Injection system

Abstract

An automated injection device is provided, comprising a syringe holder and a retraction assembly. The syringe holder comprises two identical components that are separate from and interlocked with each other. The retraction assembly comprises a reciprocating member and a driven member, the driven member having a movable latch. The driven member has a coupled configuration in which the latch is biasedly coupled to the reciprocating member, and a disengaged configuration in which the latch slides into a curved surface of the reciprocating member.

Description

[0001] This application is a divisional application of invention patent application No. 202080021700.2 entitled "Injection System", filed on March 6, 2020. Technical Field

[0002] This article relates to drug injection devices, and more particularly to automated injection devices. Background Technology

[0003] Patients with various illnesses often need to self-inject medications. Several devices have been proposed to facilitate these injections. One type of device is the auto-injection device. This type of device typically includes a trigger assembly that, when operated by the user, causes the device to automatically insert the syringe needle (which is positioned within the device housing before triggering) into the user's body. The device then automatically injects a dose of medication through the inserted needle. The device can then automatically retract the syringe back into the device housing.

[0004] Some automated injection devices include a syringe holder that engages with the flange of the syringe. The syringe holder may simply support the flange, or in some cases, allow the syringe to move between a retracted and extended position. Some syringe holders are one-piece constructions. Some syringe holders only partially surround the syringe, for example, around the syringe at a 270-degree angle, to leave an opening through which the syringe can be inserted radially.

[0005] Some automated injection devices include a retraction assembly for automatically retracting the syringe / needle assembly. The retraction assembly may comprise two parts that are slidably engaged with each other. For example, to retract a syringe, one part slides rotatably against the other. The inventors have recognized that such sliding contact can generate friction and / or frictional variations along the sliding contact surfaces, which may prevent retraction. Improvements to the syringe holder and retraction assembly are described herein. Summary of the Invention

[0006] In some embodiments, the autoinjection device includes a housing having a proximal end and a distal end, and a syringe including a needle, a syringe body, and a plunger. The syringe can be moved within the housing from a first position to a second position distal to the first position, such that the needle moves distally towards the housing. The plunger can be moved relative to the syringe body to expel medication from the syringe body through the needle. The autoinjection device also includes a syringe holder comprising two identical, discrete, and interlocked components. Each of the two components has a proximal flange surface, a distal flange surface, and a circumferentially arched wall between the proximal and distal flange surfaces. A notch exists between the proximal flange surface, the distal flange surface, and the circumferential wall. A portion of the syringe body is received in this notch.

[0007] In another embodiment, the automated injection device includes a housing, a syringe, and a syringe holder. The housing includes a proximal end and a distal end. The syringe includes a needle, a syringe body, and a plunger. The syringe body includes a syringe flange extending radially from the syringe body, and the plunger is movable relative to the syringe body to expel medication from the syringe body through the needle. The syringe holder includes a first component and a second component that are independent of each other and interlockable. Each of the first and second components includes a proximal flange surface, a distal flange surface, a circumferentially arched wall extending between the proximal and distal flange surfaces, and a cushioning pad disposed along the distal flange surface. The materials of the proximal and distal flange surfaces are harder than the material of the cushioning pad. The proximal flange surface, the cushioning pad, and the circumferentially arched wall define a notch that receives a portion of the syringe flange. The cushioning pads of each of the first and second components collectively define an annular shape to provide full circumferential support along the syringe flange.

[0008] In some embodiments, the autoinjection device includes a housing having a proximal end and a distal end, and a syringe including a needle, a syringe body, and a plunger. The syringe can be moved within the housing from a first position to a second position distal to the first position, such that the needle moves distally toward the housing. The plunger can be moved relative to the syringe body to expel medication from the syringe body through the needle. The autoinjection device also includes a reciprocating member having a distal surface including a protrusion and a curved surface. The curved surface extends from the protrusion to define an undercut region. At least a portion of the distal surface is made of a material doped with a lubricant. The autoinjection device also includes a follower having a follower body and a latching member. The latching member is movable relative to the follower body and relative to the protrusion of the reciprocating member. The follower has a coupling configuration in which the latching member is biasedly coupled to the protrusion. The follower also has a disengaged configuration in which the latch has disengaged from the protrusion and slides into the curved surface. The follower can rotate relative to the reciprocating member, and the reciprocating member can move toward the proximal end of the housing to retract the syringe.

[0009] These and other aspects will be apparent from the following description and claims. Attached Figure Description

[0010] The invention will now be described with reference to the following accompanying drawings, in which similar reference numerals denote similar elements, in which:

[0011] Figure 1 This is a side view of an automatic injection device with a trigger assembly according to one embodiment, shown in a locked arrangement before use;

[0012] Figure 2 yes Figure 1 A longitudinal sectional view of the automatic injection device after the top cover has been removed;

[0013] Figure 3 Is with Figure 1 The other components of the device are shown separately in a perspective view of the buttons;

[0014] Figure 4a , Figure 4b These are perspective views and partial side views of the plunger element, shown separately from other device components;

[0015] Figure 5a It is an assembly including a syringe, a syringe holder, and a plunger element, wherein the syringe is shown virtually.

[0016] Figure 5b yes Figure 5a The components include a syringe holder that is partially hidden from view, and the syringe that is shown as a solid object.

[0017] Figure 5c yes Figure 5b A magnified view of a portion;

[0018] Figure 6a This is a perspective view of the syringe holder, which is separate from other device components;

[0019] Figure 6b yes Figure 6a Exploded perspective view of the syringe holder;

[0020] Figure 7a , 7b 7c, 7d, 7e and 7f are respectively Figure 6a The upper right perspective view, lower right perspective view, top view, bottom view, front view, and rear view of a portion of the syringe holder;

[0021] Figure 8 This is a perspective view of another embodiment of a syringe holder that matches a syringe, wherein a portion of the syringe holder is hidden from the view;

[0022] Figure 9a yes Figure 8 A perspective view of a portion of a syringe holder;

[0023] Figure 9b yes Figure 8 Another perspective view of a portion of the syringe holder;

[0024] Figure 10 This is a perspective view of the proximal reciprocating component, shown separately from other device components;

[0025] Figure 11a , 11b11c, 11d, and 11e are perspective views, first side views, longitudinal sectional views, top views, and bottom views of the distal reciprocating component shown separately from other device components, respectively.

[0026] Figure 12a , 12b 12c, 12d, and 12e are respectively the first perspective view, first side view, second perspective view, second side view, and longitudinal sectional view of the follower shown separately from other device components;

[0027] Figure 13a It is an assembly including a distal reciprocating member and a driven member, with the driven member shown in a connection configuration;

[0028] Figure 13b yes Figure 13b A slightly rotated view of the components, showing the interaction / cooperation between the latch of the follower and the protrusion of the distal reciprocating member;

[0029] Figure 14 yes Figure 13a Component breakdown diagram;

[0030] Figure 15a This is a perspective view of the distal reciprocating component;

[0031] Figure 15b yes Figure 15a Another perspective view of the distal reciprocating component;

[0032] Figure 16a and 16b These are perspective and side views of the grease retainer ring, shown separately from other components.

[0033] Figure 17 This is a longitudinal sectional view of the automatic injection device in its ready-to-operate arrangement.

[0034] Figure 18 This is a longitudinal sectional view of the automatic injection device after it has been triggered to perform the injection. Detailed Implementation

[0035] Now for reference Figure 1 and Figure 2 The image shows a different view of a first embodiment of an automated injection device with a trigger assembly, generally designated 20. When the trigger assembly is activated, the syringe with a needle in device 20 is automatically driven downward, causing the injection needle to protrude beyond the distal end of the device housing to pierce the user. The device can then continue to automatically inject the drug contents of the syringe through the needle, i.e., without further user intervention, after which the syringe automatically retracts, causing the needle to return to the housing.

[0036] As will be understood from the following description, device 20 is conceptually similar in various respects to the devices disclosed in U.S. Patent No. 8,734,394, filed February 24, 2011, and U.S. Patent No. 9,872,961, filed October 11, 2013, the disclosures of which are incorporated herein by reference in their entirety.

[0037] exist Figure 1 In the illustrative embodiment shown, device 20 includes a housing 22 in which the working components of the device are operatively disposed. Housing 22 may include a sleeve 26 and a body 24, which together may form the axial height of the housing. A user can rotate the sleeve 26 relative to the body 24. The sleeve may include projecting fins 93 to facilitate user rotation. The device may include a button 25, which is part of a trigger assembly and projectes axially from the proximal end 27 of the housing. In some embodiments, button 25 is unlocked when properly rotated and oriented by rotating the sleeve 26, allowing the button to be pressed distally to activate the automatic injection function of device 20. As used herein, distal and proximal refer to the axial position relative to the injection site when the device is oriented for use at the injection site; therefore, for example, the distal end of the housing refers to the end of the housing closest to the injection site.

[0038] Button 25 can be molded into a single part from a suitable durable material such as Lustran ABS 348. Figure 3 As further shown in the illustrative embodiment, button 25 may include a disc 35 having a skirt 37 extending distally from the outer periphery of the disc 35. The end disc 35 may have a flat proximal side 38 on which a user can directly apply force to selectively push the button to actuate the device. A notch 40 may be formed in the skirt 37 at its distal end; this notch 40 may extend axially and form a groove that receives a rib of sleeve 26 to bond button 25 and sleeve 26 together without relative rotation. A set of three equally spaced resilient fingers 42 may be provided at the base of the skirt 37 to position button 25 on reciprocating member 200; each finger 42 may have a pawl on its radially inner side. Each finger 42 may be adjacent to one of three equally spaced fingers 46, which have an inwardly angled stop 48 also provided in the skirt 37 for attachment to the reciprocating member 200.

[0039] The tapered flange portion 52 may have a sloping surface that serves as an actuating element for the trigger, which utilizes a cam effect to drive (cam-controlled) the fork of the trigger, thereby unlocking the fork from the trigger assembly. Cam-driven actuation can be implemented using actuating elements of different designs (including non-sloping actuating elements), thereby disengaging the fork in alternative embodiments.

[0040] In some embodiments, device 20 includes a syringe filled with medication. Figure 2 As shown, the syringe, generally designated 130, includes a barrel 132 with a flange 133 and an injection needle 134 mounted at the distal end of the barrel and in fluid communication with the drug contents of the barrel. Although the needle 134 shown is a single needle and is generally intended to be sized for subcutaneous delivery, the device can be adapted to accommodate various sizes or types of needles known in the art, including but not limited to needles consisting of one or more shortened injection needles, including microneedle arrays that allow injection at different depths, such as intradermal injection.

[0041] Generally, device 20, particularly the technology claimed in this application, can be used to inject a variety of drugs or therapeutic agents into a person in need. The syringe for the device or the claimed technology can be filled with any of a variety of therapeutic agents. Device 20 may also include a reservoir of drug, for example, located within the body 132 of the syringe or cartridge. In another embodiment, the system may include one or more devices comprising a device and a drug. The term "drug" refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs such as lispro insulin or glargine insulin, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory peptides (GIPs), GIP analogs, GIP derivatives, gastric acid regulator analogs, gastric acid regulator derivatives, therapeutic antibodies for treating psoriasis, ulcerative colitis, Crohn's disease, pain, migraines, and any therapeutic agent capable of being delivered via the aforementioned device. The drug used in the device may be formulated with one or more excipients. The device is typically operated by a patient, caregiver, or healthcare professional in the manner described above to deliver medication into the human body. The device, or the technology claimed in this application, can thus generally be operated in the manner described above with respect to device 20 to inject such a therapeutic agent from a syringe into the human body.

[0042] The plunger mechanism may include a plunger element (generally indicated by 136) and a resilient sealing member or piston 138 that seals the drug within a cylinder 132.

[0043] The plunger element 136 can be molded into a single piece from a lightweight yet strong and sufficiently flexible material, such as the DELRIN 311DP from DuPont Engineering Polymers. Figure 4a As further shown, the plunger element 136 includes a cylindrical base 140, which may be hollow to have a cross-shaped center 142. The distal side 144 of the base 140 operably abuts against the piston 138 during plunger advance. A ribbed rod 146 may extend axially upward from the top of the base 140, either rigidly or inflexibly, to a disc-shaped flange 150 with a diameter larger than that of the base 140. A plunger arm 152 may be formed on the radial outer periphery of the flange 150 and may extend axially and distally from the flange 150 in a relationship spaced apart from the plunger rod 146.

[0044] Four equally spaced bosses 153 can project upward from the flange 150. The bosses 153 can help to... Figure 2 The drive helical spring 155 shown is centered and acts on the flange 150 to bias the plunger element 136 distally within the device 20.

[0045] The plunger element 136 may include a resilient fork, generally designated 160, which serves as part of a trigger assembly. In the illustrated embodiment, a single fork 160 may latch onto the reciprocating member until released by pushing in button 25, which allows spring 155 to distally bias the plunger element 136 for needle insertion and injection. In some embodiments, the plunger includes one and only one resilient fork. However, in other embodiments, the plunger may include more than one resilient fork.

[0046] The fork head 160 may include upright, tapering fingers 162 that project axially from the center of the flange 150 to be centered on the axis of the housing 22. The fingers 162 may be flexible due to their structure, allowing bending movement of the fingers 162 when used on the fork head to release it. Figure 4b As shown, the fork head 160 may include a triangular protrusion 165 centrally located across the width between the two sides of the finger member 162. The protrusion 165 may include a ramp surface 167 extending inwardly and proximally from the tip 169 of the protrusion 165 at an angle to form an outward ramp for camming of the fork head to achieve release. The ramp surface 167 extends from the tip 169 to the proximal end 168. The distal side 170 of the protrusion 165 is not used for latching and is transverse to the axial direction.

[0047] A pair of latching surfaces 172 may be disposed on the nearest side portion 171 of the extension 174 of the finger 162. The latching surfaces 172 and the extension 174 are located on either side of the protrusion 165 and are radially inwardly spaced from the ramp surface 167 at the height of the latching surfaces along the fork 160. The latching surfaces 172 are configured to be generally axially aligned with the finger 162, and each may have a slight undercut, thus tilting slightly distally as it extends radially toward the ramp surface 167. The latching surfaces 172 are disposed at a certain height along the axial length of the ramp surface 167, for example near the proximal end 168. At this location, the contact forces on the ramp surface may tend to cause the latching element to translate and deflect, which may result in a lower and more consistent unlocking force compared to a rocking or pivoting motion caused by a latching surface that is significantly higher or lower than the ramp surface. This rocking or pivoting motion causes additional deformation of the fork 160, making the unlocking action less smooth.

[0048] The rear surface of the protrusion 165 may project rearward beyond the extension 174 to define the safety protrusion 178. When the button 25 is in its locked orientation, the safety protrusion 178 may be supported / aggregated by the safety arm 72.

[0049] Figure 5a An assembly including a plunger element 136, a syringe holder 185, and a syringe 130 is shown. The plunger rod 146 of the plunger element 136 extends through an opening 158 in the syringe holder 185 and extends into the syringe holder. Figure 5b and 5c As shown, the figure conceals a portion of the syringe holder, which surrounds the radial flange 133 of the syringe 130. Also as... Figure 5b and 5c As shown, the syringe holder also surrounds the base 140 of the plunger element. The syringe holder 185 can be configured to provide complete circumferential support to the syringe flange 133 of the syringe 130. While such a syringe holder may be necessary, a syringe holder design that allows for manufacture and assembly is also required in high-volume manufacturing settings.

[0050] Figure 6a An illustrative embodiment of a fully assembled syringe holder is shown. The syringe holder may consist of a first component 156 and a coupled second component 157. Components 156 and 157 may be coupled to each other by various attachment mechanisms, such as adhesives, ultrasonic welding, mechanical interlocking, etc. Figure 6b An exploded view of the syringe holder is shown. The two halves of the syringe holder are assembled together to define a cavity 450 that receives the syringe flange 133 during device assembly, such that the syringe holder 185 surrounds the flange 133.

[0051] In some embodiments, the syringe holder 185 consists of two identical interlocking components. Figure 7a An embodiment of a component is shown. Figure 7a The component shown is the first component 156 of the syringe holder, but the second component 157 can also be used with... Figures 7a-7f The components shown are identical. Making the first and second components identical can have the advantage of requiring only one shape to be manufactured, and can facilitate the assembly of the syringe holder by avoiding the need to orient specific components on a particular side of the syringe holder. Other embodiments of components having at least some of the features described herein may include components that are not identical but still provide interlocking and support for the flange.

[0052] The first component 156 may include a proximal flange surface 402, a distal flange surface 404, and a circumferentially arched wall 410 disposed between the proximal flange surface 402 and the distal flange surface 404. An axial notch 460 is defined between the proximal flange surface 402 and the distal flange surface 404. The notch 460 is sized to receive the flange 133 of the syringe (see...). Figure 5c The axial thickness of the wall. The proximal flange surface 402 may include a proximal flange extending from the wall, and the distal flange surface 404 may include a distal flange extending from the wall and parallel to the proximal flange.

[0053] In some embodiments, the syringe holder 185 may include a cushioning pad 187 that defines the distal boundary of the notch 460. (See reference...) Figure 5c When the flange is held by the syringe holder, the distal surface of the syringe flange 133 can abut against and be supported by the proximal surface 187A of the buffer pad 187. In some embodiments, the remainder of the syringe holder is made of a material with a hardness greater than that of the buffer pad 187. The buffer pad 187 can provide shock absorption or other impact damping to, for example, reduce the likelihood of the syringe breaking during actuation of the autoinjection device, and / or reduce the impact noise between the syringe and the syringe holder during syringe movement. The buffer pad can be made by overmolding material onto the syringe holder. The buffer pad can be made of a compressible material such as an elastomer or closed-cell foam.

[0054] In some embodiments, the cushioning pad may be arcuate to fit the shape of the circumferentially arched wall 410 and / or the shape of the distal flange surface 404. In some embodiments, sections of the cushioning pad 187 are configured and shaped, for example, annular, to provide full circumferential (i.e., 360-degree) support to the entire flange 133 when components 156, 157 are joined. To this end, in some embodiments, the component is shaped to surround the flange so that the cushioning pad 187 can provide this full support to the flange 133, for example, to withstand the spring insertion drive force.

[0055] In some embodiments, the syringe holder 185 may include one or more radially inwardly extending protrusions, wherein the protrusions may facilitate centering of the syringe within the syringe holder by contacting the syringe body below the syringe flange. Figure 7a In the illustrated embodiment, the syringe holder includes a protrusion 188 extending from the radially inner surface 189 of the cushioning pad 187. The protrusion may be made of the same cushioning material as the cushioning pad 187 and may be integrally formed as a single component with the cushioning pad 187. The protrusion can be radially compressed to a greater extent than any radial compression of the surface 189 by the syringe body. In the illustrated embodiment, the cushioning pad 187 of each component includes a pair of protrusions 188a and 188b (e.g., ...). Figure 7d As shown in the figure, the protrusions help center the syringe together in four positions when the components are coupled together. In one example, the coupled components define four protrusions arranged at equal angular intervals. The number of protrusions provided when the components are coupled can vary between two or more. In another embodiment, one or more protrusions may optionally include protrusion 191, which may be positioned along the radial inner surface 189 closer to the latching protrusion 430 than the teeth 420, and in some embodiments adjacent to the end of the radial inner surface 189 near the latching protrusion, as shown in 7a. In other embodiments, protrusions may be provided near the end of the radial inner surface 189 near the teeth 420, in addition to or instead of protrusion 191. Protrusion 191 may be included therein to support the syringe during the snap-fit ​​engagement of the two components of the syringe carrier when the portion of component 156 or 157 including the latching protrusion 430 is bent radially outward due to engagement with the teeth 420 of another component. After the snap-fit ​​engagement, the protrusion 191 can also provide additional support to the syringe at locations where there may be gaps between the buffer pads when engaged.

[0056] The proximal flange surface 402 can provide a support engagement with the proximal surface of the base 140 of the plunger element.

[0057] Each component of the syringe holder may define an opening 45 defined by a wall facing the radial plunger, which forms part of the opening 158 of the fully assembled syringe holder. The shape and size of this opening 45 can be determined to receive the plunger element in a manner that provides sliding support to the plunger body. In the example shown, the opening 45 in each component has a U-shape, wherein opposing parallel planar sides are connected to each other by circular sides.

[0058] The edges 405, 407 of the proximal flange surface of one portion of the syringe holder (which are laterally disposed relative to the opening portion 45) can be complementaryly shaped to mate with the edge of the other portion, for example, as shown in the figure. Figure 6a As shown. The edges can have a planar shape. In the illustrated embodiment, each edge is a non-linear shape, including protrusions and recesses.

[0059] In some embodiments, each component of the syringe holder 185 may include a first sidewall end 411 and a second sidewall end 412, wherein a circumferentially arched wall 410 extends from the first sidewall end 411 to the second sidewall end. In the illustrated embodiment, the first sidewall 411 is arranged to be recessed relative to edge 407, and the second sidewall 412 is arranged to protrude relative to edge 405.

[0060] The syringe holder 185 may include interlocking components that interlock to form a fully assembled syringe holder. In some embodiments, the interlocking components extend from the sidewall ends of each portion of the syringe holder. Figure 7a and 7b In the illustrated embodiment, the interlocking components include teeth 420 and latching protrusions 430, each tooth 420 having a notch 421 and each latching protrusion 430 having an accompanying groove 432. The teeth 420 may extend from one sidewall of the illustrated first sidewall end 411, and the protrusions 430 extend from the other sidewall of the illustrated second sidewall end 412. The shape and size of each of the teeth 420 and notches 421 of the first component 156 of the syringe holder complements and engages with the corresponding groove 432 and protrusion 430 of the second component 157 of the syringe holder to interlock the two components of the syringe holder together.

[0061] like Figure 7c Top view and Figure 7d As shown in the bottom view, each component of the syringe holder can be approximately C-shaped. (As...) Figure 7e Front view and Figure 7f As shown in the rear view, the syringe holder may include a window 490 that passes entirely through the circumferential arched wall 410 of the syringe holder.

[0062] like Figure 5a As shown in the optimal configuration, the syringe holder 185 can completely surround the outer periphery of the syringe body, i.e., it surrounds the syringe body 360 degrees. The proximal and distal flange surfaces 402, 404 of each component together completely cover the proximal surface 133A and / or distal surface 133B of the syringe flange 133, as shown in the optimal configuration. Figure 5aAs shown. When the delivery device uses a higher spring force to drive the plunger, for example due to larger drug volumes such as 2 to 3 ml and / or higher viscosity drugs, this structure of a syringe holder that completely surrounds and / or covers the syringe flange may be advantageous. This structure allows the driving force to be distributed over a larger area of ​​the syringe flange, which can help reduce the likelihood of breakage of the syringe flange, which is typically made of glass.

[0063] However, it should be understood that other structures for the syringe holder are also possible. Figure 8 An alternative embodiment is shown. Figure 8 In this design, a portion of the syringe holder 185' is removed to better visualize the engagement of the syringe flange 133' with the syringe holder. The proximal flange surface 402' and distal flange surface 404' of the two components of the syringe holder 185' can be configured together to provide full 360-degree support to the syringe flange 133'. The syringe holder may also include a cushioning pad 440 arranged along the proximal surface of the distal flange surface 404'. In use, the flange 133' will rest against the cushioning pad at a location between the cushioning pad and the proximal flange surface 402'.

[0064] like Figures 9a-9b As shown, in this embodiment, the syringe holder 185' has a wall 410', which is unlike... Figure 7a The illustrated embodiment extends laterally from one side to the other. The shortened wall 410' relative to the longer circumferential extensions of the proximal and distal flange surfaces 402', 404' allows for lateral spaces 495, 496 on the sides of the lateral ends of the wall 410'. In some embodiments, these spaces 495, 496 can be used to accommodate syringes with flanges of different shapes, such as… Figure 8 The syringe shown has a cutting flange.

[0065] The syringe holder may have interlocking components in the form of a protrusion 425 and a recess 426. The protrusion 425 of the first component of the syringe holder interlocks with the recess 426 of the second component. These interlocking components may have other snap-fit ​​structures. Due to the shortened wall 410', the interlocking feature structure is illustrated as being defined by the corresponding flange surfaces 402', 404'. In practice, the protrusion 425 and the recess 426 are illustrated as being defined by the radially inward edges 405', 407' of the corresponding flange surfaces 402', 404'. In one embodiment, the circumferentially arched wall 410' partially surrounds the outer periphery of the syringe flange 133', and the proximal flange surfaces 402' of each component together completely cover the proximal surface 133A' of the syringe flange 133'. Figure 8As shown, the distal flange surface 404' of each component together completely covers the distal surface 133B' of the syringe flange 133', with a cushioning pad 440 arranged between them.

[0066] The device 20 may have a delay mechanism, which includes a reciprocating element generally indicated by 200, a driven element 250 releasably latched to the reciprocating element 200, and a dual-function biasing member 275 acting between the reciprocating element and the driven element. The reciprocating element 200 may be composed of a reciprocating element 250 and a driven element 260. Figure 10 and Figures 11a-11e The proximal reciprocating member 202 and the distal reciprocating member 204, as further shown in the figure, are fixedly connected during manufacturing and assembly. U.S. Patent No. 9,872,961 describes in more detail the interaction between the proximal reciprocating member 202 and the distal reciprocating member 204, as well as the characteristic structure of the proximal reciprocating member 202.

[0067] The distal reciprocating member 204 includes a distal region 270, and a flange 272 transitioning from the body 210 to the region 270 is designed to engage the syringe holder 185. As the distal reciprocating member 204 moves proximally during retraction, the flange 272 abuts against the distal surface of the syringe holder 185, thereby causing the syringe holder 185 and syringe barrel 132 to move proximally by the proximal movement of the distal reciprocating member 204. A recess 280 in the body 210 of the distal reciprocating member receives a housing key to secure the reciprocating member 200 in a rotationally resistant / non-rotatably rotatable manner within a cavity in the cannula 26. In some embodiments, the device includes a different drive system in which the syringe holder 185 and syringe barrel can remain stationary (i.e., not moving proximally), while the syringe holder still functions for the syringe flange.

[0068] Tabs 282 and 284 project radially from the distal region 270 and serve as latching elements or hooks to engage the follower. A notch 286 leading to a cavity 288 within tab 282 receives a proximal protrusion 289 of biasing member 275.

[0069] An angled latching surface 290 is arranged on the distal side of the opening 292, aligned with an axially extending channel 294 formed in the inner surface of the body 210 of the distal reciprocating member. The channel 294 accommodates a plunger arm 152 that can extend through the opening 292 to unlock the locking mechanism described below.

[0070] Figures 12a-12eThe follower 250 is further shown, including a proximal portion 298 having protruding ledges 300 and 302 that serve as latching elements engaging with latching tabs 282 and 284 of the reciprocating member. A channel 304 and an opening 306 in the proximal portion 298 allow axial movement of the tabs 282 and 284 therein for fabrication of assemblies and for releasing the reciprocating member relative to the follower during device use. The opening 306 tapers to a slotted portion 310 adapted to tightly receive the radial protrusion 312 of the biasing member 275.

[0071] During device assembly, the radially projecting flange 316 can snap through a latching element in the body 24. The inner surface of the driven portion 298 includes an inwardly projecting ring 318 with a spring-centering lip 320. A sleeve-shaped distal portion 322 of the driven member 250 hangs from the driven portion 298 and has a smaller diameter. A slot 324 in the distal edge of the portion 322 defines four damping fins 326 of the driven member. The size of the slot 324 can be adjusted to produce different delay times. A flexure arm 330 constitutes a locking member for the driven member 250 to limit its rotation relative to the reciprocating member 200; the flexure arm 330 has an upwardly extending latch 332 at its end.

[0072] Figure 14 An exploded view of the distal reciprocating member 204, the biasing member 275, and the follower 250 is shown. The biasing member 275 can function as both a torsion spring and a compression spring, and performs torsional preloading and axial preloading during the manufacturing and assembly of the device 20. The biasing member 275 is illustrated as a cylindrical spring composed of a helical coiled wire 311, having a reciprocating engagement tip in the form of a proximal protrusion 289 and an engagement tip 312 following thereafter.

[0073] Figure 13a and 13b An assembly of a distal reciprocating member 204 and a follower 250, shown in a coupled configuration, is illustrated. In the coupled configuration, the latch 332 of the follower engages with a protrusion 213 on the distal surface 211 of the distal reciprocating member 204.

[0074] like Figure 15a and 15b As shown, the distal surface 211 of the distal reciprocating member 204 has an undercut region 215 adjacent to the protrusion 213. The undercut region 215 has a curved shape. In some embodiments, the rear surface 335 may be curved, and the undercut region 215 may be curved to facilitate sliding engagement between the two.

[0075] like Figure 12dAs shown, due to the cantilevered flexible arm 330 capable of deflecting relative to the follower body, the latch 332 of the follower can move axially relative to the follower body 251. The latch 332 may include a front surface 333 and a rear surface 335. During rotation of the follower relative to the reciprocating member, the sliding contact between the latch surface and the reciprocating member generates frictional changes, thereby hindering / disadvantaging the uniform rotational speed of the follower. When the follower is in Figure 13b In the engagement configuration, the front surface 333 engages with the protrusion 213. When the follower is in the disengaged configuration and rotates relative to the distal reciprocating member 204, the rear surface 335 may slidably engage with the undercut region 215. In the disengaged configuration, the latch 332 disengages from the protrusion 213. In some embodiments, the front surface 333 may be a flat surface that engages the flat surface portion 214 of the protrusion 213 in a face-to-face relationship. At least one or both of the front surface 333 and the flat surface portion 214 may be slightly angled to facilitate latching with and / or disengaging from the protrusion 213. In some embodiments, the rear surface 335 may be curved to facilitate disengagement of the latch from the protrusion and / or facilitate slidable engagement with the undercut region 215.

[0076] The distal reciprocating member 204 may include a lubricated material to facilitate movement of the distal reciprocating member 204 within the device housing, particularly during needle retraction operations. In one example, the entire distal reciprocating member comprises a lubricated material. In some embodiments, at least the distal surface 211 of the distal reciprocating member is made of a lubricated material. This material may facilitate disengagement of the latch 332 from the protrusion 213 and / or facilitate sliding engagement between the latch 332 and the undercut region 215 as the follower 250 rotates relative to the distal reciprocating member. In some embodiments, the lubricated material may be used to reduce friction and / or frictional variation between the distal reciprocating member and the latch during movement of the follower relative to the distal reciprocating member. The lubricated material may also be used to reduce friction and / or frictional variation between the tabs 282, 284 and the protruding edges 300, 302. In some embodiments, the material may be a polysiloxane-doped material. In some embodiments, the material may be made of polycarbonate doped with 2% polysiloxane. In some embodiments, all or at least a portion of the follower 250 may be made of a copolymer to reduce friction and / or frictional variation between the distal reciprocating element and the follower. In some embodiments, at least one of the distal surfaces 211 of the distal reciprocating element is made of a lubricant-infused material, the rear surface 335 may be curved, the undercut region 215 may be curved, and the copolymer follower or any combination thereof may be used to provide a retraction assembly for an automated injection device that facilitates syringe retraction by reducing sliding engagement friction and / or by reducing frictional variations that occur during retraction. This embodiment can reduce any frictional delay variations in the rotational speed and timing of the follower to allow for more consistent retraction speed and timing of the reciprocating element / syringe retraction and / or retraction at the end of the delivery cycle, avoiding factors that lead to stalled retraction.

[0077] The device may include Figure 16a and 16b A further illustrated grease retainer 340 provides a support surface for damping fluid as the follower 250 rotates relative to it. The retainer 340 includes an annular body 342 through which the syringe barrel is adapted. The retainer 340 is axially supported within the housing 22. The retainer body 342 includes a generally U-shaped wall defining an annular hollow portion 346.

[0078] Damping compounds such as silicone grease thickened with polytetrafluoroethylene (PTFE) can be used. Figure 2(As shown) The annular hollow portion 346 is filled. The follower fin 326 is adapted within the hollow portion 346 such that compound 350 is disposed radially inside and outside such fin 326, and between adjacent fins 326, and as a thin film disposed between the underside of the fin and the base of the retaining ring wall, thereby causing a damping or delaying effect when the follower fin 326 attempts to rotate relative to the retaining ring.

[0079] The structure of device 20 will be further understood from the description of an illustrative embodiment of the operation of device 20 after the end cap has been removed in preparation for injection. To arrange device 20 for injection, the user manually rotates the cannula 26 and thus the button 25 to the unlocked position, in which the device is ready for injection.

[0080] Figure 17 A cross-sectional view of the device in the unlocked state is shown. When the user subsequently applies a distal force to button 25, button 25 begins to move downward into sleeve 26, thereby abutting against ramp surface 167 and driving flange surface 54. As button 25 continues to move further distally, wherein flange portion 52 is further inserted into the opening of the reciprocating member, flange surface 54 slides along ramp surface 167. During this sliding, flange portion 52 uses a cam effect to drive fork 160 to move radially outward, because contact between flange portion 52 and support ring surface 234 prevents flange portion 52 from bending in the opposite radial outward direction. Contact between flange portion 52 and support surface on proximal reciprocating member 202 prevents flange portion 52 from twisting. As the finger 162 bends, the fork 160 is driven outward by the cam effect until the latch surface 172 disengages from the latch surface on the proximal reciprocating member. At this point, due to the spring 155 directly deflecting the plunger element 136 downward to drive the plunger element and thus the piston 138, the proximal portion of the plunger fork 160 passes downward through the reciprocating member. This driving motion causes the syringe barrel 132 and syringe holder 185 to move distally relative to the reciprocating member and the housing, thereby causing the tip of the needle 134 to protrude beyond the distal end of the housing to pierce the user's skin, and then forcing the drug contents of the syringe to be injected through the needle.

[0081] As the plunger element 136 moves distally during drug injection, the arm 152 abuts against the latch 332 of the follower 250, causing the flexible arm 330 to deflect distally. This allows the front surface 333 of the latch to slide distally across the protrusion 213 of the distal reciprocating member 204, thereby disengaging the latch 332 from the protrusion 213. As the latch 332 disengages from the protrusion 213 of the distal reciprocating member 204, the follower 250 is in a disengaged configuration, thus unlocking the follower 250 to allow it to rotate relative to the distal reciprocating member 204. Figure 18 The arrangement of the device 20 at this moment during use is shown.

[0082] Driven by the torsional preload of the bias member 275, the follower 250 rotates against the damping effect of the damping compound 350. During rotation, any remaining medication can be properly expelled from the syringe through the needle. When the follower 250 has rotated such that the reciprocating tabs 282 and 284 have moved away from the protruding edges 300 and 302, the reciprocating member 200 and the follower 250 are unlocked, allowing the compression-preloaded bias member 275 to relax. This forces the reciprocating member 200 to retract proximally into the syringe holder 185 and the syringe barrel 132 together with the syringe holder, thereby retracting the distal tip of the injection needle 134 into a protected retracted position within the housing 22.

[0083] Although the automated injection device described herein has been illustrated and described with a preferred design, modifications to the device are possible within the spirit and scope of this disclosure. For example, while in the illustrated embodiment the biasing element released by the trigger assembly is a plunger that itself contacts the syringe piston, in alternative embodiments the trigger assembly may be used to release a different biasing element, or an element biased by a component other than a coil spring. Therefore, this application is intended to cover any variations, uses, or alterations of the device using its general principles. Furthermore, this application is intended to cover deviations from the scope of this disclosure within the known or conventional practices in the field to which this automated injection device pertains.

[0084] Various aspects of at least one embodiment of the invention have thus been described, and it should be understood that various changes, modifications, and improvements will readily occur to those skilled in the art. Such changes, modifications, and improvements are intended to be part of this disclosure and are intended to fall within the spirit and scope of the invention. Therefore, the above description and drawings are merely illustrative.

[0085] This disclosure describes various aspects, including but not limited to the following:

[0086] 1. An automatic injection device, comprising:

[0087] A housing, comprising a proximal end and a distal end;

[0088] A syringe comprising a needle, a syringe body, and a plunger, the syringe being movable within the housing from a first position to a second position distal to the first position, such that the needle is moved distally to the housing, and the plunger being movable relative to the syringe body to expel medication from the syringe body through the needle;

[0089] A syringe holder comprising a first component and a second component that are identical to each other, independent of each other, and interlocked together, each of the first component and the second component comprising:

[0090] Proximal flange surface;

[0091] distal flange surface;

[0092] A circumferentially arched wall between the proximal flange surface and the distal flange surface; and

[0093] A notch is located between the proximal flange surface, the distal flange surface, and the circumferential arched wall, wherein a portion of the syringe body is received in the notch.

[0094] 2. The automatic injection device according to aspect 1, wherein each of the first and second components of the syringe holder includes a protruding tooth that interlocks with the other of the first and second components.

[0095] 3. The automatic injection device according to any one of aspects 1-2, wherein the syringe holder includes a buffer pad, and the material hardness of the proximal flange surface and the distal flange surface is greater than the material hardness of the buffer pad.

[0096] 4. The automatic injection device according to aspect 3, wherein the syringe body includes a syringe body flange, and the buffer pad contacts the syringe body flange.

[0097] 5. The automatic injection device according to aspect 3, wherein the buffer pad includes at least one radial protrusion extending from the radially inner surface of the buffer pad.

[0098] 6. The automatic injection device according to any one of aspects 1-5, wherein the syringe body includes a syringe body flange, the circumferentially arched wall of the syringe holder partially surrounds the outer periphery of the syringe flange, and the proximal flange surfaces of each of the two components together completely cover the proximal surface of the syringe flange.

[0099] 7. The automatic injection device according to any one of aspects 1-6, wherein the syringe body includes a syringe body flange, and the proximal flange surfaces of each of the two components together completely cover the proximal surface of the syringe flange.

[0100] 8. The automatic injection device according to any one of aspects 1-7, wherein the syringe holder completely surrounds the outer periphery of the syringe body.

[0101] 9. The automatic injection device according to any one of aspects 1-8, wherein each of the first and second components of the syringe holder includes a first sidewall end and a second sidewall end, the circumferentially arched wall extending from the first sidewall end to the second sidewall end, the first sidewall end having teeth, and the second sidewall end having a latching protrusion, wherein the teeth of the first component of the syringe holder interlock with the latching protrusion of the second component of the syringe holder.

[0102] 10. An automatic injection device, comprising:

[0103] A housing, comprising a proximal end and a distal end;

[0104] A syringe including a needle, a syringe body, and a plunger, the syringe body including a syringe flange extending radially from the syringe body, and the plunger being movable relative to the syringe body to expel medication from the syringe body through the needle;

[0105] A syringe holder comprising a first component and a second component that are independent of each other but interlocked together, each of the first component and the second component comprising:

[0106] Proximal flange surface;

[0107] distal flange surface;

[0108] A circumferentially arched wall extending between the proximal flange surface and the distal flange surface;

[0109] A buffer pad is arranged along the distal flange surface, wherein the material hardness of the proximal flange surface and the distal flange surface is greater than the material hardness of the buffer pad; and

[0110] A notch defined by the proximal flange surface, the buffer pad, and the circumferential arched wall, the notch receiving a portion of the syringe flange, wherein the buffer pads of each of the first and second components together define an annular shape to provide full circumferential support along the syringe flange.

[0111] 11. The automatic injection device according to aspect 10, wherein the buffer pad includes at least one protrusion that contacts the syringe body below the syringe flange, the at least one protrusion being arranged adjacent to one end of the radially inner surface of the buffer pad of each of the first and second components.

[0112] 12. The automatic injection device according to any one of aspects 10-11, wherein the first component and the second component are identical to each other, each of the first component and the second component having an interlocking element configured to be connected to each other and a wall that jointly defines an opening surrounding the movable plunger.

[0113] 13. An automatic injection device, comprising:

[0114] A housing, comprising a proximal end and a distal end;

[0115] A syringe comprising a needle, a syringe body, and a plunger, the syringe being movable within the housing from a first position to a second position distal to the first position, such that the needle is moved distally to the housing, and the plunger being movable relative to the syringe body to expel medication from the syringe body through the needle;

[0116] A reciprocating component having a distal surface including a protrusion and a curved surface extending from the protrusion to define an undercut region; at least a portion of the distal surface is made of a lubricant-doped material; and

[0117] A follower having a follower body and a latching member movable relative to the follower body and relative to the protrusion of the reciprocating member;

[0118] in:

[0119] The driven member has a coupling configuration in which the latch is biasedly coupled to the protrusion, and

[0120] The follower has a disengaged configuration in which the latch has disengaged from the protrusion and slidably engages with the curved surface, the follower is rotatable relative to the reciprocating member, and the reciprocating member is movable toward the proximal end of the housing to retract the syringe.

[0121] 14. The automatic injection device according to aspect 13, wherein the latch includes a cantilevered arm having a protrusion at one end.

[0122] 15. The automatic injection device according to aspect 14, wherein the protrusion has a straight front surface and a curved rear surface, wherein when the follower is in the engagement configuration, the straight front surface contacts the protrusion, and when the follower is in the disengagement configuration, the curved rear surface contacts the curved surface.

[0123] 16. The automatic injection device according to any one of aspects 13-15, wherein the material doped with lubricant comprises polysiloxane.

[0124] 17. The automatic injection device according to any one of aspects 13-16, wherein the entire reciprocating component is made of a material incorporating a lubricant.

[0125] 18. The automatic injection device according to any one of aspects 13-17 further includes a spring, which is compressed between the reciprocating member and the driven member when the driven member is in the coupling configuration.

[0126] 19. The automatic injection device according to aspect 18, wherein the spring is preloaded in a torsional manner when the driven member is in the coupling configuration.

[0127] 20. The automatic injection device according to any one of aspects 13-19, wherein, after the driven member has rotated by a predetermined rotation angle, the reciprocating member is movable toward the proximal end of the housing.

[0128] 21. The automatic injection device according to aspect 1, 11 or 13, wherein the syringe body contains a drug.

[0129] 22. The automatic injection devices according to aspects 1 and 11 can be combined individually or together with other aspects described herein.

Claims

1. An automatic injection device comprising: a housing comprising a proximal end and a distal end; a syringe comprising a needle, a syringe body, a syringe flange, and a plunger, the plunger being movable relative to the syringe body to expel a medicament from the syringe body through the needle; and a syringe carrier comprising a first part and a second part independent of each other and interlocked together, each of the first part and the second part comprising a proximal flange surface, a distal flange surface, a circumferential arcuate wall between the proximal flange surface and the distal flange surface, and a gap between the proximal flange surface, the distal flange surface, and the circumferential arcuate wall, wherein each of the first part and the second part of the syringe carrier comprises a bumper pad disposed between the proximal flange surface and the distal flange surface, the bumper pad having a proximal surface and a radially inner surface, the proximal flange surface and the distal flange surface having a material hardness greater than a material hardness of the bumper pad; wherein when the first part and the second part are interlocked and coupled around the syringe, a portion of the syringe body is received in the gap, the first part and the second part of the syringe carrier being configured to completely surround an outer circumference of the syringe body, wherein a distal surface of the syringe flange is supported by the proximal surface of the bumper pad of each of the first part and the second part, wherein the radially inner surface of the bumper pad of each of the first part and the second part comprises at least one protrusion that radially contacts the syringe body under the syringe flange.

2. The automatic injection device of claim 1, wherein, the at least one protrusion comprises a plurality of protrusions, wherein when the first part and the second part are interlocked, the plurality of protrusions of each of the first part and the second part are arranged to facilitate centering of the syringe body within the syringe carrier by contacting the syringe body under the syringe flange.

3. The automatic injection device of claim 1, wherein, the at least one protrusion is arranged adjacent to an end of the radially inner surface of the bumper pad of each of the first part and the second part.

4. The automatic injection device of claim 1, wherein, the at least one protrusion is made of the same material as the bumper pad.

5. The automatic injection device of claim 1, wherein, the at least one protrusion is capable of being radially compressed to a greater extent than the radial compression of the radially inner surface.

6. The automatic injection device of claim 1, wherein, when the first part and the second part are interlocked, the bumper pad of the first part and the bumper pad of the second part together are configured to provide full circumferential support to the syringe flange.

7. The automatic injection device of claim 1, wherein, each of the first part and the second part has an interlocking component.

8. The automatic injection device of claim 7, wherein, the interlocking component comprises a notched tooth extending from one of the sidewalls of each of the first part and the second part and a slotted latch protrusion extending from the other sidewall, the notched tooth of the first part being shaped and dimensioned to complementarily mate with the slotted latch protrusion of the second part.

9. The automatic injection device of claim 8, wherein, The bumper includes a plurality of protrusions contacting the syringe body below the syringe flange, wherein one of the plurality of protrusions is closer to the latch protrusion than the tooth.

10. The automatic injection device of claim 1, wherein, The syringe flange has a cut flange shape configuration.

11. The automatic injection device of claim 1, further comprising a shuttle, the shuttle being engageable with the syringe carrier during proximal movement of the shuttle.

12. The automatic injection device of claim 11, wherein, The shuttle is configured to move the syringe within the housing from a first position to a second position distal to the first position to move the needle toward a distal end of the housing.

13. The automatic injection device of claim 12, further comprising a follower having a follower body and a follower latch, the follower latch being movable relative to the follower body and relative to a shuttle protrusion, wherein the follower has a coupled configuration in which the follower latch is biasedly coupled to the shuttle protrusion and the follower latch disengages from the shuttle protrusion as the plunger moves distally, whereby the follower moves from the coupled configuration to a decoupled configuration in which the follower latch has disengaged from the shuttle protrusion, the follower is rotatable relative to the shuttle, and the shuttle moves toward a proximal end of the housing to retract the syringe as the follower rotates.

14. The automatic injection device of claim 13, wherein, The follower latch includes a cantilevered arm having a follower protrusion at one end of the cantilevered arm.

15. The automatic injection device of claim 13, wherein, The shuttle includes a lubricant-infused material.

16. The automatic injection device of claim 13, further comprising a spring (155) compressed between a portion of the shuttle and the plunger, wherein the plunger moves relative to the syringe body by the spring (155) to expel a medicament from the syringe body through the needle.

17. The automatic injection device of any one of claims 13-16, further comprising a biasing member (275), wherein the follower rotates relative to the shuttle by the biasing member (275).

18. The automatic injection device of claim 1, wherein, The syringe body contains a medicament.

19. A syringe carrier for coupling to a syringe within a medicament delivery device, the syringe including a syringe flange, the syringe carrier comprising: a first component, a second component independent of and interlockable with the first component, wherein each of the first and second components includes a proximal flange surface, a distal flange surface, a circumferential dome-shaped wall between the proximal flange surface and the distal flange surface, a bumper pad, and a gap between the proximal flange surface, the distal flange surface, and the circumferential dome-shaped wall, wherein each of the first and second components of the syringe carrier includes a bumper pad disposed between the proximal flange surface and the distal flange surface, the bumper pad having a proximal surface and a radially inner surface, wherein the gap is configured to receive a portion of the syringe, wherein the proximal flange surface and the distal flange surface have a greater material hardness than the material hardness of the bumper pad, wherein, when the first and second components are interlocked, the first and second components are configured to completely surround a circumference of the syringe flange of the syringe, and a distal surface of the syringe flange is supported by the proximal surface of the bumper pad of each of the first and second components; wherein the radially inner surface of the bumper pad of each of the first and second components includes at least one protrusion that radially contacts a syringe body below the syringe flange.

20. The syringe carrier of claim 19, wherein, the at least one protrusion includes a plurality of protrusions, wherein, when the first and second components are interlocked, the plurality of protrusions of each of the first and second components are arranged to facilitate centering of a syringe body within the syringe carrier by contacting the syringe below the syringe flange.

21. The syringe carrier of claim 19, wherein, the at least one protrusion is arranged adjacent to an end of the radially inner surface of the bumper pad of each of the first and second components.

22. The syringe carrier of claim 19, wherein, the at least one protrusion is capable of being radially compressed to a greater extent than the radial compression of the radially inner surface.

23. The syringe carrier of claim 19, wherein, when the first and second components are interlocked, the bumper pad from each of the first and second components is configured to provide full circumferential support to the syringe flange.

24. The syringe carrier of claim 19, wherein, the first and second components are identical components.

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