Safety injection system and method
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-10
- Publication Date
- 2026-04-10
Smart Images
Figure CN121843735A_ABST
Abstract
Description
Technical Field
[0001] The present invention generally relates to injection systems, apparatuses, and processes that facilitate varying degrees of control over the injection process, and particularly to apparatuses and methods related to safe injection systems, apparatuses, and processes that retract the needle at least partially into the plunger member after injection. Background Technology
[0002] Millions of syringes are consumed daily in healthcare settings, such as Figure 1A As shown in (2). A typical syringe (2) includes a tubular body (4), a plunger (6), and an injection needle (8). Figure 1B As shown, this syringe (2) can be used not only to inject fluids into a patient but also to draw or discharge fluids from containers such as vials, bottles, bags, or other drug containment systems (10). In practice, due to regulatory restrictions in some countries, such as the United States, and considerations of aseptic maintenance, when using vials (10) with syringes (2) in a patient-specific setting, these vials can only be used for a single patient and must then be disposed of—leading to significant medical waste in the disposal of vials and leftover medicine, and even periodic shortages of certain critical medications. (Refer to...) Figure 2A Three Luer-type syringes (12) are shown, each having a Luer connector geometry (14) disposed on the distal side, allowing them to be coupled to other devices with matching similar geometries, such as... Figure 2B The Luer multi-head catheter assembly (16) is shown. With or without the use of an intravenous infusion bag, Figure 2B The Luer multi-head catheter assembly can be used to administer intravenous liquid medications to patients. Figure 2A The Luer connector (14) of the syringe can be called a "male" Luer connector, while Figure 2B(18) can be referred to as a “female” Luer connector; one of the Luer interfaces can be threaded (in which case, the configuration can be referred to as a “Luer lock” configuration), allowing the two sides to be engaged by relative rotation, which can be combined with compressive loads. In other words, in a Luer lock embodiment, rotation (possibly accompanied by compression) can be used to engage the threads within the male connector (14), which are configured to engage the flange on the female connector (18), bringing the device together into a fluid-tight connection. In another embodiment, a tapered / conical interface geometry can be used to provide Luer engagement by compression without threads or rotation (this configuration can be referred to as a “slip-on” or “conical” Luer configuration). Although such Luer connectors are considered relatively safe for the operator, there is a risk of drug spillage / leakage and component breakage during the assembly of Luer connectors. On the other hand, the use of needle injection configurations brings the risk of sharp needle contact or puncture of unwanted persons or structures. For this purpose, so-called “safety syringes” have been developed.
[0003] Figure 3 An embodiment of a safety syringe (20) is shown, wherein a tubular shroud member (22) is spring-biased to cover the needle (8) when it is released from a proximal / retracted position relative to the syringe body (4). The tubular needle shroud (22) is “locked” in a distal / extended configuration such that the needle shroud (22) can no longer return to the proximal / retracted position to prevent accidental needle pricks after injection.
[0004] Figures 4A-4B Another embodiment of the safety syringe (24) is shown. With this configuration, after the plunger (6) is fully inserted relative to the syringe body (4), the retractable needle (26) is configured to retract (28, 26) into a safe position within the tubular body (4), such as... Figure 4B As shown. This self-contracting configuration may be associated with the following problems: blood splashing / aerosolization issues, safe storage of preloaded energy (which may fail and activate before it is expected), loss of accuracy in administering the full dose due to residual dead space within the spring compression volume, and / or loss of control over the rate of retraction that may be associated with pain and patient anxiety.
[0005] Complicating the syringe market further is the increasing demand for pre-filled syringe components, such as... Figure 5A and 5B As shown, it typically includes a syringe body or "drug-sealed containment delivery system" (34), a plunger head, a plug or stop (36), and a distal seal or cap (35) that can be mounted on a Luer-type interface. Figure 5A The position of the cap 35 is shown; Figure 5BThe cap has been removed to reveal 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 head (36). The plunger head (36) may comprise a standard butyl rubber material and may be coated with, for example, a biocompatible smooth coating (e.g., polytetrafluoroethylene (“PTFE”)) to facilitate preferred sealing and relative movement characteristics with respect to the relevant syringe body structure and materials. Figure 5B The proximal end of the syringe body (34) includes a conventional integral / one-piece syringe flange (38), which 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 a full circumference or a partial circumference of the syringe body (34). A partial flange is called a “truncated flange”, while the other is called a “full flange”. The flange is used to grip the syringe with a finger to provide support for pushing the plunger to inject. The syringe body (34) preferably comprises a translucent material, such as glass or polymer. To form a closed volume within the chamber or reservoir (40) and to facilitate the expulsion of the associated fluid through the needle, a plunger head (36) can be disposed within the syringe body (34). The syringe body (34) can be defined in a substantially cylindrical shape (i.e., such that a plunger head 36 with a circular cross-sectional shape can establish a seal relative to the syringe body (34)) or configured to have other cross-sectional shapes (e.g., elliptical).
[0006] Such components are ideal because they can be standardized and precisely mass-produced by a select few manufacturers worldwide, capable of meeting all the world's ever-changing regulations regarding the selection of filling, packaging, and drug / pharmaceutical interface materials and component use. However, this simple configuration often fails to meet the emerging global standards for single-use, safety, automatic failure, and needle-puncture resistance. Therefore, some suppliers have shifted to more "vertical" solutions, such as... Figure 5C As shown in (41), this solution attempts to satisfy all or at least some of the standards with a single solution; because it attempts to satisfy these standards in many different situations, these products may have significant limitations (including those mentioned above). Figure 3-4B (Some limitations described) and relatively high inventory and usage costs.
[0007] Some safety injection systems include a spring for generating force to retract the needle and a spring lock for holding the spring in compression for an appropriate time to retract the needle after injection. Some spring locks cause the force to be unevenly distributed from the spring to the plunger assembly, resulting in warping of the plunger assembly over time, which hinders the function of the safety injection system. Therefore, a safety injection system with a spring lock is needed to address these limitations. Summary of the Invention
[0008] The embodiments relate to injection systems. More specifically, these embodiments relate to safe injection systems.
[0009] In one embodiment, the injection system includes a syringe body having a proximal end and a distal end and defining an internal space within the syringe. The system also includes a stop member disposed within the internal space. The system further includes a needle hub assembly coupled to the syringe body at its distal end. The needle hub assembly includes a needle hub and a needle coupled to the needle hub and having a proximal end. Furthermore, the system includes a plunger member coupled to the stop member and configured to be actuated to insert the stop member distally into the internal space of the syringe relative to the syringe body and the needle hub. The plunger member includes a plunger body defining a plunger internal space, a retraction member disposed within the plunger internal space and configured to be coupled to the proximal end of the needle, and a spring disposed within the plunger internal space and configured to retract the retraction member proximally within the plunger internal space, the spring having a compressed state and a released state. The retraction member includes a locking element and a trigger movably disposed within the locking element along a longitudinal axis of the locking element. The locking element has multiple distal arms configured to interfere with the proximal end of the needle, and multiple spring locking elements configured to hold the spring in a compressed state. The trigger defines a proximal radial extension, a distal radial extension, and an annular groove located between the proximal and distal radial extensions.
[0010] In one or more embodiments, the plurality of spring locking elements includes a first spring locking element and a second spring locking element disposed on radially opposite sides of the locking element. The first spring locking element and the second spring locking element can distribute the force from the spring equally to the plunger body through the locking element.
[0011] In one or more embodiments, the plunger body defines a plurality of openings corresponding to a plurality of spring-locking elements, and a plurality of distally facing surfaces defining a respective proximal end of a corresponding opening among the plurality of openings. Each of the plurality of spring-locking elements may include a proximally facing ramp configured to engage with a corresponding distally facing surface of the corresponding opening under the action of a proximal force / proximal-oriented force of a spring on the locking element to radially push the spring-locking element inward. Each of the plurality of spring-locking elements may include a notch / groove configured to facilitate rotation / deflection of the spring-locking element toward and away from the trigger.
[0012] In one or more embodiments, the locking member includes a first longitudinal post and a second longitudinal post disposed on radially opposite sides of the locking member, and an annular portion coupled to the respective proximal ends of the first and second longitudinal posts and disposed proximal to a plurality of spring locking members. The annular portion may be configured orthogonal to the first and second posts / perpendicular to the first and second posts to align the retraction member with the plunger body. The locking member may define a plurality of windows therein.
[0013] In one or more embodiments, the trigger includes a radially extending annular portion, and the locking member includes a plurality of radially inwardly extending protrusions configured to interfere with the radially extending annular portion to temporarily prevent axial movement of the trigger relative to the locking member. The plurality of radially inwardly extending protrusions may include first, second, and third radially inwardly extending protrusions. A second radially inwardly extending protrusion may be disposed on the locking member on a side opposite to the first and third radially inwardly extending protrusions. The radially extending annular portion and the plurality of radially inwardly extending protrusions may be configured to provide multiple rest / pause configurations during the assembly of the retraction member. The trigger may include a second radially extending annular portion. The second radially extending annular portion and the plurality of radially inwardly extending protrusions may be configured to prevent the spring from prematurely transitioning from a compressed state to a released state during an accidental drop of the system.
[0014] In one or more embodiments, the proximal end of the needle defines a radially extending member at its proximal end, and a locking member defines a plurality of rotatable needle locking arms configured to interfere with the radially extending member to allow proximal movement of the radially extending member over the plurality of rotatable needle locking arms while preventing distal movement of the radially extending member over the plurality of rotatable needle locking arms. The locking member may also define a distal stop configured to interfere with the plurality of rotatable needle locking arms to prevent distal rotation of the plurality of rotatable needle locking arms over the distal stop. The distal stop may define an opening therethrough configured to receive the needle. The needle may also have a tubular connecting member configured to receive the distal end of the proximal end of the needle, wherein the proximal end of the needle defines one or more channels at its distal end.
[0015] The above and other embodiments of the present invention are described in the following detailed description. Attached Figure Description
[0016] This patent or application document contains at least one color drawing. A color drawing copy of the published text of this patent or application may be provided by the United States Patent and Trademark Office upon request and for the necessary fee.
[0017] Figures 1A to 5C This illustrates several aspects of the conventional syringe configuration.
[0018] Figure 6A perspective view of a safety injection system according to some embodiments is shown.
[0019] Figure 7 An exploded view is shown before the needle hub assembly, according to some embodiments, is assembled onto the syringe body.
[0020] Figure 8 An exploded view of a pin header assembly according to some embodiments is shown.
[0021] Figure 9 An exploded view of a needle assembly according to some embodiments is shown.
[0022] Figure 10 A perspective view of a needle hub assembly mounted on the syringe body of a safety injection system according to some embodiments is shown.
[0023] Figure 11 An exploded view of the retraction member and plunger member according to some embodiments is shown.
[0024] Figure 12 A perspective view of a card lock (top) and a trigger (bottom) according to some embodiments is shown.
[0025] Figure 13 The diagram shows perspective views of a trigger assembled into a card lock in a locked state (top) and an unlocked state (bottom) according to some embodiments.
[0026] Figure 14 Side views of a card lock in a locked state (top) and an unlocked state (bottom) according to some embodiments are shown.
[0027] Figures 15 to 21 This is a longitudinal sectional view illustrating a method for administering an injection using a safety injection system according to some embodiments and for safely disposing of the used system by retracting the needle after injection.
[0028] Figure 22 and Figure 23 A perspective view of a trigger according to some embodiments is shown.
[0029] Figure 24 The diagram shows a side view of a card lock in a locked state (top) and an unlocked state (bottom) according to some embodiments.
[0030] To better understand how the above and other advantages and objectives of the various embodiments are obtained, embodiments have been described in more detail with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements with similar structures or functions are indicated by similar reference numerals throughout the text. It should be understood that these drawings depict only some exemplary embodiments and should not be considered as limiting the scope of the embodiments. Detailed Implementation
[0031] Exemplary safe injection system
[0032] refer to Figure 6 The diagram shows a perspective view of a safety injection system (600), which, according to some embodiments, has a conventional, off-the-shelf, pre-filled syringe body (34) with a conventional stop member (36) provided therein. The stop member (36), together with the syringe body (34), defines a syringe chamber (40). The stop member (36) blocks the proximal end of the syringe chamber (40). The safety injection system (600) also includes a plunger member (44) which is connected to the proximal end of the stop member (36), for example, via a conventional threaded connection. A needle hub assembly (606) is provided at the distal end of the syringe chamber (40) and fitted with a needle guard / cap (63) for storage.
[0033] The safety injection system (600) controls the injection of fluid from the syringe chamber (40) through a needle hub assembly (606), which is driven by the user to insert a plunger member (44) distally relative to the syringe body (34). The plunger member (44) includes a space defining an internal plunger space (70; see also...) Figure 15 The plunger housing component (69) and the plunger actuation interface (128) connected to the plunger housing component (69) at the proximal end of the plunger housing component (69).
[0034] The safety injection system (600) has a stoked needle configuration, wherein when presented to the user, the needle hub assembly (606), which includes a needle hub (608) and a needle assembly (610), is in place and ready to be injected after the needle guard (63) is removed. Figure 7 An exploded view of the needle hub assembly (606) according to some embodiments is shown before it is mounted onto the syringe body (34). The distal end of the syringe body (34) includes a Luer tapered interface (33).
[0035] Figure 8 An exploded view of a needle hub assembly (606) according to some embodiments is shown. The needle hub (608) includes a locking ring (810) configured to secure the needle hub (608) to the distal end of the syringe body (34) (see [link]). Figure 6The needle hub (608) also includes a needle locking member (820) configured to removably engage the needle tip assembly (610) with the needle hub (608). The needle hub (608) also includes a gasket (830) configured to minimize fluid leakage around the outer side of the needle tip assembly (610). The gasket is positioned around the needle tip assembly (610) between the end of the Luer interface and the interior of the needle hub and is configured to prevent leakage of the contents of the drug chamber during syringe storage and during drug administration to the patient.
[0036] Figure 9 An exploded view of a needle assembly (610) according to some embodiments is shown. The needle assembly (610) includes a distal end (48) and a proximal end (50) of a needle interconnected by a needle connecting member (52). The distal end of the proximal end (50) defines a pair of longitudinal channels (54) that form a fluid passage from the syringe chamber (40; see also...) Figure 6 The needle flows through the longitudinal channel (54), the needle connector (52), the distal end of the needle (48), and reaches the safety injection system (600; see also) Figure 6 The exterior of the needle. Although a pair of longitudinal channels are shown, an alternative embodiment may be formed in one longitudinal channel at the proximal end (50) of the needle. In addition, three or more longitudinal channels may be formed at the proximal end of the needle.
[0037] Figure 10 The perspective view shows a longitudinal channel (54) leading to the needle connecting member (52) according to some embodiments. The proximal end of the needle (50) defines a radially extending member (56) at its proximal end.
[0038] Although the pre-embedded needle shown in the illustration is in place, it can be removably coupled to the syringe body (34) via a Luer interface (not shown), with the proximal end (50) of the needle component extending through the Luer interface and into the syringe chamber (40). In other embodiments, the needle may be fixedly or removably mounted on a flange on the cartridge body rather than on the syringe. Alternatively, the needle may be fixedly or removably mounted at the end of a dual-chamber injection system. Alternatively, the needle may be fixedly or removably mounted at the end of a sequential injection system. Figure 6 and Figure 15 In the illustrated embodiment, the main parts of the safety needle retraction hardware are housed within the plunger interior space (70) defined by the plunger housing (69).
[0039] An exemplary dual-spring locking retraction member for a safety injection system
[0040] Figure 11 A safe injection system (e.g.) according to some embodiments is shown. Figure 6An exploded view of the retraction member (1100) of the system (600) shown. The retraction member (1100) includes a spring (1110) in a compressed state, a locking element (1120), and a trigger (1150). Most of the components of the retraction member (1100) are disposed within the plunger interior space (70; see also) defined by the plunger body (69). Figure 15 In this way, the plunger component (44) has approximately the same dimensions as a conventional plunger component and can be used with a conventional syringe body (34) and a conventional stop component (36). The spring (1110) is held in a compressed state by a locking element (1120) and a trigger (1150), as described below, which interfere with the plunger body (69) to prevent the spring (1110) from extending proximally.
[0041] Figure 12 A perspective view of the locking member (1120) and trigger (1150) before assembly according to some embodiments is shown. The locking member (1120) is a generally tubular body defining a pair of rotatable needle locking arms (1122) configured to interfere with the radially extending member (56) to allow the radially extending member (56) to move the rotatable needle locking arms (1122) proximally while preventing the radially extending member (56) from moving distally over the plurality of rotatable needle locking arms (1122). Thus, the needle locking arms (1122) allow the radially extending member (56) to be locked or held by the locking member (1120). The locking member (1120) also includes a distal stop (1124) configured to interfere with the needle locking arms (1122) to prevent the needle locking arms (1122) from rotating distally over the distal stop (1124). Thus, the distal stop (1124) prevents the needle locking arm (1122) from releasing the captured radial extension member (56). The distal stop (1124) defines an opening (1121) configured to receive the needle assembly (610). Therefore, the needle locking arm (1122) and the distal stop (1124) cooperate to allow the locking member (1120) to engage or grip the radial extension member (56) and the needle assembly (610) connected thereto, such that proximal movement of the locking member (1120) retracts the needle assembly (610) proximally and at least partially into the plunger interior space (70).
[0042] The locking element (1120) also defines a pair of rotatable spring-locking elements (1126) configured to interfere with the plunger body (69) as described below, to prevent the spring (1110) compressed by the locking element (1120) from extending proximally. Each spring-locking element (1126) includes a notch (1128) at its proximal end configured to facilitate radial screwing of the spring-locking element (1126) into and out of the locking element (1120). Each spring-locking element (1126) defines a proximal-facing ramp (1130) configured to mate with each of a plurality of distal-facing surfaces forming a corresponding plurality of openings (72) in the plunger body (69) (see [link]). Figures 18 to 20 ), so as to convert the proximal force from the spring (1110) into a radially inward force, thereby pushing the distal end of the spring lock (1126) radially inward.
[0043] A pair of spring-loaded locking elements (1126) are positioned on opposite sides of the locking element (1120) to evenly distribute the force generated by the spring (1110) to the plunger member (44). This even distribution of force prevents the plunger member (44) from bending / warping over time when the safety injection system (600) is stored prior to use.
[0044] The locking member (1120) also defines a first longitudinal post and a second longitudinal post (1132) located on radially opposite sides of the locking member (1120). The locking member (1120) also defines an annular portion (1134) connected to the respective proximal ends of the first longitudinal post and the second longitudinal post (1132). The annular portion (1134) is disposed proximal to the spring locking member (1126). The annular portion (1134) is configured to be perpendicular / orthogonal to the first longitudinal post and the second longitudinal post (1132) to align the locking member (1120) and the usual retraction member (1100) with the plunger body (69). In this way, the annular portion (1134) can compensate for unequal forces applied by the respective spring locking member of the pair of spring locking members (1126).
[0045] The locking element (1120) also defines a plurality of windows (1136) to facilitate the assembly of the locking element (1120) and the trigger (1150). Furthermore, the locking element (1120) defines first, second, and third radially inwardly extending protrusions (1138). The trigger (1150) may include at least one radially extending annular portion (1152) configured to interfere with the second radially inwardly extending protrusion (1138) to temporarily prevent axial movement of the trigger (1150) relative to the locking element (1120) during its assembly. In an alternative embodiment, the radially extending annular portion (1152) may be configured to interfere with the first radially inwardly extending protrusion and / or the third radially inwardly extending protrusion (1138). This temporary interference positions the trigger annular groove (1158) in an axial position, allowing the spring locking element (1126) to rotate inward during the assembly of the plunger rod (44). Move the trigger (1150) distally until the distal radial extension (1156) contacts the inner surface (1157); see also Figure 15 It overcomes the temporary interference and positions the trigger (1150) between the spring locks (1126), so that the spring (1100) remains in the compressed position.
[0046] The trigger (1150) also defines a proximal radial extension and a distal radial extension (1154, 1156), between which an annular groove (1158) is defined. Figure 13 Perspective views of the latch (1120) and trigger (1150) assembled according to some embodiments in a locking configuration (top) and an unlocking configuration (bottom). In the locking configuration, the proximal radial extension (1154) interferes with each of the pair of spring-loaded latches (1126) to prevent rotation in a radially inward direction. As the trigger (1150) moves proximally relative to the latch (1120)—this movement can be achieved by pushing the plunger member (44) distally relative to the trigger (1150) and the latch (1120) thereto—the latch (1120) and trigger (1150) transition from the locking configuration (top) to the unlocking configuration (bottom). Figure 13As shown in the lower figure, moving the trigger (1150) proximally relative to the locking member (1120) causes the annular groove (1158) between the proximal and distal radial extensions (1154, 1156) to align with the spring locking member (1126). This alignment allows the spring locking member (1126) to rotate radially inward, effectively removing interference between the proximal-facing bevel (1130) and the distal-facing surface forming the corresponding plurality of openings in the plunger body (69). Removing this interference allows the locking member (1120) to move proximally relative to the plunger body (69), resulting in the expansion of the spring (1110) and the retraction of the needle assembly (610). The distal radial extension (1154) is shown with a slight taper (about 3 degrees on each side) that provides a distal bias force on the trigger (1150) when in contact with the spring lock (1126) to resist the force of the compression spring (1100) to hold the trigger (1150) in the distal / extended position during storage, transport, handling and accidental drops.
[0047] Two or more radially extending annular portions (1152) may be provided, configured to interfere with radially inwardly extending protrusions (1138) to position the trigger (1150) in a longitudinal position relative to the locking member (1120), preventing the trigger (1150) from sliding proximally during the accidental drop of the safety injection system (600) onto the thumb pad (128), thereby preventing premature release of the spring locking member (1126) and the interconnected spring (1110) (see [link]). Figure 22-24 ).
[0048] Figure 14 Side views of the locking configuration (above) and unlocking configuration (below) of the card lock (1120) according to some embodiments are shown. Figure 14 It is also shown that the distal stop (1124) can interfere with the distal rotation of the rotatable needle locking arm (1122), thereby enhancing the resistance to the radially extending member (56) during needle retraction; see, for example, Figure 10 ) grasping.
[0049] Figures 15 to 21 The longitudinal sectional view illustrates a method of administering an injection using the safety injection system (600) described herein according to some embodiments and retracting the needle after injection for safe disposal of the used system (600).
[0050] Figure 15A safe injection system (600) in transport / storage condition is shown. The syringe body (34) is pre-filled with injectable fluid (not shown). The sharp distal end of the distal needle member (48) is protected by a needle guard (63). A spring (1110) is kept compressed in the plunger interior space (70) by interference between a spring lock (1126) and a corresponding distal-facing surface (71) forming a plurality of openings (72) in the plunger body (69).
[0051] Figure 16 A safety injection system (600) in standby mode is shown. The needle guard (63) has been removed from the system (600).
[0052] Figure 17 A safe injection system (600) is shown after a distal force / distal directional force is applied to the stop member (36) via the plunger member (44), for example by a user pressing their thumb on the plunger operating interface (128). The radially extending member (56) of the proximal end of the needle (50) has partially penetrated into the stop member (36) without penetrating the locking member (1120). The spring (1110) remains compressed within the plunger internal space (70).
[0053] Figure 18 A safety injection system (600) is shown after a further distal force is applied to the stop member (36) via the plunger member (44). The radially extending member (56) of the proximal end of the needle (50) has moved proximally past the needle locking portion (1122) in the locking member (1120), effectively engaging the needle assembly (610) to the locking member (1120). The spring (1110) remains compressed within the plunger interior space (70).
[0054] Figure 19 A safety injection system (600) is shown after a further distal force is applied to the stop member (36) by the plunger member (44), thereby moving the stop member (36) to the distal end of the syringe body (34). The abutment of the radial extension member (56) pushes the trigger (1150), causing the locking member (1120) to move distally relative to the trigger (1150), thereby aligning the annular groove (1158) between the proximal and distal radial extensions (1154, 1156) with the spring-locking member (1126). This alignment allows the spring-locking member (1126) to rotate radially inward, effectively removing interference between the proximal-facing ramp (1130) and the distal-facing surface forming the corresponding plurality of openings in the plunger body (69). Removing this interference allows the locking element (1120) to move proximally relative to the plunger body (69), resulting in the expansion of the spring (1110) and the retraction of the needle assembly (610). Figure 20A more detailed description is given of the situation with... Figure 19 A safety injection system in the same state (600).
[0055] Figure 21 A safe injection system (600) is shown after the release of the spring (1110), thereby moving the locking member (1120) proximally within the plunger interior space (70) and retracting the needle (610) (including its pointed distal end) into the plunger interior space (70). Retraction of the pointed distal end of the needle (610) into the plunger interior space (70) allows for safe disposal of the used injection system (600). In an alternative embodiment, the pointed distal end of the needle (610) is retracted at least into the distal end of the syringe body Luer interface (33) and / or at least into the distal end of the needle hub (608).
[0056] Figure 22 and Figure 23 This is a perspective view of a trigger (2250, 2250') configured for use with the spring locking element (1126) shown and described herein. Similar to the trigger (1150) shown and described herein, the trigger (2250, 2250') defines a proximal radial extension and a distal radial extension (2254, 2256), between which an annular groove (2258) is defined. The trigger (2250, 2250') also includes two or three radially extending annular portions (2252-1, 2252-2, 2252-3). The first radially extending annular portion (2252-1) is configured to interfere with a second radially inwardly extending protrusion (1138) to temporarily prevent axial movement of the trigger (2250, 2250') relative to the locking element (1120) during its assembly. In an alternative embodiment, the first radially extending annular portion (2252-1) may be configured to interfere with the first and / or third radially inwardly extending protrusions (1138). This temporary interference positions the trigger annular groove (2258) in an axial position, allowing the spring locking member (1126) to rotate inward during the assembly of the plunger rod (44). The trigger (2252, 2252') is moved distally before the distal radial extension (2256) contacts the proximal surface (1157) on the inner surface of the locking member, overcoming the temporary interference and positioning the trigger between the spring locking members (2226), causing the spring (1100) to remain in the compressed position.
[0057] Figure 24Side views of a locking member (1120) and one of the triggers (2250, 2250') assembled in a locking configuration (top) and an unlocking configuration (bottom) according to some embodiments are shown. In the locking configuration, the proximal radial extension (2254) interferes with each of the pair of spring-loaded locking members (1126) to prevent rotation in a radially inward direction. As the triggers (2250, 2250') move proximally relative to the locking member (1120)—this movement can be achieved by pushing the plunger member (44) and the coupled locking member (1120) distally relative to the triggers (2250, 2250')—the locking member (1120) and the triggers (2250, 2250') transition from the locking configuration (top) to the unlocking configuration (bottom). Figure 19 and Figure 24 As shown in the lower figure, moving the trigger (2250, 2250') proximally relative to the locking member (1120) causes the annular groove (2258) between the proximal and distal radial extensions (2254, 2256) to align with the spring locking member (1126). This alignment allows the spring locking member (1126) to rotate radially inward, effectively removing interference between the proximal-facing bevel (1130) and the distal-facing surface forming the corresponding plurality of openings in the plunger body (69). Removing this interference allows the locking member (1120) to move proximally relative to the plunger body (69), resulting in the extension of the spring (1110) and the retraction of the needle assembly (610). The distal radial extension (2254) is shown with a slight taper (about 3 degrees on each side) that provides a distal biasing force on the trigger (2250, 2250') when in contact with the spring lock (1126) to resist the force of the compression spring (1110) to hold the trigger (2250, 2250') in the distal / extended position during storage, transport, handling and accidental drops.
[0058] Two or more radially extending annular portions (2252-1, 2252-2, 2252-3) may be provided, which are configured to interfere with the radially inwardly extending protrusion (1138) to position the trigger (2250, 2250') in multiple longitudinal positions relative to the locking member (1120), wherein the trigger (2250, 2250') cannot slide proximally during the accidental drop of the safety injection system (600) onto the thumb pad (128), thereby preventing premature release of the spring locking member (1126) and the interconnected spring (1110). Figure 23 The third radially extending ring (2252-3) can also be configured to perform a centering function inside the locking element (1120). Figure 24It is also shown that the distal stop (1124) can interfere with the distal rotation of the rotatable needle locking arm (1122) to enhance the resistance to the radially extending member (56; see, for example, [reference]). Figure 10 ) grasping.
[0059] Although the above embodiments include single-chamber safety injection systems, the scope of the claims also includes multi-chamber injection systems. For multi-chamber safety injection systems, two or more stop members are inserted into the body of the injection system (e.g., syringe body, cartridge body, etc.) to define a corresponding number of chambers.
[0060] Although the injection systems shown and described herein include syringes with pre-embedded needles, the needle guard handling device / telescopic component described herein can be used for cartridges, auto-injectors, and injection systems with Luer connectors, etc.
[0061] Various exemplary embodiments of the invention are described herein. Reference is made to these examples in a non-limiting sense. They are provided to illustrate broader aspects of the invention's applicability. Various changes may be made to the described invention, and equivalents may be substituted, without departing from the true spirit and scope of the invention. Furthermore, numerous modifications may be made to adapt particular circumstances, materials, composition, processes, operations, or steps to the purpose, spirit, or scope of the invention. Moreover, those skilled in the art will understand that each individual variation described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any other plurality of embodiments without departing from the scope or spirit of the invention. All such modifications are within the scope of the claims relating to this disclosure.
[0062] Any of the described devices for performing the diagnostic or interventional (therapeutic) procedures discussed may be provided in a packaged combination for use when performing such interventions. These supply “kits” may further include instructions for use and be packaged in a sterile tray or container typically used for this purpose.
[0063] This invention includes methods that can be implemented using the apparatus discussed. The method may include the action of providing such a suitable apparatus. This provision can be performed by an end user. In other words, the "providing" action merely requires the end user to obtain, access, approach, locate, set, activate, power on, or otherwise provide the necessary apparatus in the method discussed. The methods described herein can be performed in any logically possible order of the events and in the sequence of the events.
[0064] Exemplary aspects of the invention, as well as details regarding material selection and manufacture, have been set forth above. For example, those skilled in the art will understand that one or more smooth coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, PTFE, ETFE, hydrophilic gels, or silicones) can be used in conjunction with various parts of the device (e.g., relatively large interface / interface surfaces of movable coupling portions), for example, to manipulate or advance these objects with low friction relative to other parts of the device or nearby tissue structures, if desired. The same applies to the method-based aspects of the invention, in terms of additional actions typically or logically employed.
[0065] Furthermore, although the invention has been described with reference to several examples that optionally incorporate various features, the invention is not limited to what has been described or indicated for various variations of the invention. Various changes can be made to the described invention, and equivalents (whether cited herein or not included for brevity) can be substituted without departing from the true spirit and scope of the invention. Moreover, where numerical ranges are provided, it should be understood that every intermediate value between the upper and lower limits of the range, as well as any other value or intermediate value within the range, is included within the scope of the invention.
[0066] Furthermore, any optional features contemplated by the invention may be stated and claimed independently or in combination 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 related claims, the singular forms “a,” “an,” “the,” and “the” include plural objects unless otherwise specifically stated. In other words, the use of articles allows for “at least one” more items discussed in the specification and in the claims relating to this disclosure. It should also be noted that such claims may be drafted to exclude any optional elements. Therefore, this statement is intended as a premise for the use of exclusive terms (such as “only,” “only,” etc.) or “negative” limitations related to the elements of the recited claims.
[0067] Without using such exclusive terms, the term "comprising" in claims relating to this disclosure shall allow for the inclusion of any additional elements, whether or not a given number of elements are listed in such claims, or any added features that may be considered to alter the nature of the elements described in such claims. Except as specifically defined herein, all technical and scientific terms used herein are to be given the broadest possible meaning in their common understanding while preserving the validity of the claims.
[0068] The scope of this invention is not limited to the examples provided and / or the descriptions involved, but is limited only by the scope of the claims relating to this disclosure.
Claims
1. A system for injection, the system comprising: A syringe body having a proximal end and a distal end, and defining an internal space within the syringe; A stop member, wherein the stop member is disposed within the internal space of the syringe; A needle hub assembly, coupled to the syringe body at a distal end, and comprising: Needle hub, and A needle, which is connected to a needle hub and has a proximal end of the needle; A plunger assembly connected to a stop assembly and configured to be manipulated such that the stop assembly is distally inserted into the internal space of the syringe relative to the syringe body and needle hub. The plunger component includes: The plunger body defines the internal space of the plunger. A retraction member, disposed within the internal space of the plunger and configured to connect to the proximal end of the needle, and A spring, disposed within the internal space of the plunger and configured to cause a retraction member to retract proximally within the internal space of the plunger, the spring having a compressed state and a released state. The retraction component includes: The locking component has: Multiple distal arms, the multiple distal arms being configured to interfere with the proximal end of the needle, and Multiple spring locking elements, the multiple spring locking elements being configured to hold the spring in a compressed state, and A trigger, movably disposed within the locking member along the longitudinal axis of the locking member, and defining: Proximal radial extension, The distal radial extension and An annular groove located between the proximal radial extension and the distal radial extension.
2. The system according to claim 1, wherein, The plurality of spring locking elements include a first spring locking element and a second spring locking element disposed on radially opposite sides of the locking element.
3. The system according to claim 2, wherein, The first and second spring locking components distribute the force from the springs evenly onto the plunger body through a locking mechanism.
4. The system according to claim 1, wherein, The plunger body defines a plurality of openings corresponding to the plurality of spring locking elements and a plurality of distally facing surfaces, the plurality of distally facing surfaces defining a corresponding proximal end of a respective opening among the plurality of openings. Each of the plurality of spring locking members includes a proximal-facing bevel that is configured to engage with a corresponding distal-facing surface of a corresponding opening under the proximal force of a spring from the locking member, thereby pushing the spring locking member radially inward.
5. The system according to claim 4, wherein, Each of the plurality of spring locking elements includes a slot configured to facilitate rotation of the spring locking element toward and away from the trigger.
6. The system according to claim 1, wherein, The locking mechanism includes: A first longitudinal support and a second longitudinal support are disposed on opposite radial sides of the locking element; and An annular portion is connected to the corresponding proximal ends of the first and second longitudinal pillars and is disposed on the proximal side of the plurality of spring locking members.
7. The system according to claim 6, wherein, The annular portion is configured to be at right angles to the first and second pillars so that the retracting member is aligned with the plunger body.
8. The system according to claim 1, wherein, The card lock has multiple windows defined within it.
9. The system according to claim 1, wherein, The trigger includes a radially extending annular portion, and The locking element includes a plurality of radially inwardly extending protrusions configured to interfere with the radially extending annular portion to temporarily prevent the trigger from moving axially relative to the locking element.
10. The system according to claim 9, wherein, The plurality of radially inwardly extending protrusions include first, second, and third radially inwardly extending protrusions, and The second radially inwardly extending protrusion is disposed on the side of the locking member opposite to the first radially inwardly extending protrusion and the third radially inwardly extending protrusion.
11. The system according to claim 9, wherein, The radially extending annular portion and the plurality of radially inwardly extending protrusions are configured to provide multiple docking configurations during the assembly of the retractable component.
12. The system according to claim 9, wherein, The trigger includes a second radially extending annular portion.
13. The system according to claim 12, wherein, The second radially extending annular portion and the plurality of radially inwardly extending protrusions are configured to prevent the spring from prematurely transitioning from a compressed state to a released state during an accidental drop of the system.
14. The system according to claim 1, wherein, The proximal end of the needle has a radially extending member defined at the proximal end of the proximal end of the needle, and The locking member defines a plurality of rotatable needle locking arms, which are configured to interfere with the radial extension member to allow the radial extension member to move proximally past the plurality of rotatable needle locking arms while preventing the radial extension member from moving distally past the plurality of rotatable needle locking arms.
15. The system according to claim 14, wherein, The locking mechanism also defines a distal stop, which is configured to interfere with the plurality of rotatable needle locking arms to prevent the plurality of rotatable needle locking arms from rotating distally past the distal stop.
16. The system according to claim 15, wherein, The distal stop defines an opening through which the distal stop is configured to receive a needle.
17. The system according to claim 1, wherein, The needle also has a tubular connecting member configured to receive the distal end of the proximal end of the needle, and The proximal end of the needle defines one or more channels located at the distal end of the proximal end of the needle.