Medication delivery device with medication cartridge and needle assembly

Abstract

Embodiments of the present disclosure relate to a medication delivery device. The medication delivery device includes: a housing comprising a proximal end, a distal end, and a portion extending between the proximal end and the distal end that comprises an outer surface; a cartridge assembly configured to hold a fluid, wherein the cartridge assembly is disposed at least partially in a first recess in the outer surface of the portion of the housing extending between the proximal end and the distal end; and a needle assembly comprising: a needle assembly housing; and a needle, wherein: the needle assembly is disposed at least partially in a second recess in the portion of the housing extending between the proximal end and the distal end, and at least a portion of the needle is configured to extend through a septum of the cartridge assembly.

Description

MEDICATION DELIVERY DEVICE WITH MEDICATION CARTRIDGE AND NEEDLE ASSEMBLYFIELD OF THE DISCLOSURE

[0001] The present disclosure relates generally to fluid delivery devices, such as injection devices. More specifically, the present disclosure relates to a needle assemblies of fluid delivery devices.BACKGROUND

[0002] Conventional injection devices are often used to inject a medication into a patient via a needle. It is sometimes advantageous for the medication to be administered without the presence of a medical professional, such as when the medication is to be administered frequently (e.g., daily at different times during each day). However, it may be a challenge to ensure that needles are maintained in a sterile environment prior to use in injections, as well to ensure that the medication is administered safely, efficiently, and in a proper amount. Furthermore, some patients are uncomfortable with seeing or directly handling needles.SUMMARY

[0003] According to an exemplary embodiment of the present disclosure, a medication delivery device is provided. The medication delivery device includes: a housing comprising a proximal end, a distal end, and a portion extending between the proximal end and the distal end that comprises an outer surface; a cartridge assembly configured to hold a fluid, wherein the cartridge assembly is disposed at least partially in a first recess in the outer surface of the portion of the housing extending between the proximal end and the distal end; and a needle assembly comprising: a needle assembly housing; and a needle, wherein: the needle assembly is disposed at least partially in a second recess in the portion of the housing extending between the proximal end and the distal end, and at least a portion of the needle is configured to extend through a septum of the cartridge assembly.

[0004] According to an exemplary embodiment of the present disclosure, a needle assembly is provided. The needle assembly includes: a housing; a connector portion extending from the housing, wherein the connector portion is configured to engage a corresponding portion of a medication delivery device housing; a needle; a needle support coupled to the needle and disposed in the housing; and a driven member disposed at least partially in the housing andconfigured to be driven to move the needle support to move to and from an extended configuration, in which fluid may be transferred through the needle, and a compact configuration, in which fluid may not be transferred through the needle.

[0005] According to an exemplary embodiment of the present disclosure, a method of assembling a medication delivery device is provided. The medication delivery device includes a housing, a cartridge assembly, and a needle assembly. The method includes: inserting the cartridge assembly at least partially into a first recess in an outer surface of a portion of the housing, the portion of the housing extending from a proximal end of the housing to a distal end of the housing; and after inserting the cartridge assembly, inserting the needle assembly at least partially into a second recess in the outer surface of the portion of the housing such that a portion of the needle assembly covers at least a portion of the cartridge assembly.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Various aspects, techniques, and embodiments of the present technology disclosed herein are described below with reference to the accompanying drawings. It should be appreciated that the figures are not necessarily drawn to scale. Items appearing in multiple figures may be indicated by the same reference numeral. For purposes of clarity, not every component may be labeled in every figure. Features of the present technology will become more apparent and techniques for how to attain the features of the present technology will be better understood by reference to the following detailed description considered in conjunction with the accompanying drawings, wherein:

[0007] FIG. 1A shows a perspective view of a cartridge assembly partially inserted in a housing of a medication delivery device.

[0008] FIG. IB shows a perspective view of a partially assembled medication delivery device including the cartridge assembly and housing of FIG. 1 A.

[0009] FIG. 1C shows a perspective view of a needle assembly and the partially assembled medication delivery device of FIG. IB.

[0010] FIGs. ID, IE, IF, and 1G show views of the assembled medication delivery device.

[0011] FIG. 2A shows a perspective view of a cartridge assembly.

[0012] FIG. 2B shows a perspective view of the cartridge assembly of FIG. 2A in a partially disassembled state.

[0013] FIG. 3A shows a perspective view of a needle assembly.

[0014] FIG. 3B shows a perspective view of the needle assembly of FIG. 3A in a partially disassembled state.

[0015] FIG. 4A shows diagrams of a needle assembly in an initial compact configuration.

[0016] FIG. 4B shows diagrams of the needle assembly of FIG. 4A in an extended configuration.

[0017] FIG. 4C shows diagrams of the needle assembly of FIG. 4A in a retracted configuration.

[0018] FIG. 5 shows a perspective view of a cartridge assembly.

[0019] FIG. 6 shows a perspective view of the cartridge assembly of FIG. 5 in a partially disassembled state.

[0020] FIG. 7A shows a perspective view of a cartridge assembly and a driver gear configured to rotationally drive a portion of the cartridge assembly.

[0021] FIG. 7B shows another perspective view of the cartridge assembly and the driver gear of FIG. 7A.

[0022] FIG. 8 shows a block diagram of a motor assembly comprising a plurality of driver assemblies and a controller for controlling the driver assemblies.

[0023] FIG. 9 shows a side plan view of a needle assembly with a translucent housing.

[0024] FIG. 10 shows a perspective view of a needle assembly showing a needle mechanism.

[0025] FIGs. 11 A and 1 IB show perspective views of a needle mechanism, depicting opposite sides of the needle mechanism.

[0026] FIGs. 12A and 12B show perspective views of a driven member of a needle system, depicting opposite sides of the driven member.

[0027] FIG. 12C shows a side view of a needle mechanism of in a compact configuration.

[0028] FIG. 12D shows a side view of the needle mechanism of FIG. 12C in an extended configuration.

[0029] FIGs. 13A, 13B, and 13C show views of a needle mechanism in a compact standby configuration before use, an extended configuration during use, and a compact retracted configuration after use, respectively.

[0030] FIG. 14 shows a side view of the needle mechanism in the needle assembly in the retracted configuration, after use.

[0031] FIG. 15 shows a cross-sectional side view of a needle mechanism disposed in a housing, with the needle mechanism being in the extended configuration.

[0032] FIG. 16 shows a longitudinal cross section of a portion of a needle mechanism.

[0033] FIG. 17 shows a block diagram of a medication delivery device including a controller, a motor assembly, a cartridge assembly, and a needle assembly.

[0034] FIGs. 18A, 18B, 18C, 18D, 18E, 18F, and 18G show an illustrative process for assembling a needle assembly.DETAILED DESCRIPTION

[0035] Provided herein are examples of fluid delivery devices (e.g., medication delivery devices), as well as examples of components included in the fluid delivery devices and techniques for assembling fluid delivery devices. As will be appreciated, although some examples of the fluid delivery devices are described herein in connection with administering medication to a patient, such devices are not limited to use in medical applications and may additionally or alternatively be used in other non-medical applications (e.g., where a precise amount of fluid is to be delivered).

[0036] The fluid delivery devices described herein can include multiple components. In some embodiments, the fluid delivery devices include reusable components as well as disposable components. For example, the fluid delivery device can include a reusable housing to which disposable components can be loaded, such as (a) a medication vial or fluid chamber and / or (b) a needle assembly. The inventors have recognized and appreciated that various factors can be important for fluid delivery devices. For example, ease of use of a fluid delivery device can be important for operators of the device. The fluid delivery devices provided herein may enable the side-loading of a medication vial or fluid chamber into a housing of a fluid delivery device, thus facilitating a simple assembly process. Furthermore, when the medication vial or fluid chamber is side loaded into the housing of the fluid delivery device, a label on the medication vial or fluid chamber may be exposed, enabling a user to quickly identify and verify the contents of the fluid delivery device prior to use. Another factor that can be important for fluid delivery devices is user safety. For example, in addition to enabling a user to easily identify a fluid that is being injected, it can be important to prevent a user from reusing the same needle for multiple injections. A needle assembly of the fluid delivery devices provided herein may include a mechanism that prevents it from being reinserted into the fluid delivery device after the needle(s) in the needle assembly have been used, thus preventing a user from reusing the needle(s) for multiple injections.

[0037] FIGs. 1A, IB, and 1C show perspective views of a medication delivery device in partially disassembled states, and FIGs. ID, IE, IF, and 1G show different views of the medication delivery device in an assembled state. The assembled medication delivery device may include housing 150, cartridge assembly 110, and needle assembly 120. The medication delivery device may have a proximal end 160 and a distal end 170.

[0038] As shown in FIG. 1 A, an outer surface of housing 150 may include recess 153 configured to receive the cartridge assembly 110. In some embodiments, the walls of recess 153 are shaped to conform to the cartridge assembly 110. For example, the walls of recess 153 may be at least partially rounded to conform to the rounded shape of the cartridge assembly 110. The rounded walls of recess 153 may assist in quickly positioning the cartridge assembly 110 within recess 153.

[0039] In some embodiments, the housing 150 includes a connector portion 155 positioned within and / or adjacent to recess 153. Connector portion 155 may be configured to engage a corresponding connector portion (not shown) of the cartridge assembly 110 so as to hold the cartridge assembly 110 in place when it is positioned in recess 153, as shown in FIG. IB. The connector portion 155 and the corresponding connector portion of the cartridge assembly 110 may form any suitable connection mechanism such as, for example, a snap mechanism, as aspects of the technology described herein are not limited in this respect. While FIG. 1A shows a single connector portion 155, the housing 150 may include any suitable number of connector portions configured to engage with corresponding connector portions on the cartridge assembly 110, as aspects of the technology described herein are not limited in this respect. For example, the housing 150 may include another connector portion (not shown) positioned directly across from connector portion 155 within and / or adjacent to recess 153.

[0040] As shown in FIGs. 1A and IB, to assemble the medication delivery device (at least partially) the cartridge assembly 110 may be inserted into recess 153 of housing 150. This may include positioning the proximal end of the cartridge assembly 110 against a wall of the recess 153 nearest the proximal end 160 of the medication delivery device, then tipping the remainder of the cartridge assembly 110 into the recess 153 (e.g., by rotating the cartridge assembly 110 around its proximal end). Connector portion(s) on the cartridge assembly 110 may engage connector portion(s) 155, snapping the cartridge assembly 110 into place.

[0041] In some embodiments, the housing 150 additionally, or alternatively, includes one or more indents 151. Indent(s) 151 may be used to assist removal of the cartridge assembly 110 when disassembling the medication delivery device. For example, pressure may be applied to the cartridge assembly 110 to lift it from the housing 150. The indent(s) 151 may expose more surface area of the cartridge assembly 110, making it easier for a user to apply pressure to it (e.g., by pushing on the cartridge assembly 110 using his or her fingers).

[0042] As shown in FIGs. 1A, IB, and 1C, housing 150 may additionally include recess 154 configured to receive a needle assembly 120. The walls of the recess 154 may be configured toconform to the shape of the needle assembly 120. In some embodiments, there is an opening in the wall at the distal end of recess 154 such that a least a side of the needle assembly 120 is exposed at the distal end 170 of the medication delivery device. The exposed side of the needle assembly 120 may include a hole 121 through which a needle may extend. For example, as shown in FIG. 1G, needle portion 123-1 may be configured to extend through hole 121.

[0043] In some embodiments, there is an opening in the wall separating recess 153 from recess 154 that enables at least a portion of the cartridge assembly 1 10 to interact with at least a portion of the needle assembly 120 when the medication delivery device is assembled. For example, as shown in FIG. 1G, needle portion 123-2 may be configured to extend through the septum 114 of the cartridge assembly 110.

[0044] In some embodiments, the housing 150 additionally includes connector portion(s) 152. As shown in FIGs. 1A, IB, and 1C, connector portion(s) 152 may be positioned adjacent to the recess 154 and may extend at least partially around the perimeter of the housing 150. In some embodiments, the connector portion(s) 152 may be configured to engage corresponding connector portion(s) 122 of the needle assembly 120 when the needle assembly 120 is positioned in recess 154. For example, the connector portion(s) 152 may include loop portion(s) 152-1 configured to receive corresponding latch(es) on the connector portion(s) 122. While only one connector portion is shown, it should be appreciated that housing 150 may include one or more other connector portions such as one positioned on the opposite side of housing 150 from the side where connector portion 152 is positioned. For example, the view of the medication delivery device in FIG. IE shows two connector portions 122 of the needle assembly 120 engaging corresponding portions of the housing.

[0045] As shown in FIGs. 1C and ID, to assemble the medication delivery device (at least partially) the needle assembly 120 may be inserted into recess 154 of housing 150. This may include applying pressure to the top surface of the needle assembly 120 to cause the connector portion(s) 152 to engage the corresponding connector portion(s) 122 of the needle assembly 120, thereby snapping the needle assembly into place. In some embodiments, the connector portion(s) 122 are configured to disengage from the corresponding connector portion(s) 152 in response to pressure applied to the connector portion(s) 122.

[0046] In some embodiments, when the medication delivery device is assembled, as shown in FIGs. ID, IE, IF, and 1G, at least a portion of the needle assembly 120 is configured to extend over at least a portion of the cartridge assembly 110. This may help to hold the cartridge assembly 110 in place when the connection mechanism holding the needle assembly 120 inrecess 154 is stronger than the connection mechanism holding the cartridge assembly 110 in recess 153.

[0047] FIG. 2A and FIG. 2B show cartridge assembly 110 in an assembled state and a partially disassembled state, respectively. The cartridge assembly 110 may include cartridge 113, drive assembly 115, and housing 112. Additionally, the cartridge assembly 110 may include label 111. Examples of cartridge assemblies are described herein including at least with respect to FIGs. 5- 8. Although cartridge assemblies are described herein, other medication containers may be used such as septum syringes, stake-needled syringes, and other glass or polymer containers. Thus, the term “cartridge” is inclusive of these other medication containers.

[0048] The cartridge 113 may be configured to hold a fluid (e.g., a liquid medication) therein. The fluid may be confined to a fluid chamber 117 delimited by a piston 116 configured to seal a proximal opening of the cartridge 113 and delimited by a septum 114 configured to seal a distal opening of the cartridge 113. In some embodiments, the piston 116 may be configured to provide a movable seal against an internal surface of the cartridge 113, to prevent the fluid in the fluid chamber 117 from leaking out of a proximal end of the fluid chamber 117 even during movement of the piston 116 along the internal surface of the cartridge 113. The septum 114 may be formed of a self-sealing material (e.g., an FDA-rated elastomeric material such as medical-grade silicone, medical-grade ethylene propylene diene monomer (EPDM), and the like) that may be pierced by a piercing object of the needle system during an injection process, to enable the fluid in the fluid chamber 117 to flow out of the fluid chamber 117 during the injection process, and that may reseal to provide a fluid-tight seal after the piercing object is retracted from the septum 114. In some embodiments, the retraction of the piercing object out of the septum 114 and the subsequent resealing of the septum 114 may prevent contamination of the fluid remaining in the fluid chamber 117, such that the remaining fluid may be used in future injection processes. In some embodiments, the fluid in the fluid chamber 117 may be sufficient for multiple injections (e.g., multiple doses of medication). An example of cartridge 113 is described herein including at least with respect to cartridge 550 shown in FIGs. 5 and 6.

[0049] Devices according to the present disclosure may carry and dispense one or more liquid medications, which may also be referred to as medications or drugs and maybe held in the fluid chamber 117. Such medications may include, for example, epinephrine, anaesthetics, analgesics, steroids, insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives,combined GIP / GLP-1 agonists such as tirzepatide or retatrutide, basal insulins, such insulin efsitora alfa, oxyntomodulin analogs, oxyntomodulin derivatives, and other treatments for diabetes and / or obesity, such as with lepodisiran (LPA siRNA), volenrelaxin, amylin agonist long acting, PNPLA3 siRNA, AP0C3 siRNA, DACRA qw II, GIPR agonist long acting, glucose sensing insulin receptor agonist, nisotirostide, bimagrunab, NRG4 agonist, SCAP siRNA, mazdutide, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mirikizumah that can be used for treatment of Crohn’s disease or ulcerative colitis, IL- 17 antibody analogs or derivatives, such as ixekizumab that can be used for treatment of plaque psoriasis, IL- 13 antibody analogs or derivatives, such as lebrikizumab that can be used for treatment of atopic dermatitis, therapeutic agents for pain-related and / or migraine treatments, such as galcanezumab or lasmiditan, or for treatment of atopic dermatitis, such as with lebrikizumab ucenprubart, for treatment of Alzheimer’ s and / or dementia, such as with donanemab, remternetug, or GRN gene therapy, for treatment of Parkinson’s disease and / or Gaucher’s disease, such as with GBA1 gene therapy, for treatment of Hidradenitis Suppurativa, such as with eltrekibart, for treatment of rheumatoid arthritis, such as with peresolimab, and any therapeutic agent, such as with CD19, that is capable of delivery by the devices described herein. Devices according to the present disclosure may be operated in a manner generally as described herein by a user (for example, a healthcare professional, a caregiver, or another person) to deliver one or more medications to a patient (for example, another person or the user).

[0050] The label 111 may include information about the medication delivery device, the fluid held within cartridge 113, and / or any other suitable information, as aspects of the technology described herein are not limited in this respect. The label 111 may display the information in writing and / or graphics. Additionally, or alternatively, the label 111 may be a smart label configured to transmit the information to an electronic device (e.g., a mobile device) and / or configured to cause the electronic device to access the information. For example, the smart label may include a quick-response (QR) code that, when scanned, may cause the electronic device to access a webpage and / or launch an app that displays the information. Additionally, or alternatively, the smart label may include a near-field communication (NFC) tag and / or radio frequency identification (RFID) tag that is configured to transmit the information to the electronic device when read by a corresponding reader.

[0051] The cartridge 113 may be held in a housing 112 of the cartridge assembly 110. In some embodiments, portions of the internal surface of the housing 112 may serve as spacers that keep the cartridge 113 at a predetermined position in a cartridge chamber of the housing 112. In someembodiments, when the cartridge 113 is fully inserted in the cartridge chamber, the septum 114 may extend out of a distal end of the housing 112, such that the septum 114 may be positioned in a recess of the needle system. An example of housing 112 is described herein including at least with respect to housing 502 shown in FIGs. 5 and 6.

[0052] The drive assembly 115 may be configured to drive movement of the piston 116 to eject the fluid in the fluid chamber 117 out of the distal end of the cartridge 113. The drive assembly1 15 may be referred to as a “driven” assembly because the drive assembly 115 may itself be driven to move and, in turn, may convert a received drive force to a force that causes the piston116 to move along an axis of the cartridge assembly 110. An example drive assembly 600 is described herein including at least with respect to FIGs. 5 and 6.

[0053] FIG. 3A and FIG. 3B show needle assembly 120 in an assembled state and a partially disassembled state, respectively. As shown in FIG. 3B, the needle assembly 120 may include at least part of a needle mechanism that includes driven member 128, needle connector 129, septum needle 130-1, injection needle 130-2, septum-needle support 127-1, and injection-needle support 127-2. The needle mechanism components may be enclosed, at least partially, between upper housing 126-1 and lower housing 126-2, which together may define the housing of the needle assembly. Additionally, a label 125 may be affixed to the upper housing 126-1. Example aspects of a needle assembly are described herein including at least with respect to FIGs. 9-16. In some embodiments, the needle assembly 120 is shown without any seals or foils for sterilization. The components and arrangement of the needle assembly 120 allows it to be assembled without seals, foils, and / or O-rings, and can be assembled sterile-packed prior to sterilization. As discussed later, seals, foils, and / or O-rings may be included in the needle assembly 120 to maintain sterile conditions for the components.

[0054] In some embodiments, the needle mechanism includes the injection-needle support 127-2 and the septum-needle support 127-1, which generally may be positioned relative to a common plane, and which may be slidably coupled to one another via the driven member 128. In some embodiments, the driven member 128 may be positioned on a first side of the common plane and the supports 127-1, 127-2 may be positioned on a second side of the common plane opposite the first side. The supports 127-1, 127-2 may have engagement portions configured to engage with the driven member 128 to move the supports 127-1, 127-2 in opposite directions such that the septum and injection needles 130-1, 130-2 may move in opposite directions. In some embodiments, the supports 127-1, 127-2 may be sized and shaped to fit within a housing 126-1, 126-2 of the needle assembly 120, as shown in FIGs. 3A and 3B, and may be configured tomove within the housing 126-1, 126-2 to move the injection needle 130-2 and the septum needle 130-1 to and from an extended configuration, in which the needles 130-2, 130-1 extend at least partially outside of the housing 126-1, 126-2, and at least one compact configuration (e.g., a preinjection standby configuration, a post-injection retracted configuration), in which the needles 130-1, 130-2 are within the housing 126-1, 126-2. Examples of extended and compact configurations are shown in FIGs. 4A-4C.

[0055] According to some embodiments of the present technology, the needle mechanism may comprise a rack-and-pinion configuration, in which the supports 127-1, 127-2 may include first and second racks with engagement portions, and in which the driven member 128 may include a pinion gear configured to mo v ably interact with the engagement portions of the racks to move the racks in opposite directions. Examples of a rack-and-pinion configuration are described herein including at least with respect to FIGs. 11A-11B. As will be appreciated, although the engagement portions of the driven member 128 are shown to be teeth of a pinion gear, and although the supports 127-1, 127-2 are shown to have engagement portions that are teeth configured to engaged with the teeth of the pinion gear, in some embodiments the driven member 128 and the supports 127-1, 127-2 may have other movement structures configured to interact with each other to move the injection and septum needles 130-2, 130-1 in opposite directions. For example, such a movement structure may comprise a threaded screw and / or a zip chain and / or another structure having complementary portions.

[0056] For the sake of simplicity, FIG. 3B may be considered to show an embodiment of a front side of the needle mechanism, while the rear side of the needle mechanism is not shown. It should be understood, however, that the terms “front” and “rear” do not indicate required orientations of the features described for the needle mechanism. In some embodiments, a rear side of the driven member 128 may comprise an actuating member (not shown), which may be configured to engage with a driver (e.g., driver 124 shown in FIG. 1G) of a medication delivery device or a rib of the housing. For example, when the needle mechanism is in an activated position such as when properly loaded into housing 150, the actuating member of the driven member 128 may be engaged by the driver such that rotation of the driver may cause rotation of the actuating member, which in turn may cause rotation of the driven member 128 (e.g., the engagement portions of the pinion gear of the driven member 128). Alternatively, when the needle mechanism is not in the activated position, the actuating member of the driven member 128 may be engaged by a rib of the housing such that rotation of the actuating member may be prevented. For example, the actuating member may comprise slot-shaped recess configured toslide along the rib when not in the activated position and, when in the activated position, to engage with a bar-shaped protrusion of the driver. In some embodiments, the actuating member may comprise a plurality of recesses (e.g., see the indentations or recesses 820a” in FIG. 9) configured to engage with a plurality of complementary protrusions of a driver (e.g., a shaft head). For example, the actuating member may comprise recesses of a specific size and / or a specific shape and / or a specific number that may be driven when the driver has protrusions that are complementary, such that the complementary protrusions may serve as a key structure to engage with and drive the actuating member. In some embodiments, one side of the actuating member may comprise the slot-shaped recess to engage with the rib when not in the activated position, and another side of the actuating member may comprise one or more shaped recesses configured to be driven by the driver with the complementary protrusions (i.e., the key structure).

[0057] The label 125 may include information about the needle assembly 120, the medication delivery device(s) with which the needle assembly 120 is to be used, the cartridge assembly or assemblies with which the needle assembly 120 is to be used, and / or any other suitable information, as aspects of the technology described herein are not limited in this respect. The label 125 may display the information in writing and / or graphics. Additionally, or alternatively, the label 125 may be a smart label configured to transmit the information to an electronic device (e.g., a mobile device) and / or configured to cause the electronic device to access the information. For example, the smart label may include a quick- response (QR) code that, when scanned, may cause the electronic device to access a webpage and / or launch an app that displays the information. Additionally, or alternatively, the smart label may include a near-field communication (NFC) tag and / or radio frequency identification (RFID) tag that is configured to transmit the information to the electronic device when read by a corresponding reader.

[0058] FIGs. 4A, 4B, and 4C show examples of a needle assembly in different configurations. FIG. 4A shows a needle mechanism in an initial compact configuration. For example, the needle mechanism may be in the initial compact configuration prior to use during an injection event. As shown in FIG. 4A, the slot-shaped recesses of the actuating member 403 are aligned with protrusions 402 of a driver 712. The needles 401-1, 401-2 are positioned within housing 406 and are connected by needle connector 410.

[0059] Each of the needle supports 405-1, 405-2 can include a mechanical stop (also referred to as a stopping portion) (shown as 414-1, 414-2, respectively). The stopping portions 414-1, 414-2 may be a ramped protrusion extending away for the body of the needle support toward the axis.The stopping portions 414-1, 414-2 are configured to engage corresponding mechanical stops, referred to as stopping portions, 412-1, 412-2 of the housing 406. As shown, the stopping portions 414-1, 414-2 are disposed toward the ends of the housing during injection (shown to the left of stopping portion 412-1 and to the right of stopping portion 412-2, respectively, in the figures). The stopping portions 412-1, 412-2 may be a ramped protrusion extending away for an inner wall of the housing 406 and away from axis toward the stopping portions 414-1, 414-2. The shape of the ramped portions of each of the stopping portions 414- 1 , 414-2 and the stopping portion 412-1, 412-2 can facilitate movement of the needle supports in a first direction as the stopping portions of the corresponding needle support and the housing slidably engage one another, and inhibit movement of the needle supports in an opposite, second direction as the stopping portions of the corresponding needle support and the housing (as shown in FIG. 4C). FIG. 4A show the stopping portions 414-1 of the needle support 405-1 on the axially outer side (relative to the driven member 408) of the corresponding stopping portions 412-1, or the unlocked configuration, and the same for the needle support 405-2. Driven member 408 may have a detent mechanism to fix its angular orientation relative to the housing that surround the driven member 408 so that during handling the needle supports remain in an initial position prior to use. In one embodiment, an outer circumference of the driven member 408 may have a radial protrusion that resides initially within recess formed in the housing. The driver 712 can apply a torque force to overcome the mechanical interference fit of the detent mechanism.

[0060] During an injection, the needle mechanism may be moved from the initial compact configuration to an extended configuration. As shown in FIG. 4B, the protrusions 402 of the driver 712 (Fig. 8) may engage with the slot-shaped recesses of the actuating member 403, and rotation of the driver 712 may cause the driven member 408 to rotate. Rotation of the driven member 408 causes the needle supports 405-1, 405-2 and the corresponding needles 401-1, 401- 2 to move in opposite directions along parallel axes to the extended configuration. As shown in FIG. 4B, needles 401-1, 401-2 each extend at least partially outside of housing 406. Needle connector 410 extends to maintain the connection between the needles 401-1, 401-2 in the extended configuration. During movement, the back surface 407-1, 407-2 of the needle supports are configured to slide along a first rail wall 409- 1 , 409-2 defined along an interior of the housing 406. A second rail wall 411-1, 411-2 can extend along the axis, along which the needle hub portion of the respective needle supports 405-1, 405-2 is configured to slide along. The corresponding first rail wall and the second rail wall (e.g., 409-1, 411-1) may be radially offset from one another to define a longitudinal channel therebetween, through which thecorresponding stopping portion 414-1, 414-2 is disposed (as shown in FIG. 4C). The stopping portion 412-1, 412-2 can be located along the inner wall of the second rail wall. The rail walls may have a lubricant or made from a lubricious material do facilitate sliding. The rail walls can be configured to provide consistent movement of the needle supports.

[0061] After the injection, the needle mechanism may be moved from the extended configuration to a subsequent compact configuration. For example, as shown in FIG. 4C, the protrusions 402 of the driver 712 may engage with the slot-shaped recesses of the actuating member 403 causing the driven member 408 to rotate in the opposite direction relative to that shown in FIG. 4B. Rotation of the driven member 408 may cause the needle supports 405-1, 405-2 and corresponding needles 401-1, 401-2 to move in directions towards one another until stopping portions 414-1, 414-2 of the needle supports engage corresponding stopping portions 412-1, 412-2 of the housing 406. Engagement of the stopping portions in the subsequent compact configuration forms a lockout configuration for the needle assembly that prevents the needle supports 405-1, 405-2 and the corresponding needles 401-1, 401-2 from moving back to the extended configuration. As shown, the stopping portions 414-1, 414-2 are disposed toward the middle of the housing after injection (shown to the right of stopping portion 412-1 and to the left of stopping portion 412-2, respectively, in the figures). Additionally, in the subsequent compact configuration, the slot-shaped recesses of the actuating member 403 no longer align with the protrusions 402 of the driver 712, which also prevents movement of the needle mechanism back to the extended configuration. These features may help to prevent users from reusing a needle that has been contaminated by being exposed outside of housing 406 (e.g., during an injection).

[0062] FIG. 5 shows a perspective view of the cartridge assembly 500 in an assembled state, and FIG. 6 shows a perspective view of the cartridge assembly 500 in a partially disassembled state, according to some embodiments of the present technology. The cartridge assembly 500 may comprise a cartridge 550 configured to hold a fluid (e.g., a liquid medication) therein. The fluid may be confined to a fluid chamber 558 delimited by a piston 556 configured to seal a proximal opening of the cartridge 550 and delimited by a septum 552 configured to seal a distal opening of the cartridge 550. A septum retainer 554 may be coupled to a distal end of the cartridge 550 to hold the septum 552 in place at the distal opening of the cartridge 550. In some embodiments, the piston 556 may be configured to provide a movable seal against an internal surface of the cartridge 550, to prevent the fluid in the fluid chamber 558 from leaking out of a proximal end of the fluid chamber 558 even during movement of the piston 556 along theinternal surface of the cartridge 550. The septum 552 may be formed of a self-sealing material (e.g., an FDA-rated elastomeric material such as medical-grade silicone, medical-grade ethylene propylene diene monomer (EPDM), and the like) that may be pierced by a piercing object of the needle system during an injection process, to enable the fluid in the fluid chamber 558 to flow out of the fluid chamber 558 during the injection process, and that may reseal to provide a fluid- tight seal after the piercing object is retracted from the septum 552. In some embodiments, the retraction of the piercing object out of the septum 552 and the subsequent resealing of the septum 552 may prevent contamination of the fluid remaining in the fluid chamber 558, such that the remaining fluid may be used in future injection processes. In some embodiments, the fluid in the fluid chamber 558 may be sufficient for multiple injections (e.g., multiple doses of medication).

[0063] The cartridge 550 may be held in a housing 502 of the cartridge assembly 500. In some embodiments of the present technology, the housing 502 may have a cylindrical shape, as depicted in FIG. 6, and a plurality of ribs 514 may extend radially from an internal surface of the housing 502. The ribs 514 may serve as spacers that keep the cartridge 550 at a predetermined position in a cartridge chamber 508 of the housing 502. In some embodiments, the ribs 514 may have rib shoulders 514a configured to serve as an axial insertion limit of the cartridge 550 in the housing 502. In some embodiments, when the cartridge 550 is fully inserted in the cartridge chamber 508, an edge at a proximal end of the cartridge 550 may abut the rib shoulders 514a and the cartridge 550 may be radially centered in the cartridge chamber 508. In some embodiments, when the cartridge 550 is fully inserted in the cartridge chamber 508, the septum 552 may extend out of a distal end of the housing 502, such that the septum 552 may be positioned in a recess of the needle system.

[0064] In some embodiments of the present technology, the cartridge assembly 500 may comprise a drive assembly 600 configured to drive movement of the piston 556 to eject the fluid in the fluid chamber 558 out of the distal end of the cartridge 550. The drive assembly 600 may be referred to as a “driven” assembly because the drive assembly 600 may itself be driven to move and, in turn, may convert a received drive force to a force that causes the piston 556 to move along an axis A of the cartridge assembly 500. In some embodiments, the drive assembly 600 may comprise a driven mechanism 602, which may be a drive gear configured to be driven to rotate about the axis A. The driven mechanism 602 may comprise a spindle 602a around which an axially extendible member 606 may be wound. In some embodiments, the axially extendible member 606 may be a ribbon (element 606 may refer to either the axially extendiblemember or the ribbon interchangeably) having a distal end attached to a foot 604. The foot 604 may be configured to rotate relative to the distal end of the rotating ribbon 606. The drive assembly 600 may be configured such that rotation of the driven mechanism 602 causes the ribbon 606 to extend or expand along the axis A when the driven mechanism 602 is rotated in a first direction. In some embodiments, the driven mechanism 602 may cause the ribbon 606 to retract when the driven mechanism 602 is rotated in a second direction opposite to the first direction. As discussed below, when the ribbon 606 is driven to extend, an axial distance between the distal and proximal ends of the ribbon 606 expands or increases, causing the foot 604 to be moved axially. When the foot is in contact with the piston 556, expansion of the ribbon 606 causes the piston 556 to move axially toward the distal opening of the cartridge 550. In some embodiments, precise control of an amount of rotation of the driven mechanism 602 may cause a precise amount of expansion of the ribbon 606 and a precise amount of movement of the piston 556, which in turn may cause a precise amount of fluid to be ejected. Additional ribbon-expansion mechanisms are described in WO2017 / 165154A1, WO2019 / 118626A1, and WO2019 / 112886A1, each of which is incorporated herein by reference in its entirety.

[0065] FIGs. 7A and 7B show perspective views of the cartridge assembly 500 and a driver gear 702 configured to rotationally drive the driven mechanism 602 of the drive assembly 600, according to some embodiments of the present technology. In some embodiments, the driver gear 702 may be included as part of a cassette and may be incorporated in a housing of the cassette. In some embodiments, the driver gear 702 may comprise a disk-shaped body having a driver-gear diameter and gear teeth circumferentially spaced relative to one another along the circumferential edge surface of the disk-shaped body. In some embodiments, the driver gear 702 may comprise a spline shaft 704 extending from an axially facing surface of the driver gear 702. The spline shaft 704 may be configured to fit into the recess 602c in the surface of the driven mechanism 602, and the spline shaft 704 may have teeth configured to engage with the recessed teeth of the recess 602c. The recess 602c and a body of the spindle may have a coaxial relationship along the longitudinal axis A, as shown in FIGs. 7A and 7B. In some embodiments, the driver gear 702 may be a spur-type gear configured to be driven to rotate via a force applied to teeth 702 of the driver gear 702. Rotation of the driver gear 702 may drive rotation of the driven mechanism 602 via the spline shaft 704 of the driver gear 702 and the recess 602c and teeth of the driven mechanism 602. In some embodiments, when the cartridge assembly 500 is inserted into a housing of a cassette, the spline shaft 704 may be located along the longitudinal axis A to facilitate an insertion coupling of the spline shaft 704 with the recess 602c of thecartridge assembly 500, which may be located along the longitudinal axis A. The driver gear 702 and the driven mechanism 602 may be arranged together and may advantageously reduce an amount of thrust experienced by the ribbon 606 and by the cassette. In some embodiments, the driver-gear diameter of the body of the driver gear 702 may be at least greater than a spindlebase diameter of the spindle base of the spindle.

[0066] FIG. 8 shows a block diagram of a motor assembly 50 comprising a plurality of driver assemblies 700, 710, 720 (optional). The motor assembly 50 may be coupled to a controller 750 configured to drive each of the driver assemblies 700, 710, 720. In some embodiments of the present technology, the controller 750 may comprise at least one computer processor (e.g., a CPU) programed to control the driver assemblies 700, 710, 720 individually or in a coordinated manner with each other. In some embodiments, the driver assembly 700 may comprise the driver gear 702, discussed above, for driving rotation of the driven mechanism 602 of the drive assembly 600 for the advancement of the piston to deliver the medication. The driver assembly 700 may comprise a motor 703 configured to cause rotation of the driver gear 702. Similarly, in some embodiments, the driver assembly 710 may comprise the driver gear 712 (also referenced above also as protrusion 402 of driver 712), for driving rotation of the driven member 408 to move needles as described above. The driver assembly 710 may comprise a motor 713 configured to cause rotation of the driver gear 712. In some embodiments where the needle assembly comprises multiple needles sets (not shown in the figures) and a transfer unit configure to move each needle set into position for drug delivery , the optional driver assembly 720 may comprise the driver gear 722 for driving rotation of a transfer gear that activates the transfer unit. The driver assembly 720 may comprise a motor 723 configured to cause rotation of the driver gear 722. In some embodiments, the controller 750 may be provided with an actuator (not shown) that enables a user to initiate an injection process. For example, after the user has placed the cassette in an injection position (e.g., against the user’s own skin surface or against a skin surface of a patient), the user may manipulate the actuator to cause an automated and coordinated movement of any one of or any combination of: (1) operation of driver assembly 710 to cause rotation of the driven member 408 and activate the needle assembly to move from a retracted position to an injection position (with reference to FIGS. 4A-4B) ; (2) operation of the driver assembly 700 to cause movement of the drive assembly 600 to cause movement of the piston 556 towards the septum 552, to eject the fluid in the fluid chamber 558 by a predetermined amount corresponding to, e.g., an amount of rotation of the driven mechanism 602; and (3) operation of driver assembly 710 to cause rotation of the driven member 408 tocause the activated needle to move from the injection position to the retracted position (with reference to FIGS. 4B-4C). In some embodiments, operation of driver assembly 720 may occur between injection events to align an unused needle set for the next injection event.

[0067] According to some embodiments of the present technology, the needle system may be configured to house at least one needle assembly comprising a movable needle mechanism. During dose delivery, the needle mechanism may transition from: (1) a standby configuration, which may be an unextended or compact configuration before injection, to (2) an injection configuration, which may be an extended configuration where medication may be delivered to a patient, to (3) a retracted configuration, which may be an unextended or compact configuration after injection. The standby and retracted configurations may be a same configuration or may be different configurations. In some embodiments, the extended configuration may be a configuration in which the needle mechanism may pierce the septum 552 of the cartridge 550 to couple the needle mechanism to the cartridge 550 such that fluid may flow from the cartridge 550 into the needle mechanism. In some embodiments, the extended configuration may be a configuration in which the needle mechanism may also pierce the skin of the patient to deliver the medication sub-dermally.

[0068] In some embodiments, the needle system may include one or more needle sets in the needle assembly. For example, the needle system may include a plurality of needle sets arranged in a carousel-type structure (not shown). In some embodiments, a needle assembly 800” may be configured for a needle system configured to operate with a single cannula needle and a single septum-piercer needle. FIG. 9 shows a side plan view of the needle assembly 800”. In some embodiments, the needle assembly 800” may be disposed in a housing of the needle system such that a driven member 820” of the needle assembly 800” may be driven directly by a shaft attached to an external motor (not shown) extending through an access opening of the housing. An external side of the driven member 820” may comprise at least one indentation or recess 820a” having an atypical shape and / or may comprise a plurality of indentations or recesses 820a” having atypical shapes and / or atypical arrangements, as shown in FIG. 9. Such indentations or recess(es) 820a” may deter tampering by being difficult to engage using a conventional tool (e.g., a flat-head screwdriver, a butter knife, a fork, etc.). For example, without use of a shaft head having a proper number and a proper arrangement of the indentations or recesses 820a” in the needle assembly 800” shown in FIG. 9, the driven member 820” may not be easily rotated. In this example, the two indentations or recesses 820a” may be engagedusing a shaft head comprising two prongs having complementary shapes and spacings but may not be engaged with a conventional fork.

[0069] Other features of the needle assembly 800” may be the same as or similar to those of the needle assembly 800 described herein and therefore may have common reference numerals. Those features may be understood from the discussions herein for the needle assembly 800.

[0070] FIG. 10 is a perspective view of the needle assembly 800 showing a needle mechanism 810, according to some embodiments of the present technology. In FIG. 10, a housing 801 of the needle assembly 800 appears translucent so that the needle mechanism 810 may be seen. The needle mechanism 810 may have an unextended or compact configuration, in which components of the needle mechanism 810 may be disposed completely in the housing 801 of the needle assembly 800, and an extended configuration, in which portions of one or more components of the needle mechanism 810 may extend beyond the housing 801. In some embodiments, the housing 801 may include an exterior seal 806 and an interior seal 808, to maintain sterile conditions for the components of the needle mechanism 810 when in the compact configuration. In some embodiments, the exterior seal 806 may be positioned at a distal end of the housing 801 and may serve as part of the distal end 802 of the needle assembly 800. In some embodiments, the interior seal 808 may be provided at a proximal end of the housing 801 and may comprise the proximal end 804 of the needle assembly 800.

[0071] The needle mechanism 810 may comprise an injection needle 830, an injection-needle support 840, a septum needle 850, a septum-needle support 860, and a needle connector 870, according to some embodiments of the present technology. In some embodiments, the injection needle 830 may be mounted on and supported by the injection-needle support 840, which may be movably mounted in the housing such that the movement of the injection needle 830 is caused by movement of the injection-needle support 840. In some embodiments, the injection needle 830 may be the cannula needle discussed above and the septum needle 850 may be the septum-piercing needle discussed above. Prior to a dose delivery (i.e., an injection operation), the needle mechanism 810 may be in a standby configuration, which is a compact configuration in which the components of the needle mechanism 810 are completely within the housing 801 and ready for use. In particular, in the standby configuration, a distal end of the injection needle 830 may be within the housing and may face an internal surface of the exterior seal 806. Similarly, in the standby configuration, a proximal end of the septum needle 850 may be within the housing and may face an internal surface of the interior seal 808. During a dose delivery, the needle mechanism 810 may transition from the standby configuration to an injectionconfiguration, which may be an extended configuration in which portions of the needle mechanism 810 may extend outside of the housing. During the transition, the injection needle 830 may move (leftward in FIG. 10) to pierce the exterior seal 806, while the septum needle 850 may move (rightward in FIG. 10) to pierce the interior seal 808 and the septum 552 of the cartridge assembly 500. If the exterior seal 806 is placed against a part of a user to be injected (e.g., the user’s leg), the injection needle 830 may pierce a surface of the part of the user (e.g., skin of the user’s leg) during the transition. The injection needle 830 and the septum needle 850 may be coupled together by a needle connector 870, such that the needles 830, 850 may be in fluid communication (sometimes referred to herein as “fluidly coupled”) with each other. During a dose delivery, fluid may flow from the cartridge assembly 500 through the septum needle 850, through a flow channel or bore of the needle connector 870, and through injection needle 830 to deliver medication sub-dermally into the user. After a dose delivery, the injection and septum needles 830, 850 may be retracted back into the housing such that the needle mechanism 810 may be in a retracted configuration. In some embodiments, the retracted configuration and the standby configuration may be a same compact configuration, and the needles 830, 850 may be reusable if in compliance with product label. In some other embodiments, the retracted configuration may be different from the standby configuration such that the needles 830, 850 may not be reused, as discussed below.

[0072] The needle connector 870 fluidly couples the injection needle 830 to the septum needle 850, which may be movable relative to each other. According to some embodiments of the present technology, the needle connector 870 may be movable to allow for the needle mechanism 810 to transition from the compact configuration to the extended configuration and from the extended configuration to the compact configuration. In some embodiments, the needle connector 870 may be flexible and may be configured for bending movement and / or stretching movement and / or other movement in which the needle connector 870 may deform to change its overall shape. According to some embodiments, the needle connector 870 may comprise a flexible and resilient polymeric material, such as an elastomer, a thermoset polymer, rubber, and the like. For example, the needle connector 870 may comprise a silicone tube (e.g., a liquid silicone rubber (LSR) tube), a polyurethane tube, a Mylar® tube, and the like. As will be appreciated, for transferring medicaments, the needle connector 870 may be formed of a medical-grade material. In some embodiments, the flexible material may be sterilizable and inert to the fluid in the cartridge 550. In some other embodiments, the needle connector 870 may comprise rigid materials coupled together through flexible connections. For example, atleast one portion of the needle connector 870 may comprise a rigid tube and at least one other portion of the needle connector 870 may comprise a flexible tube coupled to the rigid tube in a leak-tight manner. In some embodiments, the needle connector 870 may be formed of semirigid segments configured to move relative to each, such as in a telescoping action. The semirigid segments may be formed of a resilient material (e.g., an elastomer) configured to form a leak-tight seal against an adjacent surface when the needle mechanism 810 is in the extended configuration.

[0073] According to some embodiments of the present technology, the needle connector 870 may comprise a flexible tube having an outlet end 872 fluidly coupled to an inlet end of the injection needle 830, and having an inlet end 874 fluidly coupled to an outlet end of the septum needle 850. In some embodiments, the outlet and inlet ends 872, 874 of the needle connector 870 may be coupled directly to the septum and injection needles 850, 830, respectively. For example, a bore diameter of the needle connector 870 may be sufficiently small such that a leak- tight seal may be established between an internal surface of the inlet end 874 of the needle connector 870 and an external surface of the septum needle 850 inserted in the inlet end 874. Similarly, the bore diameter of the needle connector 870 may be sufficiently small such that a leak-tight seal may be established between an internal surface of the outlet end 872 of the needle connector 870 and an external surface of the injection needle 850 inserted in the outlet end 872.

[0074] According to some embodiments of the present technology, an inlet end of the injection needle 830 may be couped to the outlet end 872 of the needle connector 870 via a needle retainer 842. Similarly, an outlet end of the septum needle 850 may be couped to the inlet end 874 of the needle connector 870 via a needle retainer 862. The needle retainers 842, 862 may be coupling configurations that provide leak-tight seals between the needle connector 870 and the injection and septum needles 830, 850. In some embodiments, the needle retainers 842, 862 may comprise connector couplers (discussed below) extending from the needle supports 840, 860 and configured to be secured to the needles 830, 850. In some embodiments, the output and input ends 872, 874 of the needle connector 870 may be extruded or molded or otherwise formed to provide a snug fit over the connector couplers. The needle connector 870 may be secured to the injection and septum needles 830, 850 and / or to the connector couplers of the needle supports 840, 860 in a leak-tight manner using compressive forces and / or glue and / or a protrusion (e.g., a barb) and / or a second shot, discussed below. Securing mechanisms are described below.

[0075] FIG. 13A shows the needle assembly 800 in the standby configuration, before injection. FIG. 13B shows the needle assembly in the extended configuration, during injection. FIG. 13Cshows the needle assembly 800 in the retracted configuration, after injection. Note that the needle connector 870 in FIG. 13B is shown in an unextended state and disconnected from the needles 830, 850, even though the needle assembly 800 is in the extended configuration, so that an amount of unbending and extending of the needle connector 870 to maintain fluid communication between the needles 830, 850 can be visualized. In some embodiments, portions of the needle supports 840, 860 may engage with each other when in the retracted configuration. The engaged portions may interfere with each other to prevent the needle assembly 800 from returning to the extended configuration, as discussed below.

[0076] The inventors have recognized and appreciated that for applications in which the needle connector 870 is to be used to achieve desirable delivery rates for viscous fluids and / or in applications in which a high fluid-delivery rate is desired, having the bore diameter of the needle connector 870 be small for the sake of providing a leak-tight constrictive or compressive force around the connector couplers may not be as desirable as having a relatively larger bore diameter, which would be less restrictive to fluid flow. According to some embodiments of the present technology, bore sizes of the injection needle 830, the septum needle 850, and the needle connector 870 may be sufficiently large to permit a desired fluid-delivery rate to be achieved by action of the drive assembly 600, discussed above, with the needle retainers 842, 862 (e.g., the connector couplers) providing leak-tight seals. In some embodiments, the injection and septum needles 830, 850 may have a same bore size. In some embodiments, the injection needle 830 may have a different bore size than that of the septum needle 850. In some embodiments, bore sizes of the injection needle 830, the septum needle 850, and the needle connector 870 may permit a fluid-delivery rate of at least 5 mL (or cc) in 30 seconds or faster for a fluid having a viscosity of 30 centipoise or less, or at least 3 mL in 20 seconds or faster for a fluid having a viscosity of 15 centipoise or less. For example, the fluid-delivery rate may be 3 mL in less than 20 seconds for a fluid having a viscosity of 30 centipoise or less, or may be 3 mL in less than 12 seconds for a fluid having a viscosity of 30 centipoise or less, or may be 3 mL in less than 9 seconds for a fluid having a viscosity of 15 centipoise or less.

[0077] FIGs. HA and 11B are perspective views of opposite sides of a needle mechanism 812, according to some embodiments of the present technology. For the sake of simplicity, FIG. HA may be considered to show an embodiment of a front side of the needle mechanism 812, and FIG. 11B may be considered to show an embodiment of a rear side of the needle mechanism 812. It should be understood, however, that the terms “front” and “rear” do not indicate required orientations of the features described for the needle mechanism 812. In some embodiments, atleast some of the needle mechanism 812 may form at least part of the needle mechanism 810 discussed above. FIGs. 12A and 12B are perspective views of the driven member 820, which is configured to be driven by the driver and which is configured to cause movement of the injection and septum needles 830, 850 of the needle mechanism 810.

[0078] According to some embodiments of the present technology, the needle mechanism 812 may comprise the injection-needle support 840 and the septum-needle support 860, which generally may be positioned relative to a common plane and which may be slidably coupled to one another via the driven member 820. In some embodiments, the driven member 820 may be positioned on a front side of the common plane and the supports 840, 860 may be positioned on a rear side of the common plane opposite the front side. Front sides of the supports 840, 860 may have engagement portions 846, 866 configured to engage with the driven member 820 to move the supports 840, 860 in opposite directions such that the injection and support needles 830, 850 may move in opposite directions. In some embodiments, the supports 840, 860 may be sized and shaped to fit within a housing 801 of the needle assembly 800, as shown in FIG. 10, and may be configured to move within the housing 801 to move the injection needle 830 and the septum needle 850 to and from an extended configuration, in which the needles 830, 850 extend at least partially outside of the housing 801, and at least one compact configuration (e.g., a preinjection standby configuration, a post-injection retracted configuration), in which the needles 830, 850 are within the housing 801.

[0079] According to some embodiments of the present technology, the needle mechanism 812 may comprise a rack-and-pinion configuration, in which the supports 840, 860 may include first and second racks with engagement portions, and in which the driven member 820 may include a pinion gear configured to mo v ably interact with the engagement portions of the racks to move the racks in opposite directions. In some embodiments, the injection-needle support 840 may comprise a support body 848 forming at least a portion of the first rack, shaped protrusions forming at least the engagement portions 846 or teeth of the first rack, and the needle retainer 842, which may extend from the support body 848 and which may hold a portion of the injection needle 830 therein. In some embodiments, the needle retainer 842 may be fixedly coupled with the injection needle 830 such that movement of the support body 848 may cause movement of the injection needle 830 via the needle retainer 842. In some embodiments, the needle retainer 842 may extend laterally from the support body 848. Similarly, in some embodiments, the septum-needle support 860 may comprise a support body 868 forming at least a portion of the second rack, shaped protrusions forming at last the engagement features 866 or teeth of thesecond rack, and the needle retainer 862, which may extend from the support body 868 and which may hold a portion of the septum needle 850 therein. In some embodiments, the needle retainer 862 may be fixedly coupled with the septum needle 850 such that movement of the support body 868 may cause movement of the septum needle 850 via the needle retainer 862. In some embodiments, the needle retainer 862 may extend laterally from the support body 868. In some embodiments, one of or both of the injection-needle support 840 and the septum-needle support 860 may comprise a needle guard 844, which may protect and / or provide support to a needle section extending through the needle guard 844. In some embodiments, the needle guard 844 may comprise a cylindrical sleeve through which the needle section extends.

[0080] According to some embodiments of the present technology, a rear side of the driven member 820 may comprise a pinion gear with engagement portions 824 or teeth configured to mesh with the engagement portions 846, 866 or teeth of the first and second racks forming the support bodies 848, 868. A front side of the driven member 820 may comprise an actuating member 826, which may be configured to engage with the driver 712 or the rib, as discussed above. For example, if the needle mechanism 812 is part of a first needle assembly in the activated position, the actuating member 826 of the driven member 820 may be engaged by the driver 712 such that rotation of the driver 712 may cause rotation of the actuating member 826, which in turn may cause rotation of the engagement portions 824 of the pinion gear of the driven member. In some embodiments, the actuating member 826 may comprise a plurality of recesses (e.g., see the indentations or recesses 820a” in FIG. 9) configured to engage with a plurality of complementary protrusions of a driver (e.g., a shaft head). For example, the actuating member 826 may comprise recesses of a specific size and / or a specific shape and / or a specific number that may be driven when the driver has protrusions that are complementary, such that the complementary protrusions may serve as a key structure to engage with and drive the actuating member 826. In some embodiments, one side of the actuating member 826 may comprise the slot-shaped recess 820a to engage with the rib when not in the activated position, and another side of the actuating member 826 may comprise one or more shaped recesses configured to be driven by the driver with the complementary protrusions (i.e., the key structure). Use of a key structure may prevent the driven member 820 from being tampered with by a conventional tool (e.g., a screwdriver, a nail file, a butter knife, etc.), so that the injection needle 830 may not be caused to extend outside of the housing improperly. In some embodiments, the driven member 820 may comprise a ring 822 configured to provide a seal between the driven member 820 and the housing 801. In some embodiments, the ring 822 maybe an O-ring configured to prevent debris and / or fluid from entering the housing 801 at an interface between the driven member 820 and the housing 801. In some embodiments, the ring 822 may function to retain the driven member 820 in the housing 801. In some embodiments, the ring 822 may provide a seal and also may facilitate rotation of the driven member 820. For example, the ring 822 may comprising a bearing configured to allow the driven member 820 to rotate easily when being driven by the driver 712.

[0081] As will be appreciated, although the engagement portions 824 of the driven member 820 are shown to be teeth of a pinion gear, and although the supports 840, 860 are shown to have engagement portions 846, 866 that are teeth configured to engaged with the teeth of the pinion gear, in some embodiments the driven member 820 and the supports 840, 860 may have other movement structures configured to interact with each other to move the injection and septum needles 830, 850 in opposite directions. For example, such a movement structure may comprise a threaded screw and / or a zip chain and / or another structure having complementary portions. As noted above, the driver 712 may, in turn, be driven to rotate by an electric motor (not shown).

[0082] FIGs. 12C and 12D show front and rear sides, respectively, of the needle mechanism 812 in a compact configuration (FIG. 12C) and an extended configuration (FIG. 12D), according to some embodiments of the present technology. The compact configuration may comprise a plurality of different configurations, such as the standby and retracted configurations discussed above. In the standby configuration, the injection needle 830 of the needle mechanism 812 may be disposed within the housing 801 and has not yet been used in an injection operation, e.g., to inject fluid from the cartridge 550 into a user. (See also FIG. 13A.). In the retracted configuration, the injection needle 830 has been moved or extended at least partially outside of the housing 801 for use in an injection operation and has been retracted back into the housing 801. (See FIG. 13C.) Stated differently, the standby configuration may be a pre-injection compact configuration, and the retracted configuration may be a post-injection compact configuration. In some embodiments, the standby configuration and the retracted configuration may be a same configuration. In some embodiments, the retracted configuration may be different from the standby configuration and may be a configuration in which the injection needle 830 may not be re-used. That is, the retracted configuration may be configuration that prevents the needle mechanism 810 from returning to the extended configuration.

[0083] More specifically, in the compact configuration of FIG. 12C, both the injection needle 830 and the septum needle 850 may be axially positioned entirely within the housing 801 of the needle mechanism 810. The needle connector 870, which are connected to the injection andseptum needles 830, 850, may be in a bent state (e.g., looped, curved, coiled, etc.), such that the inlet and outlet ends 874, 872 of the needle connector 870 are relatively close to each other to permit the needles 830, 850 to be disposed completely in the housing 801, as depicted in FIG. 10. In some embodiments, in the compact configuration, the inlet and outlet ends 874, 872 of the needle connector 870 may be separated from each other by a first axial distance along the axis A l of the needle mechanism 810 (see FIG. 10) or may even overlap with each other along the axis Al , as depicted in FIG. 10. Upon rotation of the driven member 820 in a direction Cl, the support 840 and the injection needle 830 may be driven in a direction DI while the support 860 and the septum needle 850 may be driven in a direction D2, such that the supports 840, 860 may slide away from each other. Movement of the supports 840, 860 may proceed until the needle mechanism 812 reaches the extended configuration at which point rotation of the driven member 820 may stop. In some embodiments, rotation of the driven member 820 may stop when a portion of the needle mechanism 812 touches the housing 801 (e.g., the support 840 and / or the support 860 touches the housing 801). In some embodiments, the directions DI and D2 may be antiparallel or approximately antiparallel with each other. For example, an angle between DI and D2 may be 180° ± 5° or 180° ± 2°. In some embodiments, the directions DI and D2 may be parallel or approximate parallel to the axis Al, as depicted in FIG. 10. In some embodiments, DI and / or D2 may not be parallel or approximately parallel to the axis Al but instead may have an angle in a range of about 5° to about 45° relative to the axis Al.

[0084] In the extended configuration of FIG. 12D, the injection needle 830 may extend axially beyond the housing 801 to pierce through the exterior seal 806, such that the needle 830 may pierce a target surface placed against the exterior seal 806. The target surface may be, e.g., an injection surface of a user. Additionally, in the extended configuration, the septum needle 850 may extend axially beyond the housing 801 to pierce through the interior seal 808 and through the septum 552 and may extend into the fluid chamber 558 of the cartridge 550. In some embodiments, a desired amount of fluid may flow from the fluid chamber to the injection needle 830 via the septum needle 850 and the needle connector 870 through action of the drive assembly 600. The needle connector 870 may be sufficiently flexible to permit movement from a bent configuration, in which the needle connector 870 may form one or more loops or a part of a loop, to an unbent configuration, in which the needle connector 870 may have a straightened or unlooped form, while maintaining fluid communication between the injection and septum needles 830, 850. As shown in FIG. 12D, the needle connector 870 may retain some curvature when the needle mechanism 812 is in the extended configuration but may have less curvaturethan when the needle mechanism 812 is in the compact configuration. In some embodiments, the needle connector 870 may be straight when the needle mechanism 812 is in the extended configuration, such that the inlet and outlet ends 872, 874 of the needle connector are separated by a second axial distance greater than the first axial distance along the axis Al.

[0085] According to some embodiments of the present technology, an injection operation may be initiated by a user and implemented using one or more motors controlled by a controller. For example, the needle assembly 800 may be installed in a dispenser or cassette comprising a motor assembly (e.g., the motor assembly 50 discussed above) and a controller (e.g., the controller 750 discussed above). In some embodiments, up receipt of an injection signal initiated by the user (e.g., through a push of a button, a toggling of a switch, etc.) the controller may cause the driver 712 to be rotated, which in turn may cause rotation of the driven member 820. The controller also may cause the drive assembly 600 to move to urge the fluid within the cartridge 550 to flow out of the cartridge 550. Timing of the movement of the drive assembly 600 and the movement of the needle mechanism 812 may be controlled by the controller so that the fluid may flow out of the injection needle 830 as soon as, or shortly after, the needle mechanism 812 reaches the extended configuration.

[0086] As noted above, the needle mechanism 812 may stop extending the supports 840, 860 when a portion of the needle mechanism 812 touches the housing 801, according to some embodiments of the present technology. In some embodiments, the housing 801 may comprise at least one blocking surface (e.g., a protrusion) configured to serve as a physical stop for movement of the support 840 and / or the support 860. In some embodiments, the needle mechanism 812 may stop when one or more of the engagement portions 824 of the driven member 820 touches a blocking portion on one of or both of the supports 840, 860 (e.g., an inability of any one or more of the engagement portions 846, 866 fails to mesh with the engagement portions 824). In some embodiments, the needle mechanism 812 may be controlled to stop by the controller based on an amount of rotation of the driver 712. In some embodiments, an amount of time for transitioning from the compact configuration to the extended configuration may be approximately 1 second or less (e.g., 1 second, 0.75 second, 0.5 second, 0.25 second).

[0087] After an injection operation, the needle mechanism 812 may be moved back to the compact configuration from the extended configuration. According to some embodiments of the present technology, the needle mechanism 812 may be retracted from the extended configuration to the compact configuration through movement of the driven member 820. In someembodiments, the driven member 820 may be rotated in a direction C2 (see FIG. 12D), which is generally opposite to the direction Cl, to cause the support 840 to move in a direction -DI (i.e., a direction opposite to the direction DI) and to cause the support 860 to move in a direction -D2 (i.e., a direction opposite to the direction D2). Such movement may cause the supports 840, 860 to slide closer together, which in turn may cause the injection and septum needles 830, 850 to retract into the housing 801. As with the injection operation discussed above, a retraction operation may be controlled by the controller. For example, the controller may cause the drive assembly 600 to stop urging the fluid out of the cartridge 550 when a desired amount of the fluid has been urged out of the cartridge 550. The controller also may cause the driven member 820 to rotate in the direction C2 to retract the needles 830, 850 into the housing 801. Such automation of the injection operation and the retraction operation may permit a lay person with no training in medical techniques to use the dispenser and the needle assembly 800 safely. Additional needle-mechanism configurations are described in WO2022 / 132675A1 and WO2022 / 132677A1, each of which is incorporated herein by reference in its entirety.

[0088] FIGs. 13C and 14 show views of the needle assembly 800 with the needle mechanism 810 in the retracted configuration, according to some embodiments of the present technology. As noted above, the compact configuration of the needle mechanism 810 may be a retracted (post-use) configuration in which the injection needle 830 may not be reused. Thus, in some embodiments, the retracted configuration may be different from the standby configuration. In some embodiments, the needle mechanism 810 may be moved from the extended configuration to the retracted configuration via an over-retraction mechanism, which may cause a portion of the support 840 and / or a portion of the support 860 to latch a blocking surface. Once latched, the needles 830, 850 may not be moved out of the housing 801. For example, once latched, movement of the injection needle 830 in FIGs. 12C and 12D in the direction DI may not occur. The over-retraction mechanism may serve as a safety mechanism to prevent the injection needle 830, which has been used and may no longer be sterile, from being reused accidentally. Alternatively or in addition to the over-retraction mechanism, in embodiments in which the needle assembly 800 is part of a plurality of needle assemblies 800 (e.g., a carousel of needle assemblies 800), a used one of the needle assemblies 800 may be prevented from being selected and / or prevented from being put in the activated position by the controller of the dispenser.

[0089] Prior to a dose delivery, the needle mechanism 810 may be in the standby configuration in which a latching portion 848 of the injection-needle support 840 and a latching portion 869 of the septum-needle support 860 are not engaged with each other. For example, in the standbyconfiguration, the latching portion 869 may be located at a position X while the latching portion 848 may be located axially leftward of the position X. In some embodiments, the latching portions 848, 869 may comprise ledges with engagement surfaces facing in opposite directions. During the dose delivery, the latching portion 869 may move from the position X rightwards, such that a portion of the septum needle 850 may move rightwards to extend outside of the housing 801. At the same time, the injection needle 830 and the support 840 may move leftward during the dose delivery, from the standby configuration to the extended configuration.

[0090] According to some embodiments of the present technology, after the dose delivery, the support 860 may move leftwards and the support 840 may move rightwards, so that the septum needle 850 and the injection needle 830 may be retracted inside the housing 801. In retracting the injection and septum needles 830, 850, the supports 840, 860 may be over-retracted such that the latching portion 869 may be moved axially leftward beyond the position X and beyond an axial position of the latching portion 849. Such over-retraction may result in the latching portion 869 rotating toward and engaging with the latching portion 848. For example, the latching portions 869, 848 may comprise surfaces that abut each other once engaged or latched, as shown in FIG. 14, preventing movement of the support 860 rightward and preventing movement of the support 840 leftward.

[0091] The inventors have recognized and appreciated that secure mounting or attachment of the injection and septum needles 830, 850 to the needle connector 870 may be desirable, to ensure leak-tight fluid flow between the needles 830, 850 during a dose delivery. The inventors also have recognized and appreciated that, when the needles 830, 850 are fine-gauge needles typical of cannula needles used to inject medicaments (e.g., insulin) and when the needle connector 870 may be thin- walled in order to provide sufficient flexibility for movement to and from the compact and extended configurations, preventing kinking of the needle connector 870 and / or preventing bending of the needles 830, 850 may be desirable, to ensure that there is no constriction that would reduce a fluid delivery rate of fluid from the cartridge 550 through the injection needle 830. The inventors have developed a support scheme in which the needle retainers 842, 862 of the supports 840, 860 may serve as supportive connector couplers configured to support both the needles 830, 850 as well as the inlet and outlet ends 874, 872 of the needle connector 870.

[0092] FIG. 15 shows a cross-sectional side view of a needle mechanism 1700 disposed in a housing 801’, according to some embodiments of the present technology. In FIG. 15, the needle mechanism 1700 is in an extended configuration in which a piercing end of an injection needle1730 extends outside of the housing 801’ and a piercing end of a septum needle 1750 extends outside of the housing 801’. A needle connector 1770 may connect non-piercing ends of the injection and septum needles 1730, 1750 such that the needles 1730, 1750 may be in fluid communication with each other. In some embodiments, the injection and septum needles 1730, 1750 may be coaxial when the needle mechanism 1700 is in the extended configuration. In some embodiments, the injection and septum needles 1730, 1750 may be parallel to each other when the needle mechanism 1700 is in the extended configuration. In some embodiments, the needle connector 1770 may be coaxial with the injection and septum needles 1730, 1750 when the needle mechanism 1700 is in the extended configuration.

[0093] FIG. 16 shows cross-sectional view of the needle mechanism 1700, according to some embodiments of the present technology. In addition to the injection and septum needles 1730, 1750 and the needle connector 1770, the needle mechanism 1700 may comprise a septum-needle support 1760 and an injection-needle support 1740. Portions of the needle mechanism 1700 configured to cause movement of the needles 1730, 1750 are described elsewhere herein and are not shown in FIG. 16.

[0094] According to some embodiments of the present technology, the support 1740 may comprise a connector coupler 1742 configured to connect the support 1740 to the injection needle 1730 and the needle connector 1770. In some embodiments, the connector coupler 1742 may extend from a main body 1741 of the support 1740 and may comprise a bore configured to receive the injection needle 1730 therein. In some embodiments, the injection needle 1730 may extend through the connector coupler 1742 such that an inlet end 1730a may be located outside of the bore of the connector coupler 1742, as shown in FIG. 16. In some other embodiments, the inlet end 1730a may be located within the bore of the connector coupler 1742. As will be appreciated, an outlet end 1730b of the injection needle 1730 may extend outside of the bore of the connector coupler 1742 in order to pierce a user during a dose delivery. A coupling end 1742a of the connector coupler 1742 may be disposed in an outlet end 1772b of a bore 1772 of the needle connector 1770. In some embodiments, the main body 1741 of the support 1740 may be elongated and the bore of the connector coupler 1742 may extend parallel to an elongation direction of the main body 1741.

[0095] A similar arrangement may be provided for the septum needle 1750 and the support 1760, according to some embodiments of the present technology. In some embodiments, the support 1760 may comprise a connector coupler 1762 configured to connect the support 1760 to the septum needle 1750 and the needle connector 1770. In some embodiments, the connectorcoupler 1762 of the support 1760 may comprise an elongated inlet protrusion 1762a configured to extend into an inlet neck of the housing 801’, as shown in FIG. 15. The elongated inlet protrusion 1762a may provide supplemental support to the septum needle 1750, which may be advantageous when the septum needle 1750 encounter frictional forces while piercing and / or retracting from the septum 552. In some embodiments, the elongated inlet protrusion 1762a may be sized to provide support without significantly increasing an amount of weight to be moved during extension and retraction of the support 1760. The connector coupler 1762 may also comprise a bore configured to receive the septum needle 1750 therein. In some embodiments, the septum needle 1750 may extend through the connector coupler 1762 such that an outlet end 1750b may be located outside of the bore of the connector coupler 1762, as shown in FIG. 16. In some other embodiments, the inlet end 1750b may be located within the bore of the connector coupler 1762. As will be appreciated, an inlet end 1750a of the septum needle 1750 may extend outside of the bore of the connector coupler 1762 in order to pierce the septum 552 of the cartridge assembly 500 during a dose delivery.

[0096] According to some embodiments of the present technology, the connector couplers 1742, 1762 and the needles 1730, 1750 may be disposed within the needle connector 1770, such that a fluid tight seal may be formed. A coupling end 1742a of the connector coupler 1742 may be disposed in an outlet end 1772b of the bore 1772 of the needle connector 1770, and a coupling end 1762a of the connector coupler 1762 may be disposed in an inlet end 1772a of the bore 1772 of the needle connector 1770. In some embodiments, the needle connector 1770 may be formed of a resilient material that produces a fluid-tight seal around the coupling ends 1742a, 1762a of the connector couplers 1742, 1762. For example, the needle connector 1770 may comprise a flexible polymeric material, such as an elastomer, a thermoset polymer, rubber, and the like. For example, the needle connector 1770 may comprise a silicone tube, or a liquid silicone rubber (LSR) tube, or a polyurethane tube, or a Mylar® tube, or the like. In some embodiments, at the outlet end 1772b of the bore 1772 of the needle connector 1770, the resilient material may stretch during insertion of the coupling end 1742a and may exert a fluid-tight compressive force around the coupling end 1742a after insertion. In some cases, the resilient material also may exert a fluid-tight compressive force around an inlet end 1730a of the injection needle disposed within the outlet end 1772b of the bore 1772. Similarly, at the inlet end 1772a of the bore 1772 of the needle connector 1770, the resilient material may stretch during insertion of the coupling end 1762a and may exert a fluid-tight compressive force around the coupling end 1762a after insertion. In some cases, the resilient material also may exert a fluid-tight compressive forcearound an outlet end 1750b of the septum needle 1750 disposed within the inlet end 1772a of the bore 1772.

[0097] According to some embodiments of the present technology, an outlet edge of the needle connector 1770 may abut a shoulder 1742b of the connector coupler 1742, as shown in FIG. 16. Similarly, in some embodiments, an inlet edge of the needle connector 1770 may abut a shoulder 1762b of the connector coupler 1762, as shown in FIG. 16. As noted above, the needle connector 1770 may have sufficient resilience to exert a compressive force around the coupling ends 1742a ,1762a to produce leak-tight seals between the coupling ends 1742a, 1762a and the bore 1772. In some embodiments, a sealing ring may be provided around an external portion of the needle connector 1770 at regions corresponding to inlet and outlet ends 1772a, 1772b of the bore 1772, to impart an additional compressive force and / or to plug leakage gaps, such that leak- tight seals are produced between the bore 1772 and the coupling ends 1742a, 1762a. For example, the sealing ring may comprise an elastic ring, or glue ring, or a gasket, or the like, located adjacent the shoulders 1742b 1762b of the connector couplers 1742, 1762.

[0098] FIG. 17 shows a block diagram of a medication delivery device 1 , according to some embodiments of the present technology. In some embodiments, the device 1 may comprise the cartridge assembly 500, the needle assembly 800 (800”), the motor assembly 50, and the controller 750, some or all of which may be housed within or partially within a housing of the device 1. In some other embodiments, the controller 750 may be external to the housing of the device 1 and may be configured to control the motor assembly 50 remotely through control signals transmitted via a dedicated cable and / or through control signals transmitted wirelessly using known technology for wireless communications.

[0099] Some embodiments provide for techniques for assembling a needle assembly, such as the needle assembly 120 described herein including at least with respect to FIGs. 1C-1G, FIGs. 3A- 3B and FIGS. 4A-4C. FIGs. 18A, 18B, 18C, 18D, 18E, and 18F show an illustrative process for assembling a needle assembly. The illustrative process may be performed manually, semi- automatically, or automatically. For example, when the process is performed semi-automatically or automatically, one or more robotic devices may be programmed and / or otherwise used to perform one or more acts of assembling the needle assembly. Aspects of the disclosed method of assembly may overcome some of the difficulties of the shipping in sterile-packed containers and / or needle assemblies without seals, foils, and / or O-rings. It is understood that additional method steps can be included to include seals, foils, and / or O-rings.

[0100] As shown in FIGs. 18A-18B, lower housing 1821 may be inserted at least partially into base 1810. For example, the lower housing 1821 may be inserted at least partially into recess 1815 formed in the top surface 1811 of the base 1810. Lower housing 1821 may include openings such that levers 1812-1, 1812-2 protrude through the openings when the lower housing 1821 is positioned in recess 1815. The levers 1812-1, 1812-2 may include spring-loaded levers, cam levers, or any other suitable type of levers, as aspects of the technology described herein are not limited in this respect.

[0101] As shown in FIG. 18B, lower housing 1821 may additionally include an opening 1816 that leaves exposed recess 1813 of the base 1810 when lower housing 1821 is positioned in recess 1815. Recess 1813 may be formed in a bottom surface of recess 1815. In some embodiments, recess 1813 may be configured to receive driven member 1822, as shown in FIG. 18C. The driven member 1822 may be inserted at least partially within lower housing 1821 and may extend at least partially below lower housing 1821 into recess 1813. The base 1810 may additionally include one or more posts 1814 extending upwards from the bottom surface of recess 1813 such that the one or more posts 1814 protrude at least partially through one or more corresponding openings in driven member 1822 when the driven member is inserted in the lower housing 1821 and recess 1813. The posts 1814 may help to align the driven member 1822.

[0102] The driven member 1822 may have a first side that includes a pinion gear configured to movably interact with the engagement portions of needle supports when the needle assembly is assembled and a second side opposite the first side that includes an actuating member (not shown), which may be configured to engage with a driver. As shown in FIG. 18C, the second side of the driven member 1822 may be positioned to face the bottom surface of recess 1813 when the driven member 1822 is inserted in the lower housing 1821 and recess 1813.

[0103] As shown in FIG. 18D, one or more components of a fluid path assembly may be inserted at least partially within lower housing 1821 over the driven member 1822. For example, fluid path assembly may include needle support 1817-1 and corresponding needle 1818, needle support 1817-2 and corresponding needle (not shown), and needle connector 1823. In some embodiments, the fluid path assembly is assembled prior to insertion into the lower housing 1821. Additionally, or alternatively, individual components of the fluid path assembly may be inserted and assembled as part of assembling the needle assembly.

[0104] In some embodiments, levers 1812-1, 1812-2 are used to align the fluid path assembly within the lower housing 1821. For example, the fluid path assembly may be inserted into the lower housing 1821 such that lever 1812-2 is positioned between needle 1818 and needlesupport 1817-2 and lever 1812-1 is positioned between the second needle (not shown) and needle support 1817- 1. In some embodiments, levers 1812-1, 1812-2 are configured to apply pressure to the needle supports and / or needles.

[0105] After the fluid path assembly is inserted into the lower housing 1821, the upper housing1824 may be attached to the lower housing 1821, as shown in FIG. 18E. For example, the lower housing 1821 and upper housing 1824 may include corresponding connector portions that engage one another when upper housing 1824 is positioned over lower housing 1821 and / or when upper housing 1824 and upper housing 1824 are pushed together. Additionally, or alternatively, the upper housing 1824 may be attached using any other suitable attachment mechanism such as, for example, using an adhesive, as aspects of the technology described herein are not limited in this respect.

[0106] Recesses 1832, 1834 may be formed in a side surface 1830 of base 1810. Recesses 1832, 1834 may be configured to receive the portion 1835 of upper housing 1824 that extends downwards along the side surface 1830 of the base 1810. A surface of base 1810 opposite to side surface 1830 may also include one or more recesses configured to receive a corresponding portion of the upper housing 1824.

[0107] As shown in FIG. 18F, label 1825 may be applied to the upper housing 1824. The label1825 may be applied using an adhesive (e.g., glue) or any other suitable application techniques, as aspects of the technology described herein are not limited in this respect. For example, the label 1825 may be a sticker that is applied to the upper housing 1824.

[0108] The assembled needle assembly 1820 may be removed from the base 1810, as shown in FIG. 18G. For example, the assembled needle assembly 1820 may simply be lifted off the base 1810. In some embodiments, after the needle assembly 1820 is removed from the base, it may be packaged using any suitable packaging. Additionally, or alternatively, the needle assembly 1820 may be used to assemble a medication delivery device (e.g., as described herein including at least with respect to FIGs. 1A-1G).CONCLUSION

[0109] It should be understood that various alterations, modifications, and improvements may be made to the structures, configurations, and methods discussed above, and are intended to be within the spirit and scope of the technology disclosed herein. Further, although advantages of the present technology are indicated, it should be appreciated that not every embodiment of the present technology will include every described advantage. Some embodiments may notimplement any features described as advantageous herein. Accordingly, the foregoing description and attached drawings are by way of example only.

[0110] It should be understood that some aspects of the present technology may be embodied as one or more methods, and acts performed as part of a method of the present technology may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than shown and / or described, which may include performing some acts simultaneously, even though shown and / or described as sequential acts in various embodiments.

[0111] Various aspects of the present technology may be used alone, in combination, or in a variety of arrangements not specifically discussed in the embodiments described in the foregoing and is therefore not limited in its application to the details and arrangement of components set forth in the foregoing description or illustrated in the drawings. For example, aspects described in connection with one embodiment may be combined in any manner with aspects described in connection with one or more other embodiments.

[0112] Various aspects are described in this disclosure, including the summary, which include, but are not limited to, the following aspects:

[0113] In various aspects of the disclosure, a medication delivery device includes a housing including a proximal end, a distal end, and a portion extending between the proximal end and the distal end that includes an outer surface, a cartridge assembly configured to hold a fluid, wherein the cartridge assembly is disposed at least partially in a first recess in the outer surface of the portion of the housing extending between the proximal end and the distal end, and a needle assembly including a needle assembly housing, and a needle, wherein the needle assembly is disposed at least partially in a second recess in the portion of the housing extending between the proximal end and the distal end, and at least a portion of the needle is configured to extend through a septum of the cartridge assembly.

[0114] In various aspects of the disclosure, the needle assembly housing includes a connector portion configured to engage a corresponding portion of the housing.

[0115] In various aspects of the disclosure, the connector portion extends at least partially along a perimeter of the housing, wherein the perimeter defines a plane that is substantially perpendicular to a longitudinal axis of the housing.

[0116] In various aspects of the disclosure, the connector portion of the needle assembly is configured to disengage from the corresponding portion of the housing in response to pressure applied to the connector portion.

[0117] In various aspects of the disclosure, a portion of the needle assembly housing extends over a portion of the cartridge assembly and is configured to secure the cartridge assembly at least partially within the first recess.

[0118] In various aspects of the disclosure, the cartridge assembly includes a connector portion configured to engage a corresponding portion of the housing of the medication delivery device.

[0119] In various aspects of the disclosure, the connector portion of the cartridge assembly is configured to disengage from the corresponding portion of the housing after the needle assembly has been removed from the housing and in response to pressure applied to the cartridge assembly.

[0120] In various aspects of the disclosure, the housing further includes at least one indentation that exposes at least a portion of the cartridge assembly.

[0121] In various aspects of the disclosure, a wall of the first recess is at least partially rounded, and wherein a housing of the cartridge assembly is at least partially rounded.

[0122] In various aspects of the disclosure, the cartridge assembly includes a cartridge having a fluid chamber containing the fluid and a movable piston, wherein the fluid comprises a medication.

[0123] In various aspects of the disclosure, the cartridge assembly further includes a label affixed to a housing of the cartridge assembly, wherein the label includes a near field communication (NFC) tag configured to, when accessed by an electronic device, cause the electronic device to display information associated with the cartridge assembly.

[0124] In various aspects of the disclosure, a needle assembly, including a housing; a connector portion extending from the housing, wherein the connector portion is configured to engage a corresponding portion of a medication delivery device housing; a needle; a needle support coupled to the needle and disposed in the housing; and a driven member disposed at least partially in the housing and configured to be driven to move the needle support to move to and from an extended configuration, in which fluid may be transferred through the needle, and a compact configuration, in which fluid may not be transferred through the needle.

[0125] In various aspects of the disclosure, the needle assembly further includes: a lockout configuration whereby the needle support is inhibited from moving after being in the extended configuration.

[0126] In various aspects of the disclosure, the housing includes a stopping portion, and the needle support includes a stopping portion that is in engagement with the stopping portion of the housing to define the lockout configuration.

[0127] In various aspects of the disclosure, the needle is a first needle, and wherein the needle assembly further includes: a second needle; and a flexible connector having a first end connected to a non-piercing end of the first needle and a second end connected to a non-piercing end of the second needle, the flexible connector forming a fluid path.

[0128] In various aspects of the disclosure, when the needle support is in an initial compact configuration, the driven member is in a first configuration configured to engage at least a portion of a driver, and when the needle support is in a subsequent compact configuration, the driven member is in a second configuration configured to prevent engagement with at least the portion of the drive.

[0129] In various aspects of the disclosure, the connector portion includes a first latch extending from a first side of the housing, and the needle assembly further includes a second latch extending from a second side of the housing.

[0130] In various aspects of the disclosure, a method of assembling a medication delivery device, including: inserting a cartridge assembly at least partially into a first recess in an outer surface of a portion of a housing, the portion of the housing extending from a proximal end of the housing to a distal end of the housing; and after inserting the cartridge assembly, inserting a needle assembly at least partially into a second recess in the outer surface of the portion of the housing such that a portion of the needle assembly covers at least a portion of the cartridge assembly.

[0131] In various aspects of the disclosure, inserting the needle assembly at least partially into the second recess includes causing a connector portion of the needle assembly to engage a corresponding portion of the housing, wherein the connector portion of the needle assembly extends at least partially along a perimeter of the medication delivery device.

[0132] In various aspects of the disclosure, inserting the cartridge assembly at least partially into the first recess includes: inserting a proximal end of the cartridge assembly at least partially into a proximal end of the first recess; and after inserting the proximal end of the cartridge assembly, rotating the cartridge assembly about the inserted proximal end to insert a distal end of the cartridge assembly at least partially into a distal end of the first recess.

[0133] In various aspects of the disclosure, inserting the cartridge assembly at least partially into the first recess includes causing a connector portion of the cartridge assembly to engage a corresponding portion of the housing of the medication delivery device.

[0134] Use of ordinal terms such as “first,” “second,” “third,” etc., in the description and the claims to modify an element does not by itself connote any priority, precedence, or order of oneelement over another, or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one element or act having a certain name from another element or act having a same name (but for use of the ordinal term) to distinguish the elements or acts.

[0135] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0136] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

[0137] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified.

[0138] As used herein in the specification and in the claims, the phrase “equal” or “the same” in reference to two values (e.g., distances, widths, etc.) means that two values are the same within manufacturing tolerances. Thus, two values being equal, or the same, may mean that the two values are different from one another by ±5%.

[0139] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0140] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0141] Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. Use of terms such as “including,” “comprising,” “having,” “containing,” and “involving,” and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0142] The terms “approximately” and “about” if used herein may be construed to mean within ±20% of a target value in some embodiments, within ±10 % of a target value in some embodiments, within ±5% of a target value in some embodiments, and within ±2% of a target value in some embodiments. The terms “approximately” and “about” may equal the target value.

[0143] The term “substantially” if used herein may be construed to mean within 95% of a target value in some embodiments, within 98% of a target value in some embodiments, within 99% of a target value in some embodiments, and within 99.5% of a target value in some embodiments. In some embodiments, the term “substantially” may equal 100% of the target value.

Claims

CLAIMSWhat is claimed is:

1. A medication delivery device, comprising: a housing comprising a proximal end, a distal end, and a portion extending between the proximal end and the distal end that compnses an outer surface; a cartridge assembly configured to hold a fluid, wherein the cartridge assembly is disposed at least partially in a first recess in the outer surface of the portion of the housing extending between the proximal end and the distal end; and a needle assembly comprising: a needle assembly housing; and a needle, wherein: the needle assembly is disposed at least partially in a second recess in the portion of the housing extending between the proximal end and the distal end, and at least a portion of the needle is configured to extend through a septum of the cartridge assembly.

2. The medication delivery device of claim 1, wherein the needle assembly housing comprises a connector portion configured to engage a corresponding portion of the housing.

3. The medication delivery device of claim 2, wherein the connector portion extends at least partially along a perimeter of the housing, wherein the perimeter defines a plane that is substantially perpendicular to a longitudinal axis of the housing.

4. The medication delivery device of any of claims 2-3, wherein the connector portion of the needle assembly is configured to disengage from the corresponding portion of the housing in response to pressure applied to the connector portion.

5. The medication delivery device of any of claims 1-4, wherein a portion of the needle assembly housing extends over a portion of the cartridge assembly and is configured to secure the cartridge assembly at least partially within the first recess.

6. The medication delivery device of any of claims 1-5, wherein the cartridge assembly comprises a connector portion configured to engage a corresponding portion of the housing of the medication delivery device.

7. The medication delivery device of claim 6, wherein the connector portion of the cartridge assembly is configured to disengage from the corresponding portion of the housing after the needle assembly has been removed from the housing and in response to pressure applied to the cartridge assembly.

8. The medication delivery device of any of claims 1-7, wherein the housing further comprises at least one indentation that exposes at least a portion of the cartridge assembly.

9. The medication delivery device of any of claims 1-8, wherein the cartridge assembly comprises a cartridge having a fluid chamber containing the fluid and a movable piston, wherein the fluid comprises a medication.

10. The medication delivery device of any of claims 1-9, wherein the cartridge assembly further comprises a label affixed to a housing of the cartridge assembly, wherein the label comprises a near field communication (NFC) tag configured to, when accessed by an electronic device, cause the electronic device to display information associated with the cartridge assembly.

11. A needle assembly, comprising : a housing; a connector portion extending from the housing, wherein the connector portion is configured to engage a corresponding portion of a medication delivery device housing; a needle; a needle support coupled to the needle and disposed in the housing; and a driven member disposed at least partially in the housing and configured to be driven to move the needle support to move to and from an extended configuration, in which fluid may be transferred through the needle, and a compact configuration, in which fluid may not be transferred through the needle.

12. The needle assembly of claim 11, wherein the needle assembly further comprises:a lockout configuration whereby the needle support is inhibited from moving after being in the extended configuration.

13. The needle assembly of any of claims 11-12, wherein the housing includes a stopping portion, and the needle support includes a stopping portion that is in engagement with the stopping portion of the housing to define the lockout configuration.

14. The needle assembly of any of claims 11-13, wherein the needle is a first needle, and wherein the needle assembly further comprises: a second needle; and a flexible connector having a first end connected to a non-piercing end of the first needle and a second end connected to a non-piercing end of the second needle, the flexible connector forming a fluid path.

15. The needle assembly of any of claims 11-14, wherein: when the needle support is in an initial compact configuration, the driven member is in a first configuration configured to engage at least a portion of a driver, and when the needle support is in a subsequent compact configuration, the driven member is in a second configuration configured to prevent engagement with at least the portion of the driver.

16. The needle assembly of any of claims 11-15, wherein: the connector portion comprises a first latch extending from a first side of the housing, and the needle assembly further comprises a second latch extending from a second side of the housing.

17. A method of assembling a medication delivery device, comprising: inserting a cartridge assembly at least partially into a first recess in an outer surface of a portion of a housing, the portion of the housing extending from a proximal end of the housing to a distal end of the housing; and after inserting the cartridge assembly, inserting a needle assembly at least partially into a second recess in the outer surface of the portion of the housing such that a portion of the needle assembly covers at least a portion of the cartridge assembly.

18. The method of claim 17, wherein inserting the needle assembly at least partially into the second recess comprises causing a connector portion of the needle assembly to engage a corresponding portion of the housing, wherein the connector portion of the needle assembly extends at least partially along a perimeter of the medication delivery device.

19. The method of any of claims 17-18, wherein inserting the cartridge assembly at least partially into the first recess comprises: inserting a proximal end of the cartridge assembly at least partially into a proximal end of the first recess; and after inserting the proximal end of the cartridge assembly, rotating the cartridge assembly about the inserted proximal end to insert a distal end of the cartridge assembly at least partially into a distal end of the first recess.

20. The method of any of claims 17-19, wherein inserting the cartridge assembly at least partially into the first recess comprises causing a connector portion of the cartridge assembly to engage a corresponding portion of the housing of the medication delivery device.

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