Multi-use drug-delivery device

Abstract

To provide a drug-delivery device 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.SOLUTION: A device is configured to use work done by a user in actuating a loading button to load one or more springs. When the user actuates a dosing button after actuating the loading button, the device is configured to (i) release the one or more loaded springs to operate a drive member and drive a needle assembly that is in operational alignment with the drive member from a retracted position to an injection position, (ii) drive a pump to pump fluid drug from a 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] The present disclosure relates to devices and methods for delivering drugs. More specifically, the present disclosure relates to multi-purpose drug delivery devices.

Background Art

[0002] Some drug delivery devices, such as autoinjectors, store potential energy in a compressed spring that is released when the device is actuated. This stored energy is used to drive various functions of such drug delivery devices, such as insertion of a needle into a patient and release of liquid from a drug reservoir. However, long-term storage of potential energy in a spring can be problematic because the resultant force from the compressed spring can cause deformation of the device materials over the device's storage period. Additionally, basic physical and material properties require a spring that stores sufficient potential energy over the storage period for the device to be of a particular minimum size to drive the aforementioned functions of the drug delivery device, which can increase the device size. Ideally, the spring should either not be stressed or be stressed minimally over the device's storage period and then be loaded and released in a relatively short time during use of the device.

Summary of the Invention

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

[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 and configured to be manually actuated to load the one or more springs using the work performed by the actuation of the load button, and a dosing button coupled to the housing and configured to be manually actuated after actuation of the load button to release the one or more loaded springs, operate the drive member to drive the needle assembly from the retracted position to the injection position, pump the drug fluid from the drug reservoir through the driven needle assembly by driving the pump, and retract the driven needle assembly from the injection position to the retracted position.

[0005] 2. The device according to aspect 1, further comprising a drug fluid contained within the drug reservoir.

[0006] 3. The device according to any one of aspects 1 to 2, wherein the needle assembly includes a first needle assembly of a plurality of needle assemblies, and the plurality of needle assemblies are disposed within a needle cartridge within the housing.

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

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

[0009] 6. The device according to any one of aspects 1 to 5, comprising one or more linear springs movable between an axially extended configuration and an axially compressed configuration, wherein actuation of the loading button loads one or more linear springs by moving the one or more linear springs to the axially compressed configuration, and actuation of the dosing button after actuation of the loading button releases the one or more linear springs by moving the one or more linear springs to the axially extended configuration and operating a drive member.

[0010] 7. The device according to any one of aspects 1 to 6, comprising one or more clock springs movable between a wound-back configuration and a wound-up configuration, wherein actuation of the loading button loads one or more clock springs by moving the one or more clock springs to the wound-up configuration using the work performed by actuation of the loading button, and actuation of the dosing button after actuation of the loading button releases the one or more clock springs by moving the one or more clock springs to the wound-back configuration and driving a pump.

[0011] 8. One or more springs comprise a first linear spring and a second linear spring, each being movable between an axially extended configuration and an axially compressed configuration, the device further comprising a primary slide and a secondary slide, the primary slide being configured to slide parallel to the linear axis of the device between a first primary slide position and a second primary slide position, the secondary slide being configured to slide parallel to the linear axis between a first secondary slide position and a second secondary slide position, the primary slide being coupled to the first linear spring, the secondary slide being coupled to both the first linear spring and the second linear spring, the device further comprising a blocker configured to prevent the primary slide from moving from the first primary slide position to the second primary slide position until released, actuation of a load button moving the secondary slide from the first secondary slide position to the second secondary slide position and moving both the first linear spring and the second linear spring to an axially compressed configuration, actuation of a dosing button after actuation of the load button releasing the blocker and enabling the first linear spring to move to an axially extended configuration, movement of the first linear spring to the axially extended configuration moving 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 operating a drive member, the device according to any of aspects 1 - 7.

[0012] 9. The device according to aspect 8 further comprises 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 being configured to be released after a predetermined time after the blocker is released to enable the second linear spring to move to an axially extended configuration, and movement of the second linear spring to the axially extended configuration moving the secondary slide from the second secondary slide position to the first secondary slide position.

[0013] 10. The primary slide and the secondary slide are coupled such that movement of the secondary slide from a second secondary slide position to a first secondary slide position causes the primary slide to move from a second primary slide position to a first primary slide position, and movement of the primary slide to the first primary slide position causes the driven needle assembly to retract from an injection position to a retracted position, the device of aspect 9.

[0014] 11. The device is a reusable device that enables a second actuation of a 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 enables a second actuation of a dosing button after the second actuation of the load button, configured to deliver a second dose of a pharmaceutical fluid, the device of any of aspects 9-10.

[0015] 12. Further comprising a clock spring rotatable between a wound configuration and a rewound configuration, a face gear rotatably locked by the clock spring, and a pawl configured to engage the face gear, actuation of the load button loading the clock spring by rotating the face gear in a first rotational direction, rotation of the face gear in the first rotational direction rotating the clock spring to the wound configuration, the pawl engaging 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 to prevent rotation of the clock spring to the rewound configuration, actuation of the dosing button after actuation of the load button disengaging the pawl from the face gear and enabling rotation of the face gear in the second rotational direction, rotation of the face gear in the second rotational direction rotating the clock spring to the rewound configuration, rotation of the face gear in the second rotational direction at a predetermined rotational angle of the face gear releasing a latch and enabling movement to a configuration where a second linear spring expands axially, movement of the second linear spring to the axially expanded configuration moving the secondary slide from a second secondary slide position to a first secondary slide position, the device of any of aspects 9-11.

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

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

[0018] 15. A method for operating a drug delivery device, comprising actuating a load button of the device to load one or more springs of the device using work performed by actuation of the load button, and after actuating the load button to release one or more loaded springs, actuating a dosing button of the device, wherein releasing one or more loaded springs causes the drive member of the device to operate to drive the pump within the device to pump a drug fluid from a drug reservoir through the driven needle assembly to the injection position, and to retract the driven needle assembly from the injection position to the retracted position.

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

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

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

[0022] 19. The method according to any one of aspects 15 to 18, further comprising actuating an unlock button of the device to unlock a dosing button for actuation.

[0023] 20. The method according to any one of aspects 15 to 19, wherein only energy released from one or more loaded springs is used to operate a drive member to drive a pump and to retract a 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 be slidably movable parallel to a linear axis of the device between a first primary slide position and a second primary slide position, the primary slide being coupled to the first linear spring, a secondary slide configured to be slidably movable parallel to the linear axis of the device between a first secondary slide position and a second secondary slide position, the secondary slide being coupled to the first linear spring and the second linear spring, a blocker configured to prevent the primary slide from moving from the first primary slide position to the second primary slide position until released, a load button manually actuated to move the secondary slide from the first secondary slide position to the second secondary slide position using work performed by actuation of the load button to compress both the first linear spring and the second linear spring, a dosing button manually actuated after actuation of the load button to release the blocker and enable the primary slide to move from the first primary slide position to the second primary slide position under a biasing pressure from the compressed first linear spring, the movement of the primary slide to the second primary slide position operating the drive member to drive the needle assembly from the retracted position to the injection position.

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

[0026] 23. The primary slide and the secondary slide are coupled, and the movement of the secondary slide from the second secondary slide position to the first secondary slide position causes the primary slide to move from the second primary slide position to the first primary slide position, and the movement of the primary slide to the first primary slide position causes the driven needle assembly to retract from the injection position to the retracted position, the mechanism according to aspect 22.

[0027] 24. The device further comprises a clock spring rotatable between a wound configuration and a rewound configuration, a face gear rotatably locked by the clock spring, and a pawl configured to engage the face gear, wherein the actuation of the load button loads the clock spring by rotating the face gear in a first rotational direction, the rotation of the face gear in the first rotational direction rotates the clock spring to the wound configuration, the pawl engages the face gear after the rotation of the clock spring to the wound configuration to prevent the face gear from rotating in a second rotational direction opposite to the first rotational direction and to prevent the clock spring from rotating to the rewound configuration, and the actuation of the dosing button after the actuation of the load button disengages the pawl from the face gear to allow the face gear to rotate in the second rotational direction, and the rotation of the face gear in the second rotational direction rotates the clock spring to the rewound configuration and rotates the face gear by a predetermined rotation angle in the second rotational direction, which is configured to release the latch and allow the secondary slide to move from the second secondary slide position to the first secondary slide position under the biasing pressure from the compressed second linear spring, the mechanism according to any one of aspects 22 to 23.

[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 a first primary slide position to a second primary slide position until released, the method comprising actuating a load button of the device to move the secondary slide from a first secondary slide position to a second secondary slide position, the actuation being such that the movement of the secondary slide axially compresses both the first linear spring and the second linear spring; and after actuating the load button, releasing the blocker and actuating a dosing button of the device to move the primary slide from the first primary slide position to the second primary slide position under the biasing pressure from the compressed first linear spring, the actuation being such that the movement of the primary slide to the second primary slide position actuates 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 aspect 25, further comprising the device 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 the user actuates the load button until released, and releasing the latch at a predetermined time after releasing the blocker to enable the secondary slide to move from the second secondary slide position to the first secondary slide position under the biasing pressure from the compressed second linear spring.

[0030] 27. The method of aspect 26, 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 causes the primary slide to move 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 driven needle assembly from the injection position to the retracted position.

[0031] 28. 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. During the operation of the load button, the work performed by the operation of the load button is used to rotationally wind the face gear and the clock spring in a first rotational direction to load the clock spring. After loading the clock spring, the pawl is engaged with the face gear and rotated in a second rotational direction opposite to the first rotational direction to prevent the clock spring from unwinding. During the operation of the dosing button, the pawl is disengaged from the face gear and rotated in the second rotational direction to allow the clock spring to unwind. When the clock spring unwinds by a predetermined rotation angle, the latch is released to allow the secondary slide to move from the second secondary slide position to the first secondary slide position under the biasing pressure from the compressed second linear spring. The method according to any one of aspects 25 to 27, including the above.

[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 being disposed in a separate retracted position within the needle cartridge, the needle cartridge, one or more springs, and a load button coupled to the housing, the load button being configured to be manually actuated and using the work performed by the actuation of the load button to load one or more springs and advance the needle cartridge so that the first needle assembly of the plurality of needle assemblies is displaced out of alignment with the drive member and the second needle assembly of the plurality of needle assemblies is moved into alignment with the drive member. A dosing button coupled to the housing, the dosing button being manually actuated after the actuation of the load button to release 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 the injection position. A device comprising a dosing button coupled to the housing.

[0033] 30. The device according to aspect 29, further configured such that after the drive member is operated to drive the second needle assembly to the injection position, the second needle assembly is retracted to its retracted position using energy released from one or more springs.

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

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

[0036] 33. The device according to aspect 32, wherein after the drive member is operated to drive the second needle assembly to the injection position, the pump is driven to pump the drug fluid from the drug reservoir through the second needle assembly using energy released from one or more springs.

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

[0038] 35. The device according to any one of aspects 29 - 34, further comprising a release button configured to prevent actuation of the dosing button until the release button is moved to a release configuration.

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

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

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

[0042] 39. A method for operating a drug delivery device comprising one or more springs, a loading button, a dosing button, a drive member, and a needle cartridge holding a plurality of needle assemblies, each needle assembly being disposed in a retracted position within the needle cartridge, the method comprising: actuating the loading button of the device, using the work performed by actuating the loading button to advance the needle assemblies such 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 using the work performed by actuating the loading button to load one or more springs; and, after actuating the loading button, actuating the dosing button of the device to release one or more loaded springs, using the energy released from 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 according to aspect 39, wherein releasing one or more loaded springs uses the energy released from one or more loaded springs to retract the second needle assembly to its retracted position after driving the second needle assembly to the injection position.

[0044] 41. The needle cartridge comprises a plurality of Geneva wheel members, the device further comprises a Geneva wheel configured to engage with the Geneva wheel members, the Geneva wheel rotates in response to the actuation of a load button, and the engagement between the Geneva wheel and the Geneva wheel members rotates the needle cartridge, whereby the first needle assembly is moved out of operational alignment with the drive member and the second needle assembly is moved into operational alignment with the drive member, according to the method of any one of Aspects 39 - 40.

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

[0046] 43. Driving the pump to pump the drug fluid from the drug reservoir through the second needle assembly using the energy released from one or more loaded springs by releasing the one or more loaded springs, according to the method of Aspect 42.

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

[0048] 45. Further comprising the actuation of an unlock button to unlock the dosing button, according to the method of any one of Aspects 39 - 44.

[0049] 46. Only the energy released from one or more loaded springs is used to operate the drive member, according to the method of any one of Aspects 39 - 45.

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

[0051] 48. The method according to any one of aspects 43 to 45, wherein only energy released from one or more loaded springs is used to operate the drive member and to 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, and a load button coupled to the housing, the load button being configured to be manually actuated and using the work performed by the actuation of the load button to load one or more springs to advance the needle cartridge, whereby 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 the dosing position, the load button, and a dosing button coupled to the housing, the dosing button being manually actuated after actuation of the load button to release one or more loaded springs to drive the pump and to pump the drug fluid from the drug reservoir through the second needle assembly.

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

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

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

[0056] 53. The device according to any one of aspects 49 to 52, further comprising an unlocking button configured to prevent the operation of the dosing button until the unlocking button is moved to the unlocking configuration.

[0057] 54. One or more springs comprise one or more clock springs movable between a wound-up configuration and a wound-back configuration, and the operation of the load button loads one or more clock springs by moving one or more clock springs to the wound-up configuration using the work done by the operation of the load button, and the operation of the dosing button after the operation of the load button releases one or more clock springs by moving one or more clock springs to the wound-back configuration to drive the pump. The device according to any one of aspects 49 to 53.

[0058] 55. One or more springs each comprise one or more linear springs movable between an axially expanded configuration and an axially compressed configuration, and the operation of the load button moves one or more linear springs to the axially compressed configuration using the work done by the operation of the load button, and the operation of the dosing button after the operation of the load button releases one or more linear springs by moving one or more linear springs to the axially expanded configuration to operate a drive member. The device according to any one of aspects 50 to 54.

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

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

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

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

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

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

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

[0066] 63. The method according to any one of aspects 59 - 62, further comprising actuating an unlock button to unlock the dosing button.

[0067] 64. One or more springs comprise one or more clock springs, loading one or more springs includes rotationally winding one or more clock springs, releasing one or more loaded springs enables one or more clock springs to be wound back, and driving a pump using energy released by one or more wound-back clock springs, the method according to any one of Aspects 59 to 63.

[0068] 65. One or more springs comprise one or more linear springs, loading one or more springs includes compressing one or more linear springs, releasing one or more springs enables one or more linear springs to expand, and operating a drive member using energy released by one or more expanding linear springs, the method according to any one of Aspects 60 to 64.

[0069] 66. Only energy released from one or more loaded springs is used to drive a pump, the method according to any one of Aspects 59 to 65.

[0070] 67. Only energy released from one or more loaded springs is used to drive a pump and to operate a drive member, the method according to any one of Aspects 60 to 65.

[0071] 68. Only energy released from one or more loaded springs is used to drive a pump, operate a drive member, and retract a second needle assembly, the method according to any one of Aspects 61 to 65.

Brief Description 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 better understood by referring to the following description of embodiments of the invention in conjunction with the accompanying drawings.

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[0073] Throughout the several views, corresponding reference numerals indicate corresponding parts. The examples described herein illustrate exemplary embodiments of the invention and such examples should not be construed as limiting the scope of the 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 needle cartridge egress, needle insertion, needle retraction, unlocking a dosing button, forming a fluid path from a reservoir to a patient, and pump pumping.

[0075] According to one aspect of the present disclosure, a device disclosed herein uses an action performed by a user in a first actuation step (e.g., by pressing a button) to load one or more springs and effect egress of a needle holding cartridge. A second actuation step by the user releases one or more loaded springs (e.g., linear compression springs) to drive a needle into subcutaneous / intramuscular tissue of a patient. 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). This pump then draws fluid from a reservoir and delivers it to the patient. At the end of dosing, additional energy from one or more loaded springs is released to retract the needle and reset the device. A lock mechanism associated with a physical sense button mechanically locks out the device to reduce the likelihood that a user will accidentally trigger the second actuation step and prevent the user from triggering the second actuation step until the device is pressed against the patient's body.

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

[0077] Figure 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 loading button 102, a dosing button 104, and an optional on-body sensing button 106.

[0078] The device 100 also includes a drug reservoir 150. The reservoir 150 can be a rigid or elastomeric container configured to store a drug. The device 100 can further include the drug stored within the reservoir 150. In another embodiment, the system can include the device 100 and one or more devices containing the drug. The term "drug" refers to, but is not limited to, one or more therapeutic agents 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 that can be delivered by the device 100. The drug used within the device can be formulated with one or more excipients. The device is operated by a patient, caregiver, or healthcare professional in the manner generally described herein to deliver the drug to a person.

[0079] The device 100 also includes a pump 180. The pump 180 can comprise any suitable pump that draws fluid drug from the reservoir 150 and delivers the aforementioned fluid drug through a fluid pathway into the patient's body. An 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] Device 100 also includes a needle cartridge 300 that holds a plurality of needle assemblies. Each individual needle assembly within cartridge 300 may include an injection needle and a support hub, and the support hub provides a gripping surface and / or an extrusion surface that holds the aforementioned needle and enables individual handling of the needle assembly by an insertion / retraction mechanism. Each needle assembly may be configured for use in a single injection. After the needle assembly has been used, the needle assembly may be retracted into the needle cartridge 300. After all of the needle assemblies within cartridge 300 have been used, the entire cartridge may be replaced and / or discarded. In some disposable embodiments of device 100, once all of the needles within cartridge 300 have been used, the entire device 100 may be discarded.

[0081] Device 100 also includes a needle insertion / retraction mechanism 500 that, when actuated by a user, drives an individual needle assembly within cartridge 300 that is operationally aligned with mechanism 500 from a retracted position to an injection position, and then, after injection is complete, retracts the aforementioned individual needle assembly from the injection position back to the retracted position. Mechanism 500 can include a single hammer or arm that performs both driving and retraction of the individual needle assemblies, or alternatively, mechanism 500 can include a plurality of hammers / arms, some of which drive the needle assemblies and some of which retract the needle assemblies. Device 100 also includes a cartridge indexing mechanism 400 that, when actuated, advances or indexes the cartridge 300 to move a spent or used needle assembly out of operational alignment with mechanism 500 and positions a new unused needle assembly in operational alignment with mechanism 500.

[0082] Device 100 can be used by a user to inject a fluid drug stored in reservoir 150 into a patient's body. As used herein, "user" can 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" can refer to a person receiving an injection. In some embodiments, "user" and "patient" can be the same person, for example, when the device is used by the patient to inject themselves. In some embodiments, "user" and "patient" can be different people, for example, when the device is used by a caregiver to inject a patient.

[0083] Device 100 can be operated by a user by first pressing a load button 102 to "load" the device. When the user presses load button 102, the work done by the user in pressing the button is captured and / or collected by an energy transfer, storage, and release mechanism 200. Mechanism 200 can include one or more mechanical components such as gears, gear trains, slide racks, pinion couplers, wires, and / or other mechanical linkage mechanisms, which transfer the work done by the user to other parts of device 100. For example, the work done by the user can be transferred to a cartridge indexing mechanism 400 that advances or indexes cartridge 300. Mechanism 200 can also include one or more springs (e.g., linear springs, torsion springs, clock springs, etc.), which 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 start the injection by pressing the dosing button 104. However, in some embodiments, the dosing button 104 is initially locked so that the user cannot press it down. The dosing button 104 can then be unlocked, for example, by a button or another unlocking component. In such embodiments, the user can unlock the dosing button 104 by actuating the unlock button 106. For example, the user can press the unlock button 106 with their finger. Alternatively, in preparing for the injection, the user can actuate the unlock button 106 (e.g., the unlock button 106 takes the form of a body-sensing button 106) by pressing the device 100 against the patient's body. In such embodiments, when the device 100 is pressed against the patient's body, the unlock button 106 is depressed, thereby unlocking the dosing button 104. The remainder of the present disclosure refers to the body-sensing button 106, but it should be understood that this is only one embodiment of the device 100. The main function of the button 106 is to unlock the dosing button 104, and the button 106 does not necessarily take the form of a body-sensing button.

[0085] Subsequently, when the user presses the dosing button 104, the needle insertion / retraction mechanism 500 is driven, and the potential energy stored by the mechanism 200 for energy transmission, storage, and release (e.g., by one or more springs) is released to insert the individual needle assemblies for injection. The energy stored by the mechanism 200 is also released to drive the pump 180 to pump the liquid drug from the reservoir 150 through the inserted needle assemblies to the patient. In other embodiments, in addition to or alternatively to driving the needle assemblies, the driven needle assemblies 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 assemblies 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 generates heat or gas) is required. Instead, all the energy required to drive the device 100, including assigning the cartridge 300, inserting and retracting the needles, and pumping the drug, is provided by the user.

[0086] Figures 2 and 3 provide perspective views of the (respective) top and bottom surfaces of the exemplary device 100. For simplicity of explanation only, Figures 2 - 27A, 27B, and 27C use the coordinate system in the x, y, and z directions indicated by the arrow 201.

Number

Number

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

[0088] FIGS. 4, 5, and 6 show the internal components of device 100 when the upper housing 101 has been removed. FIG. 4 presents a top view of device 100, FIG. 5 presents a perspective view of device 100, and FIG. 6 presents an exploded perspective view of device 100.

[0089] In the embodiment shown in FIGS. 4 to 6, the cartridge 300 can take the form of a circular carousel having a generally planar upper surface 301 and a generally planar bottom surface 303 (see FIG. 6). The cartridge 300 has a central shaft 310 that extends from the upper surface to the lower surface through the vertical axis at the center of the cartridge. The central shaft 310 can be configured to accommodate a central spindle 302 that extends vertically upward from the inner surface of the lower housing 103 (see FIG. 6). When the central spindle 302 is inserted through the central shaft 310, the carousel 300 is configured to rotate about the central spindle 302. The carousel 300 defines a plurality of cavities 304a, b, c, etc. (collectively or individually referred to herein as "cavity" or "(plural) cavities" 304 as appropriate). Each cavity 304 extends radially outward from the central shaft 310 toward the circumferential direction of the cartridge radius and includes an opening in the upper surface 301 and an opening in the bottom surface 303.

[0090] Each cavity 304 houses needle assemblies 306a, b, c (referred to herein, as needed, collectively or individually as "needle assembly" or "(plural) needle assemblies" 306). One exemplary embodiment of needle assembly 306 is shown in FIGS. 22A and 22B. In this embodiment, needle assembly 306 includes a J-shaped needle or cannula 312, which, as described below, has a first leg segment 324 configured to penetrate the drug septum 182 and draw fluid drug therefrom, and a second leg segment 326 configured to be driven into the patient's body for injecting the drug. Needle 312 is held within a support hub 314 having a needle support base 316. In addition to holding and supporting needle 312, needle support base 316 also mounts a shelf-like protrusion 328. Needle support base 316 also mounts an upright arm component 320 having a tongue 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 on November 17, 2011, the entire contents of which are expressly incorporated herein by reference.

[0091] Returning to FIGS. 4-6, the cartridge 300 includes an intermittent rotational drive device. For example, the cartridge 300 includes a plurality of Geneva wheel members 308a, b, c (collectively or individually referred to herein as "Geneva wheel members" or "(plural) Geneva wheel members" 308 as needed), which interact with a Geneva wheel 410 to index the cartridge 300 and advance it one increment at a time, as described in more detail below. Each Geneva wheel member includes a substantially planar member that extends radially outward in a horizontal plane from the cartridge 300. Each Geneva wheel member may include a vertical, concave, arcuate wall 309 (see FIG. 5) at the outermost extent of such respective wheel member away from the central shaft 310. When the Geneva wheel member aligns with the Geneva wheel 410, this vertical, concave wall 309 fits into the inner hub 411 of the 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. All pairs of adjacent Geneva wheel members (e.g., 308a and 308b) define a gap between the aforementioned wheel members into which the Geneva pin 412 can fit.

[0092] In this embodiment, the reservoir 150, which takes the form of an elastomeric container (most clearly visible in FIG. 6), is configured to contain a drug. The reservoir 150 can be configured such that the drug can be pre-filled and provided to the user, or can be configured to be filled by the user. The pump 180 (also most clearly visible 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 Aug. 26, 2019, entitled "ROTARY PLUNGER PUMP SUBSYSTEMS", the entire contents of which are incorporated herein by reference. As will be discussed in more detail below, the pump 180 can be driven to pump a liquid drug from the reservoir 150 towards the drug septum 182, where the drug is pushed into individual needles and from there can be pushed into the patient.

[0093] The energy transfer, storage, and release mechanism 200 shown in FIGS. 5-6 includes a secondary slide 202, a primary slide 210, a latch 216, a dosing button lock 224, a blocker 226, a face gear 230, a gear train including gears 232, 234, 235, 238, and 240, and a latch assembly 250. Here, each of these components will 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 (such as gears, rods, wires, etc.). The slide 202 is configured to be slidably movable parallel to the x-axis of the device 100 between a secondary slide distal position and a secondary slide proximal position, as will be described in more 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 and substantially rectangular-shaped member whose major axis is 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 channel 209 defined between the 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 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 lock 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 the channel 209. The distal end of the spring 204 abuts against the inner surface of the distal wall 207, and the proximal end of the spring 204 abuts against a tab (not shown) extending downward from the inner surface of the upper housing 101.

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

[0096] Returning to FIGS. 4-6, the primary slide 210 is configured to be slidably movable parallel to the x-axis of the device 100 between a primary slide distal position and a primary slide proximal position, as will be described in more 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 and substantially rectangular member and has a major axis that is also aligned with the x-axis of the device 100. The primary slide 210 includes 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-top channel 223 defined between the body portions of the left wall 217 and the right wall 215. The primary slide 210 also includes a locking tab 214 that extends horizontally outward from the right wall 217 (i.e., the -y side) of the slide 210 and a pair of fins 227 that extend proximally from the proximal wall 225. The left wall 215 and the right wall 217 define a slot 211 that extends therethrough in the lateral (y-direction), and the fins 227 define a channel 220 that extends therethrough in the lateral (y-direction). When the device 100 is fully assembled (see FIGS. 4-6), the compression tab 208 of the secondary slide 202 is configured to extend through the slot 211 and also through the interior volume of the primary slide 210. The primary slide 210 also houses a spring 212 within its channel 223. The distal end of the spring 212 abuts the proximal face of the compression tab 208 of the secondary slide 202, and the proximal end of the spring 212 abuts the inner face of the proximal wall 225 of the primary slide 210.

[0097] The latch 216 is configured to rotate in a horizontal plane about an axis 229 and includes a latch tab 218. When the latch 216 rotates in the counterclockwise direction (when viewed from above), an over-rotation prevention mechanism (shown as a spring 222) prevents the latch 216 from over-rotating and biases the latch 216 back to its neutral position in the clockwise direction (i.e., as shown in FIGS. 4-5), where the major axis of the latch 216 is parallel to the x-axis of the 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 dosing button lock 224 interacts with other components to prevent the user from depressing the dosing button 104 until the physical sense button 106 is depressed. The dosing button lock 224 is shown in more detail in FIGS. 13A and 13B. In this embodiment, the lock 224 includes a vertical panel 232 that defines a pin slot 244. The slot 244 can extend obliquely in the +x / +z direction. The lock 224 also includes, for example, a horizontal panel 237 that extends from the vertical panel 232 so as to be orthogonal. The horizontal panel 237 defines another pin slot 247 that extends in the +x direction. The horizontal panel 237 also includes a blocker member 236 in the form of a substantially flat tab that aligns with a horizontal flat surface and extends beyond the vertical panel 232 from the distal end of the horizontal panel 237. The member 236 is also shown to extend laterally in the -y direction beyond the vertical panel 232.

[0099] FIG. 7A provides a cross-sectional perspective view of device 100 when cut along plane 1-1 (see FIGS. 4-5), and best shows how the dosing button lock 224 interacts with the body-mounted sensing button 106 when device 100 is fully assembled. For clarity, the lower housing 103 is rendered transparent. The body-mounted sensing button 106 can translate vertically 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 therearound. The upper end of spring 114 abuts the inner surface of cavity 120, and the lower end of spring 114 abuts the upper surface inside button 106. Spring 114 biases button 106 downward out of cavity 120. When the user presses the bottom side of device 100 against their body, the user's pressing force overcomes the biasing force of spring 114 and translates button 106 upward into cavity 120. When the pressing force is removed, the spring force allows button 106 to return to its biased-out position. Pin 118 is configured to extend horizontally from the left side of shaft 116. When device 100 is assembled, pin 118 is configured to ride within a pin slot 244 of dosing button lock 224. As will be discussed in more detail below, the interaction between pin 118 and pin slot 244 of dosing button lock 224 causes dosing button lock 224 to translate in the proximal direction (i.e., in the -x direction) when button 106 is pushed upward into cavity 120.

[0100] Returning to FIGS. 4 - 6, the blocker 226 interacts with the dosing button lock 224 to prevent the user from depressing the dosing button 104 until the dosing button 104 is unlocked, i.e., until the physical sense button 106 is depressed. When the dosing button 104 is unlocked and depressed, the blocker 226 also interacts with a 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 parts, namely, a block tab 242, a button seat 239, and an arm 275. The button seat 239 takes the form of a substantially planar surface or member (having a circular shape in this embodiment, although other shapes are possible) oriented parallel to the horizontal plane of the device 100. The block tab 242 is attached to the left side (i.e., the +y side) of the button seat 239 and takes the form of a substantially planar surface or member oriented parallel to the vertical plane of the device 100 extending in both the +y / +z directions away from the seat 239. The arm 275 is also attached to the button seat 239 circumferentially spaced from the tab 242 and extends generally in the +x direction. The arm 275 comprises a fin 232 disposed at its distal end and extending in the +y direction. The fin 232 comprises a top surface 260, a bottom surface 262, a proximal face 266, and a distal face 268. As best seen in FIG. 14B, the top surface 260 and the bottom surface 262 are angled, i.e., they are parallel to a plane oriented in the -x / +z direction.

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

[0102] The dosing button 104 can translate vertically into or out of a dosing button cavity 121 defined within the upper housing 101 (see FIG. 7B). The dosing button 104 comprises a vertical dosing button shaft 112 which is coupled to a blocker 226 such that the button 104 and the blocker 226 translate vertically together. In the embodiment shown in FIG. 7B, the dosing button shaft 112 is coupled to the blocker 226 using a screw, although any suitable positive attachment method (e.g., heat staking, one-way snap, etc.) can be used. A dosing button spring 110 coaxially surrounds the dosing 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 a surface facing upwardly inside the dosing button cavity 121. The spring 110 biases the button 104 (and the blocker 226 attached to the button 104) upwardly. When the user depresses the button 104, the shaft 112 transmits the downward pressing force of the button 104 to the button seat 239 of the blocker 226. When the blocker 226 is unlocked as described above, the downward pressing force of the user translates the button 104 and the blocker 226 (including the button seat 239) downwardly.

[0103] The mechanism 200 also includes a face gear 230 and a gear train including gears 232, 234, 235, 238, and 240, each of which is best seen in FIG. 6. The face gear 230 takes the form of a circular gear including a plurality of upward teeth 231. The face gear 230 is coupled to the clock spring 228. Both the face gear 230 and the clock spring 228 are arranged parallel to the horizontal plane and configured to rotate about the central axis 233. The clock spring 228 resists the rotational movement of the face gear 230 about the central axis 233. In other words, when the face gear 230 is rotated in a first rotational direction about the central axis 233, tension is applied to the clock spring 228, thereby storing potential energy within the clock spring 228. The face gear 230 interacts with the drive gear 240 and then interacts with and drives the gear 232. The gear 232 also interacts with and drives a small gear 234 that is rotatably coupled to the gear 235 such that the gears 234 and 235 rotate together. Next, the gear 235 interacts with the gear 238 that provides rotational torque to the pump 180. The number of gears, the relative sizes of the gears and teeth, and the configuration can be selected to provide the rotational speed and torque required to drive the pump.

[0104] Figures 9 and 10 provide additional more detailed views of the face gear 230 and clock spring 228, and show how they interact with the latch 216. Figure 9 provides a top perspective view where certain components (e.g., slides 202, 210, blocker 226, dosing button lock 224, and latch assembly 250) have been removed to expose the face gear 230 and clock spring 228. Figure 10 provides a bottom perspective view where the bottom housing 103 is rendered transparent to better view the bottom side of the face gear 230. As can be seen in Figure 9, the top surface of the face gear 230 defines a plurality of notches 270a, b, c, d, e (referred to herein collectively or individually as "notches" or "(plural) notches" 270 as necessary). The embodiment of the face gear 230 depicted in Figure 9 defines five notches (notch 270c is hidden under gear 240 in Figure 9), while other embodiments where the face gear 230 defines fewer or more notches are possible. The notches are shown radially spaced from each other and may be equally radially spaced. Each notch is shaped to accommodate a pawl 256, as will be described in more detail below with reference to Figure 23A. As best seen in Figure 10, the face gear 230 also includes a plurality of fins 272a, b, c, d, e (referred to herein collectively or individually as "(plural) fins" or "fins" 272 as necessary). Again, the embodiment of the face gear 230 depicted in Figures 9 and 10 includes five fins, while other embodiments where the face gear 230 includes fewer or more fins are possible. The fins are shown radially spaced from each other 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 has an inclined leading edge and a straight trailing edge. As shown, the fins may be radially offset from the notches. As best seen in Figure 10, the latch 216 further includes a downwardly extending arm 274 that extends downwardly from the horizontal plane of the latch tab 218 to the horizontal plane of the face gear 230.As will be discussed in further detail below, each fin 272 is sized and arranged such that when the face gear 230 rotates to a position where such fins 272 are aligned with the arms 274, they displace the arms 274 by pushing them radially outward.

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

[0106] The cartridge ejection mechanism 400 is depicted in FIGS. 4-5. The mechanism 400 includes a pinion coupler 406 having teeth 408 that interact with the teeth of a slide rack 243 that faces laterally when the rack 243 is linearly translated, driving the pinion coupler 406 to rotate. 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 circumference smaller than the first circumference stacked on top of the aforementioned planar disk. A Geneva pin 412 extends vertically upward from the upper surface of the planar disk. The Geneva pin 412 interacts with a Geneva wheel member 308 of the cartridge 300 by fitting within a gap between adjacent wheel members as best seen in FIG. 4.

[0107] The needle insertion / retraction mechanism 500 is depicted in FIGS. 4-6, as well as FIGS. 22A and 22B. The mechanism 500 includes a drive member or hammer 502. As will be discussed in more detail below, the proximal end of the hammer 502 includes a head 503 that interacts with a needle assembly 306 within the cartridge 300 that engages the actuated hammer 502. 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 enter into a channel 220 defined within a fin 227 of the primary slide 210 (see FIG. 5). Thus, proximal or distal translation of the primary slide 210 applies a force to the pin 504 of the hammer 502, thus rotating the hammer 502 about the pin 506.

[0108] Here, the operation of the device 100 will be described. FIGS. 15A to 15D depict a series of states of the device 100 during operation according to some embodiments. FIG. 15A shows the device 100 in an initial neutral state before the user begins to press down on the load button 102. While in this neutral state, the spring 204 of the secondary slide 202 biases the slide 202 in the distal direction against a stop (e.g., when the surface of the secondary slide 202 hits a stop within the upper housing 101 or the lower housing 103, or when the distal surface of the compression tab 208 hits the distal wall 221 of the primary slide 210). The position of the secondary slide 202 in this initial neutral state of the device 100 is referred to herein as the secondary slide distal position. Similarly, while in this neutral state, the spring 212 of the primary slide 210 biases the slide 210 in the distal direction until the slide 210 hits a stop within the upper housing 101 or the 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 and is labeled 308a and 308b in FIG. 15A.

[0109] Figure 15B depicts what happens when the user begins to apply a proximal force to the load button 102, as indicated by arrow 606. Moving the load button 102 in the proximal direction causes the secondary slide 202 to translate in a proximal direction parallel to the x-axis of the device 100, thereby compressing spring 204 against a tab (not shown) that extends 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 spring 212 against the inner surface of the proximal wall 225 of the primary slide 210. In this way, the movement of the secondary slide 202 in the proximal direction compresses both spring 204 and spring 212. As the secondary slide 202 translates proximally, the lock tab 206 eventually presses against the latch tab 218 of the latch 216. Both the lock tab 206 and the latch tab 218 have inclined surfaces, and when they are both pushed, they rotate the latch 216 counterclockwise (as viewed from above) about axis 229, as indicated by arrow 608 in Figure 15C. Eventually, as the secondary slide 202 continues to translate proximally, the lock tab 206 clears the latch tab 218, at which point the latch 216 rotates clockwise (as viewed from above) about axis 229 due to the biasing pressure of spring 222, as shown by arrow 610 in Figure 15D. As depicted in Figure 15D, the latch tab 218 slides to a predetermined position behind (i.e., distal to) the lock tab 206, thereby preventing the secondary slide 202 from translating distally. The position of the secondary slide 202 shown in Figure 15D is referred to herein as the secondary slide proximal position.

[0110] The proximal movement of the secondary slide 202 also translates the side-facing slide rack 243 in the proximal direction, as indicated by the arrows 604 in FIGS. 15B-D. Due to the engagement between the teeth of the side-facing slide rack 243 and the teeth 408 of the pinion coupler 406, the proximal movement of the side-facing slide rack 243 rotates the pinion coupler 406 clockwise (when viewed from above), as indicated 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 where the pin 412 first engaged, as shown in FIG. 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 1 increment counterclockwise (when viewed from above), as indicated by arrow 612. When the pin 412 is in the re-engaged state, the pin 412 maintains its position so that the cartridge does not rotate, and the Geneva wheel 410 cannot rotate further because the side-facing rack 243 is disengaged from the teeth 408, as depicted in FIG. 18C.

[0111] By the end of the series of states depicted by FIGS. 15A - D, the work done by the user when 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 to release 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 will be explained below). The work done by the user is also used to allocate the cartridge 300 in one increment or advance it in one increment, whereby one spent or used needle assembly is taken out of operational alignment with the drive member or hammer 502 and a new unused needle assembly is placed in operational alignment with the hammer 502.

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

[0113] Figures 17A and 17B show 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 show the movement of other components. Due to the engagement between gears 232 and 240, when gear 232 rotates in a rotational motion in the direction of arrow 614, it causes gear 240 to rotate in the direction of arrow 616. When gear 240 rotates in the direction of arrow 616, it then drives face gear 230 to rotate in the direction of arrow 618. When face gear 230 rotates in the direction of arrow 618, tension is applied to clock spring 228. As previously discussed, face gear 230 defines a plurality of notches 270 on its upper surface. When face gear 230 rotates in the direction of arrow 618, one of these notches 270 eventually aligns with pawl 256 of latch assembly 250. When this alignment occurs, pawl 256 slides into notch 270 under the biasing pressure of torsion V-shaped spring 258, thereby preventing face gear 230 from rotating in the reverse direction as indicated by arrow 618.

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

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

[0116] Figure 18A shows the initial neutral state of device 100, where secondary slide 202 is positioned at its most distal extent (i.e., in the secondary slide distal position as in Figure 15A). In Figure 18B, secondary slide 202 translates proximally in the direction of arrow 604 in response to the user depressing load button 102, as described above. As secondary slide 202 translates proximally, lower pins 274a, 274b engage the proximal edges of slide rack slots 245a, 245b, thereby causing platform 249, downward 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 Figure 18C. Since slide rack slots 245a, 245b extend obliquely in the +x / +y direction, this continued proximal translation of platform 249 in the -x direction also causes platform 249 to translate radially away from pinion coupler 406 and in the -y direction, as indicated by arrow 607. This translation in the -y direction causes the teeth of side-facing slide rack 243 to disengage from the teeth 408 of pinion coupler 406.

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

[0118] By pressing the load button 102, the device 100 is loaded. After the slide racks 241, 243 are disengaged from the gear 232 and the pinion coupler 406 respectively, the device 100 is ready to be placed on the patient's body for injection. Figure 20A shows the configuration of the device 100 after it is loaded but before it is pressed against the patient's body. In this configuration, the blocker member 236 of the dosing button lock 224 is positioned under the blocker 226, thereby preventing the blocker 226 from translating downward. This prevents the user from prematurely triggering the device 100. Figure 20B shows what happens when the user presses the device 100 against the patient's body. When the device 100 is pressed against the patient's body, an upward force is applied to the sensing button 106 on the body, which overcomes the downward biasing pressure of the sensing button spring 114 and translates the button 106 upward in the direction of arrow 620 into the sensing button cavity 120. When the sensing button 106 on the body moves upward, the pin 118 rides into the pin slot 244 of the dosing button lock 224 as described above. Since the pin slot 244 of the vertical panel 232 extends obliquely in the +x / +z direction, moving the pin 118 upward within the pin slot 244 causes the dosing button lock 224 to also translate in the proximal direction (i.e., the -x direction) as indicated by arrow 622. When the dosing button lock 224 translates in the proximal direction, 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 dosing button 104, thereby preparing 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 (and thus the dosing button 104 has been unlocked), but before the dosing button 104 is depressed. In this state, the block tab 242 of the blocker 226 is positioned in front of the lock tab 214 of the primary slide 210, thereby preventing the primary slide 210 from translating proximally in the -x direction. As previously discussed, this position of the primary slide 210 is referred to herein as the primary slide distal position. FIG. 21B shows what happens when the user depresses the dosing button 104. When the dosing 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 dosing 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 dosing button shaft 112. This causes the blocker 226 to also translate downward in the direction of arrow 626. As the blocker 226 translates downward, the block tab 242 clears the lock tab 214 of the primary slide 210, thereby enabling the primary slide 210 to translate proximally in the direction of arrow 628 (i.e., in the -x direction). Since the spring 212 was previously compressed by the proximal movement of the compression tab 208 of the secondary slide 202 (as described above), when the block tab 226 clears the lock tab 214, the primary slide 210 is propelled proximally by the loaded spring 212. The position of the primary slide 210 when it has translated to its maximum proximal extent is referred to herein as the primary slide proximal position.

[0120] Figures 22A - B provide a profile view of device 100, showing how movement of the primary slide 210 in the proximal direction drives the needle assembly 306 within cartridge 300 from a retracted position to an injection position. Figure 22A shows the configuration of device 100 before the user presses the dosing button 104. In this state, the needle assembly 306 is disposed in a retracted position within cavity 304 of cartridge 300. When the primary slide 210 is propelled forward by spring 212, the primary slide 210 applies a proximal - direction force to pin 504 of hammer 502 in the direction of arrow 630. This proximal - direction force rotates hammer 502 in the direction of arrow 631 about pin 506. As hammer 502 rotates in the direction of arrow 631, hammer head 503 depresses shelf 328 of needle assembly 306 within cartridge 300 that is operationally aligned with hammer 502, thereby driving the needle assembly downward in the direction of arrow 632 to its injection position as shown in Figure 22B. As needle assembly 306 translates downward, the first leg segment 324 of needle 312 penetrates the drug septum 182, and the second leg segment 326 of needle 312 projects downward from needle aperture 108 within lower housing 103 and pierces the patient's skin and into the patient's body. In this way, when the needle assembly 306 is in its injection position, needle 312 establishes a fluid path from drug septum 182 into the patient's body. When the needle assembly is disposed in the injection position, the biasing force of spring 212 biases the primary slide 210 in the proximal direction, thereby maintaining a downward pressure on shelf 328 by hammer head 503 until the needle assembly is retracted (as described below). This ensures that the needle assembly maintains an appropriate depth within the patient's body and within 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 dosing button 104. In this initial position, the fin 232 of the blocker 226 is positioned just 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. Since the bottom surface 262 is angled obliquely in the -x / +z direction, the downward movement of the bottom surface 262 rotates the pin 252 horizontally about the axis 264 in the direction indicated by the arrow 638 (see FIGS. 23B and 23C). As the pin 252 rotates in the direction of arrow 638, the torsion V - shaped spring 258 transmits a rotational torque onto the claw 256 in the direction of arrow 640 (again about the axis 264).

[0122] Figures 24A - C show the interaction between the blocker 226 and the latch assembly 250 from another perspective. Figure 24A shows the state of the device 100 after the 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 when depressing the load button 102 is stored in the form of potential energy within the coiled clock spring 228 coupled to the face gear 230. However, the face gear 230 and the clock spring 228 are prevented from unwinding by a pawl 256 that fits into one of the notches 270 defined on the face gear 230. When the user presses the dosing button 104, the button 104 translates downward in the direction of arrow 624. This downward force applied to the button 104 also translates the blocker 226 downward, and as previously discussed, the latch pin 252 rotates in the direction of arrow 638 and the pawl 256 rotates in the direction of arrow 640. The rotation of the pawl 256 in the direction of arrow 640 disengages the pawl 256 from the notch 270, thereby enabling the face gear 230 and the clock spring 228 to unwind in the direction of arrow 642, as shown in Figure 24B.

[0123] Referring back to FIG. 23C, when the user continues to press the load button 104 downward and the blocker 226 continues to translate downward, the latch pin 252 finally disengages from 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 its downward translation, the entire fin 232 slides under the latch pin 252, so the latch pin 252 clears the proximal surface 266. When the user stops pressing the button 104 downward, the button 104 and the blocker 226 rise upward again due to the biasing pressure of the dosing button spring 110. At this point, the latch pin 252 contacts the upper surface 260 of the fin 232. Since the upper surface 260 of the fin 232 is also angled obliquely in the -x / +z direction, the upper surface 260 rotates the latch pin 252 in the opposite direction about the axis 264 here, i.e., in the direction of arrow 644. When the pin 252 rotates in the direction of arrow 644, the torsion V-shaped spring transmits the rotational torque of the claw 256 in the direction of arrow 646.

[0124] FIGS. 25A - 25C are views of the device 100 seen from below, and the lower housing 103 is rendered transparent to better show how the unwinding of the face gear 230 unlatch the latch 216. FIG. 25A depicts the device 100 after the claw 256 has been disengaged from one of the notches 270 of the face gear 230 and the face gear 230 and the clock spring 228 have begun to unwind in the direction of arrow 642. While the face gear 230 and the clock gear 228 are being unwound, the needle insertion / retraction mechanism 500 drives the needle assembly 306 to the injection position as previously discussed and as shown in FIGS. 22A - B. Also, while the face gear 230 is being unwound, the face gear drives the rotation of the gears 240, 232, 234, 235, and 238 (see FIG. 6). Next, the rotation of the gear 238 provides a rotational input to the pump 180, pumping liquid drug from the reservoir 150 through the septum 182 and the driven needle 312 into the patient.

[0125] Figures 28 through 35A through 35D illustrate one possible embodiment of pump 180. Pump 180 includes mounting frame 602, rotary drive shaft 604, rotary plunger 802, pump housing 702, and return spring 624. The 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 rotary input to pump 180, and this input rotates rotary drive shaft 604 about longitudinal axis 701 in the direction of arrow 705 (e.g., clockwise), as shown in FIG. 29.

[0126] Figures 30A - 30D and 31 depict the rotary plunger 802 in more detail according to some embodiments. Figures 30A - 30D depict the plunger 802 from four separate side views, while Figure 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 side wall 820. A plunger pin 804 projects radially outward from the side wall 820 of the plunger 802 and can be rigidly fixed thereto. In some embodiments, the pin 804 and the side wall 820 can be formed from one integral structural component, while in other embodiments, the pin 804 can be a separate component that is adhered, joined, inserted, or molded into the side wall 820. As shown, the pin 804 can be arranged adjacent to the first end 812 of the plunger 802. However, the pin can be arranged at any point along the length of the plunger 802. As best seen in Figure 31, the plunger 802 can include a portion of a reduced cross-sectional area defined by a notch 810 disposed adjacent to the second end 814. The notch 810 is recessed beneath the side wall 820 and is defined by a substantially planar longitudinal portion 816 connected to a lip 818 that steps inward from the cylindrical side wall 820 of the plunger 802. The portion 816 and the lip 818 can intersect in a transverse relationship. In one embodiment, the planar portion 816 of the notch 810 faces in 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] The plunger 802 is received within the pump housing 702. One exemplary embodiment of the housing 702 is shown in more detail in FIGS. 32 and 33, where FIG. 32 provides a perspective view of the housing 702 and FIG. 33 provides a cross-sectional view of the housing 202 when cut along line 3-3. The housing 702 can be constructed from any suitable and relatively rigid material such as olefin plastics (e.g., cyclic olefin copolymer and / or polypropylene). The mating surface between the housing 702 and the plunger 802 can be lubricated with a suitable pharmaceutical container lubricant such as silicone oil.

[0128] The housing 702 comprises a first section 708, an intermediate section 710, and a third section 712, which are three sections, each being arranged along a common axis 701. The first section 708 comprises side walls 722 that define 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 718, but is angled offset such that the first end 754 of the track 718 is further away from the intermediate section 710 than the second end 750 on the opposite side of the track 718. The second end 750 is connected to the first end 754 of the track 718 via an upwardly inclined portion 752 and a downwardly inclined portion 756. The first section 708 also comprises two tabs 710a, 710b that receive and support the plunger 802.

[0129] The intermediate section 710 includes a side wall 724 and one or more axial ridge portions 714 that project radially outward from the side wall 724. The one or more ridge portions 714 have a radially inward stepped portion 716 that is oriented toward a third section 712 of the housing 702. As best shown in FIG. 33, the side wall 724 defines an internal cavity 730 along an axis 701 that has an open first end 760 and a closed second end 762. The side wall 724 also defines an inlet port 726 and an outlet port 728 as shown to be 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., at an angular spacing of 180 degrees from each other) along a transverse axis 703 that extends perpendicular to the longitudinal axis 701. The inlet port 726 and the outlet port 728 pass through the side wall 724 and are in fluid communication with the cavity 730. The ducts are shown to be arranged in the arms with a liquid-tight seal. The inlet port 726 is fluidly connected to an inlet duct 704, while the outlet port 728 is fluidly connected to an 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 discharged through the outlet port 728 / outlet duct 706.

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

[0131] When the plunger 802 is received within the housing 702, the plunger 802 is configured to rotate about the longitudinal axis 701 within the cavity 730. The plunger 802 is also configured to translate longitudinally along the longitudinal axis 701 within the cavity 730. The biasing pressure of the return spring 624 causes the pin track 718 to always abut and / or engage beneath the plunger pin 804 while the plunger 802 is rotating within the cavity 730. When the plunger 802 is received within the cavity 730, the surfaces defining the notch 810 (i.e., surfaces 816, 818) and the inner wall of the cavity 730 (i.e., the inner surface of the side wall 724) together define the working chamber 902 (see FIGS. 34A-34D), which, as the plunger moves within the cavity, is not in fluid communication with the port, then is in fluid communication with the inlet port, then is not in fluid communication with the port, then is in fluid communication with the outlet port, and this is repeated and occurs sequentially.

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

[0133] In FIGS. 34A and 35A, the plunger 802 is rotated so that the plunger pin 804 faces left in FIGS. 34A and 35A. When the plunger pin 304 is oriented in this direction, the spring 624 engages the pin 804 with the lowest portion of the pin track 718 (i.e., the second end 750), thereby longitudinally translating the plunger 802 to the position farthest from the housing 702 within the cavity 730. While the plunger 802 is in this farthest 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, and the working chamber 902 is adapted to have the minimum volume among any of the four configurations depicted in FIGS. 34A-34D and FIGS. 35A-35D. Also, while the plunger 802 is in this farthest position, the notch 810 is oriented outside the page in FIG. 34A and downward in FIG. 35A. As described above, the notch 810 and the inner wall of the cavity 730 (i.e., the inner surface of the side wall 724) define the working chamber 902. When the notch 810 is so oriented, the curved side wall 820 of the plunger 802 firmly presses against the inner surface of the side wall 724 surrounding the inlet port 726 and the outlet port 728, respectively, establishing a fluid tight seal that blocks both ports. As a result, the working chamber 902 is not in fluid communication with either port while in this configuration.

[0134] In FIGS. 34B and 35B, the plunger 802 is rotated so that the plunger pin 804 is directed into the page in FIG. 34B and upward in FIG. 35B. When the plunger pin 804 is directed in this direction, the spring 624 engages the pin 804 with the inclined portion 752 above the pin track 718. As a result, when the plunger 802 rotates, the plunger 802 moves out of the housing 702 and translates longitudinally, thereby increasing the volume of the working chamber 902. Also, in this configuration, the notch 810 is oriented to the left in FIGS. 34B and 35B, thereby opening a fluid communication between the working chamber 902 and the inlet port 726. The opened fluid communication and the increasing volume of the working chamber 902 cause fluid to be drawn into the working chamber 902 from the inlet port 726 when the pin 804 rotates (or, if the fluid is stored under pressure in the drug reservoir, allow the fluid to enter the working chamber 902).

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

[0136] In FIGS. 34D and 35D, the plunger 802 is rotated so that the plunger pin 804 is directed outwardly of the page in FIG. 34D and downwardly in FIG. 35D. When the plunger pin 804 is directed in this direction, the spring 624 engages the pin 804 against the downwardly inclined portion 756 of the pin track 718. As a result, as the plunger 802 rotates, the plunger 802 translates longitudinally within the housing 702, whereby the volume of the working chamber 902 decreases. Also, in this configuration, the notch 910 is oriented to the right in FIGS. 34D and 35D, thereby opening fluid communication between the working chamber 902 and the outlet port 728. The opened fluid communication and the decreasing volume of the working chamber 902 cause fluid to be discharged from the working chamber 902 through the outlet port 728 as the pin 804 rotates. In this configuration, the curved sidewall 820 of the plunger 802 continuously presses tightly against the inwardly offset segment 732, thereby maintaining a fluid tight seal that blocks the inlet port 726.

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

[0138] Here, since the operation of the pump 180 has been described, the attention will be returned to FIGS. 25A - C. After a predetermined time (while the drug is being pumped to the patient by the pump), the face gear 230 finally rotates to a position where one of its fins 272 aligns with the arm 274 of the latch 216. The inclined leading edge of the fin 272 comes into contact with the arm 274, thereby pushing the latch 216 and rotating it in the direction of arrow 644 as shown in FIG. 25B. As a result, as will be described below, the latch 216 unlocks the secondary slide 202. As the gear 232 continues to rotate, the fin 272 finally clears the arm 274 of the latch 216, and the latch 216 moves back to its neutral position in the direction of arrow 646 under the biasing pressure of the spring 222.

[0139] Figures 26A - C show the same sequence as Figures 25A - C of the state of device 100, and better show how slides 202 and 210 move in response to the unlocking of latch 216 from above. Figure 26A shows device 100 after pawl 256 has been disengaged and face gear 230 has started to unwind, but before latch 216 is unlocked. In this state, the latch tab 218 of latch 216 is positioned distal to the lock tab 206 of secondary slide 202, thereby preventing secondary slide 202 from translating distally under the biasing pressure of spring 204. In Figure 26B, latch 216 rotates in the direction of arrow 644, thereby clearing lock tab 206. This enables 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 secondary slide 202 translates distally, compression tab 208 contacts the distal wall 221 of primary slide 210, and primary slide 210 also translates distally in the direction of arrow 650 (i.e., in the +x direction). Finally, latch 216 rotates in the direction of arrow 646 under the biasing pressure of spring 222 and returns to its neutral position (Figure 26C). However, since lock tab 206 is now distal to latch tab 218 here, the rotation of latch 216 back to its neutral position does not stop secondary slide 202 from translating distally until it hits the stop. As shown in Figure 26C, secondary slide 202 finally translates back to its secondary slide distal position, and primary slide 210 finally translates back to its primary slide distal position.

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

[0141] Terms such as "first", "second", "third", "primary", "secondary", etc., whether used in the embodiments for carrying out the invention or in the claims, are provided to distinguish similar elements and are not necessarily for describing a continuous or chronological order. Such terms are interchangeable in an appropriate environment (unless specifically disclosed otherwise), and it should be understood that the embodiments of the disclosure described herein are operable in other sequences and / or arrangements other than those described or illustrated herein.

[0142] Although the present invention has been described as having exemplary designs, the present invention may be further modified within the scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the present invention using the general principles of the present invention. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice within the art to which the present invention pertains.

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

[0144] In at least some of the above embodiments, when the user actuates the load button, one or more springs within the drug delivery device are loaded. Next, when the user actuates the dosing button, the one or more loaded springs are released to (i) operate the drive member to drive the needle assembly from the retracted position to the injection position in operative alignment with the drive member, (ii) drive the pump to pump the drug fluid from the 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 drive all of the functions (i) through (iii) above. For example, in some embodiments, releasing one or more loaded springs (upon actuation of the dosing button) can drive only function (i), but not drive functions (ii) and (iii). In other embodiments, releasing one or more loaded springs upon actuation of the dosing button can drive only functions (i) and (ii), and (iii) cannot be driven. In yet other embodiments, releasing one or more loaded springs upon actuation of the dosing button can drive functions (ii) and (iii), but cannot drive function (i). Generally, embodiments that achieve any one or more of the above functions (i) through (iii) by releasing one or more springs (upon actuation of the dosing button) are also within the scope of the present disclosure.

[0145] Further, in at least some of the above embodiments, the needle cartridge is not dispensed when one or more loaded springs are released when the user actuates the dosing button, but rather is dispensed when the user actuates the dosing button. However, in other embodiments, the needle cartridge can be dispensed when one or more loaded springs are released when the user actuates the dosing button.

Claims

**Claim 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 and configured to be manually actuated to load the one or more springs using work performed by actuation of the load button, a dosing button coupled to the housing and 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, operate the pump to pump the drug fluid from the drug reservoir through the driven needle assembly, and retract the driven needle assembly from the injection position to the retracted position, **Claim 2** The device of claim 1, further comprising the drug fluid contained within the drug reservoir. **Claim 3** The device according to any one of claims 1-2, wherein the needle assembly includes a first needle assembly of a plurality of needle assemblies, and the plurality of needle assemblies are disposed within a needle cartridge within the housing. **Claim 4** The device of claim 3, wherein actuation of the load button advances the needle cartridge such that a second needle assembly of the plurality of needle assemblies is moved out of alignment with the drive member and the first needle assembly is moved into alignment with the drive member. **Claim 5** The device according to any one of claims 1-4, further comprising an unlock button configured to prevent actuation of the dosing button until the unlock button is moved to an unlocked configuration. **Claim 6** The one or more springs comprise one or more linear springs movable between an axially expanded configuration and an axially compressed configuration, and 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. The operation of the dosing button after the operation of the load button moves the one or more linear springs to a configuration extended in the axial direction, and operates the drive member to release the one or more linear springs, according to any one of claims 1 to 5.

7. The one or more springs comprise one or more clock springs movable between a wound-up configuration and a wound configuration, The operation of the load button loads the one or more clock springs by moving the one or more clock springs to the wound configuration using the work done by the operation of the load button, The operation of the dosing button after the operation of the load button moves the one or more clock springs to the wound-up configuration and drives the pump to release the one or more clock springs, according to any one of claims 1 to 6.

8. The one or more springs comprise a first linear spring and a second linear spring, each movable between an axially extended configuration and an axially compressed configuration, The device further comprises a primary slide and a secondary slide, The primary slide is configured to be slidably movable parallel to the linear axis of the device between a first primary slide position and a second primary slide position, The secondary slide is configured to be slidably movable parallel to the linear axis between a first secondary slide position and a second secondary slide position, The primary slide is coupled to the first linear spring, The secondary slide is coupled to both the first linear spring and the second linear spring, The device further comprises 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 operation of the load button moves the secondary slide from the first secondary slide position to the second secondary slide position, moving both the first linear spring and the second linear spring to the axially compressed configuration, After the operation of the load button, the operation of the dosing button enables the release of the blocker and allows the first linear spring to move to a configuration where it is expanded in the axial direction. The 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 the movement of the primary slide to the second primary slide position actuates the drive member. The device according to any one of claims 1 to 7.

9. 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 the operation of the load button until it is released. The latch is configured to be released after a predetermined time after the blocker is released so as to allow the second linear spring to move to a configuration where it is expanded in the axial direction. The 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. The device according to claim 8.

10. The primary slide and the secondary slide are coupled, and the movement of the secondary slide from the second secondary slide position to the first secondary slide position causes the primary slide to move from the second primary slide position to the first primary slide position. The movement of the primary slide to the first primary slide position retracts the driven needle assembly from the injection position to the retracted position. The device according to claim 9.

11. The device is a reusable device, enabling 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. Then, after the second actuation of the load button, a second actuation of the dosing button is enabled, configured to deliver a second dose of the pharmaceutical fluid. The device according to any one of claims 9 to 10.

12. Further comprising a clock spring rotatable between a wound-back configuration and a wound configuration, a face gear rotatably locked by the clock spring, and a pawl configured to engage with the face gear. Actuation of the 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 its wound configuration. The pawl engages the face gear after rotation of the clock spring to its wound configuration and is configured to prevent rotation of the face gear in a second rotational direction opposite the first rotational direction and to prevent rotation of the clock spring to its unwound configuration. Actuation of the dosing button after actuation of the load button disengages the pawl from the face gear and enables rotation of the face gear in the second rotational direction, and rotation of the face gear in the second rotational direction rotates the clock spring to its unwound configuration. Rotation of the face gear in the second rotational direction at a predetermined rotation angle of the face gear releases a latch and enables movement of the second linear spring to a configuration in which it expands in the axial direction, and movement of the second linear spring to its axially expanded configuration moves the secondary slide from the second secondary slide position to the first secondary slide position. The device according to any one of claims 9 to 11.

13. The device according to any one of claims 1 to 12, wherein the pump is a rotary plunger pump.

14. The device according to any one of claims 1 to 13, wherein the device is configured to operate the drive member to drive the pump and retract the driven needle assembly using only energy released from the one or more loaded springs.

15. A method for operating a drug delivery device, Actuating a load button of the device to load one or more springs of the device using work performed by actuation of the load button; Actuating a dosing button of the device after actuating the load button to release the one or more loaded springs, wherein releasing the one or more loaded springs Operates a drive member of the device to drive a needle assembly within the device from a retracted position to an injection position. Drive the pump of the device to pump the drug fluid from the drug reservoir through the driven needle assembly and Retract the driven needle assembly from the injection position to the retracted position, the method comprising: **Claim 16** The method according to claim 15, wherein the drug reservoir is disposed within the device and contains a drug fluid. **Claim 17** The method according to any one of claims 15 to 16, wherein the needle assembly is a first needle assembly of a plurality of needle assemblies, and the plurality of needle assemblies are disposed within a needle cartridge. **Claim 18** The method according to claim 17, further comprising advancing the needle cartridge in response to actuation by a user of the load button, such that a second needle assembly of the plurality of needle assemblies is displaced out of operative alignment with the drive member and the first needle assembly is displaced into operative alignment with the drive member. **Claim 19** The method according to any one of claims 15 to 18, further comprising actuating an unlock button of the device to unlock the dosing button for actuation. **Claim 20** The method according to any one of claims 15 to 19, wherein the drive member is actuated to drive the pump and retract the driven needle assembly using only energy released from the one or more loaded springs. **Claim 21** A needle insertion mechanism for a drug delivery device, comprising: A drive member; A needle assembly disposed at a retracted position within a housing of the drug delivery device; A primary linear spring; A secondary linear spring; A primary slide configured to be slidably movable parallel to a linear axis of the device between a first primary slide position and a second primary slide position, the primary slide being coupled to the first linear spring; A secondary slide configured to be slidably movable parallel to the linear axis of the device between a first secondary slide position and a second secondary slide position, the secondary slide being coupled to the first linear spring and the second linear spring; A blocker configured to prevent the primary slide from moving from the first primary slide position to the second primary slide position until released. A loading button configured to be manually actuated to move the secondary slide from the first secondary slide position to the second secondary slide position using the work done by actuating the loading button to compress both the first linear spring and the second linear spring. A dosing button configured to be manually actuated after actuation of the loading button to release the blocker and enable the primary slide to move from the first primary slide position to the second primary slide position under the biasing pressure from the compressed first linear spring, wherein the movement of the primary slide to the second primary slide position operates the drive member to drive the needle assembly from the retracted position to the injection position. The needle insertion mechanism comprises the dosing button. **Claim 22** 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 loading button until it is released. The mechanism according to claim 21, wherein the latch is released at a predetermined time after the release of the blocker to enable the secondary slide to move from the second secondary slide position to the first secondary slide position under the biasing pressure from the compressed second linear spring. **Claim 23** The mechanism according to claim 22, wherein the primary slide and the secondary slide are coupled, and movement of the secondary slide from the second secondary slide position to the first secondary slide position causes the primary slide to move 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 driven needle assembly from the injection position to the retracted position. **Claim 24** The device further comprises a clock spring rotatable between a wound configuration and a rewound configuration, a face gear rotatably locked by the clock spring, and a pawl configured to engage the face gear. Actuation of the loading 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. The claw is configured to engage the face gear after rotation to the wound configuration of the clock spring, prevent the face gear from rotating in a second rotation direction opposite to the first rotation direction, and prevent the clock spring from rotating to the unwound configuration. Actuation of the dosing button after actuation of the load button disengages the claw from the face gear, allows the face gear to rotate in the second rotation direction, and rotation of the face gear in the second rotation direction rotates the clock spring to the unwound configuration. The mechanism according to any one of claims 22 to 23, wherein rotating the face gear in the second rotation direction by a predetermined rotation angle releases the latch and allows the secondary slide to move from the second secondary slide position to the first secondary slide position under the biasing pressure from the compressed second linear spring.

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 a first primary slide position to a second primary slide position until released. Actuating a load button of the device to move the secondary slide from a first secondary slide position to a second secondary slide position, the movement of the secondary slide being actuated to axially compress both the first linear spring and the second linear spring. After actuating the load button, releasing the blocker and actuating a dosing button of the device to move the primary slide from a first primary slide position to a second primary slide position under the biasing pressure from the compressed first linear spring, the movement of the primary slide to the second primary slide position being actuated to operate a drive member and drive a needle assembly disposed within the device from a retracted position to an injection position.

26. 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 the user actuates the load button until it is released. The method according to claim 25, further comprising releasing the latch at a predetermined time after release of the blocker, enabling the secondary slide to move from the second secondary slide position to the first secondary slide position under the biasing pressure from the compressed second linear spring.

27. The primary slide and the secondary slide are coupled, and movement of the secondary slide from the second secondary slide position to the first secondary slide position causes the primary slide to move 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 driven needle assembly from the injection position to the retracted position. The method according to claim 26.

28. The needle handling mechanism further comprises a clock spring, a face gear coupled to the clock spring, and a pawl configured to engage the face gear. During actuation of the load button, loading the clock spring by rotationally winding the face gear and the clock spring in a first rotational direction using the work performed by actuation of the load button. After loading the clock spring, engaging the pawl with the face gear and rotating in a second rotational direction opposite to the first rotational direction to prevent the clock spring from unwinding. During actuation of the dosing button, disengaging the pawl from the face gear and rotating in the second rotational direction to enable the clock spring to unwind. When the clock spring unwinds by a predetermined rotation angle, releasing the latch to enable the secondary slide to move from the second secondary slide position to the first secondary slide position under the biasing pressure from the compressed second linear spring. The method according to any one of claims 25 to 27.

29. A device for storing and handling a needle, comprising: a housing; a drive member; A needle cartridge that holds a plurality of needle assemblies, each needle assembly being disposed in a separate retracted position within the needle cartridge, a cartridge; one or more springs; A load button coupled to the housing, manually actuated to load the one or more springs and advance the needle cartridge using the work done by actuation of the load button, so that the first needle assembly of the plurality of needle assemblies is moved out of alignment with the drive member and the second needle assembly of the plurality of needle assemblies is moved into alignment with the drive member, a load button; A dosing button coupled to the housing, manually actuated after actuation of the load button to release the one or more loaded springs, operate the drive member, and drive the second needle assembly from its retracted position within the needle cartridge to an injection position, a dosing button, a device comprising.

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

31. The needle cartridge includes a plurality of Geneva wheel members; The device further comprises a Geneva wheel configured to engage the Geneva wheel members; The Geneva wheel is configured to rotate in response to actuation of the load button, and the engagement between the Geneva wheel and the Geneva wheel members rotates the needle cartridge, so that the first needle assembly is moved out of alignment with the drive member and the second needle assembly is moved into alignment with the drive member, the device according to any one of claims 29 to 30.

32. The device according to any one of claims 29 to 31, further comprising a drug reservoir configured to contain a drug fluid and a pump in fluid communication with the drug reservoir.

33. The device according to claim 32, wherein after the device operates the drive member to drive the second needle assembly to the injection position, the device drives the pump and uses the energy released from the one or more springs to pump the drug fluid from the drug reservoir through the second needle assembly.

34. The device according to any one of claims 32 to 33, wherein the pump is a rotary plunger pump.

35. The device according to any one of claims 29 to 34, further comprising the unlocking button configured to prevent the operation of the dosing button until the unlocking button is moved to the unlocking configuration.

36. The device according to any one of claims 29 to 35, wherein the device is configured to operate the drive member using only the energy released from the one or more loaded springs.

37. The device according to any one of claims 30 to 35, wherein the device is configured to operate the drive member using only the energy released from the one or more loaded springs to retract the second needle assembly.

38. The device according to any one of claims 33 to 35, wherein the device is configured to operate the drive member using only the energy released from the one or more loaded springs to drive the pump.

39. A method for operating a drug delivery device comprising one or more springs, a loading button, a dosing button, a drive member, and a needle cartridge holding a plurality of needle assemblies, each needle assembly being disposed in a retracted position within the needle cartridge, the method comprising: actuating a loading button of the device; using the work performed by the actuation of the loading button to advance the needle cartridge such that a first needle assembly of the plurality of needle assemblies is moved out of alignment with the drive member and a second needle assembly of the plurality of needle assemblies is moved into alignment with the drive member; and actuating to load the one or more springs using the work performed by the actuation of the loading button. To release the one or more loaded springs, after actuation of the loading button, actuating the dosing button of the device, thereby releasing the one or more loaded springs and using the 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 the injection position, the method comprising: actuating.

40. Releasing the one or more loaded springs uses the 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. The method according to claim 39.

41. The needle cartridge comprises a plurality of Geneva wheel members. The device further comprises a Geneva wheel configured to engage with the Geneva wheel member. The Geneva wheel rotates in response to actuation of the loading button, and the engagement between the Geneva wheel and the Geneva wheel member rotates the needle cartridge, whereby the first needle assembly is moved out of alignment with the drive member and the second needle assembly is moved into alignment with the drive member. The method according to any one of claims 39 to 40.

42. The device further comprises a drug reservoir configured to contain a drug fluid and a pump in fluid communication with the drug reservoir. The method according to any one of claims 39 to 41.

43. Releasing the one or more loaded springs drives the pump and uses the energy released from the one or more loaded springs to pump the drug fluid from the drug reservoir through the second needle assembly. The method according to claim 42.

44. The method according to any one of claims 42 to 43, wherein the pump is a rotary plunger pump.

45. The method according to any one of claims 39 to 44, further comprising actuating an unlock button to unlock the dosing button.

46. Only the energy released from the one or more loaded springs is used to operate the drive member. The method according to any one of claims 39 to 45.

47. The method according to any one of claims 40 to 45, 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.

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

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, configured to be manually actuated, using the work performed by the actuation of the loading button to load the one or more springs, advancing the needle cartridge such 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 the dosing position; 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 the pump and pump the drug fluid from the drug reservoir through the second needle assembly.

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

51. The device according to claim 50, further configured to retract the second needle assembly to the dosing position using the energy released from the one or more springs after the device has operated the drive member to drive the second needle assembly to the injection position.

52. The device according to any one of claims 49 to 51, wherein the pump is a rotary plunger pump.

53. The device according to any one of claims 49 to 52, further comprising the unlocking button configured to prevent the operation of the dosing button until the unlocking button is moved to the unlocking configuration.

54. The one or more springs comprise one or more clock springs movable between a wound configuration and an unwound configuration, actuating the loading button loads the one or more clock springs by moving the one or more clock springs to the wound configuration using the work done by the actuation of the loading button, actuating the dosing button after actuating the loading button releases the one or more clock springs by moving the one or more clock springs to the unwound configuration to drive the pump, the device according to any one of claims 49 to 53.

55. The one or more springs each comprise one or more linear springs movable between an axially expanded configuration and an axially compressed configuration, actuating the loading button moves the one or more linear springs to the axially compressed configuration using the work done by the actuation of the loading button, actuating the dosing button after actuating the loading button releases the one or more linear springs by moving the one or more linear springs to the axially expanded configuration to operate the drive member, the device according to any one of claims 50 to 54.

56. The device according to any one of claims 49 to 55, configured to drive the pump using only the energy released from the one or more loaded springs.

57. The device according to any one of claims 50 to 55, configured to drive the pump and operate the drive member using only the energy released from the one or more loaded springs.

58. The device according to any one of claims 51 to 55, configured to drive the pump, operate the drive member, and retract the second needle assembly using only the energy released from the one or more loaded springs.

59. A method for operating a drug delivery device, comprising: actuating a loading button of the device, Advance the needle cartridge of the device using the work done through the actuation of the load button, such that a first needle assembly of a plurality of needle assemblies stored within the needle cartridge is moved out of a dosing position within the device and a second needle assembly of the plurality of needle assemblies is moved to the dosing position, and Actuate using the work done by the actuation of the load button to load one or more springs within the device, Actuate the dosing button of the device after actuation of the load button to release the one or more loaded springs and drive a pump using the energy released from the one or more loaded springs to pump a drug fluid from a drug reservoir of the device through the second needle assembly, a method comprising.

60. The device further comprises a drive member, The dosing position is in operational alignment with the drive member, The method according to claim 59, wherein releasing the one or more loaded springs operates the drive member to drive the second needle assembly to an injection position.

61. The method according to claim 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.

62. The method according to any one of claims 59 to 61, wherein the pump is a rotary plunger pump.

63. The method according to any one of claims 59 to 62, further comprising actuating an unlock button to unlock the dosing button.

64. The one or more springs comprise one or more clock springs, Loading the one or more springs includes rotationally winding the one or more clock springs, The method according to any one of claims 59 to 63, wherein releasing the one or more loaded springs enables unwinding the one or more clock springs and driving the pump using the energy released by the one or more unwound clock springs.

65. The one or more springs comprise 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 enables the one or more linear springs to expand and uses the energy released by the one or more expanding linear springs to operate the drive member, the method according to any one of claims 60 to 64. **Claim 66** The method according to any one of claims 59 to 65, wherein only the energy released from the one or more loaded springs is used to drive the pump. **Claim 67** The method according to any one of claims 60 to 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. **Claim 68** The method according to any one of claims 61 to 65, wherein only the energy released from the one or more loaded springs is used to drive the pump, to operate the drive member, and to retract the second needle assembly.

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