Automatic injector with three-position needle guard

Abstract

An injector includes a housing having a proximal end and a distal end opposite the proximal end. The housing extends along a longitudinal axis. A medicament container is disposed within the housing, the medicament container containing a medicament. A needle is coupled to a proximal end of the medicament container and is in fluid communication with the medicament container. A trigger mechanism includes a needle guard that is retractably coupled to the proximal end of the housing and is movable along the longitudinal axis between an extended position, an intermediate position, and a retracted position. A cap is removably coupled to the proximal end of the housing, and when the cap is coupled to the proximal end of the housing, the needle guard is in the intermediate position.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 609,481, filed December 13, 2023, entitled “Autoinjector with Three-Position Needle Guard,” which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates in general to pharmaceutical injection devices, and in some embodiments to needle-assisted injectors having a three-position needle guard. Summary of the Invention

[0004] In one embodiment, there is a syringe comprising: a housing having a proximal end and a distal end opposite the proximal end, the housing extending along a longitudinal axis; a drug container disposed within the housing, the drug container containing a drug; a needle coupled to the proximal end of the drug container and in fluid communication with the drug container; a triggering mechanism including a needle guard retractably coupled to the proximal end of the housing and movable along the longitudinal axis between an extended position, an intermediate position, and a retracted position; and a cap removably coupled to the proximal end of the housing, the needle guard being in the intermediate position when the cap is coupled to the proximal end of the housing.

[0005] In some embodiments, the needle protector extends a first length from the housing in an extended position and a second length from the housing in an intermediate position. In some embodiments, the first length is greater than the second length. In some embodiments, the first length is approximately 21 mm. In some embodiments, the second length is approximately 17 mm.

[0006] In some embodiments, when the cap is attached to the housing, the needle protector is pushed distally along the longitudinal axis from an extended position to an intermediate position. In some embodiments, the needle protector covers a portion of the needle in the intermediate position. In some embodiments, when the cap is attached to the housing, a needle guard, attached to the needle and configured to cover at least a portion of the needle, extends distally through an opening in the cap. In some embodiments, the needle guard separates from the needle via the cap when the cap is detached from the housing. In some embodiments, the needle protector moves from an extended position to a retracted position in response to a user pressing the needle protector against the injection site. In some embodiments, the needle protector moves from a retracted position to an extended position when the user removes the syringe from the injection site. In some embodiments, the needle protector moves from the retracted position to the extended position via a biasing member. In some embodiments, once the needle protector has moved from the retracted position to the extended position, it is prevented from moving relative to the housing.

[0007] In some embodiments, the syringe also includes a biasing member configured to push the needle protector distally along the longitudinal axis to an extended position when the cap is not attached to the housing. In some embodiments, the needle protector covers the entire length of the needle in the extended position.

[0008] In some embodiments, the triggering mechanism further includes: a push rod configured to move a plunger capable of engaging the distal end of the push rod relative to the medication container; a trigger member configured to engage the push rod and prevent movement of the push rod when the needle protector is in the extended position; and an energy source engaging the distal end of the push rod, the energy source being configured to move the push rod distally relative to the housing. In some embodiments, movement of the needle protector from the extended position to the retracted position disengages the trigger member from the push rod, thereby allowing the energy source to move the plunger relative to the medication container to expel medication through the needle.

[0009] In another embodiment, a syringe includes: a housing having a proximal end and a distal end opposite the proximal end, the housing extending along a longitudinal axis; a drug container disposed within the housing, the drug container containing a drug; a needle coupled to the distal end of the drug container and in fluid communication with the drug container; a triggering mechanism including a needle guard retractably coupled to the distal end of the housing and movable along the longitudinal axis between an extended position, a neutral position, and a retracted position; and a cap removably coupled to the distal end of the housing. In some embodiments, the needle guard is in the neutral position when the cap is coupled to the distal end of the housing. In some embodiments, the needle guard extends from the housing by a first length in the extended position and by a second length in the neutral position. In some embodiments, the first length is greater than the second length. In some embodiments, when the cap is coupled to the housing, the needle guard is pushed distally along the longitudinal axis from the extended position to the neutral position.

[0010] In another embodiment, a method of delivering a drug to a subject is provided, the method comprising: providing a syringe including: a housing having a proximal end and a distal end opposite the proximal end, the housing extending along a longitudinal axis; a drug container disposed within the housing, the drug container containing a drug; a needle coupled to the distal end of the drug container and in fluid communication with the drug container; and a triggering mechanism including a needle guard retractably coupled to the distal end of the housing and movable along the longitudinal axis between an extended position, an intermediate position, and a retracted position; and coupling a cap to the housing such that the needle guard is moved distally along the longitudinal axis from the extended position to the intermediate position.

[0011] In some embodiments, the method of delivering the medication to the subject further includes: removing the cap from the housing, thereby allowing a biasing member disposed in the housing to move the needle protector distally along the longitudinal axis from an intermediate position to an extended position; pressing the needle protector against the injection site of the subject, thereby moving the needle protector from the extended position to a retracted position; and removing the syringe from the injection site, thereby allowing the biasing member to move the needle protector distally along the longitudinal axis from the retracted position to the extended position. In some embodiments, the needle protector extends from the housing by a first length in the extended position and by a second length in the intermediate position. In some embodiments, the first length is greater than the second length. In some embodiments, the first length is approximately 21 mm and the second length is approximately 17 mm. Attached Figure Description

[0012] The foregoing overview and the following detailed description of embodiments of the injection device will be better understood when read in conjunction with the accompanying drawings of exemplary embodiments. However, it should be understood that the invention is not limited to the precise arrangements and tooling methods shown.

[0013] In the attached diagram: Figure 1 This is a perspective view of an injection device in a pre-injection state according to a first exemplary embodiment of the present invention; Figure 2 yes Figure 1 A front sectional view of the injection device, with the cap removed; Figure 3 yes Figure 1 The injection device regarding Figure 2 A side sectional view taken from a plane at a 90-degree angle to the plane; Figure 4A yes Figure 1 Front view of the front housing of the injection device; Figure 4B yes Figure 1 Side view of the front housing of the injection device; Figure 5 yes Figure 1 A perspective view of the drug container of the injection device; Figure 6 yes Figure 1 A perspective view of the needle protector of the injection device; Figure 7 yes Figure 1 A perspective view of the plunger of the injection device; Figure 8 yes Figure 1 A perspective view of the triggering mechanism of the injection device; Figure 9 It is in the process of being pushed in. Figure 1 A front sectional view of the injection device; Figure 10 It is in the process of being pushed in. Figure 1 The injection device Figure 9 A side sectional view taken from a plane at a 90-degree angle to the plane; Figure 11 It is in a locked state. Figure 1 A front sectional view of the injection device; Figure 12 It is in a locked state. Figure 1 The injection device regarding Figure 11 A side sectional view taken from a plane at a 90-degree angle to the plane; Figure 13 yes Figure 1 A front sectional view of the cap of the injection device; Figure 14 This is a front sectional view of an injection device in a pre-injection state according to a second exemplary embodiment of the present invention; Figure 15A yes Figure 1 A partial front sectional view of the injection device, with the cap on it and the needle protector in the middle position; Figure 15B yes Figure 1 A front view of the injection device, with the cap removed and the needle protector in the extended position; and Figure 15C yes Figure 1 A front view of the injection device, with the cap removed and the needle protector in the retracted position. Detailed Implementation

[0014] Refer to the accompanying drawings for details, wherein the same reference numerals throughout indicate the same elements. Figures 1 to 13 An injection device according to a first exemplary embodiment of the present invention is shown, generally designated as 100.

[0015] Figure 1An exemplary injection device 100 according to a first exemplary embodiment of the present disclosure is shown. It should be noted that, in the context of this disclosure, the terms "distal" and "proximal" are used with reference to the position of the injection device 100 relative to the user when held by the user. Thus, a feature located distal to the second feature will be further away from the user (i.e., towards the injection end of the injection device 100), and vice versa. Those skilled in the art will understand that alternative embodiments employing certain features described herein can be configured as needle-free jet injectors, needle-assisted jet injection devices, powered injectors, low-pressure autoinjectors, or other mechanized injectors. According to some embodiments, the injection device 100 is a disposable syringe. In some embodiments, the injection device 100 can be modified to provide multiple and / or variable doses during repeated injections. According to some embodiments, the injection device 100 is a disposable syringe with a locking feature. For example, the injection device 100 may facilitate the injection of a drug stored within the injection device 100 and may include a locking feature that prevents the user from attempting to reuse the injection device 100 after a drug has been dispensed. In one embodiment, the locking feature is activated during drug dispensing, rather than during use of the injection device 100. For example, the locking feature can be activated to prevent the user from subsequently attempting to use the injection device 100, even if the injection device 100 is not actually used for injection, but the triggering mechanism 108 is unintentionally activated (e.g., during transport, handling, etc. of the device) and the drug is dispensed. The operation of the injection device 100 including the locking feature is described in further detail below.

[0016] According to some embodiments, the injection device 100 can deliver any suitable liquid medication or agent. Furthermore, the injection device 100 can allow administration by an individual without formal training (e.g., self-administration or administration by another family member or other caregiver who may not be a formally trained healthcare provider). Therefore, the injection device 100 can be used in situations where self-administration / caregiver administration would be beneficial, including but not limited to drug overdose or alcohol dependence. Additionally, the injection device 100 can be used to administer a wide variety of medications. For example, the injection device 100 can be used to administer drugs, water-soluble agents, peptides, proteins, reservoir formulations, and oil-soluble agents. In one embodiment, the injection device 100 is designed to induce a strong and smooth expulsion of the agent, which may be necessary for viscous formulations (including but not limited to biologics). In some embodiments, the injection device 100 is designed to administer the agent very rapidly.

[0017] The injection device 100 may include a needle protector with three positions. When the cap is attached to the injection device, the needle protector 100 can be partially retracted to the intermediate position. The intermediate position allows the use of various needles of different lengths. The ability to use multiple needles with a single syringe can reduce manufacturing costs by allowing the same parts to be used in multiple applications, which can reduce downstream costs for patients and other consumers.

[0018] The injection device 100 includes a housing 102 having a proximal end and a distal end opposite to the proximal end, the housing along a longitudinal axis L. A Extension. The injection device 100 may also include various parts and / or components housed within the housing 102. For example... Figure 2 , Figure 3 and Figures 9 to 12 As shown, these components may include a drug container 104, a needle 106, and a triggering mechanism 108. The housing 102 may be a single piece, or alternatively, the housing 102 may be a multi-piece assembly joined together, for example, by means of snap-fit ​​connection, press-fit connection, threaded engagement, adhesive, welding, etc.

[0019] In one embodiment, housing 102 includes a front subassembly and a rear subassembly joined together, for example, via snap-fit ​​connection, press-fit connection, threaded engagement, adhesive, welding, etc. The front subassembly may include a needle protector 110, a biasing member 112, a bushing 114, and a front housing 116. The rear subassembly may include a rear cap 118, a power source 120, a push rod 122, a trigger mechanism 108, and a rear housing 124. Providing two subassemblies increases the ability to adjust the components in each subassembly, allowing for customization and repeatability in manufacturing.

[0020] like Figure 2 , Figure 3 and Figures 9 to 12 As shown, in one embodiment, a drug container 104 is at least partially disposed within a front housing 116. The drug container 104 may contain a drug including an opioid antagonist or a pharmaceutically acceptable salt thereof. When disposed in an injection device 100, the drug container 104 may be disposed within a sleeve 126 of the front housing 116. The front housing 116 may be coupled to the distal end of the housing 102 via, for example, a snap-fit ​​connection, a press-fit connection, a threaded connection, an adhesive, welding, etc. According to some embodiments, the injection device 100 may be configured to inject a drug stored in a pre-filled drug delivery device. Pre-filled drug delivery devices manufactured using a blown glass process may have significant dimensional tolerances and inhomogeneities. Therefore, features of the front housing 116 may be used to accommodate shape irregularities and to properly position and place the pre-filled drug delivery device within the injection device 100. Other drug containers, such as pre-filled drug delivery devices made of polymers, may also be accommodated.

[0021] The pharmaceutical container 104 may include a cylindrical body 166 configured to hold at least 1 mL of pharmaceutical agent. In some embodiments, the cylindrical body 166 may hold at least 1.5 mL, at least 2 mL, at least 2.5 mL, or at least 3 mL. Figure 5 As shown, plunger 130 is disposed within drug container 104. Plunger 130 can be associated with push rod 122 of the subsequent sub-assembly, as described in more detail below. During injection, energy source 120 is directed along longitudinal axis L... A Push the push rod 122 to the distal end to displace the plunger 130 distally through the medicine container 104, thereby dispensing the medicine through the needle 106. Figures 2 to 3 The injection device 100 in its pre-injection state is shown. The operation of the injection device 100, including its various stages and positions, is described in further detail below.

[0022] Sleeve 126 is configured to hold a medicine container 104, which may include a needle 106 extending from its distal end. The needle 106 may be in fluid communication with the medicine container 104. A bushing 114 may be disposed within sleeve 126 to receive the proximal end of the medicine container 104. Figure 5 As shown, the medication container 104 may include an edge 164 of an engaging bushing 114. The edge 164 may be generally circular and have a circumference larger than that of the cylindrical body 166. The bushing 114 may be secured relative to the housing 102 to prevent distal movement of the medication container 104 relative to the housing 102 during injection. In some embodiments, the medication container 104 may include, for example, a separate glass ampoule and needle, or a pre-filled delivery device. In one embodiment, the sleeve 126 may include an integral medication container. The needle 106 may be coupled to the medication container 104 via threaded connection, snap-fit ​​connection, friction fit, or any suitable coupling construction.

[0023] Additionally, such as Figures 4A to 4B As shown, the sleeve 126 may include various features, such as protrusions 128, configured to engage the front housing 116 to the housing 102. For example, protrusions 128 may be concentrically symmetrical and configured to engage an opening in the housing 102 to the front housing 116 of the housing 102. In one embodiment, protrusions 128 are disposed on legs 129, which may be concentrically symmetrical and configured to engage features of the housing 102. Additionally, the sleeve 126 may include locking features, such as locking protrusions 131, disposed on legs 133, which may be concentrically symmetrical and configured to engage features of the needle protector 110, thereby locking the injection device 100 to prevent the user from attempting to use the already injected injection device 100, as discussed in more detail below.

[0024] In one embodiment, housing 102 includes an opening configured to engage with sleeve 126 to attach and secure sleeve 126 to housing 102, and housing includes at least one window that can provide a visual indication of whether injection device 100 has been injected. For example, in the pre-injection state, the window may allow a user to see the medication container 104 and the stored medication, and in the injection state, the window shows one or more internal components, such as a trigger mechanism 108 or a portion of push rod 122, which may be a specially selected color to indicate to the user that injection device 100 has been injected, and in one embodiment, it is sufficiently different from other colors visible to the user of injection device 100 (in one embodiment, having normal vision) before injection, so as to be clearly different from or contrast with any other colors present or prominently present. For example, in one embodiment, the color is different from the color of all other components of injection device 100 before injection, or different from the color visible to the user before injection, so as to be noticeable (e.g., introducing a completely new color scheme). In one embodiment, the new color that appears after injection comes from a dissimilar portion of the color wheel, or may contrast with, or be complementary to, the color visible on the injection device 100. In one embodiment, the new color indicates a warning, such as red or orange. In one embodiment, the color visible on the injection device 100 in the pre-injection state (and in one embodiment, including when the cap 136 is on and / or removed from the injection device 100) is, for example, gray and blue. In one embodiment, red is introduced when the injection device 100 is injected. In one embodiment, the new color may be introduced after injection but before the needle protector 110 is locked in the extended position.

[0025] like Figure 5 As shown, needle 106 may include an injection tip 106a configured to penetrate the user's skin and a hollow orifice 106b in fluid communication with a medication container 104 to facilitate delivery of medication from the medication container 104 to the user during injection. In one embodiment, needle 106 may be 22 gauge. In some embodiments, needle 106 is between 22 and 29 gauges. In some embodiments, needle 106 may be between 25 and 28 gauges, and in other embodiments, approximately 27 gauges, but alternatively, other needle sizes may be used, wherein other components are cooperatively configured to produce the desired injection. In one embodiment, needle 106 is a 5 / 8" post-attached needle. In some embodiments, needle 106 is a post-attached needle with a length between 1 / 2" and 3 / 4" of the post. In some embodiments, needle 106 may be between 9 / 16" and 11 / 16" of the post.

[0026] In some embodiments, thin-walled needles may be used. Thin-walled needles may have the same outer diameter as a standard-gauge post or "conventional wall" needle, but allow for a flow rate at least one size larger. For example, a size 22 thin-walled needle may allow the same flow rate as a size 21 conventional wall needle. Thin-walled needles may have a wall thickness of less than 0.05 mm. Thin-walled needles may have wall thicknesses of less than 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, or 0.09 mm. Thin-walled needles may have wall thicknesses between 0.02 mm and 0.09 mm, between 0.03 mm and 0.08 mm, between 0.04 mm and 0.07 mm, and between 0.05 mm and 0.06 mm. In some embodiments, thin-walled needles can be used without the risk of bending when the injection device 100 is configured to operate via manual needle insertion prior to injection.

[0027] like Figures 2 to 3 As shown, in one embodiment, the injection device 100 includes a needle protector 110, which is at least partially slidably mounted within the distal end of the housing 102. The needle protector 110 can be configured to engage a trigger mechanism 108 to actuate the injection of the injection device 100. Figure 2 , Figure 3 and Figures 9 to 12 As shown, in one embodiment, the needle protector 110 is slidably movable relative to the housing 102 between an extended (e.g., distal, protected) position and a retracted (e.g., proximal) position. In one embodiment, in the extended position, the needle protector 110 covers the needle 106, and in the retracted position, the needle 106 is not covered by the needle protector 110 and is thus exposed. For example, Figures 2 to 3 The needle protector 110 is shown in the extended position, and Figures 9 to 10 The needle protector 110 is shown in the retracted position. (See diagram.) Figures 2 to 3 As shown, in one embodiment, the needle protector 110 is resiliently biased toward an extended position via a biasing member 112, which may be disposed, for example, between the distal surface of the front housing 116 and the inner surface of the distal end of the needle protector 110. In some embodiments, the biasing member 112 comprises a compression spring; however, other suitable energy sources may be used, such as an elastomer or a compressed gas spring, or a gas generator, or other suitable energy storage components.

[0028] like Figures 9 to 10As shown, when the needle protector 110 is in the retracted position, the needle 106 extends a length X from the housing 102. The length X can be at least 5 mm. In some embodiments, the length X is at least 2 mm, at least 3 mm, at least 4 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, or at least 10 mm. In some embodiments, the length X is between 2 mm and 10 mm, between 3 mm and 9 mm, between 4 mm and 8 mm, or between 5 mm and 7 mm.

[0029] The injection device 100 can be configured to deliver the volume of medication subcutaneously to a user. In some embodiments, the injection device 100 can be configured to deliver the volume of medication intramuscularly to a user. The length X can be determined based on the specific application of the injection device 100. For example, the length X can be greater for intramuscular delivery than for subcutaneous delivery.

[0030] like Figure 6 As shown, in one embodiment, the needle protector 110 includes a distal portion 132 and a leg 134 extending proximally from the distal portion 132. In one embodiment, the distal portion 132 of the needle protector 110 includes a skin contact member on its distal surface. The distal portion 132 may be shaped to be substantially identical to the housing 102. The distal portion 132 includes an opening (not shown) through which the needle 106 can pass.

[0031] The needle protector 110 may also include a protrusion 132a, such as Figure 6 As shown. Figure 13 As shown, the protrusion 132a can engage the engagement feature 138 of the cap 136, preventing the needle protector 110 from proximal displacement when engaged with the engagement feature 138 of the cap 136. In one embodiment, the needle protector 110 includes a stop surface 140. The stop surface 140 can be configured to abut the inner surface of the front housing 116 to limit proximal displacement of the needle protector 110. For example, when the needle protector 110 is displaced proximally during injection under the force applied by the user, the stop surface 140 will contact the inner surface of the front housing 116, preventing further proximal displacement of the needle protector 110. The distance between the skin contact member and the stop surface 140 can be adjusted during manufacturing to adjust the length X of the needle 106 extending from the housing 102.

[0032] In one embodiment, the support leg 134 of the needle protector 110 is configured to be received in an opening in the front housing 116. Furthermore, the support leg 134 may include a ridge 142 configured to engage a recess (not shown) in the front housing 116 to facilitate alignment and guidance of the support leg 134 during axial displacement of the needle protector 110. Figure 6As shown, the leg 134 also includes a push-in actuation member, such as a cam surface 144 at the proximal end of the leg 134. In one embodiment, the leg 134 and the cam surface 144 may be concentrically symmetrical. The cam surface 144 is configured to engage and displace the trigger mechanism 108 to actuate the injection device 100. The proximal end of the leg 134 may also be inclined so that the leg 134 engages the trigger mechanism 108 when the needle protector 110 is displaced from the extended position to the retracted position.

[0033] The needle protector 110 extends a length Y from the front housing 116. The length Y is sufficient to cover the needle 106 in the extended position. In some embodiments, the needle protector 110 can be held in the extended position when the cap 136 is attached to the front housing 116. Figures 4A to 4B As shown, the front housing 116 may include a protrusion 146 extending from its distal end, the protrusion being angled to allow the cap 136 to be rotatably fastened thereto. In some embodiments, the cap 136 may be snap-fitted or friction-fitted to the front housing 116.

[0034] In some embodiments, when the cap 136 is attached to the front housing 116, the cap 136 can force the needle guard 110 from the extended position toward the retracted position into an intermediate position without initiating the injection device 100. The needle guard (e.g., attached to the needle 106) Figure 14 The needle guard 243 can be configured to cover at least a portion of the needle 106. When the cap 136 is attached to the housing, the needle guard can extend distally through the orifice of the cap 136. An intermediate position may reduce the length of the injection device 100, or may be necessary because the length of the needle 106 requires the needle guard 110 to be longer than the length that the cap 136 can accommodate. An intermediate position allows the injection device 100 to accommodate various needles while maintaining the same coverage area. The needle guard 110 can cover a portion of the needle 106 in the intermediate position. When the cap 136 is secured to the front housing 116, the needle guard 110 can partially expose the needle 106 within the cap 136. This intermediate position may also be referred to as the storage position of the needle guard 110.

[0035] like Figures 15A to 15B As shown, the length Y can reach a first length Y1 at the extended position and a second length Y2 at the intermediate position. The first length Y1 can be greater than the second length Y2. Figure 15BAs shown, in the extended position, the length Y1 can be approximately 21 mm. In some embodiments, in the extended position, the length Y1 is approximately 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, or 26 mm. In some embodiments, in the extended position, the length Y1 is between 15 mm and 26 mm, between 16 mm and 25 mm, between 17 mm and 24 mm, between 18 mm and 23 mm, between 19 mm and 22 mm, or between 20 mm and 21 mm. Figure 15A As shown, at the midpoint, the length Y2 can be approximately 17 mm. In some embodiments, at the midpoint, the length Y2 is approximately 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, or 27 mm. In some embodiments, at the midpoint, the length Y2 is between 3 mm and 27 mm, between 4 mm and 26 mm, between 5 mm and 25 mm, between 6 mm and 24 mm, between 7 mm and 23 mm, between 8 mm and 22 mm, between 9 mm and 21 mm, between 10 mm and 20 mm, between 11 mm and 19 mm, between 12 mm and 18 mm, between 13 mm and 17 mm, or between 14 mm and 16 mm. like Figure 15C As shown, in the retracted position, the length Y3 can be approximately 4 mm. In some embodiments, in the retracted position, the length Y3 is approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm. In some embodiments, in the retracted position, the length Y3 is at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, or at least 5 mm. In some embodiments, in the retracted position, the length Y3 is between 0.1 mm and 5 mm, between 0.2 mm and 4 mm, between 0.3 mm and 3 mm, between 0.4 mm and 2 mm, or between 0.5 mm and 1 mm.

[0036] like Figures 11 to 12As shown, the injection device 100 can be in a "locked" state when the needle protector 110 moves from the retracted position to the extended position after injection. For example, the "locked" state can be observed after the user has removed the injection device 100 from the injection site. In the retracted position, nothing resists the force of the biasing member 112 to restrain the needle protector 110, and therefore, the needle protector 110 moves distally from the retracted position to the extended position under the force of the biasing member 112, thereby covering the needle 106. When the needle protector 110 moves distally from the retracted position to the extended position under the force of the biasing member 112, the radially outwardly flexed protrusion 146 engages the proximal surface of the front housing 116 and the proximal surface of the opening 148 of the push rod 122 to further prevent movement of the needle protector. Figure 11 As shown, the association between the protrusion 146 and the proximal surface of the opening 148 of the push rod 122 prevents the needle protector 110 from shifting proximally, and the association between the protrusion 146 and the proximal surface of the front housing 116 prevents the needle protector 110 from shifting distally. Therefore, the needle protector 110 is in a locked position, thereby locking the injection device 100 so that the needle 106 is covered and the needle protector 110 is locked in place, preventing the user from attempting subsequent injections. The user can then secure the cap 136 back onto the distal end of the injection device 100.

[0037] Advantageously, in one embodiment, the "locked" state depends not on the displacement of the needle protector 110, but on the dispensing of the medication stored in the medication container 104 and / or the movement of the plunger 122. For example, in the event of unintentional dispensing of medication, the injection device 100 becomes locked even if the needle protector 110 has not yet been displaced. The injection device 100 can become locked in any case where the power source 120 is activated and the plunger 122 is displaced distally, thereby displacing the plunger 130 via the plunger body 158, and thus dispensing medication from the medication container 104 via the needle 106.

[0038] like Figure 3 As shown, in one embodiment, the rear cap 118 includes a push rod retaining member 156. The push rod retaining member 156 may be a protrusion extending distally from the proximal surface of the rear cap 118. The push rod retaining member 156 may be configured to engage the trigger engagement member 154 of the push rod 122. For example, as... Figure 3 As shown, in one embodiment, the push rod retaining member 156 may be a bell-shaped protrusion and may engage with a complementary-shaped feature of the push rod 122 (e.g., a trigger engagement member 154). In one embodiment, the push rod retaining member 156 and the trigger engagement member 154 of the push rod 122 may include circular cross-sections.

[0039] like Figure 7As shown, the push rod 122 may be a generally cylindrical component. The push rod 122 may include features extending through at least one opening to receive and accommodate other components of the injection device 100. For example, the push rod 122 may include an opening 148 at its distal end, shaped and sized to receive a leg 134 of the needle protector 110. The opening 148 may allow the leg 134 of the needle protector 110 to slide relative to the push rod 122 as the needle protector 110 moves between an extended and retracted position. Although shown as a single piece, the push rod 122 may be a multi-piece assembly that can be joined together, for example, via snap-fit ​​connections, press-fit connections, threaded connections, adhesives, welding, or other suitable couplings. The push rod 122 may preferably include various features configured to facilitate the dispensing of medication stored in the drug container 104 by the push of the injection device 100.

[0040] The push rod 122 may also include an opening 150 at its proximal end, the shape and size of which are designed to receive the leg 152 of the trigger mechanism 108. The opening 150 allows the leg 152 of the trigger mechanism 108 to slide relative to the push rod 122 when the trigger mechanism 108 is moved proximally as it is engaged by the needle guard 110, which has been moved from the extended position to the retracted position.

[0041] like Figure 7 As shown, push rod 122 may include a trigger engagement member 154 extending proximally therefrom. Although the trigger engagement member 154 is shown as a protrusion, alternative embodiments of the push rod retaining member 156 that engages the rear cap 118 are contemplated, such as elongated tabs, thin tabs, recesses, protrusions, bulges, threads, etc. As discussed above, the push rod retaining member 156 may be a spherical object extending distally from the rear cap 118 within the housing 102, such that the trigger engagement member 154 prevents the push rod 122 from moving distally during engagement. In some embodiments, there may be one trigger engagement member 154, and in some embodiments, there may be more than one trigger engagement member 154 circumferentially spaced around the push rod 122.

[0042] like Figure 2 , Figure 3 and Figures 9 to 12 As shown, the push rod 122 may also include a push rod body 158, which extends along the longitudinal axis L. AThe plunger 158 extends distally from the proximal end of the plunger 122. The plunger body 158 may extend approximately from the central portion of the proximal end of the plunger 122. The plunger body 158 may extend beyond the length of the plunger 122 into the medication container 104 to engage the plunger 130. The plunger may include a receiving portion 160, which is shaped and sized to receive the distal end of the plunger body 158. The receiving portion 160 may ensure that the plunger body 158 engages the central portion of the plunger 130. In some embodiments, the plunger body 158 is coupled to the plunger 130. When the injection device 100 is pushed, the plunger body 158 may move the plunger 130 relative to the medication container 104.

[0043] like Figures 2 to 3 As shown, in some embodiments, the injection device 100 includes a triggering mechanism 108. In one embodiment, a push rod 122 is slidably mounted within a housing 102 and engaged by an energy source 120. The energy source 120 engages the distal end of the push rod 122. In one embodiment, the energy source 120 includes a compression spring; however, other suitable energy sources may be used, such as an elastomer or a compressed gas spring, a gas generator, or other suitable energy storage components. Figures 2 to 3 In the injection, the plunger 122 is in the closest position before injection. During injection, the plunger 122 is pushed distally by energy released from the energy source 120. Once the injection is complete, the plunger 122 is positioned at the furthest point. In this distal position, the needle guard 110 is locked and extends over the needle tip 106a, preventing the user from attempting subsequent injections, and the needle guard 110 can also function as a sharps protector.

[0044] While the injection device 100 can deliver approximately 0.5 mL per injection, other volumes can be injected in alternative embodiments. In some embodiments, the injection device 100 can deliver approximately 1 ml, approximately 1.5 ml, approximately 2 ml, approximately 2.5 ml, approximately 3 ml, or approximately 3.5 ml per injection. In some embodiments, the injection device 100 can deliver greater than 0.5 mL, greater than 1 mL, greater than 1.5 mL, greater than 2 mL, greater than 2.5 mL, greater than 3 mL, or greater than 3.5 mL per injection. In other embodiments, the injection volume that the injection device 100 can deliver is in the range of approximately 0.2 mL to approximately 3 mL, in the range of approximately 0.5 mL to approximately 2.75 mL, in the range of approximately 0.75 mL to approximately 2.5 mL, in the range of approximately 1 mL to approximately 2.25 mL, in the range of approximately 1.25 mL to approximately 2 mL, or in the range of approximately 1.5 mL to approximately 1.75 mL.

[0045] In one embodiment, the injection device 100 can inject 0.5 ml of a drug dissolved in an aqueous solution within about 0.1 seconds, about 0.2 seconds, about 0.3 seconds, about 0.4 seconds, about 0.5 seconds, about 0.6 seconds, about 0.7 seconds, about 0.8 seconds, about 0.9 seconds, about 1.0 seconds, or any range that can be determined from the foregoing times (e.g., about 0.5 seconds to about 1.0 seconds or about 0.4 seconds to about 0.6 seconds). In one embodiment, the injection device 100 can inject the drug at a flow rate of at least 2.5 mL / s. The flow rate can be at least 3 mL / s, at least 3.5 mL / s, at least 4 mL / s, at least 4.5 mL / s, at least 5 mL / s, or at least 5.5 mL / s. The flow rate can be between 2.5 mL / s and 5.5 mL / s, between 3 mL / s and 5 mL / s, or between 3.5 mL / s and 4.5 mL / s.

[0046] To initiate the injection of the injection device 100, the movement of the needle guard 110 from the extended position to the retracted position causes the trigger engagement member 154 to disengage from the push rod 122, thereby allowing the energy source 120 to move the plunger 130 relative to the drug container 104 to expel the drug through the needle 106. Figure 3 As shown, when the needle protector 110 is in the extended position, the blocking portion 162 of the triggering mechanism 108 prevents axial movement of the trigger engagement member 154 of the push rod 122. The blocking portion may have an internal position shaped to receive the trigger engagement member 154 to prevent it from rotating relative to the triggering mechanism 108. During proximal movement of the needle protector 110 and distal movement of the triggering mechanism 108, the blocking portion 162 may move relative to the push rod 122 and no longer engage the trigger engagement member 154. When the blocking portion 162 no longer prevents radial movement of the trigger engagement member 154, the distal force generated on the push rod 122 by the energy source 120 causes the trigger engagement member 154 to flex radially outward about the push rod retainer 156. Therefore, the push rod 122 moves freely relative to the housing 102, and causes the push rod body 158 to move the plunger 130 relative to the drug container 104. Figures 9 to 10 As shown, during injection, push rod 122 forces push rod body 158 to expel the volume of medicine contained in medicine container 104.

[0047] like Figure 13As shown, in one embodiment, the injection device 100 includes a cap 136. The cap 136 can be removably secured to the distal end of the housing 102. In one embodiment, the cap 136 can be removably secured to the distal end of the front housing 116. For example, the cap 136 can be removably attached to the distal end of the housing 102 via a threaded engagement, and the rear cap 118 can include features (e.g., a protrusion) configured to engage a portion (e.g., an opening) of the proximal end of the housing 102 to attach the rear cap 118 to the housing 102. The cap 136 can include features along the longitudinal axis L. A An extended barrel 139 is shaped and sized to receive a needle 106 therein. The barrel 139 may extend at least partially along the length of the cap 136. The proximal end of the barrel 139 may be open to receive the needle 106 and / or a portion of the medication container 104. The distal end of the barrel 139 may be closed to prevent exposure of the needle 106 when the cap 136 is engaged to the housing 102. The barrel 139 may include engagement lips 141 extending radially inward therefrom. The engagement lips 141 may extend circumferentially around the barrel 139. In one embodiment, the barrel 139 may include more than one circumferentially spaced engagement lip 141. The engagement lips 141 may be configured to engage a needle guard 243 covering the needle 106, such as... Figure 14 As shown. In one embodiment, the distal end of the cap 136 may be open and shaped to allow the needle shield 243 to extend through it. Removal of the cap 136 allows the needle shield 243 to be removed from the needle 106 in preparation for injection.

[0048] When attached to the injection device 100, the cap 136 ensures that the injection is not triggered by accidental force applied to the needle protector 110. In one embodiment, the cap 136 includes two engaging features 138. Figure 13 As shown, the cap 136 may include an engagement feature 138. The engagement feature 138 may be threaded, configured to thread-engage other features of the injection device 100. For example, the engagement feature 138 may be configured to secure the cap 136 to the distal end of the housing 102, or to thread-engage a distal portion of the housing 116. In one embodiment, the engagement feature 138 may be configured to thread-engage features (e.g., threads) of the needle protector 110 to prevent proximal displacement of the needle protector 110.

[0049] In another aspect of this disclosure, a method for delivering a drug to a subject is provided. The method may include providing a syringe 100. The syringe 100 may include a housing 102 having a proximal end and a distal end opposite the proximal end, the housing being disposed along a longitudinal axis L. AFurther, syringe 100 may include a medicine container 104 disposed within housing 102. Medicine container 104 may include a medicine. Syringe 100 may include a needle 106 coupled to and in fluid communication with the distal end of medicine container 104.

[0050] In some embodiments, syringe 100 may include a trigger mechanism 108. The trigger mechanism 108 may include a needle guard 110 retractably coupled to the distal end of housing 102. The needle guard 110 is capable of extending along the longitudinal axis L. A It moves between an extended position, a mid-position, and a retracted position. In some embodiments, the method may include attaching the cap 136 to the housing 102, thereby causing the needle protector 110 to move along the longitudinal axis L. A Move from the extended position to the proximal position to the middle position.

[0051] In some embodiments, the method may include removing the cap 136 from the housing 102, thereby allowing the biasing member 112 disposed in the housing 102 to guide the needle protector 110 along the longitudinal axis L. A The method may involve pressing the needle guard 110 against the user's injection site with sufficient force to move the needle guard 110 from the extended position to the retracted position. The method may also involve removing the syringe 100 from the injection site, thereby allowing the biasing member 112 to move the needle guard 110 distally along the longitudinal axis from the retracted position to the extended position. In this distal position, the needle guard 110 is locked and extends over the needle tip 106a, preventing the user from attempting subsequent injections, and the needle guard 110 can function as a sharps protector. The extended position may be the same as the locked position described above.

[0052] In some embodiments, the needle protector 110 extends from the housing 102 by a first length in an extended position and by a second length in an intermediate position. The first length may be greater than the second length. The first length may be approximately 21 mm. The second length may be approximately 17 mm.

[0053] Figure 14 A second exemplary embodiment of the injection device, generally designated 200, is illustrated, having a pin-shaped safety mechanism 268. The injection device 200 may be an autoinjector, a needleless jet injector, a needle-assisted jet injection device, a powered injector, a low-pressure autoinjector, or other mechanized injector.

[0054] The injection device 200 includes a housing 202 having a proximal end and a distal end opposite to the proximal end, the housing along a longitudinal axis L. A Further, the injection device 200 may also include various parts and / or components housed within the housing 202. For example... Figure 14As shown, these components may include a drug container 204, a needle 206, and a triggering mechanism 208. The housing 202 may be a single piece, or alternatively, the housing 102 may be a multi-piece assembly joined together, for example, by means of snap-fit ​​connection, press-fit connection, threaded engagement, adhesive, welding, etc.

[0055] In one embodiment, housing 202 includes a front subassembly and a rear subassembly joined together, for example, via snap-fit ​​connection, press-fit connection, threaded engagement, adhesive, welding, etc. The front subassembly may include a needle guard 210, a biasing member 212, a bushing 214, and a front housing 216. The rear subassembly may include a rear cap 218, a power source 220, a push rod 222, a trigger mechanism 208, and a rear housing 224. Providing two subassemblies increases the ability to adjust the components in each subassembly, allowing for customization and repeatability in manufacturing. The cap 236 may be releasably coupled to the front housing 216 and may receive a needle guard 243 therein.

[0056] In one embodiment, a pin-shaped safety mechanism 268 is used to keep the force spring compressed during the assembly of the injection device 200. The pin-shaped safety mechanism 268 can limit the movement of internal components of the injection device 200 by compressing the energy source 220 to prevent premature or accidental actuation. Once the injection device 200 has been fully assembled, as... Figure 14 As shown, the pin-shaped safety mechanism 268 can be removed without triggering the device. The pin-shaped safety mechanism 268 can be used during the assembly of the subsequent sub-assemblies, during transportation and handling, and at any other time before the final assembly of the injection device 200.

[0057] This document uses the term “about” or “approximately” to provide literal support for the exact number preceding it, as well as for numbers that are close to or approximately the number preceding the term. In determining whether a number is close to or approximates a specifically stated number, the close to or approximate unstated number can be a number that is substantially equivalent to the number in the context in which it is presented. It should be understood that all numerical values ​​and ranges disclosed herein are approximate values ​​and ranges, whether or not “about” is used in conjunction with them. It should also be understood that, as used herein, the term “about” in conjunction with a number means that it can be a value of ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive), ±2% (inclusive), ±3% (inclusive), ±5% (inclusive), ±10% (inclusive), or ±15% (inclusive). It should also be understood that when this article discloses a numerical range, it also specifically discloses any numerical value that falls within that range.

[0058] Those skilled in the art will understand that changes can be made to the exemplary embodiments shown and described above without departing from their broad inventive concept. It should be understood that the embodiments and claims disclosed herein are not limited to the application of the construction details and component arrangements set forth in the specification and shown in the drawings. Rather, the specification and drawings provide examples of the contemplated embodiments. The embodiments and claims disclosed herein are also capable of having other embodiments and can be practiced and implemented in various ways.

[0059] Specific features of exemplary embodiments may or may not be part of the invention protected by the claims, and various features of the disclosed embodiments may be combined. Unless otherwise expressly stated herein, the terms “a,” “an,” and “the / described” are not limited to a single element but should be interpreted as meaning “at least one.” Finally, unless otherwise expressly stated herein, the disclosed or claimed methods should not be limited to performing their steps in the order written, and those skilled in the art will readily understand that these steps may be performed in any feasible order.

Claims

1. A syringe, the syringe comprising: A housing having a proximal end and a distal end opposite to the proximal end, the housing extending along a longitudinal axis; A pharmaceutical container, wherein the pharmaceutical container is disposed within the housing, and the pharmaceutical container contains a pharmaceutical agent; A needle, which is connected to the proximal end of the drug container and is in fluid communication with the drug container; A triggering mechanism, the triggering mechanism including a needle protector, the needle protector being retractably coupled to the proximal end of the housing and movable along the longitudinal axis between an extended position, an intermediate position and a retracted position; and A cap, the cap being removably attached to the proximal end of the housing, When the cap is attached to the proximal end of the housing, the needle protector is in the intermediate position.

2. The syringe of claim 1, wherein the needle protector extends from the housing by a first length at the extended position and extends from the housing by a second length at the intermediate position.

3. The syringe according to claim 2, wherein the first length is greater than the second length.

4. The syringe of claim 3, wherein the first length is approximately 21 mm.

5. The syringe of claim 3, wherein the second length is approximately 17 mm.

6. The syringe of claim 1, wherein when the cap is attached to the housing, the needle protector is pushed distally along the longitudinal axis from the extended position to the intermediate position.

7. The syringe of claim 6, wherein the needle protector covers a portion of the needle at the intermediate position.

8. The syringe of claim 6, wherein when the cap is attached to the housing, a needle guard attached to the needle and configured to cover at least a portion of the needle extends distally through the orifice of the cap.

9. The syringe of claim 8, wherein when the cap is separated from the housing, the needle guard is separated from the needle by the cap.

10. The syringe of claim 1, wherein the needle protector moves from the extended position to the retracted position in response to a user pressing the needle protector against the injection site.

11. The syringe of claim 10, wherein when the user removes the syringe from the injection site, the needle protector moves from the retracted position to the extended position.

12. The syringe of claim 11, wherein the needle guard is moved from the retracted position to the extended position by a biasing member.

13. The syringe of claim 11, wherein the needle protector is prevented from moving relative to the housing after it has moved from the retracted position to the extended position.

14. The syringe according to claim 1, further comprising: A biasing member configured to push the needle protector distally along the longitudinal axis to the extended position when the cap is not attached to the housing.

15. The syringe of claim 14, wherein the needle protector covers the entire length of the needle in the extended position.

16. The syringe according to claim 1, wherein the triggering mechanism further comprises: A push rod, the push rod being configured to move a plunger capable of engaging the distal end of the push rod relative to the pharmaceutical container; A triggering member configured to engage the push rod and prevent the push rod from moving when the needle protector is in the extended position; and An energy source, which engages with the distal end of the push rod, is configured to move the push rod distally relative to the housing.

17. The syringe of claim 16, wherein movement of the needle guard from the extended position to the retracted position disengages the trigger member from the plunger, thereby allowing the energy source to move the plunger relative to the drug container to expel the drug through the needle.

18. A syringe, the syringe comprising: A housing having a proximal end and a distal end opposite to the proximal end, the housing extending along a longitudinal axis; A pharmaceutical container, wherein the pharmaceutical container is disposed within the housing, and the pharmaceutical container contains a pharmaceutical agent; A needle, which is connected to the distal end of the pharmaceutical container and is in fluid communication with the pharmaceutical container; A triggering mechanism, the triggering mechanism including a needle protector, the needle protector being retractably coupled to the distal end of the housing and movable along the longitudinal axis between an extended position, an intermediate position and a retracted position; and A cap, the cap being removably attached to the distal end of the housing, When the cap is attached to the distal end of the housing, the needle protector is in the intermediate position. The needle protector extends a first length from the housing at the extended position and a second length from the housing at the intermediate position. Where the first length is greater than the second length, and When the cap is attached to the housing, the needle protector is pushed distally along the longitudinal axis from the extended position to the intermediate position.

19. A method for delivering a drug to a subject, the method comprising: A syringe is provided, the syringe comprising: A housing having a proximal end and a distal end opposite to the proximal end, the housing extending along a longitudinal axis; A pharmaceutical container, wherein the pharmaceutical container is disposed within the housing and contains the pharmaceutical agent; A needle, the needle being coupled to the distal end of the pharmaceutical container and in fluid communication with the pharmaceutical container; and A triggering mechanism, the triggering mechanism including a needle protector, the needle protector being retractably coupled to the distal end of the housing and movable along the longitudinal axis between an extended position, an intermediate position and a retracted position; The cap is attached to the housing, thereby moving the needle protector distally along the longitudinal axis from the extended position to the intermediate position.

20. The method according to claim 19, further comprising: Removing the cap from the housing allows a biasing member disposed in the housing to move the needle protector distally along the longitudinal axis from the intermediate position to the extended position; The needle protector is pressed against the injection site of the subject, thereby moving the needle protector from the extended position to the retracted position; The syringe is removed from the injection site, thereby allowing the biasing member to move the needle guard distally along the longitudinal axis from the retracted position to the extended position.

21. The method of claim 19, wherein the needle protector extends a first length from the housing at the extended position and a second length from the housing at the intermediate position, and The first length is greater than the second length.

22. The method of claim 21, wherein the first length is approximately 21 mm and the second length is approximately 17 mm.

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