Drug delivery device with needle carrier

Abstract

A drug delivery device is provided having a needle assembly portion and a drug device portion, wherein the needle assembly portion is removably coupled to the drug device portion. In some embodiments, the needle of the needle assembly is movable from a retracted position to an extended position for piercing the skin of a subject. In some embodiments, the needle is also movable back to the retracted position.

Description

Background Art

[0001] Patients with many different medical conditions must frequently administer medications themselves. To allow for convenient and accurate self-medication, various devices, broadly referred to as syringe pens or injection pens, have been developed. Typically, these pens are equipped with a medication container, such as a cartridge containing a piston and multiple doses of liquid medication. A drive member, extending from the base of the syringe pen and operably connected to the pen's mechanism that controls its movement, can be moved forward to advance the piston in the cartridge, dispensing the contained medication from an outlet at the opposite end of the cartridge, typically via a needle that penetrates a stopper at that opposite end. In disposable or prefilled pens, after the pen has been used to deplete the medication supply within the cartridge, the user, who then begins using a new replacement pen, discards the entire pen. In reusable pens, after the pen has been used to deplete the medication supply within the cartridge, the pen is disassembled to allow the spent cartridge to be replaced with a new one, and then the pen is reassembled for subsequent use.

[0002] The inventors have recognized that with some drug delivery devices, a user may need to attach and / or detach a needle to and from the drug delivery device before and / or after use. The inventors have recognized a need for a device that facilitates attaching and detaching a needle assembly from a drug delivery device. Summary of the Invention

[0003] According to one aspect, a drug delivery device is provided. In some embodiments, the drug delivery device may include a needle assembly comprising a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub. The drug delivery device may also include a drug device having a container and a carrier drive element, the container having a septum disposed at an open end of the container. The needle carrier may be coupled to the drug device. A deployment trigger may be configured to activate the carrier drive element to distally move the needle hub from a retracted needle hub position to an extended needle hub position and to distally move the needle relative to the septum from the retracted needle position to the extended needle position.

[0004] According to another aspect, a method is provided. In some embodiments, the method may include providing a medical device having a container and a carrier drive element, the container having a septum disposed at an open end of the container, and providing a needle assembly comprising a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub. When the needle carrier is coupled to the medical device, the method may further include activating a deployment trigger to activate the carrier drive element to distally move the needle hub from a retracted needle hub position to an extended needle hub position and to move the needle relative to the septum from the retracted needle position to the extended needle position.

[0005] According to yet another aspect, a needle assembly for coupling to a medical device having a spring and a container with a septum containing a fluid is provided. In some embodiments, the needle assembly may include a needle carrier removably coupled to the medical device to load the spring, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub. Coupling the needle carrier to the medical device facilitates piercing the septum of the medical device with the needle. The needle hub is movable distally relative to the needle carrier to position the distal end of the needle extending beyond the needle carrier and to position the proximal end of the needle within the septum, in fluid communication with the fluid in the container.

[0006] Other advantages and novel features of the present invention will become apparent from the following detailed description of various non-limiting embodiments of the invention when considered in conjunction with the accompanying drawings. In the event that this specification and a document incorporated by reference include conflicting and / or inconsistent disclosures, this specification shall control. If two or more documents incorporated by reference contain conflicting and / or inconsistent disclosures, the document with the later effective date shall control. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Additional embodiments of the present disclosure and their features and advantages will become more apparent by referring to the description herein in conjunction with the accompanying drawings. The components in the figures are not necessarily to scale. In addition, in the accompanying drawings, the same reference numerals represent corresponding parts in different views.

[0008] Figures 1A-1E depicts a series of schematic diagrams of a drug delivery device according to one embodiment undergoing a series of steps in which a needle assembly is attached to the drug device and the needle is moved in an extending direction;

[0009] Figures 2A-2J depicts a series of schematic diagrams of a drug delivery device according to one embodiment undergoing a series of steps in which a needle assembly is attached to the drug device, the needle is moved in an extended direction to pierce the skin of a subject, and the needle assembly is removed from the drug device;

[0010] Figure 3 A schematic diagram depicting a medical device and a plurality of needle assemblies, each needle assembly contained within a separate container;

[0011] Figures 4A-4C depicts a sequence of assembly states through a series of steps in which a needle is moved from a retracted position to an extended position and coupled to a container for removal from a medical device;

[0012] Figure 5 is an exploded view of a drug delivery device according to one embodiment;

[0013] Figure 6Ais a perspective view of a needle assembly ready for use with a medical device, the needle assembly being retained within a container with a peel tab sealing the needle assembly within the container;

[0014] Figure 6B yes Figure 6B a perspective view of a container with the peel tab removed from the container;

[0015] Figure 6C Depicts a device coupled to a drug Figure 6B container;

[0016] Figure 6D Depicts removal of the drug device Figure 6C container, leaving the needle assembly coupled to the medical device;

[0017] Figure 6E depicts a trigger of a needle assembly being pushed in a proximal direction to actuate extension of the needle of the needle assembly;

[0018] Figure 6F Depicts moving to extended position Figure 6E needle;

[0019] Figure 7A depicts a container coupled to the needle assembly for removing the needle assembly from the medical device;

[0020] Figure 7B depicts a container being manipulated to remove a needle assembly from a medical device;

[0021] Figure 8A depicts a detailed view of a carrier of a needle assembly in the process of being coupled to a first portion of a medical device;

[0022] Figure 8B Depicts a first portion coupled to a medical device Figure 8A carrier;

[0023] Figures 9A-9C Depicts the process of removal from the first portion of the medical device Figure 8A carrier;

[0024] Figures 10A-10C depicts a cross-sectional view of a needle assembly coupled to a first portion of a medical device;

[0025] Figure 10D Depicts being pressed against the subject's skin to activate extension of the needle Figure 10A a trigger of a needle assembly;

[0026] Figure 10E Depicts Figure 10D The needle extends into the subject's skin;

[0027] Figure 10F depicts removing a needle assembly from a medical device using the container body;

[0028] Figures 11A-11F depicts a view of a needle carrier according to one embodiment;

[0029] Figures 12A-12E depicts a view of a first portion of a medical device according to one embodiment;

[0030] Figures 13A-13E depicts a view of a needle hub according to one embodiment;

[0031] Figures 14A-14F depicts a diagram of a trigger according to one embodiment;

[0032] Figures 15A-15F depicts a view of a container according to one embodiment;

[0033] Figures 16A-16H depicts a series of schematic diagrams of a drug delivery device according to one embodiment undergoing a series of steps in which a needle assembly is attached to the drug device, the needle is moved in an extended direction to pierce the skin of a subject, the needle is moved in a retracted direction, and the needle assembly is removed from the drug device;

[0034] Figure 17 is an exploded view of a drug delivery device according to one embodiment;

[0035] Figure 18A is a perspective view of a needle assembly and a medical device ready for use with the medical device;

[0036] Figure 18B yes Figure 18A a perspective view of the needle assembly and medical device with the peel tab removed;

[0037] Figure 18C yes Figure 18B a perspective view of a needle assembly and a medical device, wherein the collar of the medical device is rotated to receive the needle assembly;

[0038] Figure 18D yes Figure 18C a perspective view of a needle assembly and a medical device, wherein the needle assembly is coupled to the medical device;

[0039] Figure 18E yes Figure 18D a perspective view of a needle assembly and a medical device, wherein the needle assembly is coupled to the medical device;

[0040] Figure 18F yes Figure 18E A perspective view of a needle assembly and a medical device, wherein the needle of the needle assembly is in an extended position;

[0041] Figure 18G yes Figure 18E A perspective view of a needle assembly and medical device with the needle in a retracted position;

[0042] Figure 19 yes Figure 18G a perspective view of a needle assembly and a medical device, wherein the needle assembly is removed from the medical device;

[0043] Figures 20A-20F depicts a cross-sectional view of a needle assembly coupled to a medical device;

[0044] Figures 21A-21B Depicts removal of the drug device Figure 20A a cross-sectional view of a needle assembly;

[0045] Figure 22A and 22B Two perspective views showing the collar in a deactivated state prior to use;

[0046] Figure 23A and 23B shows two perspective views of the collar after it has been rotated to an activated state;

[0047] Figure 24A and 24B Two perspective views of the collar are shown after the needle has been moved to an extended position;

[0048] Figure 25A and 25B Two perspective views of the collar are shown after the needle has been moved to a retracted position;

[0049] Figures 26A-26C depicts the arrangement of a cam of a needle assembly as the drug delivery device undergoes a series of needle extension steps;

[0050] Figures 27A-27B depicts the arrangement of the needle carrier as the drug delivery device undergoes a series of needle retraction steps;

[0051] Figures 28A-28F depicts a view of a needle carrier according to one embodiment;

[0052] Figures 29A-29F depicts a view of a cam according to one embodiment;

[0053] Figures 30A-30D depicts a view of a hub according to one embodiment;

[0054] Figures 31A-31E depicts a diagram of a collar according to one embodiment; and

[0055] Figures 32A-32DDepicted is a view of a portion of a portion of a medical device according to one embodiment. DETAILED DESCRIPTION

[0056] The present disclosure relates to a drug delivery device having a needle assembly that is removably attachable to another portion of the drug delivery device. The other portion of the drug delivery device will be referred to herein as the drug device, and the combination of the needle assembly and the drug device will be referred to herein as the drug delivery device. In some embodiments, the drug device can include a portion of the drug delivery device that contains or is configured to contain a drug.

[0057] In one aspect, the needle assembly is configured to be attached to the medical device by a user without requiring the user to touch and / or view the needle of the needle assembly.

[0058] In one aspect, the needle assembly includes a needle disposal container that can be used to install the needle assembly to the device, which is then removed from the needle assembly for operation of the device and then used again as a tool to remove the needle assembly from the device and contain the used needle assembly.

[0059] In another aspect, the needle assembly is configured to be removed from the medical device by a user without requiring the user to touch the needle of the needle assembly, and in some embodiments, without requiring the user to observe the needle of the needle assembly.

[0060] In another aspect, the needle assembly includes a needle disposal container integrated into the needle assembly, which can be used to install the needle assembly to the device, the needle disposal container remaining with the needle assembly for operation of the device, and then used as a tool to remove the needle assembly from the device and contain the used needle assembly.

[0061] As described above, in some embodiments, the drug device portion of a drug delivery device may contain a drug. The term "drug" refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs (such as insulin lispro or insulin glargine), insulin derivatives, GLP-1 receptor agonists (such as dulaglutide or liraglutide), glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxygenomodulin analogs, oxygenomodulin derivatives, therapeutic antibodies, and any other therapeutic agent capable of being delivered via the aforementioned devices. Drugs used in the device may be formulated with one or more excipients. The device is typically operated by the patient, caregiver, or healthcare professional in the manner described above to deliver the drug to the patient.

[0062] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe these embodiments. It will be understood, however, that this is not intended to limit the scope of the invention.

[0063] Figures 1A-1E A schematic diagram of a drug delivery device and an operational sequence of an illustrative embodiment of the drug delivery device are shown. The drug delivery device includes a needle assembly 1001 and a drug device 5001. In this embodiment, the needle assembly includes a needle carrier 201 and a needle 101 having a proximal end 121 and a distal end 141. The drug device 5001 includes a drug container 5301 and a coupling end 5501 configured to be received by the needle carrier 201 of the needle assembly 1001.

[0064] exist Figure 1A In FIG. 5 , the needle assembly 1001 is in the process of being coupled to the coupling end 5501 of the medical device 5001. The coupling end 5501 of the medical device 5001 is inserted into the needle carrier, thereby generating Figure 1B The arrangement shown, wherein the drug device 5001 is coupled to the needle carrier 201. Figure 1C As shown in the cross-sectional view of FIG, with the drug device 5001 coupled to the needle carrier 201, the proximal end 121 of the needle 101 pierces the septum 5201 of the drug container 5301. Figure 1C As shown in the cross-section of FIG, the drug container 5301 further includes an interior 5321 and a piston 5401 movable relative to the interior 5321 and the diaphragm 5201. As understood by those skilled in the art, the piston can be moved by various conventional piston drive actuators in the art.

[0065] In the next step in the sequence, as Figure 1D As shown, the needle 101 is moved to the extended position so that the distal end 141 of the needle extends beyond the distal end 241 of the needle carrier 201 by a distance D so as to pierce the skin of the subject. Figure 1E As seen in FIG, the piston 5401 is then driven distally to expel the drug from the interior 5321 of the drug container 5301 through the needle 101 and into the subject. Figure 1E As shown, the needle 101 can be movable to a retracted position in which the distal end 141 of the needle is moved to a position proximal to the distal end 241 of the needle carrier 201. However, in other embodiments, the needle remains in the extended position.

[0066] Figures 2A-2J A series of schematic diagrams depict a drug delivery device according to one embodiment undergoing a series of operating steps.

[0067] like Figure 2AAs shown, a drug delivery device includes a needle assembly 100 and a drug device 500. In this illustrative embodiment, needle assembly 100 is initially contained within a container 200 having a body 210 and a cap 220. The drug device may include a first portion 502 and a second portion 504. In some embodiments, first portion 502 includes a coupling end 550 configured to couple with needle assembly 100. In some embodiments, first portion 502 of drug device 500 may house a drug container. In some embodiments, second portion 504 of drug device 500 may include a device actuator. In some embodiments, activation of the device actuator is used to expel drug from the drug container.

[0068] As a first step, the cover 220 is removed from the container body 210 to expose the needle assembly 100 located within the container 200. Next, the needle assembly 100 is coupled to the medical device 500. In some embodiments, with the needle assembly 100 positioned within the container body 210, the user couples the carrier 20 of the needle assembly 100 to the medical device 500 by holding the container body 210 and moving the container body toward the coupling end 550 of the medical device 500 until the needle assembly 100 contacts and couples to the medical device 500. Figure 2B As shown, the needle assembly 100 may remain within the container body 210 during coupling of the needle assembly 100 to the coupling end 550 of the medical device 500 .

[0069] Afterwards, if Figure 2C As shown, with the needle assembly's carrier 20 coupled to the medical device 500 , the container body 210 may be removed from the needle assembly 100 and the medical device 500 .

[0070] exist Figure 2D In the next step shown, the drug delivery device can be prepared to deliver a dose of medication by retracting the actuator 590. However, it should be understood that drug delivery devices can utilize other types of actuators and delivery mechanisms that do not require the actuator to be retracted for dose delivery.

[0071] Next, if Figure 2E As shown, the drug delivery device is placed against the subject's skin 5. In some embodiments, the needle assembly can include a trigger 30 that rests flush against the skin. The trigger structure can also be a shield surrounding the needle 10 to visually conceal the needle from the subject. In some embodiments, the trigger does not actually trigger needle extension, but rather triggers a biased retractable shield, and the triggering of needle extension is performed by another actuation button or by a movement made by the subject.

[0072] like Figure 2FAs shown, to begin piercing the subject's skin, the user can push the drug delivery device downward on the user's skin, thereby causing the trigger 30 to be pushed into the carrier 20 of the needle assembly, which can actuate the needle 10 to extend out of the carrier 20 and into the subject's skin 5. Next, as shown Figure 2G As shown, a user can push actuator 590 downward to expel the drug from the drug container within the medical device and through needle 10, thereby injecting the drug into the subject.

[0073] like Figure 2H As shown, after delivering the drug to the subject, the drug delivery device is removed from the skin 5. As can be understood from viewing the sequence of schematic diagrams, the trigger 30 can remain retracted within the carrier; however, in other embodiments (not shown), the trigger 30 can be returned to its extended position by biasing action once the device is removed from the subject's skin. The user can then begin the process of removing the needle assembly from the drug device 500. Figure 2I In the embodiment of the present invention, the user can push the container body 210 back onto the needle assembly to couple the needle assembly 100 to the container body 210.

[0074] like Figure 2J As shown, to remove the needle assembly from the medical device, the user can rotate the container body 210 relative to the medical device to unlock the needle assembly from the coupling end 550 of the medical device, and then pull the container body 210 away from the medical device to remove the needle assembly from the medical device. Figure 2I and 2J As shown, in some embodiments, the needle 10 remains in an extended position during removal of the needle assembly from the drug device. However, in other embodiments, the drug delivery device may include the ability to retract the needle prior to removal of the needle assembly.

[0075] In some embodiments, the drug delivery device may be packaged as a kit having the drug device and a plurality of needle assemblies, each of which is packaged in its own separate container. Figure 3As shown, the kit may include a medical device 500 having a coupling end 550, an actuator 590, and a needle driver in the form of a drive spring 560. In some embodiments, the spring is a coil spring. In some embodiments, the spring is a torsion spring. In some embodiments, the spring is a leaf spring. In some embodiments, the spring is a bellville washer. In some embodiments, the spring is a wave spring. In some embodiments, the actuator 590 can initiate the release of medication from a medication container contained within the medical device 500. In some embodiments, the drive spring 560 can function to move the needle of the needle assembly from a retracted position to an extended position, as discussed in more detail below. Multiple needle assemblies 100 can each be contained within a separate sealed container 200 having a container body 210 and a cap 220. In some embodiments, the cap 220 is a peelable seal that can be removably secured to the container body, for example, via an adhesive. The cap can have a pull tab 222 for easy removal. However, other types of caps, such as caps that engage the container body via threads or other mechanical interlocking or interference fit, may also be used. It should also be understood that springs need not be employed, but rather motors, magnets, elastomeric compounds, or any other device suitable as a carrier drive element capable of imparting motion may be employed instead, as the present disclosure is not limited in this regard.

[0076] Figures 4A-4C A sequence of needle assembly states is depicted as the drug delivery device progresses through a series of steps. Figure 4A The needle assembly 100 is shown prior to actuation of the needle 10. The trigger 30 is in the protruding position and the needle 10 is in the retracted position. In some embodiments, the needle assembly is arranged as follows when it is held within the container prior to being coupled to the medical device. Figure 4A shown.

[0077] Figure 4B The needle assembly is shown when the needle 10 has been moved to the extended position. Figure 4B As shown, the trigger 30 has been depressed into the carrier 20 in the retracted position.

[0078] at last, Figure 4C The needle assembly is shown moved back into the container body 210 for removal of the needle assembly from the medical device.

[0079] Figure 5An exploded view of an illustrative embodiment of a drug delivery device is shown. The drug delivery device includes a needle assembly including a needle 10, a carrier 20, a trigger 30, and a needle hub 40. The needle assembly is initially housed within a container having a container body 210 and a cap 220. The container body 210 may include a recess 213 formed in an inner wall of the body 210 for receiving a fin 23 on the carrier 20 so that the needle assembly can be coupled to the container body 210 when housed within the container body 210. Of course, it should be understood that the fin may be formed in the inner wall of the body 210 and the corresponding recess may be formed in the carrier 20, as the present disclosure is not limited in this respect. Figures 11A-11F A detailed view of the vector is provided in . Figures 15A-15E A detailed view of the container body 210 is provided.

[0080] The drug delivery device also includes a drug device comprising a first portion 502 and a second portion 504. Figure 5 In some embodiments, the first portion 502 of the medical device houses a drug container. In some embodiments, the second portion 504 of the medical device includes an actuator that, when activated, causes the drug to be expelled from the drug container.

[0081] As will be discussed in detail, in some embodiments, the needle assembly is coupled to the medical device via the needle assembly's carrier 20 physically interlocking with the coupling end 550 of the medical device. A drive spring 560 may be disposed in the coupling end 550.

[0082] Figures 6A-6F A series of steps are depicted illustrating the coupling of the needle assembly to the medical device and the extension of the needle. Figure 6A Initially, the needle assembly is held within a sealed container 200 comprising a container body 210 and a cap 220. Figure 6B As shown, the cover 220 is removed from the container body 210, thereby exposing the needle assembly so that the needle assembly can be coupled to the coupling end 550 of the first portion 502 of the medical device. Figures 6A-6F In the illustrative embodiment of the present invention, the first portion 502 of the medical device includes a drug container 530 and a drive spring 560, which is also shown in FIG. Figure 5 Shown in.

[0083] Next, if Figure 6C As shown, with the needle assembly retained within the container body 210, the container body is mounted on the coupling end 550 of the first portion 502 of the medical device by pushing the container body 210 onto the coupling end 550, which is hidden from view by the body 210. During this process, the needle assembly within the container body 210 is coupled to the coupling end 550 of the first portion 502 of the medical device.

[0084] like Figure 6D As shown, the container body 210 is removed from the needle assembly 100, leaving the needle assembly 100 coupled to the first portion 502 of the medical device. In this illustrative embodiment, the container body 210 can be used as a tool to couple the needle assembly to the medical device by pushing the container body 210 directly onto the medical device, such as by combining the container body 210 with the needle assembly 100. Figure 8A Container body 210 is then removed from needle assembly 100 by pulling container body 210 directly off the medical device and needle assembly. In some embodiments, relative twisting between the container body and needle assembly and / or medical device is not required to couple the needle assembly to the medical device and / or remove the container body from the needle assembly. However, in other embodiments, relative twisting motion may be used.

[0085] exist Figure 6E , with the container body removed, needle assembly 100 can be seen. Needle assembly 100 includes carrier 20 and trigger 30 mounted to the end of carrier 20. Needle assembly 100 also includes needle 10, with at least a portion of the needle positioned within carrier 20. At least a portion of the needle can be positioned within aperture 31 of trigger 30. Initially, the needle is in a retracted position, in which distal end 14 of the needle does not extend beyond distal end 34 of trigger 30.

[0086] To actuate the extension of the needle, e.g. Figure 6E As indicated by the arrow in FIG, a force is applied to the trigger 30 in the proximal direction. This force can be generated, for example, by pressing the trigger 30 flush against the subject's skin. Pushing the trigger causes the needle 10 to move distally to the extended position, as shown in FIG. Figure 6F In the extended position, the distal end 14 of the needle 10 has moved out of the aperture 31 of the trigger and is instead positioned distally of the distal end 34 of the trigger 30 .

[0087] at last, Figure 7A and 7B The diagram shows the removal of the needle assembly from the medical device. Figure 7A As shown, with the needle 10 still in the extended position, the user moves the container body 210 toward the needle assembly until the needle assembly is received within the container body 210. To unlock the needle assembly from the medical device, the user twists the container body 210 in either direction relative to the medical device. Then, to remove the needle assembly from the medical device, the user pulls the container body 210 directly away from the medical device.

[0088] Figure 8AA detailed view of a carrier of a coupling end and needle assembly of a medical device is shown, with the carrier shown in phantom. The carrier 20 includes a pawl 22 that interacts with the coupling end 550 of the medical device. When the carrier 20 is pushed axially onto the coupling end 550, the pawl 22 moves into the entry ramp 552 of the coupling end 550 until the pawl 22 engages a snap edge 556 and enters a recess 557, thereby locking the carrier 20 to the medical device. The recess is defined in the side wall of the device and has a distal boundary defined by the snap edge 556, a proximal boundary defined by the device body, and a pair of circumferential boundaries defined by the protrusion 524. The wall thickness of the coupling end varies in such a way that there is only clearance for the pawl 22 to enter the entry ramp and, therefore, enter the coupling arrangement at a certain angle.

[0089] If the carrier is not in the correct rotational orientation relative to the medical device during initial placement of the carrier onto the medical device, the pawl 22 can be guided by the protruding side 553 of the entry ramp 552 to rotate the carrier toward an aligned position relative to the medical device. The side 553 is shown as being tapered. During installation of the bracket 20 onto the coupling end 550, the pawl side 26 of the pawl 22 can slide against the side 553 of the entry ramp 552. The side 553 can act as a funnel, defining the narrowing width of the entry ramp in a direction toward the snap edge 556 and the recess 557.

[0090] Figure 8B Depicted is the carrier 20 coupled to the medical device. The detents 22 have snapped onto the snap edge 556 and into the recess 557 to rotationally and axially lock the carrier 20 to the medical device.

[0091] Figures 9A-9C The carrier is depicted during removal from the first portion of the medical device. Figure 9A As shown, to remove the carrier 20 from the first portion 502 of the medical device, the portions are twisted relative to each other. The carrier pawl 22 first climbs up the removal protrusion 524 on the medical device. The sliding movement of the carrier pawl 22 against the removal protrusion provides a braking feel. The pawl 22 then encounters and enters the exit ramp 554 of the medical device. Continued relative twisting causes the carrier pawl to slide along the spiral side 525 of the exit ramp ( Figure 9B ), resulting in separation of the carrier from the drug device ( Figure 9C The radial height of the outlet inclined surface 554 may be greater than the height of the inlet inclined surface.

[0092] exist Figures 11A-11F A detailed view of the vector is provided in . Figures 12A-12E A detailed view of the first portion of the medical device and its coupling end is provided.

[0093] The operation of the drug delivery device will now be described via a series of cross-sectional views. Figures 10A-10C Depicts a cross-sectional view of a needle assembly coupled to a first portion of a medical device. Figure 10A As shown, the needle assembly including the carrier 20, trigger 30, needle hub 40 and needle 10 is initially housed within the container body 210. The carrier 20 includes fins 23 received within recesses 213 of the container body 210. The carrier also includes axial guide ribs 21 with radial tips 25 that initially retain the needle hub 40 prior to use.

[0094] exist Figure 10B , the carrier 20 has been pushed onto the first portion 502 of the medical device to engage and align the carrier with the first portion 502 of the medical device. At this stage, the needle carrier 20 has not yet fully engaged the medical device and the needle 10 has not yet entered the septum 520 of the medical device.

[0095] When the needle carrier 20 is pushed further onto the medical device into the fully engaged position, as shown Figure 10C As shown, the proximal end 12 of the needle 10 pierces the septum 520 of the medical device. Figure 10C As shown in the enlarged view of FIG, the trigger 30 includes ribs 35 that interact with the legs 41 of the hub 40, which will be discussed below. The engagement of the carrier 20 with the medical device also axially compresses a drive spring 560, also referred to as a loading spring, located on the medical device against the trigger 30. Due to the engagement of the carrier 20 with the medical device, and because the needle hub is initially locked to the carrier, the spring 560 remains compressed. Figure 10C As shown in the enlarged view of FIG, the legs 41 engage the crosspiece 29 of the carrier. More specifically, each leg 41 includes a recessed area 41a defined by a radial portion 41b extending outwardly from an axial leg portion 41c. Thus, a gripping surface 41d is formed that engages the outer surface 29a of the crosspiece 29. Thus, the outer surface 29a is sized to fit within the recess 41a to facilitate securement prior to deployment. It should be understood that in some embodiments, engagement of the carrier 20 with the medical device does not require loading of the drive spring 560.

[0096] Next, Figure 10D The trigger 30 of the drug delivery device is shown pushed against the skin 5 of the subject. As a result, the trigger 30 moves in the proximal direction towards the needle carrier 20. Figure 10D, movement of the trigger in the proximal direction causes the contact surface 36 of the trigger rib 35 to contact and push against the hub legs 41 of the needle hub 40, thereby moving the hub legs 41 radially inward until the hub legs leave the inner surface of the rib 35 and are released from the crosspiece 29 of the carrier 20, thereby releasing the needle hub 40 to be movable relative to the carrier 20. As the needle hub 40 is free to move distally relative to the carrier 20, the spring 560 that has been applying force to the needle hub is free to expand axially and release its stored potential energy, thereby pushing the needle hub 40 to move distally relative to the carrier, as shown in FIG. Figure 10E The needle 10 attached to the needle hub 40 moves distally with the needle hub into an extended position in which the distal end 14 of the needle 10 moves through the aperture 31 of the trigger 30 and penetrates the skin 5 of the subject.

[0097] like Figure 10E As shown in the enlarged view of , in some embodiments, distal movement of the needle hub causes the needle hub legs 41 to move toward and into the radial recesses 33 inside the trigger 30, thereby locking the needle hub 40 to the trigger 30. In some embodiments, the needle hub is locked in place and the needle cannot be redeployed.

[0098] Figures 13A-13E A detailed view of the needle hub is provided. Figures 14A-14F A detailed view of the trigger is available in .

[0099] at last, Figure 10F A container body 210 is shown for removing the needle assembly 100 from the medical device. The container body 210 may be used as a sharps guard to help prevent the needle from being accidentally touched.

[0100] Figures 11A-11F Various views of a needle carrier 20 are depicted according to one illustrative embodiment. Figure 11A and 11B perspective, and in Figure 11C and 11D End view and Figure 11E In the side view of the container, the fins 23 can be seen to be received by recesses in the container body. Figure 11F The guide ribs 21 can be seen in the cross-sectional view of Figure 11B 、 11DThe pawl 22 can be seen in FIG11F and FIG11F . As shown in this embodiment, the needle carrier 20 includes a generally cup-shaped, cylindrical carrier body 230 defining a cavity 232 therein. The carrier body 230 includes a head portion 234 having a reduced cross-sectional area relative to a main body portion 236. The fins 23 are shown extending axially along the main body portion 236 and radially outward therefrom. The pawl 22 is formed along the main body portion 236 at the end of the pawl arm 22a. The head portion 234 is configured to receive a trigger 30 (not shown), which is shaped to fit over the head portion 234. The head portion 234 includes axial slots for receiving guide ribs. A first axial slot 242 is configured to receive a support rib 244. A second axial slot 238 is configured to receive a trigger guide rib 35. The head portion defines a longitudinal bore 240 extending therethrough. The guide rib 21 may be defined as a continuous surface defining an aperture, such as at the proximal end of the guide rib 21, with the radial tip 25 protruding within the body portion cavity 232. An aperture 237 is formed in the end wall 239 of the head portion 234.

[0101] Figures 12A-12E Various views of a first portion 502 of a medical device are depicted according to an illustrative embodiment. Figure 12A Perspective drawing and Figure 12D The coupling end 550 can be seen in the side view of FIG. The coupling end 550 includes an inlet bevel 552 and an outlet bevel 554 defined by a protruding side 553, each outlet bevel having a spiral side 525. The coupling end 550 also includes a snap edge 556 and a recess 557, as well as a removal protrusion 524.

[0102] Figures 13A-13E Various views of a needle hub 40 according to an illustrative embodiment are depicted. Needle hub 40 includes a plurality of legs 41 that are movable in radially inward and outward directions. The hub also includes slots 45 configured to receive guide ribs 21 from carrier 20. Hub 40 also includes aperture 43 through which the needle is positioned. The needle can be secured to the hub in any suitable manner, such as via adhesive, insert molding, mechanical interlocking, welding, integral formation with the needle, UV light-activated glue, or any other suitable arrangement. Hub 40 can have a generally cup-shaped body 50 having an axial end wall 52 and a cylindrical side wall 54 extending from the end wall. Legs 41 are formed along the side wall. In one embodiment, there are three circumferentially spaced legs. Legs 41 can be integrally formed into side wall 54 and cantilevered therefrom so that legs 41 can flex. A central axial body 56 is shown extending distally from end wall 52 and includes aperture 43. The slot 45 is shown having a first portion 57 formed in the end wall 52 and extending radially outward from the center body 56 and a second portion 58 extending axially along the side wall 54 .

[0103] Figures 14A-14F Various views of a trigger 30 according to an illustrative embodiment are depicted. The trigger includes ribs 35 having contact surfaces 36 for urging the needle hub legs radially inward to release the needle hub for needle extension, as described above. Also as described above, after the needle is extended, recesses 33 distal to the ribs receive the needle hub legs to lock the hub in place, thereby preventing subsequent needle deployment. The trigger 30 includes a cup-shaped body 60 having an axial end wall 62 and a cylindrical side wall 64 shaped to define a trigger cavity 66 for receiving the head portion 234 of the carrier body 230. The ribs 35 are axially disposed along the inner surface of the side wall and are circumferentially spaced apart from one another. Support ribs 244 are axially sandwiched between the ribs 35 along the inner surface and are circumferentially spaced apart from one another. Aperture 31 is formed in the end wall 62.

[0104] Figures 15A-15F Various views of a container body 210 are depicted according to one illustrative embodiment. The container body includes a recess 213 that receives the fin 23 of the needle carrier to couple the container body to the needle assembly. The body 210 is generally cup-shaped, having an axial end wall 214 and a side wall 215 extending from the end wall 214 to define a container cavity 216 sized and shaped to receive the carrier 20. A radial flange 217 may extend from the proximal end of the side wall 215 and may be sized to provide additional contact surface for the cap seal. The recess 213 is defined along the inner surface of the side wall. The end wall 214 may be generally hemispherical.

[0105] According to one aspect, a drug delivery device can be configured such that a needle of the device remains concealed from a subject during all steps of operation of the device. For example, the needle can remain concealed during attachment of the needle assembly to the drug device and during removal of the needle assembly from the drug device. The drug delivery device can include a deployment mechanism that moves the needle from a retracted position to an extended position to pierce a subject and allow delivery of a drug to the subject, and a retraction mechanism that retracts the needle after injection of the drug.

[0106] Figures 16A-16H A series of schematic diagrams depicting a drug delivery device according to one embodiment undergoing a series of operating steps. Figure 16A As shown, the drug delivery device may include a needle assembly 1000 and a drug device 1500. The drug device may include a first portion 1502 housing a drug container and a second portion 1504 including an actuator 1590 and an actuating mechanism for expelling drug from the drug container for injection into a subject.

[0107] The first portion 1502 of the medical device may include a coupling end 1550 for coupling to the needle assembly 1000 . Figure 16BThe process of coupling the needle carrier 1120 of the needle assembly 1000 to the medical device is illustrated. As will be discussed in more detail below, in some embodiments, to couple the carrier to the medical device, the user pushes the carrier onto the medical device, rotates the carrier relative to the medical device, and then pushes the carrier further onto the medical device again.

[0108] Next, if Figure 16C As shown, the drug delivery device is set for injection by pulling back the actuator 1590. It should be understood that many different types of actuation mechanisms can be integrated into drug delivery devices, and that what is shown in the illustrative embodiments provided is not intended to limit drug delivery devices.

[0109] Next, if Figure 16D As shown, the drug delivery device is placed flush against the skin of a subject, with the needle carrier 1120 in contact with the skin 5 .

[0110] The drug delivery device is now ready to be actuated to inject the drug into the subject. In some embodiments, actuation of the device actuator 1590 (e.g., by pushing the actuator in a distal direction) can cause multiple actions to occur. First, Figure 16E As shown, pressing down on the actuator 1590 may cause the needle 1010 to extend from the needle carrier 1120 and penetrate the skin 5. Next, the device may allow the drug to be discharged from the drug container, through the needle, and into the subject's body. Finally, as shown Figure 16G As shown, the device can retract the needle into the needle carrier 1120. As a result, with the needle retracted inside the needle carrier, when the drug delivery device is removed from the subject's skin, the needle is no longer external to the device, thereby helping to prevent inadvertent contact with the needle and allowing the subject to avoid seeing the needle.

[0111] Finally, if Figure 16H As shown, the needle assembly can be removed from the medical device 1500 by pulling the needle carrier 1120 in a distal direction away from the medical device.

[0112] Figure 17An exploded view of an illustrative embodiment of a drug delivery device is shown. The drug delivery device includes a needle assembly comprising a needle 1010, a carrier 1120, a needle hub 1040, and a cam 1050. In some embodiments, the carrier 1120 may initially house the other components of the needle assembly. In some embodiments, a proximal cover 1220 may be positioned on the proximal end of the carrier 1120, and a distal cover 1221 may be positioned on the distal end of the carrier 1120. In some embodiments, the proximal cover 1220 may be removed from the needle carrier 1120 to expose the components within the carrier and allow the needle carrier to be coupled to the drug device. In some embodiments, the proximal cover is a peelable seal. In some embodiments, the distal cover 1221 is not configured to be removed, but rather is configured to be pierced by a needle. However, in other embodiments, the distal cover 1221 is configured to be removed.

[0113] The drug device side may include a first portion 1502 and a second portion 1504. The first portion 1502 may house a drug container. In some embodiments, the second portion 1504 may include a device actuator and may include an actuation mechanism for triggering the release of the drug from the drug container. Figure 17 As shown, the medical device further includes a collar 1570, a drive spring 1560, a retraction trigger 1582, and an extension trigger 1584. In some embodiments, the drive spring 1560 is a torsion spring.

[0114] As will be discussed in detail, in some embodiments, the needle assembly is coupled to the medical device via the carrier 1120 being physically interlocked with the coupling end 1550 of the medical device.

[0115] Figures 18A-18G Describes a process that goes through a series of steps Figure 17 The drug delivery device of the present invention comprises the steps of coupling the needle assembly to the drug device, extending the needle, and retracting the needle. Figure 18A Initially, the components of the needle assembly are held within the needle carrier 1120, which is sealed via the proximal cap 1220 and the distal cap 1221. Figure 18B As shown, the proximal cover 1220 is removed from the carrier 1120, thereby exposing the other components of the needle assembly and preparing the carrier 1120 to be coupled to the coupling end 1550 of the first portion 1502 of the medical device. Figures 18A-18G In the illustrative embodiment of FIG. 5 , the first portion 502 of the medical device includes a collar 1570 at the coupling end 1550 of the medical device.

[0116] In some embodiments, the collar 1570 is rotatable between a deactivated orientation in which the needle carrier cannot be coupled to the collar and an activated orientation in which the needle carrier can be coupled to the collar. Figure 18BShown is the collar in a deactivated state. In this state, the needle carrier 1120 is physically prevented from sliding onto the collar.

[0117] exist Figure 18C , the collar 1570 has been rotated to the activated orientation. The needle carrier can now be slid onto the collar 1570. The user first pushes the carrier 1120 onto the collar, then rotates the carrier relative to the collar, and finally pushes the carrier further onto the collar, thereby causing the needle assembly to be coupled to the medical device, as shown in FIG. Figure 18D and 18E The needle carrier may be retained to the medical device via a stopper, which will be discussed in further detail below.

[0118] Next, if Figure 18F As shown, the user actuates the medical device and activates the extension trigger 1584, which causes the needle 1010 to move from the retracted position to the extended position, piercing the distal cover 1221 in the process. It should be understood that in this embodiment, both an extension and a retraction trigger are provided; however, the present disclosure is not limited in this regard. Thus, in one embodiment, only an extension trigger is provided. In another embodiment, only a retraction trigger is provided.

[0119] Following this, the retraction trigger 1582 is activated, which causes the needle 1010 to move back to a retracted position within the carrier 1120 .

[0120] In some embodiments, the user may be able to remove the needle assembly from the medical device. Figure 19 As shown, needle carrier 1120 can be directly pulled out from the medical device to remove the needle assembly. In some embodiments, the needle assembly is configured to prevent the used needle assembly from being reattached to the medical device, which will be described in further detail below.

[0121] Figures 20A-20F Provided when Figure 17 A series of cross-sectional views of a drug delivery device as it undergoes a series of operating steps.

[0122] Figure 20A The drug delivery device is shown in a state where the needle assembly has not yet been coupled to a drug device. The needle assembly includes a needle carrier 1120, and a needle 1010, a needle hub 1040, and a cam 1050 housed within the needle carrier 1120. A distal cap 1221 is also located at the distal end of the needle carrier 1120. On the side of the drug device, the drug device includes a collar 1570 and a torsion spring 1560.

[0123] exist Figure 20A , the collar 1570 is shown in a deactivated state. In the deactivated state, the collar is in a rotational orientation relative to the needle carrier, which prevents the needle carrier from sliding onto the collar. Figure 20AAs shown, in the deactivated state, the collar arms 1571 are aligned with the protrusions 1121 of the needle carrier. The presence of the collar arms 1571 physically interferes with the protrusions 1121 of the needle carrier, thereby preventing the needle carrier from moving onto the collar.

[0124] like Figure 20B As shown, the collar can be rotated relative to the needle carrier to an activated state. In the activated state, the groove 1572 on the collar is now in rotational alignment with the bracket protrusion 1121, thereby leaving clearance for the bracket to be pushed onto the collar.

[0125] The spring 1560 is initially held in a coiled state. In other words, the spring 1560 has stored spring potential energy before the drug delivery device is actuated. Figure 20B In the position shown, the spring 1560 is maintained in its coiled state by the presence of the extension trigger 1584. Figure 20B As shown in the enlarged view of , extending trigger 1584 physically prevents collar 1570 from rotating, which in turn prevents spring 1560 from being able to unwind.

[0126] Figure 20C The needle carrier 1120 is shown pushed onto the collar 1570 with the carrier projection 1121 received within the groove of the collar. In this initial engagement phase, the needle 1010 has not yet entered the septum 1520 of the drug container 1530.

[0127] After this initial engagement with the medical device, the needle carrier is rotated relative to the medical device and then pushed further onto the medical device, resulting in full engagement of the needle carrier with the medical device, as shown. Figure 20D In the fully engaged stage, the proximal end 1012 of the needle 1010 has penetrated the septum 1520 and entered the interior of the drug container 1530. Figure 20D As shown in the enlarged view of FIG, when fully engaged, the carrier 1120 and the first portion 1502 of the medical device are in a contact area 1501. When the user pushes the needle carrier against the injection site, the axial force between the needle carrier and the medical device is transferred in the contact area 1501. Figures 28A-28F A detailed view of the carrier is shown in Figures 31A-31E A detailed view of the collar is shown in FIG.

[0128] Next, in preparation for injecting the drug into the subject, the drug delivery device is held against the subject's skin 5, with the distal cap 1221 at the end of the needle carrier held in contact against the skin.

[0129] The user actuates the drug delivery device to pull back on the extension trigger 1584, thereby moving the trigger in the proximal direction, which releases the collar 1570 to rotate due to the unwinding of the torsion spring 1560. The rotation of the collar rotates the cam 1050, which, due to the radial end 1052 of the arm 1041 riding on the cam surface 1051, causes the needle hub 1040 to extend the needle 1010, thereby moving the needle from the retracted position to the extended position, in which the distal end 1014 of the needle 1010 penetrates through the distal cover 1221 and enters the skin 5 of the subject, as shown in FIG. Figure 20E shown.

[0130] exist Figure 20E In the needle extension stage shown, the torsion spring 1560 is still partially wound. Due to the presence of the retraction trigger 1582, the spring 1560 is prevented from further unwinding. Figure 20E As shown in the enlarged view of , retracting trigger 1582 physically prevents rotation of collar 1570, which in turn inhibits further unwinding of the spring.

[0131] Next, retraction trigger 1582 is released, pulling it proximally away from collar 1570, allowing the collar to rotate freely due to the unwinding of spring 1560. This further rotation of the collar drives cam 1050 and needle hub 1040 to retract the needle. Releasing the retraction trigger can be accomplished by any suitable arrangement. For example, pulling the device away from the user's skin can cause the retraction trigger to release. Completion of the injection and needle withdrawal, along with a short delay, can cause the retraction trigger to release. In one embodiment, the retraction trigger is automatically actuated after the injection is complete. For a full dose, and to avoid excessive "drip" after needle withdrawal, a suitable delay after the injection is complete may be desirable. This delay may be approximately 5 seconds before the needle retracts. This delay can be automatic, or it can be a command to the user to hold the device against the skin, and then the release trigger is moved when the device is removed from the user's skin.

[0132] In some embodiments, the needle assembly can be removed from the medical device after the drug is injected. Figure 21A and 21B As shown, the needle carrier 1120 is removed from the collar 1570 by pulling the carrier away from the collar in a distal direction. The protrusions 1121 of the bracket slide out of the grooves 1572 of the collar and the arms 1571 bend radially inward to allow the bracket to be removed from the collar. Figure 21B , the carrier is shown completely removed from the medical device. Here, the needle carrier 1120 is a multifunctional component because the carrier can be used to mount the needle assembly to the device, can remain with the needle assembly for operation of the device, can be used as a tool to remove the needle assembly from the device, and can contain the spent needle assembly after use.

[0133] Figures 22A-25B Depicts the position of the collar relative to the device as it undergoes a series of operating steps. Figure 17 Rotational position of the medical device of an embodiment. To facilitate visualization of the components, the collar is shown in dotted lines.

[0134] first, Figure 22A and 22B Two perspective views of the collar prior to use are shown, where the collar is in an inactive state. The collar is rotatably mounted to the housing 1503 of the first portion of the medical device. The collar includes first and second collar stops 1573 and 1575, which initially contact against the housing 1503. Figure 22A As seen in FIG, the first collar stop 1573 initially contacts the first housing stop 1509. Figure 22B As seen in FIG, the second collar stop 1575 initially contacts the second housing stop 1505. Figures 31A-31E A detailed view of the collar is shown in Figures 32A-32D A detailed view of the housing is shown in FIG.

[0135] Figure 23A and 23B Two perspective views of the collar are shown after it has been rotated and placed in an activated state. In this state, the first collar stop 1573 is in contact with the extension trigger 1584, and the second collar stop 1575 is in the air. The contact between the first collar stop 1573 and the extension trigger 1584 prevents the collar from rotating further and prevents the spring 1560 from unwinding.

[0136] Next, when the extension trigger 1584 is released and pulled back in the proximal direction, the collar is allowed to rotate due to the unwinding of the spring 1560 until the second collar stop 1575 contacts the retraction trigger 1582, as shown. Figure 24B As shown. The first ring stopper 1573 is in the air, as shown. Figure 24A shown.

[0137] Next, when the retraction trigger 1582 is released and pulled back in the proximal direction, the collar is allowed to rotate further due to the unwinding of the spring 1560 until the first and second collar stops contact the housing 1503 of the first portion of the medical device, as shown. Figure 25A and 25B shown.

[0138] Figures 26A-26C Depicted is the arrangement of the cam and needle hub of the needle assembly as the drug delivery device undergoes a series of needle extension steps. To facilitate visualization of the components, the carrier is shown in dotted lines. Figure 26ACam 1050 is shown in an initial angular position prior to use of the drug delivery device. The cam may include tabs 1055 that are initially aligned with carrier tabs 1121 to allow carrier 1120 to couple with the collar of the drug delivery device. The cam may include detents 1056 received by inner wall surface 1129 of carrier 1120 to help maintain the cam's position within the carrier prior to use. The cam may include teeth 1054 that abut against arms 1041 of needle hub 1040 to hold the hub in place during puncture of the septum with the proximal end of the needle. The cam may include an extended cam surface 1051 (also referred to as an extended spiral 1051) on which radial ends 1052 of arms 1041 ride. The cam may also include a retraction cam surface (also referred to as retraction helix 1053) defined by a radially inwardly extending lip 1053a that also interacts with the radial end 1052 of the arm 1041 during rotation of the cam. Specifically, as the cam rotates in one direction, a first surface 1057 of the radial end 1052 (see FIG. Figure 30A ) rides along the extended cam surface 1051, and when the cam rotates in the opposite direction, the second surface 1059 of the radial end 1052 (see Figure 30A ) rides along the retract cam surface 1053. Figures 30A-30D A detailed view of the needle hub is shown in Figures 29A-29F A detailed view of the cam is shown in .

[0139] Figure 26B The cam is shown in an intermediate angular position, where the extension trigger has been released and the collar is rotated, causing the cam to also rotate (shown in a counterclockwise direction). The rotation of the cam causes the extension screw 1051 of the cam to push against the arm 1041 of the hub, thereby driving the hub 1040 in the distal direction to move the needle 1010 into the extended position, as shown. Figure 26C As shown, the cam is in the final angular position of the needle extension. In the extended state, the hub 1040 is held between the extension spiral 1051 and the retraction spiral 1053 of the cam.

[0140] Figure 27A and 27B Depicted is the arrangement of the needle carrier as the drug delivery device undergoes a series of needle retraction steps. Figure 27A The state of the cam is shown when the retraction trigger has been released and the collar is rotated, causing the cam to also rotate (still in a counterclockwise direction). The rotation of the cam causes the retraction screw 1053 to pull the arm 1041 against the needle hub 1040 in a proximal direction, thereby moving the needle 1010 into the retracted position, as shown in FIG. Figure 27BAn inner radial lip 1053a is formed along the retraction helix 1053 which grips the ends of the arms of the needle hub during retraction.

[0141] In this retracted state, the stopper 1056 on the cam engages the carrier wall, thereby preventing the cam from rotating. Additionally, in some embodiments, the cam protrusion 1055 is misaligned with the carrier protrusion 1121, which prevents the carrier from being mounted on the collar of the medical device. This arrangement helps prevent needle reuse.

[0142] Figures 28A-28F Various views of a needle carrier 1120 according to an illustrative embodiment are depicted. The needle carrier 1120 includes a cylindrical body 1123. A projection 1121 is formed on the inner wall of the body, adjacent the end, and extends along a portion of the axial length of the body 1123 and extends radially inward. A central bore region 1124 extends along the central axis and is used to guide the hub, particularly the central shaft 1058 of the needle hub 1040 (see FIG. 1 ). Figure 30A ). Radially inwardly extending struts 1125 couple the hub guide to the inner wall of the body. A bearing surface 1126 on each strut supports the central hole 1062 of the cam 1050. A retaining clip holds the cam to the bracket 1120. Cam rotation stop 1128 (the beginning of cam rotation) and cam rotation clip 1129 (the end of cam rotation) limit the extent of the cam's rotational displacement.

[0143] Figures 29A-29F Various views of a cam 1050 are depicted according to one illustrative embodiment. Cam 1050 includes a generally cylindrical body 1060 having an extension cam surface 1051 and a retraction cam surface 1053 formed thereon. A projection 1055 is also formed on the body. The body also includes a support wall 1061 through which a central bore 1062 extends. As discussed above, the cam may include teeth 1054 (in this embodiment, the teeth 1054 extend axially on the cylindrical body in the same direction as the cam surface), a stop 1056 (disposed on the outer cylindrical body at the apex of the retraction cam surface), an extension helix 1051, and a retraction helix 1053.

[0144] Figures 30A-30DVarious views of a needle hub 1040 are depicted according to an illustrative embodiment. The hub may include arms 1041 that interact with the cam of the needle assembly during needle extension and retraction. As described above, the hub includes a central shaft 1058. Shaft 1058 may also include a hole 1043 through which the needle extends. The radially extending arms 1041 are sized to fit within a space 1127 formed in the central aperture region 1124 of the needle carrier 1120. Each arm 1041 includes a radial end 1052 having a first surface 1057 and a second surface 1059. The first surface is configured to travel along the extension cam surface 1051 when the cam rotates in one direction, and the second surface 1059 is configured to travel along the retraction cam surface 1053 when the cam rotates in the opposite direction. The forward face 1061 is configured to facilitate allowing the needle to pierce the septum. In this regard, the face 1061 acts as a bearing surface to transmit forces applied to the carrier when the carrier is inserted onto the first portion 1502 of the medical device.

[0145] Figures 31A-31E Various views of a collar 1570 according to one illustrative embodiment are depicted. As shown, the collar has a generally cylindrical body 1580 formed with arms 1571 and slots 1572. The arms include abutment surfaces 1581 that prevent insertion of the needle carrier 1120 along the slots 1582 defined by the arms 1571. The arms also include beveled surfaces 1584 that cause the arms to flex radially inward (due to gaps 1583 between the arms and the body) to allow removal of the needle carrier. As described above, the slots 1572 can be configured to receive projections of the needle carrier during insertion. The collar can include first and second collar stops 1573, 1575, which interact with the housing of the medical device and with the retraction and extension triggers that mark the end of travel. The collar can also include separate ribs 1585 that engage collar retention grooves 1587 to retain the collar on the first portion 1502. Notches 1586 may be formed along the inner surface to anchor the ends of the torsion springs.

[0146] Figures 32A-32D Various views of the housing 1503 of the first portion 1502 of the medical device are depicted according to one illustrative embodiment. As described above, the housing 1503 may include a first housing stop 1509 and a second housing stop 1505 that interact with the collar during operation of the device. Figure 32BAs shown, the housing can include a retraction trigger slot 1512 through which the retraction trigger can move, and an extension trigger slot 1514 through which the extension trigger can move. The housing can also include an alignment slot 1506 configured to receive a protrusion of the needle carrier during coupling of the needle carrier to the housing. A trigger slot 1590 can be formed on the inner wall of the housing. The distal end of the housing includes a collar retaining groove 1587.

[0147] It should be understood that the illustrated medical device is illustrative, as the needle assembly described herein can be adapted for use with various configurations of medical devices, including pen-shaped drug injection devices of varying configurations, injection devices of varying shapes, and infusion pump devices. The drug can be of any type that can be delivered by such a medical device. The illustrated device is illustrative and not restrictive, as the needle assembly described can be used in other devices of varying configurations.

[0148] To clarify the usage of the following phrases and to provide notice to the public, “at least one of , , ..., and <N>” or “at least one of , , ..., or <N> or a combination thereof” or “, , ..., and / or <N>” are defined by applicant in the broadest sense, superseding any other implicit definition above or below, unless applicant expressly states otherwise, to mean one or more elements selected from the group consisting of A, B, ..., and N. In other words, these phrases mean one or more elements of A, B, ..., and N, including any one element alone or in combination with one or more other elements, which other elements may also be combined to include additional elements not listed.

[0149] Although various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Therefore, the embodiments described herein are examples, not the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all described advantages will be achieved with every embodiment.

[0150] Various aspects are described in this disclosure, including but not limited to the following:

[0151] 1. A drug delivery device comprising a needle assembly, the needle assembly comprising: a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub; a drug device having a container and a carrier drive element, the container having a septum disposed at an open end of the container, the needle carrier being coupleable to the drug device; and a deployment trigger configured to activate the carrier drive element to move the needle hub distally from a retracted needle hub position to an extended needle hub position and to move the needle distally relative to the septum from the retracted needle position to the extended needle position.

[0152] 2. The drug delivery device according to aspect 1, further comprising a cup-shaped body configured to accommodate a needle carrier, a needle hub and a needle, the cup-shaped body being removably coupled to the needle carrier.

[0153] 3. The drug delivery device according to aspect 2, wherein the cup-shaped body further comprises a cover sealed to the cup-shaped body to house the needle carrier, the needle hub and the needle in a sealed space before the needle carrier is coupled to the drug device.

[0154] 4. The drug delivery device according to aspect 2, wherein one of the cup-shaped body and the needle carrier comprises a fin and the other comprises a recess shaped to receive the fin during mating of the cup-shaped body and the needle carrier.

[0155] 5. A drug delivery device according to any one of aspects 1 to 4, wherein the carrier drive element includes an axially compressible spring, wherein the needle carrier is removably connected to the drug device to load the spring, wherein the deployment trigger is connected to the distal end of the needle carrier, and the deployment trigger is actuated by applying a force against the deployment trigger in a proximal direction to unload the spring.

[0156] 6. A drug delivery device according to aspect 5, wherein the spring is arranged between the needle hub and the drug device, the needle hub includes a leg, and the leg is positioned to set the deployment trigger in a pre-actuated structure relative to the needle carrier, wherein the spring is loaded in an axially compressed structure, and in response to actuation of the deployment trigger, the deployment trigger deflects the leg of the needle hub radially inwardly so that when the spring is unloaded to its axially expanded structure, the needle hub moves distally.

[0157] 7. A drug delivery device according to aspect 5, wherein the deployment trigger is coaxially arranged relative to the needle carrier, and the deployment trigger is axially movable relative to the needle carrier between a covering position and a trigger position, wherein, in the trigger position, the distal end of the needle does not extend beyond the distal end of the deployment trigger, and during movement to the trigger position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, through which the needle hub is distally urged to the extended needle hub position by the unloading spring so that the distal end of the needle extends distally beyond the opening of the deployment trigger.

[0158] 8. The drug delivery device according to any one of aspects 1 to 7 further comprises a cam radially arranged in a coaxial relationship between the needle hub and the needle carrier, the cam being configured to rotate to drive the needle hub to move the needle in at least one of an extension direction and a retraction direction.

[0159] 9. The drug delivery device of aspect 8, wherein the drug device comprises a collar rotatable under the biasing force of the spring, wherein the cam is rotationally locked with the collar in response to the needle carrier being coupled to the collar.

[0160] 10. A drug delivery device according to aspect 9, wherein, in response to the cam rotating a first amount, the cam slidably engages the needle hub to advance the needle in the extension direction, and wherein, in response to the cam rotating another amount, the cam slidably engages the needle hub to retract the needle in the retraction direction.

[0161] 11. The drug delivery device of aspect 10, wherein the deployment trigger selectively engages the collar, and disengagement of the deployment trigger from the collar facilitates rotation of the collar a first amount.

[0162] 12. The drug delivery device of aspect 11, further comprising a retraction trigger selectively engaging the collar, and disengagement of the retraction trigger from the collar after disengagement of the deployment trigger facilitates rotation of the collar by another amount.

[0163] 13. The drug delivery device according to any preceding aspect, wherein distal movement of the needle from the retracted needle position to the extended needle position comprises movement of the needle through a septum.

[0164] 14. The drug delivery device of aspect 13, wherein the drug device comprises an outer housing and wherein the septum remains stationary relative to the outer housing during movement of the needle through the septum.

[0165] 15. The drug delivery device of aspect 13, wherein the septum remains stationary relative to the needle carrier during coupling of the needle carrier to the drug device, upon puncture of the septum by the needle, and during movement of the needle through the septum to the extended needle position.

[0166] 16. The drug delivery device according to any preceding aspect, wherein the drug device further comprises a drug container comprising a piston, the piston being movable relative to the drug container to expel the drug from the drug container.

[0167] 17. A method comprising: providing a medical device having a container and a carrier drive element, the container having a septum disposed at an end opening of the container; providing a needle assembly comprising a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub; when the needle carrier is coupled to the medical device, activating a deployment trigger to activate the carrier drive element to move the needle hub distally from a retracted needle hub position to an extended needle hub position and to move the needle relative to the septum from the retracted needle position to the extended needle position.

[0168] 18. The method according to aspect 17 further includes: providing a cup-shaped body containing a needle assembly, the needle assembly including a deployment trigger, the carrier drive element including a spring, and the needle assembly can be removed from the cup-shaped body; installing the cup-shaped body to the medical device to connect the needle carrier to the medical device, the cup-shaped body containing the needle assembly; removing the cup-shaped body from the needle assembly and the medical device, the needle being in a retracted needle position after piercing the septum; after activating the deployment trigger, installing the cup-shaped body on the needle assembly while connecting the needle assembly to the medical device; connecting the cup-shaped body to the needle assembly; and with the needle assembly connected to the cup-shaped body, moving the cup-shaped body away from the medical device to remove the needle assembly from the medical device.

[0169] 19. The method of aspect 18, wherein the step of mounting the cup-shaped body on the needle assembly occurs when the needle is in the extended needle position.

[0170] 20. The method of aspect 18, further comprising the step of rotating the cup-shaped body relative to the medical device when the needle assembly is coupled to the cup-shaped body to unlock the needle assembly from the medical device before the step of moving the cup-shaped body away from the medical device.

[0171] 21. The method of any of aspects 17-20, wherein the deployment trigger is mounted to the needle carrier and is movable relative to the needle carrier.

[0172] 22. The method of aspect 21, wherein in the retracted needle position, the distal end of the needle is flush with or proximal to the distal end of the deployment trigger.

[0173] 23. The method of aspect 21, wherein in the extended needle position, the distal end of the needle is distal to the distal end of the deployment trigger.

[0174] 24. The method of aspect 21, wherein depressing the deployment trigger comprises depressing the deployment trigger against the skin of the subject.

[0175] 25. The method of any of aspects 17-24, further comprising the step of moving the needle in a retracting direction after the needle is moved from the retracted needle position to the extended needle position.

[0176] 26. The method of any one of aspects 17-25, wherein the medical device holds a drug container; and further comprising the step of moving a piston relative to the drug container to expel the drug from the drug container.

[0177] 27. A method according to aspect 21, wherein pressing the deployment trigger to unload the spring causes the deployment trigger to move axially relative to the needle carrier from a covering position to a trigger position, wherein, in the trigger position, the distal end of the needle does not extend beyond the distal end of the deployment trigger, and during movement to the trigger position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, thereby causing the needle hub to move distally to the extended needle hub position by unloading the spring, so that the distal end of the needle extends distally beyond the opening of the deployment trigger.

[0178] 28. The method of any of aspects 17-27, further comprising coupling the needle carrier to the medical device to load the spring.

[0179] 29. The method of aspect 28, wherein coupling the needle carrier to the medical device comprises piercing a septum of a drug container in the medical device with the proximal end of the needle.

[0180] 30. The method of aspect 29, wherein movement of the needle from the retracted needle position to the extended needle position comprises movement of the needle through and relative to the septum.

[0181] 31. The method of any of aspects 17-30, further comprising activating a retraction trigger to move the needle from the extended needle position in a retraction direction.

[0182] 32. A needle assembly for coupling to a medical device, the medical device having a spring and a container with a septum, which contains a fluid, the needle assembly comprising: a needle carrier that is removably coupled to the medical device to load the spring; a needle hub that is movable relative to the needle carrier; a needle coupled to the needle hub; and wherein coupling of the needle carrier to the medical device facilitates piercing the septum of the medical device with the needle, wherein the needle hub is movable in a distal direction relative to the needle carrier to position the distal end of the needle to extend beyond the needle carrier and to position the proximal end of the needle to remain within the septum, in fluid communication with the fluid of the container.

[0183] 33. The needle assembly of aspect 32, further comprising a cup-shaped housing containing the needle carrier, the deployment trigger, the needle hub, and the needle.

[0184] 34. The needle assembly of any of aspects 32-33, wherein the needle hub is disposed within the needle carrier and is coaxial with respect to the needle carrier.

[0185] 35. The needle assembly of any of aspects 32-34, wherein the deployment trigger is mounted to the needle carrier and is movable relative to the needle carrier.

[0186] 36. A needle assembly according to any one of aspects 32-35, wherein the deployment trigger is coaxially arranged relative to the needle carrier, and the deployment trigger is axially movable between a covering position and a trigger position relative to the needle carrier, wherein in the trigger position, the distal end of the needle does not extend beyond the distal end of the deployment trigger, and during movement to the trigger position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, thereby causing the needle hub to be advanced distally to the extended needle hub position by unloading the spring, so that the distal end of the needle extends distally beyond the opening of the deployment trigger.

[0187] 37. The needle assembly according to any one of aspects 32-36 further includes a rotatable cam radially mounted in a coaxial relationship between the needle hub and the needle carrier, wherein, in response to rotation of the cam caused by unloading of the spring, the needle hub is advanced distally to an extended needle hub position so that the distal end of the needle extends distally beyond the opening of the needle carrier.

[0188] 38. The needle assembly of aspect 37, wherein, in response to rotation of the cam caused by further unloading of the spring, the needle hub advances proximally to the retracted needle hub position such that the distal end of the needle is within the needle carrier.

[0189] 39. The needle assembly of any of aspects 32-38, further comprising a deployment trigger configured to unload the spring to move the needle hub distally from the retracted needle hub position to the extended needle hub position and to move the needle distally from the retracted needle position to the extended needle position.

Claims

1. A drug delivery device comprising: a needle assembly comprising a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub; a medical device having a container having a septum disposed at an end opening of the container and a carrier drive element, the needle carrier being coupleable to the medical device; and A trigger is deployed that is configured to activate the carrier drive element to move the needle hub distally from the retracted needle hub position to the extended needle hub position and to move the needle distally relative to the septum from the retracted needle position to the extended needle position. 2 . The drug delivery device of claim 1 , further comprising a cup-shaped body configured to house a needle carrier, a needle hub, and a needle, the cup-shaped body being removably coupled to the needle carrier.

3. The drug delivery device according to claim 2, wherein: The cup-shaped body further includes a cover sealed to the cup-shaped body to house the needle carrier, the needle hub, and the needle in a sealed space before the needle carrier is coupled to the medical device.

4. The drug delivery device according to claim 2, wherein: One of the cup-shaped body and the needle carrier includes a fin, and the other includes a recess shaped to receive the fin during mating of the cup-shaped body and the needle carrier.

5. The drug delivery device according to claim 1, wherein: The carrier drive element comprises an axially compressible spring, wherein the needle carrier is removably coupled to the medical device to load the spring, wherein the deployment trigger is coupled to a distal end of the needle carrier, and wherein the deployment trigger is actuated by a force applied to the deployment trigger in a proximal direction to unload the spring.

6. The drug delivery device according to claim 5, wherein: The spring is disposed between the needle hub and the medical device, the needle hub including legs positioned to position the deployment trigger in a pre-actuated configuration relative to the needle carrier, wherein the spring is loaded in an axially compressed configuration and, in response to actuation of the deployment trigger, the deployment trigger deflects the legs of the needle hub radially inwardly, causing the needle hub to move distally when the spring is unloaded to its axially expanded configuration.

7. The drug delivery device according to claim 5, wherein: The deployment trigger is coaxially disposed relative to the needle carrier, the deployment trigger being axially movable relative to the needle carrier between a covering position and a triggering position, wherein, in the triggered position, the distal end of the needle does not extend beyond the distal end of the deployment trigger, and during movement to the triggered position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, through which the needle hub is distally urged to the extended needle hub position by unloading the spring such that the distal end of the needle extends distally beyond the opening of the deployment trigger.

8. The drug delivery device of claim 5 , further comprising a cam disposed radially between the needle hub and the needle carrier in a coaxial relationship, the cam configured to rotate to drive the needle hub to one of: move the needle in an extending direction and move the needle in a retracting direction.

9. The drug delivery device according to claim 8, wherein: The medical device includes a collar rotatable under the biasing force of the spring, wherein the cam is rotationally locked with the collar in response to the needle carrier being coupled to the collar.

10. The drug delivery device according to claim 9, wherein: In response to the cam rotating a first amount, the cam slidably engages the needle hub to advance the needle in an extend direction, and wherein in response to the cam rotating another amount, the cam slidably engages the needle hub to retract the needle in a retract direction.

11. The drug delivery device according to claim 10, wherein: The deployment trigger selectively engages the collar, and disengagement of the deployment trigger from the collar facilitates rotation of the collar a first amount.

12. The drug delivery device of claim 11, further comprising a retraction trigger that selectively engages the collar, and wherein disengagement of the retraction trigger from the collar subsequent to disengagement of the deployment trigger facilitates rotation of the collar by another amount.

13. A drug delivery device according to any one of the preceding claims, wherein: Movement of the needle distally from the retracted needle position to the extended needle position includes movement of the needle through the septum.

14. The drug delivery device according to claim 13, wherein: The medical device comprises an outer housing, and the septum remains stationary relative to the outer housing during movement of the needle through the septum.

15. The drug delivery device of claim 13, wherein: During coupling of the needle carrier to the medical device, the septum remains stationary relative to the needle carrier in the event of a needle piercing the septum, and during movement of the needle through the septum to the extended needle position.

16. A drug delivery device according to any one of the preceding claims, wherein The medical device further includes a drug container comprising a piston and a drug, wherein the piston is movable relative to the drug container to expel the drug from the drug container.

17. A needle assembly for coupling to a medical device having a spring and a container with a septum, the container containing a fluid, the needle assembly comprising: a needle carrier removably coupleable to the medical device to load the spring; a needle hub movable relative to the needle carrier; a needle coupled to the needle hub; and wherein coupling of the needle carrier to the medical device facilitates piercing the septum of the medical device with the needle, and wherein the needle hub is movable in a distal direction relative to the needle carrier to position the distal end of the needle to extend beyond the needle carrier and to position the proximal end of the needle to remain within the septum in fluid communication with the fluid of the container.

18. The needle assembly of claim 17, further comprising a cup-shaped housing containing the needle carrier, the deployment trigger, the needle hub, and the needle.

19. The needle assembly of claim 17, wherein The needle hub is disposed within the needle carrier and is coaxial with respect to the needle carrier.

20. The needle assembly of claim 18, wherein The deployment trigger is mounted to the needle carrier and is movable relative to the needle carrier.

21. The needle assembly of claim 18, wherein The deployment trigger is coaxially disposed relative to the needle carrier, the deployment trigger being axially movable relative to the needle carrier between a covering position and a triggering position, wherein, in the triggered position, the distal end of the needle does not extend beyond the distal end of the deployment trigger, and during movement to the triggered position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, thereby causing the needle hub to be advanced distally to the extended needle hub position by unloading of the spring such that the distal end of the needle extends distally beyond the opening of the deployment trigger.

22. The needle assembly of claim 17, further comprising a rotatable cam mounted radially between the needle hub and the needle carrier in a coaxial relationship, wherein In response to rotation of the cam caused by unloading of the spring, the needle hub is advanced distally to an extended needle hub position such that the distal end of the needle extends distally beyond the opening of the needle carrier.

23. The needle assembly of claim 22, wherein: In response to rotation of the cam caused by further unloading of the spring, the needle hub advances proximally to a retracted needle hub position such that the distal end of the needle is within the needle carrier.

24. The needle assembly of claim 17 further comprising a deployment trigger configured to unload the spring to move the needle hub distally from the retracted needle hub position to the extended needle hub position and to move the needle distally from the retracted needle position to the extended needle position.

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