Needle assembly and fluid delivery system having a needle assembly

Abstract

One or more needle assemblies for a fluid delivery device include a needle support containing a connector coupler and have various manufacturing methods for forming a leak-proof seal around the needle. The flexible connector has a connector bore that forms a fluid path communicating with the bore of the needle. A driven member is at least partially located within a housing and is driven to move the needle support so that it moves between a compact configuration in which fluid cannot be transported through the needle and an expanded configuration in which fluid can be transported through the needle. A movable carousel can move a selected needle assembly from among many needle assemblies to an operational position for fluid or drug delivery.

Description

Technical Field

[0001] The present disclosure generally relates to fluid delivery devices such as infusion devices. More specifically, the present disclosure relates to the needle assembly of a fluid delivery device.

Background Art

[0002] Conventional infusion devices are often used to inject a pharmaceutical fluid into a patient through a needle. In cases where the drug is administered frequently (e.g., daily at different times during the day), it may be advantageous for the drug to be administered without a medical professional present. However, it can be difficult to ensure that the needle is maintained in a sterile environment prior to injection and that the drug is administered safely, efficiently, and in the appropriate amount. Additionally, some patients may be uncomfortable seeing or handling the needle directly.

Summary of the Invention

[0003] In a first aspect of the present disclosure, a needle assembly is disclosed. The needle assembly includes a housing and a needle. A needle support is disposed within the housing and includes a connector coupler molded around the needle to form a leak-proof seal around the needle. A flexible connector is disposed within the housing and has a connector bore that forms a fluid path in fluid communication with the bore of the needle. The connector includes a first end attached to the connector coupler. A driven member is disposed at least partially within the housing and is configured to drive the needle support to move between an extended configuration in which fluid can be transferred through the needle and a compact configuration in which fluid cannot be transferred through the needle. The non-puncturing end of the needle extends beyond the connector coupler and is disposed within the connector bore, and the puncturing end of the needle extends beyond the connector coupler. In the compact configuration, the connector is curved in a loop or partial loop shape and the needle is disposed within the housing. In the extended configuration, the connector has an elongated shape, at least a portion of the puncturing end of the needle extends beyond the housing, and the connector bore of the first end of the connector is parallel or coaxial with the connector bore of the second end of the connector.

[0004] In a second aspect of the present disclosure, a needle system is disclosed, comprising a housing, a movable carousel at least partially located within the housing, and a plurality of selectable needle assemblies mounted on the carousel. The needle assemblies are at least partially located within the housing. Each needle assembly includes a needle, a needle support having a connector coupler molded around the needle to form a leak-proof seal around the needle, and a flexible connector having a connector bore forming a fluid path in fluid communication with the bore of the needle. The connector includes a first end attached to the connector coupler. A driven member is configured to drive the needle support between an extended configuration in which fluid can be transported through the needle and a compact configuration in which fluid cannot be transported through the needle. A needle driver is configured to engage with a selected needle assembly when the selected needle assembly is in the operating position, and to move the needle support of the selected needle assembly between the compact and extended configurations. The movable carousel is configured to move the selected needle assembly to the operating position.

[0005] A third aspect of this disclosure discloses a method for manufacturing a needle assembly. The method comprises one or more of the following steps: molding a needle support around a needle so that a connector coupler of the needle support surrounds a section of the needle, forming a leak-proof seal around the section of the needle, and so that the non-puncture end of the needle extends beyond the connector coupler; inserting a portion of the connector coupler into the bore of an elastic and flexible connector so that the non-puncture end of the needle is positioned within the bore of the connector. [Brief explanation of the drawing]

[0006] Various aspects, techniques, and embodiments of the Art disclosed herein are described below with reference to the accompanying drawings. It should be understood that the drawings are not necessarily drawn to scale. Items appearing in multiple drawings may be indicated by the same reference numeral. For clarity, not all components are referenced in all drawings. The features of the Art will be more clearly defined and the techniques for achieving these features will be better understood by referring to the following detailed description in conjunction with the accompanying drawings. [Figure 1] This is a perspective view of a dispenser including the cartridge assembly and needle system. [Figure 2] Figure 1 is a perspective view of the cartridge assembly. [Figure 3] Figure 1 is a perspective view of the cartridge assembly in a partially disassembled state. [Figure 4A] Figure 1 is a perspective view of the cartridge assembly in the longitudinal direction. [Figure 4B] This is another perspective view of the longitudinal cross-section of the cartridge assembly shown in Figure 1. [Figure 4C] This is a cross-sectional perspective view of the cartridge assembly in Figure 1, cut along plane 4C in Figure 4A. [Figure 4D] Figure 4A is a plan view of a slice of the cartridge assembly from Figure 1, cut along the parallel plane 4D. [Figure 4E] Figure 1 is a plan view of the proximal end of the cartridge assembly. [Figure 4F] A perspective view of the proximal end of the cartridge assembly's feet. [Figure 4G] This is a perspective view of the ribbon and the bearing configured to engage with the foot shown in Figure 4F. [Figure 5] This is a schematic plan view showing a longitudinal cross-section of a portion of the proximal end of the first modified example 5A and the second modified example 5B of the cartridge assembly shown in Figure 1. [Figure 6A]This is an elevation and side view of an axially expandable ribbon. In Figures 6A and 6B, the distal end of the ribbon is on the left and the proximal end is on the right. In Figures 6A and 6B, the ribbon is in an unstressed state and has a tapered helical structure. [Figure 6B] This is an elevation and side view of an axially expandable ribbon. In Figures 6A and 6B, the distal end of the ribbon is on the left and the proximal end is on the right. In Figures 6A and 6B, the ribbon is in an unstressed state and has a tapered helical structure. [Figure 6C] Figure 6A is an elevation end view of an axially expandable ribbon in a state where no stress is applied. Figure 6C shows the outer surface of the distal end of the ribbon. [Figure 6D] Figure 6A is an elevation end view of an axially expandable ribbon in a state where no stress is applied. Figure 6D shows the inner surface of the distal end of the ribbon. [Figure 7A] This is a perspective view of the cartridge assembly and the driver gear configured to rotate a portion of the cartridge assembly. [Figure 7B] Figure 7A is another perspective view of the cartridge assembly and driver gear. [Figure 7C] Figure 7A is a perspective view of the driver gear. [Figure 8] This is a perspective view of a dispenser including the cartridge assembly and needle assembly. [Figure 9A] Figure 8 is a perspective view of the needle assembly. [Figure 9B] Figure 9A is a plan view of the cross-section of the needle assembly in Figure 9A, cut along plane 9B. Figure 9B shows the left side of plane 9B. [Figure 9C] Figure 9A is a perspective view of the needle assembly in a partially disassembled state. [Figure 10] Figure 10 shows a perspective view of a cassette with a dispenser partially inserted into the cassette housing. A driver gear for driving movement within the dispenser is shown. [Figure 11A] These are perspective views of the longitudinal cross-sections of the needle assembly partially inserted into the cassette housing and a portion of the fully inserted needle assembly. In Figure 11A, the gear lock of the needle assembly is in the locked position. In Figure 11B, the gear lock is in the unlocked position. [Figure 11B] These are perspective views of the longitudinal cross-sections of the needle assembly partially inserted into the cassette housing and a portion of the fully inserted needle assembly. In Figure 11A, the gear lock of the needle assembly is in the locked position. In Figure 11B, the gear lock is in the unlocked position. [Figure 12A] This is a perspective view of the distal section of the dispenser. [Figure 12B] This is the same diagram as Figure 12A, but the housing of the dispenser needle assembly appears semi-transparent. [Figure 12C] Figure 12B is a perspective view of the distal section of the dispenser in a partially disassembled state. [Figure 13A] These are plan views of the longitudinal cross-section of the needle assembly in the locked and unlocked states, respectively. In Figure 13A, the transmission gear (idler) is prevented from rotating the needle moving gear of the needle assembly by a spring that presses the lock plate against the housing protrusion. In Figure 13B, the transmission gear (idler) and the needle moving gear are engaged, and the transmission gear (idler) is separated from the housing protrusion and therefore not prevented from rotating the needle moving gear. [Figure 13B] These are plan views of the longitudinal cross-section of the needle assembly in the locked and unlocked states, respectively. In Figure 13A, the transmission gear (idler) is prevented from rotating the needle moving gear of the needle assembly by a spring that presses the lock plate against the housing protrusion. In Figure 13B, the transmission gear (idler) and the needle moving gear are engaged, and the transmission gear (idler) is separated from the housing protrusion and therefore not prevented from rotating the needle moving gear. [Figure 13C]It is a plan view of a transverse cross section of the needle assembly of FIG. 13A cut through the lock plate, showing a portion of the lock plate that prevents rotational movement of the needle selector. [Figure 13D] It is a plan view of a transverse cross section of the needle assembly of FIG. 13A cut through the transmission gear (idler), showing a lip provided with a housing protrusion that prevents rotational movement of the transmission gear. [Figure 14A] It is an elevation side view of the distal section of the cassette. [Figure 14B] It is a perspective view of the distal end of the cassette of FIG. 14A. In FIG. 14B, the latch of the cassette housing is latched to the dispenser of the cassette, preventing the dispenser from moving relative to the housing. [Figure 14C] It is a perspective view of the distal end of FIG. 14B. In FIG. 14C, the latch is disengaged from the dispenser, and the biasing spring of the gear lock of the dispenser allows the dispenser to move outward relative to the cassette housing. [Figure 14D] It is a perspective view of the distal end of FIG. 14C. In FIG. 14D, after being disengaged, the dispenser is movable out of the cassette housing, and a new dispenser is movable into the cassette housing. [Figure 15A] It is a plan view of a longitudinal cross section of the distal end of the cassette. In FIG. 15A, the latch of the cassette housing is latched to the latch receiver of the cassette dispenser, preventing the dispenser from moving relative to the housing. [Figure 15B] It is a plan view of a longitudinal cross section of the distal end of FIG. 15A. In FIG. 15B, the latch of the cassette housing is disengaged from the latch receiver of the dispenser, and the biasing spring of the gear lock of the dispenser allows the dispenser to move outward relative to the housing. [Figure 15C] It is a plan view of a longitudinal cross section of the distal end of FIG. 15B. In FIG. 15C, after being disengaged, the dispenser is movable out of the cassette housing, and a new dispenser is movable into the housing. [Figure 16A]This is an elevation and side view of the distal section of the cassette. [Figure 16B] Figure 16A is a perspective view of the distal end of the cassette. In Figure 16B, the cassette's latch release actuator is in a holding position that prevents the dispenser from moving relative to the cassette housing. [Figure 16C] Figure 16B is a perspective view of the distal end. In Figure 16C, the latch release actuator is moved to the release position by a lateral force, which allows the latch to pivot and disengage from the engaging surface of the dispenser, and then the biasing spring of the dispenser's gear lock allows the dispenser to move outward relative to the housing. [Figure 16D] Figure 16C is a perspective view of the distal end. In Figure 14D, after disengagement, the dispenser is movable out of the cassette housing, and a new dispenser is movable into the cassette housing. [Figure 17A] This is a plan view of the longitudinal cross-section of the distal end of the cassette. In Figure 17A, the latch of the cassette housing latches onto an engagement surface protruding from the cassette dispenser, preventing the dispenser from moving relative to the housing. [Figure 17B] Figure 15A is a plan view of the longitudinal cross-section of the distal end. In Figure 17B, the latch of the cassette housing is pivoted by an actuator to disengage from the engaging surface protruding from the dispenser, allowing the biasing spring of the dispenser's gear lock to move the dispenser relative to the cassette housing. [Figure 17C] Figure 17B is a plan view of the longitudinal cross-section of the distal end. In Figure 17C, after disengagement, the dispenser is movable out of the housing, and a new dispenser is movable into the cassette housing. [Figure 18A]Figures 18A and 18B show a perspective view of the cassette housing during the insertion of the dispenser into the cassette housing, and a perspective view of the dispenser fully inserted into the cassette housing, respectively. In Figures 18A and 18B, the driver gear for rotating the dispenser's needle selection gear is located in an opening, through which the driver gear rotates the needle selection gear. [Figure 18B] Figures 18A and 18B show a perspective view of the cassette housing during the insertion of the dispenser into the cassette housing, and a perspective view of the dispenser fully inserted into the cassette housing, respectively. In Figures 18A and 18B, the driver gear for rotating the dispenser's needle selection gear is located in an opening, through which the driver gear rotates the needle selection gear. [Figure 18C] Figure 18B is an enlarged perspective view of the compartment of the cassette housing. In Figure 18C, the dispenser needle assembly is fully inserted into the compartment, and the driver gear is not shown in the opening, so that a portion of the needle selection gear is visible through the opening. Although not fully visible in Figure 18C, a portion of another opening is shown, through which another driver gear can rotate the dispenser needle movement gear (e.g., via a transmission gear). [Figure 19] This is a block diagram of a motor assembly comprising multiple driver assemblies and a controller for controlling the driver assemblies. [Figure 20A] Figure 20A is a perspective view of a cassette with a dispenser fully inserted into the cassette housing. In Figure 20A, the driver gear engages with the dispenser's drive assembly, and the dispenser's cartridge is aligned with the housing window and can be seen through the housing window. [Figure 20B] Figure 20A is a perspective view of the cassette while the dispenser is inserted into the housing. [Figure 21] This is a block diagram of a drug delivery device, including a cassette, motor assembly, and controller. [Figure 22A]This is a perspective view of the proximal end of the needle system attached to the cartridge assembly. [Figure 22B] Figure 22A is a perspective view of the distal end of the needle system, showing only the housing of the cartridge assembly. [Figure 22C] Figure 22A is a perspective view of the proximal end of the needle system, without showing the needle assembly housing. [Figure 22D] Figure 22C is a perspective view of the distal end of the needle system, without showing the identification ring. [Figure 22E] Figure 22A is a perspective view of the internal part of the needle system. [Figure 22F] Figure 22A is a perspective view of the needle system, where a portion of the needle system housing appears semi-transparent. [Figure 22G] Figure 22A is a perspective view of the distal end of the needle system. [Figure 23A] Figure 22B is a perspective view of the proximal end of the needle system, showing the opening through which the index gear of the needle system is exposed. [Figure 23B] This is a perspective view of the proximal end of the index gear. [Figure 23C] This diagram shows the stabilizer portion relative to the teeth of the index gear when the needle assembly is in the operating position of the needle system. [Figure 24A] This is a longitudinal cross-sectional view of the needle system. [Figure 24B] This is a magnified cross-sectional view of a part of the needle system. [Figure 25] This is a perspective view of the needle assembly of a needle system. [Figure 26A] This is a side perspective view of the needle system, showing the access opening for engaging with the needle assembly in the operating position. [Figure 26B] This figure shows the needle driver of the needle system, which drives the movement of a portion of the needle assembly in the operating position. [Figure 26C] This diagram shows an external driver that extends through the housing of the needle system to rotate the needle driver. [Figure 27A]This is a side view of a needle assembly with a translucent housing. [Figure 27B] Figure 27A is a perspective view of the needle system incorporating the needle assembly. [Figure 28] This is a perspective view of the needle assembly showing the needle mechanism. [Figure 29A] This is a perspective view of the needle mechanism, showing both sides of the needle mechanism. [Figure 29B] This is a perspective view of the needle mechanism, showing both sides of the needle mechanism. [Figure 30A] This is a perspective view of the driven component of the needle system, showing both sides of the driven component. [Figure 30B] This is a perspective view of the driven component of the needle system, showing both sides of the driven component. [Figure 31A] This is a side view of the needle mechanism in the compact configuration shown in Figure 30A. [Figure 31B] This is a side view of the needle mechanism in the expanded configuration shown in Figure 30B. [Figure 32A] This figure shows the needle mechanism in a compact standby configuration before use, an extended configuration during use, and a compact retracted configuration after use, respectively. [Figure 32B] This figure shows the needle mechanism in a compact standby configuration before use, an extended configuration during use, and a compact retracted configuration after use, respectively. [Figure 32C] This figure shows the needle mechanism in a compact standby configuration before use, an extended configuration during use, and a compact retracted configuration after use, respectively. [Figure 33] This is a side view showing the needle mechanism within the needle assembly in its retracted configuration after use. [Figure 34] This is a cross-sectional side view of the needle mechanism located within the housing, showing the needle mechanism in an extended configuration. [Figure 35] This is a longitudinal cross-sectional view of a part of the needle mechanism. [Figure 36A] This figure shows various configurations for connecting a needle to the needle connector of a needle mechanism. [Figure 36B]This figure shows various configurations for connecting a needle to the needle connector of a needle mechanism. [Figure 36C] This figure shows various configurations for connecting a needle to the needle connector of a needle mechanism. [Figure 36D] This figure shows various configurations for connecting a needle to the needle connector of a needle mechanism. [Figure 36E] This figure shows various configurations for connecting a needle to the needle connector of a needle mechanism. [Modes for carrying out the invention]

[0007] This specification provides examples of fluid delivery devices and examples of components included in fluid delivery devices. As can be understood, while some embodiments of fluid delivery devices are described herein in relation to the administration of drugs to patients, such devices are not limited to use in medical applications and may be used additionally or alternatively in other non-medical applications (e.g., applications where precise amounts of fluid are delivered).

[0008] The inventors recognize and understand that various factors can be important for fluid delivery devices. In particular, ease of use of a fluid delivery device may be important, but minimizing medical waste may also be important. The fluid delivery device provided herein provides multiple needles that can be individually operated to deliver multiple doses of a drug from a single vial or fluid chamber, thus reducing the waste associated with multiple needle packages and / or multiple single-dose vials of a drug. Multiple doses may be infused at different times using different needles among the needles, or doses may be infused at different times using a single needle among the needles. For example, a patient may use one needle for multiple infusions on one day and another needle for multiple infusions on another day. In some embodiments, a single-needle configuration can also be used according to the techniques described herein.

[0009] Referring here to the drawings, Figure 1 shows a perspective view of a dispenser 10 comprising a cartridge assembly 100 and a needle system 200 according to several embodiments of the Art. The dispenser 10 can be used in a fluid delivery cassette as described below. The needle system 200 may be located at the distal end of the dispenser 10. For clarity, the term “distal” may be used herein to identify a location closer to the needle exit of the needle system (e.g., closer to the end that contacts the patient into which the needle is injected), and the term “proximal” may be used herein to identify a location further from the needle exit. As discussed below, the dispenser 10 can form one embodiment of a drug delivery device. While several embodiments of drug delivery devices may be described herein and / or shown in the drawings, it should be understood that some embodiments of drug delivery devices may not be shown in the drawings and / or described, or may not be shown in detail in the drawings and / or described in detail. For example, the housing of the drug delivery device may contain the dispenser 10. The housing of the drug delivery device may include other components and electronics to enable the dispenser to operate. For example, the housing may include one or more motors for driving movement within or relative to the dispenser 10, and a computer processor for controlling the operation of one or more motors.

[0010] Figure 2 shows a perspective view of an assembled cartridge assembly 100 according to some embodiments of the present technology, and Figure 3 shows a perspective view of a partially disassembled cartridge assembly 100 according to some embodiments of the present technology. The cartridge assembly 100 may include a cartridge 150 configured to hold a fluid (e.g., a liquid drug) therein. The fluid may be confined in a fluid chamber 158 defined by a piston 156 configured to seal the proximal opening of the cartridge 150 and a partition 152 configured to seal the distal opening of the cartridge 150. A partition retainer 154 is coupled to the distal end of the cartridge 150 to hold the partition 152 in place at the distal opening of the cartridge 150. In some embodiments, the piston 156 may be configured to provide a movable seal to the inner surface of the cartridge 150 to prevent the fluid in the fluid chamber 158 from leaking out from the proximal end of the fluid chamber 158 even as the piston 156 moves along the inner surface of the cartridge 150. The partition wall 152 may be formed from a self-sealing material (e.g., FDA-rated elastomer material such as medical-grade silicone or medical-grade ethylene propylene diene monomer (EPDM)) and may be punctured by a puncture object of the needle system 200 during the injection process to allow the fluid in the fluid chamber 158 to flow out of the fluid chamber 158 during the injection process, and may be resealed to provide a fluid-sealing seal after the puncture object has retracted from the partition wall 152. In some embodiments, the retraction of the puncture object from the partition wall 152 and the subsequent resealing of the partition wall 152 can prevent contamination of the fluid remaining in the fluid chamber 158, and as a result, the remaining fluid can be used in future injection processes. In some embodiments, the fluid in the fluid chamber 158 may be sufficient for multiple injections (e.g., multiple doses of a drug).

[0011] The device according to this disclosure may transport and dispense one or more liquid pharmaceuticals, which may also be referred to as drugs or medicines, and which may be held in a fluid chamber 158. Such drugs include, for example, epinephrine, anesthetics, analgesics, steroids, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric suppressor polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tylzepatide or retatrutide, basal insulin such as insulin efcitra alfa, oxytomodulin analogs, oxytomodulin derivatives, and repodisilan (LPA siRNA), borenrelaxin, long-acting amylin agonists, PNPLA3 siRNA, APOC3 siRNA, DACRA qw II, long-acting GIPR agonists, glucose-sensing insulin receptor agonists, nisotyrostoids, bimagrunab, NRG4 agonists, and SCAP. The therapeutic antibodies may include, but are not limited to, siRNA, mazdutide, and other therapeutic agents for treating diabetes and / or obesity; IL-17 antibody analogs or derivatives such as mirikizumab, which can be used to treat Crohn's disease or ulcerative colitis; ixekizumab, which can be used to treat psoriasis vulgaris; IL-13 antibody analogs or derivatives such as lebrikizumab, which can be used to treat atopic dermatitis; therapeutic agents for treating pain-related and / or migraines such as galcanezumab or rasmiditane; therapeutic agents for treating Alzheimer's and / or dementia such as donanemab, remternetug, or GRN gene therapy for treating atopic dermatitis; therapeutic agents for treating Parkinson's disease and / or Gaucher disease such as GBA1 gene therapy; therapeutic agents for treating sweat gland abscesses such as eltrequivat; therapeutic agents for treating rheumatoid arthritis such as peresolimab; and any therapeutic agent such as CD19 that can be delivered by the device described herein.The devices described herein can be operated by a user (e.g., a healthcare professional, caregiver, or another person) in the manner generally described herein to administer one or more drugs to a patient (e.g., another person or user).

[0012] The cartridge 150 can be held within the housing 102 of the cartridge assembly 100. In some embodiments of the art, the housing 102 may have a cylindrical shape, as shown in Figure 3, and a plurality of ribs 114 may extend radially from the inner surface of the housing 102. The ribs 114 may function as spacers that hold the cartridge 150 in place within the cartridge chamber 108 of the housing 102. In some embodiments, the ribs 114 may have rib shoulders 114a configured to function as axial insertion limits for the cartridge 150 within the housing 102. In some embodiments, when the cartridge 150 is fully inserted into the cartridge chamber 108, the proximal edge of the cartridge 150 may abut against the rib shoulders 114a, and the cartridge 150 may be radially centered within the cartridge chamber 108. In some embodiments, when the cartridge 150 is fully inserted into the cartridge chamber 108, the partition wall 152 may extend outward from the distal end of the housing 102 so that the partition wall 152 can be positioned within a recess of the needle system 200.

[0013] In some embodiments of this technology, the cartridge assembly 100 may include a drive assembly 300 configured to drive the movement of a piston 156 to discharge the fluid in the fluid chamber 158 from the distal end of the cartridge 150. The drive assembly 300 can be called a “driven” assembly because it can be driven to move itself and then convert the received driving force into a force that moves the piston 156 along axis A of the cartridge assembly 100. In some embodiments, the drive assembly 300 may include a driven mechanism 302, which may be a drive gear 302 configured to be driven to rotate about axis A. The driven mechanism 302 may include a spindle 302a, around which an axially expandable member 306 may be wound. In some embodiments, the axially expandable member 306 may be a ribbon (element 306 may interchangeably refer to either the axially expandable member or the ribbon) having a distal end attached to a leg 304. The leg 304 may be configured to rotate relative to the distal end of the rotating ribbon 306. The drive assembly 300 may be configured such that when the driven mechanism 302 is rotated in a first direction, the rotation of the driven mechanism 302 causes the ribbon 306 to expand or inflate along axis A. In some embodiments, the driven mechanism 302 may retract the ribbon 306 when the driven mechanism 302 is rotated in a second direction opposite to the first direction. As described below, when the ribbon 306 is driven to expand, the axial distance between the distal and proximal ends of the ribbon 306 expands or increases, causing the leg 304 to move axially. When the leg is in contact with the piston 156, the expansion of the ribbon 306 causes the piston 156 to move axially toward the distal opening of the cartridge 150. In some embodiments, precise control of the amount of rotation of the driven mechanism 302 can result in precise amounts of expansion of the ribbon 306 and precise amounts of movement of the piston 156, and consequently, precise amounts of fluid to be released.Additional ribbon extension mechanisms are described in International Publication Nos. 2017 / 165154A1, International Publication Nos. 2019 / 118626A1, and International Publication Nos. 2019 / 112886A1, each of which is incorporated herein by reference in its entirety.

[0014] Figures 4A and 4B are longitudinal cross-sectional perspective views of a cartridge assembly 100 according to several embodiments of the present art. Figure 4C is a cross-sectional perspective view of a cartridge assembly 100 cut along plane 4C in the diagram of the cartridge assembly 100 shown in Figure 4A, according to several embodiments of the present art. In Figures 4A and 4B, the foot 304 of the drive assembly 300 is spaced apart from the piston 156. As can be understood, during the injection process, the foot 304 may be in contact with the piston 156. The distal surface of the foot 304 may have a groove 304a configured to engage with a protrusion 156a on the proximal surface of the piston 156. For example, the groove 304a may be circular, and the protrusion 156a may be a bump configured to fit into the groove 304a when the foot 304 and the piston 156 are in contact with each other. In some embodiments, the leg 304 may be configured to rotate about axis A, while the convex portion 156a remains fixed in the rotational direction when the piston 156 is being pushed by the leg 304.

[0015] According to some embodiments of the present technology, the foot 304 may be connected to the distal end of the ribbon 306 by a bearing 308, which may rotate during the expansion and retraction of the ribbon 306, or it may be possible to keep the foot 304 stationary during the expansion and retraction of the ribbon 306. In some embodiments, the proximal surface of the foot 304 may have a socket recess configured to receive a ball-shaped projection of the bearing 308, which may rotate within the socket recess during the expansion and retraction of the ribbon 306.

[0016] Figure 4F is a perspective view of the proximal surface of a foot 304 according to some embodiments of the Art. Figure 4G is a perspective view of a bearing 308 mounted on a ribbon 306 according to some embodiments of the Art. The proximal surface of the foot 304 may be in contact with the distal surface of the bearing 308 (as shown in Figure 4A), while the distal surface of the foot 304 may be in contact with the piston 156. The foot 304 may have a recess configured to receive a projection of the bearing 308, as shown in Figure 4A. In one example, the proximal surface may comprise a curved concave well 304c, over which the curved convex surface 308a of the bearing 308 may be pressed and rotated during the injection operation. In some embodiments, the bearing 308 may have a peripheral edge extending from a stem with a reduced cross-sectional area, the edge used to hold the bearing 308 within the well 304c. In some embodiments, the foot 304 may comprise one or more retaining structures 304b extending radially inward from adjacent side walls configured to hold the edge of the bearing 308 within the well 304c, so that the bearing 308 can rotate relative to the well 304c. For example, the structure 304b may comprise an overhang configured to hold a portion of the edge of the bearing 308 therein. In some embodiments, one or both of the foot 304 and the bearing 308 may be formed of a low-friction hard plastic. For example, the bearing 308 and / or the foot 304 may be formed of one or any combination of polyimide, nylon, oligooxymethylene (POM), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polycarbonate, etc. In some embodiments, the well 304c may be filled with silicone grease.

[0017] Figure 4D is a plan view of a slice of the cartridge assembly 100 shown in Figure 4A, cut along a parallel plane 4D, according to some embodiments of the present technology.

[0018] According to some embodiments of the present technology, when the ribbon 306 is fully retracted, some or all of the ribbon 306 may be wound into a coil, so as to be wound around the spindle 302a, the loops of the coil having proximal edges that are generally aligned with each other and distal edges that are generally aligned with each other. Thus, when the ribbon 306 is fully retracted, the coil may be compact and fit within the ribbon chamber 110 of the housing 102 located at the proximal end 104 of the housing 102. In some embodiments, when the driven mechanism 302 rotates to expand the ribbon 306, axially elongated spindle ribs 302b projecting radially from the longitudinal portion of the spindle 302a may contact rib latches 306c projecting from the surface of the ribbon 306, thereby rotating and unwinding the ribbon 306. In some embodiments, the spindle ribs 302b and rib latches 306c may be structured to have complementary angles for latching or hooking each other, as depicted in Figure 4D. In some embodiments, the ribbon 306 may be unraveled to form a helix having an axial length controlled by the amount of rotation of the driven mechanism 302. Thus, controlled movement of the piston 156 can be achieved through controlled rotation of the driven mechanism, and as a result, controlled discharge of fluid in the fluid chamber 158 can be achieved. In some embodiments, the cartridge assembly 100 may be structured so that a predetermined number of rotations of the driven mechanism 302 can result in a movement of 0.2 mm, 0.3 mm, 0.4 mm, or 0.5 mm of the foot 304. In some embodiments, one complete rotation (e.g., a 360° rotation) can result in a known amount of movement of the foot 304 and / or a known amount of movement of the piston 156 pushed by the foot 304.

[0019] According to some embodiments of the present technology, the ribbon 306 may be unwound "from inside to outside" such that the innermost loop of the coil in contact with the spindle rib 302b is unwound first, and then expands or inflates to form a growing helix. For example, Figures 3, 4A, and 4B depict the receding portion 306a of the ribbon 306 formed from the outer coil loop of the ribbon 306, and the expanding portion 306b of the ribbon 306 that expands from the inner coil loop of the ribbon 306 to form a helix.

[0020] The helix formed from the expanded portion 306b of the ribbon 306 may be guided by the helical guide 112 from the ribbon chamber 110 of the housing 102 to the cartridge chamber 108 of the housing. The unexpanded or retracted portion 306a of the ribbon 306 may remain wound within the ribbon chamber 110. In some embodiments of the art, the helical guide 112 may be a tubular section of the housing 102 having a diameter smaller than the diameter of the cartridge chamber 108. The diameter of the helix may correspond to the diameter of the helical guide 112. In some embodiments, the ribs 114 of the housing 102 may extend radially from the inner surface of the housing 102 and may contact the outer surface of the helical guide 112 as depicted in Figure 4D.

[0021] Figure 4E shows a plan view of the proximal end 104 of the cartridge assembly 100 according to some embodiments of the present technology. The driven mechanism 302 may be fitted within the ribbon chamber 110 of the housing 102, or it may be mounted on a lip 110b extending from the inner surface of the ribbon chamber 110 (see Figure 5). The driven mechanism 302 may be constructed to engage with a driver, described later, and be rotated by the driver. In some embodiments, the surface of the driven mechanism 302 may include a recess 302c configured to receive a spline shaft therein. The recess 302c may be formed within the spindle base 302e of the spindle 302a, with the longitudinal portion extending therefrom. The spindle base 302e may include a disc-shaped body having a spindle base diameter. The recess 302c may have concave teeth 302d configured to engage with corresponding teeth of the spline shaft. As understood, the driven mechanism 302 may consist of other structures that enable the driven mechanism 302 to be rotated. For example, instead of the recess 302c, a shaft (e.g., a spline shaft) may be provided on the surface of the driven mechanism 302, and it may be configured to engage with an electric motor having a recess (e.g., a spline-shaped recess) that fits into the shaft, and to be rotated by this electric motor.

[0022] Figure 5 schematically shows plan views of longitudinal sections of a portion of the proximal end of a first modification 5A and a second modification 5B of the cartridge assembly 100 according to several embodiments of the present technology. The first and second modifications 5A and 5B may consist of a housing 102', which is a modification of the housing 102. The first modification 5A may include a ribbon container 116 that can be inserted into the housing 102, which can facilitate manufacturing by allowing the ribbon bobbin, including the ribbon container 116, ribbon 306, and driven mechanism 302, to be manufactured separately and easily installed as a unit in the housing 102'. In some embodiments, the ribbon chamber 110' of the ribbon container 116 may have a distal base that is inclined to facilitate helical formation by providing space for the inner loop of the coil to unravel, while the outer loop is relatively restricted to remain together within the coil. The second modification 5B may have a ribbon container 116' similar to the ribbon container 116, but may have a ribbon chamber 110'' with a smaller volume than the ribbon chamber 110' of the first modification 5A, and the shorter axial dimension results in a tighter ribbon chamber 110'' in the axial direction. The axially tighter ribbon chamber 110'' may be sized such that it is closely related to the width between the edges of the ribbon in order to facilitate restraint and slip reduction when the ribbon 306 is moving into the extended configuration. A second modification 5B may include a driven mechanism 302' having a concave outer surface, where the periphery of the driven mechanism 302' may be coplanar with the proximal edge 102a' of the housing 102', but the rest of the driven mechanism 302' may be recessed relative to the proximal edge 102a'. Such a recessed configuration can advantageously allow for more secure engagement between the driven mechanism 302' and the driver, thus enabling greater confidence that rotation or partial rotation of the driven mechanism 302' will result in predictable axial movement of the plunger 156. In another modification, the ribbon containers 116, 116' may not be insertable components into the housing 102', but may instead be integral parts of the housing 102'.For example, the housing 102' may be formed from molded plastic such that the ribbon chamber of the housing 102' may have an internal structure corresponding to the ribbon containers 116, 116'. As shown in Figure 5, the surfaces of the spindles 302a, 302a' may have a tapered profile so that the diameter of the spindles 302a, 302a' can gradually decrease from a relatively large diameter at the proximal end to a relatively small diameter at the distal end. In some embodiments, the spindles 302a, 302a' may have a conical shape. The tapered profile of the spindles 302a, 302a' may allow for the smooth movement of the ribbon 306 relative to the spindles 302a, 302a' as the helix expands in length in the axial direction. For example, the tapered profile may allow the innermost coil of the ribbon 306 to gradually unwind and become part of the expanding helix. In some embodiments, the spindle ribs 302b, 302b' may extend radially from the tapered surface of the spindles 302a, 302a', so that the radial distance d from the radial outer edge of each spindle rib 302b, 302b' to axis A is the same along the axial length of each spindle rib 302b, 302b', as shown in Figure 5. Such a configuration of the spindle ribs 302b, 302b' may result in the helix having a cylindrical shape.

[0023] Figures 6A and 6B show elevation and side views of the ribbon 306 in an unstressed state according to several embodiments of the present technology. In Figures 6A and 6B, the distal end of the ribbon 306 is on the left and the proximal end of the ribbon 306 is on the right. The distal end of the ribbon may be structured as a latch 306f that can engage directly with the foot 304 or with the bearing 308, as described herein.

[0024] According to some embodiments of the present technology, the ribbon 306 is not confined within the ribbon chamber 110 and, when no force is applied to the ribbon 306 (e.g., no stress is applied), the ribbon 306 can be formed of an elastic material such that it can form a tapered helix having a diameter that changes from the first end of the tapered helix to the second end of the tapered helix, as shown in Figures 6A and 6B. The taper may be formed along the cross-sectional area of ​​the helix that increases from the distal end to the proximal end along axis A. The tapered helix may or may not have gaps between the segments or loops of the helix when viewed in a side view (e.g., in Figures 6A and 6B). Figure 6C shows a view of the end of the ribbon 306 in a stress-free state, where the outer surface of the latch 306f is visible (e.g., viewed from the distal end to the proximal end of the ribbon 306). Figure 6D shows a view of the end of the ribbon 306 in an unstressed state, where the inner surface of the latch 306f is visible (for example, by viewing the tapered helix from the proximal end to the distal end of the ribbon 306). An advantageous aspect of the ribbon 306 having a tapered structure is that such a structure can facilitate the manufacture of the cartridge assembly 100. In the tapered structure, the ribbon 306 can be easily folded into a coil by applying an axial force (for example, by the pressing action between two fingers) to compress the distal and proximal ends toward each other, facilitating the insertion of the coil onto the spindle 302a and into the ribbon chamber 110. For example, a tapered helix can be crushed to form a coil when the first end of the tapered helix is ​​positioned relative to a flat surface (e.g., a table) and an axial force is applied to the second end toward the flat surface. By applying materials and molding techniques to the ribbon 306, a desired tapered profile can be obtained.

[0025] According to some embodiments of the present technology, the rib latch 306c of the ribbon 306 described above may protrude from one of the two surfaces of the ribbon 306. In some embodiments, the rib latch 306c may protrude from a surface that forms the inner surface of a tapered helix, as shown in Figures 6A, 6B, and 6C. The rib latch 306c may be configured to engage with and slide along the spindle rib 302b when the ribbon 306 is expanding or extending in the axial direction. In some embodiments, as described above, the rib latch 306c of the innermost loop of the coil (e.g., the innermost loop of the receding portion 306a of the ribbon 306) may be in contact with the spindle rib 302b and rotated by the rotation of the spindle rib 302b to form a growing or elongating helix. The innermost loop of the coil may be a continuously changing portion of the ribbon 306 as the helix elongates. A rib latch 306c that slides along the spindle rib 302b can continuously slide away from the spindle rib 302 as the helix extends. Similarly, a rib latch 306c on the retracted portion 306a of the ribbon 306 may continuously engage with the spindle rib 302b as the helix extends. In some embodiments, computerized control of the amount of rotation of the drive mechanism 302 may cause the ribbon 306 to expand to one or more predetermined positions, each predetermined position corresponding to a known amount (or known increment) of fluid being discharged from the fluid chamber 158 relative to a previous predetermined position.

[0026] According to some embodiments of the present technology, the groove 310 may be provided on the surface of the ribbon 306 opposite to the surface on which the rib latch 306c is provided. In some embodiments, the groove 310 may be provided on the outer surface of the ribbon 306, as shown in Figures 6A and 6B. The groove 310 may be configured to slide along a protruding ridge 110a adjacent to the proximal end of the helical guide 112. In some embodiments, the movement of the ribbon 306 along the ridge 110a and along the spindle rib 302b may cause the elongation helix to be cylindrical or cylindrical, which structurally can provide the helix with enhanced rigidity against the piston 156 while pressing against the piston 156. In some other embodiments, the movement of the ribbon 306 along the ridge 110a and along the spindle rib 302b may cause the elongation helix to be tapered or conical. In some embodiments, the raised portion 110a may be helical ridges 111a, 111a' on the inner surfaces of the ribbon containers 116, 116'. The helical ridges 111a, 111a' may fit into the groove 310 and engage slidably during helical extension.

[0027] The edges of the ribbon may include complementary coupling features that allow adjacent edges of the ribbon to interlock when a helical configuration is formed and the ribbon expands axially, and in some embodiments, allow them to discouple from each other when the ribbon is retracted and transitions to a coil configuration. According to some embodiments of the art, the ribbon 306 may comprise a plurality of pegs 306d arranged along a first edge of the ribbon 306, and a plurality of holes 306e arranged along a second edge of the ribbon opposite to the first edge. In some embodiments, the pegs 306d may protrude from a surface forming the inner surface of the ribbon 306, as depicted in Figures 6A, 6B, and 6C. That is, the pegs 306d and the rib latches 306c may protrude from the same surface of the ribbon 306, and the rib latches 306c may extend longitudinally from an edge region near the pegs 306c to the second edge of the ribbon 306. The pegs 306d and holes 306e may be configured such that an increasing number of pegs are received in an increasing number of holes to form a spiral such that each loop of the spiral interlocks with at least one adjacent loop of the spiral when the ribbon 306 is expanding or enlarged.

[0028] Figures 6A and 6B show the ribbon 306 in an expanded configuration forming a tapered spiral, but these are illustrative for illustrative purposes only to illustrate the aspects of the ribbon 306, and it should be understood that this may allow the ribbon 306 to unwind from the coil in a zipper-like configuration to form a spiral, such that as the ribbon 306 expands, the lower edge of the spiral loop (formed, for example, from the lower edge of the ribbon 306) adheres to the upper edge of the spiral loop (formed, for example, from the upper edge of the ribbon 306), and the ribbon 306 unwinds on itself in a structured manner. In some embodiments, the ribbon 306 may be manufactured and deployed within the cartridge assembly 100, as shown in Figure 1, with the ribbon 306 wound around itself, such that some, most, or all of the ribbon 306 is retracted into a coil having a height corresponding to the distance between the edges of the ribbon 306 (without requiring force to be applied to the ribbon 306 to keep the ribbon 306 in the coil, for example. As a result, in the initial configuration (for example, before using the dispenser 10 to administer any of the fluids in the fluid chamber 158), some, most, or all of the ribbon 306 may be retracted and coiled around itself. As discussed herein, when the ribbon 306 expands and joins on itself to form a helix, a structured and tapered shape or a cylindrical shape may be formed, each of which can provide precise and effective administration through the precise expansion of the helix.

[0029] Figures 7A and 7B show perspective views of a cartridge assembly 100 and a driver gear 402 configured to rotationally drive a driven mechanism 302 of a drive assembly 300, according to some embodiments of the present technology. Figure 7C shows a perspective view of the driver gear 402. In some embodiments, the driver gear 402 may be included as part of a cassette or incorporated into the housing of a cassette. In some embodiments, the driver gear 402 may comprise a disc-shaped body having the diameter of the driver gear and gear teeth spaced circumferentially apart from each other along the circumferential edge surface of the disc-shaped body. In some embodiments, the driver gear 402 may comprise a spline shaft 404 extending from the axially facing surface of the driver gear 402. The spline shaft 404 may be configured to fit into a recess 302c on the surface of the driven mechanism 302, and the spline shaft 404 may have teeth configured to engage with concave teeth 302d of the recess 302c. The recess 302c and the body of the spindle 302a may be coaxial along the longitudinal axis A, as shown in Figures 7A and 7B. In some embodiments, the driver gear 402 may be a spur gear configured to rotate via a force applied to the teeth 402a of the driver gear 402. The rotation of the driver gear 402 can drive the rotation of the driven mechanism 302 via the spline shaft 404 of the driver gear 402, and the recess 302c and teeth 302d of the driven mechanism 302. In some embodiments, when the cartridge assembly 100 is inserted into the cassette housing, the spline shaft 404 may be positioned along the longitudinal axis A to facilitate insertion coupling of the spline shaft 404 with the recess 302c of the cartridge assembly 100, and this position may be along the longitudinal axis A. The driver gear 402 and the driven mechanism 302 may be arranged together to advantageously reduce the amount of thrust experienced by the ribbon 306 and the cassette. In some embodiments, the driver gear diameter of the body of the driver gear 402 may be at least greater than the spindle base diameter of the spindle base 302e of the spindle 302a.

[0030] Figure 8 shows a perspective view of the dispenser 10 according to several embodiments of the present technology. In Figure 8, the housing 202 of the needle assembly 200 is shown as translucent so that the internal components can be seen. Figure 9A shows a perspective view of the needle assembly 200, and Figure 9C shows a perspective view of the needle assembly 200 in a partially disassembled state. Figure 9B shows a plan view of a cross-section of the needle assembly 200 cut along plane 9B of Figure 9A.

[0031] According to some embodiments of this technology, the needle assembly 200 may be attached to the distal end of the cartridge assembly 100 such that the partition wall 152 of the cartridge assembly 100 is received in a recess of the needle assembly 200. In some embodiments, during the injection process, the lancing device of the needle assembly 200 may be driven to puncture the partition wall 152, allowing the fluid in the fluid chamber 158 to be discharged from the fluid chamber 158. For example, the partition wall 152 may be punctured according to the techniques described in International Publication No. 2022 / 132675A1 and International Publication No. 2022 / 132677A1, each of which is incorporated herein by reference in whole. Examples of housings for drug delivery devices that can be coupled to the dispenser 10 can be found in these documents. In some embodiments where the fluid is a liquid drug, the fluid discharged from the fluid chamber 158 may be injected into the patient through the needle 216 of the needle assembly 200. The needle assembly 200 may carry a single needle or multiple needles (e.g., two needles, three needles, four needles, etc.) as discussed herein.

[0032] According to some embodiments of the present technology, the needle assembly 200 may comprise a plurality of needles 216 that can be individually actuated for use. The needle assembly 200 may comprise a needle selection gear 204 that can be driven to move a selected needle from among the needles 216 to an operating position. The selected needle 216 may be the next needle among the plurality of needles 216, or a specific needle among the plurality of needles 216. The selected needle 216 may be rotated to the operating position by the rotation of the needle selection gear 204 via the operation of a driver assembly 600 (Figure 19) as described below. In some embodiments, each needle 216 of the needle assembly 200 may be operably connected to a needle moving gear 208 and a gear assembly 208a, which may be configured to move the needle 216 axially from a retracted position within the housing 202, where the needle tip is retracted from the base surface 202c at the distal end of the housing 202, to an injection position, where the needle tip extends beyond the base surface 202c (e.g., into the patient). If the needle 216 is not in the operating position, the needle 216 cannot move from the retracted position to the injection position.

[0033] According to some embodiments of the present technology, when the needle 216 is in the operating position ("actuated needle"), the transmission gear 206 of the needle assembly 200 can drive the movement of the needle 216 between the injection position and the retracted position. The transmission gear 206 is also referred to herein as the idler 206. In some embodiments, when the actuated needle 216 is in the operating position, the teeth of the needle moving gear 208 of the actuated needle 216 may mesh with the teeth of the transmission gear 206 such that the rotation of the transmission gear 206 can drive the rotation of the needle moving gear 208. The transmission gear 206 may be driven to rotate via the operation of a driver assembly 400 (Figure 19) as described below. The rotation of the needle moving gear 208 by the transmission gear 206 can move the actuated needle 216 axially from the retracted position to the injection position.

[0034] The inventors recognize and understand that safety is an important consideration in the use of dispenser 10, especially when dispenser 10 is used by laypeople who have not been trained to handle needles and / or injection fluids (e.g., liquid drugs). Accordingly, the inventors have provided a gear lock mechanism for dispenser 10. The gear lock mechanism may prevent the needle selection gear 204 from positioning any of the needles 216 in an operating position and / or prevent the transmission gear 206 from moving any of the needle moving gears 208 unless certain unlocking features are met, as discussed herein.

[0035] One such gear locking mechanism is a locking spring 210, which may comprise a U-shaped spring surface 210a configured to prevent rotation of the needle selection gear 204 and the transmission gear 206 when the locking spring 210 is in the locked position. Figure 9B shows the left side surface of the needle assembly 200 in plane 9B (see Figure 9A) with the locking spring 210 in the locked position, according to some embodiments of the art. When the locking spring 210 is in the locked position, a projection 210b of the spring surface 210a enters into a space within the needle assembly 200, preventing rotation of the needle selection gear 204. For example, the projection 210b may span one of the gear assemblies 208a, as shown in Figure 9B, or be inserted between two of the gear assemblies 208a, thereby preventing rotation of the needle selection gear 204 and preventing movement of the needle 216 to the working position. In addition, when the lock spring 210 is in the locked position, the base of the spring surface 201a may abut against the transmission gear 206 to prevent the transmission gear 206 from rotating. For example, a protrusion on the stem portion of the transmission gear 206 may be seated in a recess in the base of the lock spring 210 so that the transmission gear 206 cannot rotate. In some embodiments, the lock spring 210 and the transmission gear 206 may be mounted on a support frame 212 of the needle assembly 200. The support frame 212 may be mounted on a needle subassembly 214 including the needle 216, needle selection gear 204, and needle moving gear 208, and may be arranged so that when the lock spring 210 is in the unlocked position, the transmission gear 206 can rotate the needle moving gear 208 of the needle 216 which is in the operating position. In some embodiments, the transmission gear 206 may be movably mounted on the frame post 212a of the support frame 212, and the projection 210b of the spring surface 210a may span both the transmission gear 206 and the frame post 212a, as depicted in Figure 9B.As described below, when the lock spring 210 is moved from the locked position to the unlocked position, the base of the spring surface 210a may be shifted away from the transmission gear 206, and the projection 210b of the spring surface may be shifted away from the gear assembly 208a, thereby enabling the needle selection gear 204 to rotate the selected needle of the needles 216 to an operating position adjacent to the transmission gear 206, and also enabling the transmission gear 206 to rotate and drive the needle moving gear 208 of the actuated needle 216.

[0036] Figure 10 shows a perspective view of a cassette 20 comprising a dispenser 10 partially inserted into a cassette housing 22, according to some embodiments of the present technology. In some embodiments, the needle assembly 200 and the cartridge assembly 100 are assembled together to form the dispenser 10, but when the dispenser 10 is not installed in the cassette housing 22, the locking spring 210 is in the locked position. This can function as a safety mechanism to prevent accidental movement of the needle 216 to the injection position. In some embodiments, the cassette housing 22 may include a compartment 26 configured to receive the needle assembly 200. When the dispenser 10 is fully inserted into the cavity of the cassette housing 22, a portion of the compartment 26 can move the locking spring 210 to the unlocked position.

[0037] Figure 11A shows a partial longitudinal perspective view of a needle assembly 200 partially inserted into a compartment 26 of a cassette housing 22, according to some embodiments of the present technology. Since the needle assembly 200 is not fully inserted into the compartment 26, the locking spring 210 of the needle assembly 200 may be in the locked position. In some embodiments, when the base 24 of the cassette housing 22 is not aligned with the base 202c of the housing 202 of the needle assembly 200, the needle assembly 200 may not be fully inserted into the compartment 26, such that the internal recess 28b of the compartment 26 does not engage with the edge of the housing 202, as depicted in Figure 11A. The arrows in Figure 11A indicate the direction of movement of the needle assembly 200 relative to the cassette housing 22 during the installation of the dispenser 10 into the cassette housing 11. The compartment 26 may include a base 26a supporting a tongue base 28a and a tongue 28 projecting axially from the tongue base 28a. The tongue 28 may be configured to engage with the lock spring 210 when the needle assembly 200 is fully inserted into the compartment 26 of the cassette housing 22, thereby moving the lock spring 210 from a locked position to an unlocked position. Figure 11B shows the needle assembly 200 fully inserted into the compartment 26 of the cassette housing 22 such that the base 24 of the cassette housing 22 is coplanar with the base 202c of the housing 202 of the needle assembly 200. When fully inserted, the tongue 28 extending from the base 26a of the compartment 26 can push a portion of the lock spring 210, compressing the lock spring 210 and moving it, thereby shifting the base of the spring surface 210a away from the transmission gear 206 and shifting the projection 210b of the spring surface 210a away from the gear assembly 208a, thus unlocking the lock spring 210. Such a shift allows the needle selection gear 204 to rotate, thus allowing the selected needle among the needles 216 to move to the operating position, and also allows the transmission gear 206 to rotate, driving the needle movement gear 208 of the operating needle 216.

[0038] Figure 12A shows a perspective view of the distal section of dispenser 40 according to several embodiments of the Art. Dispenser 40 may be similar in many respects to dispenser 10 described above. Parts of dispenser 40 that are the same as dispenser 10 may be represented by the same reference number. Parts of dispenser 40 that are modifications of dispenser 10 may be represented by a modified version of the same reference number (e.g., with ' or' added after the reference number). In some embodiments, the gear lock mechanism of dispenser 40 may differ from the gear lock mechanism of dispenser 10. Figure 12B is the same figure as Figure 12A, but shows the housing 202' of the needle assembly 200' of dispenser 40 as semi-transparent. Figure 12C shows a perspective view of the distal section of dispenser 40 in a partially disassembled state according to several embodiments of the Art.

[0039] According to some embodiments of the present technology, the gear locking mechanism of the dispenser 40 may include a locking spring 211, which may include a locking plate 211a and a coil spring 211b configured to prevent rotation of the needle selection gear 204 and the transmission gear 206' when the locking spring 211 is in the locked position. In some embodiments of the present technology, Figure 13A shows a longitudinal section view of the needle assembly 200' in the locked position, and Figure 13B shows the same view of the needle assembly 200' in the unlocked position. In some embodiments, the locking spring 211 and the transmission gear 206' may be movably mounted on the needle subassembly 214 via a support frame 212'. The coil spring 211b, the locking plate 211a, and the transmission gear 206' may be movably mounted on the frame post 212a' of the support frame 212' such that the coil spring 211b biases the locking plate 211 and the transmission gear 206' to the unlocked position. In the unlocked position, the end of the frame post 212a' may be partially positioned within the cavity 206a of the transmission gear 206'. As depicted in Figure 13A, the coil spring 211b may bias the lock plate 211a against the transmission gear 206a' so that, when stationary, the transmission gear 206' is pressed against a rib or lip 203 protruding from the housing 202', preventing the transmission gear 206' from rotating. In this position, the transmission gear 206' does not need to be fully engaged with the needle moving gear 208 of the actuated needle 216, as shown in Figure 13A. In addition, when the coil spring 211b is stationary, the lock plate 211a may compress a portion of the needle subassembly 214, preventing the rotation of the needle selection gear 204. Figure 13C shows a plan view of a lateral cross-section of the needle assembly 200' cut through the lock plate 211a when the lock spring 211 is in the locked state, showing the blocking portion 211c of the lock spring 211 which extends into a portion of the needle subassembly 214 and abuts against the surface of the needle subassembly 214, thus preventing rotation of the needle selection gear 204.Figure 13D shows a plan view of a lateral cross-section of the needle assembly 200' cut through the transmission gear 206' when the lock spring 211 is in the locked position, and shows the lip 203 of the housing 202' that prevents rotational movement of the transmission gear 206'.

[0040] According to some embodiments of this technology, when an axial force is applied to the lock spring 211, the lock spring can be moved from a locked position to an unlocked position. The direction of this axial force is indicated by arrow F in Figure 13B. The axial force can compress the coil spring 211b, allowing axial movement of the lock plate 211a away from preventing rotation of the needle selection gear 204, and can allow axial movement of the transmission gear 206' away from the lip 203, thus allowing the needle selection gear 204 to rotate, and also allowing the transmission gear 206' to rotate. In some embodiments, the axial force can be applied by a driver gear 602 which may be mounted on the cassette housing 22 before or after the dispenser 40 is fully installed in the cassette housing 22. The driver gear 602 can extend through the opening 27b of the cassette housing (see Figures 10, 18A, and 18C) and apply an axial force to the transmission gear 206', pushing it in the direction of arrow F away from the lip 203. The transmission gear 206' can then push the lock plate 211a in the direction of arrow F, moving the lock plate 211a away from the obstructing movement of the needle selection gear 204. In some embodiments, the driver gear 602 can engage with the gear handle 207 of the transmission gear 206' (e.g., a slot, a protruding bar, etc.) to push and / or rotate the transmission gear 206'. The driver gear 602 may include a portion having a shaft configuration, but other gear configurations are intended. In some embodiments, the driver gear 602 may be part of a motor assembly, as described below. The cassettes 20, 20' and the motor assembly may be part of a drug delivery device and may be at least partially housed within the housing of the drug delivery device.

[0041] As can be understood, by applying force to the transmission gear 206' in the direction of arrow F, the needle assembly 200' (and dispenser 40) can be pushed out of the cassette housing 22. In the relevant scheme, the natural state of the lock spring 210 can prevent the dispenser 10 from remaining in the fully inserted position (Figure 11B) as shown in Figures 10, 11A, and 11B, and can remain in the partially inserted position (Figure 11A) within the cassette housing 22 unless a retaining force is applied to hold the dispenser 10 in the fully inserted position within the cassette housing 22.

[0042] A latch mechanism can be used to hold dispensers 10 and 40 in place within the cassette housing 22. In some embodiments of this technology, Figures 14A to 14D and 15A to 15C illustrate a first type of latch mechanism that may be used, and Figures 16A to 16D and 17A to 17C illustrate a second type of latch mechanism that may be used.

[0043] A first type of latching mechanism may, according to some embodiments of the Art, comprise a latch 32 configured to engage with a latch receiver 220. The latch 32 may be movably mounted to a compartment 26' of the cassette housing 22 via a connector 30a. The latch receiver 220 may comprise a ledge projecting onto the outer surface of the housing 202, 202' of the needle assembly 200, 200'. The latch 32 may comprise an engaging surface 32a configured to abut against the ledge of the latch receiver 220 to hold the needle assembly 200, 200' within the compartment 26' when in the latched position, as schematically shown in Figure 15A. The latch 32 may also comprise an actuator 30 that can be operated by a user to release the latch 32 from engagement with the latch receiver 220. In some embodiments, the actuator 30 and the latch 32 may be formed as a single structure, with the engaging surface 32a of the latch 32 located on the inner surface of the structure and the actuator 30 located on the outer surface of the structure. In some embodiments, the latch 32 may be disengaged by the user by sliding the actuator 30 in a lateral release direction (or a direction having a lateral component) parallel to the contact surface 34 of the cassette housing 22. For example, Figures 14C and 15B show arrows indicating the direction of movement of the actuator 30 for releasing or disengaging the latch 32. In some embodiments, the surface of the actuator 30, the contact surface 34 of the cassette housing 22, and the contact surface 218 of the needle assembly 200, 200' may be substantially coplanar such that the actuator 30 cannot be operated in the lateral release direction when the contact surface 218 of the needle assembly 200, 200' is positioned relative to the injection surface (e.g., the skin surface of the patient to which the fluid in the fluid chamber 158 is injected). Such a coplanar structure can advantageously prevent accidental release or disengagement of the latch 32 by the user during the injection process. In some embodiments, the latch 32 and the latch receiver 220 may include complementary inclined surfaces configured to slide against each other during the insertion of the needle assembly 200, 200' into the compartment 26' of the cassette housing 22.Once the needle assemblies 200, 200' are fully inserted into compartment 26', the latch 32 can snap into the latched position as the latch receiver 220 drops into the recess of the latch 32 and the engaging surface 32a of the latch 32 contacts the latch receiver 220, as depicted in Figure 15A. In some embodiments, the connector 30a may be a spring that biases the latch 32 so that, when the needle assemblies 200, 200' and compartment 26' of the cassette housing 22 are in the latched position, the latch 32 remains latched to the latch receiver 220 until the actuator 30 is operated in the lateral release direction, as described above. In some embodiments, when the actuator 30 is operated to release or disengage the needle assemblies 200, 200' from the latch receiver 220, the spring force of the lock springs 210, 211 of the needle assemblies 200, 200' biases the dispensers 10, 40, as shown in Figure 15C, so that the dispensers 10, 40 can be ejected from the cassette housing 22.

[0044] A second type of latching mechanism may, according to some embodiments of the present art, comprise a latch 32' configured to engage with a latch receiver 220'. The latch 32' may be pivotably mounted to a compartment 26" of the cassette housing 22 via a hinged connector (not shown). The latch 32' may comprise an engaging surface 32a' configured to abut against a ledge of the latch receiver 220' to hold the needle assemblies 200, 200' within the compartment 26" when in the latched position, as schematically shown in Figure 17A. The latch 32' may also comprise an actuator 30' that can be operated by a user to release the latch 32 from engagement with the latch receiver 220. In some embodiments, the actuator 30' may be configured to pivot the latch 32' from the latched position (Figure 17A) to the released position (Figure 17B). In some embodiments, the latch 32' may be positioned in the released position by a user by sliding the actuator 30' laterally (or in a direction having a lateral component) parallel to the contact surface 34 of the cassette housing 22. For example, Figures 16C and 17B show arrows indicating the direction of movement of the actuator 30' for releasing or disengaging the latch 32'. In some embodiments, the surface of the actuator 30', the contact surface 34 of the cassette housing 22, and the contact surface 218 of the needle assembly 200, 200' may be generally coplanar so that when the contact surface 218 of the needle assembly 200, 200' is positioned relative to the injection surface, the actuator 30' cannot be operated to pivot the latch 32' to the released position, thereby preventing accidental release or disengagement of the latch 32' during the injection process. In some embodiments, the actuator 30' may be equipped with a spring that biases the actuator 30' so that when the needle assembly 200, 200' and the section 26'' of the cassette housing 22 are in the latched position, the latch 32' remains latched to the latch receiver 220' until the actuator 30' is operated and the engaging surface 32a' of the latch 32' pivots away from the latch receiver 220', as described above.In some embodiments, when the actuator 30' is operated to release or disengage the needle assemblies 200, 200' from the latch receiver 220', the spring force of the lock springs 210, 211 biases the dispensers 10, 40, as shown in Figure 17C, so that the dispensers 10, 40 can be ejected from the cassette housing 22.

[0045] According to some embodiments of this technology, Figure 18A shows the cassette housing 22 during insertion of the dispenser 10 into the cassette housing 22, and Figure 18B shows the cassette housing 22 after the dispensers 10 and 40 have been fully inserted into the cassette housing 22. In Figures 18A and 18B, the driver gear 502 for rotating the needle selection gear 204 of the needle assembly 200 of the dispenser 10 is located in an opening 27a within section 26, 26', 26” through this opening 27a, allowing the driver gear 502 to contact and rotate the needle selection gear 204. In some embodiments, the driver gear 502 may include a portion having a worm gear configuration, but other gear configurations are intended. In some embodiments, the driver gear 502 may be part of a driver gear assembly 502A (Figure 10) having at least one other gear, and the driver gear assembly 502A may be incorporated into the housing of the drug delivery device as described herein. Figure 18C shows an enlarged view of section 26, 26', 26” of the cassette housing 22, showing the teeth of the needle selection gear 204 through the opening 27a. Although not fully visible in Figures 18A to 18C, openings 27b are provided in sections 26, 26', and 26'', allowing the aforementioned driver gear 602 to contact and rotate the transmission gears 206, 206' of the dispensers 10 and 40. As described above, in some embodiments, once the dispenser 40 is fully inserted into the cassette housing 22 and the driver gear 602 is mounted in the cassette housing 22, the driver gear 602 can apply a force to the transmission gear 206' that can move the lock spring 211 to the unlocked position.

[0046] Figure 19 shows a block diagram of a motor assembly 50 comprising a plurality of driver assemblies 400, 500, and 600. The motor assembly 50 may be coupled to a controller 700 configured to drive each of the driver assemblies 400, 500, and 600. In some embodiments of the art, the controller 700 may comprise at least one computer processor (e.g., a CPU) programmed to control the driver assemblies 400, 500, and 600 individually or in coordination with each other. In some embodiments, the driver assembly 400 may comprise the above-described driver gear 402 for driving the rotation of the driven mechanism 302 of the drive assembly 300. The driver assembly 400 may comprise a motor 403 configured to cause the rotation of the driver gear 402. Similarly, in some embodiments, the driver assembly 500 may comprise the above-described driver gear 502 for driving the rotation of the needle selection gear 204. The driver assembly 500 may comprise a motor 503 configured to cause the rotation of the driver gear 502. In some embodiments, the driver assembly 600 may include the aforementioned driver gear 602 for driving the rotation of the transmission gears 206, 206'. The driver assembly 600 may also include a motor 603 configured to cause the rotation of the driver gear 602. In some embodiments, the controller 700 may be provided with an actuator (not shown) that allows the user to initiate the injection process.For example, after the user has positioned the cassette in the injection position (e.g., against the user's own skin surface or against the patient's skin surface), the user may operate the actuator to produce an automated cooperative movement of any one or any combination of the following: (1) the needle 216 of the needle assembly 200, 200' is positioned in the operating position through the rotation of the needle selection gear 204 via the driver assembly 600; (2) the drive assembly 300 moves the piston 156 toward the partition wall 152, for example, to release a predetermined amount of fluid in the fluid chamber 158 corresponding to the amount of rotation of the driven mechanism 302; and (3) the transmission gears 206, 206' move to move the activated needle 216 from the retracted position to the injection position and from the injection position to the retracted position. As described above, the movement of the transmission gears 206, 206' may also allow the partition wall 152 to be punctured and the fluid to be released into the activated needle 216.

[0047] As can be understood, the cassette housing 22 may have a different form from the one shown in Figure 10. Figure 20A shows a diagram of a cassette 20', where the cassette housing 22' is generally molded into a rectangle and may be sized to be easily grasped by the user. In some embodiments of the art, the cassette housing 22' may have rounded edges and / or slightly curved surfaces, as shown. In some embodiments, the cassette housing 22' may have an internal cavity molded to receive the dispenser 10. For example, the internal cavity of the cassette housing 22' may have a substantially cylindrical portion for receiving the cartridge assembly 100 and a compartment 25 molded to receive the needle assembly 200. Figure 20B shows the dispenser 10 inserted into the cassette housing 22' to form the cassette 20'. In some embodiments, the cassette housing 22' may be configured with a recess for housing the driver gear 402. Optionally, a window 22a may be provided in the cassette housing 22' to allow observation of the position of the piston 156 and / or the fluid level. Although not shown in Figures 20A and 20B, the cassette housing 22' may also include an opening for the driver gears 502, 602 to contact the needle assembly 200.

[0048] Figure 21 shows a block diagram of a drug delivery device 1 according to several embodiments of the present technology. In some embodiments, the device 1 may comprise a cassette 20, 20', a motor assembly 50, and a controller 700, some or all of which may be housed within the housing of the device 1, or partially within the housing. In some other embodiments, the controller 700 may be located outside the housing of the device 1 and may be configured to remotely control the motor assembly 50 through control signals transmitted via a dedicated cable and / or through control signals transmitted wirelessly using known techniques for wireless communication.

[0049] Figures 22A and 22B are perspective views of the proximal and distal ends of a needle system 2000 mounted on a cartridge assembly 100, according to several embodiments of the present technology. In Figure 22B, for simplicity, only the cartridge housing 102 of the cartridge assembly 100 is shown.

[0050] According to some embodiments of the present technology, the needle system 2000 may be configured to house at least one needle assembly comprising a movable needle mechanism. During dose delivery, the needle mechanism may transition from (1) a standby configuration, which may be a non-expanded or compact configuration before injection, to (2) an injection configuration, which may be an expanded configuration, in which case the drug can be delivered to the patient, and (3) a retracted configuration, which may be a non-expanded or compact configuration after injection. The standby and retracted configurations may be the same configuration or different configurations. In some embodiments, the expanded configuration may be configured such that the needle mechanism punctures the partition wall 152 of the cartridge 150 and connects the needle mechanism to the cartridge 150, so that fluid can flow from the cartridge 150 into the needle mechanism. In some embodiments, the expanded configuration may also be configured such that the needle mechanism punctures the patient's skin to deliver the drug subcutaneously.

[0051] According to some embodiments of the present technology, the needle system 2000 may comprise a plurality of needle assemblies 800 and a housing 250 in which the needle assemblies 800 can be arranged. In some embodiments, the needle assemblies 800 may be arranged around a common axis of rotation R, which may be different from axis A of the cartridge assembly 100, as shown in Figure 22B. In some embodiments, axis R may not be parallel to axis A. Details of the needle assemblies and needle mechanisms are described below.

[0052] Figure 22C shows a perspective view of the proximal end of the needle system 2000 with the housing 250 removed, according to some embodiments of the art. Figure 22D shows a perspective view of the distal end of the needle system 2000 with the housing 250 and the identification ring 233 removed. In some embodiments, the needle system 2000 may include an index gear 232 configured for the rotational motion of the needle system 2000 within the housing 250. The needle assembly 800 of the needle system 2000 may be mounted and rotatably fixed to the index gear 232 such that the rotation of the index gear 232 can cause the needle assembly 800 to rotate within the housing 250. The index gear 232 may be a carousel supporting the needle assembly 800. In some embodiments, the identification ring 233 can help to keep the needle assembly 800 within the index gear 232. As shown in Figure 22C, the identification ring 233 may consist of two segments, which allows for easy placement of the identification ring 233 on the needle assembly 800 and the index gear 232. In other embodiments, the identification ring 233 may be a single segment or may include three or more segments. In some embodiments, the needle system 2000 without the housing 250 may have a frustoconical shape, as shown in Figure 22C, with the distal end of the needle system 2000 having a larger area than the proximal end. In some embodiments, the gear teeth 232a of the index gear 232 may be spaced apart circumferentially around the circumferential surface of the index gear 232. For example, the teeth 232a may be located on the edge of the proximal end of the index gear 232, as shown in Figures 22C and 22D.

[0053] Figure 22E shows the needle system 2000 and cartridge assembly 100, with the housing 250, index gear 232, and identification ring 233 of the needle system 2000 removed so that the relative positions of the needle assembly 800 and cartridge assembly 100 can be seen. The needle assembly 800 may include needle mechanisms, which in some embodiments may be needle mechanisms 810, 1700, discussed below. In some embodiments, the housing 250 may comprise a first section 250b in which some of the needle assemblies 800 may be located, and a second section 250c in which a driver 245 (described below) may be located. According to some embodiments of the Art, the needle system 2000 may comprise four needle assemblies 800 arranged circumferentially around an axis R. For example, the four needle assemblies 800 may be arranged such that their distal ends resemble a quadrant of pi, and each quadrant has a surface that can be aligned to form the distal surface 240 of the needle system 2000. In some embodiments, the needle assembly 800 may be configured to rotate about an axis R so that a selected needle assembly 800 can be rotated to align with the cartridge assembly 100. As shown in Figure 22E, the internal seal 808 of the lower of the needle assemblies 800 is aligned with the cartridge assembly 100, while the other unselected ones are not. Once the selected needle assembly 800 is positioned in the aligned position, the driver 245 of the needle system 2000 may engage with the selected needle assembly 800, as shown in Figure 22E and as will be discussed in more detail elsewhere in this specification. The driver 245 may be configured to move the injection needle of the selected needle assembly 800 to the injection position so that fluid can flow out of the cartridge assembly 100. As shown in Figure 22E, the unselected needle assemblies 800 may not be aligned with the cartridge assembly 100.In some embodiments, each needle assembly 800 may have a tapered shape such that, when the needle assemblies 800 are arranged together, the radial cross section at or near the distal end of the arrangement ("distal cross section") may have a larger area than the radial cross section at or near the proximal end of the arrangement ("proximal cross section"). In some embodiments, each needle assembly 800 may be at least partially arranged within the frustoconical body of the index gear 232 so that the index gear 232 and the needle assembly 800 can rotate in concert, as shown in Figures 22C and 22D. The tapered shape of the needle assembly 800 and the frustoconical shape of the needle system 2000 without the housing 250 may help reduce the overall size of the needle system 2000. In some embodiments, the needle assembly 800 may have a tapered shape, but the distal end of the needle assembly 800 does not need to be pi-shaped. The tapered shape may correspond to the angle between axis A and axis R.

[0054] Figure 22F shows a perspective view of the needle system 2000, in which the first section 250b of the housing 250 is semi-transparent, and as a result, the internal portion of the housing 250 can be seen. According to some embodiments of the Art, the housing 250 may include a viewer 230 for identifying which needle assembly 800 is in the working position and ready for use in dose delivery, as described below. In some embodiments, the identification ring 233 may have identification markings corresponding to each needle assembly 800, and the viewer 230 may be a window in the housing 250 through which identification markings (e.g., numbers, letters, one or more words, graphics, colors, etc.) can be seen to visually indicate which of the needle assemblies 800 is in the working position. The viewer 230 may allow the user to confirm that the selected needle assembly is the needle assembly 800 in the working position. The markings may include tactile indicators, such as protrusions and / or recesses of various shapes and sizes. An audible indicator can be associated with a needle system that has a sensor capable of detecting the position of the needle assembly, allowing the patient to be informed of the current position of the needle assembly and / or whether the needle has been used or whether a new needle assembly is needed.

[0055] Figure 22G shows a perspective view of the distal end of the needle system 2000. According to some embodiments of the Art, the needle system 2000 may include a protective cover 240a covering the distal surface 240. In some embodiments, the protective cover 240a may include an opening or window 242 that exposes the distal surface of one selected needle assembly 800 in the working position. The material of the cover 240a may also have mechanical properties to prevent a needle from an unselected one from inadvertently puncturing the cover. During dose delivery, the injection needle of the selected needle assembly 800 in the working position can expand through the window 242 to puncture the target surface. In some embodiments, the window 242 may indicate the approximate puncture position of the injection needle. In some embodiments, an identification mark on the outer surface of the selected needle assembly 800 in the working position can be seen through the window 242. Therefore, the window 242 may allow the user to see which needle assembly 800 is being used for injection, and may allow the user to properly position the needle system 2000 on the target surface for dose delivery. For example, the user may align the window 242 with the area of ​​the target surface to be punctured by the injection needle.

[0056] As described above, the needle assembly 800 can be selectively actuated for use via the index gear 232. According to some embodiments of the Art, the needle assembly 800 may be movable within the housing 250 so that a selected needle assembly 800 can be rotated to the actuated position via the action of the index gear. In some embodiments, the actuated position may be a position in which the selected needle assembly 800 is aligned to puncture the partition wall 152 of the cartridge 150. The index gear 232 may be a needle selection gear driven to move the needle assembly 800 from the actuated position, thereby moving a newly selected needle assembly 800 to the actuated position, or moving a previously selected needle assembly 800 from the actuated position. For example, the index gear 232 may be similar to the needle selection gear 204 described above. The newly selected needle assembly 800 may be, for example, one of the next needle assemblies 800 adjacent to the previously selected needle assembly 800, or, for example, one of a particular needle assembly 800 that is not adjacent to the previously selected needle assembly 800. In some embodiments, the index gear 232 may be coupled to a rotating mechanism configured to rotate the needle assembly 800 around an axis R. The index gear 232 may be driven to rotate, and then the rotating mechanism may rotate the newly selected needle assembly 800 to the working position. In some embodiments, the index gear 232 may be rotated directly by the motor shaft, or indirectly by the motor via at least one transmission gear, or manually (for example, by scrolling the gear with a finger). In some embodiments, the index gear 232 may be rotated by a transmission gear located at least partially within the housing 250.

[0057] According to some embodiments of the present technology, the housing 250 may include an opening 234 through which a portion of the index gear 232 can be accessed, as shown in Figures 22F and 23A, to be driven by an external component of the housing 250. The opening 234 may allow a portion of the teeth 232a of the index gear exposed in the opening 234 to interact with, for example, an index driver (not shown). For example, the index driver may be similar to the drive gear 502 described above.

[0058] According to some embodiments of the present technology, the needle system 2000 may have a structure configured to facilitate the proper placement of a selected needle assembly 800 into its working position. Such a structure can maintain the alignment or orientation of the carousel after assembly, during shipping and handling, until the device indexes the carousel. Such a structure can also maintain the carousel position when disposable items are removed and replaced.

[0059] For example, the housing 250 may include at least one structure configured to engage with at least one corresponding structure of the index gear 232 to indicate that the needle assembly 800 is seated in the working position. In some embodiments, the housing 250 may include a stabilizer 252 configured to engage one by one with a plurality of trenches 232b corresponding to the needle assembly 800, as shown in Figures 23A–23C. The trenches 232b may have a one-to-one correspondence with the needle assembly 800. The stabilizer 252 may include a projecting peg 252a configured to drag along the surface of the body of the index gear 232 during the rotation of the index gear 232 in the needle selection operation, and to fall into one of the trenches 232b when one of the needle assemblies 800 is aligned in the working position. The peg 252a is shown extending radially inward, and the trenches 232b are shown facing radially outward. In some embodiments, as the index gear 232 is rotated, the peg 252a may emit an audible sound (e.g., a click) for each alignment that occurs. For example, if needle assembly 1 is in the working position for the previous dose delivery and needle assembly 3 is selected for use for the next dose delivery, the index gear 232 may be rotated to a first alignment for needle assembly 2, at which point a click and / or physical indication of alignment may be present, and then rotated to a second alignment for needle assembly 3, at which point another click and / or physical indication of another alignment may be present. In some embodiments, the trench 232b may have a curve or recess sized to accommodate or seat the peg 252a therein. In some embodiments, during the rotation of the index gear 232, the stabilizer 252 and the peg 252b may exert a first radial force on the index gear 232, thereby causing the index gear 232 to experience a first rotational resistance when the peg 252b is not seated in one of the trenches 232b. When one of the needle assemblies 800 is aligned with the operating position, the ballast 252 and peg 252b may exert a second force on the index gear 232 that is lower than the first force, such that the index gear 252 may receive a second rotational resistance that is lower than the first rotational resistance.The difference between the first rotational resistance and / or audible click and the second rotational resistance and / or audible click may help facilitate proper positioning of the selected needle assembly 800 to its operating position and prevent rotational movement of the selected needle assembly 800 from its position during dose delivery. In some embodiments, the housing 250 may comprise a plurality of stabilizers 252 (e.g., one stabilizer 252 for each of the trenches 232b).

[0060] Figure 24A is a longitudinal cross-sectional view of the needle system 2000, showing some details of the needle assembly 800 relative to the cartridge assembly 100 according to several embodiments of the present technology, and Figure 24B shows a magnified cross-section of a portion of the needle system 2000. For simplicity, only the cartridge housing 102 of the cartridge assembly 100 is shown in Figure 24A.

[0061] According to some embodiments of the present technology, the needle system 2000 may include four needle assemblies 800, of which a first needle assembly 800a and a second needle assembly 800b are shown in Figure 24A. In Figure 24A, the first needle assembly 800a is in the working position, and fluid can be transferred out of the cartridge 150 of the cartridge assembly 100 through the first needle assembly 800a, and as the needle of the first needle assembly 800a is extended, as discussed below, the fluid can be transferred out from the distal end of the first needle assembly 800a. In some embodiments, the needle system 2000 may allow only one of the needle assemblies 800 to be in the working position at any given time. For example, when the first needle assembly 800a is in the working position, the second needle assembly 800b and the other needle assemblies of the needle system 2000 may be prevented from transferring fluid from the cartridge 150.

[0062] According to some embodiments of the present technology, in the operating position, the septum puncture needle (described below) of the first needle assembly 800a may be aligned with the septum 152 of the cartridge assembly 100 so that the septum puncture needle can move along axis E1 to puncture the septum 152. In Figure 24A, the septum 152 is not shown. However, the region 152a where the septum is located is shown in Figure 24A. In some embodiments, the septum puncture needle of the first needle assembly 800a may be coaxial with axis A of the cartridge assembly 100 when in the operating position. That is, in some embodiments, axis E1 may be coaxial with axis A. As described above, when the first needle assembly 800a is aligned with the septum 152, the second needle assembly 800b and the other needle assemblies 800 do not have to be aligned with the septum 152. For example, as shown in Figure 24A, when the first needle assembly 800a is in the working position, the septum puncture needle of the second needle assembly 800b may be aligned along direction F1 so that the septum 152 cannot be punctured. Similarly, the septum puncture needles of other needle assemblies 800 that are not in the working position may also be aligned along a direction that does not allow puncture of the septum 152. In some embodiments, direction F1 and axis E1 may be at an angle to each other in the range of about 0° to about 15° (e.g., 4°, or 8°, or 10°, or 12°), but may be greater. In some embodiments, direction F1 may be positioned at an angle of about 8° with respect to axis E1. It should be understood that each of the unselected needle assemblies 800 may be oriented at a different angle with respect to axis E1. In some embodiments, by arranging the needle assemblies 800 so that they are inclined relative to each other, the overall size of the needle system 2000 can be reduced compared to a parallel arrangement of the needle assemblies 800. In other embodiments, direction F1 may be positioned at an angle of approximately 0° (or substantially parallel) to axis E1.

[0063] According to some embodiments of the present technology, when the first needle assembly 800a is in the working position, the cannula needle (described below) may be moved to puncture a target surface (e.g., the user's skin). At the same time, the cannula needles of the second needle assembly 800b and the other needle assemblies 800 of the needle system 2000 may not be moved to puncture a target surface or any other surface.

[0064] According to some embodiments of the present technology, after dose delivery using the first needle assembly 800a, another needle assembly 800 of the needle system 2000 may be activated for use. For example, if a second needle assembly 800b is selected for subsequent use, the second needle assembly 800b may be moved to the activated position via the index gear 232 so that the septum puncture needle of the second needle assembly 800b is aligned with the septum 152 and axis E1. In some embodiments, when the second needle assembly 800b is in the activated position, the septum puncture needle of the second needle assembly 800b may be coaxial with the cartridge assembly 100, as described above. When the second needle assembly 800b is in the activated position, the septum puncture needle of the first needle assembly 800a may no longer be aligned with the cartridge assembly 100 and may no longer be aligned along E1. Furthermore, when the second needle assembly 800b is in the operating position, the first needle assembly 800a and the other needle assemblies of the needle system 2000 may be prevented from transferring fluid from the cartridge assembly 100.

[0065] As described above, the needle assembly 800, when not in the operating position, does not need to transfer fluid from the cartridge assembly 100. According to some embodiments of the present technology, the cannula needle and septum puncture needle of the needle assembly 800, when not in the operating position, can be prevented from moving so as not to puncture the septum 152 and the user's skin.

[0066] According to some embodiments of the present technology, the needle assembly 800 may each include a driven member 820 configured to cause movement of the cannula and septum puncture needle, as shown in Figure 25. Each driven member 820 may be configured to rotate to cause movement of their respective cannulas and septum puncture needles. In some embodiments, the driver 245 of the needle system 2000 may be configured to drive movement of a selected needle assembly 800 in an operating position by rotating the driven member 820 of the selected needle assembly 800. For example, as shown in Figure 24A, a portion 245a of the driver 245 may engage with a portion 820a of the driven member 820 of a first needle assembly 800a in an operating position, thereby causing the driven member 820 to rotate and move the cannula and septum puncture needle of the first needle assembly 800a. In some embodiments, portion 245a of the driver 245 may be provided with a projection 245a, and portion 820a of the driven member 820 may be provided with a recess 820a that is molded to receive the projection 245a therein.

[0067] According to some embodiments of the present technology, the recess 820a may be a channel, and the inner surface of the housing 250 may include a rib 222 configured to engage with the recess 820a of the driven member 820 of a needle assembly 800 that is not in the operating position, thereby preventing rotational movement of the driven member 820. For example, as shown in Figures 24A and 24B, the recess 820a (channel) in the driven member 820 of a second needle assembly 800b that is not in the operating position engages with the rib 222 of the housing 250 so that rotational movement of the driven member 820 can be prevented relative to the second needle assembly 800b.

[0068] According to some embodiments of the present technology, for each needle assembly 800, the driven member 820 may be configured to interact with the needle mechanism of the needle assembly 800 to extend and retract the cannula and septal puncture needle of the needle assembly 800. The driven member 820 of a needle assembly in the working position (e.g., the first needle assembly 800a in Figure 24A) may also be configured to interact with the driver 245, which may rotate the driven member 820 to move the needle mechanism, as described above. In some embodiments, the recess 820a of the driven member 820 may be configured to align with and receive the projection 245a of the driver 245.

[0069] Figure 25 shows a perspective view of the needle assembly 800 according to several embodiments of the present technology. In some embodiments, the projection 245a may be a rod-like structure configured to seat in a recess 820a (channel) when the needle assembly 800 is in the working position. As described above, the same channel forming the recess 820a may engage with the rib 222 when the needle assembly 800 is not in the working position.

[0070] Referring back to Figure 24A, during dose delivery of the first needle assembly 800a in the working position, the projection 245a of the driver 245 may be received in the recess 820a of the driven member 820 and rotate to rotate the driven member 820. According to some embodiments of the Art, when the driven member 820 is rotated in a first direction by the driver 245, the cannula and septum puncture needle may be moved away from each other so that the first needle assembly 800a can transition from a standby configuration to an extended configuration. The standby configuration may be the configuration of the first needle assembly 800a before it is moved to the working position and used for dose delivery. The extended configuration may be the configuration in which the septum puncture needle punctures the septum 152 and the cannula needle punctures the protective cover or seal 806 of the first needle assembly 800a. Upon puncture, the fluid in the cartridge 150 of the cartridge assembly 100 may be drained from the cartridge 150 into the first needle assembly 800a via the action of the driven assembly 300, as described above. After dose delivery, the driver 245 may rotate in a second direction opposite to the first direction, retracting the cannula and septum puncture needle of the first needle assembly 800a into a retracted configuration. In the retracted configuration, the septum puncture needle does not need to expand through the septum 152, and the cannula needle does not need to expand through the protective cover or seal 806. In some embodiments, the standby configuration and the retracted configuration may be the same configuration. In some other embodiments, the retracted configuration may be configured to prevent the first needle assembly 800a from being reused (for example, for another dose delivery).

[0071] Figure 26A is a perspective view of a needle system 2000 showing a second section 250c of the housing 250 according to some embodiments of the present technology. The second section 250c may also be a driver section of the housing 250 configured to expose at least a portion of the outside of the driver 245, thereby allowing access to the driver 245 for interaction with, for example, an external motor. The inside of the driver 245 may be configured with portion 245a to drive the driven member 820 of the selected needle assembly 800 to the operating position, as described above. In some embodiments, the external motor may comprise a small electric motor housed in a portable cassette in which the cartridge assembly 100 and / or needle system 2000 may be arranged.

[0072] According to some embodiments of the present technology, the needle system 2000 may include engagement structures of a non-conventional shape and / or arranged non-conventionally to prevent manual tampering by a user using a conventional tool (e.g., a flathead screwdriver, a butter knife, etc.) to rotate the driver 245. Such structures can prevent misuse and contamination of the needle of the needle system 2000 by making it difficult to drive the needle's movement without the appropriate tool. In some embodiments, the outside of the driver 245 may have a plurality of protrusions 245c configured to engage with complementary surfaces on a shaft 260 attached to an external motor (not shown) used to rotate the driver 245, as shown in Figures 26B and 26C. In some embodiments, the protrusions 245c may be configured to form slot-shaped driver recesses 245b. The driver recesses 245B may be configured to engage with surfaces 261a, 261b of a rod-shaped shaft head 261 extending from the shaft 260. In some embodiments, the second section 250c of the housing 250 may have an access opening 250a that allows access to the driver recess 245b, as shown in Figure 26A. In some embodiments, the driver recess 245b may be aligned with the access opening 250a such that a portion of the driver recess 245b is below the second section 250c of the housing 250. In such a configuration, the rod-shaped shaft head 261 may not engage with the driver 245 by simply moving radially (vertically) inward into the driver recess 245b. In some embodiments, the rod-shaped shaft head 261 engages with the driver 245 by axial movement (parallel to axis A) into a cavity 250d below the second section 245c of the housing 250 at the end of the rod-shaped shaft head 261, and then moves radially inward so that the rod-shaped shaft head 261 moves away from the second section 250c of the housing 250, at which point the driver 245 may be rotated by the rotation of the rod-shaped shaft head 261 (for example, via contact between the longitudinal surface 261b of the rod-shaped shaft head 261 and the projection 245c of the driver 245).For example, during dose delivery, after the axial and radial movements discussed above, the rod-shaped shaft 261 may be seated in the driver recess 245b, and a rotational force may be exerted on at least one of the projections 245c of the driver 245, causing the driver 245 to rotate. The rotation of the driver 245 may then rotate the driven member 820 of the first needle assembly 800a (in the operating position) so that the needle mechanism of the first needle assembly 800a can expand or retract the cannula and septum puncture needle of the first needle assembly 800a. In some embodiments, the shaft 260 may be configured to rotate the driver 245 in a first direction to expand the needle and in a second direction opposite to the first direction to retract the needle.

[0073] The needle assembly 800 is described in relation to a needle system 2000 which may include a plurality of needle assemblies 800 arranged in a carousel-type structure. According to some embodiments of the Art, the needle assembly 800” may be configured for a needle system 2000” which is configured to work with a single cannula needle and a single septum puncture needle. Figure 27A shows a side view of the needle assembly 800”. Figure 27B shows a perspective view of the needle system 2000” incorporating the needle assembly 800”. In some embodiments, the needle assembly 800” may be located within a housing 250” of the needle system 2000” so that the driven member 820” of the needle assembly 800” may be directly driven by a shaft attached to an external motor (not shown) that extends through an access opening 250a” of the housing 250” without the use of an intervening driver (e.g., without a driver 245). The outer surface of the driven member 820” may have at least one recess or indentation 820a” having an irregular shape, and / or a plurality of recesses or indentations 820a” having an irregular shape and / or an irregular arrangement, as shown in Figure 27A. Such recesses or indentations 820” can prevent unauthorized modification by being difficult to engage with using conventional tools (e.g., flathead screwdrivers, butter knives, forks, etc.). For example, the driven member 820” may not rotate easily unless a shaft head having the appropriate number and arrangement of recesses or indentations 820a” in the needle assembly 800” shown in Figure 27A is used. In this example, two recesses or indentations 820a” can be engaged using a shaft head including two prongs having complementary shapes and spacing, but cannot be engaged with a conventional fork.

[0074] Other features of needle assembly 800” may be the same as or similar to the features of needle assembly 800 described herein, and therefore may have common reference numerals. These features can be understood from the description herein of needle assembly 800.

[0075] Figure 28 is a perspective view of a needle assembly 800 showing a needle mechanism 810 according to several embodiments of the present technology. In Figure 28, the housing 801 of the needle assembly 800 appears translucent so that the needle mechanism 810 can be seen. The needle mechanism 810 may have a non-expandable or compact configuration in which the components of the needle mechanism 810 can be entirely housed within the housing 801 of the needle assembly 800, or an expandable configuration in which some of the components of the needle mechanism 810 can extend beyond the housing 801. In some embodiments, the housing 801 may include an external seal 806 and an internal seal 808 to maintain a sterile state for the components of the needle mechanism 810 when in the compact configuration. In some embodiments, the external seal 806 may be located at the distal end of the housing 801 and may function as part of the distal end 802 of the needle assembly 800. In some embodiments, the internal seal 808 may be located at the proximal end of the housing 801 and may be part of the proximal end 804 of the needle assembly 800.

[0076] According to some embodiments of the Art, 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. In some embodiments, the injection needle 830 may be mounted on and supported by the injection needle support 840, and the injection needle support may be movably mounted within the housing 250 such that the movement of the injection needle 830 is caused by the movement of the injection needle support 840. In some embodiments, the injection needle 830 may be the cannula needle described above, and the septum needle 850 may be the septum puncture needle described above. Prior to dose delivery (i.e., injection operation), the needle mechanism 810 may be in a standby configuration, which is a compact configuration in which the components of the needle mechanism 810 are entirely within the housing 801 and ready for use. In particular, in the standby configuration, the distal end of the injection needle 830 may be within the housing 250 and facing the inner surface of the external seal 806. Similarly, in the standby configuration, the proximal end of the septum needle 850 may be inside the housing 250 or facing the inner surface of the internal seal 808. During dose delivery, the needle mechanism 810 can transition from the standby configuration to the infusion configuration, which may be an extended configuration in which a portion of the needle mechanism 810 can extend outside the housing 250. During the transition, the infusion needle 830 may move (to the left in Figure 28) to puncture the external seal 806, while the septum needle 850 may move (to the right in Figure 28) to puncture the internal seal 808 and septum 152 of the cartridge assembly 100. If the external seal 806 is positioned relative to a part of the user being injected (e.g., the user's leg), the infusion needle 830 may puncture the surface of that part of the user (e.g., the 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 and 850 are in fluid communication with each other (sometimes referred to herein as "fluidically coupled"). During dose delivery, fluid can flow from the cartridge assembly 100 through the septum needle 850, through the flow path or bore of the needle connector 870, and through the injection needle 830 to deliver the drug subcutaneously to the user. After dose delivery, the injection needle 830 and the septum needle 850 may be retracted into the housing 250 such that the needle mechanism 810 may be in a retracted configuration.In some embodiments, the retracted configuration and the standby configuration may be the same compact configuration, and the needles 830 and 850 may be reusable. In some other embodiments, the retracted configuration may differ from the standby configuration, as will be discussed below, such that the needles 830 and 850 cannot be reused.

[0077] The needle connector 870 fluidly connects the injection needle 830 to the partition needle 850, and the partition needles may be movable relative to each other. According to some embodiments of the art, the needle connector 870 may be movable to allow the needle mechanism 810 to transition from a compact configuration to an extended configuration and from an extended configuration to a compact configuration. In some embodiments, the needle connector 870 may be flexible and configured for bending and / or stretching and / or other movements in which the needle connector 870 may deform and change its overall shape. According to some embodiments, the needle connector 870 may include flexible and elastic polymer materials such as elastomers, thermosetting polymers, and rubber. For example, the needle connector 870 may include silicone tubing (e.g., liquid silicone rubber (LSR) tubing), polyurethane tubing, Mylar® tubing, etc. As understood, for transporting pharmaceuticals, the needle connector 870 may be formed from medical-grade materials. In some embodiments, the flexible material may be sterilizable and inert to the fluid in the cartridge 150. In some other embodiments, the needle connector 870 may comprise rigid materials that are coupled together through a flexible connection. 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-proof manner. In some embodiments, the needle connector 870 may be formed from semi-rigid segments configured to move relative to one another, such as in a nesting operation. The semi-rigid segments may be formed from an elastic material (e.g., an elastomer) configured to form a leak-proof seal against adjacent surfaces when the needle mechanism 810 is in an extended configuration.

[0078] 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 the inlet end of an injection needle 830, and an inlet end 874 fluidly coupled to the outlet end of a partition needle 850. In some embodiments, the outlet end 872 and the inlet end 874 of the needle connector 870 may be directly coupled to the partition and injection needles 850, 830, respectively. For example, the bore diameter of the needle connector 870 may be small enough so that a leak-proof seal can be established between the inner surface of the inlet end 874 of the needle connector 870 and the outer surface of the partition needle 850 inserted into the inlet end 874. Similarly, the bore diameter of the needle connector 870 may be small enough so that a leak-proof seal can be established between the inner surface of the outlet end 872 of the needle connector 870 and the outer surface of the injection needle 850 inserted into the outlet end 872.

[0079] According to some embodiments of this technology, the inlet end of the injection needle 830 may be coupled to the outlet end 872 of the needle connector 870 via a needle retainer 842. Similarly, the outlet end of the partition needle 850 may be coupled 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 a leak-proof seal between the needle connector 870 and the injection needle 830 and partition needle 850. In some embodiments, the needle retainers 842, 862 may comprise a connector coupler (discussed below) that extends from the needle support 840, 860 and is configured to be fixed to the needles 830, 850. In some embodiments, the output end 872 and input end 874 of the needle connector 870 may be extruded, molded, or otherwise formed to provide a sliding fit on the connector coupler. The needle connector 870 may be fixed in a leak-proof manner to the injection and bulkhead needles 830, 850 and / or to the connector couplers of the needle supports 840, 860 by compressive force and / or adhesive and / or protrusions (e.g., burrs) and / or a second shot, as discussed below. The fixing mechanism is described below.

[0080] Figure 32A shows the needle assembly 800 in a standby configuration before injection. Figure 32B shows the needle assembly in an extended configuration during injection. Figure 32C shows the needle assembly 800 in a retracted configuration after injection. Note that the needle connector 870 in Figure 32B is shown in a non-extended state, disconnected from the needles 830 and 850, even though the needle assembly 800 is in an extended configuration, and as a result, the amount of non-bending and extension of the needle connector 870 to maintain fluid communication between the needles 830 and 850 can be visualized. In some embodiments, portions of the needle supports 840 and 860 may engage with each other when in the retracted configuration. The engaged portions may interfere with each other to prevent the needle assembly 800 from returning to an extended configuration, as will be discussed below.

[0081] The inventors recognize and understand that for applications in which the needle connector 870 is used to achieve a desired delivery rate for viscous fluids, and / or in applications where a high fluid delivery rate is desired, reducing the bore diameter of the needle connector 870 to provide a leak-proof clamping or compressive force around the connector coupler may be as undesirable as having a relatively large bore diameter that is less restrictive to the fluid flow. According to some embodiments of the Art, the bore sizes of the injection needle 830, the bulkhead needle 850, and the needle connector 870 may be large enough to allow the desired fluid delivery rate to be achieved by the operation of the driven assembly 300 described above, with the needle retainers 842, 862 (e.g., the connector coupler) providing a leak-proof seal. In some embodiments, the injection needle 830 and the bulkhead needle 850 may have the same bore size. In some embodiments, the injection needle 830 may have a different bore size than the bulkhead needle 850. In some embodiments, the bore sizes of the injection needle 830, the partition needle 850, and the needle connector 870 can enable a fluid delivery rate of at least 5 mL (or cc) within 30 seconds for fluids with a viscosity of 30 centipoise or less, or at least 3 mL within 20 seconds for fluids with a viscosity of 15 centipoise or less. For example, the fluid delivery rate may be 3 mL in less than 20 seconds for fluids with a viscosity of 30 centipoise or less, or 3 mL in less than 12 seconds for fluids with a viscosity of 30 centipoise or less, or 3 mL in less than 9 seconds for fluids with a viscosity of 15 centipoise or less.

[0082] Figures 29A and 29B are side-side perspective views of the needle mechanism 812 according to several embodiments of the present technology. For simplicity, Figure 29A may be considered to show a front embodiment of the needle mechanism 812, and Figure 29B may be considered to show a rear embodiment of the needle mechanism 812. However, it should be understood that the terms “front” and “rear” do not indicate the required orientation of the features described for the needle mechanism 812. In some embodiments, at least some of the needle mechanism 812 may form at least some of the needle mechanism 810 described above. Figures 30A and 30B are perspective views of the driven member 820, which is configured to be driven by a driver 245 (discussed above) and to cause injection of the needle mechanism 810 and movement of the partition needles 830, 850.

[0083] According to some embodiments of the present technology, the needle mechanism 812 may include an injection needle support 840 and a partition needle support 860, which may generally be arranged with respect to a common plane and may be slidably coupled to each other via a driven member 820. In some embodiments, the driven member 820 may be located on the front side of the common plane, and the supports 840, 860 may be located on the rear side of the common plane opposite to the front side. The front sides of the supports 840, 860 may have engaging portions 846, 866 configured to engage with the driven member 820 and move the supports 840, 860 in opposite directions, so that the injection needle 830 and the support needle 850 can move in opposite directions. In some embodiments, the supports 840, 860 may be sized and molded to fit within the housing 801 of the needle assembly 800, as shown in Figure 28, and may be configured to move the injection needle 830 and the partition needle 950 between an expanded configuration in which the needles 830, 850 move within the housing 801 and extend at least partially outside the housing 801, and at least one compact configuration (e.g., a pre-injection standby configuration, a post-injection retraction configuration) in which the needles 830, 850 are inside the housing 801.

[0084] According to some embodiments of the present technology, the needle mechanism 812 may have a rack and pinion configuration, and the support members 840, 860 may include a first rack and a second rack having engaging portions, and the driven member 820 may include a pinion gear configured to movably interact with the engaging portions of the racks to move the racks in opposite directions. In some embodiments, the injection needle support member 840 may include a support body 848 that forms at least a portion of the first rack, molded projections that form at least an engaging portion 846 or teeth of the first rack, and a needle holder 842 that may extend from the support body 848 and may hold a portion of the injection needle 830 therein. In some embodiments, the needle holder 842 may be fixedly coupled to the injection needle 830 such that movement of the support member 848 may cause movement of the injection needle 830 through the needle holder 842. In some embodiments, the needle holder 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 a second rack, at least an engaging feature 866 or molded projection forming teeth of the second rack, and a needle holder 862 that may extend from the support body 868 and may hold a portion of the septum needle 850 therein. In some embodiments, the needle holder 862 may be fixedly coupled to the septum needle 850 such that movement of the support body 868 may cause movement of the septum needle 850 through the needle holder 862. In some embodiments, the needle holder 862 may extend laterally from the support body 868. In some embodiments, one or both of the injection needle support 840 and the septum needle support 860 may comprise a needle guard 844, which may protect a needle section extending through the needle guard 844 and / or provide support to the needle section. In some embodiments, the needle guard 844 may include a cylindrical sleeve through which the needle section extends.

[0085] According to some embodiments of the present technology, the rear side of the driven member 820 may include an engaging portion 824 or a pinion gear having teeth, configured to mesh with the engaging portions 846, 866 or teeth of the first and second racks forming the supports 848, 868. The front side of the driven member 820 may include an actuator 826, which can be configured to engage with a driver 245 or a rib 222, as described above. For example, if the needle mechanism 812 is part of a first needle assembly 800a in an operating position (see Figure 24A), the actuator 826 of the driven member 820 may be engaged by the driver 245 such that rotation of the driver 245 can cause rotation of the actuator 826, which in turn can cause rotation of the engaging portion 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 800b that is not in the operating position (see Figure 24A), the actuating member 826 of the driven member 820 may be engaged by a rib 222 of the housing 250 so that rotation of the actuating member 826 can be prevented. For example, the actuating member 826 may have a slot-shaped recess (e.g., recess 820a in Figure 25) configured to slide along the rib 222 when not in the operating position and to engage with the rod-shaped projection 245a of the driver 245 when in the operating position (see Figure 25B). In some embodiments, the actuator 826 may include a plurality of recesses (see, for example, the recess or recess 820a” in Figure 27A) configured to engage with a plurality of complementary projections of a driver (e.g., a shaft head). For example, the actuator 826 may have a particular size and / or shape and / or number of recesses that can be driven when the driver has complementary projections, so that the complementary projections can function as a key structure for engaging with and driving the actuator 826. In some embodiments, one side of the actuator 826 may have a slot-shaped recess 820a for engaging with the rib 222 when not in the actuated position, and the other side of the actuator 826 may have one or more shaped recesses configured to be driven by a driver having complementary projections (i.e., a key structure).The use of a key structure can prevent the driven member 820 from being improperly altered by conventional tools (e.g., screwdrivers, nail files, butter knives, etc.), and as a result, the injection needle 830 can not be improperly extended outside the housing 250. In some embodiments, the driven member 820 may include 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 801 at the interface between the driven member 820 and the housing 801. In some embodiments, the ring 822 may function to hold the driven member 820 within the housing 801. In some embodiments, the ring 822 may also provide a seal and may facilitate the rotation of the driven member 820. For example, the ring 822 may include a bearing configured to allow the driven member 820 to rotate easily when driven by the driver 245.

[0086] As can be understood, the engaging portion 824 of the driven member 820 is shown to be a tooth of a pinion gear, and the support members 840, 860 are shown to have engaging portions 846, 866 which are teeth configured to engage with the teeth of the pinion gear; however, in some embodiments, the driven member 820 and the support members 840, 860 may have other moving structures configured to interact with each other to move the injection needle 830 and the partition needle 850 in opposite directions. For example, such a moving structure may comprise another structure having a threaded screw and / or a zip chain and / or complementary parts. As described above, the driver 245 may be driven to rotate by an electric motor (not shown).

[0087] Figures 31A and 31B show the front and rear views, respectively, of the needle mechanism 812 in a compact configuration (Figure 31A) and an extended configuration (Figure 31B) according to several embodiments of the present technology. The compact configuration may include several different configurations, such as the standby configuration and the retracted configuration described above. In the standby configuration, the injection needle 830 of the needle mechanism 812 may be located within the housing 801 and is not yet used in an injection operation, for example, to inject fluid from the cartridge 150 to the user (see also Figure 32A). In the retracted configuration, the injection needle 830 has moved or extended at least partially outside the housing 801 for use in an injection operation and has retracted back into the housing 801 (see Figure 32C). In other words, 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 the same configuration. In some embodiments, the retracted configuration may differ from the standby configuration and may be a configuration in which the injection needle 830 cannot be reused. In other words, the retracted configuration may be a configuration that prevents the needle mechanism 810 from returning to the extended configuration.

[0088] More specifically, in the compact configuration of Figure 31A, both the injection needle 830 and the partition needle 850 may be entirely axially positioned within the housing 801 of the needle assembly 810. The needle connector 870 connected to the injection needle 830 and the partition needle 850 may be bent (e.g., loop-shaped, curved, coiled, etc.) such that the inlet end 874 and outlet end 872 of the needle connector 870 are relatively close to each other, as depicted in Figure 28, allowing the needles 830 and 850 to be fully positioned within the housing 801. In some embodiments, in the compact configuration, the inlet end 874 and outlet end 872 of the needle connector 870 may be separated from each other by a first axial distance along the axis A1 of the needle assembly 810 (see Figure 28), or they may overlap each other along the axis A1, as depicted in Figure 28. When the driven member 820 rotates in direction Cl, the support 840 and injection needle 830 may be driven in direction D1, while the support 860 and partition needle 850 may be driven in direction D2, resulting in the supports 840 and 860 sliding away from each other. The movement of the supports 840 and 860 may proceed until the needle mechanism 812 reaches an extended configuration, which is the point at which the rotation of the driven member 820 can be stopped. In some embodiments, the rotation of the driven member 820 may be stopped when a part of the needle mechanism 812 comes into contact with the housing 801 (e.g., the support 840 and / or support 860 come into contact with the housing 801). In some embodiments, directions D1 and D2 may be antiparallel or nearly antiparallel to each other. For example, the angle between D1 and D2 may be 180°±5° or 180°±2°. In some embodiments, directions D1 and D2 may be parallel or nearly parallel to axis Al, as shown in Figure 28. In some embodiments, D1 and / or D2 do not have to be parallel or nearly parallel to axis A1, but instead may have angles in the range of about 5° to about 45° with respect to axis A1.

[0089] In the extended configuration of Figure 31B, the injection needle 830 may extend axially beyond the housing 801 and puncture the external seal 806, thereby puncturing a target surface positioned relative to the external seal 806. The target surface may be, for example, the user's injection surface. In addition, in the extended configuration, the partition needle 850 may extend axially beyond the housing 801 and puncture through the internal seal 808 and through the partition 152, and may extend into the fluid chamber 158 of the cartridge 150. In some embodiments, a desired amount of fluid may flow from the fluid chamber to the injection needle 830 through the partition needle 850 and needle connector 870 via the action of the driven assembly 300. The needle connector 870 may be sufficiently flexible to allow movement from a bent configuration in which the needle connector 870 can form one or more loops or part of a loop, to a non-bent configuration in which the needle connector 870 can have a straight or loop-free form, while maintaining fluid communication between the injection needle 830 and the partition needle 850. As shown in Figure 31B, the needle connector 870 may maintain a certain curvature when the needle mechanism 812 is in an extended configuration, but may have a smaller curvature than when the needle mechanism 812 is in a compact configuration. In some embodiments, the needle connector 870 may be linear such that when the needle mechanism 812 is in an extended configuration, the inlet end 872 and outlet end 874 of the needle connector are separated by a second axial distance greater than a first axial distance along axis A1.

[0090] According to some embodiments of the present technology, the injection operation may be implemented using one or more motors initiated by a user and controlled by a computer. For example, the needle assembly 800 may be installed in a dispenser or cassette comprising a motor assembly (e.g., the motor assembly 50 described above) and a controller (e.g., the controller 700 described above). In some embodiments, upon receiving an injection signal initiated by a user (e.g., via the pressing of a button, the towing of a switch, etc.), the computer rotates the driver 245, thereby rotating the driven member 820. The computer may also move the driven assembly 300 to cause the fluid in the cartridge 150 to flow out of the cartridge 150. The timing of the movement of the driven assembly 300 and the movement of the needle mechanism 812 may be controlled by the computer so that the fluid can flow out of the injection needle 830 as soon as, or immediately thereafter, the needle mechanism 812 reaches the extended configuration.

[0091] As described above, according to some embodiments of the technology, the needle mechanism 812 can stop extending the supports 840, 860 when a portion of the needle mechanism 812 contacts the housing 801. In some embodiments, the housing 801 may have at least one blocking surface (e.g., a projection) configured to function as a physical stop for the movement of the supports 840 and / or 860. In some embodiments, the needle mechanism 812 may stop when one or more of the engaging portions 824 of the driven member 820 contact a blocking portion on one or both of the supports 840, 860 (e.g., one or more of the engaging portions 846, 866 cannot engage with the engaging portion 824). In some embodiments, the needle mechanism 812 may be controlled by a computer to stop based on the amount of rotation of the driver 245. In some embodiments, the amount of time to transition from a compact configuration to an extended configuration may be about 1 second or less (e.g., 1 second, 0.75 seconds, 0.5 seconds, 0.25 seconds).

[0092] After the injection operation, the needle mechanism 812 may be moved to return from the extended configuration to the compact configuration. According to some embodiments of the art, the needle mechanism 812 may be retracted from the extended configuration to the compact configuration through the movement of the driven member 820. In some embodiments, the driven member 820 may be rotated in a direction C2 (see Figure 31B) generally opposite to direction Cl to move the support 840 in direction D1 (i.e., the direction opposite to direction D1) and the support 860 in direction D2 (i.e., the direction opposite to direction D2). Such movement may cause the supports 840 and 860 to slide closer together, which in turn may retract the injection and partition needles 830 and 850 into the housing 801. As with the injection operation described above, the retraction operation may be controlled by a computer. For example, the computer may cause the driven assembly 300 to stop pushing fluid out of the cartridge 150 when a desired amount of fluid has been pushed out of the cartridge 150. The computer can also rotate the driven member 820 in direction C2 to retract the needles 830 and 850 into the housing 801. Such automation of the injection and retraction operations may enable laypeople without medical technology training to safely use the dispenser and needle assembly 800. Further configurations of the needle mechanism are described in International Publication No. 2022 / 132675A1 and International Publication No. 2022 / 132677A1, each of which is incorporated herein by reference in whole.

[0093] Figures 32C and 33 show a needle assembly 800 with a needle mechanism 810 in a retracted configuration according to some embodiments of the present technology. As described above, the compact configuration of the needle mechanism 810 may be a retracted (post-use) configuration in which the injection needle 830 cannot be reused. Thus, in some embodiments, the retracted configuration may differ from the standby configuration. In some embodiments, the needle mechanism 810 may be moved from an extended configuration to a retracted configuration via an over-retraction mechanism, which may involve latching a blocking surface to part of the support 840 and / or part of the support 860. When latched, the needles 830, 850 cannot be moved out of the housing 801. For example, when latched, movement of the injection needle 830 in direction D1 in Figure 31 cannot occur. The over-retraction mechanism can function as a safety mechanism to prevent accidental reuse of the injection needle 830, which may have been used and no longer be sterilized. In embodiments where a needle assembly 800 is part of a plurality of needle assemblies 800 (e.g., a carousel of needle assemblies 800), as an alternative to, or in addition to, an over-retraction mechanism, the used needle assembly 800 may be prevented from being selected and / or placed in the working position by the dispenser's computer. The device may be configured to detect the angular position of the driven member 820 that results in over-retraction. The sensing may be magnetic, optical, potentiometer, or any known sensing for detecting angular position. In one embodiment, a motor that operably controls the driven member 820 may be sensed via an encoder sensor configured to sense the rotation of the motor's drive shaft. When an over-retraction position is detected, a display may be provided to the patient to notify them that the needle assembly has been used. The notification may involve the patient using a new device, or the patient removing the needle assembly and replacing it with a new one. The motor may be swiveled to a reset position for the coupled drive assembly, which will realign and connect to the orientation of the drive member 820 of the new needle assembly.

[0094] Prior to dose delivery, the needle mechanism 810 may be in a standby configuration in which the latch portion 848 of the injection needle support 840 and the latch portion 869 of the septum needle support 860 are not engaged with each other. For example, in the standby configuration, the latch portion 869 may be located at position X, while the latch portion 848 may be located to the axial left of position X. In some embodiments, the latch portions 848 and 869 may have ledges having engaging surfaces facing in opposite directions. During dose delivery, the latch portion 869 may move to the right from position X, thereby allowing a portion of the septum needle 850 to move to the right and extend outside the housing 801. Simultaneously, the injection needle 830 and support 840 may move to the left from the standby configuration to the extended configuration during dose delivery.

[0095] According to some embodiments of this technology, after dose delivery, the support 860 may move to the left and the support 840 may move to the right, thereby retracting the septum needle 850 and the injection needle 830 into the housing 801. When retracting the injection needle 830 and the septum needle 850, the supports 840 and 860 may be retracted excessively so that the latch portion 869 can move axially to the left beyond position X and beyond the axial position of the latch portion 849. Such excessive retraction may result in the latch portion 869 rotating toward the latch portion 848 and engaging with the latch portion 210. For example, the latch portions 869 and 848 have surfaces that abut each other when engaged or latched, as shown in Figure 33, which can prevent the support 860 from moving to the right and the support 840 from moving to the left.

[0096] The inventors recognize and understand that secure attachment or mounting of the injection needle 830 and the partition needle 850 to the needle connector 870 may be desirable to ensure leak-proof fluid flow between the needles 830 and 850 during dose delivery. The inventors also recognize and understand that when the needles 830 and 850 are microgauge needles typical of cannula needles used to inject drugs (e.g., insulin), and when the needle connector 870 may be thin-walled to provide sufficient flexibility for movement between compact and expanded configurations, preventing twisting of the needle connector 870 and / or preventing bending of the needles 830 and 850 may be desirable to ensure that there is no stenosis, which would reduce the fluid delivery rate of the fluid from the cartridge 150 through the injection needle 830. The inventors have developed a support scheme in which the needle holders 842, 862 of the supports 840, 860 are configured to support both the needles 830, 850 and the inlet and outlet ends 874, 872 of the needle connector 870, and can function as a support connector coupler.

[0097] Figure 34 shows a cross-sectional side view of a needle mechanism 1700 arranged within a housing 801' according to several embodiments of the present technology. In Figure 34, the needle mechanism 1700 is in an extended configuration in which the puncture end of the injection needle 1730 extends outside the housing 801' and the puncture end of the partition needle 1750 extends outside the housing 801'. A needle connector 1770 can connect the non-puncture ends of the injection needle 1730 and the partition needle 1750 so that the needles 1730 and 1750 can be in fluid communication with each other. In some embodiments, the injection needle 1730 and the partition needle 1750 may be coaxial when the needle mechanism 1700 is in an extended configuration. In some embodiments, the injection needle 1730 and the partition needle 1750 may be parallel to each other when the needle mechanism 1700 is in an extended configuration. In some embodiments, the needle connector 1770 may be coaxial with the injection needle 1730 and the partition needle 1750 when the needle mechanism 1700 is in an extended configuration.

[0098] Figure 35 shows a cross-sectional view of the needle mechanism 1700 according to several embodiments of the present technology. In addition to the injection needle 1730, the partition needle 1750, and the needle connector 1770, the needle mechanism 1700 may also include a partition needle support 1760 and an injection needle support 1740. The parts of the needle mechanism 1700 configured to cause movement of the needles 1730 and 1750 are described elsewhere in this specification and are not shown in Figure 35.

[0099] According to some embodiments of the present technology, the support 1740 may include a connector coupler 1742 configured to connect the support 1740 to an injection needle 1730 and a needle connector 1770. In some embodiments, the connector coupler 1742 may extend from the body 1741 of the support 1740 and may include a bore configured therein to receive the injection needle 1730. In some embodiments, the injection needle 1730 may extend through the connector coupler 1742 such that its inlet end 1730a may be located outside the bore of the connector coupler 1742, as shown in Figure 35. In some other embodiments, the inlet end 1730a may be located inside the bore of the connector coupler 1742. As understood, the outlet end 1730b of the injection needle 1730 may extend outside the bore of the connector coupler 1742 for puncturing the user during dose delivery. The coupling end 1742a of the connector coupler 1742 may be located within the exit end 1772b of the bore 1772 of the needle connector 1770. In some embodiments, the body 1741 of the support 1740 may be elongated, and the bore of the connector coupler 1742 may expand parallel to the direction of extension of the body 1741.

[0100] According to some embodiments of the present technology, a similar arrangement may be provided for the partition needle 1750 and the support 1760. In some embodiments, the support 1760 may include a connector coupler 1762 configured to connect the support 1760 to the partition needle 1750 and the needle connector 1770. In some embodiments, the connector coupler 1762 of the support 1760 may include an elongated inlet projection 1762c configured to extend into the inlet neck of the housing 801', as shown in Figure 34. The elongated inlet projection 1762c can provide auxiliary support to the partition needle 1750, which may be advantageous when the partition needle 1750 encounters frictional forces while puncturing the partition 152 and / or retracting from the partition 152. In some embodiments, the elongated inlet projection 1762c may be sized to provide support without significantly increasing the weight moved during the extension and retraction of the support 1760. The connector coupler 1762 may also include a bore configured to receive a partition needle 1750 therein. In some embodiments, the partition needle 1750 may expand through the connector coupler 1762 such that its exit end 1750b may be located outside the bore of the connector coupler 1762, as shown in Figure 35. In some other embodiments, the inlet end 1750b may be located inside the bore of the connector coupler 1762. As understood, the inlet end 1750a of the partition needle 1750 may expand outside the bore of the connector coupler 1762 to puncture the partition 152 of the cartridge assembly 100 during dose delivery.

[0101] According to some embodiments of the present technology, connector couplers 1742, 1762 and needles 1730, 1750 may be arranged within a needle connector 1770 so that a fluid-sealing seal can be formed. The coupling end 1742a of connector coupler 1742 may be located at the exit end 1772b of the bore 1772 of the needle connector 1770, and the coupling end 1762a of connector coupler 1762 may be located at the inlet end 1772a of the bore 1772 of the needle connector 1770. In some embodiments, the needle connector 1770 may be formed from an elastic material that generates a fluid-sealing seal around the coupling ends 1742a, 1762a of the connector couplers 1742, 1762. For example, the needle connector 1770 may include flexible polymer materials such as elastomers, thermosetting polymers, and rubber. For example, the needle connector 1770 may comprise a silicone tube, or a liquid silicone rubber (LSR) tube, or a polyurethane tube, or a Mylar® tube, etc. In some embodiments, at the exit end 1772b of the bore 1772 of the needle connector 1770, the elastic material may stretch during insertion of the coupling end 1742a and exert a liquid-tight compressive force around the coupling end 1742a after insertion. In some cases, the elastic material may also exert a liquid-tight compressive force around the inlet end 1730a of an injection needle positioned within the exit end 1772b of the bore 1772. Similarly, at the inlet end 1772a of the bore 1772 of the needle connector 1770, the elastic material may stretch during insertion of the coupling end 1762a and exert a liquid-tight compressive force around the coupling end 1762a after insertion. In some cases, the elastic material may also exert a fluid-tight compressive force around the outlet end 1750b of the partition needle 1750, which is positioned within the inlet end 1772a of the bore 1772.

[0102] According to some embodiments of the present technology, as shown in Figure 35, the exit edge of the needle connector 1770 may abut against the shoulder portion 1742b of the connector coupler 1742. Similarly, in some embodiments, the inlet edge of the needle connector 1770 may abut against the shoulder portion 1762b of the connector coupler 1762, as shown in Figure 35. As described above, the needle connector 1770 may have sufficient elasticity to exert compressive force around the coupling ends 1742a, 1762a to generate a leak-proof seal between the coupling ends 1742a, 1762a and the bore 1772. In some embodiments, a sealing ring may be provided around the outer portion of the needle connector 1770 in the region corresponding to the inlet end 1772a and the exit end 1772b of the bore 1772 to apply additional compressive force and / or close the leakage gap, thereby generating a leak-proof seal between the bore 1772 and the coupling ends 1742a, 1762a. For example, the sealing ring may include an elastic ring, adhesive ring, or gasket located adjacent to the shoulder portions 1742b and 1762b of the connector couplers 1742 and 1762.

[0103] Figures 36A to 36E show cross-sections of structures for coupling a needle to a needle connector via a connector coupler, according to several embodiments of the present technology. The coupling structure may be used for an injection needle 1730 and / or a partition needle 1750. To avoid repetition in the explanation, the coupling structure including the partition needle 1750 is omitted, but it is similar to the one including the injection needle 1730. Figure 35 shows needles 1730 and 1750 coupled to the needle connector 1770 via the same type of coupling structure, but it should be understood that in some embodiments, the injection needle 1730 may be coupled to the needle connector 1770 via a first coupling structure, while the partition needle 1750 may be coupled to the needle connector 1770 via a second coupling structure different from the first coupling structure.

[0104] Figure 36A shows one embodiment of a coupling structure for an injection needle 1730 in which an adhesive 1745 can be used to provide a leak-proof seal between the outlet end 1772b of the bore 1772 and the connector coupler 1742. For example, the adhesive 1745 may form a ring that seals the outlet end 1772b as it abuts against the shoulder 1742b of the connector coupler 1742, as shown in Figure 36A.

[0105] Figure 36B shows one embodiment of a coupling structure for an injection needle 1730, wherein the coupling end 1742a' of the connector coupler 1742 is provided with a circumferential return portion 1746. The needle connector 1770 may be formed of an elastic material (e.g., LSR) that generates a fluid seal around the return portion 1746 by applying a compressive force around the return portion 1746. Optionally, the coupling structure shown in Figure 36B may be used with a seal ring and / or adhesive (e.g., an adhesive ring 1745). In some embodiments, the distal edge of the needle connector 1770 may be positioned adjacent to the shoulder portion 1742b of the connector coupler 1742.

[0106] Figure 36C shows one embodiment of a coupling structure for an injection needle 1730, in which the annular ring 1747 or hub is located at the distal end 1770a of the needle connector 1770. Similar to the coupling structure shown in Figure 36B, the coupling end 1742a' of the connector coupler 1742 may include a circumferential return portion 1746. The needle connector 1770 may be formed of an elastic material (e.g., LSR) that generates a fluid seal around the return portion 1746 by applying a compressive force around the return portion 1746. The annular ring 1747 may have an outer diameter larger than the outer diameter of a portion of the needle connector 1770 adjacent to the annular ring 1747. In some embodiments, the distal edge of the annular ring 1747 may be located adjacent to the shoulder portion 1742b of the connector coupler 1742. The annular ring 1747 may be used to facilitate the assembly of the needle mechanism 1700 by serving as an easily handled object that can be grasped (e.g., between two fingers) by the user while sliding the needle connector 1770 onto the coupling end 1742a' of the connector coupler 1742. Optionally, the coupling structure shown in Figure 36C may be used in conjunction with a sealing ring and / or adhesive (e.g., adhesive ring 1745).

[0107] Figure 36D shows an embodiment of a coupling structure for an injection needle 1730, where a gasket 1748 may be used to provide a leak-proof seal between the needle connector 1770 and the connector coupler 1742. That is, instead of the adhesive ring 1745 in the coupling structure shown in Figure 36A, the gasket 1748 may provide a leak-proof seal. In some embodiments, the gasket 1748a may be positioned around the coupling end 1742a such that the end face of the gasket 1748 can abut against the shoulder portion 1742b of the connector coupler 1742, and the inner surface of the gasket 1748 can surround the coupling end 1742a and form a leak-proof seal around it. The gasket may be formed from a flexible polymer material. For example, the gasket 1748 may be formed from a gasket material including any one or any combination of silicone (e.g., LSR), polyurethane, Mylar®, etc. The gasket 1748 may be installed by an injection molding process after the needle connector 1770 is installed on the connector coupler 1742. For example, the gasket 1748 may be formed by placing the needle connector 1770 and the connector coupler 1742 in a mold molded to form the gasket 1748 adjacent to the shoulder portion 1742b of the connector coupler 1742, and then injecting a fluid form of gasket material into the mold. The gasket material may flow into holes and gaps, sealing them and creating a leak-proof seal around the coupling end 1742a.

[0108] Figure 36E shows an embodiment of the coupling structure of the injection needle 1730, where the needle connector 1770 is configured similarly to that in Figure 36C. That is, the needle connector 1770 may have an annular ring 1747 located at the distal end 1770a. Similar to the coupling structure shown in Figure 36D, the coupling structure in Figure 36E may include a gasket 1748 positioned around the outer surface of the annular ring 1747 such that the end face of the gasket 1748 can abut against the shoulder portion 1742b of the connector coupler 1742, and the inner surface of the gasket 1748 surrounds the outer surface of the annular ring 1747, forming a leak-proof seal around it.

[0109] According to some embodiments of the present technology, the needle connector 1770 may be formed by extrusion molding, injection molding, or by one or more other techniques capable of producing a flexible tubular structure that can be moved from a compact configuration to an expanded configuration and back, as discussed above. In some embodiments, the supports 1740, 1760 may be formed of a rigid material (e.g., hard plastic, metal, etc.).

[0110] According to some embodiments of the present technology, a method for manufacturing a needle assembly may include molding a needle support (e.g., 1740) around a needle (e.g., 1730) such that a connector coupler (e.g., 1742) of the needle support surrounds a section of the needle and can form a leak-proof seal around the section of the needle. The non-puncture end of the needle may extend beyond the connector coupler. The method may further include inserting a portion of the connector coupler into a bore (e.g., 1772) of an elastic and flexible connector (e.g., 1770) such that the non-puncture end of the needle can be positioned within the bore of the connector. In some embodiments, the insertion may increase the diameter of the bore at the first end of the connector, thereby allowing a compressive force to be exerted on the connector coupler by the first end of the connector to form a leak-proof seal between the connector and the connector coupler. In some embodiments, the first end of the connector may be provided with an annular ring (e.g., 1747) having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end, and insertion may include sliding the first end of the connector around the connector coupler using the annular ring. In some embodiments, the connector coupler may be provided with a circumferential return portion (e.g., 1746), and insertion may include engaging the inner surface of the bore at the first end of the connector with the return portion to form a leak-proof seal between the connector and the connector coupler. The first end of the connector may be provided with an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end, and insertion may include sliding the first end of the connector around the return portion of the connector coupler using the annular ring. In some embodiments, the method may further include molding a gasket around the joint between the first end of the connector and the connector coupler to form a leak-proof seal between the connector and the connector coupler. The first end of the connector may be provided with an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end, and the joint may be located between the annular ring and the connector coupler.In some embodiments, the connector may be formed from a material comprising one or any combination of medical-grade silicone, medical-grade thermoplastic elastomer, and Tygon®.

[0111] conclusion Various changes, modifications, and improvements can be made to the structures, configurations, and methods described herein, and it should be understood that these are intended to be within the spirit and scope of the technology disclosed herein. Furthermore, while the advantages of the technology are shown, it should be understood that not all embodiments of the technology will include all described advantages. Some embodiments may not implement any features described herein as advantageous. Therefore, the foregoing descriptions and accompanying drawings are for illustrative purposes only.

[0112] It should be understood that some aspects of this technology may be embodied as one or more methods, and that the actions performed as part of the methods of this technology may be ordered in any preferred manner. Therefore, even if they are illustrated and / or described as a series of actions in various embodiments, embodiments can be constructed in which the actions are performed in a different order than those illustrated and / or described, which may include performing several actions simultaneously.

[0113] Various aspects of this technology may be used individually, in combination, or in various arrangements not specifically described in the embodiments described above, and therefore, in their application, they are not limited to the details and arrangements of components shown in the description or illustrated in the drawings. For example, an aspect described in relation to one embodiment may be combined in any way with aspects described in relation to one or more other embodiments.

[0114] The use of ordinal terms such as “first,” “second,” and “third” in the detailed description and claims to modify elements does not, by itself, imply any priority, order, or sequence of one element relative to another, or the temporal order in which actions in a method are performed, but is used solely as a label to distinguish elements or differences, to distinguish one element or action having a particular name from another element or action having the same name (but using an ordinal term).

[0115] All definitions defined and used herein should be understood to govern dictionary definitions, definitions in documents incorporated by reference, and / or the ordinary meanings of the defined terms.

[0116] In this specification and in the claims, the indefinite articles "a" and "an" should be understood to mean "at least one" unless explicitly stated otherwise.

[0117] When used in the specification and claims herein, the phrase “at least one” relating to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, and not necessarily including at least one of each element or all elements specifically listed in the list of elements, nor excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements referred to by the phrase “at least one,” whether related to or unrelated to those specifically identified elements.

[0118] As used herein and in the claims, the phrase “equal” or “same” with respect to two values ​​(e.g., distance, width, etc.) means that the two values ​​are the same within manufacturing tolerances. Thus, two values ​​being equal or the same may mean that the two values ​​differ from each other by only ±5%.

[0119] As used herein and in the claims, the phrase “and / or” should be understood to mean “either or both” of the elements thus combined, i.e., elements that exist as a combination in some cases and separately in others. Multiple elements listed using “and / or” must be interpreted in the same way, i.e., “one or more” of the elements thus combined. Other elements other than those specifically identified by the “and / or” clause may exist optionally, whether related to those specifically identified elements or not. Thus, as a non-restrictive example, a reference to “A and / or B” when used in conjunction with open-ended language such as “comprising” may, in one embodiment, refer to A only (optionally including elements other than B), in another embodiment, refer to B only (optionally including elements other than A), in yet another embodiment, refer to both A and B (optionally including other elements), and so on.

[0120] Where used herein 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” should be interpreted as inclusive; that is, it should be interpreted as including not just one but one or more of multiple elements or lists of elements, and optionally including additional items not listed. Only terms that are explicitly indicated in the opposite way, such as “only one of” or “exactly one of,” or, where used in the claims, “consisting of,” should be interpreted as including exactly one element of multiple elements or lists of elements. In general, where used herein, the term “or” should be interpreted as indicating only an exclusive choice (i.e., “one or the other but not both”) when followed by an exclusive term such as “either,” “one of,” “only one of,” or “exactly one of.” When used in patent claims, "consisting essentially of" shall have the ordinary meaning as it has in the field of patent law.

[0121] Furthermore, the terminology and grammar used herein are for illustrative purposes only and should not be considered limiting. The use of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof herein means to include the items listed therein and their equivalents, as well as any additional items.

[0122] When used herein, the terms “approximately” and “about” may be interpreted to mean within ±20% of the target value in some embodiments, within ±10% of the target value in some embodiments, within ±5% of the target value in some embodiments, and within ±2% of the target value in some embodiments. The terms “approximately” and “about” may also be equal to the target value.

[0123] When used herein, the term “substantially” may be interpreted to mean, in some embodiments, within 95% of the target value, in some embodiments, within 98% of the target value, in some embodiments, within 99% of the target value, and in some embodiments, within 99.5% of the target value. In some embodiments, the term “substantially” may be equal to 100% of the target value.

[0124] Various aspects, including but not limited to the following aspects, are described in this disclosure.

[0125] In various aspects of this disclosure, the connector is formed from an elastic material that exerts a compressive force on the inlet portion of the connector coupler.

[0126] In various aspects of this disclosure, the connector coupler includes a circumferential return portion configured to form a leak-proof seal with the first end of the connector.

[0127] In various aspects of this disclosure, the first end of the connector includes an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end.

[0128] In various aspects of this disclosure, the first end of the connector includes an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end.

[0129] In various aspects of this disclosure, a molded gasket is located around the joint between the first end of the connector and the connector coupler and is configured to form a leak-proof seal between the first end of the connector and the connector coupler.

[0130] In various aspects of the present disclosure, the needle is a first needle, the needle support is a first needle support, the connector coupler is a first connector coupler, the needle assembly further includes a second needle and a second needle support including a second connector coupler disposed within a housing and molded around the second needle to form a leak-proof seal around the second needle, the connector includes a second end attached to the second connector coupler, the driven member is configured to drive the second needle support between an extended configuration in which fluid can be transported through the second needle and a compact configuration in which fluid cannot be transported through the second needle, the non-puncturing end of the second needle extends beyond the connector coupler and is located within a connector bore, the puncturing end of the second needle extends beyond the connector coupler, in the compact configuration the second needle is located within a housing, and in the extended configuration at least a portion of the puncturing end of the second needle extends beyond the housing.

[0131] In various aspects of the present disclosure, the driven member is configured to move a first needle support and a second needle support simultaneously in opposite directions, and the compact configuration includes a pre-injection standby configuration in which the first needle support and the second needle support are ready to be moved to an expanded configuration for injection, and a post-injection retracted configuration in which the first needle support and the second needle support are prevented from being moved to an expanded configuration, and the driven member is configured to move the first needle support and the second needle support from the standby configuration to the expanded configuration and from the expanded configuration to the retracted configuration.

[0132] In various aspects of the present disclosure, the first needle support and the second needle support include complementary engaging portions configured to engage with each other when the first needle support and the second needle support are moved from an extended configuration to a retracted configuration.

[0133] In various embodiments of this disclosure, the needle assembly has an injection rate of 3 mL in less than 12 seconds for a fluid having a viscosity of 30 centipoise or less.

[0134] In various embodiments of this disclosure, the needle assembly has an injection rate of 3 mL in less than 9 seconds for a fluid having a viscosity of 15 centipoise or less.

[0135] In various aspects of the present disclosure, an index gear is at least partially located within a housing and configured to drive a carousel to move a selected needle assembly to an operating position, a needle movement lock is configured to prevent the driven member of a selectable needle assembly from being rotated when it is not in the operating position, and when a selected needle assembly is in the operating position and engaged with a needle driver, the rest of the selectable needle assembly is not engaged with the needle driver.

[0136] In various aspects of this disclosure, the needle movement lock includes a rib that extends from the surface of the housing and engages with a channel of the driven member of the selectable needle assembly when not in the operating position.

[0137] In various aspects of the present disclosure, the driver includes at least one projection configured to engage with a channel of the driven member of the selected needle assembly when the selected needle assembly is in the operating position, and the rib includes at least one segment arranged circumferentially around a portion of the housing such that the rib and at least one projection of the driver are aligned when the carousel is driven and moving.

[0138] In various aspects of the present disclosure, the carousel is configured to be mounted on a cartridge assembly, and the longitudinal axis of the needle of the selected needle assembly in the operating position is aligned parallel to or coaxial with the longitudinal axis of the cartridge assembly, while the longitudinal axes of the needles of the remaining selectable needle assemblies are not parallel to or coaxial with the longitudinal axis of the cartridge assembly.

[0139] In various aspects of the present disclosure, the housing includes at least one structure configured to engage with at least one corresponding structure of a movable carousel to indicate that a selected needle assembly is in the working position, and to hold the movable carousel in the working position when the carousel is not rotating.

[0140] In various aspects of the present disclosure, the first end of the connector includes an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end, and insertion includes using the annular ring to slide the first end of the connector around the connector coupler.

[0141] In various aspects of the present disclosure, the connector coupler includes a circumferential return portion, and insertion involves engaging the inner surface of the bore at the first end of the connector with the return portion to form a leak-proof seal between the connector and the connector coupler.

[0142] In various aspects of this disclosure, a gasket is molded around the joint between the first end of the connector and the connector coupler to form a leak-proof seal between the connector and the connector coupler.

[0143] In various aspects of the present disclosure, a method for manufacturing a needle assembly includes molding a needle support around a needle such that a connector coupler of the needle support surrounds a section of the needle and forms a leak-proof seal around the section of the needle, with the non-puncture end of the needle extending beyond the connector coupler, and inserting a portion of the connector coupler into the bore of an elastic and flexible connector such that the non-puncture end of the needle is positioned within the bore of the connector.

[0144] In various aspects of the present disclosure, the first end of the connector includes an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end, and insertion includes using the annular ring to slide the first end of the connector around the connector coupler.

[0145] In various aspects of the present disclosure, the connector coupler includes a circumferential return portion, and insertion involves engaging the inner surface of the bore at the first end of the connector with the return portion to form a leak-proof seal between the connector and the connector coupler.

[0146] Various aspects of this disclosure further include forming a gasket around the joint between the first end of the connector and the connector coupler to form a leak-proof seal between the connector and the connector coupler.

Claims

1. A needle assembly, Housing and A needle, A needle support comprising a connector coupler disposed within the housing and molded around the needle to form a leak-proof seal around the needle, A flexible connector having a connector bore disposed within the housing and forming a fluid path that communicates fluidly with the bore of the needle, and comprising a first end attached to the connector coupler, The driven member comprises, at least partially, a driven member disposed within the housing, and configured to move between an extended configuration, which moves the needle support so that fluid can be transported through the needle, and a compact configuration, which prevents fluid from being transported through the needle. The non-puncturing end of the needle extends beyond the connector coupler and is positioned within the connector bore. The puncture end of the needle extends beyond the connector coupler, In the compact configuration described above, the connector is curved in a loop shape or a partial loop shape, and the pins are arranged within the housing. In the aforementioned extension configuration, the connector has an elongated shape, and at least a portion of the puncture end of the needle extends beyond the housing, In the extended configuration, the connector bore at the first end of the connector is parallel or coaxial with the connector bore at the second end of the connector, in the needle assembly.

2. The needle assembly according to claim 1, wherein the connector is formed from an elastic material that applies compressive force to the inlet portion of the connector coupler.

3. The needle assembly according to claim 2, wherein the connector coupler comprises a circumferential return portion configured to form a leak-proof seal together with the first end of the connector.

4. The needle assembly according to claim 2, wherein the first end of the connector comprises an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end.

5. The needle assembly according to claim 3, wherein the first end of the connector comprises an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end.

6. The needle assembly according to claim 2, further comprising a gasket molded around the joint between the first end of the connector and the connector coupler, configured to form a leak-proof seal between the first end of the connector and the connector coupler.

7. The aforementioned needle is the first needle, The needle support is a first needle support, and The connector coupler is a first connector coupler, and The needle assembly is The second needle, The system further comprises a second needle support, which is disposed within the housing and includes a second connector coupler molded around the second needle to form a leak-proof seal around the second needle, The connector comprises a second end attached to the second connector coupler, The driven member is configured to drive the second needle support between the extended configuration in which fluid can be transported through the second needle and the compact configuration in which fluid cannot be transported through the second needle, and The non-puncturing end of the second needle extends beyond the connector coupler and is positioned within the connector bore. The puncture end of the second needle extends beyond the connector coupler, In the compact configuration described above, the second needle is located within the housing, and The needle assembly according to any one of claims 1 to 6, wherein in the extended configuration, at least a portion of the puncture end of the second needle extends beyond the housing.

8. The driven member is configured to move the first needle support and the second needle support simultaneously in opposite directions. The aforementioned compact configuration is A standby configuration before injection, wherein the first needle support and the second needle support are ready to be moved to the extended configuration for injection, The invention comprises a post-injection retraction configuration which prevents the first needle support and the second needle support from moving to the expansion configuration, and The needle assembly according to claim 7, wherein the driven member is configured to move the first needle support and the second needle support from the standby configuration to the extended configuration and from the extended configuration to the retracted configuration.

9. The needle assembly according to claim 8, wherein the first needle support and the second needle support have complementary engaging portions configured to engage with each other when the first needle support and the second needle support are moved from the extended configuration to the retracted configuration.

10. The needle assembly according to any one of claims 1 to 9, wherein the needle assembly has an injection rate of 3 mL in less than 12 seconds for a fluid having a viscosity of 30 centipoise or less.

11. The needle assembly according to claim 10, wherein the needle assembly has an injection rate of 3 mL in less than 9 seconds for a fluid having a viscosity of 15 cmpoise or less.

12. A drug delivery system, A cassette housing having a drug reservoir and a partition wall at the outlet end of the reservoir, A drug delivery system comprising a needle assembly according to any one of claims 1 to 12, which can be attached to the aforementioned exit end.

13. It is a needle system, Housing and A movable carousel, at least partially disposed within the housing, A plurality of selectable needle assemblies, mounted on the carousel and at least partially located within the housing, wherein each of the needle assemblies is needle, A needle support comprising a connector coupler molded around the needle to form a leak-proof seal around the needle, and A flexible connector having a connector bore that forms a fluid path in fluid communication with the bore of the needle, the flexible connector comprising a first end attached to the connector coupler, A needle assembly comprising, The needle support is driven to move between an extended configuration in which fluid can be transported through the needle and a compact configuration in which fluid cannot be transported through the needle, A needle driver is configured to engage with the selected needle assembly when the selected needle assembly is in the operating position, and to move the needle support of the selected needle assembly between a compact configuration and an extended configuration. A needle system in which the movable carousel is configured to move the selected needle assembly to the operating position.

14. An index gear, at least partially located within the housing and configured to drive the carousel to rotate and move the selected needle assembly to the operating position, The selected needle assembly further comprises a needle movement lock configured to prevent the driven member from rotating when it is not in the operating position, The needle system according to claim 13, wherein when the selected needle assembly is in the operating position and engaged with the needle driver, the remaining of the selectable needle assemblies are not engaged with the needle driver.

15. The needle system according to claim 14, wherein the needle movement lock comprises a rib extending from the surface of the housing, the rib engaging with a channel of the driven member of the selectable needle assembly when not in the operating position.

16. The driver comprises at least one projection configured to engage with the channel of the driven member of the selected needle assembly when the selected needle assembly is in the operating position, and The needle system according to claim 15, wherein the rib comprises at least one segment arranged circumferentially around a portion of the housing such that the rib and the at least one projection of the driver align when the carousel is driven and moves.

17. The carousel is configured to be attached to the cartridge assembly, The longitudinal axis of the needle of the selected needle assembly in the operating position is parallel to or coaxially aligned with the longitudinal axis of the cartridge assembly, and The needle system according to any one of claims 13 to 16, wherein the longitudinal axis of the needle of the remaining of the selectable needle assemblies is not parallel or coaxial with the longitudinal axis of the cartridge assembly.

18. The needle system according to any one of claims 13 to 17, wherein the housing comprises at least one structure configured to engage with at least one corresponding structure of the movable carousel, to indicate that the selected needle assembly is in the operating position, and to hold the movable carousel in the operating position when the carousel is not rotating.

19. A method for manufacturing a needle assembly, wherein the method is The connector coupling of the needle support surrounds the section of the needle, forming a leak-proof seal around the section of the needle, the non-puncture end of the needle extends beyond the connector coupling, and A method comprising inserting a portion of the connector coupling into the bore of an elastic and flexible connector, wherein the non-puncturing end of the needle is positioned within the bore of the connector.

20. The first end of the connector is provided with an annular ring having an outer diameter larger than the outer diameter of a portion of the connector adjacent to the first end, and The method according to claim 19, wherein the insertion includes using the annular ring to slide the first end of the connector around the connector coupler.

21. The connector coupler is equipped with a circumferential return portion, The method according to claim 19 or 20, wherein the insertion includes engaging the inner surface of the bore at the first end of the connector with the return portion to form the leak-proof seal between the connector and the connector coupler.

22. The method according to any one of claims 19 to 21, further comprising molding a gasket around the joint between the first end of the connector and the connector coupler to form a leak-proof seal between the connector and the connector coupler.

Images