allowing the plunger 802 to translate longitudinally out of the cavity 730 and to its farthest position relative to the housing 702. In this configuration, the distal end 814 of the plunger 802 is positioned at its shallowest position within the cavity 730, such that the working chamber 902 is at its maximum volume of any of the four configurations shown in FIGS. 34A-34D and 35A-35D. Also in this configuration, the notch 810 is oriented into the page in FIG. 34C or upward in FIG. 35C. With the notch 802 so oriented, the curved sidewall 820 of the plunger 802 will again establish a fluid-tight seal with both the inlet port 726 and the outlet port 728, meaning that the working chamber 902 is not in fluid communication with either port.

[0136] 34D and 35D, plunger 802 is rotated so that plunger pin 804 is pointing outward from the page in FIG. 34D and downward in FIG. 35D. With plunger pin 804 oriented in this direction, spring 624 engages pin 804 against downwardly sloping portion 756 of pin track 718. As a result, as plunger 802 rotates, it translates longitudinally into housing 702, thereby decreasing the volume of working chamber 902. Also, in this configuration, notch 910 is oriented to the right in FIGS. 34D and 35D, thereby opening fluid communication between working chamber 902 and outlet port 728. The open fluid communication and decreasing volume of working chamber 902 allow fluid to be expelled from working chamber 902 through outlet port 728 as pin 804 is rotated. In this configuration, the curved sidewall 820 of the plunger 802 continues to press tightly against the inwardly offset segments 732 , thereby maintaining a fluid-tight seal blocking the inlet port 726 .

[0137] A complete pump cycle is made up of the four configurations described above in Figures 34A-34D and 35A-35D. For further details regarding the operation and / or configuration of pump 180, or for alternative embodiments of pump 180 that may be used, see U.S. Provisional Patent Application No. 62 / 891,600, filed August 26, 2019, entitled "ROTARY PLUNGER PUMP SUBSYSTEMS," the entire contents of which are incorporated herein by reference.

[0138] Now that the operation of pump 180 has been described, attention is returned to FIGS. 25A-C. After a predetermined period of time (while medication is being pumped to the patient), face gear 230 eventually rotates to a position where one of its fins 272 is aligned with arm 274 of latch 216. The angled leading edge of fin 272 comes into contact with arm 274, thereby pushing latch 216 to rotate in the direction of arrow 644, as shown in FIG. 25B. This causes latch 216 to unlock secondary slide 202, as described below. As gear 232 continues to rotate, fin 272 eventually clears arm 274 of latch 216, and latch 216 moves back to its neutral position in the direction of arrow 646 under the biasing pressure of spring 222.

[0139] 26A-C show the same sequence as FIGS. 25A-C of the state of device 100, better illustrating from above how slides 202 and 210 move in response to the unlocking of latch 216. FIG. 26A shows device 100 after pawl 256 has disengaged and face gear 230 has begun to unwind, but before latch 216 has unlocked. In this state, latch tab 218 of latch 216 is positioned distal to locking tab 206 of secondary slide 202, thereby preventing secondary slide 202 from translating distally under the biasing pressure of spring 204. In FIG. 26B, latch 216 has rotated in the direction of arrow 644, thereby clearing locking tab 206. This allows secondary slide 202 to translate distally in the direction of arrow 648 (i.e., in the +x direction) due to the biasing pressure of compressed spring 204. As the secondary slide 202 translates distally, the compression tab 208 contacts the distal wall 221 of the primary slide 210, causing the primary slide 210 to also translate distally in the direction of arrow 650 (i.e., the +x direction). Eventually, the latch 216 rotates in the direction of arrow 646 back to its neutral position ( FIG. 26C ) under the biasing pressure of the spring 222. However, because the locking tab 206 is now distal to the latch tab 218, rotation of the latch 216 back to its neutral position does not stop the secondary slide 202 from translating distally until it hits a stop. As shown in FIG. 26C , the secondary slide 202 eventually translates back to its secondary slide distal position, and the primary slide 210 eventually translates back to its primary slide distal position.

[0140] 27A-C show the same sequence of states of device 100 as FIGS. 25A-C and 26A-C, but from the side to better illustrate how distal movement of primary slide 210 retracts needle 312 in needle insertion / retraction mechanism 500. FIG. 27A shows device 100 after pawl 256 has disengaged and face gear 230 has begun to unwind, but before latch 216 has unlocked. In this state, needle assembly 306 is in its injection position, and head 503 of hammer 502 is in contact with ledge 328 of needle assembly 306. In FIG. 27B, primary slide 210 begins to translate distally, thereby rotating hammer 502 about pin 506 in the direction of arrow 654. This rotation of hammer 502 causes head 503 to contact the underside of tang 322 of needle assembly 306, pulling the entire needle assembly upward in the direction of arrow 652. This upward movement retracts needle assembly 306 from its injection position to its retracted position. In particular, first leg segment 324 of needle 312 is withdrawn from drug septum 182 and second leg segment 326 is withdrawn from the patient's body, thereby blocking the fluid pathway between drug septum 182 and the patient's body. As primary slide 210 continues to translate distally and hammer 502 continues to rotate about pin 506 in the direction of arrow 654, head 503 of hammer 502 eventually disengages from tang 322 of needle assembly 306, as shown in FIG. 27C .

[0141] Terms such as "first," "second," "third," "primary," "secondary," and the like, whether used in the detailed description or the claims, are provided to distinguish between similar elements and do not necessarily describe a sequential or chronological order. It is understood that terms so used are interchangeable under appropriate circumstances (unless otherwise expressly disclosed), and that the disclosed embodiments described herein are capable of operation in other sequences and / or arrangements other than those described or illustrated herein.

[0142] While this invention has been described as having an exemplary design, the invention can be further modified within the scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

[0143] For example, in some embodiments, the drug delivery device may not include a needle cartridge that holds multiple needle assemblies; instead, the device may include only a single needle assembly. Such a device may be configured for single use, rather than multiple uses. This single needle assembly may be configured to be inserted and / or retracted using the insertion / retraction mechanism discussed above.

[0144] In at least some of the above-described embodiments, one or more springs within the drug delivery device are loaded when a user activates a load button. Then, when a user activates a dose button, the one or more loaded springs are released to (i) operate a drive member to drive the needle assembly in operative alignment with the drive member from the retracted position to the injection position, (ii) operate a pump to pump drug fluid from a drug reservoir through the driven needle assembly, and (iii) retract the driven needle assembly from the injection position to the retracted position. However, in other embodiments, releasing one or more loaded springs need not activate all of the functions (i) through (iii) above. For example, in some embodiments, releasing one or more loaded springs (upon activation of the dose button) can activate only function (i), but not functions (ii) and (iii). In other embodiments, releasing one or more loaded springs upon activation of the dose button can activate only functions (i) and (ii), but not (iii). In still other embodiments, releasing one or more loaded springs upon actuation of the dose button can drive functions (ii) and (iii), but not function (i). In general, embodiments in which releasing one or more springs (upon actuation of the dose button) accomplishes any one or more of the above functions (i)-(iii) are also within the scope of this disclosure.

[0145] Furthermore, in at least some of the embodiments described above, the needle cartridge is indexed when the user actuates the dose button, rather than when one or more loaded springs are released when the user actuates the dose button. However, in other embodiments, the needle cartridge may be indexed when one or more loaded springs are released when the user actuates the dose button.

Claims

1. A drug delivery device comprising one or more springs, a load button, a dosing button, a drive member, a pump and a needle assembly, the one or more springs are configured to be loaded by work done by actuation of the load button to store energy when the load button is actuated, and to be unloaded by releasing the stored energy when the dose button is actuated after actuation of the load button; The drug delivery device uses the energy released from the one or more springs to: activating the drive member to drive the needle assembly within the drug delivery device from a retracted position to an injection position; activating the pump to pump drug fluid from a drug reservoir through the activated needle assembly; and The drug delivery device is configured to retract the actuated needle assembly from the injection position to the retracted position.

2. The drug delivery device of claim 1 , wherein the drug reservoir is disposed within the drug delivery device and contains a drug fluid.

3. 3. The drug delivery device of claim 1, wherein the needle assembly is a first needle assembly of a plurality of needle assemblies disposed in a needle cartridge.

4. The drug delivery device of claim 3, wherein the needle cartridge is configured to advance in response to actuation of the load button, thereby moving a second needle assembly of the plurality of needle assemblies out of operational alignment with the drive member and moving the first needle assembly into operational alignment with the drive member.

5. The drug delivery device described in any one of claims 1 to 4, wherein the drug delivery device is configured to use only the energy released from the one or more springs to operate the drive member to drive the pump and retract the driven needle assembly.

6. 1. A needle insertion mechanism for a drug delivery device, the needle insertion mechanism comprising: a primary slide coupled to a first linear spring; a secondary slide coupled to the first linear spring and a second linear spring; and a blocker configured to prevent the primary slide from moving from a first primary slide position to a second primary slide position until released; The needle insertion mechanism includes: moving the secondary slide from a first secondary slide position to a second secondary slide position to axially compress both the first linear spring and the second linear spring when a load button of the drug delivery device is actuated; releasing the blocker to move the primary slide from a first primary slide position to a second primary slide position under biasing pressure from the compressed first linear spring when a dose button of the drug delivery device is actuated after actuation of the load button; a needle insertion mechanism configured such that movement of the primary slide to the second primary slide position operates a drive member to drive a needle assembly disposed within the drug delivery device from a retracted position to an injection position.

7. the drug delivery device further comprising a latch that prevents the secondary slide from moving from the second secondary slide position to the first secondary slide position after actuation of the load button until released; 7. The needle insertion mechanism of claim 6, wherein the needle insertion mechanism is configured to release the latch at a predetermined time after release of the blocker to allow the secondary slide to move from the second secondary slide position to the first secondary slide position under biasing pressure from the compressed second linear spring.

8. 8. The needle insertion mechanism of claim 7, wherein the primary slide and the secondary slide are coupled such that movement of the secondary slide from the second secondary slide position to the first secondary slide position moves the primary slide from the second primary slide position to the first primary slide position, and movement of the primary slide to the first primary slide position retracts the actuated needle assembly from the injection position to the retracted position.

9. The needle insertion mechanism further comprises a clock spring, a face gear coupled to the clock spring, and a pawl configured to engage with the face gear; The needle insertion mechanism includes: during actuation of the load button, using work done by actuation of the load button to load the clock spring by rotationally winding the face gear and the clock spring in a first rotational direction; after loading the clock spring, engaging the pawl with the face gear and rotating it in a second rotational direction opposite the first rotational direction to prevent the clock spring from unwinding; disengaging the pawl from the face gear and rotating it in the second rotational direction during actuation of the dose button, thereby allowing the clock spring to unwind; 9. The needle insertion mechanism of claim 7 or 8, configured to release the latch when the clock spring unwinds a predetermined angle of rotation to allow the secondary slide to move from the second secondary slide position to the first secondary slide position under biasing pressure from the compressed second linear spring.

10. 1. A drug delivery device comprising one or more springs, a load button, a dose button, a drive member, and a needle cartridge holding a plurality of needle assemblies, each needle assembly disposed in a retracted position within the needle cartridge; the one or more springs are configured to be loaded by work done by actuation of the load button to store energy when the load button is actuated, and to be unloaded by releasing the stored energy when the dose button is actuated after actuation of the load button; The drug delivery device comprises: advancing the needle cartridge such that, when the load button is actuated, a first needle assembly of the plurality of needle assemblies moves out of operative alignment with the drive member and a second needle assembly of the plurality of needle assemblies moves into operative alignment with the drive member using work done by actuating the load button; the drug delivery device is configured to use energy released from the one or more springs to operate the drive member when the dose button is actuated after actuation of the load button to drive the second needle assembly from the retracted position within the needle cartridge to an injection position.

11. The drug delivery device of claim 10, wherein the drug delivery device is configured to retract the second needle assembly to the retracted position using energy released from the one or more springs that are loaded after driving the second needle assembly to the injection position.

12. the needle cartridge comprises a plurality of Geneva wheel members; the drug delivery device further comprising a Geneva wheel configured to engage with the Geneva wheel member; 12. The drug delivery device of claim 10 or 11, wherein the Geneva wheel rotates in response to actuation of the load button, and engagement between the Geneva wheel and the Geneva wheel member rotates the needle cartridge, thereby moving the first needle assembly out of operative alignment with the drive member and moving the second needle assembly into operative alignment with the drive member.

13. The drug delivery device of any one of claims 10 to 12, further comprising a drug reservoir configured to contain a drug fluid, and a pump in fluid communication with the drug reservoir.

14. The drug delivery device of claim 13, wherein the drug delivery device is configured to use energy released from the one or more loaded springs to drive the pump and pump the drug fluid from the drug reservoir through the second needle assembly.

15. 15. The drug delivery device of claim 13 or 14, wherein the pump is a rotary plunger pump.

16. A drug delivery device according to any one of claims 10 to 15, wherein only the energy released from the one or more loaded springs is used to operate the drive member.

17. 16. The drug delivery device of claim 11, wherein only the energy released from the one or more loaded springs is used to operate the drive member and to retract the second needle assembly.

18. 16. A drug delivery device according to claim 14 or 15, wherein only the energy released from the one or more loaded springs is used to operate the drive member and drive the pump.

19. A drug delivery device comprising one or more springs, a load button, a dose button, a pump, a drug reservoir, and a needle cartridge holding a plurality of needle assemblies, the one or more springs are configured to be loaded by work done by actuation of the load button to store energy when the load button is actuated, and to be unloaded by releasing the stored energy when the dose button is actuated after actuation of the load button; The drug delivery device comprises: advancing the needle cartridge such that, when the load button is actuated, a first needle assembly of the plurality of needle assemblies moves out of a dosing position within the drug delivery device and a second needle assembly of the plurality of needle assemblies moves into the dosing position using work done through the actuation of the load button; and the drug delivery device is configured to use energy released from the one or more springs when the dose button is actuated after actuation of the load button to drive the pump to pump drug fluid from the drug reservoir through a second needle assembly.

20. the drug delivery device further comprising a drive member; the dispensing position is in operative alignment with the drive member; 20. The drug delivery device of claim 19, wherein the drug delivery device is configured to use energy released from the one or more springs to operate the drive member to drive the second needle assembly to an injection position.

21. The drug delivery device of claim 20, wherein the drug delivery device is configured to use energy released from the one or more springs to operate the drive member to drive the second needle assembly to the injection position, and then retract the second needle assembly to the dosing position.

22. 22. The drug delivery device of any one of claims 19 to 21, wherein the pump is a rotary plunger pump.

23. the one or more springs comprising one or more clock springs; loading the one or more springs includes rotationally winding the one or more clock springs; releasing the one or more loaded springs includes allowing the one or more clock springs to unwind; A drug delivery device according to any one of claims 19 to 22, wherein the drug delivery device is configured to drive the pump using energy released by the one or more unwinding clock springs.

24. the one or more springs comprising one or more linear springs; loading the one or more springs includes compressing the one or more linear springs; Releasing the one or more springs includes allowing the one or more linear springs to expand; 22. The drug delivery device of claim 20 or 21, wherein the drug delivery device is configured to use energy released by the one or more expanding linear springs to operate the drive member.

25. A drug delivery device according to any one of claims 19 to 24, wherein only the energy released from the one or more loaded springs is used to drive the pump.

26. 22. A drug delivery device according to claim 20 or 21, wherein only the energy released from the one or more loaded springs is used to drive the pump and to operate the drive member.

27. 22. The drug delivery device of claim 21, wherein only the energy released from the one or more loaded springs is used to drive the pump to operate the drive member and retract the second needle assembly.

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