Injection system and method

Abstract

A safety injection system includes an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof. The system also includes a stop member disposed in the interior space of the injection system body. The system also includes a plunger member configured to be manipulated to insert the stop member relative to the injection system body. In addition, the system includes a hub assembly coupled to the needle attachment interface. The hub assembly includes a hub defining a locking space at a distal end, a needle lock defined by the hub in the locking space, and a needle removably coupled to the hub through the needle lock.

Description

Technical Field

[0001] The present invention relates generally to injection systems and injection devices, and more particularly to injection systems and injection devices associated with healthcare environments. Even more particularly, the present invention relates to injection systems and injection devices including retractable needles, and methods for manufacturing, assembling, and using the same. Background Art

[0002] Millions of syringes / syringes are consumed every day in healthcare settings, e.g. Figure 1A (2) As shown. A typical syringe (2) includes a tubular body (4), a plunger (6) and an injection needle (8). Figure 1B As shown, such a syringe (2) can be used not only to inject fluid into a patient's body, but also to extract or discharge fluid from a container such as a medicine bottle, glass vial, bag or other drug containing system (10). In practice, due to regulatory restrictions in some countries such as the United States and considerations of aseptic maintenance, when a medicine bottle (10) with a syringe (2) is used in a patient-specific environment, such a medicine bottle can only be used for a single patient and then must be disposed of - resulting in a large amount of medical waste in the disposal of medicine bottles and leftover medicines, and even leading to periodic shortages of certain key drugs.

[0003] Reference Figure 2A , shows three Luer-type syringes (12), each having a distally disposed Luer connector geometry (14) so ​​that they can be coupled with other devices having similar mating geometry, e.g. Figure 2B The Luer multi-tip catheter assembly (16) shown. With or without an IV bag, Figure 2B The Luer multi-tip catheter assembly can be used to administer liquid medications intravenously to patients. Figure 2A The Luer connector (14) of the syringe may be referred to as a "male" Luer connector, while Figure 2B(18) can be referred to as a "female" luer fitting; one of the luer interfaces can be threaded (in which case the configuration can be referred to as a "luer lock" configuration), such that the two sides can be coupled by relative rotation, which can be combined with a compression load. In other words, in one luer lock embodiment, rotation (possibly accompanied by compression) can be utilized to engage threads within the male fitting (14) that are configured to engage a flange on the female fitting (18) and bring the devices together into a fluid-tight coupling. In another embodiment, a tapered / conical interface geometry can be utilized to provide a luer engagement by compression without threads or rotation (this configuration can be referred to as a "slip-on" or "conical" luer configuration). While such luer couplings are considered relatively safe for the operator, there is a risk of drug spillage / leakage and part breakage during assembly of the luer coupling. On the other hand, the use of a needle injection configuration carries the risk of sharp needle contact or injury to an unintended person or structure. For this reason, so-called "safety syringes" have been developed.

[0004] Figure 3 One embodiment of a safety syringe (20) is shown, in which a tubular shroud member (22) is spring-biased to cover the needle (8) upon release from a locked position relative to the syringe body (4). Figures 4A-4B Another embodiment of a safety syringe (24) is shown. With this configuration, a retractable needle (26) is configured to retract (28, 26) to a safe position within the tubular body (4) after the plunger (6) is fully inserted relative to the syringe body (4), as shown. Figure 4B This self-contracting configuration can be associated with the following issues: blood splatter / aerosolization issues, safe storage of pre-loaded energy (which can fail and activate prematurely), loss of accuracy in administering a full dose injection due to residual dead space within the spring compression volume, and / or loss of control over retraction speed that can be associated with pain and patient anxiety.

[0005] Complicating the syringe market further is the increasing demand for pre-filled syringe assemblies, such as shown in Figure 5A and Figure 5B which generally include a syringe body or "drug containment vessel delivery system" (34), a plunger head, plug or stopper (36), and a distal seal or cap (35) that can be mounted on a luer-type interface Figure 5A showing the cap 35 in place; Figure 5BThe cap is removed to show the luer interface 14. Liquid medication may be present in a volume or medication reservoir (40) between the distal seal and the distal end (37) of the plunger tip (36). The plunger tip (36) may comprise a standard butyl rubber material and may be coated with, for example, a biocompatible lubricious coating (e.g., polytetrafluoroethylene ("PTFE")) to facilitate preferred sealing and relative movement characteristics with respect to the associated syringe body structure and materials. Figure 5B The proximal end of the syringe body (34) includes a conventional integral / integral injection system flange (38) that is integrally formed with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and can be configured to surround the entire circumference or a portion of the circumference of the syringe body (34). Part of the flange is referred to as a "cut-off flange" and the other portion is referred to as a "full flange." The flange is used to grasp the injection system with the fingers to provide support for pushing the plunger to perform an injection. The syringe body (34) preferably includes a translucent material, such as glass or a polymer. In order to form a closed volume within the chamber or reservoir (40) and to facilitate the discharge of the associated fluid through the needle, a plunger head (36) can be provided within the syringe system body (34). The syringe body (34) can define a substantially cylindrical shape (i.e., such that a plunger head (36) having a circular cross-sectional shape can establish a seal relative to the syringe body (34)), or can be configured to have other cross-sectional shapes, such as an elliptical shape.

[0006] Such components are ideal because they can be standardized and precisely mass-produced by a small number of manufacturers worldwide who can meet all the ever-changing regulations in the world regarding fill, packaging, and drug / drug interface material selection and component / ingredient use. However, such simple configurations often do not meet the new world standards for single-use, safety, automatic deactivation, and needlestick resistance. Therefore, some suppliers have turned to more "vertical" solutions, such as Figure 5C (41) in the , the solution attempts to meet all or at least some of the criteria with a single solution; because of the attempt to meet these criteria in many different situations, these products may have significant limitations (including the above reference Figure 3-4B some limitations described in

[15] ) and relatively high inventory and usage costs.

[0007] Some injection system bodies are formed by molding polymers, such as cyclic olefin copolymer ("COC") or cyclic olefin polymer ("COP"). Molding injection system bodies is a cost-effective and high-throughput method of manufacturing injection system components with acceptable error rates.

[0008] Exemplary safety injection systems (e.g., systems having a polymeric injection system body) include a needle retraction system. Some needle retraction systems include a needle lock assembly that releasably / temporarily couples the needle assembly to a needle hub (and the injection system body / syringe body coupled thereto) until the needle lock assembly disengages, allowing the needle assembly to be at least partially retracted into the injection system body / syringe body. The needle lock assembly typically remains locked and secured throughout the injection process, during which a proximally directed / proximally directed force of 0.25 lbf (pounds-force) to 0.5 lbf may be applied to the needle assembly during penetration of the patient's skin. Retracting the needle assembly causes the distal end of the sharpened needle within the needle hub or injection system body / syringe body to move to prevent accidental needle sticks. Some existing needle retraction systems include numerous components that increase system cost and manufacturing / assembly complexity.

[0009] There is a need for a needle retraction system and components thereof that address the shortcomings of currently available configurations. Specifically, there is a need for a needle lock assembly having a reduced number of parts while maintaining the ability to releasably / temporarily couple the needle assembly to the needle hub. There is also a need for a means for fixedly coupling the needle hub or needle attachment interface to the body of the injection system. Addressing these and other limitations of needle retraction systems allows for a cost-effective and easily manufactured needle retraction system to be incorporated into a safer injection system. Summary of the Invention

[0010] Various embodiments relate to an injection system. Specifically, the embodiments relate to a safety injection system having a needle lock assembly and a needle hub coupling device that has a small number of parts (e.g., one or two) to reduce cost and simplify manufacturing / assembly.

[0011] In one embodiment, a safety injection system includes an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof. The system also includes a stop member disposed within the injection system body interior space. The system also includes a plunger member configured to be manipulated to insert the stop member relative to the injection system body. Furthermore, the system includes a needle hub assembly coupled to the needle attachment interface. The needle hub assembly includes a needle hub defining a locking space at a distal end thereof, a needle lock defined by the needle hub within the locking space, and a needle removably coupled to the needle hub via the needle lock.

[0012] In one or more embodiments, the needle lock includes a distally extending arm extending from the needle hub body at a hinge, the distally extending arm being configured to rotate about the hinge away from the needle. The arm may define an inwardly and proximally facing bevel. The needle may define an expanded diameter section configured to apply a distally directed force / distal force on the inwardly and proximally facing bevel to rotate the distally extending arm about the hinge away from the needle. The distally extending arm may rotate and elastically or plastically deform. The needle may define a reduced diameter section configured to interfere with the distally extending arm to removably couple the needle to the needle hub.

[0013] In one or more embodiments, the arm defines an outwardly and distally facing bevel. The needle can define an outwardly and proximally facing bevel that is configured to interfere with the outwardly and distally facing bevel of the arm to prevent the needle from moving proximally relative to the needle hub. The needle hub can define a window that is configured to allow the distal end of the arm in the locking space to be observed from the outside of the needle hub. The needle lock can be configured to open when a proximally facing force of less than 3 lbf is applied to the needle. The needle lock can be configured to prevent opening when a proximally facing force of less than 0.25 lbf is applied to the needle. In an alternative embodiment, the proximally facing force applied to the needle required to open the needle lock can be configured to be greater than 1 lbf and / or less than 2.5 lbf.

[0014] In one or more embodiments, the system includes a backing component that is partially located within the interior space of the injection system body and partially located within the needle hub, the backing component including an enlarged diameter proximal portion disposed within the interior space of the injection system body and a reduced diameter distal portion disposed within the needle hub. The backing component may include a distal end configured to seal after the needle is proximally retracted past the distal end of the backing component. The enlarged diameter proximal portion may define a plurality of external ribs. The enlarged diameter proximal portion may have a star-shaped cross-section. The enlarged diameter proximal portion may define a plurality of chamfered edges.

[0015] In one or more embodiments, the system includes a compression ring for securing the needle hub assembly to the needle attachment interface. The needle hub may define a needle hub snap, and the compression ring may define a mounting snap configured to interfere with the needle hub snap to couple the compression ring and the needle hub. The compression ring may define a plurality of internal extrusion ribs on an inner surface thereof. The plurality of internal extrusion ribs may be configured to accommodate variability of other components of the system during assembly. The needle hub may define a plurality of external extrusion ribs on an outer surface thereof. The plurality of external extrusion ribs may be configured to accommodate variability of other components of the system during assembly.

[0016] In one or more embodiments, the needle hub includes a retaining ring having a living hinge formed at its proximal end. The retaining ring can be configured to bend proximally about the living hinge to facilitate mounting the needle hub on the needle attachment interface. The needle attachment interface can include a protrusion configured to interfere with the retaining ring under the action of a radially inward force from the compression ring to couple the needle hub to the needle attachment interface.

[0017] In another embodiment, a safety injection system includes an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle hub assembly at a distal end thereof. The system also includes a stop member disposed in the injection system body interior space. The system also includes a plunger member configured to be manipulated to insert the stop member relative to the injection system body. Furthermore, the system includes a backing component having a proximal portion with an increased diameter disposed in the injection system body interior space and a distal portion with a reduced diameter disposed in the needle hub. The needle hub assembly includes a needle hub having a reduced diameter distal portion, and a needle defining a reduced diameter section configured to interfere with the reduced diameter section of the backing component located in the reduced diameter distal portion of the needle hub to removably couple the needle to the needle hub.

[0018] In another embodiment, an injection system includes an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof. The system also includes a stop member disposed within the injection system body interior space. The system also includes a plunger member configured to be manipulated to insert the stop member relative to the injection system body. Furthermore, the system includes an interface ring defining an internal thread. Furthermore, the system includes a compression ring configured to slide proximally over the interface ring and apply a radially inward force to secure the interface ring to the needle attachment interface.

[0019] In one or more embodiments, the interface ring defines a side opening, and the compression ring defines an inwardly facing tongue disposed in the side opening to couple the compression ring and the interface ring. The compression ring may define an external protrusion configured to increase a user's grip on the compression ring.

[0020] In another embodiment, a method of assembling a safety injection system includes threading a backing component onto a needle by inserting the needle distally onto the backing component, wherein the backing component includes a proximal portion having an enlarged diameter and a distal portion having a reduced diameter. The method also includes distally inserting the needle and the backing component therethrough into a needle hub. The method further includes mounting the needle, backing component, and needle hub onto an injection system body having a needle attachment interface at its distal end by inserting the proximal end of the needle into a distal opening of the injection system body and attaching the needle hub to the needle attachment interface. The method also includes inserting a stop member into an interior of the injection system body. The method also includes coupling a plunger member to the stop member.

[0021] In one or more embodiments, attaching the needle hub to the needle attachment hub includes sliding a compression ring over the proximal end of the needle hub to apply a radially inward force to the proximal end of the needle hub and the needle attachment hub.

[0022] In another embodiment, a safe injection system includes an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof. The system also includes a stop member disposed within the injection system body interior space. The system further includes a plunger member configured to be manipulated to insert the stop member relative to the injection system body. Furthermore, the system includes a needle hub assembly coupled to the needle attachment interface. The needle hub assembly includes a needle hub defining a locking space at a distal end thereof, a needle lock defined by the needle hub within the locking space, and a needle removably coupled to the needle hub via the needle lock. The needle hub defines a clamping ring having radially inwardly extending compression ribs near its proximal end.

[0023] In one or more embodiments, the needle attachment interface defines a circumferential neck configured to accommodate radially inwardly extending compression ribs when the needle hub assembly is coupled to the needle attachment interface. The system can include a compression ring configured to secure the needle hub assembly to the needle attachment interface. The needle hub can define a needle hub buckle. The compression ring can define a mounting buckle configured to interfere with the needle hub buckle to couple the compression ring and the needle hub.

[0024] In one or more embodiments, the compression ring is configured to apply a radially inward force to an outer surface of the clamping ring when the compression ring is coupled to the needle hub. The outer surface of the clamping ring may define a plurality of substantially flat surfaces and a plurality of arcuate surfaces. The compression ring and the clamping ring may be configured such that when the compression ring is coupled to the needle hub, the compression ring applies a radially inward force to the plurality of arcuate surfaces of the outer surface of the clamping ring. When the compression ring is coupled to the needle hub, a substantially flat surface of the plurality of substantially flat surfaces may align with a structurally weak portion of the compression ring.

[0025] In one or more embodiments, the compression ring has a distal unlocked configuration in which the compression ring is not coupled to the needle hub. The compression ring can have a proximal locked configuration in which the compression ring is coupled to the needle hub. The radially inward portion of the radially inwardly extending compression rib can be configured to be compressed when the compression ring moves from the distal unlocked configuration to the proximal locked configuration. The needle hub can define a counterbore / counter bore configured to receive the proximal portion of the needle attachment interface while maintaining a gap between an outer surface of the proximal portion of the needle attachment interface and an inner surface of the counterbore.

[0026] In another embodiment, a safety injection system includes an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof. The system also includes a stop member disposed within the injection system body interior space. The system also includes a plunger member configured to be manipulated to insert the stop member relative to the injection system body. Furthermore, the system may include a needle hub assembly coupled to the needle attachment interface. The needle hub assembly includes a needle hub defining a locking space at its distal end, a needle lock defined by the needle hub within the locking space, and a needle removably coupled to the needle hub via the needle lock. Furthermore, the system includes a compression ring configured to secure the needle hub assembly to the needle attachment interface. The compression ring defines a proximal-facing surface and a distal-facing surface configured to facilitate or restrict movement of the compression ring and the safety injection system within the autoinjector housing.

[0027] In one or more embodiments, the compression ring defines a radially outwardly facing surface for aligning the compression ring and the safety injection system within the autoinjector housing.

[0028] In another embodiment, an autoinjector includes an autoinjector housing and a disposable injection device. The disposable injection device includes an injection device body defining a proximal opening at a proximal end thereof, an injection device body interior space, and a needle attachment interface at a distal end thereof. The disposable injection device also includes a stop member disposed within the injection device body interior space. The disposable injection device also includes a plunger member configured to be manipulated to insert the stop member relative to the injection device body. Furthermore, the disposable injection device includes a needle hub assembly coupled to the needle attachment interface. The needle hub assembly includes a needle hub defining a locking space at its distal end, a needle lock defined by the needle hub within the locking space, and a needle removably coupled to the needle hub via the needle lock. Furthermore, the disposable injection device includes a compression ring configured to secure the needle hub assembly to the needle attachment interface. The compression ring defines a proximally facing surface and a distally facing surface, the proximally facing surface being configured to limit proximal movement of the compression ring and the safety injection device within the auto-injector housing, the distally facing surface being configured to limit distal movement of the compression ring and the safety injection device within the auto-injector housing.

[0029] In one or more embodiments, the automatic syringe housing defines a distal space for accommodating the needle hub and the compression ring. The automatic syringe housing may define a pair of locking members that define the distal space. Each of the pair of locking members may define a respective distal-facing surface that is configured to interfere with the proximal-facing surface of the compression ring to limit proximal movement of the compression ring and the safety injection device within the distal space of the automatic syringe housing. The automatic syringe housing may define a distal protrusion that defines the distal space. The distal protrusion may define a proximal-facing surface that is configured to interfere with the distal-facing surface of the compression ring to limit distal movement of the compression ring and the safety injection device within the distal space of the automatic syringe housing. The compression ring may define a radially outward surface that is configured to align the compression ring and the safety injection system within the distal space defined by the automatic syringe housing.

[0030] In another embodiment, a method for performing a safety injection using a safety injection system includes inserting a disposable injection device into an autoinjector housing until a proximal surface of a compression ring contacts corresponding distal surfaces of a pair of locking elements, thereby securing the compression ring of the safety injection device within a distal space of the autoinjector housing. The method also includes removing a rigid needle shield from a distal end of the autoinjector housing to expose a sharp distal end of the needle. The method also includes depressing an activation button of the autoinjector housing to release a main spring of the autoinjector housing, thereby distally moving the disposable injection device until a distally facing surface of the compression ring contacts a proximal facing surface of a distal protrusion. Furthermore, the method includes causing the main spring to distally move a plunger member to distally insert a stop member relative to an injection device body. Furthermore, the method includes continuing to distally move the plunger member to distally insert the stop member into the distal end of the injection device body, thereby releasing a retraction spring lock in the plunger member of the disposable injection device. The method also includes releasing the retraction spring lock to allow a retraction spring in the plunger member to pull the needle proximally until the sharpened distal end of the needle is disposed in the needle hub.

[0031] These and other embodiments of the invention are described in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The following drawings are for illustration purposes only. The drawings are not intended to limit the scope of the present disclosure. The foregoing and other aspects of the embodiments are described in more detail with reference to the accompanying drawings, in which the same elements in different drawings are designated by common reference numerals, wherein:

[0033] Figures 1A to 5C Various aspects of a conventional syringe configuration are shown.

[0034] Figure 6 is a side view of a safety injection system before an injection is completed, according to some embodiments.

[0035] Figure 7 According to some embodiments Figure 6 A longitudinal cross-sectional view of the safety injection system is shown after the injection is complete and the needle assembly is retracted into the interior of the plunger member.

[0036] Figure 8 and Figure 9 Detailed side and longitudinal cross-sectional views depict a needle hub assembly according to some embodiments coupled to a needle attachment interface of an injection system / syringe body.

[0037] Figures 10 to 12 Two perspective views and a photograph of the distal end of a needle hub according to some embodiments ( Figure 12 ), the distal end defining a locking space and an integral needle lock assembly disposed therein.

[0038] Figure 13 is a perspective view of the distal end of a needle hub according to some embodiments.

[0039] Figure 14 and Figure 15 are side views and detailed side views depicting a needle hub to which a needle assembly is removably coupled via a needle lock assembly, thereby forming a needle hub assembly according to some embodiments.

[0040] Figure 16 and Figure 17 A detailed longitudinal cross-sectional view and detailed photograph depict a needle assembly removably coupled to a needle hub via a needle lock assembly, thereby forming a needle hub assembly according to some embodiments.

[0041] Figure 18 and Figure 19 is a detailed longitudinal cross-sectional view depicting the assembly of the needle hub assembly 610 according to some embodiments.

[0042] 20A to 20C A spacer component for use in a needle hub assembly according to some embodiments is depicted in side view, longitudinal cross-sectional view, and perspective view.

[0043] Figure 21 and Figure 22 Before the needle assembly is retracted into the needle seat ( Figure 21 ) and after ( Figure 22 ) is a detailed longitudinal cross-sectional view of the needle seat assembly.

[0044] Figures 23A to 23C 1 and 2 are side views, longitudinal cross-sectional views, and perspective views of a spacer component 2100 for a needle hub assembly according to other embodiments.

[0045] Figure 24A and 24B A needle hub assembly according to some embodiments is depicted in longitudinal cross-section and detailed longitudinal cross-section.

[0046] Figure 25 A longitudinal cross-sectional view of a needle hub assembly according to some embodiments is depicted.

[0047] Figure 26A and Figure 26B A longitudinal cross-sectional view and a detailed longitudinal cross-sectional view of a needle hub assembly according to some embodiments are depicted.

[0048] Figure 27A 、 Figure 27B and Figure 27C A longitudinal cross-sectional view of the needle hub assembly is depicted.

[0049] 28A to 28D 、 29A to 29D as well as 30A to 30DSchematic diagrams depict three methods of assembling the needle hub assembly 2610 according to some embodiments.

[0050] Figure 31 1 is a schematic perspective view depicting a spacer component for use in a needle hub assembly including a needle lock assembly according to some embodiments.

[0051] Figure 32 is a schematic diagram depicting a needle hub assembly according to some embodiments, comprising a needle hub and a needle lock assembly configured to removably couple a needle assembly to the needle hub.

[0052] Figure 33 is a schematic diagram of a needle hub assembly according to some embodiments, which includes a needle hub and a spacer component disposed therein.

[0053] Figure 34A and Figure 34B is a schematic diagram depicting a method of assembling a needle hub assembly 610 according to some embodiments.

[0054] Figure 35 and Figure 36 Depicted in perspective exploded view and partially exploded side view are a needle hub assembly including a spacer component and a compression ring according to some embodiments.

[0055] Figure 37 and Figure 38 are distal and proximal perspective views of a compression ring according to some embodiments.

[0056] Figure 39 is a distal perspective view of a compression ring according to some embodiments.

[0057] Figures 40 to 42 A needle hub configured for use with a compression ring according to some embodiments is depicted in side, longitudinal, and perspective views.

[0058] Figure 43A and Figure 43B , in side and longitudinal cross-sectional views, depict a needle hub according to some embodiments having a clamping ring that bends / flexes proximally about a living hinge.

[0059] Figure 44 is a perspective view of a needle hub for use with a compression ring according to some embodiments.

[0060] Figures 45 to 50 Depicted are methods, according to some embodiments, of coupling a needle hub assembly to a needle attachment interface of a syringe body using a compression ring to form a safety injection system.

[0061] Figure 51An interface ring, according to some embodiments, is shown that is configured to couple to a needle attachment interface of a syringe body, thereby providing an internally threaded interface for a needle hub.

[0062] Figure 52 Depicted is a compression ring configured to slide proximally over the hub ring and apply a radially inward force to couple the hub ring to the needle attachment hub, according to some embodiments.

[0063] Figures 53 to 57 Depicted are methods according to some embodiments of coupling an interface ring to a needle attachment interface of a syringe body using a compression ring to provide an internally threaded interface for a needle hub.

[0064] Figure 58 Injection system 5800 is depicted as a partially exploded side view, according to some embodiments.

[0065] Figure 59 is a detailed side view of the distal end of a syringe body according to some embodiments.

[0066] Figure 60 is a side view depicting the injection system after the needle hub assembly is installed on the syringe body, according to some embodiments.

[0067] Figure 61A and 61B 1 are side and longitudinal cross-sectional views of a fully assembled injection system in its transport / storage configuration according to some embodiments.

[0068] Figure 62A and 62B are side views of a needle hub assembly according to some embodiments, wherein the compression ring is in a distal unlocked state ( Figure 62A ) and proximal locking state ( Figure 62B ).

[0069] Figure 63A and Figure 63B are longitudinal sectional views of needle hub assemblies according to some embodiments, wherein the compression ring is in a distal unlocked state ( Figure 63A ) and proximal locking state ( Figure 63B ).

[0070] Figure 64A and 64B are detailed longitudinal sectional views of needle hub assemblies according to some embodiments, wherein the compression ring is in a distal unlocked state ( Figure 64A ) and proximal locking state ( Figure 64B ).

[0071] Figure 65A and 65Bare longitudinal cross-sectional views of a needle hub assembly 5810 mounted on a syringe body according to some embodiments, wherein the compression ring is in a distal unlocked configuration ( Figure 65A ) and proximal locking configuration ( Figure 65B ).

[0072] Figure 66 is a detailed longitudinal cross-sectional view depicting a needle hub assembly mounted on a needle attachment hub of a syringe body with the compression ring in a proximal locked configuration, according to some embodiments.

[0073] Figure 67 and Figure 68 1 and 2 are front and rear perspective views of a compression ring 6700 according to some embodiments.

[0074] Figure 69 is a rear perspective view depicting a needle hub according to some embodiments.

[0075] Figure 70 is an axial cross-sectional view of a clamping ring secured around the neck of a syringe body by a compression ring, according to some embodiments.

[0076] Figure 71 FIG. 1 is a force diagram illustrating a needle hub coupled to a syringe body via a compression ring according to some embodiments.

[0077] Figure 72 is a rear perspective view of an autoinjector housing 7200 according to some embodiments.

[0078] Figure 73 is an exploded view of an autoinjector according to some embodiments.

[0079] Figure 74 is a longitudinal cross-sectional view of an autoinjector in a transport / storage configuration according to some embodiments.

[0080] Figure 75 and Figure 76 is a longitudinal cross-sectional view and a detailed longitudinal cross-sectional view, depicting an autoinjector in a ready configuration according to some embodiments.

[0081] Figure 77 and Figure 78 2 is a longitudinal cross-sectional view and a detailed longitudinal cross-sectional view of an autoinjector in an injection-complete configuration according to some embodiments.

[0082] Figure 79 and Figure 80 are longitudinal section views and detailed longitudinal section views depicting an autoinjector in a needle retracted / safety configuration according to some embodiments.

[0083] To better understand how the above and other advantages and objectives of various embodiments are achieved, embodiments are described in more detail with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements of similar structure or function are represented by similar reference numerals throughout. It should be understood that these drawings depict only certain illustrative embodiments and are not to be considered as limiting the scope of the embodiments. DETAILED DESCRIPTION

[0084] Exemplary Safety Injection System

[0085] Figure 6 FIG. 6 is a side view illustrating a safe injection system 600 according to some embodiments before an injection is completed. The safe injection system 600 includes a needle hub assembly 610 coupled to an injection system body / syringe body 650. The needle hub assembly 610 may be used as shown in FIG. Figure 6 and Figure 7 The snap ring shown or Figure 8 and 9 The compression ring 3500 is shown coupled to the injection system body / syringe body / syringe barrel 650. The syringe body 620 can be a glass syringe body or a molded polymer syringe body. The needle hub assembly 610 includes a needle assembly 630. The safe injection system 600 also includes a stop member 660 disposed in the interior space 652 of the syringe body 650, and a plunger member 670 coupled to the stop member 660.

[0086] Figure 7 for Figure 6 A longitudinal cross-sectional view of a safety injection system 600 is shown. After an injection is completed, the needle assembly 630 is retracted into the interior space 672 of the plunger member 670 to protect the system 600 from accidental needle sticks. The safety injection system 600 includes a needle retraction system 680, which includes a needle catcher 682, a spring 684, and a spring lock 686. The needle catcher 682 is configured to receive and couple to the proximal end 632 of the needle assembly 630 for retracting the needle assembly 630. When released by the spring lock 686, the spring 684 exerts a proximal force on the needle assembly 630 after the injection is completed, pulling the needle assembly 630 at least partially into the needle hub assembly 610, the syringe body 620, and / or the plunger member 670. This causes the sharp distal end 634 of the needle assembly 630 to be disposed within the needle hub assembly 610, the syringe body 620, and / or the plunger member 670, thereby preventing accidental needle sticks. In some embodiments, the proximal force is from about 2 lbf (pounds-force) to about 3 lbf.

[0087] Needle hub assembly 610 includes an integral needle lock assembly 620 formed / defined integrally by needle hub assembly 610. Needle lock assembly 620 is configured to releasably couple needle assembly 630 to needle hub assembly 610 in a locked configuration. In the locked configuration, needle lock assembly 620 prevents needle assembly 630 from moving relative to needle hub assembly 610 and syringe body 650 coupled thereto. When needle lock assembly 620 transitions from the locked configuration to the unlocked configuration, needle assembly 630 is no longer coupled to needle hub assembly 610 and is therefore free to move relative to needle hub assembly 610 and syringe body 650. In other words, in the unlocked configuration, needle lock assembly 620 allows needle assembly 630 to be at least partially retracted into needle hub assembly 610, syringe body 620, and / or plunger member 670, as described above.

[0088] Exemplary Needle Hub Assembly

[0089] Figure 8 and Figure 9 A needle attachment interface 654 is coupled to an injection system / syringe body 650 according to some embodiments (see Figure 9 ) are detailed side and longitudinal cross-sectional views of a needle hub assembly 610 of the present invention. The needle hub assembly 610 includes a needle hub 612, a needle assembly 630 having a sharp distal end 634, and an integral needle lock assembly 620 that removably couples the needle assembly 630 to the needle hub 612. The needle assembly also includes a needle distal cannula 635 that conforms to a hypodermic needle gauge system. The needle gauge can range from 34 gauge to 10 gauge. According to some embodiments, a typical needle for an injection system is 27 gauge x 1 / 2" (inch) long. The higher the needle gauge, the smaller the diameter. The needle hub 612 defines an outer annular groove 614 that is configured to facilitate removable coupling of a rigid needle shield (not shown) to the needle hub 612. The needle hub assembly 610 also includes a spacer component 3100 and a compression ring 3500. Various embodiments of the integral needle lock assembly 620, spacer component 2000, and compression ring 3500 are depicted and described herein (e.g., see Figure 9 )

[0090] Exemplary integrated needle lock assembly

[0091] Figures 10 to 12 FIG2 is a perspective view and a photograph of the distal end of a needle hub 612 according to some embodiments, wherein the needle hub 612 defines a locking space 616 and an integral needle lock assembly 620 disposed in the locking space 616. The needle lock assembly 620 can be formed during the injection molding process of the needle hub 612 of the needle hub assembly 610. The needle lock assembly 620 includes a pair of distally extending arms 622 configured to rotate about a hinge 624 (also defined by the needle hub 612) to allow the needle assembly 630 (see FIG2 ) to be inserted into the needle hub 612. Figure 18 and 19) is inserted distally at least partially through needle lock assembly 620, thereby connecting needle assembly 630 to needle hub assembly 610.

[0092] The needle hub 612 is further provided with a pair of distally facing columns 626 for guiding the needle assembly 630 at least partially through the distal opening 618 of the needle hub 612 during assembly. The distally facing columns 626 are configured to provide an extended internal funnel-shaped surface for guiding / aligning the needle assembly 630 into position during assembly. In some alternative embodiments, the needle hub 612 can also be formed without the distally facing columns. The needle hub 612 further defines a pair of windows 611 configured to allow visual confirmation of the removable coupling of the needle assembly 630 and the needle hub 612.

[0093] Figure 13 FIG is a perspective view of the distal end of the needle hub 612′ according to some embodiments. The needle hub 612′ is similar to Figures 10 to 12 One difference between hub 612' and hub 612 is that hub 612' further defines a pair of proximally facing posts 628 configured to guide needle assembly 630 at least partially distally through distal opening 618 defined by hub 612 during assembly.

[0094] Figure 14 and Figure 15 Depicted in side and detailed side views are needle hub 612 to which needle assembly 630 is removably coupled via needle lock assembly 620 , thereby forming needle hub assembly 610 , according to some embodiments. Figure 16 and Figure 17 is a detailed longitudinal cross-sectional view and detailed photograph depicting needle assembly 630 removably coupled to needle hub 612 via needle lock assembly 620 to form needle hub assembly 610 according to some embodiments.

[0095] like Figure 16As shown, the needle assembly 630 defines a reduced diameter section / recess 636 in which the respective distal ends of the distally extending arms 622 are disposed, and the respective distal ends of the distally extending arms 622 interfere with the section / recess 636 to removably couple the needle assembly to the needle hub 612. The reduced diameter section 636 can be an annular groove. As shown, the annular groove can be formed in the needle assembly 630, or for large diameter needles, the annular groove can be integrally formed in the needle distal cannula 635. Each distally extending arm 622 also defines an inwardly and proximally facing ramp 621 that is configured to receive a distally directed force applied by the expanded diameter section 638 defined by the needle assembly 630, causing the distally extending arm 622 to rotate about the hinge 624 away from the needle assembly 630 during assembly of the needle hub assembly 610 (see Figure 18 and Figure 19 ).

[0096] Each distally extending arm 622 further defines an outwardly and distally facing ramp 623. Reduced diameter section 636 defines an outwardly and proximally facing ramp 631. Outwardly and distally facing ramps 623 of distally extending arms 622 are configured to interfere with outwardly and proximally facing ramps 631 of reduced diameter section 636 to prevent needle assembly 630 from moving proximally of needle hub 612. During assembly of needle assembly 630 into needle hub assembly 610, hinge 624 elastically deforms, thereby allowing the arm 622 of the corresponding hinge 624 to quickly return to contact between proximally and distally facing ramps 631 and 623. Due at least in part to the interference between the two ramps 623, 631, the needle assembly 630 is configured to remain coupled to the needle hub 612 during an injection (including inserting the needle into a patient), which in some embodiments can apply a proximal force of up to 0.25 lbf to 0.5 lbf to the needle assembly 630. Furthermore, in some embodiments, the needle lock 620 is configured to remain locked during an injection under a proximal force of up to 0.25 lbf to 0.5 lbf applied to the needle assembly 630. The needle lock 620 is configured to be unlocked with a proximal force of less than 3 lbf applied to the needle assembly 630 (e.g., by a spring 684) to allow the needle assembly 630 to be retracted after the injection. To accommodate needles exhibiting higher patient penetration forces (e.g., 18 gauge), needle lock 620 can be configured to remain locked at forces of up to 0.25 lbf to 2.5 lbf to ensure that the needle remains securely in place during an injection. Needle lock 620 can be configured to unlock with a proximal force of less than 5 lbf applied to needle assembly 630 (e.g., via spring 684) to allow needle assembly 630 to be retracted after an injection.

[0097] Figure 18 and Figure 19 Assembly of the hub assembly 610 is shown in accordance with some embodiments. Figure 18 A state prior to the needle assembly 630 being removably coupled to the hub 612 during assembly of the hub assembly 610 is shown. As a distally directed force is applied to the needle assembly 630 relative to the hub 612, the distally extending arms 622 are rotated about the hinges 624 away from the needle assembly 630, opening the needle lock 620, as a distally directed force is applied to the inwardly and proximally facing ramp 621 of the arm 622 by the diameter expanding section 638 defined by the needle assembly 630. Opening the needle lock allows the needle assembly 630 to move distally relative to the hub 612 to place the distal end of the arms 622 in the diameter reducing section / notch 636 (see Figure 19 ).

[0098] Exemplary gasket components

[0099] 20A to 20C A side view, a longitudinal cross-sectional view, and a perspective view of a grommet component 2000 for a hub assembly (not shown) in accordance with some embodiments is shown. The grommet component 2000 includes a diameter expanding proximal portion 2010 and a diameter reducing distal portion 2050.

[0100] The diameter expanding proximal portion 2010 defines a plurality of external ribs 2012. The plurality of external ribs 2012 are configured to form a fluid-tight seal with the distal end of the syringe body 650 (see Figure 21 ). The external ribs 2012 are also configured to allow the grommet component 2000 to compress uniformly at the interface of the syringe body 650 and the grommet component 2000, thereby minimizing and / or preventing leakage of plasticizer / mineral oil (e.g., from the TPE elastomer used to manufacture the grommet component 2000) as the grommet component 2000 is compressed. The external ribs 2012 give the diameter expanding proximal portion 2010 a star-shaped longitudinal cross-section. Furthermore, the outer diameter 2014 defined by the external ribs 2012 is configured to mate with the inner surface of the hub 612 to align the longitudinal axis 2016 of the grommet component 2000 and the longitudinal axis 633 of the proximal end 632 of the needle assembly 630 with the longitudinal axis 619 of the hub 612. This alignment of the proximal end 632 of the needle assembly 630 facilitates automatic assembly of the hub assembly 610 to the syringe body 650 and automatic penetration of the proximal end 632 of the needle assembly 630 within the inner diameter of the distal end of the syringe body 650.

[0101] As Figure 20B , Figure 21 and Figure 22As shown, the grommet component 2000 also defines a distal end 2052 that is resiliently openable to allow the distal end of the needle assembly 630 to pass therethrough during assembly of the hub assembly 610. When the needle assembly 630 is partially disposed in the grommet component 2000, the distal end 2052 of the grommet component 2000 is also biased to close to form a fluid-tight seal around the needle assembly 630. This fluid-tight seal maintains the flow of the injectable fluid from inside the syringe body 650 only through the needle assembly 630 and not around the needle assembly 630. Upon withdrawal of the needle assembly 630 from the proximal end of the grommet component 2000, the distal end 2052 of the grommet component 2000 is further biased to close to form a fluid-tight seal (see Figure 22 ).

[0102] Figures 23A to 23C is a side view, a longitudinal cross-sectional view, and a perspective view of a grommet component 2300 for a hub assembly (not shown) according to some other embodiments. The grommet component 2300 includes a proximal portion 2310 of enlarged diameter and a distal portion 2350 of reduced diameter. The grommet component 2300 also defines a distal end 2352 Figure 23B ). The proximal portion 2310 of enlarged diameter defines a plurality of chamfers / bevels 2312. The plurality of external chamfers 2312 are configured to form a fluid-tight seal with the distal end of the syringe body. The external chamfers 2312 are also configured to allow uniform compression of the grommet component 2300 at the interface of the syringe body 650 and the grommet component 2300 (see Figure 21 ), thereby minimizing and / or preventing the leakage of plasticizer / mineral oil when the grommet component 2300 is compressed.

[0103] Figure 24A and Figure 24B is a longitudinal cross-sectional view and a detailed longitudinal cross-sectional view of a hub assembly 2410 according to some embodiments. Figure 24A and Figure 24B The difference between the hub assembly 2410 shown and the hub assembly 610 shown in Figures 6 to 22 is that there is no unique needle lock assembly 620 in the hub assembly 2410 (see Figures 6 to 22 ). Instead, a grommet component 2420 disposed in the hub 2412 of the hub assembly 2410 performs the function of removably coupling the needle assembly 630 to the hub 2412.

[0104] The backing component 2420 includes an expanded diameter proximal portion 2421 and a reduced diameter distal portion 2425. The needle assembly 630 defines a reduced diameter section / recess 636, which can be an annular groove. The reduced diameter distal portion 2425 of the backing component 2420 and the needle assembly 630 are configured (e.g., sized and shaped) such that fully inserting the backing component 2420 and the needle assembly 630 into the needle hub 2412 exerts a radially inward force on the reduced diameter distal portion 2425 of the backing component 2420 to squeeze the distal end portion 2426 of the reduced diameter distal portion 2425, which is composed of a resilient material, into the reduced diameter section 636 of the needle assembly 630, thereby removably coupling the needle assembly 630 to the needle hub 2412. The reduced diameter distal portion 2425 of the backing component 2420 and the needle assembly 630 are also configured such that the needle assembly 630 remains coupled to the needle hub 2412 until a predetermined amount of proximally directed force (e.g., between 0.25 lbf and 3 lbf) is applied to the needle assembly 630 relative to the needle hub 2412.

[0105] Figure 25 FIG2 is a longitudinal cross-sectional view of a needle hub assembly 2510 according to some embodiments. The backing component 2520 includes an enlarged diameter proximal portion 2521 and a reduced diameter distal portion 2525. The reduced diameter distal portion 2525 of the backing component 2520 is longitudinally longer than the reduced diameter distal portion 2425 of the backing component 2420. The needle hub 2512 defines a similar distal space 2514 to accommodate the reduced diameter distal portion 2525 of the backing component 2520. The increased longitudinal length of the reduced diameter section 2525 of the backing component 2520 increases the friction between the backing component 2520 and the needle assembly 630. Therefore, the lengths of the reduced diameter section 2525 and the distal space 2514 of the needle hub 2512 can be adjusted to adjust the amount of proximal force required to remove the needle assembly 630 from the needle hub 2512.

[0106] Figure 26A and Figure 26Bis a longitudinal cross-sectional view and detailed longitudinal cross-sectional view of a needle hub assembly 2610 according to some embodiments. The grommet component 2620 includes a proximal portion 2621 of enlarged diameter and a distal portion 2625 of reduced diameter. The distal portion 2625 of reduced diameter of the grommet component 2620 is longer in the longitudinal direction than the distal portions 2425, 2525 of reduced diameter of the grommet components 2420, 2520. In addition, the distal portion 2625 of reduced diameter of the grommet component 2620 includes a tapered / truncated distal portion 2627 that includes a distal end 2626 of the distal portion 2625 of reduced diameter of the grommet component 2620. The needle hub 2612 defines a distal space 2614 of similar length to accommodate the distal portion 2625 of reduced diameter of the grommet component 2620. In addition, the distal space 2614 includes an inwardly tapered portion 2616 that is configured to receive and apply a radially inward force to the tapered distal portion 2627 of the distal portion 2625 of reduced diameter of the grommet component 2620. Thus, the length of the distal portion 2625 of reduced diameter of the grommet component 2620, the taper of the tapered distal portion 2627 of the grommet component 2620, the length of the needle hub 2612, and the taper of the inwardly tapered portion 2616 of the needle hub 2612 can all be adjusted to adjust the magnitude of the proximally directed force required to remove the needle assembly 630 from the needle hub 2612.

[0107] Figure 27A 、 Figure 27B and Figure 27C are longitudinal cross-sectional views of the needle hub assemblies 2410, 2510, and 2610 described herein. Comparing Figure 27A 、 Figure 27B and Figure 27C demonstrates the differences in the dimensions and shapes of the respective grommet components 2420, 2520, 2620 and the shapes of the respective needle hubs 2412, 2512, 2612.

[0108] Figure 28A 、 Figure 28B 、 Figure 28C and Figure 28D schematically depict a method of assembling the needle hub assembly 2610 according to some embodiments. In Figure 28A , the needle assembly 630 is positioned adjacent the grommet component 2620 in preparation for assembly. In Figure 28B , the needle assembly 630 is distally passed into the grommet component 2620 until the distal end 634 of the needle assembly 630 is located within the grommet component 2620. The needle assembly 630 with the passed-in grommet component 2620 is also positioned adjacent the needle hub 2612 in preparation for assembly. In Figure 28C, the needle assembly 630 with the inserted backing member 2620 is inserted into the needle hub 2612 until the backing member 2620 abuts the distal surface 2616 defining the distal space 2614. The tapered distal portion 2627 of the backing member 2620 and the inwardly tapered portion 2616 of the needle hub 2612 cooperate to guide the needle assembly 630 into the needle hub 2612. The backing member 2620 protects the distal end 634 of the needle assembly 630 during insertion into the needle hub 2612. Figure 28D 26. In the embodiment of the present invention, the needle assembly 630 is further distally passed through the backing member 2620 in the needle hub 2612 until the expanded diameter section 638 defined by the needle assembly 630 abuts the distal end surface 2616 defining the distal space 2614. At this point, the needle assembly 630 is removably coupled to the backing member 2620 as described herein. Although the backing member 2620 shown in these figures is one embodiment, other embodiments may be used when assembling the needle hub assembly. Figures 20A-20C 、 Figures 23A-23C 、 Figures 24A-24B 、 Figure 25 、 Figures 26A-26B and Figure 31 Any of the pad components 2000, 2300, 2420, 2520, 2620 shown in.

[0109] Figure 29A 、 Figure 29B 、 Figure 29C and Figure 29D Schematically depicts a method of assembling the needle hub assembly 2610 according to some embodiments. Figure 29A In FIG, the spacer component 2620 is positioned adjacent to the needle hub 2612 in preparation for assembly. Figure 29B , the backing component 2620 is inserted into the needle hub 2612 until the backing component 2620 abuts the distal surface 2616 defining the distal space 2614. The tapered distal portion 2627 of the backing component 2620 and the inwardly tapered portion 2616 of the needle hub 2612 cooperate to guide the backing component 2620 into the needle hub 2612. The needle assembly 630 is also positioned above the backing component 2620 in the needle hub 2612 in preparation for assembly. Figure 29C In FIG, a proximally facing funnel 2622 defined by spacer component 2620 guides distal end 634 of needle assembly 630 into spacer component 2620. Figure 29D 26. In the embodiment of the present invention, the needle assembly 630 is further distally passed through the backing member 2620 in the needle hub 2612 until the expanded diameter section 638 defined by the needle assembly 630 abuts the distal end surface 2616 defining the distal space 2614. At this point, the needle assembly 630 is removably coupled to the backing member 2620 as described herein. Although the backing member 2620 shown in these figures is one embodiment, other embodiments may be used when assembling the needle hub assembly. Figures 20A-20C、 Figures 23A-23C 、 Figures 24A-24B 、 Figure 25 、 Figures 26A-26B and Figure 31 Any of the pad components 2000, 2300, 2420, 2520, 2620 shown in.

[0110] Figure 30A 、 Figure 30B 、 Figure 30C and Figure 30D Schematically depicts a method of assembling the needle hub assembly 2610 according to some embodiments. Figure 30A In FIG, the spacer component 2620 is positioned adjacent to the needle assembly 630 in preparation for assembly. Figure 30B , the backing member 2620 is inserted distally over the needle assembly 630 until the proximal end 632 of the needle assembly 630 is disposed in the backing member 2620. The distal end 634 of the needle assembly 630 is also inserted distally into the needle hub 2612. Figure 30C , the needle assembly 630 with the inserted spacer component 2620 is further inserted distally into the needle hub 2612 until the expanded diameter section 638 defined by the needle assembly 630 abuts the distal surface 2616 defining the distal space 2614. Figure 30D , the backing member 2620 is further inserted distally over the needle assembly 630 and into the needle hub 2612 until the backing member 2620 abuts the distal end surface 2616 defining the distal space 2614. At this point, the needle assembly 630 is removably coupled to the backing member 2620 as described herein. At this point, the needle assembly 630 is removably coupled to the backing member 2620 as described herein. Although the backing member 2620 shown in these figures is one embodiment, other embodiments may be used when assembling the needle hub assembly. Figures 20A-20C 、 Figures 23A-23C 、 Figures 24A-24B 、 Figure 25 、 Figures 26A-26B and Figure 31 Any of the pad components 2000, 2300, 2420, 2520, 2620 shown in.

[0111] Figure 31 Schematic diagram in perspective, depicting a spacer component 3100 for a needle hub assembly 610 including a needle lock assembly 620 according to some embodiments. Spacer component 3100 is similar to Figure 23A 、 Figure 23B and Figure 23CThe backing component 2300 is shown. The backing component 3100 includes a proximal portion 3110 with an expanded diameter and a distal portion 3150 with a reduced diameter. In addition, the distal portion 3150 with a reduced diameter of the backing component 3100 includes a tapered distal portion 3154. The backing component 3100 also defines a distal end 3152 that is configured to elastically open to allow the distal end of the needle assembly 630 (see FIG. Figure 32 ) is passed distally during assembly of the needle hub assembly 610. When the needle assembly 630 is partially disposed in the backing member 3100, the distal end 3152 of the backing member 3100 is also biased closed to form a fluid-tight seal around the needle assembly 630. This fluid-tight seal ensures that the injectable fluid from the interior of the syringe body 650 flows only through the needle assembly 630, and not around the needle assembly 630. After the needle assembly 630 is proximally withdrawn from the backing member 3100, the distal end 3152 of the backing member 3100 is further biased closed to form a fluid-tight seal.

[0112] Figure 32 Schematically illustrated is a needle hub assembly 610 according to some embodiments, comprising a needle hub 612 and a needle lock assembly 620 configured to removably couple a needle assembly 630 to the needle hub 612. The needle hub 612 defines a distal space 613 sized and shaped to receive the reduced diameter distal portion 3150 of the spacer component 3100.

[0113] Figure 33 Schematically depicted is a needle hub assembly 610 according to some embodiments, comprising a needle hub 612 and a backing member 3100 disposed therein. The needle hub assembly 610 is coupled to a syringe body 650.

[0114] Figure 34A and 34B A method of assembling a needle hub assembly 610 according to some embodiments is schematically described. Figure 34A In FIG, the spacer component 3100 is passed from the proximal end to the distal end 634 of the needle assembly 630. The spacer component 3100 and the needle assembly 630 are positioned near the needle hub 612 in preparation for assembly. Figure 34B , the spacer component 3100 and the needle assembly 630 are inserted distally into the needle hub 612 until the enlarged diameter proximal portion 3110 of the spacer component 3100 abuts the shoulder 615 in the needle hub 612 and the enlarged diameter portion 638 defined by the needle assembly 630 abuts the distal end surface 617 in the needle hub 612 (see FIG. Figure 32 ). At this point, the needle assembly 630 is removably coupled to the spacer component 3100, as described herein. Figures 33 to 34BAs shown, the spacer component 3100 can be used in a needle hub assembly 610 that is configured to be coupled to a needle attachment interface 654 of a syringe body 650 using a metal clamp (see FIG. Figure 9 )superior.

[0115] Exemplary Compression Ring

[0116] Figure 35 and Figure 36 FIG2 is a perspective exploded view and a partially exploded side view of a needle hub assembly 610 according to some embodiments, which includes a needle hub 4012 having an integral needle lock assembly 4020, a needle assembly 630, and a spacer component 2000. The needle hub assembly also includes a compression ring 3500 configured to couple the needle hub assembly 4010 to the needle attachment interface 654 of the syringe body 650 (see FIG2 ). Figure 9 and Figure 43). The compression ring 3500 is an optional embodiment for coupling the needle hub assembly 4010 to the needle attachment interface 654 of the syringe body 650 (see Figure 9 and 43). Figure 35 and Figure 36 Also depicted is a rigid needle shield 100 that is configured to be removably coupled to the needle hub assembly 4010 .

[0117] Figure 37 and Figure 38 35 is a distal and proximal perspective view of a compression ring 3500 according to some embodiments. The compression ring defines an inner diameter 3540, an outer diameter 3530, a distal-facing surface 3522, and a proximal-facing surface 3512. The compression ring 3500 defines two pairs of temporary / preset snaps 3510 that are configured to removably position the compression ring 3500 on the needle hub 4012 in a distal position during assembly. The compression ring 3500 also defines a pair of opposing mounting snaps 3520 that are configured to couple the compression ring 3500 to the needle hub 4012 in a proximal position to complete assembly.

[0118] Figure 39 is a distal perspective view of a compression ring 3900 according to some embodiments. The compression ring 3900 defines two pairs of temporary snaps 3910 that are configured to removably position the compression ring 3900 on the needle hub 4012 in a distal position during assembly. The compression ring 3900 further defines a pair of opposing mounting snaps 3920 that are configured to couple the compression ring 3900 to the needle hub 4012 in a proximal position to complete assembly. The compression ring 3900 further defines a plurality of internal extrusion ribs 3930 that are configured to accommodate / provide tolerance for variability in other components (e.g., the needle hub 4012) during assembly.

[0119] Figures 40 to 42 1 and 2 are side, longitudinal, and perspective views of a needle hub 4012 configured for use with compression rings 3500, 3900, according to some embodiments. Needle hub 4012 defines an integral needle lock assembly 4020, which is similar to integral needle lock assembly 620 defined by needle hub 612 and described herein. Needle hub 4012 also includes a pair of hub catches 4019 configured to interfere with mounting catches 3520, 3920 in compression rings 3500, 3900 to couple compression rings 3500, 3900 to needle hub 4012.

[0120] The needle hub 4012 is further provided with a clamping ring 4090 at its proximal end. The inner diameter of the clamping ring 4090 is configured to be Figure 43A and Figure 43B ) of the needle attachment interface 654 (see Figure 43A and Figure 43B ) forms a snap fit on a radial extension 656 (e.g., a Luer connector protrusion) defined by. Figure 43A and Figure 43B As shown, the clamping ring 4090 defines a pair of living hinges 4092 that are configured to flex to allow the radial extension 656 to pass distally through the clamping ring 4090 during assembly. Figure 43A and Figure 43B 4092 are side and longitudinal cross-sectional views showing a needle hub 4012 having a proximally bent clamping ring 4090 about a living hinge 4092, according to some embodiments. Figure 43A and Figure 43B The needle assembly, spacer assembly, and compression ring are omitted.

[0121] Figure 44 is a perspective view of a needle hub 4012 ′ configured for use with compression rings 3500 , 3900 , according to some embodiments. Figure 44 The needle seat 4012' and Figure 41 The difference between the needle hub 4012 shown in FIG. 43 is that the clamping ring 4090 ′ further defines a plurality of external extrusion ribs 4094 that are configured to accommodate / provide tolerance for variability in other components (eg, the rigid needle shield 100 ) during assembly.

[0122] Figures 45 to 50 The needle hub assembly 4010 is shown coupled to the needle attachment interface 654 of the syringe body 650 using a compression ring 3500 (see FIG. Figure 47 、 Figure 48 and Figure 50 ) to form a method of safe injection system 600. Figure 45 , the needle hub assembly 4010 and the rigid needle shield 100 removably coupled thereto are positioned adjacent the syringe body 650 in preparation for assembly. The compression ring 3500 is positioned distally of the needle hub 4012 and is held in place by a temporary catch 3510. In the distal position, the temporary catch 3510 prevents the compression ring 3500 from moving distally in this "installed on syringe" position.

[0123] Figures 46 to 48 For side view and detailed longitudinal section ( Figure 47 and Figure 48 ), depicting the process of inserting the needle attachment interface 654 of the syringe body 650 into the needle hub assembly 4010. Figure 47 and Figure 48 The following steps are shown: the needle attachment hub 654 is inserted distally into the needle hub assembly 4010 so that the retaining ring 4090 forms a snap fit on the radial extension 656 (e.g., Luer boss) defined by the needle attachment hub 654 of the syringe body 650 (see FIG. Figure 48 ). In this step, the compression ring 3500 is held in a distal position on the needle hub 4012 in the "installed on syringe" position. Also in this step, the retaining ring 4090 can be bent, as described herein, to allow the radial extension 656 to pass distally through the retaining ring 4090.

[0124] Figure 49 and Figure 50 The final step of the method of coupling the needle hub assembly 4010 to the needle attachment interface 654 of the syringe body 650 is depicted in a side view and a detailed longitudinal cross-sectional view. In this final step, the compression ring 3500 is moved proximally on the clamping ring 4090 and reaches a proximal position to complete the assembly. In the proximal position, the compression ring 3500 exerts a radially inward force on the clamping ring 4090, thereby coupling the needle hub 4012 to the needle attachment interface 654 of the syringe body 650 and preventing the needle hub 4012 from being removed therefrom. Figure 49 and Figure 50 In the illustrated configuration, the mounting buckles 3520 of the compression ring 3500 interfere with the hub buckles 4019 of the needle hub 4012 to couple the compression ring 3500 to the needle hub 4012. Figure 49 and Figure 50 Following the final steps shown, the syringe body 650 may be filled with medication (not shown), and a stop member and plunger member (not shown) may be added to complete assembly of the safe injection system 600 .

[0125] In the locked configuration, the inner diameter 3540 of the compression ring 3500 (see Figure 37 ) and the outer diameter 4096 of the clamping ring 4090 (see Figure 40) forms a press fit / interference fit. This interference fit squeezes the clamping ring 4090, causing the inner diameter of the clamping ring 4090 to become smaller, clamping on the distal end of the syringe body 650 to prevent the needle hub assembly 610 from moving distally relative to the syringe body 650.

[0126] In some embodiments, the compression ring 3500 and / or the needle hub 4012 / clamping ring 4090 may be made of an engineering plastic polymer, such as a polycarbonate polymer, PEI (e.g., Ultem (registered trademark)), PEEK, etc. In some embodiments, a reinforcing material, such as glass or carbon fiber, may be added to the engineering plastic polymer forming the compression ring 3500 and / or the needle hub 4012 / clamping ring 4090 to increase its rigidity.

[0127] Exemplary locking threaded collar ring

[0128] Figure 51 An interface ring 5100 is shown according to some embodiments, which is configured to couple to the needle attachment interface 654 of the syringe body 650 (see FIG. Figure 53 ) to provide an internal threaded interface 5110 to the needle hub (not shown). The interface ring 5100 also defines a side opening 5124 for connecting the compression ring 5200 (see Figure 52 ). The interface ring also defines a living hinge 5130, similar to the living hinge 4092 in the clamping ring 4090 described herein.

[0129] Figure 52 A compression ring 5200 is shown, according to some embodiments, configured to slide proximally over the interface ring 5100 and apply a radially inward force to couple the interface ring 5100 to the needle attachment interface 654 (see FIG. Figure 53 The compression ring 5200 defines an inwardly facing tongue 5224 configured to be disposed in the side opening 5124 of the interface ring 5100 to couple the compression ring 5200 and the interface ring 5100. The compression ring 5200 further defines a plurality of external protrusions 5230 configured to enhance a user's grip on the compression ring 5200.

[0130] Figures 53 to 57 A method of coupling the interface ring 5100 to the needle attachment interface 654 of the syringe body 650 using the compression ring 5200 is shown to provide an internally threaded interface 5110 for a needle hub (not shown) in accordance with some embodiments. Figure 53 In FIG. 5 , the interface ring 5100 is disposed adjacent to the needle attachment interface 654 of the syringe body 650 , and the compression ring 5200 is disposed adjacent to the interface ring 5100 on the other side of the syringe body 650 .

[0131] Figure 54 andFigure 55 The side view and longitudinal section view show the interface ring 5100 sliding proximally on the needle attachment interface 654 of the syringe body 650 until the movable hinge portion 5300 of the interface ring 5100 is located on the radial extension 656 (e.g., Luer connector protrusion) defined by the needle attachment interface 654 of the syringe body 650.

[0132] Figure 56 and Figure 57 The side view and longitudinal cross-sectional view depict the compression ring 5200 being slid proximally over the interface ring 5100 until the inward tabs 5224 of the compression ring 5200 are located in the side openings 5124 of the interface ring 5100 to couple the compression ring 5200 and the interface ring 5100. In this position, the compression ring 5200 applies a radially inward force to couple the interface ring 5100 to the needle attachment interface 654. Coupling the interface ring 5100 to the needle attachment interface 654 provides an internally threaded interface for coupling a needle hub (not shown) with an externally threaded interface, such as a Luer coupling.

[0133] Exemplary clamping ring

[0134] Figures 58 to 71 An injection system 5800 is shown that includes a needle hub 6900 having a clamping ring 6990 having a pair of arcuate, radially inwardly extending crushing ribs 6996 (see FIG. Figure 69 ) and other features (described below), according to various embodiments, the crush ribs and other features are configured to minimize and disperse the pressure applied to the compression ring 6700 (see Figure 67 and Figure 68 ) on the compression ring 6700. Minimizing and distributing the reaction force applied to the compression ring 6700 reduces the risk of cracking the compression ring 6700, which can be formed by injection molding. During the injection molding process of the compression ring 6700, a liquid polymer is introduced into a circular mold and travels in two directions from an injection point in the circular mold to a bonding point approximately opposite the injection point. The bonding point of the compression ring 6700 formed by the above process is a structural weak point, and applying radially outward force to the braiding point can cause the compression ring 6700 to break. Figures 58 to 71 The illustrated embodiment minimizes and distributes the reaction forces applied to the compression ring 6700 to reduce its cracking.

[0135] Irregularities in standard off-the-shelf syringes, which may be made of glass or polymer, can also exacerbate the compression ring cracking problem described above. Figure 59is a detailed side view depicting the distal end of a syringe body 650, according to some embodiments. The syringe body 650 includes a syringe boss 5252 configured to retain the needle hub assembly on a needle attachment interface 5253 formed on the distal end of the syringe body 650. The syringe body 650 also includes a neck 5254 directly adjacent to / proximate to the syringe boss 5252. The neck 5254 can have an irregular (e.g., uneven) surface and / or a varying diameter along the longitudinal axis. In some embodiments, the neck 5254 can taper / cone from a relatively smaller diameter proximal to the syringe boss 5252 to a relatively larger diameter in a proximal direction. The regular surface of the neck 5254 and / or the variability of its diameter can increase the reaction force applied to the compression ring 6700 in a radially outward direction.

[0136] Figure 58 In a partially exploded side view, an injection system 5800 is shown according to some embodiments. The injection system 5800 includes a needle hub assembly 5810 and a syringe body 650. Figure 58 In FIG. 5 , the needle hub assembly 5810 is positioned distally of the syringe body 650 and is ready to be mounted thereon. The rigid needle shield 100 is coupled to the distal end of the needle hub assembly 5810. The syringe body 650 and the rigid needle shield 100 are standard off-the-shelf / off-the-shelf syringe bodies and standard off-the-shelf rigid needle shields, respectively. The needle hub assembly 5810 is similar to Figures 35 to 50 Needle hub assembly 600 is shown and described herein.

[0137] Figure 60 6 is a side view illustrating the injection system 5800 after the needle hub assembly 5810 is mounted on the syringe body 650, according to some embodiments. Note that in this embodiment, the outer diameter of the compression ring 6700 is larger than the outer diameter of the syringe body 650. In some embodiments, the outer diameter of the compression ring 6700 is approximately 10 mm.

[0138] Figure 61A and Figure 61B 5 and 6 are side and longitudinal cross-sectional views of the fully assembled injection system 5800 in its transport / storage configuration. Figure 61B As shown, the injection system 5800 includes a needle retraction system in a plunger member 670 that is coupled to a readily available stop member 660. The needle retraction system includes a retraction spring 684 configured to pull the needle 630 so that the sharp distal end 634 (see FIG. Figure 63A and Figure 63B ) is set in the needle seat 6900.

[0139] Figure 62A and Figure 62Bare side views, respectively depicting the needle hub assembly 5810 according to some embodiments, wherein the compression ring 6700 is respectively in a distal unlocked configuration ( Figure 62A ) and proximal locking configuration ( Figure 62B The compression ring 6700 is slid proximally on the clamping ring 6905 of the needle hub 6900 to unlock the compression ring 6700 from the distal unlocking configuration ( Figure 62A ) into the proximal locking configuration ( Figure 62B ).

[0140] Figure 63A and Figure 63B are longitudinal cross-sectional views of the needle hub assembly 5810 according to some embodiments, wherein the compression ring 6700 is in a distal unlocked configuration ( Figure 63A ) and proximal locking configuration ( Figure 63B The compression ring 6700 is slid proximally over the clamping ring 6905 of the needle hub 6900 to unlock the compression ring 6700 from the distal unlocking configuration ( Figure 63A ) into the proximal locking configuration ( Figure 63B ).

[0141] Figure 64A and Figure 64B Detailed longitudinal cross-sectional views of the needle hub assembly 5810 are depicted according to some embodiments, wherein the compression ring 6700 is in a distal unlocked configuration ( Figure 64A ) and proximal locking configuration ( Figure 64B The compression ring 6700 is slid proximally over the clamping ring 6905 of the needle hub 6900 to unlock the compression ring 6700 from the distal unlocking configuration ( Figure 64A ) into the proximal locking configuration ( Figure 64B In the locked configuration, the inner diameter 6740 of the compression ring 6700 (see Figure 68 ) is configured to be aligned with the outer diameter 6906 of the clamping ring 6905 (see Figure 69 ) forms an interference fit. This interference fit compresses the clamping ring 6905, causing the inner diameter of the compression ribs 6910 (described below) to become smaller, clamping on the syringe neck 5254 and / or syringe protrusion 5252 to prevent the needle hub 6900 from moving distally relative to the syringe body 650. The clamping ring 6905 defines a pair of radially inwardly extending compression ribs 6910 that are configured to compress the needle hub assembly 5810 when it is mounted on the needle attachment interface 5253 and the compression ring 6700 is in the position shown in FIG. Figure 666910. The compression ring 6700 is shown in the proximal locked configuration shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69. The compression ring 6700 is shown in FIG. 69.

[0142] The retaining ring 6905 also defines a counterbore / counter bore 6920, which is a space having an inner diameter greater than the outer diameter of the neck 5254 of the syringe body 650, so that when the needle hub assembly 5810 is installed on the needle attachment interface 5253, only the extrusion rib 6910 contacts the neck 5254 of the syringe body 650, with the compression ring 6700 in the proximal locked state, as shown. Figure 66 Limiting the contact between the crush rib 6910 and the neck 5254 directs any radially outward reaction force away from the proximal edge of the compression ring 6700 to reduce rupture of the compression ring 6700.

[0143] Figure 65A and Figure 65B is a longitudinal sectional view showing the needle hub assembly 5810 mounted on the syringe body 650 according to some embodiments, wherein the compression ring 6700 is in a distal unlocked configuration ( Figure 65A ) and proximal locking configuration ( Figure 65B The compression ring 6700 is slid proximally over the clamping ring 6905 of the needle hub 6900 to unlock the compression ring 6700 from the distal unlocking configuration ( Figure 65A ) into the proximal locking configuration ( Figure 65B ).

[0144] Figure 66 Detailed longitudinal cross-sectional view of the needle hub assembly 5810 is shown mounted on the needle attachment interface 5253 of the syringe body 650 with the compression ring 6700 in a proximal locked configuration, according to some embodiments.

[0145] Figure 67 and Figure 68 6700 according to some embodiments. The compression ring 6700 defines an inner diameter 6740 (see Figure 68). The compression ring 6700 defines a proximal-facing surface 6710 and a distal-facing surface 6720. The proximal-facing and distal-facing surfaces 6710 and 6720 of the compression ring may be tapered, conical, and / or flat. The proximal-facing surface 6710 and the distal-facing surface 6720 are configured to facilitate or limit the movement of the compression ring 6700 relative to, for example, Figures 72 to 80 Movement of the auto-injector housing shown. For example, the auto-injector housing can apply a distal force to the proximally facing surface 6710 to move the compression ring 6700 and the disposable injection device coupled thereto in a distal direction. In the case of an auto-injector, the distal movement can be limited by the interference / interference between the distally facing surface 6720 and the proximally facing surface of the compression ring 6700. Similarly, the auto-injector housing can apply a proximally facing force to the distally facing surface 6720 to move the compression ring 6700 and the disposable injection device coupled thereto in a proximally facing direction. In the case of an auto-injector, the proximal movement can be limited by the interference / interference between the proximally facing surface 6710 and the distally facing surface of the compression ring 6700.

[0146] The compression ring 6700 further defines a radially outwardly facing surface 6730 configured to be disposed within the housing of the autoinjector (e.g., Figures 72 to 80 6700 and the disposable injection device coupled thereto are aligned in the embodiment shown in FIG. For example, the autoinjector housing can define a circular space sized and shaped to receive the compression ring 6700 and align with the radially outward surface 6730 defined by the compression ring 6700. The compression ring 6700 further defines a pair of opposing mounting catches 4702 configured to couple the compression ring 6700 to the needle hub 6900 in a proximal locked configuration to complete the assembly.

[0147] Figure 69 6 is a rear perspective view of a needle hub 6900 according to some embodiments. The needle hub defines a clamping ring 6905 at its proximal end, which is configured to removably couple the needle hub 6900 to the needle attachment interface 5253 of the syringe body 650. The clamping ring 6905 further defines a pair of arcuate, radially inwardly extending extrusion ribs 6910 as described above. The clamping ring 6905 also defines a counterbore (space) as described above. In addition, the needle hub 6900 defines a pair of needle hub snaps 6919, which are configured to interfere with a pair of opposing mounting snaps 4702 defined by the compression ring 6700 to couple the compression ring 6700 to the needle hub 6900 in the proximal locked configuration, thereby completing the assembly.

[0148] Figure 70FIG2 is an axial cross-sectional view of a clamping ring 6905 secured around the neck 5254 of the syringe body 650 by a compression ring 6700, according to some embodiments. The clamping ring 6905 of the needle hub 6900 defines a plurality (e.g., four) substantially planar surfaces 6930 interleaved with a corresponding plurality (e.g., four) arcuate surfaces 6940 around the outer circumference of the clamping ring 6905. When the compression ring 6700 is moved from a distal unlocked configuration to a proximal locked configuration, the compression ring 6700 applies a radially inward force to the clamping ring 6905. The corresponding plurality of substantially planar surfaces 6930 and the arcuate surfaces 6940 of the clamping ring 6905 are configured to direct the applied force toward the arcuate surfaces 6940 and away from the substantially planar surfaces 6930. Consequently, a reaction force is also directed toward the arcuate surfaces 6940 and away from the substantially planar surfaces 6930.

[0149] Figure 71 FIG. 6 is a schematic diagram illustrating the forces acting on a needle hub 6900 coupled to a syringe body 650 via a compression ring 6700 , according to some embodiments. Figure 71 The first and second portions 6730 and 6740 of the compression ring 6700 are shown to receive smaller and larger reaction forces, respectively, corresponding to the plurality of substantially flat surfaces 6930 and the arcuate surface 6940, respectively, covering the clamping ring 6905. If one of the first portions 6730 of the compression ring 6700 is aligned with a structurally weak joint of the compression ring 6700, the configuration of the clamping ring 6905 and the compression ring 6700 can direct the reaction forces generated during assembly radially outward away from the joint of the compression ring 6700. This, in turn, reduces the chance of the compression ring 6700 fracturing at its structurally weak portion.

[0150] In some embodiments, the compression ring 6700 and / or the needle hub 6900 / clamping ring 6905 can be made of an engineering plastic polymer, such as a polycarbonate polymer, PEI (e.g., Ultem), PEEK, etc. In some embodiments, a reinforcing material, such as glass or carbon fiber, can be added to the engineering plastic polymer forming the compression ring 6700 and / or the needle hub 6900 / clamping ring 6905 to increase its rigidity.

[0151] Exemplary automatic injector

[0152] Figures 72 to 80 An autoinjector having an autoinjector housing 7200 containing a disposable injection device 5800 is depicted according to some embodiments. The disposable injection device 5800 may be similar to Figures 58 to 71 Injection system 5800 shown and described herein.

[0153] Figure 727200 is a rear perspective view of an auto-injector housing 7200 according to some embodiments. The auto-injector housing 7200 includes an auto-injector housing body 7210, an activation button 7220, and a rigid needle shield support 100'.

[0154] Figure 73 is an exploded view of an autoinjector according to some embodiments. The autoinjector housing 7200 includes an autoinjector housing body 7210, an activation button 7220, an arm-shaped collar 7222, a rigid needle shield support 100', and a base portion 7212. The autoinjector housing 7200 also includes a main spring 7230, which is retained by a main spring lock 7232 in a spring support 7234. The autoinjector housing 7200 also includes a plunger collar 7240 configured to retain a portion of the plunger member 640 therein. Furthermore, the autoinjector housing 7200 includes a syringe collar 7240 configured to retain a needle hub and at least a distal portion of the syringe body / sleeve 650 therein.

[0155] The disposable injection device 5800 is also disposed within the auto-injector housing 7200. The disposable injection device 5800 may be used with Figures 58 to 71 The injection system 5800 shown and described herein is the same. Generally, the disposable injection device 5800 comprises a syringe body 650, a plunger member 640 and a rigid needle shield 100 that covers a needle hub (not shown) and a substantial portion of a needle (not shown) in the hub.

[0156] Figure 74 FIG is a longitudinal cross-sectional view of an auto-injector in a transport / storage configuration according to some embodiments. In the transport / storage configuration, the main spring 7230 and the retraction spring 684 of the auto-injector housing 7200 are both held in a compressed / energized state by respective locks. In addition, the sharp distal end 634 of the needle 630 is covered by the rigid needle shield 100 and the rigid needle shield support 100 ′. Figure 74As shown, the disposable injection system 5800 includes a syringe body 650 having a stop member 660 incorporated therein. The disposable injection system 5800 also includes a needle hub 6900 and a needle 630 removably coupled thereto. As described herein, the needle hub is coupled to the syringe body 650 via a compression ring 6700. The disposable injection system 5800 also includes a plunger member 670 including a retraction system including a retraction spring 684. At the end of an injection, when the plunger member 670 has been manipulated by the main spring 7230 of the autoinjector housing 7200 to move the stop member 662 to the distal end of the syringe body 670, the retraction spring lock releases the retraction spring 684 from its energized / compressed configuration to withdraw at least the proximal end of the needle 630 into the plunger member 670 through the stop member 660. This positions the sharpened distal end 634 of the needle 630 within the needle hub 6900, enabling safe disposal of the disposable injection device and, in some embodiments, the auto-injector housing 7200.

[0157] Figure 75 The auto-injector is shown in a longitudinal cross-sectional view in a ready state according to some embodiments. The auto-injector can be removed from the housing 7210 by pulling the rigid needle shield support 100' distally to separate it from the auto-injector housing 7210. Figure 74 The transport / storage configuration shown converts to Figure 75 When the rigid needle shield holder 100' is removed from the autoinjector housing 7210, it removes the rigid needle shield 100 from the needle hub 6900 of the disposable injection device 5800, thereby placing the autoinjector in the ready configuration.

[0158] Figure 76This is a detailed longitudinal cross-sectional view of an autoinjector in a ready state, according to some embodiments. The distal end of the autoinjector housing 7210 defines an autoinjector base / patient contact surface 7212. The sharpened distal end 634 of the needle 630 is positioned a distance 638 from the autoinjector base / patient contact surface 7212, making the autoinjector relatively safe from accidental needle sticks prior to injection. The autoinjector housing 7210 includes a pair of distal locking elements 7251 that define a distal space 7252 configured to accommodate the needle hub 6900 and the compression ring 6700. The walls of the distal space 7252 defined by the distal locking elements 7251 cooperate with the radially outward surface 6730 of the compression ring 6700 to align the compression ring 6700, the needle hub 6900, and the needle 630 within the distal space 7252 and the autoinjector housing 7200. Each of the pair of distal locking members 7251 further defines a respective distally facing surface 7250 that interferes with the proximally facing surface 6710 of the compression ring 6700 to limit proximal movement of the compression ring 6700 within the distal space 7252. Figure 76 In the ready configuration, the disposable injection device 5800 is positioned such that the distal-facing surface 6720 of the compression ring 6700 is a distance 636 from a distal protrusion 7254 defined by the autoinjector housing 7200. The distal protrusion 7254 defines the distal end of the distal space 7252 and is the proximal stop for the needle 630 to travel during insertion / penetration into a patient.

[0159] Figure 77 is a longitudinal sectional view of an automatic injector in an injection completed configuration according to some embodiments. By pressing the activation button 7220, the automatic injector can be Figure 75 The ready configuration shown is converted to Figure 77 In the injection-complete configuration shown, the activation button 7220 actuates the main spring lock 7232 to release the compressed main spring 7230. The released main spring 7230 initially expands and moves the disposable injection device 5800 distally until distal movement is stopped by the compressed ring 6700. When the patient contact surface 7212 abuts the patient's skin, distal movement of the disposable injection device 5800 inserts the sharpened distal end 634 of the needle 630 into the patient's body. The main spring 7230 then further expands and distally moves the plunger member 670 to drive the stop member 660 distally, thereby injecting the drug from the syringe body 650 and placing the autoinjector in the primed configuration.

[0160] Figure 78Detailed longitudinal cross-sectional view of an autoinjector in an injection-completed configuration according to some embodiments. The distal protrusion 7254 defined by the autoinjector housing body 7210 has a proximally facing surface configured to interfere with the distally facing surface 6720 of the compression ring 6700 to limit distal movement of the compression ring 6700 in the distal space 7252, as shown in FIG. Figure 78 As shown in FIG. After the main spring has moved the disposable injection device 5800 distally until the distal-facing surface 6720 of the compression ring 6700 abuts the distal protrusion 7254, the sharpened distal end 634 of the needle 630 extends a distance 638' distal of the autoinjector base / patient contact surface 7212. The distance 639 represents the distance between the autoinjector base / patient contact surface 7212 and the distal-facing surface 6720 of the compression ring 6700. Thus, the compression ring 6700 travels within the distal space 7252 from the proximal stop defined by the distal-facing surfaces 7250 of the pair of distal locks 7251 to the distal stop defined by the distal protrusion 7254.

[0161] Figure 79 and Figure 80 The longitudinal section view and detailed longitudinal section view of the automatic injector in the needle retraction / safety configuration according to some embodiments. Figure 77 The injection completed configuration shown is converted to Figure 79 and Figure 80 The needle retraction / safety configuration shown is to actuate the retraction spring lock to release the compressed retraction spring 684. Needle catcher 7882 (see Figure 78 ) is configured to receive and couple to the proximal end 632 of the needle assembly 630 (see Figure 78 ), for retracting the needle assembly 630. The released retraction spring 684 expands and pulls the needle detent 7882 and the needle assembly 630 coupled thereto proximally until its sharp distal end 634 is at least disposed in the needle hub 6900. In other embodiments, the needle 630 can be pulled proximally until its sharp distal end 634 is disposed in the plunger member 670. Disposing the sharp distal end 634 of the needle 630 in the needle hub 6900 or the plunger member 670 allows the disposable injection device 5800 and the auto-injector housing 7200 containing the disposable injection device 5800 to be safely disposed of.

[0162] While the autoinjector housing 7200 described herein may be disposable, in other embodiments, the autoinjector housing may be a reusable injection device, wherein the disposable injection device can be removed from the reusable injection device after injection and replaced with a new disposable injection device. Portions of such a reusable injection device may cooperate with the proximal-facing surface 6710 and the distal-facing surface 6720 of the compression ring 6700 to drive the compression ring 6700 and the attached disposable injection device 5800 in distal and proximal directions within the reusable injection device / autoinjector.

[0163] Although the above-described method of manufacturing / assembling a safety injection system includes various operations performed in a particular order, methods according to other embodiments may include operations performed in a different order.

[0164] Various exemplary embodiments of the present invention are described herein. Reference is made to these examples in a non-limiting sense. They are provided to illustrate the broader applicable aspects of the present invention. Various changes may be made to the described invention, and equivalents may be substituted, without departing from the true spirit and scope of the present invention. In addition, many modifications may be made to adapt specific circumstances, materials, compositions of matter, processes, process actions, or steps to the purpose, spirit, or scope of the present invention. In addition, it will be understood by those skilled in the art that each individual variation described and illustrated herein has discrete components and features that can be easily separated or combined with the features of any other several embodiments, without departing from the scope or spirit of the present invention. All of these modifications are within the scope of the claims associated with this disclosure.

[0165] Any device described for performing the diagnostic or interventional (therapeutic) procedure in question may be provided in packaged combination for use in performing such interventions. These supply "kits" may further include instructions for use and be packaged in sterile trays or containers typically used for this purpose.

[0166] The present invention includes methods that can be implemented using the devices discussed. The methods can include the act of providing such suitable devices. This provision can be performed by the end user. In other words, the act of "providing" simply requires the end user to obtain, access, access, locate, set up, activate, power on, or otherwise provide the necessary devices for the methods discussed. The methods described herein can be performed in any logically possible order of the events described, as well as the order of the events described.

[0167] Exemplary aspects of the present invention and details about material selection and manufacturing have been set forth above. As for other details of the present invention, these can be understood in conjunction with the patents and publications cited above and what is generally known or understood by those skilled in the art. For example, it will be understood by those skilled in the art that one or more lubricious coatings (e.g., hydrophilic polymers, such as polyvinyl pyrrolidone-based compositions, fluoropolymers, such as tetrafluoroethylene, PTFE (polytetrafluoroethylene), ETFE (ethylene-tetrafluoroethylene copolymer), hydrophilic gels or silicones) can be used in conjunction with various parts of the device (e.g., the relatively large interface / interface surface of the removable coupling portion), such as to manipulate or propel these objects with low friction relative to other parts of the device or nearby tissue structures if necessary. With regard to the additional actions typically or logically employed, this is also true for the method-based aspects of the present invention.

[0168] Furthermore, although the present invention has been described with reference to several examples, which optionally incorporate various features, the present invention is not limited to the contents described or indicated for the various variations of the present invention. Various changes may be made to the described invention, and equivalents (whether referenced herein or omitted for brevity) may be substituted without departing from the true spirit and scope of the present invention. Furthermore, where a numerical range is provided, it is understood that each intermediate value between the upper and lower limits of the range, and any other stated or intermediate value within the stated range, is encompassed within the present invention.

[0169] In addition, it is contemplated that any optional features of the invention variations may be independently elaborated and claimed, or combined with any one or more features described herein. References to singular items include the possibility of multiple identical items. More specifically, as used herein and in the associated claims, the singular forms "one," "an," "said," and "the" include plural objects unless otherwise specifically stated. In other words, the use of articles allows for "at least one" of the items discussed in the specification and in the claims associated with this disclosure. It should also be noted that such claims can be drafted to exclude any optional elements. Therefore, this statement is intended to serve as a premise basis for the use of exclusive terms (such as "only," "only," etc.) associated with the recorded claim elements or the use of "negative" limitations.

[0170] In the absence of such exclusive terms, the word "comprising" in the claims relating to the present disclosure shall permit the inclusion of any additional elements, regardless of whether a given number of elements is recited in such claims or the added features may be considered to transform the nature of the elements recited in such claims. Unless specifically defined otherwise, all technical and scientific terms used herein are given the broadest commonly understood meaning possible while maintaining claim validity.

[0171] The scope of the present invention is not limited to the examples provided and / or subject specification, but is only limited by the scope of the claims associated with this disclosure.

Claims

1. A safety injection system comprising: an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof; A stop member disposed in the interior space of the injection system body; a plunger member configured to be manipulated to insert the stop member relative to the injection system body; as well as A needle hub assembly coupled to the needle attachment interface and comprising: a needle hub defining a locking space in a distal end thereof, a needle lock defined by the needle hub in the locking space, and A needle is removably coupled to the needle hub via a needle lock.

2. The system according to claim 1, wherein: The needle lock includes a distally extending arm extending from the needle hub body at a hinge, and Therein, the distally extending arm is configured to rotate about the hinge portion away from the needle.

3. The system according to claim 2, wherein: The arm defines a medially and proximally facing beveled surface.

4. The system according to claim 3, wherein: The needle defines an expanded diameter section configured to exert a distal force on the inwardly and proximally facing ramp to rotate the distally extending arm about the hinge portion away from the needle.

5. The system according to claim 2, wherein: The needle defines a reduced diameter section configured to interfere with the distally extending arm to removably couple the needle to the needle hub.

6. The system according to claim 2, wherein: The arm defines a laterally and distally facing beveled surface.

7. The system according to claim 6, wherein: The needle defines a laterally and proximally facing bevel surface configured to interfere with the laterally and distally facing bevel surface of the arm to inhibit proximal movement of the needle relative to the needle hub.

8. The system according to claim 2, wherein: The needle hub defines a window configured to allow viewing of the distal ends of the arms in the locking space from an exterior of the needle hub.

9. The system according to claim 1, wherein: The needle lock is configured to open upon application of a proximal force of less than 3 lbf to the needle.

10. The system according to claim 1, wherein: The needle lock is configured to prevent opening upon application of a proximal force of less than 0.25 lbf to the needle.

11. The system of claim 1 , further comprising a spacer component disposed partially within the interior space of the injection system body and partially within the needle hub. in, The pad component comprises: an enlarged diameter proximal portion disposed within the interior space of the injection system body, and A distal portion of reduced diameter is disposed in the needle hub.

12. The system according to claim 11, wherein The spacer component includes a distal end configured to seal after the needle is proximally retracted past the distal end of the spacer component.

13. The system according to claim 11, wherein: The expanded diameter proximal portion defines a plurality of external ribs.

14. The system according to claim 11, wherein: The enlarged diameter proximal portion has a star-shaped cross-section.

15. The system according to claim 11, wherein The enlarged diameter proximal portion defines a plurality of chamfered edges.

16. The system of claim 1, further comprising a compression ring configured to secure the needle hub assembly to the needle attachment hub.

17. The system according to claim 16, wherein: The needle seat defines the needle seat buckle, and The compression ring defines a mounting buckle configured to interfere with the needle hub buckle to couple the compression ring and the needle hub.

18. The system according to claim 16, wherein: The needle hub includes a clamping ring defining a living hinge at a proximal end thereof.

19. The system according to claim 18, wherein: The clamping ring is configured to flex proximally about the living hinge to facilitate mounting the needle hub onto the needle attachment hub.

20. The system of claim 18, wherein: The needle attachment hub includes a protrusion configured to interfere with the clamping ring under the radially inward force from the compression ring to couple the needle hub to the needle attachment hub.

21. The system of claim 16, wherein: The compression ring defines a plurality of internal crush ribs on an inner surface thereof.

22. The system of claim 21, wherein: The plurality of internal extrusion ribs are configured to accommodate variability in other components of the system during assembly.

23. The system of claim 16, wherein: The needle hub defines a plurality of external crush ribs on an outer surface thereof.

24. The system of claim 23, wherein: The plurality of external extrusion ribs are configured to accommodate variability in other components of the system during assembly.

25. A safety injection system comprising: an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle hub assembly at a distal end thereof; A stop member disposed in the interior space of the injection system body; a plunger member configured to be manipulated to insert the stop member relative to the injection system body; as well as a spacer component having an enlarged diameter proximal portion disposed within the interior space of the injection system body and a reduced diameter distal portion disposed within the needle hub; Among them, the needle seat assembly includes: a needle hub having a distal portion with a reduced diameter, and A needle defines a reduced diameter section configured to interfere with a reduced diameter portion of the spacer component in the reduced diameter distal end portion of the needle hub to removably couple the needle to the needle hub.

26. An injection system comprising: an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof; A stop member disposed in the interior space of the injection system body; a plunger member configured to be manipulated to insert the stop member relative to the injection system body; an interface ring defining an internal thread; as well as A compression ring is configured to slide proximally over the hub ring and apply a radially inward force to secure the hub ring to the needle attachment hub.

27. The system of claim 26, wherein the interface ring defines a side opening, and in, The compression ring defines an inwardly facing tab configured to be disposed in the side opening to couple the compression ring and the interface ring.

28. The system of claim 26, wherein: The compression ring defines an external protrusion configured to enhance a user's grip on the compression ring.

29. A method of assembling a safety injection system, comprising: threading a spacer member onto the needle by inserting the needle distally over the spacer member, wherein the spacer member includes a proximal portion having an enlarged diameter and a distal portion having a reduced diameter; inserting the needle and the spacer member extending through the needle distally into the needle hub; installing the needle, the spacer component, and the needle hub onto an injection system body having a needle attachment hub at its distal end by inserting the proximal end of the needle into the distal opening of the injection system body and attaching the needle hub to the needle attachment hub; inserting a stop member into the interior of the injection system body; as well as The plunger member is coupled to the stop member.

30. The method according to claim 29, wherein Attaching the needle hub to the needle attachment hub includes sliding a compression ring over the proximal end of the needle hub to apply a radially inward force to the proximal end of the needle hub and the needle attachment hub.

31. A safety injection system comprising: an injection system body defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof; a stop member disposed in the interior space of the injection system body; a plunger member configured to be manipulated to insert the stop member relative to the injection system body; as well as A needle hub assembly coupled to the needle attachment interface and comprising: a needle hub defining a locking space in a distal end thereof, a needle lock defined by the needle hub in the locking space, and a needle removably coupled to the needle hub via a needle lock, Therein, the needle hub defines a clamping ring having a radially inwardly extending crush rib adjacent a proximal end of the clamping ring.

32. The system of claim 31, wherein: The needle attachment hub defines a circumferential neck configured to receive the radially inwardly extending crush rib when the needle hub assembly is coupled to the needle attachment hub.

33. The system of claim 32, further comprising a compression ring configured to secure the needle hub assembly to the needle attachment hub.

34. The system of claim 33, wherein: The needle seat defines the needle seat buckle, and The compression ring defines a mounting buckle configured to interfere with the needle hub buckle to couple the compression ring and the needle hub.

35. The system of claim 33, wherein: The compression ring is configured to apply a radially inward force to an outer surface of the clamping ring when the compression ring is coupled to the needle hub.

36. The system of claim 35, wherein: The outer surface of the clamping ring defines a plurality of substantially flat surfaces and a plurality of arcuate surfaces, and The compression ring and the clamping ring are configured such that when the compression ring is coupled to the needle seat, the compression ring applies radially inward forces to the multiple arcuate surfaces of the outer surface of the clamping ring.

37. The system of claim 36, wherein: When the compression ring is coupled to the needle hub, a substantially flat surface of the plurality of substantially flat surfaces is aligned with a structurally weakened portion of the compression ring.

38. The system of claim 33, wherein: The compression ring has a distal unlocked configuration in which the compression ring is uncoupled from the needle hub, and Therein, the compression ring has a proximal locking configuration in which the compression ring is coupled to the needle hub.

39. The system of claim 38, wherein: The radially inward portions of the radially inwardly extending crush ribs are configured to be compressed when the compression ring moves from the distal unlocked configuration to the proximal locked configuration.

40. The system of claim 31 , wherein: The needle hub defines a counterbore configured to receive a proximal portion of the needle attachment hub while maintaining a gap between an outer surface of the proximal portion of the needle attachment hub and an inner surface of the counterbore.

41. A safety injection system comprising: an injection system body, the injection system defining a proximal opening at a proximal end thereof, an injection system body interior space, and a needle attachment interface at a distal end thereof; a stopper member disposed in the interior space of the injection system body; a plunger member configured to be manipulated to insert the stop member relative to the injection system body; A needle hub assembly coupled to the needle attachment interface and comprising: a needle hub defining a locking space in a distal end thereof, a needle lock defined by the needle hub in the locking space, and a needle removably coupled to the needle hub via a needle lock; and a compression ring configured to secure the needle hub assembly to the needle attachment interface, Therein, the compression ring defines a proximal-facing surface and a distal-facing surface configured to facilitate or restrict movement of the compression ring and the safety injection system within the autoinjector housing.

42. The system of claim 41, wherein: The compression ring defines a radially outward surface configured to align the compression ring with the safety injection system within the autoinjector housing.

43. An automatic injector comprising: Autoinjector housing; and A disposable injection device comprising: an injection device body defining a proximal opening at a proximal end thereof, an injection device body interior space, and a needle attachment interface at a distal end thereof, a stopper member disposed in the interior space of the injection device body, a plunger member configured to be manipulated to insert the stop member relative to the injection system body, A needle hub assembly coupled to the needle attachment interface and comprising: a needle hub defining a locking space in a distal end thereof, a needle lock defined by the needle hub in the locking space, and a needle removably coupled to the needle hub via a needle lock, and a compression ring, which is used to secure the needle hub assembly to the needle attachment interface, Among them, the compression ring defines: a proximally facing surface configured to limit proximal movement of the compression ring and the safety injection device within the autoinjector housing, and A distally facing surface is configured to limit distal movement of the compression ring and the safety injection device within the autoinjector housing.

44. The autoinjector of claim 43, wherein The autoinjector housing defines a distal space configured to receive the needle hub and the compression ring therein.

45. The autoinjector of claim 44, wherein The autoinjector housing defines a pair of locking members defining the distal space, and wherein each locking member of the pair of locking members defines a respective distally facing surface configured to interfere with a proximally facing surface of the compression ring to restrict proximal movement of the compression ring and the safety injection device within the distal space of the auto-injector housing.

46. ​​The autoinjector of claim 45, wherein The autoinjector housing defines a distal projection defining a distal space, and The distal protrusion defines a proximally facing surface configured to interact with a distally facing surface of the compression ring to limit distal movement of the compression ring and the safety injection device within the distal space of the autoinjector housing.

47. The system of claim 46, wherein: The compression ring defines a radially outward surface configured to align the compression ring with the safety injection system within a distal space defined by the autoinjector housing.

48. A method of performing a safe injection using the autoinjector of claim 47, comprising: inserting the disposable injection device into the autoinjector housing until the proximally facing surface of the compression ring interferes with corresponding distally facing surfaces of the pair of locking elements to secure the compression ring of the safety injection device within the distal space of the autoinjector housing; removing a rigid needle shield from a distal end of the autoinjector housing to expose a sharp distal end of the needle; depressing a firing button of the autoinjector housing to release a main spring of the autoinjector housing, thereby moving the disposable injection device distally until the distally facing surface of the compression ring interferes with the proximally facing surface of the distal protrusion; a main spring distally moving the plunger member to distally insert the stop member relative to the injection device body; The main spring continues to move the plunger member distally to insert the stop member distally into the distal end of the injection device body, thereby releasing the retraction spring lock in the plunger member of the disposable injection device; as well as The released retraction spring lock allows the retraction spring in the plunger member to pull the needle proximally until the sharpened distal end of the needle is disposed in the needle hub.

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