Fluid delivery system with needle assembly

Abstract

To provide a needle assembly configured to deliver fluid through the surface.SOLUTION: A needle assembly configured to be part of a drug delivery device comprises a plurality of extendable and retractable needles. The needles are fluidly coupled with a flexible connector, which is configured to maintain fluid connection between the needles throughout their movement. When the needles are extended, a first needle pierces a patient's skin, and a second needle pierces a septum of a drug cartridge to deliver a medication. Once the medication has been delivered, the needles may then retract within a needle assembly housing. The needle assembly may also be part of a partially disposable drug delivery device and may be used together with a plurality of different drug cartridges. A plurality of embodiments of the needle assembly are disclosed.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present disclosure relates to a needle assembly for delivering a fluid. More specifically, the present disclosure relates to a needle assembly for delivering a fluid. The present invention relates to a retractable needle assembly configured to deliver a fluid through a surface. [Background technology]

[0002] Conventional injection devices often require, for example, the injection of a drug from a sealed container such as a vial. Driving needles through surfaces to withdraw fluids from surfaces, take samples in chemical instrumentation, etc. Consider the example of injecting a patient with a drug without the presence of a medical professional. It may be beneficial to administer the drug by hand (e.g., if it is taken frequently). to ensure that the environment is kept sterile and that drugs are administered safely and effectively. In addition, some patients may have difficulty seeing or directly handling needles. Some people find it unpleasant. Summary of the Invention

[0003] A needle assembly configured as part of a drug delivery device includes a plurality of retractable needles. The needles are fitted with flexible connectors configured to maintain a fluid connection between the needles throughout the needle movement. As the needles extend, the first needle pierces the patient's skin and the second needle The needle of 2 pierces the septum of the drug container. When the drug is delivered, the needle is inserted into the housing of the needle assembly. The needle assembly can also be retracted into the catheter. The needle assembly may be part of a needle dispenser and may be used with multiple different drug containers. Multiple embodiments of the present invention are disclosed.

[0004] In one embodiment, the drug delivery device includes a reservoir for containing a medication and a needle adapter coupled to the reservoir. The needle assembly includes a first needle configured to interface with the container. The needle support includes a housing having a first end and a second end. The first needle support and the second needle support are The first needle is coupled to the first needle support and the second needle is coupled to the second needle support. A movable connector is in fluid communication between the first needle and the second needle. A drive mechanism is configured to move the needle assembly from the first configuration to the second configuration. In the first configuration, the first needle and the second needle are positioned completely within the housing. In the second configuration, the first needle extends beyond the first end of the housing and the second needle is A delivery mechanism is coupled to the container and a needle assembly extends beyond the second end of the second gag. When in the configuration, the needle is configured to push the medicament through the second needle and the first needle.

[0005] In another embodiment, the needle assembly is coupled to a fluid delivery mechanism and interfaces with a surface. The first needle is coupled to the first needle support and the second needle is coupled to the housing. The needle is coupled to a second needle support. A movable connector couples the first needle to the second needle. A driving mechanism is supported by the housing and drives the first needle support in a first direction and the second needle support in a second direction. The needle support is configured to drive the needle support in a second direction.

[0006] In yet another embodiment, a method of operating a device includes: driving a first drive mechanism of the device a first time; The method includes the step of actuating a first drive mechanism to axially extend a first needle from a retracted configuration. and moving the second needle in a second direction toward a septum of the medication container. activating a second drive mechanism, the second drive mechanism driving the needle through the second needle; activating a second drive mechanism to expel the medicament from the first needle and expel the first needle. subsequent to activating the second drive mechanism, activating the first drive mechanism a second time; The first drive mechanism moves the first needle in a second direction from the axially extended configuration to the retracted configuration. and actuating the first drive mechanism a second time to move the second needle outwardly from the septum in a first direction. Step.

[0007] In another embodiment, the needle assembly interfaces with a surface at a first end; The housing includes a second end configured to interface with the container. Each of the needle mechanisms includes a first needle fluidly coupled to a second needle. A drive mechanism is configured to engage at least one of the needle mechanisms, the first needle being a first and a second needle is driven in a second direction generally opposite to the first direction. The mechanism is configured to rotate the multiple needle mechanisms within the housing.

[0008] In yet another embodiment, the drug delivery device includes a housing and a catheter configured to hold a fluid. and a housing configured to push fluid out of the container with a variable force. and a first motor configured to move the needle assembly from the first configuration to the second configuration. In the first configuration, the needle assembly is retracted and in the second configuration, the needle assembly is extended. The assembly extends into fluid communication with the container. [Brief description of the drawings]

[0009] The present disclosure is best understood by reference to the following description of the embodiments of the present invention taken in conjunction with the accompanying drawings, in which: The above and other features and advantages, and the manner in which they are accomplished, will become more apparent and will be readily understood by those skilled in the art. The invention itself is better understood.

[0010] [Figure 1] FIG. 1 is a simplified cross-sectional view of an exemplary drug delivery device.

[0011] [Diagram 2] FIG. 1 is a simplified cross-sectional view of another exemplary drug device with a removable cassette and needle assembly.

[0012] [Diagram 3] FIG. 13 is a simplified cross-sectional view of yet another exemplary drug device with a removable needle assembly.

[0013] [Figure 4] FIG. 2 is a side elevation view of an exemplary drug delivery device having a cassette and a drive module. [Diagram 5] FIG. 5 is a vertical cross-sectional view of the device of FIG.

[0014] [Figure 6] FIG. 6 is a cross-sectional view taken along line BB in FIG. 5.

[0015] [Figure 7] FIG. 6 is a cross-sectional view taken along line CC in FIG. 5.

[0016] [Figure 8] FIG. 5 is an exploded view of the device of FIG. 4 showing the drive module and cassette separated. [Figure 9] FIG. 5 is an exploded view of the device of FIG. 4 showing the drive module and cassette separated. [Figure 10] FIG. 5 is an exploded view of the device of FIG. 4 showing the drive module and cassette separated.

[0017] [Figure 11]FIG. 2 is a perspective view of another embodiment of an exemplary drug delivery device having a cassette and a needle assembly.

[0018] [Figure 12] FIG. 12 is an exploded view of the device of FIG.

[0019] [Figure 13] FIG. 12 is a perspective view of a cartridge from the device of FIG.

[0020] [Figure 14] FIG. 12 is a perspective view of the drive mechanism of the device of FIG.

[0021] [Figure 15] FIG. 15 is a schematic diagram of the drive mechanism of FIG. 14.

[0022] [Figure 16] FIG. 15 is a schematic diagram of a control system for the drive mechanism of FIG. 14.

[0023] [Figure 17] FIG. 1 is a perspective view of an exemplary needle assembly.

[0024] [Figure 18] FIG. 18 is a rear view of the needle assembly of FIG.

[0025] [Figure 19] FIG. 18 is an exploded view of the needle assembly of FIG.

[0026] [Figure 20] FIG. 18 is a cross-sectional view of the needle assembly of FIG.

[0027] [Figure 21] FIG. 18 is a perspective view of a needle mechanism within the needle assembly of FIG. [Figure 22] FIG. 18 is a perspective view of a needle mechanism within the needle assembly of FIG.

[0028] [Figure 23]FIG. 23 is a side elevational view of the needle mechanism of FIGS. 21 and 22 excluding the drive member. [Figure 24] FIG. 23 is a side elevational view of the needle mechanism of FIGS. 21 and 22 excluding the drive member.

[0029] [Diagram 25] FIG. 23 is a perspective view of the drive member of the needle mechanism of FIGS. 21 and 22; [Figure 26] FIG. 23 is a perspective view of the drive member of the needle mechanism of FIGS. 21 and 22;

[0030] [Figure 27] 21 and 22, illustrating movement of the needle mechanism from the first configuration of FIG. 27 to the second configuration of FIG. 28. [Figure 28] 21 and 22, illustrating movement of the needle mechanism from the first configuration of FIG. 27 to the second configuration of FIG. 28.

[0031] [Figure 29] FIG. 13 is a perspective view of another embodiment of a needle assembly.

[0032] [Diagram 30] FIG. 30 is a rear view of the needle assembly of FIG. 29.

[0033] [Diagram 31] FIG. 30 is an exploded view of the needle assembly of FIG.

[0034] [Diagram 32] FIG. 30 is a perspective view of a needle mechanism within the needle assembly of FIG. 29;

[0035] [Diagram 33] FIG. 13 is a perspective view of yet another embodiment of a needle assembly.

[0036] [Diagram 34] FIG. 34 is an exploded view of the needle assembly of FIG.

[0037] [Diagram 35]FIG. 34 is a perspective view of a needle mechanism within the needle assembly of FIG. 33;

[0038] [Diagram 36] FIG. 36 is a perspective view of a needle support of the needle mechanism of FIG. 35;

[0039] [Figure 37] FIG. 36 is a perspective view of a drive member of the needle mechanism of FIG.

[0040] [Figure 38] 39 is a side view of the needle mechanism in the needle assembly of FIG. 33 , illustrating movement of the needle mechanism from the first configuration of FIG. 38 to the second configuration of FIG. 39 . [Figure 39] 39 is a side view of the needle mechanism in the needle assembly of FIG. 33 , illustrating movement of the needle mechanism from the first configuration of FIG. 38 to the second configuration of FIG. 39 .

[0041] [Diagram 40] 11A-11C are perspective views of yet another embodiment of a needle assembly in a first and second configuration, respectively. [Diagram 41] 11A-11C are perspective views of yet another embodiment of a needle assembly in a first and second configuration, respectively.

[0042] [Diagram 42] FIG. 42 is an exploded view of the needle assembly of FIGS. 40-41.

[0043] [Diagram 43] 1 is a schematic diagram of an exemplary wireless communication system for use with a drug delivery device.

[0044] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrated examples represent exemplary embodiments of the present invention, and such examples are not to be construed as limiting the present invention in any manner. It should not be construed as limiting the scope of the disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] Exemplary drug delivery devices 11, 12, 13, 126 and 1000 are shown in FIGS. 1. Each of the illustrated devices 11, 12, 13, 126, and 1000 includes: A user (e.g., a patient, a caregiver, or a medical professional) manually administers the medication to the patient. In certain embodiments, the present invention provides a reusable pen-type drug injection device that can be easily handled. In this way, the user can selectively set a dose and then inject the set dose into the patient. Devices 11, 12, 13, 126, and 1000 are intended to be examples. FIG. 1 is a schematic diagram of a needle assembly according to another embodiment of the present invention; The present invention is not limited to the above, but may be used in any device.

[0046] Drugs are delivered by such devices 11, 12, 13, 126, and 1000. The medicament may be in fluid form or any other suitable form. The drug may be, but is not limited to, insulin, insulin lispro, or insulin glargine. Any insulin analogue, insulin derivative, GLP such as daraglutide or liraglutide -1 receptor agonists, glucagon, glucagon analogues, glucagon derivatives, gastric inhibitory poly GIP / GLP-1 receptor peptides (GIP), GIP analogs, GIP derivatives, e.g. Dual agents in any combination of the above, such as agonists, oxyntomodulin analogs, ogonists, 11, 12, 13, 126, and 1 The device includes one or more therapeutic agents, including any therapeutic agent capable of being delivered by the device. Drugs such as those used in 11, 12, 13, 126, and 1000 may contain one or more excipients. It may be formulated with.

[0047] Referring initially to FIG. 1, an exemplary embodiment of a drug delivery device 11 is shown. The drug delivery device 11 extends from a proximal end 19 to a distal end 18 and includes a housing 15, a first a motor 22, a drive system 25, a cartridge 30 configured to hold a medicament; and a needle assembly 50. In the illustrated embodiment, the drug delivery device 11 includes a needle Distal end 18 is configured to allow assembly 50 to deliver medication from within cartridge 30 to a patient. The cartridge 30 is configured to be placed adjacent to the skin of a patient. The syringe may be described as a syringe or a catheter, and generally contains a drug and at least partially contains the drug. The device is configured to deliver

[0048] The cartridge 30 of FIG. 1 additionally includes a fluid housing or barrel 31, a plunger or The stopper 33 and the partition wall 35 are provided. The drug is inserted into the fluid housing 3 by the stopper 33. 1. Activation of the first motor 22 actuates the drive system 25 to 3, driving the needle 33 downward, pushing the drug toward the septum 35 and ultimately through the needle assembly 50. The first motor 22 is controlled by a motor controller (not shown). Adjusting the force applied to the drive system 25 and / or the speed at which the drive system 25 is operated It is possible.

[0049] The needle assembly 50 additionally includes a first needle 51, a second needle 53, and a first and second needle 54. 1, 53 coupled to a needle drive mechanism 55, and configured to actuate the needle drive mechanism 55. and an optional second motor 57. Activation of the second motor 57 activates the needle drive mechanism 55. is actuated to drive the first needle 51 toward the distal end 18 and the second needle 53 toward the proximal end 19. The needle 51 is driven toward the patient so that the first needle 51 at least pierces the patient's skin and the second needle 53 is spaced apart. In some embodiments, the drug delivery device 11 is in an extended configuration that pierces the wall 35. In such an embodiment, the first motor 22 is included, and the second motor 57 is not included. The first motor 22 is arranged such that activation of the first motor 22 additionally operates the needle drive mechanism 55. As will be described in more detail below, the needle drive mechanism 55 may be coupled or connected to the needle drive mechanism 55 so as to The first needle 51 and the second needle 53 are arranged such that the drug passes from the cartridge 30 through the second needle 53. 5 and 6, are fluidly coupled to each other to allow flow through the first needle 51 and ultimately to the patient. will be done.

[0050] The drug delivery device 11 is configured as a single device and, after use, It may also be configured to be disposable. In the illustrated embodiment, cartridge 30 and the needle assembly 50 is fixedly coupled to the drug delivery device 11; and / or The cartridge 30 is an integral part of the drug delivery device 11. May contain drugs or may contain drugs delivered in multiple doses / injections In embodiments in which the cartridge 30 contains multiple doses of a drug, the first motor 22 drives each dose. may be configured to expel only a portion of the drug in the cartridge 30 in terms of volume, Needle assembly 50 may include multiple sets of needles for injecting medication into a patient.

[0051] 2, another embodiment of the drug delivery device 12 is shown. Delivery device 12 functions similarly to drug delivery device 11 of FIG. 1 and includes similar components. However, the drug delivery device 12 includes a cartridge 30 and a needle assembly 50 in a housing. The needle assembly 15 is removable from the drug delivery device 11. The assembly 50 and the cartridge 30 may be separate components or may be integrated into a single unit. In the illustrated embodiment, the housing 15, the first motor 22, drive system 25, and second motor 57 may all be reusable, Cartridge 30 and needle assembly 50 may be disposable. A user may insert and use multiple cartridges 30 and needle assemblies 50 together or separately. As with drug delivery device 11, the drug delivery device The cartridge 30 of the dispenser 12 may still contain a single dose or multiple doses of medication. The cartridge 30 and needle assembly 50 may include threads, a bayonet coupler, screws, rivets, etc. locking, snapping, ball detent mechanism, spring system, pin, magnet, friction fit, adhesive, or other suitable coupling devices, and combinations thereof. The housing 15 of the drug delivery device 12 may be coupled to the housing 15 by any suitable coupling mechanism. In embodiments in which cartridge 30 and needle assembly 50 are separate components, Any suitable coupling device, such as a In the illustrated embodiment, the second motor 57 is connected to the housing 15 and is not shown as part of needle assembly 50 or cartridge 30. Alternatively, the needle assembly 50 may be attached to the housing 15 when the needle assembly 50 is coupled to the housing 15. In other embodiments, the second motor 57 may be part of the needle assembly 50. Optionally, the needle assembly 50 may be connectable and disconnectable to the housing 15 having the needle assembly 50. .

[0052] Referring now to Figure 3, another embodiment of a drug delivery device 13 is shown. Cartridge 30 is fixedly coupled to housing 15 and needle assembly 50 is attached to housing 15. The drug delivery device 13 is similar to the drug delivery device of FIG. The device 11 and the drug delivery device 12 of FIG. The needle assembly 50 may be disposable, while the housing 15 may be reusable. In the illustrated embodiment, the housing 15 and cartridge 30 include different numbers of needle assemblies. In some embodiments, the cartridge 30 may be used multiple times with the cartridge 50. As previously described with respect to drug delivery device 12, the needle Assembly 50 is coupled to housing 15 by any suitable coupling device or system. Additionally, a second motor 57 may be integrated into the housing 15 or part of the needle assembly 50. Additional embodiments, configurations, and features of drug delivery devices and their components are described herein. and further details are discussed below.

[0053] 4-10, another embodiment of a drug delivery device 126 is provided. The delivery device 126 includes a reusable drive module 128 and a cassette 130 . The needle assembly 132 is securable to a threaded distal end of a drug-containing cartridge 134. The reusable drive module 128 includes a hub in which an electric motor 138 is mounted. The housing 136 includes a drive gear 140 coupled to the output shaft of the electric motor 138. A portion of the drive gear 140 protrudes outward from the housing 136. 2, whereby the cassette 130 is attached to the reusable drive module 128. When the driven gear 142 is engaged, it can engage with the driven gear 142 in the cassette 130.

[0054] The cassette 130 includes a housing 144 that defines a first T-shaped projection 146. The stud 136 has a corresponding first T-shaped slot 146 that receives the first T-shaped protrusion 146. The cassette 130 also defines a second T-shaped slot 148 on the housing 136. 52. The second T-shaped projection 150 is received by the second T-shaped projection 146. 0 slides into the T-slots 148, 152, the reusable drive module 128 A spring biases the upper latch member 154 to pivot and engage a protruding lip on the cassette to lock the cassette in place. The button 156 engages the latch member 154 to prevent the set 130 from slipping out of engagement. The drug delivery device 126 defines a first major axis 54. The drive ribbon 170 further includes a drive member mechanism defining a minor parallel axis 56. The drive ribbon 170 is disposed within the cassette 130, and the trust member 172 is aligned in the axial direction of the drive ribbon 170. Controls directional extension.

[0055] The drug delivery device 126 administers the above-mentioned medication to the patient through a needle assembly 132. In the illustrated embodiment, the cassette 130 includes a reusable drive module. The drive ribbon 170 is generally configured to be decoupled from the first to extend needle 133 outwardly from needle assembly 132 along major axis 54 of needle assembly 132; and and / or by pushing the stopper 180 through the cartridge 134. The drug delivery device 126 and many of its variations are configured to push the drug out. Examples are disclosed in WO 2019 / 112886 published on June 13, 2019. No. 6,399,433, the entire disclosure of which is expressly incorporated herein by reference.

[0056] 11 and 12, another exemplary drug delivery device 1000 is shown. The drug delivery device 1000 may include the drive module 128 of FIGS. The cassette 200 is configured for use with an exemplary drive module. The cassette 200 includes a drive system 250, a cartridge 220, and a seal 230. The exemplary cassette includes a needle assembly 400 (further described in FIGS. 29-32). The drive module 200 includes a T-shaped protrusion 246 configured to interact with a corresponding drive module. It also includes one or more mating elements such as (similar to T-shaped protrusions 146, 150).

[0057] A cartridge 220 is positioned within the cassette 200 and adapted to hold the medications described above. The needle assembly 400 is generally configured to interact with a surface, such as the skin of a patient. , configured to pierce the surface with a first needle (shown elsewhere). Upon puncturing the needle, the drive system 250 drives the drug from within the cartridge 220 into the needle assembly 4. 00 into or through the surface. The needle assembly 400 then The needle assembly 400 is configured to retract the needle within the assembly 400. The needle assembly 400 is shown in FIG. Although shown in the illustrated embodiments of 12 and 13, any of the needle assemblies disclosed herein may be used. It should be understood that the embodiment may be used in the drug delivery device 1000.

[0058] Similar to the drug delivery device 126, in the illustrated embodiment, the cassette 200 includes a drug delivery The needle assembly 400 may be attached to or detached from an element of the device 1000, in this case the needle assembly 400. In the illustrated embodiment, the needle assembly 400 is configured with a needle assembly coupler 210. Although the needle assembly 400 may be coupled to the cassette 200 via an additional The needle assembly may be configured to couple directly to the cassette 200 without the need for an additional coupler. The cassette 400 may be permanently or removably coupled to the cassette 200 (FIGS. 1- As discussed above with respect to 3), threaded, plug-in couplers, screws, rivets, snaps , ball detent mechanism, spring system, pins, magnets, friction fit, adhesive, or any other suitable fastener. Any suitable coupling device, including but not limited to, suitable coupling devices and combinations thereof. It may be coupled to cassette 200 through a coupling device or system. , the needle assembly 400 may be an integral part of the cassette 200. may be a disposable component or may be used multiple times with different cassettes 200. Cassette 200 may be configured to be wholly or partially disposable. For example, the cassette 200 and drive system 250 may be reusable, Cartridge 220 may be disposable. 20 is connectable and disconnectable to the cassette 200 and / or the drive system 250 In another embodiment, the cassette 200, the drive system 250, and the cartridge Each of the cartridges 220 may be disposable, or the entire drug delivery device 1000 may be disposable. It may be disposable.

[0059] 12 and 13, cartridge 220 includes a fluid housing 222, The fluid housing 222 includes a stopper 224, a septum 226, and a septum seal 228. 224 and septum 226. The septum 226 is held within the fluid housing 222 by a septum 226. Punctured by a septum needle (shown elsewhere) to allow flow through the needle The stopper 224 or piston is configured to be inserted into the fluid housing 222. The fluid in the fluid housing 222 slides along the inside of the housing 222, increasing the pressure within the housing 222 and forcing the fluid through the diaphragm 222. 6 through a septum needle in stopper 2. 24 is driven by a drive system 250, while in other embodiments, the stopper 224 is , may be driven by any mechanical, electrical, or human actuated drive system. Typical drive systems include a drive screw, a linear actuator actuated by, for example, a spring or an electric motor. The bulkhead seal 228 is a flow The bulkhead 226 is configured to be held on the hub 221 of the body housing 222. The cartridge 220 is assembled by any standard method known in the art. For example, the septum 226 may be positioned relative to the hub 221 and the septum seal may be The fluid housing 222 can then be filled with fluid. In an exemplary embodiment, the cart can be filled with the cartridge and sealed with a stopper 224. Each component of ridge 220 is sterilized prior to use. The fluid housing 222 is made of glass, plastic, The fluid retaining member may be made of plastic or any other material adapted to retain fluid. The septum seal 228, septum 226, and stopper 224 are made of elastomer, plastic, The material may be made of acrylic, acrylic resin, or any other polymer or composite material.

[0060] 12 and 14, an exemplary embodiment of a drive system 250 includes a support a body 256, a collar 252, an actuating member 251 having a driven gear 253, a driving member 254, and and a fastener 258. The driven gear 253 of the actuation member 251 is connected through the cassette 200. 1-3 , and is exposed to a user or an external mechanism. 4 ) and then driven by the driving gear 142 . 254, which engages the stopper 224 in the cartridge 220. In the illustrated embodiment, the driving member 254 is a drive screw and the driven gear 253 is The driven gear 253 is threaded so that it is driven by the driving member 254 moves axially toward or away from the stopper 224 In other embodiments, other drive systems are used, such as a rack and pinion drive system. Both the actuation member 251 and the drive member 254 are supported by a support 256. The support 256 is coupled to the cassette 200 via the collar 252 and the fasteners 258 . In the illustrated embodiment, the fasteners 258 are screws, but in other embodiments, the fasteners 258 may be rivets, nails, Clips, clamps, snaps, welds, adhesives, or other fastening devices or systems Other exemplary implementations of the drive system 250 include The form is described in WO 2019 / 112886, which was incorporated by reference above. is.

[0061] 14 to 16, the first motor 22 is driven by a driven gear. 253. The product delivery device 1000 may include any of the needle mechanisms 55, 390, 490, 590 described herein. A second motor 57 (shown in FIGS. 1-3) is configured to operate a needle mechanism such as In embodiments where the drug delivery device does not include a second motor 57, The first motor 22 may be configured to actuate the needle mechanism.

[0062] Each of the first motor 22 and the optional second motor 57 is connected to a motor controller 26. 0. As used herein, the term "logic" or "control logic" refers to The term includes one or more programmable processors, application specific integrated circuits (ASICs), Field Programmable Gate Arrays (FPGAs), Digital Signal Processors (D SP), hardwired logic, or software executed on a combination of these. and / or firmware. Thus, various logic may be included in accordance with an embodiment. may be implemented in any suitable manner while remaining in accordance with the embodiments disclosed herein. The controller 260 may be included in the drug delivery device 1000 or may be external. The controller 260 may include software stored in the memory 264 of the controller 260. At least one processor 262 (e.g., The software / firmware code may include a processor, a When executed by the processor 262, the controller 260 executes the control algorithm described herein. The controller 260 includes instructions 265 that cause the system to perform functions. and receiving information from the device (e.g., drug data, patient data, drug delivery device data, data, needle assembly data) to control the operation of the first motor 22 and / or the second motor 57. determining at least one drug delivery control parameter that can be partially controlled; The controller 260 may include one or more communication links. to communicatively couple to the drug delivery device 1000 via one or more interfaces. An exemplary interface may include or be communicatively coupled to a Exemplary communication links include wired and wireless signal transmitters and receivers. For example, serial communication), for example, Bluetooth (registered trademark), IEEE802.11, Wireless communication links, such as short-range wireless links, including proprietary wireless protocols, and / or similar The term "communications link" means at least one Another direction The communication link may refer to the ability to communicate any type of information to a The communication link may be an intermittent communication link, an ad-hoc communication link, and / or the like. The signal may be transmitted via a communication link.

[0063] FIG. 16 illustrates one or more interfaces 268 and memory communicatively coupled to each other. 264 and a processor 262. may include computer readable storage media in the form of volatile and / or non-volatile memory; It may be removable, non-removable, or a combination thereof. In addition, the memory 264 may provide the processor 262 with instructions for implementing the system components discussed herein. Implementing aspects of the embodiment and / or including control logic as described in more detail below. , executable instructions for carrying out aspects of the method and procedure embodiments discussed herein. 265 (e.g., computer code, machine usable instructions, etc.) 4, the processor 262 and the interface 268 can communicate with each other via one or more buses. The data and / or information may be acquired on a predefined schedule. The received data may be provided to the controller 260 at any time, or may be queued in memory and requested. The signal may be provided to the controller 260 when the signal is received.

[0064] The logic of the controller 260 controls the rotation of the first motor 22 and / or the second motor 57. The actuator may be configured to adjust the speed or force of actuation provided by the motor. may be constant or may be variable. For example, is viscous, the force applied by the first motor 22 to drive the stopper 224 In a further example, the actuation of the first or second motor 22, 57 can be increased. The speed can be adjusted to vary the speed of actuation of the needle mechanism. May operate more slowly to improve comfort and reduce irritation. In an embodiment, the controller may include a controller for controlling the received information / data (e.g., patient data, medication data, etc.) data, usage history data, dosage data, drug delivery device data, needle assembly data, Based on the data, the operation parameters of the first motor 22 and / or the second motor 57 are calculated. Additionally, the controller 260 may control the drive member 254 and / or the needle mechanism. The speed of the motors 22, 57 may be varied during start-up to avoid constant or non-linear movement of the mechanism. For example, the speed / acceleration of the second motor 57 of the needle mechanism can be controlled by the controller. The control algorithm of the controller 260 instructions 265 prevents damage to components and / or of needle support to prevent hard stops to minimize drug cavitation The needle can be controlled to decelerate near the end of its travel. Another advantage is that it is easier to insert the needle into the patient. The rate of penetration can be controlled to minimize pain, discomfort, or other undesirable sensations. A starting angular position of a rotary actuator shaft, such as a drive shaft of a second motor. (as shown in FIG. 27 , the needle mechanism is in a first, retracted configuration before and / or after use); and End angular position (as shown in FIG. 28, in which the needle mechanism is in a second extended configuration for use), and a position sensing assembly (not shown) that includes an optical encoder, sliding contacts, and magnetic sensing. The incremental angular position between the start and end positions can be monitored via the actuator. The motor shaft is within a certain percentage of the movement within the start and / or end position, e.g., 1% to 5%. % range, the speed rate of the second motor will be The speed of the second motor can be reduced so that its speed is zero or significantly reduced. Two or more settings for the start and / or end positions, e.g., high, medium, and low settings These may be preconfigured at the time of manufacture or may be configured by dials or buttons. The information may be provided to the HCP or patient via a user interface such as a touch screen. The settings may have different percentages in end / start angular positions and / or different deceleration rates. This can be adjusted. The settings may differ between the start and end positions. For example, To provide the patient with the most comfortable experience possible, the speed during needle insertion should be adjusted according to the type / amount of medication. The controller 260 may, for example, control the first motor 57 before the second motor 57. The controller 260 may control the timing of motor activation, such as activating the motor 22. Also, receiving data based on needle position indicative of a position of at least one needle in the needle assembly. and varying a speed, force, or position of at least one needle based on the position data. It is possible.

[0065] 17-20, an exemplary embodiment of a needle assembly 300 is shown. As previously mentioned, any of the illustrated needle assemblies or variations thereof may be used in drug delivery devices. Further, the disclosed needle assembly can be used in the drug delivery device 1000. 00, for example in chemical sampling equipment or in other applications where needles are used. The needle assembly 300 includes an assembly housing 310, an inner housing 312, and an inner a first needle support 320 coupled to a first needle 330; The second needle support 340, the movable connector 360, the drive member 370, and the O-ring 380 are Further, the needle assembly 300 includes an outer seal 230 and an inner seal 231. A first needle support 320, a first needle 330, a second needle support 340, a second needle 350, The movable connector 360 and the movable connector 360 together constitute a needle mechanism 390. The sealant 230 and the inner sealant 231 are attached to the needle assembly 300 before the needle assembly 300 is used. 300 and also to maintain sterility within the needle assembly 300. The present invention is designed to help

[0066] In the illustrated embodiment, the needle assembly 300 is inserted into the patient's lining to deliver the medication described above. The first or distal end 3 of the needle assembly 300 is configured to interact with the skin. 92 is positioned against the skin and a second or proximal end 394 of the needle assembly 300 is The needle assembly 300 may be attached directly to the cassette 200 or to the needle adapter 202. The first end 392 and / or the second end 393 are configured to couple through the assembly coupler 210. Alternatively, the outer seal 230 may aid in placing the needle assembly 300 against the patient's skin. A fastener, which may include an adhesive, for securing the needle assembly 300 to the cassette 200. As shown in FIG. 20, the inner housing 312 may also include a housing 310 and needle mechanism 390 is supported by inner housing 312. In this embodiment, needle assembly 300 may include only one housing, with the inner housing The housing 312 may be integral with the assembly housing 310 .

[0067] 20-24, when the needle mechanism 390 is in the first configuration, the needle assembly 3 20-24 show the needle in the first configuration. 3 shows various views of mechanism 390. In a first configuration, first needle 330 and second needle 350 are: The first needle 330 is generally aligned parallel to one another along the central axis A1. and second needle 350 are oriented in generally opposite directions along axis A1. The second needle 350 is directed toward the first end 392 of the needle assembly 300. 300. As will be described later, the first needle 33 The first and second needles 350 move generally along axis A1 when the needle assembly 300 is activated. It is configured to:

[0068] 21-28, an exemplary embodiment of a needle mechanism 390 is shown. The needle support 320 and the second needle support 340 are disposed generally along a common plane, and the drive unit The first and second needle supports 320, 340 are slidably coupled to each other via a material 370. The first side of the needle support 370 is configured to interact with the drive member 370, and the first and second needle supports The second sides of 320, 340 interact with and support the first and second needles 330, 350. In the illustrated embodiment, the first and second needle supports 320, 34 0 is approximately rectangular in shape and fits within needle assembly 300, as shown in FIG. In another embodiment, the first and second needle supports 320, 340 are configured as follows: Any shape that accommodates the movement of needles 330, 350 and fits within needle assembly 300. In the illustrated embodiment, the needle mechanism 390 comprises a rack and pinion arrangement, Each of the first needle support 320 and the second needle support 340 is a rack, and the drive member 37 0 includes a pinion gear. The first needle support 320 includes a support body 324, a support engagement feature 322 and a needle holder 326. The needle holder 326 holds at least one of the first needle 330. The needle holder 326 is configured to couple to a first needle 330 by inserting a portion of the needle holder 326. , thereby coupling the first needle 330 to the first needle support 320. Similarly, the second needle support The carrier 340 includes a support body 344, a support engagement feature 342, and a needle holder 346. The second needle 350 is coupled to the second needle support 340 via a needle holder 346. As best shown in FIG. 24, a first needle support 320 and a second needle support 340 are provided. One or both of the needle guards 352 may additionally include a needle guard 352 to protect the needle, and / or may function to provide additional strength to the needle. The housing is cylindrical having a bore extending through the needles 330, 331, 332, 333, 334, 335, 336, 337, 338, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 350, 351, 352 50 will be extended.

[0069] The first needle 330 and the second needle 350 are fluidly coupled to each other via a movable connector 360. The movable connector 360 is movable relative to each of the needles 330 and 350. The movable connector 360 can bend, curve, stretch, or otherwise deform. Thus, the movable connector 360 may be made of an elastomer, a thermoset, The material may be made of a flexible material such as a resistant polymer or rubber. In another embodiment, the movable connector 360 is made of silicone. 60 may be constructed from rigid materials bonded together via flexible connections. In an embodiment, the movable connector 360 may be formed of a relatively rigid material and may be elastically movable. In the illustrated embodiment of FIG. 0 has a first end 362 fluidly coupled to the end of the first needle 330 and an end 362 fluidly coupled to the end of the second needle 350. The movable connector 3 is a flexible tube having a first end 362 and a second end 364 fluidly coupled to the movable connector 3. The ends 362, 364 of the flexible tube of 60 are connected to the needle ends 330, 350 or respective needles. The retainer 326, 346 may be directly coupled to the flexible tube 326, 346, as described further below. The ends 362, 364 are configured to move with the needles 330, 350.

[0070] As best seen in FIGS. 25 and 26, the drive member 370 is fitted with the drive engagement feature 37 2 and an actuating member 374. An O-ring 380 is attached to the drive member 370 and the assembly housing. To provide a better seal between the housing 310 or when the drive member 370 is in the assembly, on the drive member 370 to allow it to rotate more easily within the housing 310. The drive engagement feature 372 may be configured to interact with the support engagement features 322 and 342. In the illustrated embodiment, the drive engagement feature 372 as well as the support engagement feature 322 and 342 are teeth or pinions configured to mesh with each other in a rack and pinion mechanism. In other embodiments, any of the engagement features in needle mechanism 390 may be a protrusion and a recess. such as joints, screws and threads, zipper type features, or any other complementary engaging features. Additionally, in the illustrated example, The actuating member 374 is a flat object such as a flat head screwdriver on the actuator shaft. In another embodiment, the actuating member 374 is configured to be actuated by rotation. The shaft of an electric motor, a shaft connected to a torsion spring, or the rotation of a knob In one exemplary embodiment, the drive system 250 and the drive Both members 370 are driven by electric motors, such as the first motor 22 and the second motor 57. Each is driven independently (FIG. 15). One electric motor drives the drive system 250 and the drive The movement of both members 370 can be controlled by their own respective It may have an actuating motor.

[0071] 27 and 28, needle mechanism 390 is actuated by drive member 370 to a first The needle support 320 is configured to allow movement of the first needle support 320 and the second needle support 340 . Needle mechanism 390 may be configured in a first, retracted configuration, as shown in FIG. 27, before and / or after use, and in a second, retracted configuration, as shown in FIG. 8 to a second, extended configuration in use.

[0072] In the first retracted configuration of FIG. 27, both the first needle 330 and the second needle 350 are in the assembled The movable connector 360 is located completely axially within the housing 310. The needles 330, 350 are compressed (e.g., bent) between the adjacent tube ends 362, 364. The adjacent tube ends 362, 364 are arranged in a first (closed or looped) configuration. When the drive member 370 rotates in the direction C1, the needle mechanism 390 The first needle support 320 and the drive member 370 are held in the second configuration until rotation of the drive member 370 stops. The first needle 330 is driven in the direction D1, and the second needle support 340 and the second needle 350 are driven in the direction D2. In the illustrated embodiment, D1 and D2 are substantially parallel in a plane and are mutually Moreover, they are nearly parallel to the axis A1 (see FIG. 20). In the configuration, D1 and D2 may be angled relative to each other and not approximately parallel to A1. This is also fine.

[0073] In the second, extended configuration, the first needle 330 extends axially beyond the assembly housing 310. 2 and extends through the outer seal 230 to contact whatever surface the needle assembly 300 is placed against. Additionally, a second needle 350 extends into the assembly housing 3. 10 and passes through the internal seal 231 and the bulkhead 226 to form a fluid housing. Since the movable connector 360 is movable, the needle mechanism 390 moves , maintaining fluid communication between the first needle 330 and the second needle 350. The movable connector 360 In the second configuration, the distal tube ends 362, 364 extend between the needles 330, 350. The tubes 362, 364 may be arranged in a first configuration. In the second configuration, the first needle 330 is separated by a second distance that is greater than the distance. Being fluidly coupled to the cartridge 220, the fluid within the fluid housing 222 The needle 350, the movable connector 360, and the first needle 330 are then inserted into any body or surface. In an exemplary embodiment, the first needle 330 is inserted into the blood vessel 310. The drive system 250 is activated after the needle mechanism 390 is in the second configuration to drive the cartridge. The fluid within 220 is forced out into the body or surface punctured by the first needle 330. In this embodiment, some components of needle mechanism 390 and / or inner housing 312 may When the needle mechanism 390 reaches the second configuration, the first needle support 320 and the second needle support 34 0. Such stopping features may include blocking members, protrusions, etc. , a detent, or the absence of an engagement member within a portion of needle mechanism 390.

[0074] From the second configuration, needle mechanism 390 can be similarly returned to the first configuration by reverse actuation of drive member 370. As shown in FIG. 28, the drive member 37 is configured to be movable back and forth. 0 drives the first needle support 320 in the direction D2 and drives the second needle support 340 in the direction D1. In an exemplary embodiment, the needle mechanism may be rotated in a direction C2 substantially opposite to C1 in order to move the needle mechanism. The needle mechanism 390 is adapted to pump fluid from the cartridge 220 through the needle mechanism 390 into the second cartridge 220 after the fluid has been pumped therethrough. The drug delivery device 1000 is moved from the first configuration to the second configuration. In an embodiment used to reach the target, first needle 330 is extended from needle assembly 300. After injection, the patient is able to extend the first needle 330 and retract the first needle 330 into the needle assembly 300. Thus, the medication can be injected without having to directly view or handle the first needle 330 .

[0075] 29-32, needle assembly 400 is shown. 400 is similar to needle assembly 300, but instead of a single needle mechanism, it has four needle assemblies. 00 includes a plurality of needle mechanisms 490. In the illustrated embodiment, four needle mechanisms 490 are shown. However, any number of needle mechanisms 490 may be used. Each of the needle mechanisms 490 includes a first A first needle support 420 coupled to a needle 430, a second needle support 450 coupled to a second needle The needle assembly includes a body 440, a movable connector 460, a drive member 470, and an O-ring 480. Each needle mechanism 490 in needle assembly 400 corresponds to an individual needle in needle assembly 300, as described above. The needle mechanism operates essentially the same as mechanism 390. In an exemplary embodiment, one needle mechanism at a time. 490 is activated, and thus, when needle assembly 400 is in use, only one needle mechanism 49 0 is in the second extended configuration. Further, in an exemplary embodiment, each of the needle mechanisms 490 is It is sterilized before use.

[0076] Needle assembly 400 additionally comprises a housing 410 and a number of internal seals 431. The internal seal 431 is configured to function similarly to the internal sealant 231, but This is accomplished with multiple separate smaller seals instead of one large seal. As can be seen clearly, the internal seals 431 (one of which is omitted in the illustrated embodiment) are The cassette 2 is positioned to cover the hole in the housing 410. When the cassette 200 is coupled to the needle assembly 400, the cassette 200 includes a single internal seal 43. 1, or each of the internal seals 431 may include a single cartridge 220 aligned with the A plurality of cartridges 220 may be included for alignment with one another.

[0077] The needle assembly 400 may also include a rotating assembly (not shown). The assembly may be configured to align one of the needle mechanisms 490 with the cartridge 220. Rotating the entire needle assembly 400 or just the needle mechanism 490 within the needle assembly 400 Then, the needle mechanism 490 aligned with the cartridge 220 (needle mechanism 39 0) to move from the first configuration to the second configuration, and the second needle support 44 0 can pierce the inner seal 431 and the septum 226, and the first needle support 420 piercing the surface or skin on which the seal 230 and needle assembly 400 are positioned; Needle mechanism 490 can then be returned to the second configuration (e.g., needle assembly After drug delivery as described above with respect to 300, the rotating assembly then rotates another needle mechanism 490. The cartridge 220 can then be rotated to align with the cartridge 220. 0 to activate a new needle mechanism 490 aligned with needle number 0 to re-puncture the same cartridge 220. Alternatively, a new cartridge 220 may be used. The rotating assembly is driven by another gear, screw, rack, or other gear engagement feature. Additionally, the rotating assembly may be driven by an electric motor.

[0078] In another embodiment, at least one of the rotating assembly, the housing 410, and the needle mechanism 490 may be At least one engagement feature to stop the rotating assembly in a properly aligned configuration Examples of engagement features include recesses, grooves, latches, protrusions, detents, and ball mechanisms. and other locking mechanisms. Having multiple needle mechanisms 490 in needle assembly 400 This allows for multiple uses of the same needle assembly 400 so that a different sterile needle is used for each injection. Additionally, different medicaments can be delivered using the same needle assembly 400. In some embodiments, the drug may be injected through the needle mechanism 490. The product delivery device 1000 may track the number of needles used and / or which needles have been used. For example, the needle index may include a counter or needle counter (not shown) for counting the number of needles in the needle mechanism 4. 90 extends from the first configuration to the second configuration, or when needle assembly 400 rotates. The drug delivery device 1000 may be increased when each of the available needles is used. It can show the user how the

[0079] 33-34, another embodiment of a needle assembly 500 is shown. Needle assembly 500 includes a housing 510, a rotating assembly 514, and a plurality of needle mechanisms. Each needle mechanism 590 includes a first needle support 520 coupled to a first needle 530. , a second needle support 540 coupled to a second needle 550, a movable connector 560, a drive member 5 70, a drive member actuator 578, and an O-ring 580. In this embodiment, a multiple needle mechanism 590 is shown, however, a single needle mechanism may be used, similar to the embodiment shown in FIG. Any number of needle mechanisms 590 may be used, including one needle mechanism 590. Movable Connector 560 may have various features in common with the movable connector 360 described above.

[0080] The rotating assembly 514 includes an exposed driven gear 512 and is coupled to the housing 510. In an exemplary embodiment, driven gear 512 is configured to be driven by a motor. 514 to rotate the housing 510 via the rotating assembly 514. In this embodiment, the rotating assembly 514 may not include a driven gear 512, but may instead include a driven gear 512. grips that are rotated by a motor or other engagement features that are rotated by a motor or another device. In yet another embodiment, the rotation may be performed using a different user feature, such as a Rotation assembly 514 rotates housing 51 instead of rotating the entire needle assembly 500. 0. The needle mechanism 590 may be configured to rotate only the needle mechanism 590 within the needle mechanism 590.

[0081] 35-39, needle mechanism 590 of needle assembly 500 includes a drive screw axle. Each of the first needle support 520 and the second needle support 540 is configured as an assembly. The first needle support includes an engagement feature 522, a support body 524, and a needle holder 526. 520 and second needle support 540 are configured to engage with a drive member 570 . Each of the first and second needle supports 520, 540 is adapted for interaction with a drive member 570. The needles 530, 550 are generally curved to accommodate the needles 530, 550 and are positioned generally adjacent to each other. In another embodiment, the first and second needle supports 520, 540 are configured to is configured to position the first and second needles 530, 550 on opposite sides of a central axis. Each engagement feature 522 is adapted to interact with a drive engagement feature 572 of a drive member 570. In the illustrated embodiment, the engagement feature 522 is configured to threadably engage the drive member 570. The engagement feature 522 is shown as a thread, and the drive member 570 is a threaded member such as a screw. The drive engagement feature 572 is shown as a trough or root in the thread. The feature 522 is received within or otherwise interacts with a drive engagement feature 572 of the drive member 570. In the illustrated embodiment, the drive engagement feature of the drive member 570 572 indicates that the rotation of the drive member 570 rotates in opposite axial directions of the first and second needle supports 520, 540. are oppositely oriented along opposite halves of the drive member 570 to cause unidirectional movement. The drive gear 578 rotates in such a way that the rotation of the drive member actuator 578 rotates the drive member 570. Each drive member 570 is coupled to the drive member 57 0 to stop the movement of the first needle support 520 and / or the second needle support 540 along the In the illustrated embodiment, the at least one stop feature 573 is configured as follows: The drive member 570 includes a stop feature 573 on each half of the drive member 570 .

[0082] 38-39, needle mechanism 590 extends in the same manner as needle mechanisms 390 and 490. The needle mechanism can be extended and retracted, but using a different drive mechanism. 590 can be configured in a first retracted configuration before and / or after use, as shown in FIG. 9, the needle assembly 50 may be moved between a first extended configuration and a second extended configuration in use. Within needle mechanism 590, drive member actuator 578 is rotatably connected to drive member 570. The drive member 570 is locked in place and, when rotated, causes rotation of the drive member 570. The engagement features 522 on the first needle support 520 and the second needle support 540 allow the drive member 570 to When rotated, the first needle support 520 and the second needle support 520 move in opposite axial directions along the drive member 570. Each needle mechanism 590 is configured to move the needle support 540. Starting in a first configuration, rotating the drive member 570 in a first direction causes the first needle The support 520 moves in a direction D1 and the second needle support 540 moves in a direction D2, thereby This causes needle mechanism 590 to move to the second configuration. When 590 reaches the second configuration, the movement of the first needle support 520 and the second needle support 540 Next, the driving member 570 moves the first needle support 520 in the direction D2, The needle mechanism 590 is moved from the second configuration to the first configuration by moving the second needle support 540 in the direction D1. The needle assembly can be rotated in a second, opposite direction to move the needle assembly from the first configuration to the second, opposite direction. As discussed with respect to the 300, all of the following applies: first configuration, second configuration, needle, use, etc. The above disclosure of may be applied to needle assembly 500. All of the above disclosures of multiple needle mechanisms and rotating assemblies discussed above relate to needle assemblies. The present invention can also be applied to the needle assembly 500. Thus, needle assembly 500 is similar to needle assembly 300 and needle assembly 400 in that it is It takes up less space than a lock and pinion mechanism.

[0083] 40-42, another embodiment of a needle assembly 600 is shown. The needle assembly 600 has the same configuration as the needle assembly 600 except that the needle assembly 600 produces non-parallel needle motion. , functions similarly to the previously described embodiments of needle assemblies 300, 400, 500. The needle 600 includes a housing 610 and a first needle 612 supported by a first needle support 620. 30, a second needle 650 supported by a second needle support 640, and the first needle 630 and and a movable connector 660 configured to fluidly couple the first needle support 650 to the second needle support 660. A drive member 6 is configured to cause movement of the body 620 and the second needle support 640. 70, an O-ring 680, and a drive member 6 driven by an external source (e.g., a motor). and a driven gear member 678 configured to drive the needle assembly 70. The bridge 600 includes a first seal 230 and at least one second seal 631 .

[0084] Similar to the previously described embodiments of needle assemblies 300, 400, and 500, needle assembly 600 40, a first retracted configuration before and / or after use, and a second retracted configuration as shown in FIG. In this way, the device can be moved between the first configuration of FIG. , the first needle 630 and the second needle 650 are both retracted within the housing 610 . In the second configuration of FIG. 41, the first needle 630 extends from the housing 610 in a first direction D1. The second needle 650 extends from the housing 610 in a second direction D3, where D1 is generally equal to D3. In some embodiments, D1 is generally perpendicular to D3. As can be seen, the drive member 670 is configured as a pinion and is connected to the first needle support 6 20 and the second needle support 640 are generally adapted to engage opposite sides of the drive member 670. In this configuration, the rotation of the drive member 670 As a result, the first needle support 620 and the second needle support 640 are generally in non-parallel directions D1, D Move axially to 3.

[0085] Multiple embodiments of needle assemblies and needle mechanisms are disclosed. The features and configurations may be used alone or in combination with other features and configurations in any other disclosed It should be understood that many of the features discussed may be applied to embodiments of drug delivery devices. 1000, but they may be any of the drug delivery devices described herein. It may also be applied to the other embodiments 11, 12, 13, 126, or modifications thereof.

[0086] Referring now to FIG. 43, a computing device 700 includes a Any of the drug delivery devices 11, 12, 13, 126, 1000, for example drug delivery devices The computer may be used to communicate with and / or operate the computer device 1000. The mobile device 700 illustratively includes a mobile device such as a smartphone. Alternatives include, but are not limited to, laptops, desktops, tablets, etc. Any suitable computing device may be used, including a remote or server computer. This is also fine.

[0087] The computing device 700 includes software stored in the memory 720 of the device 700. At least one processor 710 for executing software and / or firmware. The software / firmware code, when executed by the processor 710, At least one processor 700 includes instructions that cause the device 700 to perform the functions described herein. The processor 710 illustratively includes a control processor that operates to activate the drug delivery device 1000. The memory 720 includes logic and / or applications 715. The memory 720 may be any suitable computer-readable medium that is accessible by the This may be a single storage device or multiple storage devices, internal or external to the processor 710. Exemplary memory may be located anywhere in the world and may include both volatile and non-volatile media. The 720 has random access memory (RAM), read-only memory (ROM), and Erasable Programmable Read-Only Memory (EEPROM), Flash Memory, Magnetic Storage A device, optical disk storage, or other device configured to store data and and any other suitable media accessible by the server 710.

[0088] The computing device 700 is in communication with a processor 710 and receives user input. Feed data into the system and use the data, information, and prompts generated by the system The user interface 705 is operable to receive and display the user The interface 705 is for receiving user input and providing the user input to the system. In the illustrated embodiment, the user interface includes at least one input device. The face 705 is a touch screen operable to display data and receive user input. A graphical user interface (GUI) that includes a touch screen display. The screen display allows the user to navigate through the presented information, menus, buttons and other Interacting with the data to receive information from the system and to provide user input to the system Alternatively, a keyboard, keypad, microphone, A mouse pointer or other suitable user input device may be provided.

[0089] The computing device communicates with the drug delivery device 1000 through a signal 750. The signal 750 may be a wireless or wired signal. A processor 760, a cartridge ID 770, and / or a communication device similar to the processor 710. The communication device 780 may include a communication device 780 for communicating with the communication device 740 or a drug Signals to / from other components of the delivery device 1000 (e.g., cartridge ID 770) 750. The cartridge ID 770 can be transmitted and received by the drug delivery device 100. It can be any type of mechanism or device that provides data about components of a system. For example, the cartridge ID 770 may be data regarding the type of liquid or drug in the cartridge 220. A catalog that provides data (e.g., specific drug, viscosity, volume, dosage, injection schedule, etc.) It may be a chip or an RFID indicator on the cartridge 220 (FIG. 12). Other components, such as an assembly or a motor, may be associated with other devices associated with the drug delivery device 1000. data (e.g., needle assembly type, needle length / positioning, patient information, treatment history information, model The ID may include an ID for communicating information about the motor (such as the type of motor, motor characteristics, etc.).

[0090] In some embodiments, the drug delivery device 1000 may be configured to detect whether a drug has been delivered to a patient. An indicator (not shown) may be provided to provide some indication of , or an indication of the end of administration. The indicator may be, for example, a light (e.g., an LED) , visual display such as a screen, vibration, sound, transmission of signals, separate computing device ( For example, display on a smartphone or computer as mentioned above, mechanical visual interface indicators (e.g., windows in the device housing to indicate barrel movement), or The indicator may also include any combination of the following: Check whether the cassette is properly inserted, the power information of the device (e.g. device on / off, battery level), patient information, any information that may be provided by the ID above Drug delivery devices 10 including, but not limited to, Any other information regarding the operation of 00 may be displayed to the user.

[0091] In some embodiments, the drug delivery device 1000 detects device-related information. In an exemplary embodiment, the cassette 10 may include a number of sensors (not shown) for detecting the temperature of the cassette. 00 is a skin probe that detects whether the device is properly positioned against the patient's skin. In some embodiments, the device is properly positioned. If the skin sensor does not indicate this, the drug delivery device 1000 will not activate the needle assembly. Other examples of optional sensors include a drug level sensor, Pressure sensors, accelerometers, force / thrust sensors, drive systems, cartridges, housings, and and / or position sensors for the components of the needle assembly, pH sensors, or any combination thereof. This includes, but is not limited to, matching.

[0092] The terms "first," "second," "third," etc. are used herein. Whether used in the claims or elsewhere in this specification, it is important to distinguish between similar elements. The information is provided for illustrative purposes only and is not necessarily intended to be sequential or chronological. The terms so used are interchangeable under appropriate circumstances (unless otherwise expressly disclosed). Unless otherwise specified, the disclosed embodiments described herein are not to be construed as limiting the present invention as claimed. It should be understood that other sequences and / or configurations are possible.

[0093] While the present invention has been described as having an exemplary design, the present invention is not limited to the scope of the present disclosure. This application is therefore intended to cover the general principles of the invention. It is intended to cover any variations, uses, or adaptations of the invention as used herein. The present invention relates to a method and apparatus for producing a method for the production of a compound according to the present invention. The present invention is not intended to be construed as limiting such departures from the present disclosure as are within the ordinary course of known or customary practice. It is intended to be.

[0094] Various aspects are described in this disclosure, including but not limited to the following aspects.

[0095] 1. A drug delivery device comprising a container for containing a medication and a needle assembly coupled to the container. the needle assembly having a first end configured to interface with the container; and a housing having a second end, a first needle support positioned within the housing. and a second needle support, a first needle coupled to the first needle support, and a second needle coupled to the second needle support. a second needle connected to the first needle; a movable connector in fluid communication between the first needle and the second needle; a drive mechanism configured to move the needle assembly from the first configuration to the second configuration. In the first configuration, the first needle and the second needle are positioned completely within the housing. In the second configuration, the first needle extends beyond the first end of the housing and the second needle a needle assembly including a drive mechanism, the drive mechanism extending beyond the second end of the housing; and coupled to the needle assembly for threading the second needle and the first needle when the needle assembly is in the second configuration. and a delivery mechanism configured to push the medicament through the drug delivery device.

[0096] 2. The method of claim 1, wherein the container is configured to be detached from the needle assembly. Product delivery device.

[0097] 3. The drug delivery device of aspect 1 or 2, wherein the movable connector is flexible.

[0098] 4. The drug delivery device of aspect 3, wherein the movable connector is a flexible tube.

[0099] 5. Aspects 1-4, in which the drive mechanism is configured to operate at a plurality of different operating speeds 2. A drug delivery device according to any one of the preceding claims.

[0100] 6. Each of the first needle support and the second needle support includes a rack, and the drive mechanism The pin is configured to drivably engage with the racks of the first and second needle supports. 6. The drug delivery device according to any one of aspects 1 to 5, which is a neon gear.

[0101] 7. An embodiment in which the drive mechanism includes a drive screw that is in threaded engagement with the first needle support and the second needle support. 7. A drug delivery device according to any one of 1 to 6.

[0102] 8. The first end of the housing includes a seal, and the container is adjacent the second end of the housing. a first needle pierces the seal when moving from the first configuration to the second configuration; The drug delivery device according to any one of aspects 1 to 7, wherein the first needle pierces the septum, and the second needle pierces the septum. vinegar.

[0103] 9. The drive mechanism is further configured to return the needle assembly from the second configuration to the first configuration. The drug delivery device according to any one of aspects 1 to 8,

[0104] 10. The device further includes an electric motor, the electric motor controlling at least one of the delivery mechanism and the drive mechanism. The drug delivery device according to any one of aspects 1 to 9, further comprising: Vice.

[0105] 11. Signals related to the operation of the drug delivery device to and from a computing device 11. The method of claim 1, further comprising a communication device configured to transmit and receive the The drug delivery device described herein.

[0106] 12. A needle assembly adapted to couple to a fluid delivery mechanism and interface with a surface. The housing is configured as described above, and a first needle is coupled to the first needle support, and a second needle support is coupled to the first needle support. a second needle coupled to the first needle; a movable connector coupling the first needle to the second needle; and a housing. and driving the first needle support in a first direction and the second needle support in a second direction. and a drive mechanism configured to drive in a direction.

[0107] 13. A first motor configured to push fluid through a fluid delivery mechanism; and a second motor configured to actuate the mechanism. Senburi.

[0108] 14. A state in which the first motor and the second motor are configured to operate with variable force. 14. The needle assembly according to claim 13.

[0109] 15. Both the first needle support and the second needle support are configured to engage with a drive mechanism. 15. The needle assembly of any one of aspects 12 to 14, further comprising at least one engagement feature. Nburi.

[0110] 16. At least one engagement feature is a recess and the drive mechanism interfaces with the recess. a protrusion configured to receive the first and second directions along a first axis; and wherein at least one engagement feature is defined about a second axis perpendicular to the first axis. 16. The needle assembly of claim 15.

[0111] 17. At least one engagement feature is a screw thread, the drive mechanism is a drive screw, and the drive Rotation of the moving screw causes the first needle support to move in a first direction and the second needle support to move in a second direction. The first direction and the second direction are along a first axis, and the at least one engagement 16. The needle assembly of claim 15, wherein the alignment feature is defined about a second axis parallel to the first axis. Nburi.

[0112] 18. The first direction and the second direction are both approximately collinear and approximately opposite to each other. 18. The needle assembly of any one of aspects 12 to 17,

[0113] 19. The movable connector is connected to at least one of the first needle support and the second needle support. 19. The method of any one of aspects 12 to 18, wherein the first and second members are configured to bend in response to movement relative to one another. 2. The needle assembly as described above.

[0114] 20. The movable connector is connected to the first needle support throughout the entire movement of the first needle support and the second needle support. a flexible tube configured to maintain a fluid connection between the needle and the second needle. 20. The needle assembly according to claim 19.

[0115] 21. The fluid delivery mechanism is configured to deliver a variable amount of fluid to the patient. 21. A needle assembly according to any one of 2 to 20.

[0116] 22. A method of operating a device, comprising: activating a first drive mechanism of the device for a first time; a first drive mechanism for driving the first needle from a retracted configuration to an axially extended configuration; in a first direction and a second needle in a second direction toward a septum of the drug container; a step of first activating the drive mechanism and a step of activating a second drive mechanism, A second drive mechanism drives the drug out of the first needle through the second needle and out of the first needle. a step of starting the second drive mechanism; and a step of starting the first drive mechanism following the start of the second drive mechanism. activating the mechanism a second time, the first drive mechanism axially extending the first needle. a second needle moving in a second direction from the extended configuration to a retracted configuration and moving the second needle in a first direction outwardly from the septum. and activating the first drive mechanism a second time.

[0117] 23. The first and second needles are fluidically connected using flexible connectors throughout each step. 23. The method of embodiment 22, wherein said compound is specifically linked to said nucleic acid.

[0118] 24. The first drive mechanism and the second drive mechanism are driven by at least one electric motor. 24. The method of claim 22 or 23, wherein the

[0119] 25. Prior to the step of activating the first drive mechanism, couple the drug container to the needle assembly. 25. The method of any one of aspects 22 to 24, further comprising the step of:

[0120] 26. After activating the first drive mechanism for a second time, a step of disconnecting the drug container from the needle assembly is performed. 26. The method of embodiment 25, further comprising the step of:

[0121] 27. After starting the first drive mechanism for the first time, increase the index of the needle counter. 27. The method of any one of aspects 22 to 26, further comprising the step of:

[0122] 28. A needle assembly, the needle assembly having a first end that interfaces with a surface and a second end that interfaces with a surface. a housing configured to interface with the container at an end; and a plurality of needle mechanisms. a plurality of needle mechanisms, each needle mechanism comprising a first needle fluidly coupled to a second needle; at least one drive configured to engage at least one of the needle mechanisms; A mechanism, wherein a first needle is driven in a first direction and a second needle is driven in a direction generally opposite to the first direction. and a plurality of needle mechanisms disposed within the housing, the needle mechanisms being driven in a second direction. and a rotation mechanism configured to rotate the needle.

[0123] 29. The rotating mechanism extends at least partially beyond the housing and interfaces with the motor. 30. The needle assembly of embodiment 28, comprising a driven gear configured to interface with the needle.

[0124] 30. A rotating mechanism positions a first needle of one of the needle mechanisms near the surface, the needle mechanism 30. The needle adapter according to claim 28 or 29, configured to position the second needle proximate the container. Senburi.

[0125] 31. The first direction is toward the first end of the housing and the second direction is toward the The needle assembly of embodiment 30, wherein the needle assembly is in a direction toward the second end of the housing.

[0126] 32. A drug delivery device comprising a housing and a hub configured to hold a fluid. at least one reservoir within the housing and configured to expel fluid from the reservoir with a variable force. a first motor and a needle assembly configured to move from a first configuration to a second configuration. In the first configuration, the needle assembly is retracted and in the second configuration, the needle assembly is extended. and a needle assembly, the needle assembly extending into fluid communication with the container. .

[0127] 33. A first motor moves the needle assembly from a first configuration to a second configuration, embodiment 32 The drug delivery device according to claim 1.

[0128] 34. A second motor configured to move the needle assembly from the first configuration to the second configuration. 34. The drug delivery device of any one of claims 32 to 33, further comprising a

[0129] 35. Signal to the user when fluid is being forced through the needle assembly. 35. The drug delivery device according to any one of aspects 32 to 34, further comprising an indicator configured as follows: Reach device.

[0130] 36. The method further comprising: providing a first needle and a second needle in a needle assembly; the needle assembly being in a first configuration; When moving from the first configuration to the second configuration, the first needle and the second needle are aligned along the first axis and the second axis, respectively. 36. The drug delivery device of any one of aspects 32 to 35, wherein the drug delivery device moves along an axis of the

[0131] 37. The drug delivery device of embodiment 36, wherein the first axis and the second axis are generally parallel. vinegar.

[0132] 38. The drug delivery device according to aspect 36, wherein the first axis and the second axis are generally orthogonal. .

[0133] 39. Indicate whether the drug delivery device is properly positioned against the patient's skin. 39. The method according to any one of aspects 32 to 38, further comprising a skin sensor configured to Product delivery device.

Claims

1. 1. A drug delivery device comprising: A container containing a medicament; A needle assembly coupled to the container, the needle assembly comprising: a first end and a second end configured to interface with the container; Housing, a first needle support and a second needle support positioned within the housing; a first needle coupled to the first needle support; a second needle coupled to the second needle support; a movable connector in fluid communication between the first needle and the second needle; and a driver configured to move the needle assembly from a first configuration to a second configuration In the first configuration, the first needle and the second needle are completely inserted into the housing. and in the second configuration, the first needle is positioned in front of the housing. the second needle extends beyond the second end of the housing; a needle assembly including an extending drive mechanism; a second needle assembly coupled to the container when the needle assembly is in the second configuration; a delivery mechanism configured to push the agent through the first needle and the second needle; A drug delivery device.

2. The method of claim 1 , wherein the container is configured to be separated from the needle assembly. The drug delivery device.

3. The drug delivery device of claim 1 or 2, wherein the movable connector is flexible.

4. The drug delivery device of claim 3 , wherein the movable connector is a flexible tube.

5. The drive mechanism is configured to operate at a plurality of different operating speeds.

5. A drug delivery device according to any one of claims 4.

6. each of the first needle support and the second needle support includes a rack; and the drive mechanism drivably engaging the racks of the first and second needle carriers, respectively. The drug delivery system according to any one of claims 1 to 5, wherein the pinion gear is configured to rotate in a clockwise direction. device.

7. The drive mechanism includes a drive screw that is in threaded engagement with the first needle support and the second needle support. The drug delivery device according to any one of claims 1 to 6.

8. The first end of the housing includes a seal, and the container is disposed in front of the housing. a partition wall adjacent the second end, the partition wall being configured to move from the first configuration to the second configuration; , wherein the first needle pierces the seal and the second needle pierces the septum. A drug delivery device according to any one of claims 1 to 7.

9. The drive mechanism is adapted to return the needle assembly from the second configuration to the first configuration. The drug delivery device of any one of claims 1 to 8 further comprising:

10. and an electric motor, the electric motor driving at least one of the delivery mechanism and the drive mechanism. The drug according to any one of claims 1 to 9, which is configured to activate at least one Product delivery device.

11. Signals related to the operation of the drug delivery device are transmitted to and from a computing device. A method according to any one of claims 1 to 10, further comprising a communication device configured to receive The drug delivery device described herein.

12. During movement of the needle assembly from the first configuration to the second configuration, the first needle is the second needle moves in a first direction along an axis opposite to the first direction, The drug delivery device according to any one of claims 1 to 11, which moves in a direction.

13. During movement of the needle assembly from the first configuration to the second configuration, the first needle is The second needle moves in a first direction along an axis, and the second needle moves in a second direction perpendicular to the first direction along an axis. The drug delivery device according to any one of claims 1 to 11, which moves in the direction of

14. 1. A needle assembly comprising: a housing configured to couple to the fluid delivery mechanism and interface with a surface; a first needle coupled to a first needle support; a second needle coupled to a second needle support; a movable connector coupling the first needle to the second needle; a first needle support supported by the housing and configured to drive the first needle support in a first direction; a drive mechanism configured to drive the second needle support in a second direction. , needle assembly.

15. a first motor configured to drive fluid through the fluid delivery mechanism; and a second motor configured to actuate the mechanism. Needle assembly.

16. the first motor and the second motor are configured to operate with variable forces; 16. The needle assembly of claim 15.

17. Both the first needle support and the second needle support are engaged with the drive mechanism. The at least one engagement feature according to any one of claims 14 to 16. Needle assembly.

18. The at least one engagement feature is a recess, and the drive mechanism interfaces with the recess. a protrusion configured to face the first direction and the second direction, and the at least one engagement feature is aligned along a second axis perpendicular to the first axis. The needle assembly of claim 17 , wherein the needle assembly is defined about a center.

19. the at least one engagement feature is a screw thread and the drive mechanism is a drive screw; Rotation of the drive screw moves the first needle support in the first direction and the second needle support in the second direction. The needle support moves in the second direction, and the first direction and the second direction are aligned along a first axis. and the at least one engagement feature is centered on a second axis parallel to the first axis. The needle assembly of claim 17 defined as

20. The first direction and the second direction are both substantially collinear and substantially opposite to each other. The needle assembly of any one of claims 14 to 19, which is a pair.

21. 20. The method according to claim 14, wherein the first direction and the second direction are substantially perpendicular to each other.

2. The needle assembly of claim 1 .

22. The movable connector is connected to at least one of the first needle support and the second needle support. Any of claims 14 to 21, configured to bend in response to movement of one relative to the other.

3. The needle assembly of claim 1 .

23. the movable connector, throughout the movement of the first needle support and the second needle support, a flexible tube configured to maintain a fluid connection between the first needle and the second needle; The needle assembly of claim 22 comprising a needle.

24. 13. The method of claim 1, wherein the fluid delivery mechanism is configured to deliver variable amounts of fluid to a patient.

24. A needle assembly according to any one of claims 4 to 23.

25. 1. A method of operating a device, comprising: activating a first drive mechanism of the device for a first time, the first drive mechanism being A mechanism moves the first needle in a first direction from a retracted configuration to an axially extended configuration and the second needle in a second direction from a retracted configuration to an axially extended configuration. a first actuation mechanism for actuating the first needle in a second direction toward a septum of the drug container; and activating a second drive mechanism, the second drive mechanism driving the second needle; a second drive mechanism for pushing the drug out of the first needle through the first needle; and activating the first drive mechanism a second time following activation of the second drive mechanism. The first drive mechanism moves the first needle from the axially extended configuration to the rear configuration. a second needle in the first direction outwardly from the septum to a retracted configuration; and activating the first drive mechanism a second time.

26. The first needle and the second needle are connected to each other through each step using a flexible connector. The method of claim 25, wherein the compound is intimately linked.

27. The first drive mechanism and the second drive mechanism are driven by at least one electric motor.

27. The method according to claim 25 or 26, wherein the method is activated.

28. Prior to the step of activating the first drive mechanism, the drug container is coupled to the needle assembly. The method of any one of claims 25 to 27, further comprising the step of binding to

29. After activating the first drive mechanism a second time, the drug container is disconnected from the needle assembly.

30. The method of claim 28, further comprising the step of releasing.

30. After the first drive mechanism is activated for the first time, a step of incrementing the index of the needle counter is performed. The method of any one of claims 25 to 29, further comprising the step of:

31. 1. A needle assembly comprising: A first end interfaces with a surface and a second end interfaces with a container. a housing configured to interface with the A plurality of needle mechanisms, each of which has a first needle and a second needle fluidly coupled to the first needle. a plurality of needle mechanisms including a first needle and a second needle attached to the first needle; at least one needle mechanism configured to engage at least one of the needle mechanisms; A drive mechanism, the first needle being driven in a first direction and the second needle being driven in a second direction. at least one drive mechanism driven in a second direction generally opposite to the first direction; a rotation mechanism configured to rotate the plurality of needle mechanisms within the housing; A needle assembly comprising:

32. The rotation mechanism extends at least partially beyond the housing and interfaces with a motor.

32. The needle assembly of claim 31, comprising a driven gear configured to interface with the needle.

33. The rotating mechanism positions a first needle of one of the needle mechanisms near a surface, 32. The method of claim 31, further comprising: positioning the second needle adjacent the container.

2. The needle assembly according to claim 1 .

34. The first direction is toward the first end of the housing, and the second direction is toward the first end of the housing.

34. The needle adapter of claim 33, wherein the direction is toward the second end of the housing. Senburi.

35. 1. A drug delivery device comprising: Housing and at least one reservoir within the housing configured to hold a fluid; a first motor configured to force the fluid out of the container with a variable force; A needle assembly configured to move from a first configuration to a second configuration, In one configuration, the needle assembly is retracted and in the second configuration, the needle assembly is and a needle assembly extending into fluid communication with the container. Chair.

36. The first motor moves the needle assembly from the first configuration to the second configuration.

36. The drug delivery device of claim 35.

37. a second actuator configured to move the needle assembly from the first configuration to the second configuration; 37. The drug delivery device of claim 35 or 36, further comprising a motor.

38. and signaling to a user when the fluid is expelled through the needle assembly. The pharmaceutical composition according to any one of claims 35 to 37, further comprising an indicator configured as follows: Product delivery device.

39. The needle assembly further comprises a first needle and a second needle within the needle assembly, the first needle being When moving from the first configuration to the second configuration, the first needle and the second needle each The drug according to any one of claims 35 to 38, wherein the drug moves along a first axis and a second axis. Product delivery device.

40. 40. The drug delivery device of claim 39, wherein the first axis and the second axis are generally parallel. Vice.

41. 40. The drug delivery device of claim 39, wherein the first axis and the second axis are generally orthogonal. Chair.

42. Indicating whether the drug delivery device is properly positioned against the patient's skin. The drug according to any one of claims 35 to 41, further comprising a skin sensor configured to Product delivery device.

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