Medication delivery device with medication cartridge and needle assembly
The medication delivery device addresses challenges of proper assembly, needle sterility, and safe self-administration by incorporating a cartridge and needle assembly with safety features and smart labeling, ensuring easy and safe medication delivery.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- ELI LILLY & CO
- Filing Date
- 2025-11-06
- Publication Date
- 2026-05-15
AI Technical Summary
Conventional injection devices face challenges in ensuring proper assembly, maintaining needle sterility, safe and efficient medication administration, and addressing patient discomfort with needle handling, especially for self-administered medications.
A medication delivery device with a cartridge assembly and needle assembly featuring a cartridge housing, drive assembly, and needle assembly, including features like a lift-tab, latch tooth, and retractable lip for easy assembly and safety mechanisms to prevent needle reuse, along with a smart label for identification and verification.
Facilitates easy and safe self-administration of medications by ensuring proper assembly, maintaining needle sterility, and preventing needle reuse, while enabling precise fluid delivery and user-friendly identification of medication contents.
Smart Images

Figure US2025054303_15052026_PF_FP_ABST
Abstract
Description
[0001] MEDICATION DELIVERY DEVICE WITH MEDICATION CARTRIDGE AND NEEDLE ASSEMBLY
[0002] FIELD OF THE DISCLOSURE
[0003] [1] The present disclosure relates generally to fluid delivery devices, such as injection devices.
[0004] BACKGROUND
[0005] [2] 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 the patient is able to properly assemble the injection device, that the needles are maintained in a sterile environment prior to use in injections, and that the medication is administered safely, efficiently, and in a proper amount. Furthermore, some patients are uncomfortable with seeing or directly handling needles.
[0006] SUMMARY
[0007] [3] According to an exemplary embodiment of the present disclosure, a cartridge assembly is provided. In some embodiments, the cartridge assembly includes: a cartridge 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; and a lift-tab portion formed in the outer surface; a cartridge disposed in the cartridge housing and including a plunger; and a drive assembly, the drive assembly including: a drive housing coupled to the proximal end of the cartridge housing.
[0008] [4] According to an exemplary embodiment of the present disclosure, a cartridge assembly is provided. In some embodiments, the cartridge assembly includes: a cartridge housing, including: an outer surface including a bottom portion, a top portion, and two lateral portions extending between the bottom and top portions; a latch tooth extending from the bottom portion of the outer surface; and at least one hook portion including: at least one protrusion extending from at least one of the two lateral portions of the outer surface; or at least one opening in the at least one of the two lateral portions of the outer surface; and a cartridge configured to hold a fluid, wherein the cartridge is disposed in a cavity defined by the outer surface of the cartridge housing. [5] According to an exemplary embodiment of the present disclosure, a medication delivery device is provided. In some embodiments, the 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, the proximal and distal ends defining an axis; a recess formed in the outer surface of the portion extending between the proximal end and the distal end, the recess including a load surface and two lateral surfaces, the load surface being configured to receive a cartridge assembly radially towards the axis; a first housing coupling portion disposed along the load surface, the first housing coupling portion including a retractable lip; and at least one second housing coupling portion disposed along at least one of the two lateral surfaces of the recess.
[0009] [6] According to an exemplary embodiment of the present disclosure, a needle assembly is provided. In some embodiments, the needle assembly includes: a needle assembly housing, including: a top surface, a bottom surface, and a pair of lateral surfaces extending between the top and bottom surfaces; a first coupling portion including a respective latchable surface defined by each of the pair of lateral surfaces; a pair of grips, each of the grips extending over a corresponding one of the lateral surfaces; and a needle disposed in the needle assembly housing.
[0010] [7] According to an exemplary embodiment of the present disclosure, a medication delivery device is provided. In some embodiments, the 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, the proximal and distal ends defining an axis; a recess formed in the outer surface of the portion extending between the proximal end and the distal end; a first housing coupling portion including a pair of housing latches disposed in the recess; and a second housing coupling portion including a first plurality of facets configured to contact a second plurality of facets disposed on a needle assembly housing.
[0011] [8] According to an exemplary embodiment of the present disclosure, a method of assembling a cartridge assembly is provided. In some embodiments, the method includes the steps of: inserting a drive ribbon into a proximal cavity of a drive housing; coupling a driven mechanism to the drive housing over the proximal cavity so that a portion of the driven mechanism is engaged with the drive ribbon and the drive ribbon is in an axially compacted configuration; coupling a bushing to a distal end of the drive housing; coupling a medication cartridge to the distal end of the drive housing wherein the medication cartridge is disposed within the bushing; and coupling a cartridge housing to the drive housing wherein the cartridge housing surrounds the medication cartridge, thereby forming the cartridge assembly.
[0012] BRIEF DESCRIPTION OF THE DRAWINGS
[0013] [1] 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:
[0014] [2] FIG. 1 A shows a perspective view of a medication delivery device in an assembled configuration.
[0015] [3] FIG. IB shows a perspective view of the medication delivery device of FIG. 1 A in a disassembled configuration.
[0016] [4] FIG. 2A shows a cross-sectional side view of a cartridge assembly with a drive ribbon in a compact configuration.
[0017] [5] FIG. 2B shows a cross-sectional side view of the cartridge assembly of FIG. 2A with the drive ribbon in an extended configuration.
[0018] [6] FIG. 2C shows a perspective view of the cartridge assembly of FIG. 2A in a disassembled configuration.
[0019] [7] FIGs. 2D and 2E show perspective views of a driver gear configured to rotate a driven mechanism of a drive assembly.
[0020] [8] FIG. 3 shows a block diagram of a motor assembly comprising a plurality of driver assemblies and a controller for controlling the driver assemblies.
[0021] [9] FIGs. 4A and 4B show perspective distal and proximal views, respectively, of the top of a needle assembly with a needle in a compact configuration.
[0022]
[0010] FIGs. 4C and 4D show perspective distal and proximal views, respectively, of the top of the needle assembly of FIG. 4A and FIG. 4B with the needle in an extended configuration.
[0023]
[0011] FIG. 4E shows a perspective view of the bottom of the needle assembly shown in FIGS. 4A-4D with the needle in the compact configuration.
[0012] FIG. 4F shows a perspective view of the bottom of the needle assembly shown in FIG. 4E with the needle in the extended configuration.
[0024]
[0013] FIG. 5 shows a side plan view of a needle assembly portion with a translucent housing.
[0025]
[0014] FIG. 6 shows a perspective view of a needle assembly portion showing a needle mechanism.
[0026]
[0015] FIGs. 7A and 7B show perspective views of a needle mechanism, depicting opposite sides of the needle mechanism.
[0027]
[0016] FIGs. 8A and 8B show perspective views of a driven member of a needle assembly, depicting opposite sides of the driven member.
[0028]
[0017] FIG. 8C shows a side view of a needle mechanism in a compact configuration.
[0029]
[0018] FIG. 8D shows a side view of the needle mechanism of FIG. 8C in an extended configuration.
[0030]
[0019] FIGs. 9 A, 9B, and 9C 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.
[0031]
[0020] FIG. 10 shows a side view of the needle mechanism in the needle assembly in the retracted configuration, after use.
[0032]
[0021] FIG. 11 shows a cross-sectional side view of a needle mechanism disposed in a housing, with the needle mechanism being in the extended configuration.
[0033]
[0022] FIG. 12 shows a longitudinal cross section of a portion of a needle mechanism.
[0034]
[0023] FIG. 13 A shows diagrams of a needle mechanism in an initial compact configuration.
[0035]
[0024] FIG. 13B shows diagrams of the needle mechanism of FIG. 13 A in an extended configuration.
[0036]
[0025] FIG. 13C shows diagrams of the needle mechanism of FIG. 13 A in a retracted compact configuration.
[0037]
[0026] FIG. 14A shows a perspective view of a driven member of a needle assembly having a detent, according to a first embodiment.
[0038]
[0027] FIG. 14B shows a side view of a driven member of a needle assembly having a detent, according to a second embodiment.
[0039]
[0028] FIG. 15 shows a block diagram of a medication delivery device including a controller, a motor assembly, a cartridge assembly, and a needle assembly.
[0029] FIG. 16A shows a side view of a cartridge assembly.
[0040]
[0030] FIG. 16B shows a cross-sectional side view of a housing of a medication delivery device.
[0041]
[0031] FIG. 17 A shows a side view of a partially assembled medication delivery device including the cartridge assembly of FIG. 16A and the housing of FIG. 16B.
[0042]
[0032] FIG. 17B shows a diagram indicating the direction of torque imparted on a driven mechanism.
[0043]
[0033] FIG. 17C shows hook portions of the cartridge housing of FIG. I7B coupled to corresponding coupling portions associated with the housing of a medication delivery device.
[0044]
[0034] FIG. 18 shows a method of assembling a medication delivery device including a cartridge assembly and a needle assembly.
[0045]
[0035] FIGs. 19A, 19B, and 19C show a method of coupling a needle assembly to a coupling portion of the housing of a medication delivery device.
[0046]
[0036] FIG. 19D shows a mechanism for preventing the coupling of the needle assembly to the coupling portion of the housing of the medication delivery device.
[0047]
[0037] FIG. 20A shows a coupling portion of a needle assembly comprising a plurality of facets.
[0048]
[0038] FIG. 20B shows a coupling portion of the housing of a medication delivery device comprising a plurality of facets.
[0049]
[0039] FIG. 21 shows a method for assembling a cartridge assembly.
[0050] DETAILED DESCRIPTION
[0051]
[0040] 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).
[0052]
[0041] 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) a medication vial or fluid chamber and / or (b) a needle assembly 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.
[0053]
[0042] FIG. 1A and FIG. IB show perspective views of a medication delivery device 100. FIG. 1A shows the medication delivery device 100 in an assembled state. FIG. IB shows the medication delivery device in a disassembled state. The medication delivery device 100 includes a housing 120, a cartridge assembly 140, and a needle assembly 160. The medication delivery device 100 has a proximal end 165 and a distal end 175.
[0054]
[0043] FIG. 2A, FIG. 2B, and FIG. 2C show cross-sectional side views of the cartridge assembly 140. The cartridge assembly 140 includes housing 210, a cartridge 202 disposed in the housing 210, and a drive assembly 250 disposed at least partially in an opening of a proximal end 265 of the housing 210. The cartridge assembly may additionally include label 205.
[0055]
[0044] The cartridge 202 may be configured to hold a fluid (e.g., a liquid medication) therein. The fluid may be confined to a fluid chamber delimited by a plunger 206 configured to seal a proximal opening of the cartridge 202 and delimited by a septum 201 configured to seal a distal opening of the cartridge 202. In some embodiments, the plunger 206 may be configured to provide a movable seal against an internal surface of the cartridge 202, to prevent the fluid in the fluid chamber from leaking out of a proximal end of the fluid chamber even during movement of the plunger 206 along the internal surface of the cartridge 202. The septum 201 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 assembly during an injection process, to enable the fluid in the fluid chamber to flow out of the fluid chamber during the injection process, and that may reseal to provide a fluid-tight seal after the piercing object is retracted from the septum 201. In some embodiments, the retraction of the piercing object out of the septum 201 and the subsequent resealing of the septum 201 may prevent contamination of the fluid remaining in the fluid chamber, such that the remaining fluid may be used in future injection processes. In some embodiments, the fluid in the fluid chamber may be sufficient for multiple injections (e.g., multiple doses of medication).
[0056]
[0045] 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 may be held in the fluid chamber of container 202. 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, APOC3 siRNA, DACRA qw II, GIPR agonist long acting, glucose sensing insulin receptor agonist, nisotirostide, bimagrunab, solbinsiran,NRG4 agonist, SCAP siRNA, mazdutide, eloralintide, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mirikizumab 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, simepdekinra, 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, epiregulin antibody, or for treatment of atopic dermatitis, such as with lebrikizumab ucenprubart, for treatment of Alzheimer’s and / or dementia, such as with donanemab, remternetug, mevidalen, 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 CD 19, ANGPTL3 Editor, Anti-VEGF gene therapy, brenipatide, FRa ADC, FXR Agonist, intergrin a5Bl, macupatide, MAPT siRNA, Nectin-4 ADC 1 or 2, PCSK9 editor, PTK7 ADC, SCNA siRNA, UNC13A SSO, 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).
[0057]
[0046] The label 205 may include information about the medication delivery device, the fluid held within cartridge 202, and / or any other suitable information, as aspects of the technology described herein are not limited in this respect. The label 205 may display the information in writing and / or graphics. Additionally, or alternatively, the label 205 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]
[0047] The cartridge 202 may be held in a housing 210 of the cartridge assembly 140. In some embodiments, portions of the internal surface of the housing 210 may serve as spacers that keep the cartridge 202 at a predetermined position in a cartridge chamber of the housing 210. In some embodiments, when the cartridge 202 is fully inserted in the cartridge chamber, the septum 201 may extend out of a distal end 275 of the housing 210, such that the septum 201 may be positioned in a recess of the needle assembly.
[0059]
[0048] In some embodiments, drive assembly 250 is at least partially disposed in an opening the cartridge housing 210. For example, at least a portion of the housing 254 of the drive assembly 250 may be enclosed by a corresponding portion of the cartridge housing 210. In some embodiments, the cartridge housing 210 and drive housing 254 are joined via a joining mechanism. For example, cartridge housing 210 may include one or more openings (e.g., opening 222) configured to receive one or more protrusions (e.g., protrusion 251) extending from the drive housing 254. For example, the protrusion(s) may fit into the opening(s) via a snap fit. FIG. 16A shows an example of drive assembly 250 joined to cartridge housing 210 via joining mechanism 1606.
[0060]
[0049] Drive housing 254 is shown in FIGS. 2A-2B having a proximal cavity 255. In the cavity 255, a ribbon 256 in the axially retracted configuration in which a majority of the ribbon 256 overlaps itself in a spiral (as shown in FIG. 2A). Drive housing 254 includes a neck region 257 (or a reduced cross-sectional area) in communication with the cavity in which the ribbon 256 begins its transition from the retracted configuration to the axially extended configuration in which the ribbon 256 forms a helical shape as it axially lengthens to the extended configuration. Threading may be formed along the neck region 257 to guide the ribbon’s transition. Drive housing 254 is shown FIGS. 2A-2B having a distal opening 259 sized to receive the bushing 204.
[0061]
[0050] The drive assembly 250 may be configured to drive movement of the plunger 206 to eject the fluid in the fluid chamber out of the distal end of the cartridge 202. The drive assembly 250 may be referred to as a “driven” assembly because the drive assembly 250 may itself be driven to move and, in turn, may convert a received drive force to a force that causes the plunger 206 to move along an axis of the cartridge assembly 140.
[0062]
[0051] In some embodiments, the drive assembly 250 comprises a driven mechanism 258 and axially extendable member 256. The driven mechanism 258 may be a drive gear configured to be driven to rotate about the axis A. The distal end of driven mechanism 258 may comprise a spindle 258a around which an axially extendible member 256 may be wound. Driven mechanism 258 may comprise recess 258c (See FIG. 2E) along its proximal side. Driven mechanism 258 can be coupled rotationally free relative to the cavity 255 of the drive housing 254 over the retracted ribbon, as shown in FIG. 2 A. Spindle 258a may have driving surface features 261 such as, for example, teeth, ribs, or recesses, for driving engagement with surface features 263, such as, for example, teeth, ribs, or recesses, formed along the interior of the ribbon. In some embodiments, the axially extendible member 256 may be the ribbon (element 256 may refer to either the axially extendible member or the ribbon interchangeably) having a distal end attached to a foot 252 (e.g., attached via a snap mechanism). The foot 252 may be configured to rotate relative to the distal end of the rotating ribbon 256. For example, the foot 252 may provide a rotary bearing for the rotating ribbon 256 so as not to impart rotation to the plunger 206.
[0052] The drive assembly 250 may be configured such that rotation of the driven mechanism 258 causes the ribbon 256 to extend or expand along the axis A from a retracted state when the driven mechanism 258 is rotated in a first direction. FIG. 2B shows the ribbon 256 in an extended configuration. In some embodiments, the driven mechanism 258 may cause the ribbon 256 to retract when the driven mechanism 258 is rotated in a second direction opposite to the first direction. FIG. 2B shows the ribbon 256 in a retracted configuration.
[0063]
[0053] In some embodiments, when the ribbon 256 is driven to extend, an axial distance between the distal and proximal ends of the ribbon 256 expands or increases, causing the foot 252 to be moved axially. When the foot is in contact with the plunger 206, axial expansion of the ribbon 256 as it lengthens causes the plunger 206 to move axially toward the distal opening of the cartridge 202. The foot may directly contact the plunger 206 or indirectly contact the plunger 206 via plug 203. In some embodiments, precise control of an amount of rotation of the driven mechanism 258 may cause a precise amount of expansion of the ribbon 256 and a precise amount of movement of the plunger 206, which in turn may cause a precise amount of fluid to be ejected. Additional ribbon-expansion mechanisms are described in in US Pat. Publ. No. 2021 / 0046733 to Judson et al., and US Pat. Publ. No. 20210379289 to Judson et al, each of which is incorporated herein by reference in its entirety.
[0064]
[0054] As shown in FIG. 2A and FIG. 2B, the driven mechanism 258 may be partially disposed in drive housing 254. Drive housing 254 may be configured to house the ribbon 256 when the ribbon 256 is in a retracted configuration (e.g., as shown in FIG. 2A) and at least a portion of the ribbon 256 when the ribbon 256 is in an extended configuration (e.g., as shown in FIG. 2B). In some embodiments, drive housing 254 includes a threaded portion 254a configured to guide the ribbon 256 as it is extended and / or retracted. In some embodiments, the drive housing 254 is partially disposed in an opening in the cartridge housing 210 and may be separated from the cartridge housing 210 by bushing 204.
[0065]
[0055] As shown in FIG. 2A, bushing 204 has an axial bore to receive the proximal end of the cartridge 202 and is configured to be disposed between the cartridge 202, the drive housing 254, and the cartridge housing 210. As shown in FIG. 2C, bushing 204 includes a series of external ribs 267a disposed on the outer circumference of the bushing 204, a series of internal ribs 267b disposed on the inner circumference of the bushing 204, or both. The arrangement and configuration of the external and / or internal ribs 267a, 267b of the bushing 204 can provide one or more of the following functions: facilitate centering of the cartridge 202 within the bore of the cartridge housing 210; facilitate in resisting rotation of the cartridge 202 relative to the cartridge housing 210; and facilitate in biasing the cartridge 202 forward relative to the cartridge housing 210.
[0066]
[0056] One example method 2100 of assembling the cartridge assembly 140 will now be described, with reference to FIG. 2C and FIG. 21, including multiple methods of subassemblies to form the cartridge assembly 140 that will be apparent from the description below. One or more steps can be separated or combined to facilitate manufacturing. One step is forming the drive assembly 250. Ribbon 246 can be inserted into the cavity 255 of the drive housing 254 (step 2102). Ribbon 246 after being manufactured may have a tapered shape, unfurled shape as shown in FIG. 2C. The drive housing 254 may be locked into a fixture with the cavity 255 facing out. The tip of the ribbon 246 is inserted into the cavity, and farther into the neck region 257, and the remaining ribbon is axially compacted into the cavity 255 into the spiral configuration. The initial end of the ribbon 246 can be threaded within the neck region 257 so that this region of ribbon forms the helix. In another step (2104), driven mechanism 258 is coupled to the drive housing 254. The driven mechanism 258 is placed through the center of the compacted ribbon 246 and coupled to the drive housing 254, being capable of rotating relative to the drive housing, capping the ribbon 246 inside the cavity 255 to form a drive housing subassembly. The spindle of the driven mechanism is drivably engaged with the internal side of the ribbon. The drive housing subassembly can then be removed from the fixture so that the distal opening 259 of the drive housing 254 can be accessed. The foot 252 is coupled to the ribbon 246 to form the drive assembly 250. The foot 252 can then be attached to the tip of the ribbon 246 from the distal side into the distal opening 259 of the drive housing 254. In another step (2106), the bushing 204 is coupled to the drive housing 254. Bushing 204 is distal opening 259 of the drive housing 254 of the drive assembly 250. In another step (2108), cartridge 202 is coupled to the drive assembly 250 to form a cartridge drive housing subassembly. Cartridge is filled with the medication and sealed with the plunger. Cartridge 202 is inserted within the bore of bushing 204 and coupled with the distal opening 259 of the drive housing 254 of the drive assembly 250. Plug 203 may be inserted into plunger 206 prior to the attachment of the cartridge 202 to the drive assembly 250. In another step (2110), the housing 210 is attached to the drive housing 254 of the drive assembly 250. The open end of the housing 210 receives the cartridge 202 and is attached to the distal end of the drive housing 254 of the drive assembly 250. The label 205 may be affixed to the cartridge housing prior to or after attachment to the drive assembly.
[0067]
[0057] FIG. 2D and FIG. 2E show perspective views of another embodiment of the cartridge assembly and one example of the operability of the driven mechanism which can be applicable to the driven mechanism 258 of the cartridge assembly 140. A driver gear 262 is configured to rotate the driven mechanism of a drive assembly, such as driven mechanism 258 of drive assembly 250. In some embodiments, the driver gear 262 may be included as part of a medication delivery device (e.g., medication delivery device 100 shown in FIG. 1 A and FIG. IB) and may be incorporated in a housing (e.g., housing 120 shown in FIG. IB) of the medication delivery device. In some embodiments, the driver gear 262 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 262 may comprise a spline shaft 264 extending from an axially facing surface of the driver gear 262. The spline shaft 264 may be configured to fit into the recess 258c in the surface of the driven mechanism 258, and the spline shaft 264 may have teeth configured to engage with the recessed teeth of the recess 258c. The recess 258c and a body of the spindle may have a coaxial relationship along the longitudinal axis A, as shown in FIGs. 2D and 2E. In some embodiments, the driver gear 262 may be a spur-type gear configured to be driven to rotate via a force applied to teeth of the driver gear 262. Rotation of the driver gear 262 may drive rotation of the driven mechanism 258 via the spline shaft 264 of the driver gear 262 and the recess 258c and teeth of the driven mechanism 258. In some embodiments, when the cartridge assembly 140 is inserted into a housing 120 of medication delivery device 100, the spline shaft 264 may be located along the longitudinal axis A to facilitate an insertion coupling of the spline shaft 264 with the recess 258c of the cartridge assembly 140, which may be located along the longitudinal axis A. The driver gear 262 and the driven mechanism 258 may be arranged together and may advantageously reduce an amount of thrust experienced by the ribbon 256 and by the medication delivery device 100. In some embodiments, the driver-gear diameter of the body of the driver gear 262 may be at least greater than a spindle-base diameter of the spindle base of the spindle.
[0068]
[0058] FIG. 3 shows a block diagram of a motor assembly 50 comprising a plurality of driver assemblies 300, 310, 320. The motor assembly 50 may be coupled to a controller 350 configured to drive each of the driver assemblies 300, 310, 320. In some embodiments of the present technology, the controller 350 may comprise at least one computer processor (e.g., a CPU) programed to control the driver assemblies 300, 310, 320 individually or in a coordinated manner with each other. In some embodiments, the driver assembly 300 may comprise the driver gear 262, discussed above, for driving rotation of the driven mechanism 258 of the drive assembly 250. The driver assembly 300 may comprise a motor 303 configured to cause rotation of the driver gear 302. Similarly, in some embodiments, the driver assembly 310 may comprise the driver gear 312, discussed above, for driving rotation of a needle-selection gear. The driver assembly 310 may comprise a motor 313 configured to cause rotation of the driver gear 312. In some embodiments, the driver assembly 320 may comprise the driver gear 322 for driving rotation of a transfer gear. The driver assembly 320 may comprise a motor 323 configured to cause rotation of the driver gear 322. In some embodiments, the controller 350 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 medication delivery device 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) a needle of a needle assembly (e.g., needle assembly 160 shown in FIG. IB) to be positioned in the activated position through rotation of a needle-selection gear via the driver assembly 320; (2) movement of the drive assembly 250 to cause movement of the plunger 206 towards the septum 201, to eject the fluid in the fluid chamber by a predetermined amount corresponding to, e.g., an amount of rotation of the driven mechanism 258; and (3) movement of the transfer gear to cause the activated needle to move from a retracted position to an injection position and from the injection position to the retracted position. Movement of the transfer gear also may cause the septum 201 to be pierced to permit the fluid to be ejected into the activated needle.
[0069]
[0059] According to some embodiments of the present technology, the needle assembly 160 includes 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 (e.g., the retracted configuration may prevent the needle mechanism from moving into an injection configuration a second time). In some embodiments, the extended configuration may be a configuration in which the needle mechanism may pierce the septum 201 of the cartridge 202 to couple the needle mechanism to the cartridge 202 such that fluid may flow from the cartridge 202 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.
[0070]
[0060] FIG. 4A and FIG. 4B show perspective distal and proximal views, respectively, of the top of a needle assembly 160 with a needle in a compact configuration. FIG. 4C and FIG. 4D show perspective distal and proximal views, respectively, of the top of the needle assembly 160 of FIG. 4A and FIG. 4B with the needle in an extended configuration (e.g., extending outside of housing 161). FIG. 4C shows the distal portion of the needle 166a configured to pierce the skin of a patient during an injection event, thereby enabling delivery of medication sub-dermally. FIG. 4D shows the proximal portion of the needle 166b configured to pierce the septum 201 of cartridge 202. As shown in FIGS. 4A-4D, in some embodiments, needle assembly 160 includes a pair of grips (grip 163a and grip 163b) extended from the housing of the needle assembly 160. As described herein, a pair of latches may form a coupling portion used for coupling the needle assembly 160 to a housing (e.g., housing 120 shown in FIG. IB) of a medication delivery device, while the pair of grips can be used by the user to facilitate insertion and removal of the needle assembly.
[0071]
[0061] FIG. 4E and FIG. 4F show perspective proximal views of the bottom of the needle assembly 160. FIG. 4E shows the needle in the compact configuration, while FIG. 4F shows the needle in the extended configuration. In some embodiments, the needle assembly 160 includes a driven member 162 configured to engage a needle mechanism housed within the housing of the needle assembly 160. For example, when driven member 162 is rotated, it may cause the needle mechanism to transition between the compact configuration and the extended configuration. In some embodiments, rotation of the driven member 162 is caused by a driver of a medication delivery device with which the driven member 162 may be configured to engage. For example, when the needle mechanism is in an activated position, the driver may engage driven member 162 such that rotation of the driver may cause rotation of the driven member 162. Alternatively, when the needle mechanism is not in the activated position, the driver may be prevented from engaging the driven member 162, thereby preventing rotation of the driven member 162. Example techniques for causing and / or preventing rotation of a driven member of a needle assembly are described herein including at least with respect to FIGs. 5-13C.
[0072]
[0062] FIGs. 5-12 show examples of needle assemblies, aspects of which may be incorporated into the needle assembly 160 shown in FIG. IB and FIGs. 4A-4F.
[0073]
[0063] FIG. 5 shows a side plan view of the needle assembly portion 800”. In an example implementation, needle assembly portion 800” may form at least part of needle assembly 160. In some embodiments, a needle assembly portion 800” may be configured for a needle assembly configured to operate with a single cannula needle and a single septum-piercer needle. In some embodiments, the needle assembly portion 800” may be disposed in a housing such that a driven member 820” of the needle assembly portion 800” may be driven directly by a shaft attached to an external motor (not shown) extending through an access opening of the housing. Driven member 820” is an example implementation of driven member 162 shown in FIGs. 4E and 4F. 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. 5. 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 portion 800” shown in FIG. 5, the driven member 820” may not be easily rotated. In this example, the two indentations or recesses 820a” may be engaged using a shaft head comprising two prongs having complementary shapes and spacings, but may not be engaged with a conventional fork.
[0074]
[0064] Other features of the needle assembly portion 800” may be the same as or similar to those of the needle assembly portion 800 described herein and therefore may have common reference numerals. Those features may be understood from the discussions herein for the needle assembly portion 800.
[0075]
[0065] FIG. 6 is a perspective view of the needle assembly portion 800 showing a needle mechanism 810, according to some embodiments of the present technology. In an example implementation, needle assembly portion 800 may form at least part of needle assembly 160 shown in FIG. IB and FIGs. 4A-4F. For example, needle mechanism 810 may be at least partially housed within a housing of the needle assembly 160. In FIG. 6, a housing 801 of the needle assembly portion 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 portion 800 (e.g., the compact configuration shown in FIGs. 4A- 4B), and an extended configuration, in which portions of one or more components of the needle mechanism 810 may extend beyond the housing 801 (e.g., the extended configuration shown in FIGs. 4C-4D). 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 portion 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 portion 800.
[0076]
[0066] 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. The injection needle 830 is an example implementation of the distal portion of needle 166a shown in FIGs. 4C and 4F. The septum needle 850 is an example implementation of the proximal portion of needle 166b shown in FIGs. 4D and 4F. 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 (e.g., the compact configuration shown in FIGs. 4A-4B and 4E) 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 injection configuration, which may be an extended configuration (e.g., the extended configuration shown in FIGs. 4C-4D and 4F) 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. 6) to pierce the exterior seal 806, while the septum needle 850 may move (rightward in FIG. 6) to pierce the interior seal 808 and the septum 201 of the cartridge assembly 140 shown in FIG. 2C. 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 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. 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.
[0077]
[0067] 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, robber, and the like. For example, the needle connector 870 may comprise a silicone tube (e.g., a liquid silicone robber (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 202 shown in FIG. 2C. In some other embodiments, the needle connector 870 may comprise rigid materials coupled together through flexible connections. For example, at least 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 semi-rigid segments configured to move relative to each, such as in a telescoping action. The semi-rigid 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.
[0078]
[0068] 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.
[0079]
[0069] 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 extraded 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.
[0080]
[0070] FIG. 9 A shows the needle assembly portion 800 in the standby configuration, before injection. FIG. 9B shows the needle assembly portion in the extended configuration, during injection. FIG. 9C shows the needle assembly portion 800 in the retracted configuration, after injection. Note that the needle connector 870 in FIG. 9B is shown in an unextended state and disconnected from the needles 830, 850, even though the needle assembly portion 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 portion 800 from returning to the extended configuration, as discussed below.
[0081]
[0071] 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 250, 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.
[0082]
[0072] FIGs. 7A and 7B 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. 7 A may be considered to show an embodiment of a front side of the needle mechanism 812, and FIG. 7B 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, at least some of the needle mechanism 812 may form at least part of the needle mechanism 810 discussed above. FIGs. 8 A and 8B 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. Driven member 820 is an example implementation of driven member 162 shown in FIGs. 4E and 4F.
[0083]
[0073] 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 portion 800, as shown in FIG. 6, 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 pre-injection standby configuration, a post-injection retracted configuration), in which the needles 830, 850 are within the housing 801.
[0074] 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 movably interact with the engagement portions of the racks to move the racks in opposite directions. In some embodiments, the injectionneedle 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 the second 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.
[0084]
[0075] 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 245 (e.g., driver 245 shown in FIG. 9A) or the rib, as discussed above. For example, if the needle mechanism 812 is part of a first needle assembly portion in the activated position, the actuating member 826 of the driven member 820 may be engaged by the driver 245 such that rotation of the driver 245 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. On the other hand, if the needle mechanism 812 is part of a second needle assembly portion, which is not in the activated position, the actuating member 826 of the driven member 820 may be engaged by the rib of the housing such that rotation of the actuating member 826 may be prevented. For example, the actuating member 826 may comprise slot-shaped recess configured to slide 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 245. In some embodiments, the actuating member 826 may comprise a plurality of recesses (e.g., see the indentations or recesses 820a” in FIG. 5) 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 may be an O-ring configured to prevent debris and / or fluid from entering the housing 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 245.
[0085]
[0076] 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 245 may, in turn, be driven to rotate by an electric motor (not shown).
[0086]
[0077] FIGs. 8C and 8D show front and rear sides, respectively, of the needle mechanism 812 in a compact configuration (FIG. 8C) and an extended configuration (FIG. 8D), 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 202 into a user. (See also FIG. 9A.). 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. 9C.) 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.
[0087]
[0078] More specifically, in the compact configuration of FIG. 8C, 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 and septum 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. 6. 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 Al of the needle mechanism 810 (see FIG. 6) or may even overlap with each other along the axis Al, as depicted in FIG. 6. 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. 6. 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.
[0088]
[0079] In the extended configuration of FIG. 8D, 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 201 and may extend into the fluid chamber of the cartridge 202. 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 250. 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. 8D, the needle connector 870 may retain some curvature when the needle mechanism 812 is in the extended configuration but may have less curvature than 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.
[0089]
[0080] 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 computer. For example, the needle assembly portion 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 350 discussed above). In some embodiments, upon receipt of an injection signal initiated by the user (e.g., through a push of a button, a toggling of a switch, etc.) the computer may cause the driver 245 to be rotated, which in turn may cause rotation of the driven member 820. The computer also may cause the drive assembly 250 to move to urge the fluid within the cartridge 202 to flow out of the cartridge 202. Timing of the movement of the drive assembly 250 and the movement of the needle mechanism 812 may be controlled by the computer 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.
[0090]
[0081] 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 computer based on an amount of rotation of the driver 245. 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).
[0091]
[0082] 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 some embodiments, the driven member 820 may be rotated in a direction C2 (see FIG. 8D), 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 computer. For example, the computer may cause the drive assembly 250 to stop urging the fluid out of the cartridge 202 when a desired amount of the fluid has been urged out of the cartridge 202. The computer 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 portion 800 safely. Additional needle-mechanism configurations are described in US. Pat. Publ. No. 2024 / 0033446 to Gunay et al., and US. Pat. Publ. No. 2024 / 0033445 to Gunay et al., each of which is incorporated herein by reference in its entirety.
[0092]
[0083] FIGs. 9C and 10 show views of the needle assembly portion 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. 8C and 8D 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 portion 800 is part of a plurality of needle assembly portions 800 (e.g., a carousel of needle assembly portions 800), a used one of the needle assembly portions 800 may be prevented from being selected and / or prevented from being put in the activated position by the computer of the dispenser.
[0084] Prior to a dose delivery, the needle mechanism 810 may be in the standby configuration in which a latching portion 849 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 standby configuration, the latching portion 869 may be located at a position X while the latching portion 849 may be located axially leftward of the position X. In some embodiments, the latching portions 849, 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.
[0093]
[0085] 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 overretracted 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 849. For example, the latching portions 869, 849 may comprise surfaces that abut each other once engaged or latched, as shown in FIG. 10, preventing movement of the support 860 rightward and preventing movement of the support 840 leftward.
[0094]
[0086] 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 202 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.
[0095]
[0087] FIG. 11 shows a cross-sectional side view of a needle mechanism 1200 disposed in a housing 801’, according to some embodiments of the present technology. Needle mechanism 1200 is an example implementation of a needle mechanism that may be disposed in a housing of the needle assembly 160 shown in FIGs. IB and 4A-4F. In FIG. 11, the needle mechanism 1200 is in an extended configuration in which a piercing end of an injection needle 1230 extends outside of the housing 801 ’ and a piercing end of a septum needle 1250 extends outside of the housing 801 ’. The injection needle 1 30 is an example implementation of the distal portion of needle 166a shown in FIGs. 4C and 4F. The septum needle 1250 is an example implementation of the proximal portion of needle 166b shown in FIGs. 4D and 4F. A needle connector 1270 may connect non-piercing ends of the injection and septum needles 1230, 1250 such that the needles 1230, 1250 may be in fluid communication with each other. In some embodiments, the injection and septum needles 1230, 1250 may be coaxial when the needle mechanism 1200 is in the extended configuration. In some embodiments, the injection and septum needles 1230, 1250 may be parallel to each other when the needle mechanism 1200 is in the extended configuration. In some embodiments, the needle connector 1270 may be coaxial with the injection and septum needles 1230, 1250 when the needle mechanism 1200 is in the extended configuration.
[0096]
[0088] FIG. 12 shows cross-sectional view of the needle mechanism 1200, according to some embodiments of the present technology. In addition to the injection and septum needles 1230, 1250 and the needle connector 1270, the needle mechanism 1200 may comprise a septum-needle support 1260 and an injection-needle support 1240. Portions of the needle mechanism 1200 configured to cause movement of the needles 1230, 1250 are described elsewhere herein and are not shown in FIG. 12.
[0097]
[0089] According to some embodiments of the present technology, the support 1240 may comprise a connector coupler 1242 configured to connect the support 1240 to the injection needle 1230 and the needle connector 1270. In some embodiments, the connector coupler 1242 may extend from a main body 1241 of the support 1240 and may comprise a bore configured to receive the injection needle 1230 therein. In some embodiments, the injection needle 1230 may extend through the connector coupler 1242 such that an inlet end 1230a may be located outside of the bore of the connector coupler 1242, as shown in FIG. 12. In some other embodiments, the inlet end 1230a may be located within the bore of the connector coupler 1242. As will be appreciated, an outlet end 1230b of the injection needle 1230 may extend outside of the bore of the connector coupler 1242 in order to pierce a user during a dose delivery. A coupling end 1242a of the connector coupler 1242 may be disposed in an outlet end 1272b of a bore 1272 of the needle connector 1270. In some embodiments, the main body 1241 of the support 1240 may be elongated and the bore of the connector coupler 1242 may extend parallel to an elongation direction of the main body 1241.
[0098]
[0090] A similar arrangement may be provided for the septum needle 1250 and the support 1260, according to some embodiments of the present technology. In some embodiments, the support 1260 may comprise a connector coupler 1262 configured to connect the support 1260 to the septum needle 1250 and the needle connector 1270. In some embodiments, the connector coupler 1262 of the support 1260 may comprise an elongated inlet protrusion 1262a configured to extend into an inlet neck of the housing 801’, as shown in FIG. 11. The elongated inlet protrusion 1262a may provide supplemental support to the septum needle 1250, which may be advantageous when the septum needle 1250 encounter frictional forces while piercing and / or retracting from the septum 201. In some embodiments, the elongated inlet protrusion 1262a may be sized to provide support without significantly increasing an amount of weight to be moved during extension and retraction of the support 1260. The connector coupler 1262 may also comprise a bore configured to receive the septum needle 1250 therein. In some embodiments, the septum needle 1250 may extend through the connector coupler 1262 such that an outlet end 1250b may be located outside of the bore of the connector coupler 1262, as shown in FIG. 12. In some other embodiments, the inlet end 1250b may be located within the bore of the connector coupler 1262. As will be appreciated, an inlet end 1250a of the septum needle 1250 may extend outside of the bore of the connector coupler 1262 in order to pierce the septum 201 of the cartridge assembly 140 during a dose delivery.
[0099]
[0091] According to some embodiments of the present technology, the connector couplers 1242, 1262 and the needles 1230, 1250 may be disposed within the needle connector 1270, such that a fluid tight seal may be formed. A coupling end 1242a of the connector coupler 1242 may be disposed in an outlet end 1272b of the bore 1272 of the needle connector 1270, and a coupling end 1262a of the connector coupler 1262 may be disposed in an inlet end 1272a of the bore 1272 of the needle connector 1270. In some embodiments, the needle connector 1270 may be formed of a resilient material that produces a fluid-tight seal around the coupling ends 1242a, 1262a of the connector couplers 1242, 1262. For example, the needle connector 1270 may comprise a flexible polymeric material, such as an elastomer, a thermoset polymer, rubber, and the like. For example, the needle connector 1270 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 1272b of the bore 1272 of the needle connector 1270, the resilient material may stretch during insertion of the coupling end 1242a and may exert a fluid-tight compressive force around the coupling end 1242a after insertion. In some cases, the resilient material also may exert a fluid-tight compressive force around an inlet end 1230a of the injection needle disposed within the outlet end 1272b of the bore 1272. Similarly, at the inlet end 1272a of the bore 1272 of the needle connector 1270, the resilient material may stretch during insertion of the coupling end 1262a and may exert a fluid-tight compressive force around the coupling end 1262a after insertion. In some cases, the resilient material also may exert a fluid-tight compressive force around an outlet end 1250b of the septum needle 1250 disposed within the inlet end 1272a of the bore 1272.
[0100]
[0092] According to some embodiments of the present technology, an outlet edge of the needle connector 1270 may abut a shoulder 1242b of the connector coupler 1242, as shown in FIG. 12. Similarly, in some embodiments, an inlet edge of the needle connector 1270 may abut a shoulder 1262b of the connector coupler 1262, as shown in FIG. 12. As noted above, the needle connector 1270 may have sufficient resilience to exert a compressive force around the coupling ends 1242a ,1262a to produce leak-tight seals between the coupling ends 1242a, 1262a and the bore 1272. In some embodiments, a sealing ring may be provided around an external portion of the needle connector 1270 at regions corresponding to inlet and outlet ends 1272a, 1272b of the bore 1272, to impart an additional compressive force and / or to plug leakage gaps, such that leak-tight seals are produced between the bore 1272 and the coupling ends 1242a, 1262a. For example, the sealing ring may comprise an elastic ring, or glue ring, or a gasket, or the like, located adjacent the shoulders 1242b 1262b of the connector couplers 1242, 1262.
[0101]
[0093] FIGs. 13A, 13B, and 13C show examples of a needle mechanism of a needle assembly (e.g., the needle assembly 160 shown in FIGs. 4A-4F) in different configurations. FIG. 13A 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. 13 A, the slot-shaped recesses of the actuating member 1303 are aligned with protrusions 1302 of the driver. The needles 1301-1, 1301-2 are positioned within housing 1306 and are connected by needle connector 1310. The housing 1306 of needle assemblies (e.g., needle assembly 160) is shown without exterior or interiors seals of the needle assembly 800, seals can be implemented into the housing. In the case without a seal, the needle assembly 160 can be placed into a sterile packaging.
[0102]
[0094] During an injection, the needle mechanism may be moved from the initial compact configuration to an extended configuration. As shown in FIG. 13B, the protrusions 1302 of the driver may engage with the slot-shaped recesses of the actuating member 1303, and rotation of the driver may cause the driven member 1308 to rotate. Rotation of the driven member 1308 causes the needle supports 1305-1, 1305-2 and the corresponding needles 1301-1, 1301-2 to move in opposite directions along parallel axes to the extended configuration. As shown in FIG. 13B, needles 1301-1, 1301-2 each extend at least partially outside of housing 1306. Needle connector 1310 extends to maintain the connection between the needles 1301-1, 1301-2 in the extended configuration.
[0103]
[0095] After the injection, the needle mechanism may be moved from the extended configuration to a subsequent compact configuration. For example, as shown in FIG. 13C, the protrusions 1302 of the driver may engage with the slot-shaped recesses of the actuating member 1303 causing the driven member 1308 to rotate in the opposite direction relative to that shown in FIG. 13B. Rotation of the driven member 1308 may cause the needle supports 1305-1, 1305-1 and corresponding needles 1301-1, 1301-2 to move in directions towards one another until stopping portions 1314-1, 1314-2 of the needle supports engage corresponding stopping portions 1312-1, 1312-2 of the housing 1306. Engagement of the stopping portions in the subsequent compact configuration prevents the needle supports 1305-1, 1305-2 and the corresponding needles 1301-1, 1301-2 from moving back to the extended configuration. Additionally, in the subsequent compact configuration, the slot-shaped recesses of the actuating member 1303 no longer align with the protrusions 1302 of the driver, 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 1306 (e.g., during an injection).
[0104]
[0096] In some embodiments, the driven member of the needle assembly (e.g., needle assembly 160 shown in FIGs. 4A-4F) includes a detent that prevents the driven member from rotating during non-use (e.g., during shipping, storage, and / or handling). FIG. 14A shows a perspective view of a driven member of a needle assembly having a detent 1402, according to a first embodiment. As shown in FIG. 14A, the detent 1402 extends radially from the outer circumference of the driven member 1410. When positioned in cavity 1404 of the needle assembly housing, the detent 1402 holds the driven member 1410 at a predetermined angular orientation, preventing the driven member 1410 from rotating during non-use. When force is applied to the driven member 1410 (e.g., using a driver during use of the medication delivery device), the detent 1402 becomes dislodged from cavity, allowing rotation of the driven member 1410. FIG. 14B shows an alternative embodiment of a driven member 1420 having a detent 1422 disposed along its outer circumference. Detent 1422 is shown extending from the tip of a flexing arm, thereby allowing the detent 1422 to flex radially inward during initial operation. Detent configurations may also be used after retraction of needles to assist in preventing the driven member from rotating after use.
[0105]
[0097] FIG. 15 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 140, the needle assembly 160, the motor assembly 50, and the controller 350, some or all of which may be housed within or partially within a housing of the device 1. In some other embodiments, the controller 350 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.
[0106]
[0098] Some embodiments provide for techniques for assembling a medication delivery device (e.g., medication delivery device 100 shown in FIG. 1A) comprising a cartridge assembly (e.g., cartridge assembly 140 shown in FIG. IB), a needle assembly (e.g., needle assembly 160 shown in FIG. IB, and a housing (e.g., housing 120 shown in FIG. IB) in which the cartridge assembly and needle assembly are disposed. In some embodiments, each of the components of the medication delivery device includes one or more features that assist with assembly and / or disassembly of the medication delivery device.
[0107]
[0099] FIG. 16A shows a side view of the cartridge assembly 140. As described herein with respect to FIG. 2C, in some embodiments, cartridge assembly 140 includes housing 210 (e.g., configured to house a cartridge) and drive assembly 250. The housing 210 may include top portion 210a, bottom portion 210b, and lateral portions extending between the top portion 210a and bottom portion 210b. The lateral portions include a first lateral portion 210c and a second lateral portion (not shown) opposite the first lateral portion 210c.
[0108]
[0100] In some embodiments, the cartridge assembly 140 includes features that assist with assembly and / or disassembly of the medication delivery device. For example, the features may assist with side-loading the cartridge assembly 140 into recess 1621, shown in FIG. 16B, formed in the housing 120 of the medication delivery device. Additionally or alternatively, the features may assist with the removal of the cartridge assembly 140 from the side-loaded configuration.
[0109]
[0101] As shown in FIG. 16A, the housing 210 of the cartridge assembly 140 includes a lifttab portion 1602 formed therein. In some embodiments, the lift-tab portion 1602 includes one or more ribs. The lift-tab portion 1602 may serve to assist a user in lifting the cartridge assembly 140 out of a recess 1621 in housing 120 of the medication delivery device (shown in FIG. 16B), thereby disassembling the medication delivery device. For example, a user may apply pressure to the lift-tab portion 1602 to cause the cartridge assembly 140 to be removed from the recess 1621.
[0110]
[0102] The cartridge assembly 140 may additionally or alternatively include one or more hook portions formed on the lateral portion(s) of the cartridge housing 210. For example, cartridge assembly 140 includes a first hook portion 1608a formed on lateral portion 210c of the cartridge housing 210 and a second hook portion (not shown) formed on the lateral portion opposite to lateral portion 210c. As shown in FIG. 16A, the hook portion 1608a may include an opening in the lateral portion 210c of housing 210. Alternatively, though not shown, the hook portion 1608a may include a protrusion extending from the lateral portion 210c of the housing 210.
[0111]
[0103] In some embodiments, the hook portion(s) are configured to engage corresponding coupling portion(s) of the housing 120 of the medication delivery device. The coupling portion(s) may include hook portion(s) corresponding to the hook portion(s) of the cartridge assembly 140. For example, where the hook portion 1608a of the cartridge assembly 140 is an opening in the cartridge housing 210, hook portion 1628b of the medication delivery device housing 120 may include a protrusion configured to fit in the corresponding opening in cartridge housing 210. Hook portion 1628b is shown extending laterally into the recess 1621 from the walls that define the recess to be received by the hook portion 1608b that extend laterally out. For example, the protrusion and opening may form a snap fit, such that one or more surfaces of the protrusion are flush against one or more surfaces of the opening. Alternatively, when the hook portion 1628b of the cartridge assembly 140 is a protrusion extending from the cartridge housing 210, hook portion 1628b of the medication delivery device may include a cavity formed in the wall of recess 1621 configured to receive the protrusion extending from the cartridge housing. For example, the protrusion and cavity may form a snap fit, such that one or more surfaces of the protrusion are flush against one or more surfaces of the cavity.
[0112]
[0104] FIG. 17A and FIG. 17C shows the first hook portion 1608a of the cartridge assembly 140 engaged with a corresponding coupling portion of the medication delivery device housing 120 when the cartridge assembly 140 is positioned in housing 120. FIG. 17B shows a second hook portion 1608b of the cartridge assembly 140 engaged with a corresponding coupling portion (e.g., coupling portion 1628b shown in FIG. 16B) of the medication delivery device housing 120 when the cartridge assembly 140 is positioned in housing 120.
[0113]
[0105] As shown in FIG. 17A, the shape of hook portion 1608a (and the corresponding coupling portion) may help to maintain the position of the cartridge assembly 140 within the housing 120 of the medication delivery device 100. For example, the shape may help to maintain the position of the cartridge assembly 140 such that axis A of cartridge assembly 140 (shown in FIG. 2B) is substantially parallel to the axis A of medication delivery device. As shown in FIG. 17A, the shape of hook portion 1608a may be formed by an upper face 1734 and facet 1732. In some embodiments, the upper face 1734 is substantially parallel to the axis A of the medication delivery device. In some embodiments, the facet 1732 forms an angle © relative to axis A of the medication delivery device. Angle © may be any suitable angle such as, for example, at least 25°, at least 30°, at least 35°, at least 40°, at least 45°, at least 50°, at least 55°, or at least any other suitable angle, as aspects of the technology described herein are not limited in this respect. Additionally, or alternatively, angle © may be at most 75°, at most 70°, at most 65°, at most 60°, at most 55°, at most 50°, at most 45°, at most 40°, at most 35°, at most 30°, or at most any other suitable angle as aspects of the technology described herein are not limited in this respect. For example, angle © may be 45°.
[0114]
[0106] As described herein, a driver may cause rotation of driven mechanism 258 of drive assembly 250, thereby imparting torque 772 on the driven mechanism 258, as shown in FIG. 17B. When torque 772 is imparted on driven mechanism 258. it is reacted by the cartridge assembly 140, as indicated by arrow 774. While the facet(s) of the hook(s) (e.g., facet 1732 of hook portion 1608a) will carry at least some of the torque, the angle © of the facet 1732 may cause the cartridge assembly 140 to slip axially. Accordingly, in some embodiments, each of the hook portion(s) (e.g., hook portion 1608a and hook portion 1608b shown in FIG. 17C) may include an additional surface 1720. In some embodiments, the additional surface forms an angle with axis A of the medication delivery device that is smaller than the angle © formed by facet 1732. For example, the angle formed by surface 1720 relative to axis A may be 0°, at least 1°, at least 2°, at least 3°, at least 4°, at least 5°, at least 6°, at least 7°, at least 8°, at least 9°, at least 10°, at least 12°, at least 14°, at least 16°, at least 18°, at least 20°, at least 30°, or at least any other suitable angle. Additionally, or alternatively, the angle formed by the surface 1720 relative to axis A may be at most 40°, at most 35°, at most 30°, at most 25°, at most 20°, at most 18°, at most 16°, at most 14°, at most 12°, at most 10°, at most 9°, at most 8°, at most 7°, at most 6°, at most 5°, at most 4°, at most 3°, at most 2°, at most 1°, or any other suitable angle, as aspects of the technology described herein are not limited in this respect. In some embodiments, surface 1720 prevents the cartridge assembly 140 from slipping axially. For example, the angle may be 3°.
[0115]
[0107] Referring again to FIG. 16A, the housing 210 of the cartridge assembly 140 may additionally or alternatively include a latch tooth 1604 extending from the bottom portion 210b of housing 210. The latch tooth 1604 may be configured to engage a corresponding coupling portion formed in the housing 120 of the medication delivery device (shown in FIG. 16B), thereby helping to hold the cartridge assembly 140 within recess 1621. For example, as shown in FIG. 16B, the corresponding coupling portion may include a recess 1622 and retractable lip 1624. When assembled, the retractable lip 1624 may hold the latch tooth 1604 at least partially within the recess 1622. For example, one or more contact surfaces 1604b of the latch tooth 1604 may contact a load surface of recess 1622, while retractable lip 1624 applies pressure to an upper surface 1604a of the latch tooth 1604. Contact surface 1604b may define angular surfaces having a J-shape or L-shape cross-section to facilitate displacement of the retractable lip 1624 during pivot insertion into the housing. In some embodiments, the retractable lip 1624 is spring -loaded. When pressure is applied to the retractable lip (e.g., in an upwards or downwards direction), the retractable lip may be displaced. When the pressure is removed from the retractable lip, the spring force may cause the retractable lip to move back into its original position (e.g., at least partially extending over recess 1622).
[0108] FIG. 18 shows a method of assembling a medication delivery device including a cartridge assembly and a needle assembly. As shown in FIG. 18, the cartridge assembly 140 may be side loaded into a first recess (e.g., recess 1621 shown in FIG. 16B), then the needle assembly 160 is inserted into a second recess 1651. At least a portion of the needle assembly 160 may extend at least partially over at least a portion of the cartridge assembly 140, thereby holding the cartridge assembly 140 within the first recess.
[0116]
[0109] In some embodiments, the cartridge assembly 140 is side-loaded in the first recess by causing the hook portion(s) (e.g., hook portion 1608a and hook portion 1608b shown in FIG. 16A and FIGs. 17A-17C) of the cartridge assembly 140 to engage corresponding coupling portion(s) (e.g., coupling portion 1628b shown in FIG. 16B) of the medication delivery device housing 120. For example, a user may tip the proximal end 265 of the cartridge assembly into the proximal end of the first recess, thereby causing the hook portion(s) to engage the corresponding coupling portion(s) of housing 120.
[0117] [HO] In some embodiments, after causing the hook portion(s) to engage the corresponding housing 120 coupling portion(s), the distal end 275 of cartridge assembly 140 is rotated or pivoted about the hook portions towards axis A of the medication delivery device (e.g., axis A shown in FIG. 17A). In some embodiments, the distal end 275 of cartridge assembly 140 is rotated until the latch tooth 1604 contacts the surface of recess 1622 and retractable lip extends over the upper surface (e.g., upper surface 1604a shown in FIG. 16A) of the latch tooth 1604.
[0118]
[0111] As described herein, after the cartridge assembly 140 is disposed in housing 120, the method of assembling the medication delivery device includes coupling the needle assembly 160 to the housing 120 of the medication delivery device. In some embodiments, this includes inserting needle assembly 160 into recess 1651 such that the driven member 162 engages driver 1652.
[0119]
[0112] In some embodiments, the medication delivery device housing 120 includes coupling features that assist with coupling the needle assembly 160 to the housing 120. In some embodiments, the coupling features include housing latch 1654a and housing latch 1654b (collectively housing latches 1654). FIG. 19A shows the housing latches in a standby configuration, before the needle assembly 160 is inserted into the recess 1651. One or both of the latches 1654 may be spring loaded. FIG. 19B shows the needle assembly 160 partially inserted in the recess 1651. As shown in FIG. 19B, when the needle assembly 160 is partially inserted, the needle assembly 160 forces the latches 1654 away from one another. In particular, protrusion 1910a and protrusion 1910b (collectively protrusions 1910) extending from needle assembly 160 force the lips 1655 of latches 1654 away from one another. FIG. 19C shows the needle assembly 160 fully inserted in recess 1651. As shown in FIG. 19C, after the protrusions 1910 move past the lips of latches 1654, spring force causes the latches 1654 to move back towards one another. In this configuration, the lips 1655 of latches 1654 extend over protrusion 1910 as a latchable surface, holding the needle assembly 160 within recess 1651. In some embodiments, the housing 120 may include one or more button(s) (shown as buttons 185a, 185b in FIGS. 1A and IB) configured to release latches 1654 and the lips of latches from the protrusion 1910, allowing the needle assembly 160 to be removed from the housing 120 of the medication delivery device. With the buttons pressed in relative to the radial location of the grips 163, allowing the user handle removal of the needle assembly by a removal force to the grips away from the recess. In some embodiment, a single button can used to allow for the unlatching.
[0120]
[0113] In some embodiments, the needle assembly 160 and medication delivery device housing 120 include a mechanism for preventing reinsertion of the needle assembly 160 into recess 1651. The mechanism may include the alignment of the driven member 162 and driver 1652. For example, as shown in FIG. 19C, before the needle assembly 160 is used, the driven member 162 and driver 1652 may be aligned such that the needle assembly 160 can be fully inserted into the recess 1651. However, after the needle assembly 160 has been used, driven member 162 may be rotated such that the driven member 162 and driver 1652 are misaligned, preventing the needle assembly 160 from being inserted more than as shown in FIG. 19D. In such a configuration, the latches 1654 are prevented from coupling with protrusions 1910. Rather, the protrusions 1910 merely push the latches 1654 apart.
[0121]
[0114] In some embodiments, the needle assembly 160 includes features that assist with assembly and / or disassembly of the medication delivery device. For example, the needle assembly 160 may include (a) a first coupling portion that includes a latchable surface including one or more protrusions extending from a lateral surface of the housing of the needle assembly 160, (b) a second coupling portion that includes one or more coupling facets.
[0122]
[0115] With reference to FIGS. 4A-4D, the first coupling portion may include protrusions 1 10a and 1910b (collectively protrusions 1910). The protrusions 1910 form latchable surfaces configured to engage corresponding housing coupling portions (e.g., housing latches 1654) when the needle assembly inserted into the recess 1651 of the housing 120 of the medication delivery device 100.
[0123]
[0116] In some embodiments, the second coupling portion includes one or more coupling facets formed in the outer surface of the needle assembly housing. FIG. 20A shows a bottom view of the needle assembly 160 (e.g., as shown in FIG. 4E and FIG. 4F). As shown in FIG. 20A, the bottom of needle assembly 160 includes facets 2000a, 2000b, 2000c, 2000d, and 2000e (collectively facets 2000) formed in the housing.
[0124]
[0117] In some embodiments, when needle assembly 160 is coupled to the housing 120 of the medication delivery device, the needle assembly facets 2000 contact respective facets formed in the housing 120 of the medication delivery device. FIG. 20B shows a top view of the housing 120 of the medication delivery device. As shown in FIG. 20B, the housing 120 includes facets 2010a, 2010b, 2010c, 2010d, 2010e, 201 Of, and 2010g (collectively facets 2010) formed in recess 1651 of the housing 120 of the medication delivery device.
[0125]
[0118] Contact between facets 2000 and facets 2010 results in kinematic coupling. In the example of FIG. 20 A and FIG. 20B, facets 2000 include five surfaces that eliminate X, Y, Z, pitch, and yaw motions. In some embodiments, the latchable surfaces formed by protrusions 910 shown in FIGS. 4A-4D eliminate the roll degree of freedom. As a result, the combination of the kinematic coupling facets and protrusions 1910 may form a rigid joint with zero engage and / or release effort.
[0126]
[0119] Various aspects are described in the description in this disclosure, which include, but are not limited to, the following aspects of a cartridge assembly, a needle assembly, a medication delivery device, and / or a method of assembling.
[0127]
[0120] In some embodiments, the drive assembly includes a driven base member configured to rotate about an axis defined by the proximal end and the distal end of the cartridge housing.
[0128]
[0121] In some embodiments, the drive assembly includes a drive ribbon disposed in a cavity of the drive housing, the drive ribbon being axially extendable relative to the cartridge to advance the plunger of the cartridge, wherein the drive assembly is configured to cause the drive ribbon to extend axially relative to the cartridge to advance the plunger.
[0129]
[0122] In some embodiments, the driven base member includes a spindle disposed within the drive ribbon, the spindle having drive surface features configured to engage portions of the drive ribbon.
[0123] In some embodiments, the drive housing includes a threaded portion configured to guide at least a portion of the drive ribbon as the drive ribbon is axially extended relative to the cartridge.
[0130]
[0124] In some embodiments, the drive assembly includes a rotary bearing positioned between the drive ribbon and the plunger.
[0131]
[0125] In some embodiments, the rotary bearing is fastened to the drive ribbon via a snap mechanism.
[0132]
[0126] In some embodiments, the cartridge housing includes an opening in the proximal end of the cartridge housing, wherein the drive housing is positioned within the opening in the proximal end of the cartridge housing such that at least a portion of the drive housing is enclosed by a corresponding portion of the cartridge housing.
[0133]
[0127] In some embodiments, an outer surface of the portion of the drive housing includes a protrusion that extends through an opening in the corresponding portion of the cartridge housing.
[0134]
[0128] In some embodiments, the cartridge assembly is disposed in a recess formed in the outer surface of the housing of the device.
[0135]
[0129] In some embodiments, the recess is a first recess in the outer surface of the housing, and the medication delivery device includes a needle assembly disposed in a second recess in the outer surface of the housing, wherein the needle assembly includes a needle assembly housing and a needle.
[0136]
[0130] In some embodiments, a latch tooth extending from the bottom portion of the outer surface of the cartridge housing, and at least one hook portion including at least one protrusion extending from at least one of the two lateral portions of the outer surface of the cartridge housing, or at least one opening in the at least one of the two lateral portions of the outer surface of the cartridge housing, and a cartridge is configured to hold a fluid, wherein the cartridge is disposed in a cavity defined by the outer surface of the cartridge housing.
[0137]
[0131] In some embodiments, the at least one hook portion includes two hook portions, wherein a first of the two hook portions includes a first protrusion extending from a first lateral portion of the two lateral portions of the outer surface, or a first opening in the first lateral portion, and wherein a second of the two hook portions includes a second protrusion extending from a second lateral portion of the two lateral portions of the outer surface, or a second opening in the second lateral portion.
[0132] In some embodiments, the at least one hook portion includes the at least one protrusion extending from the at least one of the two lateral portions of the outer surface.
[0138]
[0133] In some embodiments, the at least one hook portion includes the at least one opening in the at least one of the two lateral portions of the outer surface.
[0139]
[0134] In some embodiments, the cartridge housing includes a lift-tab portion formed in the outer surface.
[0140]
[0135] In some embodiments, the latch tooth and the at least one hook portion are configured to couple to corresponding coupling portions of a housing of a medication delivery device.
[0141]
[0136] In some embodiments, a drive assembly is provided and includes a drive housing, wherein the drive housing is coupled to the cartridge housing via at least one snap joint.
[0142]
[0137] In some embodiments, a recess is formed in the outer surface of the portion extending between the proximal end and the distal end, the recess including a load surface and two lateral surfaces, the load surface being configured to receive a cartridge assembly radially towards the axis, the first housing coupling portion is disposed along the load surface, the first housing coupling portion includes a retractable lip, and at least one second housing coupling portion is disposed along at least one of the two lateral surfaces of the recess.
[0143]
[0138] In some embodiments, the cartridge assembly is disposed in the recess and includes a cartridge housing.
[0144]
[0139] In some embodiments, the first housing coupling portion is coupled to a corresponding latch tooth extending from the cartridge housing.
[0145]
[0140] In some embodiments, wherein the latch tooth includes a contact surface contacting the load surface of the recess; and an upper surface, wherein the retractable lip applies pressure to the upper surface.
[0146]
[0141] In some embodiments, the contact surface is flush against the load surface.
[0147]
[0142] In some embodiments, the at least one second housing coupling portion is coupled to at least one hook portion of the cartridge housing.
[0148]
[0143] In some embodiments, the at least one second housing coupling portion includes at least one protrusion extending from the at least one of the two lateral surfaces, and the at least one hook portion includes at least one opening in the cartridge housing, wherein the at least one protrusion is disposed in the at least one opening in the cartridge housing.
[0149]
[0144] In some embodiments, the at least one protrusion has walls that are flush against walls of the at least one opening in the cartridge housing.
[0145] In some embodiments, the at least one second housing coupling portion includes at least one cavity formed in the at least one of the two lateral surfaces, and wherein the at least one hook portion includes at least one protrusion extending from the cartridge housing, wherein the at least one protrusion is disposed in the at least one cavity.
[0150]
[0146] In some embodiments, a surface of the at least one protrusion is flush against a surface of the at least one cavity.
[0151]
[0147] In some embodiments, positioning the latch tooth against the load surface of the recess causes the retractable lip to at least partially extend over the latch tooth.
[0152]
[0148] In some embodiments, the at least one second housing coupling portion includes at least one protrusion extending from the at least one of the two lateral surfaces, the at least one hook portion includes at least one opening in the cartridge housing, and the step of causing the at least one protrusion to extend through the at least one opening.
[0153]
[0149] In some embodiments, the at least one second housing coupling portion includes at least one cavity formed in the at least one of the two lateral surfaces, and the at least one hook portion includes at least one protrusion extending from the cartridge housing, and the step of causing the at least one protrusion to extend into the at least one cavity.
[0154]
[0150] In some embodiments, the needle assembly further includes a gear configured to drive the needle between an extended configuration and a compact configuration.
[0155]
[0151] In some embodiments, the needle assembly further includes an anti-rotation component configured to maintain the gear in a predetermined angular orientation.
[0156]
[0152] In some embodiments, the anti-rotation component includes a detent disposed along the gear, and wherein the needle assembly housing further includes a recess configured to receive the detent of the gear.
[0157]
[0153] In some embodiments, the detent is disposed along an outer circumference of the gear defined about a gear axis, and wherein the recess of the needle assembly housing faces the gear axis.
[0158]
[0154] In some embodiments, the anti-rotation component includes a detent disposed on the needle assembly housing, and wherein the gear includes a recess configured to receive the detent of the needle assembly housing.
[0159]
[0155] In some embodiments, the needle assembly further includes a protrusion extending from the bottom surface of the needle assembly housing, wherein the protrusion is configured to be received by a corresponding coupling portion disposed on a housing of a medication delivery device.
[0160]
[0156] In some embodiments, a second coupling portion disposed on the bottom surface of the needle assembly housing, the second coupling portion including a first plurality of facets configured to contact a corresponding second plurality of facets disposed on a housing of a medication delivery device.
[0161]
[0157] In some embodiments, a needle assembly including the needle assembly housing, the needle assembly being disposed in the recess of the housing.
[0162]
[0158] In some embodiments, a first needle assembly coupling portion including a respective latchable surface defined by at least one lateral surface of the needle assembly housing; and a second needle assembly coupling portion disposed on a bottom surface of the needle assembly housing, the second needle assembly coupling portion including the second plurality of facets.
[0163]
[0159] In some embodiments, each of the first plurality of facets contacts a respective facet of the second plurality of facets.
[0164]
[0160] In some embodiments, the needle assembly includes grips extending from the needle assembly housing to wrap at least partially around the outer surface of the housing of the medication delivery device.
[0165]
[0161] In some embodiments, the latchable surface includes a protrusion, wherein each housing latch of the pair of housing latches engages the protrusion of a corresponding latchable surface.
[0166]
[0162] In some embodiments, the first housing coupling portion further includes a button that, when pressed, causes the pair of housing latches to release the protrusion.
[0167]
[0163] In some embodiments, in the coupling the medication cartridge step, the bushing is engaged between the medication cartridge, the drive housing, and the cartridge housing.
[0168]
[0164] In some embodiments, in the inserting the drive ribbon step, a distal tip of the drive ribbon is threaded within a neck region of the drive housing. CONCLUSION
[0169]
[0165] 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 not implement any features described as advantageous herein. Accordingly, the foregoing description and attached drawings are by way of example only.
[0170]
[0166] 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.
[0171]
[0167] 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.
[0172]
[0168] 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 one element 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.
[0173]
[0169] 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.
[0174]
[0170] 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.”
[0171] 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.
[0175]
[0172] 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%.
[0176]
[0173] 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 constmed 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.
[0177]
[0174] 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.
[0178]
[0175] 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.
[0179]
[0176] 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.
[0180]
[0177] 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 cartridge assembly, comprising: a cartridge 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; and a lift-tab portion formed in the outer surface; a cartridge disposed in the cartridge housing and comprising a plunger; and a drive assembly, the drive assembly comprising: a drive housing coupled to the proximal end of the cartridge housing.
2. The cartridge assembly of claim 1, wherein the drive assembly further comprises a driven base member configured to rotate about an axis defined by the proximal end and the distal end of the cartridge housing.
3. The cartridge assembly of claim 2, wherein the drive assembly further comprises a drive ribbon disposed in a cavity of the drive housing, the drive ribbon being axially extendable relative to the cartridge to advance the plunger of the cartridge, wherein the drive assembly is configured to cause the drive ribbon to extend axially relative to the cartridge to advance the plunger.
4. The cartridge assembly of claim 3, wherein the driven base member comprises a spindle disposed within the drive ribbon, the spindle having drive surface features configured to engage portions of the drive ribbon.
5. The cartridge assembly of any of claims 3-4, wherein the drive housing includes a threaded portion configured to guide at least a portion of the drive ribbon as the drive ribbon is axially extended relative to the cartridge.
6. The cartridge assembly of any of claims 3-5, wherein the drive assembly further comprises a rotary bearing positioned between the drive ribbon and the plunger.
7. The cartridge assembly of claim 6, wherein the rotary bearing is fastened to the drive ribbon via a snap mechanism.
8. The cartridge assembly of any of claims 1-7, wherein the cartridge housing comprises an opening in the proximal end of the cartridge housing, wherein the drive housing is positioned within the opening in the proximal end of the cartridge housing such that at least a portion of the drive housing is enclosed by a corresponding portion of the cartridge housing.
9. The cartridge assembly of claim 8, wherein an outer surface of the portion of the drive housing comprises a protrusion that extends through an opening in the corresponding portion of the cartridge housing.
10. 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 comprises an outer surface; and the cartridge assembly of any of claims 1 -9, the cartridge assembly disposed in a recess formed in the outer surface of the housing.
11. The medication delivery device of claim 10, wherein the recess is a first recess in the outer surface of the housing, and wherein the medication delivery device further comprises: a needle assembly disposed in a second recess in the outer surface of the housing, wherein the needle assembly comprises: a needle assembly housing; and a needle.
12. A cartridge assembly, comprising: a cartridge housing, comprising: an outer surface comprising a bottom portion, a top portion, and two lateral portions extending between the bottom and top portions; a latch tooth extending from the bottom portion of the outer surface; and at least one hook portion comprising:at least one protrusion extending from at least one of the two lateral portions of the outer surface; or at least one opening in the at least one of the two lateral portions of the outer surface; and a cartridge configured to hold a fluid, wherein the cartridge is disposed in a cavity defined by the outer surface of the cartridge housing.
13. The cartridge assembly of claim 12, wherein the at least one hook portion comprises two hook portions, wherein a first of the two hook portions comprises: a first protrusion extending from a first lateral portion of the two lateral portions of the outer surface; or a first opening in the first lateral portion, and wherein a second of the two hook portions comprises: a second protrusion extending from a second lateral portion of the two lateral portions of the outer surface; or a second opening in the second lateral portion.
14. The cartridge assembly of any of claims 12-13, wherein the at least one hook portion comprises the at least one protrusion extending from the at least one of the two lateral portions of the outer surface.
15. The cartridge assembly of any of claims 12-13, wherein the at least one hook portion comprises the at least one opening in the at least one of the two lateral portions of the outer surface.
16. The cartridge assembly of any of claims 12-15, wherein the cartridge housing further comprises a lift-tab portion formed in the outer surface.
17. The cartridge assembly of any of claims 12-16, wherein the latch tooth and the at least one hook portion are configured to couple to corresponding coupling portions of a housing of a medication delivery device.
18. The cartridge assembly of any of claims 12-17, further comprising a drive assembly comprising a drive housing, wherein the drive housing is coupled to the cartridge housing via at least one snap joint.
19. 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 includes an outer surface, the proximal and distal ends defining an axis; a recess formed in the outer surface of the portion extending between the proximal end and the distal end, the recess comprising a load surface and two lateral surfaces, the load surface being configured to receive a cartridge assembly radially towards the axis; a first housing coupling portion disposed along the load surface, the first housing coupling portion comprising a retractable lip; and at least one second housing coupling portion disposed along at least one of the two lateral surfaces of the recess.
20. The medication delivery device of claim 19, further comprising the cartridge assembly, wherein the cartridge assembly is disposed in the recess and comprises a cartridge housing.
21. The medication delivery device of claim 20, wherein the first housing coupling portion is coupled to a corresponding latch tooth extending from the cartridge housing.
22. The medication delivery device of claim 21, wherein the latch tooth comprises: a contact surface contacting the load surface of the recess; and an upper surface, wherein the retractable lip applies pressure to the upper surface.
23. The medication delivery device of claim 22, wherein the contact surface is flush against the load surface.
24. The medication delivery device of any of claims 20-23, wherein the at least one second housing coupling portion is coupled to at least one hook portion of the cartridge housing.
25. The medication delivery device of claim 24, wherein the at least one second housing coupling portion comprises at least one protrusion extending from the at least one of the two lateral surfaces, and wherein the at least one hook portion comprises at least one opening in the cartridge housing, wherein the at least one protrusion is disposed in the at least one opening in the cartridge housing.
26. The medication delivery device of claim 25, wherein the at least one protrusion has walls that are flush against walls of the at least one opening in the cartridge housing.
27. The medication delivery device of claim 24, wherein the at least one second housing coupling portion comprises at least one cavity formed in the at least one of the two lateral surfaces, and wherein the at least one hook portion comprises at least one protrusion extending from the cartridge housing, wherein the at least one protrusion is disposed in the at least one cavity.
28. The medication delivery device of claim 27, wherein a surface of the at least one protrusion is flush against a surface of the at least one cavity.
29. A method of assembling the medication delivery device of claim 20, wherein the cartridge housing comprises: a latch tooth extending from the cartridge housing; and at least one hook portion, and wherein the method comprises: coupling the at least one hook portion to the at least one second housing coupling portion; and coupling the latch tooth to the first housing coupling portion by positioning the latch tooth against the load surface of the recess.
30. The method of claim 29, wherein positioning the latch tooth against the load surface of the recess causes the retractable lip to at least partially extend over the latch tooth.
31. The method of any of claims 29-30, wherein the at least one second housing coupling portion comprises at least one protrusion extending from the at least one of the two lateral surfaces, wherein the at least one hook portion comprises at least one opening in the cartridge housing, and wherein the method further comprises causing the at least one protrusion to extend through the at least one opening.
32. The method of any of claims 29-30, wherein the at least one second housing coupling portion comprises at least one cavity formed in the at least one of the two lateral surfaces, and wherein the at least one hook portion comprises at least one protrusion extending from the cartridge housing, and wherein the method further comprises causing the at least one protrusion to extend into the at least one cavity.
33. A needle assembly, comprising: a needle assembly housing, comprising: a top surface, a bottom surface, and a pair of lateral surfaces extending between the top and bottom surfaces; a first coupling portion comprising a respective latchable surface defined by each of the pair of lateral surfaces; a pair of grips, each of the grips extending over a corresponding one of the lateral surfaces; and a needle disposed in the needle assembly housing.
34. The needle assembly of claim 33, wherein the needle assembly further comprises a gear configured to drive the needle between an extended configuration and a compact configuration.
35. The needle assembly of claim 34, wherein the needle assembly further comprises an antirotation component configured to maintain the gear in a predetermined angular orientation.
36. The needle assembly of claim 35, wherein the anti-rotation component comprises a detent disposed along the gear, and wherein the needle assembly housing further comprises a recess configured to receive the detent of the gear.
37. The needle assembly of claim 36, wherein the detent is disposed along an outer circumference of the gear defined about a gear axis, and wherein the recess of the needle assembly housing faces the gear axis.
38. The needle assembly of claim 35, wherein the anti-rotation component comprises a detent disposed on the needle assembly housing, and wherein the gear comprises a recess configured to receive the detent of the needle assembly housing.
39. The needle assembly of any of claims 33-38, wherein the needle assembly further comprises a protrusion extending from the bottom surface of the needle assembly housing, wherein the protrusion is configured to be received by a corresponding coupling portion disposed on a housing of a medication delivery device.
40. The needle assembly of any of claims 33-38, further comprising a second coupling portion disposed on the bottom surface of the needle assembly housing, the second coupling portion comprising a first plurality of facets configured to contact a corresponding second plurality of facets disposed on a housing of a medication delivery device.
41. 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 includes an outer surface, the proximal and distal ends defining an axis; a recess formed in the outer surface of the portion extending between the proximal end and the distal end;a first housing coupling portion comprising a pair of housing latches disposed in the recess; and a second housing coupling portion comprising a first plurality of facets configured to contact a second plurality of facets disposed on a needle assembly housing.
42. The medication delivery device of claim 41, further comprising a needle assembly comprising the needle assembly housing, the needle assembly being disposed in the recess of the housing.
43. The medication delivery device of claim 42, wherein the needle assembly housing comprises: a first needle assembly coupling portion comprising a respective latchable surface defined by at least one lateral surface of the needle assembly housing; and a second needle assembly coupling portion disposed on a bottom surface of the needle assembly housing, the second needle assembly coupling portion comprising the second plurality of facets.
44. The medication delivery device of claim 43, wherein each of the first plurality of facets contacts a respective facet of the second plurality of facets.
45. The medication delivery device of any of claims 43-44, wherein the needle assembly comprises grips extending from the needle assembly housing to wrap at least partially around the outer surface of the housing of the medication delivery device.
46. The medication delivery device of any of claims 43-45, wherein the latchable surface comprises a protrusion, wherein each housing latch of the pair of housing latches engages the protrusion of a corresponding latchable surface.
47. The medication delivery device of claim 46, wherein the first housing coupling portion further comprises one or more buttons that, when pressed, causes the pair of housing latches to release the protrusion.
48. A method of assembling a cartridge assembly, comprising the steps of: inserting a drive ribbon into a proximal cavity of a drive housing; coupling a driven mechanism to the drive housing over the proximal cavity so that a portion of the driven mechanism is engaged with the drive ribbon and the drive ribbon is in an axially compacted configuration; coupling a bushing to a distal end of the drive housing; coupling a medication cartridge to the distal end of the drive housing wherein the medication cartridge is disposed within the bushing; and coupling a cartridge housing to the drive housing wherein the cartridge housing surrounds the medication cartridge, thereby forming the cartridge assembly.
49. The method of claim 48, wherein in the coupling the medication cartridge step, the bushing is engaged between the medication cartridge, the drive housing, and the cartridge housing.
50. The method of claim 48, wherein in the inserting the drive ribbon step, a distal tip of the drive ribbon is threaded within a neck region of the drive housing.