Injection system and method

Abstract

An injection system includes an injection system body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof. The system also includes a proximal stop member and a distal stop member disposed in the injection system body, forming a proximal drug chamber and a distal drug chamber. The system also includes a plunger member configured to insert the proximal stop member relative to the injection system body. In addition, the system includes a valve that forms an openable barrier between the distal needle interface and the distal drug chamber. The valve includes an outer member including a distal diaphragm and an inner member. The distal septum is configured to elastically deform distally away from the inner member when pressure in the distal medication chamber increases to allow flow from the distal medication chamber to the distal needle interface.

Description

Technical Field

[0001] The present invention relates generally to injection systems, injection devices, and injection procedures for facilitating varying degrees of control over the infusion of fluids, and more particularly to systems and methods for multi-chamber injection systems with or without safety features in a healthcare environment. Background Art

[0002] Millions of syringes are consumed every day in healthcare settings, e.g. Figure 1A (2) as shown. A typical syringe (2) includes a tubular body (4), a plunger (6) and an injection needle (8). Figure 1B As shown, such a syringe (2) can be used not only to inject fluid into a patient's body, but also to extract or discharge fluid from a container such as a medicine bottle, a glass vial, a bag or other drug containing system (10). In fact, due to regulatory restrictions in some countries such as the United States and considerations of aseptic maintenance, when a medicine bottle (10) with a syringe (2) is used in a specific patient environment, such a medicine bottle can only be used for a single patient and must then be disposed of - resulting in a large amount of medical waste in the disposal of medicine bottles and remaining medicines, and even causing periodic shortages of certain key drugs. Reference Figure 2A , showing three Luer-type syringes (12), each having a distally disposed Luer fitting geometry (14) so ​​that they can be coupled with other devices having similar mating geometry, e.g. Figure 2B The Luer multi-tip catheter assembly (16) shown. With or without an IV bag, Figure 2B The Luer Multi-Tip Catheter Assemblies can be used to administer liquid medications intravenously to patients. Figure 2A The Luer connector (14) of the syringe may be referred to as a "male" Luer connector, while Figure 2B (18) may be referred to as a "female" Luer connector; one of the Luer interfaces may be threaded (in which case the configuration may be referred to as a "Luer lock" configuration) so that the two sides may be connected by relative rotation, which may be combined with a compressive load. In other words, in one Luer lock embodiment, rotation (possibly accompanied by compression) may be used to engage threads within the male connector (14), which threads are configured to engage flanges on the female connector (18) and bring the device together into a fluid-tight connection. In another embodiment, a tapered / conical interface geometry may be used to provide a Luer engagement by compression without threads or rotation (such a configuration may be referred to as a "slip-on" or "conical" Luer configuration). Although such Luer connections are considered relatively safe for the operator, there is a risk of drug spillage / leakage and part breakage during assembly of the Luer connection. On the other hand, the use of a needle injection configuration carries the risk of a sharp needle contacting or stabbing an unwanted person or structure. For this reason, so-called "safety syringes" have been developed.

[0003] Figure 3 One embodiment of a safety syringe (20) is shown in which a tubular shield member (22) is spring biased to cover the needle (8) when released from a locked position relative to the syringe body (4). Figures 4A-4B Another embodiment of a safety syringe (24) is shown. With this configuration, after the plunger (6) is fully inserted relative to the syringe body (4), the retractable needle (26) is configured to retract (28, 26) to a safe position within the tubular body (4), such as Figure 4B Such a configuration, which is configured to collapse on itself, may be associated with problems such as blood splatter / aerosolization issues, safe storage of preload energy which may fail and activate before desired, loss of accuracy in administering a full dose injection due to residual dead space within the spring compression volume, and / or loss of control over retraction speed which may be associated with pain and patient anxiety.

[0004] Further complicating the syringe market is the increasing demand for prefilled syringe components, e.g. Figure 5A and Figure 5B As shown, it generally includes a syringe body or a "drug packaging delivery system / drug closure container delivery system" (34), a plunger head, a plug or stopper (36), and a distal seal or cover cap (35) that can be mounted on a Luer-type interface ( Figure 5A The cap 35 is shown in position; Figure 5B The cap is removed to show the Luer interface 14). Liquid drug may be present in a volume or drug reservoir (40) between the distal seal and the distal end (37) of the plunger tip (36). The plunger tip (36) may comprise a standard butyl rubber material and may be coated with, for example, a biocompatible lubricious coating (e.g., polytetrafluoroethylene ("PTFE")) to facilitate preferred sealing and relative movement characteristics with respect to the associated syringe body structure and materials. Figure 5BThe proximal end of the syringe body (34) in the embodiment of the present invention includes a conventional 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 the entire circumference or a portion of the circumference of the syringe body (34). Part of the flange is referred to as a "truncated flange" and the other portion is referred to as a "full flange". The flange is used to grasp the syringe with the fingers to provide support for pushing the plunger for injection. The syringe body (34) preferably includes a translucent material, such as glass or a polymer and / or a combination thereof. In order to form a closed volume within the chamber or reservoir (40) and to facilitate the discharge of the associated fluid through the needle, a plunger head (36) can be disposed within the syringe body (34). The syringe body (34) can define a substantially cylindrical shape (i.e., such that the plunger head 36 having a circular cross-sectional shape can establish a seal relative to the syringe body (34)), or can be configured to have other cross-sectional shapes, such as an elliptical shape.

[0005] Such components are ideal because they can be standardized and precisely mass-produced by a small number of manufacturers around the world who can meet all of the world's ever-changing regulations regarding fill, packaging and drug / drug interface material selection and component / ingredient use. However, such simple configurations often do not meet new world standards for single-use, safety, automatic failure and needle-stick resistance. As a result, some suppliers have turned to more "vertical" solutions, such as Figure 5C (41) in which the solution attempts to meet all or at least some of the criteria with one solution; due to the attempt to meet these criteria in many different situations, these products may have significant limitations (including those referenced above). Figure 3-4B some limitations described in ) and relatively high storage and usage costs.

[0006] In some cases, a multi-component injection system may mix injectable components (such as liquids and / or powders) before injection. Some systems utilize a single injection device to extract a liquid component from one container and inject the liquid component into another container to dissolve the dry component therein. The dissolved dry component is then drawn into the injection device for injection into the patient. Such a system requires a large amount of handling of unsheathed needles (heads), resulting in unnecessary exposure of the user to one or more uncapped needles. In addition, manually transferring liquid components from one container to another can result in incomplete transfer of the liquid components and affect the ratio of the components in the final mixed injection. In addition, accessing and operating multiple component containers complicates the injection process, thereby increasing the risk of user error. Therefore, there is a need for a multi-component injection system that simplifies the manual acquisition and mixing of multiple components from multiple containers.

[0007] These limitations are addressed by multi-chamber injection systems that are configured to mix and inject multiple components. However, there is still a need for precise control of multi-chamber injection systems to accurately process, mix and deliver multi-component injectables.

[0008] In addition, an increasing number of injectable liquids such as drugs have another requirement of minimizing the contact time between the injectable liquid and metal such as a stainless steel needle.

[0009] There is also a need to incorporate needle stick protection technology into injection systems. The ability to retract the tip of the needle at least partially into the interior of the syringe protects the person administering the injection and the patient from inadvertent needle stick injuries.

[0010] There is a need for injection systems that address the shortcomings of currently available configurations. In particular, there is a need for a precisely controlled multi-chamber safe injection solution that can leverage the existing and relatively well-controlled supply chain for conventionally delivered prefilled syringe assemblies, such as those described in the literature. Figure 5A and Figure 5B Those described. Summary of the invention

[0011] Embodiments relate to injection systems. In particular, embodiments relate to multi-chamber safety injection systems with precise control over the processing, mixing, and delivery of multi-component injectables.

[0012] In one embodiment, an injection system includes an injection system body defining a proximal opening at a proximal end thereof and a distal needle hub at a distal end thereof. The system also includes a proximal stop member and a distal stop member disposed in the injection system body, a proximal drug chamber being formed between the proximal stop member and the distal stop member, and a distal drug chamber being formed between the distal stop member and the distal end of the injection system body. The system also includes a plunger member configured to insert the proximal stop member into the injection system body relative to the injection system body. In addition, the system includes a valve forming an openable barrier between the distal needle hub and the distal drug chamber. The valve includes an outer member including a distal diaphragm defining a distal opening therein. The valve also includes an inner member including a distally extending member configured to fit into and block the distal opening of the distal diaphragm when the distally extending member is disposed in the distal opening of the distal diaphragm. The distal septum is configured to elastically deform distally away from the inner member when pressure increases in the distal drug chamber to allow flow from the distal drug chamber to the distal needle hub.

[0013] In one or more embodiments, the distal septum is biased in a closed configuration in which the distal septum is disposed against the inner member so that the distal opening in the distal septum is positioned about the distally extending member of the inner member unless the distal septum is deformed in an open configuration in which the distal septum is disposed away from the inner member. The distal septum can be configured to transition from the closed configuration to the open configuration when the pressure in the distal drug chamber is equal to or greater than about 10 psi. When the distal septum is in the open configuration, the distal septum can apply minimal resistance to fluid flow from the distal drug chamber through the distal opening in the distal septum to the distal needle hub.

[0014] In one or more embodiments, the outer member further comprises a plurality of radially outward annular members for forming a fluid tight / fluid-tight seal between the outer member and the inner surface of the injection system body. At least one pair of longitudinally adjacent radially outward annular members of the plurality of radially outward annular members defines a space between them. The outer member may further comprise a distally extending ring configured to provide space for distal deformation of the distal diaphragm to transition from a closed configuration to an open configuration.

[0015] In one or more embodiments, the outer member defines an annular groove for securing the inner member in the outer member. The inner member may define an annular groove, and the outer member may further include a radially inward annular member configured to interfere with the annular groove in the inner member to secure the inner member in the outer member. The inner member may define a proximal opening, and when the distal diaphragm is in a closed configuration, the distal diaphragm may block fluid from flowing through the proximal opening. The outer member may be formed of a deformable material and the inner member may be formed of a rigid material.

[0016] In one or more embodiments, the system further comprises a needle member removably coupled to the distal needle hub. The inner member may define a proximally extending outer cylindrical member, and the outer member may define a proximally extending inner cylindrical member coaxially disposed around a portion of the needle and at least partially coaxially disposed within the proximally extending outer cylindrical member. The outer member may further comprise a distally facing funnel-shaped portion disposed adjacent to a distal opening in the distal septum.

[0017] In another embodiment, an injection system includes an injection system body, which defines a proximal opening at its proximal end and a distal needle hub at its distal end. The system also includes a proximal stop member and a distal stop member disposed in the injection system body, forming a proximal drug chamber between the proximal stop member and the distal stop member, and forming a distal drug chamber between the distal stop member and the distal end of the injection system body. The system also includes a plunger member configured to insert the proximal stop member relative to the injection system body. In addition, the system includes a needle member removably coupled to the distal needle hub and having an intermediate opening disposed near the distal end of the syringe body. In addition, the system includes a valve forming an openable barrier between the intermediate opening and the distal drug chamber. The valve includes an elastic diaphragm, the elastic diaphragm defining a diaphragm opening therein, and surrounding the needle member disposed near the intermediate opening therein. The valve also includes a seal surrounding the diaphragm opening, the seal configured to prevent fluid from flowing from the distal drug chamber through the intermediate opening of the needle member when the elastic diaphragm is in a closed configuration. The resilient diaphragm is configured to resiliently deform to an open configuration when pressure increases in the distal drug chamber to move the seal distally relative to the needle member to allow flow from the distal drug chamber through the intermediate opening of the needle member.

[0018] In one or more embodiments, the elastic diaphragm is biased in a closed configuration in which the seal is disposed proximally of the intermediate opening around the needle member unless the elastic diaphragm is deformed to an open configuration in which the elastic diaphragm is at least partially disposed distally of the intermediate opening. The elastic diaphragm can be configured to transition from the closed configuration to the open configuration when the pressure in the distal drug chamber is equal to or greater than about 10 psi. When the elastic diaphragm is in the open configuration, the elastic diaphragm can apply minimal resistance to fluid flow from the distal drug chamber through the distal opening in the elastic diaphragm to the distal needle hub.

[0019] In one or more embodiments, the valve further comprises a plurality of radially outward annular members for forming a fluid tight seal between the valve and the inner surface of the injection system body. At least one pair of longitudinally adjacent radially outward annular members of the plurality of radially outward annular members defines a space between them. The valve may further comprise a distally extending ring configured to provide space for the elastic diaphragm to deform distally so as to switch from a closed configuration to an open configuration. The valve may further comprise a distally facing funnel-shaped portion disposed adjacent to the diaphragm opening. The valve may be made of a deformable material.

[0020] In one or more embodiments, the valve further comprises a distally extending support member disposed adjacent to the diaphragm opening. The distally extending support member may be configured to elastically deform from a normal configuration to a contracted configuration when pressure in the distal drug chamber increases to allow the diaphragm to deform to an open configuration, thereby causing the seal to move distally relative to the fluid delivery member to allow flow from the distal drug chamber through the intermediate opening of the fluid delivery member. The distally extending support member may be configured to return from the contracted configuration to a normal configuration when normal pressure is present in the distal drug chamber.

[0021] In another embodiment, an injection system includes an injection system body, which defines a proximal opening at its proximal end and a distal needle interface at its distal end. The system also includes a stop member disposed in the injection system body, forming a medicine chamber between the stop member and the distal end of the injection system body. The system also includes a plunger member configured to insert the stop member relative to the injection system body. In addition, the system includes a needle hub assembly coupled to the distal needle interface. The needle hub assembly includes a needle hub coupled to the distal needle interface, and a needle member removably coupled to the needle hub and having an intermediate opening disposed adjacent to the distal end of the injection system body. In addition, the system includes a valve forming an openable barrier between the intermediate opening and the medicine chamber, the valve including an elastic diaphragm having a circumferential inner surface defining a diaphragm opening therein, and disposed proximal to the intermediate opening around the needle member. The circumferential inner surface is configured to form a seal around the needle member to prevent fluid from flowing from the medicine chamber to the intermediate opening of the needle member when the elastic diaphragm is in a closed configuration. The resilient diaphragm is configured to resiliently deform to an open configuration when pressure increases in the drug chamber to deform the resilient diaphragm distally relative to the needle member, thereby moving the circumferential inner surface away from the needle member to allow flow from the drug chamber to the intermediate opening of the needle member.

[0022] In one or more embodiments, the needle member is made of metal.

[0023] In another embodiment, an injection system includes an injection system body, which defines a proximal opening at its proximal end and a distal needle interface at its distal end. The system also includes a stop member disposed in the injection system body, forming a drug chamber between the stop member and the distal end of the injection system body. The system also includes a plunger member configured to insert the stop member relative to the injection system body. In addition, the system includes a valve that forms an openable barrier between the distal needle interface and the drug chamber. The valve includes a septum defining a septum opening therein, and a plug member configured to be assembled in the septum opening. The plug member is configured to block the septum opening when the septum is in a closed configuration, and the plug member is disposed in the septum to form an openable barrier between the distal needle interface and the drug chamber. The septum is configured to elastically deform to an open configuration when pressure in the drug chamber increases, so that the elastic septum is deformed distally away from the stop member, thereby allowing the plug member to separate from the septum to allow flow from the drug chamber to the distal needle interface.

[0024] In one or more embodiments, the plug member is made of metal.The plug member may include a smaller radius portion disposed longitudinally between a proximal larger radius portion and a distal larger radius portion.

[0025] These and other embodiments of the present invention are described in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] This patent or application file contains at least one drawing printed in color. Copies of this patent or patent application publication printed in color will be provided by the United States Patent and Trademark Office upon request and payment of the necessary fee.

[0027] Figures 1A to 5C Various aspects of a conventional syringe configuration are shown.

[0028] Fig. 6A and Figure 6B , in perspective and longitudinal cross-sectional views, illustrate aspects of a syringe-based dual chamber safety injection system according to some embodiments, wherein the distal needle / needle tip may be retracted into a protective configuration after use.

[0029] FIG. 7A to FIG. 7P The side cross-sectional view and the longitudinal cross-sectional view illustrate various aspects of a syringe-based dual-chamber safety injection system in method steps for mixing and injecting using the same according to some embodiments.

[0030] Figure 8 is a perspective view showing aspects of a syringe-based dual chamber injection system according to some embodiments, with various components omitted for clarity.

[0031] Fig. 9and Fig.10 A detailed longitudinal cross-sectional view illustrating aspects of a syringe-based dual chamber injection system according to some embodiments, with various components omitted for clarity.

[0032] Fig.11 and Fig.12 A detailed longitudinal cross-sectional view illustrating aspects of a syringe-based dual chamber injection system according to some embodiments, with various components omitted for clarity.

[0033] Fig.13 is a perspective view showing aspects of a syringe-based dual chamber injection system according to some embodiments.

[0034] Figures 14 to 16 is a detailed longitudinal cross-sectional view showing aspects of a syringe-based dual chamber injection system according to some embodiments.

[0035] Fig.17 is a perspective view showing aspects of a syringe-based dual chamber injection system according to some embodiments.

[0036] Fig.18 and Fig.19 is a detailed longitudinal cross-sectional view showing aspects of a syringe-based dual chamber injection system according to some embodiments.

[0037] Fig. 20 and Fig.21 2 is a perspective view and a detailed perspective view showing various aspects of a syringe-based dual chamber injection system according to some embodiments.

[0038] Figure 22 to Figure 24 is a detailed longitudinal cross-sectional view showing aspects of a syringe-based dual chamber injection system according to some embodiments.

[0039] Figure 25 to Figure 27 is a detailed perspective view showing various steps of an injection method using a syringe-based dual-chamber injection system according to some embodiments.

[0040] Fig.28 , Fig.29 and Fig.31 is a detailed perspective view of a syringe-based injection system according to some embodiments, wherein the valve is in a closed configuration ( Fig.28 and Fig.29 ) and the open configuration ( Fig.31 ).

[0041] Fig.30 and Fig.32 is a detailed longitudinal cross-sectional view of a syringe-based injection system according to some embodiments, wherein the valve is in a closed configuration ( Fig.30 ) and the open configuration ( Fig.32 ).

[0042] Figure 33 to Figure 35 is a detailed perspective view of a syringe-based injection system according to some embodiments, wherein the valve is in a closed configuration ( Fig.33 and Fig.34 ) and the open configuration ( Fig.35 ).

[0043] In order to better understand how to obtain the above and other advantages and purposes of various embodiments, the embodiments are described in more detail with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements of similar structure or function are represented by similar reference numerals throughout the text. It should be understood that these drawings only depict certain illustrated embodiments and should not be considered to limit the scope of the embodiments. DETAILED DESCRIPTION

[0044] Exemplary Pre-Filled Dual Chamber Safety Injection System

[0045] Exemplary Dual Chamber Safety Injection System

[0046] refer to Figure 6A-6B , showing a perspective view and a longitudinal cross-sectional view of a dual-chamber safety injection system, a conventional pre-filled syringe body (34) is provided with conventional proximal stopper and distal stopper (32, 36). The proximal stopper and distal stopper (32, 36) together with the syringe body (34) define a proximal drug chamber and a distal drug chamber (40, 42). The proximal stopper and distal stopper (36, 37) block the proximal and distal ends of the proximal drug chamber (40). The distal stopper (36) blocks the proximal end of the distal drug chamber (42). A needle coupling assembly (606) is provided at the distal end of the distal drug chamber (42), and a needle cover member (63) is installed for storage. The dual chamber safety injection system controls the transfer of a first drug component from a proximal drug chamber (40) to a distal drug chamber (42), and the expulsion of a mixed / combined drug from the distal drug chamber (42) to the distal side, which is affected by the user inserting a plunger member (44) sequentially therein to varying degrees relative to a syringe body (34). The plunger member (44) includes a proximal stop member (32), a plunger housing member (69), and a plunger manipulation interface (128). The first drug component (252) located in the proximal drug chamber (40) can be a liquid, such as a water-based or oil-based drug solution, a gel, or the first drug component can be a diluent for mixing with a second drug component (254) in the distal drug chamber (42). The second drug component (254) in the distal drug chamber (42) can be a drug in a dry form, such as a powder, microsphere, emulsion, lyophilized or freeze-dried drug, or a cake-like solid drug.

[0047] In some embodiments, the plunger member (44) can be configured to be manually operated to insert the proximal stop member (44) into the syringe body relative to the syringe body (34). In some embodiments, the plunger member (44) can be configured to be inserted using a spring or motor of an injection device such as an auto-injector. In some embodiments, the plunger member (44) can be configured to be inserted using a pen-type injection system.

[0048] The dual chamber safety injection system has a staked needle / staked needle configuration wherein, when presented to the user, the needle assembly, including the needle coupling assembly (606), the needle distal end / needle tip (48), the needle engaging member, and the needle proximal end (53), is mounted in position, ready for injection after removal of the needle shield member (63), which may include an elastomeric sealing material on its inner surface to engage with the needle distal end (48) or the distal housing portion (610) during storage. Alternatively, the needle shield member (63) may include a vent (not shown) for allowing pressure generated by the transfer and mixing of the drug components to escape from the interior of the syringe body (34) while preventing contaminants from entering the syringe body (34). Although the staked needle is depicted as being mounted in position, the staked needle may be removably coupled to the syringe body (34) using a Luer interface (not shown), with the needle proximal end (53) of the needle member extending through the Luer interface and into the distal drug chamber (42). Figures 6A-7P In the embodiment shown, the majority of the safety needle retraction hardware is located within the plunger housing (69).

[0049] The dual chamber safety injection system (100) has a staked needle configuration, wherein, when presented to a user, the needle assembly, including a puncture assembly ("needle") (76) and a needle coupling assembly (606)) is mounted in position, ready for injection after removal of a needle shield member (63), which may include a resilient sealing material on its inner surface to engage with the needle distal end (78) and / or distal housing portion during storage. Alternatively, the needle shield member (63) may include a vent (not shown) for allowing pressure generated by the transfer of the first drug component / diluent (252) to escape from the interior of the syringe body (34) while preventing contaminants from entering the syringe body (34). Although the staked needle is depicted as being mounted in position, the staked needle may be removably coupled to the syringe body (34) using a Luer slip or Luer lock interface (not shown), with the needle proximal end (53) of the needle member extending through the Luer interface and into the distal chamber (42). Alternatively, the needle may be fixedly or removably mounted on a flange on the cartridge body rather than on the syringe. Fig. 6A and Figure 6B In the embodiment shown, the majority of the safety needle retraction hardware is located within the plunger housing (69).

[0050] refer to Figures 7A-7P , showing aspects of a configuration that facilitates injection of a multi-component drug and retraction of the needle into the body of the syringe, wherein two or more drug components are combined immediately prior to delivery to a patient to form an injectable combination or solution. In one variation, a liquid first drug component / diluent (252) may be combined with a substantially non-liquid second drug component (254) shortly before injection, the second drug component (254) being, for example, a powdered form of a drug formulation, such as a lyophilized or freeze-dried drug component. Reference herein Figures 7A-7P The configuration described relates to a dual chamber configuration, wherein two or more chambers within the same syringe body (34) are used to deliver, mix and inject an injection solution.

[0051] refer to Fig. 7A and Figure 7B The proximal and distal drug chambers (40, 42) are formed by a distal stopper (36) located between two parts of the interior of the syringe body (34), so that the distal drug chamber (42) contains an air gap or a gas gap and a non-liquid drug (254); the proximal drug chamber (40) located on the opposite side of the distal stopper (36) contains a liquid diluent (252), which is contained proximally by the proximal stopper (32). The liquid diluent (252) is a first component of the drug, and the non-liquid drug (254) is a second component of the drug. Although as a preferred embodiment, the distal drug chamber (42) is described as containing a non-liquid drug (254), the distal drug chamber (42) can contain a liquid, solid or gel drug for mixing with the liquid diluent (252) in the proximal drug chamber (40).

[0052] refer to Figure 7C and Fig.7D , the various components of the needle coupling assembly (a so-called "stacking" needle coupling assembly (606) is shown here, but other needle assemblies described below, including Luer coupling and staked configurations, may also be used). For example, Fig. 7A As shown, the lug feature (258) is configured to facilitate coupling the needle coupling assembly (606) to the needle shield member (63). A small O-ring can be used as a sealing member (260) around the needle shaft, while a larger O-ring can be used as a sealing member (262) at the syringe body (34) / needle coupling assembly (606) interface. Optionally, the small O-ring (260) and the large O-ring (262) can be combined into a single seal that performs both O-ring sealing functions. In addition, the small O-ring (260) can be used to seal around the needle shaft and the syringe body (34).

[0053] The needle includes multiple (e.g., four) proximal openings / ports (270) configured to allow liquid diluent to enter and exit from a more distally located intermediate opening / orifice (266); see, e.g., above, FIG. 6N and Figure 7H Under the conditions described, the lumen plug (268) blocks the needle lumen to form a flow path from the proximal opening (270) to the middle opening (266). The needle also includes a distal opening (264) on the side of the lumen plug (268) opposite the middle opening (266), the distal opening (264) being fluidly coupled to the needle distal end (48) through the needle for injecting liquid into a patient.

[0054] refer to Fig. 7E The proximal harpoon interface (84) is configured to continuously penetrate the proximal stop member and the distal stop member (32, 36) and to engage with a coupling feature structure (e.g., at the end of the plunger member (44) Figure 7N and Figure 7P , element (712) shows a needle retaining feature structure) connection. Figure 7F A spike-type harpoon-shaped coupling interface (85) is shown, which is configured to continuously pierce the proximal stop member and the distal stop member (32, 36) and connect with the coupling feature in the plunger member (44) to at least partially retract the needle member into the plunger member (44) after injecting the patient.

[0055] Fig. 7A , 7B 7G-7P show a series of actions of the injection procedure using the above-mentioned dual-chamber safety injection system. Fig. 7A and Figure 7B , the injection assembly is in a stable configuration in which it can be transported or brought to an injection patient care location; the first drug component / liquid diluent (252) is isolated from the second non-liquid drug component (254), and the two are located on opposite sides of the distal stop member (36) within the syringe body.

[0056] Figure 7G and Figure 7H An initial insertion movement of the plunger member (44) is shown, causing the distal stop member (36) and the proximal stop member (32) to advance together relative to the syringe body (34). Figure 7H When the advance is sufficient to cause the proximal end (53) of the needle assembly to pierce the distal stop member (36), a fluid path is formed between the two previously isolated chambers (40, 42) of the syringe body (34), so that the liquid first drug component (252) in the proximal drug chamber (40) can flow into at least one proximal opening (270), through the delivery tube (46) and out of the more distal intermediate opening (266) to reach the non-liquid second drug component (254) in the distal drug chamber (42).

[0057] Fig.7I and Figure 7J It is shown that with further insertion, until the stop members (36, 32) are in close proximity to one another, the liquid first drug component / diluent (252) has moved into the distal drug chamber (42) to join the non-liquid second drug component (254). Figure 7K and Figure 7L Over time and / or manual agitation, the liquid first drug component / diluent (252) and the previously non-liquid second drug component (254) are shown mixing to form a mixed drug solution (272).

[0058] In some embodiments, particularly when a lyophilized non-liquid second drug component is used, a mixed drug solution (272) may be formed with minimal or no agitation or over time. In another embodiment, particularly for drugs held in suspension or emulsified drugs, vigorous shaking may be required to promote mixing. In the case of vigorous shaking, it is useful for the user to be able to remove their thumb from the plunger operating interface (128). During the transfer of the liquid first drug component (252) from the proximal drug chamber (40, 42) to the distal drug chamber (42), pressure may accumulate in the distal drug chamber (42). This pressure acts on the proximal stop member and the distal stop member (32, 36) to prevent the stop member from moving. If the user does not restrain the plunger member (44) with their thumb, the increase in pressure may also cause the stop member (32, 36) and the plunger operating interface (128) to move proximally. A mixing configuration latch or "mixing claw" in the plunger member (44) can be used to provide resistance to movement of the plunger operating interface (128) due to pressure accumulation and allow the user to release their thumb from the plunger operating interface (128) to shake or mix the drug. The mixing claw (the click sound) can also provide an audible and / or tactile indication that the transfer of the liquid first drug component (252) has been completed. The distal drug chamber (42) can also include a stirring device that assists in mixing the drug components.

[0059] When the assembly is ready to inject the mixed solution (272), the needle shield member (63) can be removed and the patient can be injected by depressing / inserting the plunger member (44) and associated stop members (36, 32) with the needle distal end (48) exposed, as shown. Figure 7M and Figure 7N See Fig.7O and Figure 7PWhen the plunger member (44) and the associated stop member (32, 36) are fully depressed / inserted, the sharp needle distal end / needle tip (48) can be automatically retracted at least partially through the distal stop member and the proximal stop member (36, 32) to a safe position within the syringe body (34), the needle coupling assembly (606), or at least partially retracted into the plunger member (44). The needle can be at least partially automatically retracted into the plunger.

[0060] Exemplary Dual Chamber Injection System with Distal Valve

[0061] Figure 8 An injection system (800) having a valve (820) disposed therein is depicted in accordance with some embodiments. Although the injection system (800) is depicted without the dual chamber component shown for clarity, the valve (820) is configured for use with a single chamber or dual chamber injection system such as described herein. In the case of a single chamber injection system, the medication will be pre-mixed and ready for injection. The illustrated injection system (800) includes an injection system body (34), a proximal stop member (32), a plunger member (44), and an elongated fluid delivery member / needle member (50; see Fig. 9 and Fig.10 ). The elongated fluid delivery member / needle member (50) can be constructed of a metal such as stainless steel. The proximal stop member (32) forms a drug chamber (42) with the injection system body (34). The injection system body (34) includes a distal needle hub (810) at its distal end. In some embodiments, the distal needle hub (810) can include a pre-attached staked needle. In some embodiments, the distal needle hub (810) can be a Luer connector.

[0062] Fig. 9Injection system (800) and valve (820) in closed configuration are described in more detail, wherein the flow between medicine chamber (42) and distal needle interface (810) is blocked. Valve (820) includes outer member (830) and inner member (850). Outer member (830) can be formed by elastic material, and inner member (850) can be formed by rigid material. The elastic material forming outer member (830) can be one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic plastic, polytetrafluoroethylene (PTFE), thermosetting plastic. Outer member (830) can be coated with lubricating polymer, such as PTFE, silicone oil and / or other lubricating coating. The rigid material forming inner member (850) can be one or more of the following materials: polymer, metal, glass, ceramic, hard rubber, stainless steel, titanium, glass coating polymer, ceramic coating polymer, cycloolefin copolymer (COC), cycloolefin polymer (COP). The inner member (850) may be coated with a lubricious polymer, such as a PTFE film, silicone oil, and / or other lubricious coatings.

[0063] The outer member (830) includes a distal septum (832) defining a distal opening (834). Fig. 9 In the illustrated embodiment, the distal opening (834) is located approximately in the center of the distal septum (832). The outer member (830) also includes a pair of outwardly facing annular members (836) configured to form a fluid tight seal between the outer member (830) and the inner surface of the injection system body (34). Fig. 9 A pair of outwardly directed annular members (836) are shown, but there may be one annular member or more than two annular members configured to form a fluid tight seal between the outer member (830) and the inner surface of the injection system body (34). The outer member (830) also includes a ring (838) extending distally to position the distal diaphragm (832) proximally away from the distal end of the injection system body (34), thereby providing a space (840) into which the distal diaphragm (832) can deflect. The outer member (830) also defines an annular groove (842) that is configured to secure the inner member (850) in the outer member (830). In Fig. 9 In the closed configuration shown, the distal diaphragm (832) is disposed against the inner member (850). When no external force is acting thereon, the distal diaphragm (832) is configured / biased to Fig. 9 Closed configuration shown.

[0064] The inner member (850) includes a distally extending member (852) configured to fit within and block a distal opening (834) of the distal septum (832) when the distal septum (832) is in a closed configuration. In various embodiments, the distally extending member (852) can be made of a polymer, plastic, metal, glass, or other material. The inner member (850) defines a pair of proximal openings (854) that are closed / blocked by the distal septum (832) when the distal septum (832) is in a closed configuration.

[0065] like Fig. 9 As shown, when the distal diaphragm (832) is in a closed configuration against the inner member (850), the distal diaphragm (832) closes the proximal opening (854), thereby blocking fluid flow therethrough. In addition, when the distal diaphragm (832) is in the closed configuration, the distally extending member (852) closes the distal opening (834) in the distal diaphragm (832), thereby blocking fluid flow therethrough.

[0066] Fig.10 The injection system (800) and valve (820) are depicted in an open configuration, enabling flow between the drug chamber (42) and the distal needle hub (810). In the open configuration, the distal septum (832) deforms / deflects distally away from the inner member (850) so as not to obstruct the proximal opening (854) in the inner member (850) and the distal opening (834) in the distal septum (832). When the pressure in the drug chamber (42) increases, the distal septum (832) is opened from the inner member (850). Fig. 9 The closed configuration shown transforms to Fig.10 In some embodiments, the distal diaphragm (832) is configured to transition from the closed configuration to the open configuration when the pressure in the drug chamber (42) is equal to or greater than about 10 psi. The distal diaphragm (832) is configured such that when the distal diaphragm (832) is in the open configuration, the distal diaphragm (832) exerts minimal resistance to the flow of fluid from the drug chamber (42) through the proximal opening and the distal opening (854, 834).

[0067] Fig.11 and Fig.12 An injection system (800') and valve (820') are depicted in a closed configuration and an open configuration, respectively, according to some embodiments. Fig.11 and Fig.12 The injection system (800') and valve (820') shown are similar to Fig. 9 and Fig.10Injection system (800) and valve (820) are shown. The difference between the injection system (800, 800') and the valve (820, 820') is that the outer member and inner member (830', 850') of the valve (820') are extended to provide space between the radially outward annular member (836') of the outer member (830'). Spacing the radially outward annular member (836') facilitates vacuum-assisted assembly to allow the valve (820') to move axially along the injection system body (34) while maintaining stability to prevent the valve (820') from tilting. Fig. 9 and Fig.10 The valve (820) shown in FIG. 8 is more suitable for machine-assisted assembly (eg, with a vent tube), which minimizes tilting of the valve (820).

[0068] Another difference between valves (820, 820') is the securing mechanism between the outer member and the inner member (830', 850'). The inner member (850') defines an annular groove (856), and the outer member (830') includes a radially inward annular member (844) configured to interfere with the annular groove (856) to secure the inner member (850') in the outer member (830').

[0069] exist Fig.11 In the closed configuration shown, distal diaphragm (832) closes proximal opening (854), thereby blocking fluid flow therethrough. Additionally, when distal diaphragm (832) is in the closed configuration, distally extending member (852) closes distal opening (834) in distal diaphragm (832), thereby blocking fluid flow therethrough. Thus, when distal diaphragm (832) is in the closed configuration, distally extending member (852) closes distal opening (834) in distal diaphragm (832), thereby blocking fluid flow therethrough. Fig.11 In the closed configuration shown, fluid is prevented from flowing from drug chamber (42) through valve (820') to needle hub member (810).

[0070] When the pressure in the drug chamber (42) increases (e.g., 10 psi), the distal diaphragm (832) switches to Fig.12 The open configuration shown enables flow between the drug chamber (42) and the distal needle hub (810). In the open configuration, the distal septum (832) deforms / deflects distally away from the inner member (850) so as not to obstruct the proximal opening (854) in the inner member (850) and the distal opening (834) in the distal septum (832). The distal septum (832) is configured such that when the distal septum (832) is in the open configuration, the distal septum (832) exerts minimal resistance to the flow of fluid from the drug chamber (42) through the proximal opening and the distal opening (854, 834).

[0071] The valve (820) can be configured to perform one, two, three, or all of the following four functions. First, during assembly and storage of the injection system (800), the valve (820) can minimize and / or eliminate movement of the non-liquid second drug component into the distal needle interface (810). Second, the valve (820) can prevent contact between stainless steel sensitive drugs and the elongated fluid delivery member / needle member (50), which can be made of stainless steel. In this way, the valve (820) can allow drugs that may corrode or degrade due to contact with stainless steel to be stored in the distal drug chamber. This is useful in dual chamber configurations and single chamber configurations, where the drugs are pre-mixed and pre-filled in the drug chamber. Third, the valve (820) can minimize and / or eliminate drug loss from the ventilated injection system (800) during shaking mixing. Fourth, in a vented injection system (800) in which the distal needle interface (810) is open to the atmosphere to allow air to escape during the transfer of liquid from the proximal chamber (40) to the distal chamber (42), the valve (820) can prevent the loss of mixed drug from the opening of the distal needle interface (810) during shaking and mixing of the drug components. The fourth function is to prevent drug loss and protect the environment from toxic drugs. These valve functions, especially the third and fourth functions, help the drug components in the proximal and distal chambers (40, 42) to be fully mixed (e.g., into a medicine bag or needle) before the mixed drug is ejected distally through the distal needle interface (810) out of the injection system body (34).

[0072] Fig.13 A dual chamber injection system (900) is depicted, according to some embodiments, wherein a valve (920) is provided. FIG. 6A to FIG. 7P The dual chamber injection system shown, the dual chamber injection system (900) includes an injection system body (34), proximal and distal stop members (32, 36), a plunger member (44) and an elongated fluid delivery member / needle member (50). The proximal and distal stop members (32, 36) together with the injection system body (34) form a proximal drug chamber and a distal drug chamber (40, 42) as described herein. The proximal and distal drug chambers (40, 42) are pre-filled with a liquid first drug component and a non-liquid second drug component (not shown for clarity; see Fig. 6A and Figure 6B 252, 254 in the figure). The elongated fluid delivery member / needle member (50) defines a central opening (52) which is fluidically coupled to the open distal end of the elongated fluid delivery member / needle member (50) through the interior of the needle, thereby forming a flow path through the elongated fluid delivery member / needle member (50).

[0073] The injection system body (34) includes a distal needle hub (910) at its distal end. In some embodiments, the distal needle hub (910) can be a Luer connector. The distal needle hub (910) can have many small spaces formed therein. If the non-liquid second drug component moves into some of the small spaces in the distal needle hub (910), the non-liquid second drug component will clog these small spaces and prevent any liquid from leaving the injection system body (34). The non-liquid second drug component in these small spaces may not dissolve, thereby changing the final concentration of the drug in the mixed drug.

[0074] The valve (920) can perform one, two, three, or all of the following four functions. First, during assembly and storage of the injection system (900), the valve (920) can minimize and / or eliminate the movement of the non-liquid second drug component into the distal needle interface (910). Second, the valve (920) can center and stabilize the elongated fluid delivery member / needle member (50), thereby facilitating the elongated fluid delivery member / needle member (50) to pierce the distal stop member (36). Third, the valve (920) can minimize and / or eliminate drug loss due to ventilated injection during shaking and mixing. Fourth, in a ventilated injection system (900) in which the distal needle interface (910) is open to the atmosphere to allow air to escape during the transfer of liquid from the proximal chamber (40) to the distal chamber (42), the valve (920) can prevent the loss of mixed drug from the opening of the distal needle interface (910) during shaking and mixing of the drug components. The fourth function is to prevent the loss of drugs and protect the environment from the harm of toxic drugs. These valve functions, especially the third and fourth functions, help the drug components in the proximal chamber and the distal chamber (40, 42) to be fully mixed before the mixed drug is ejected distally out of the injection system body (34) through the distal needle interface (910) (for example, into a drug bag or needle).

[0075] Fig.14 The injection system (900) and valve (920) in a closed configuration are described in more detail, wherein flow between the distal drug chamber (42) and the intermediate opening (52) of the elongated fluid delivery member / needle member (50) is blocked. The valve (920) can be formed of an elastic material. The elastic material can be one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic plastic, polytetrafluoroethylene (PTFE), thermosetting plastic. The valve (920) can be coated with a lubricating polymer, such as a PTFE film, silicone oil and / or other lubricating coating.

[0076] The valve (920) includes a resilient diaphragm (932) defining a diaphragm opening (934) therein and configured to receive at least a portion of the elongated fluid delivery member / needle member (50) therethrough. Fig.14 In the illustrated embodiment, the diaphragm opening (934) is located approximately in the center of the elastic diaphragm (932). The valve (920) also includes a seal (922) surrounding the diaphragm opening (934) and configured to seal when the elastic diaphragm (932) is in the Fig.14 When in the closed configuration shown, fluid is prevented from flowing from the distal drug chamber (42) through the middle opening (52) of the elongated fluid delivery member / needle member (50). The valve (920) also includes a pair of outwardly facing annular members (936) configured to form a fluid tight seal between the valve (920) and the inner surface of the injection system body (34). In some embodiments, there may be a single annular member or more than two annular members. In addition, the valve (920) includes a ring (938) extending distally to position the elastic diaphragm (932) proximally away from the distal end of the injection system body (34), thereby providing a space (940) into which the elastic diaphragm (932) can deflect. In addition, the valve (920) includes a distally facing funnel-shaped portion (944) to facilitate assembly and centering of the elongated fluid delivery member / needle member 50.

[0077] exist Fig.14 In the closed configuration shown, the resilient diaphragm (932) is disposed proximal to the intermediate opening (52) of the elongated fluid delivery member / needle member (50), thereby providing a fluid tight seal separating the intermediate opening (52) from the distal drug chamber (42). When no external force is acting on the resilient diaphragm (932), the resilient diaphragm (932) is configured / biased to Fig.14 Closed configuration shown.

[0078] Fig.15 The injection system (900) and valve (920) are depicted in an open configuration, wherein flow between the distal drug chamber (42) and the intermediate opening (52) of the elongated fluid delivery member / needle member (50) is enabled. In the open configuration, the elastic diaphragm (932) deforms / deflects distally over the intermediate opening (52), thereby opening a flow path between the distal drug chamber (42) and the intermediate opening (52) of the elongated fluid delivery member / needle member (50). When pressure in the distal drug chamber (42) increases, the elastic diaphragm (932) is deformed / deflected distally over the intermediate opening (52), thereby opening a flow path between the distal drug chamber (42) and the intermediate opening (52) of the elongated fluid delivery member / needle member (50). Fig.14 The closed configuration shown converts to Fig.15In some embodiments, the elastic diaphragm (932) is configured to transition from the closed configuration to the open configuration when the pressure in the distal drug chamber (42) is equal to or greater than about 10 psi. The elastic diaphragm (932) is configured such that when the elastic diaphragm (932) is in the open configuration, the elastic diaphragm (932) exerts minimal resistance to the flow of fluid from the distal drug chamber (42) through the intermediate opening (952).

[0079] Fig.16 The injection system (900) is shown after the injection is complete, with the elongated fluid delivery member / needle member (50) retracted into the injection system body (34) for safety. The needle may be at least partially automatically retracted into the plunger.

[0080] Fig.17 A dual chamber injection system (1000) is shown with a valve (1020) in place, according to some embodiments. FIG. 6A to FIG. 7P and Figures 13 to 16 The dual chamber injection system shown, the dual chamber injection system (1000) includes an injection system body (34), proximal and distal stop members (32, 36), a plunger member (44) and an elongated fluid delivery member / needle member (50). The proximal and distal stop members (32, 36) together with the injection system body (34) form a proximal drug chamber and a distal drug chamber (40, 42) as described herein. The proximal and distal drug chambers (40, 42) are pre-filled with a liquid first drug component and a non-liquid second drug component (not shown for clarity; see Fig. 6A and Figure 6B 252, 254 in the figure). The elongated fluid delivery member / needle member (50) defines a central opening (52) which is fluidically coupled to the open distal end of the elongated fluid delivery member / needle member (50) through the interior of the needle, thereby forming a flow path through the elongated fluid delivery member / needle member (50).

[0081] The injection system body (34) includes a distal needle hub (1010) at its distal end. In some embodiments, the distal needle hub (1010) may be a Luer connector. The distal needle hub (1010) may have many small spaces formed therein. Fig.17 The valve (1020) shown has Fig.13 The valve (920) shown has the same function.

[0082] Fig.18The injection system (1000) and valve (1020) in a closed configuration are shown in more detail, wherein the flow between the distal drug chamber (42) and the distal needle interface (1010) is blocked. The valve (1020) includes an outer member (1030) and an inner member (1050). The outer member (1030) can be formed of an elastic material, and the inner member (1050) can be formed of a rigid material. The elastic material forming the outer member (1030) can be one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic plastic, polytetrafluoroethylene (PTFE), thermosetting plastic. The outer member (1030) can be coated with a lubricating polymer, such as a PTFE film, silicone oil and / or other lubricating coatings. The rigid material forming the internal member (1050) can be one or more of the following materials: polymer, metal, glass, ceramic, hard rubber, stainless steel, titanium, glass-coated polymer, ceramic-coated polymer, cyclic olefin copolymer (COC), cyclic olefin polymer (COP). The internal member (1050) can be coated with a lubricating polymer, such as a PTFE film, silicone oil and / or other lubricating coatings.

[0083] The outer member (1030) includes a distal septum (1032) defining a distal opening (1034). Fig.18 In the illustrated embodiment, the distal opening (1034) is located approximately in the center of the distal septum (1032). The outer member (1030) also includes a pair of outwardly facing annular members (1036) configured to form a fluid tight seal between the outer member (1030) and the inner surface of the injection system body (34). Fig.18 Two outward annular members (1036) are shown, but other embodiments may include a single annular member or more than two annular members. The outer member (1030) also includes a distally extending ring (1038) to position the distal diaphragm (1032) proximally away from the distal end of the injection system body (34), thereby providing a space (1040) into which the distal diaphragm (1032) can deflect. The outer member (1030) also defines a radially inward annular member (1048) that is configured to secure the inner member (1050) in the outer member (1030). In Fig.18 In the closed configuration shown, the distal diaphragm (1032) is disposed against the inner member (1050). When no external force is acting thereon, the distal diaphragm (1032) is configured / biased to Fig.18 Shown in closed configuration. Additionally, valve (1020) includes a distally facing funnel-shaped portion (1044) to aid in assembly and centering of the elongated fluid delivery member / needle member (50).

[0084] The inner member (1050) includes a distally extending member (1052) configured to fit within and block a distal opening (1034) of the distal septum (1032) when the distal septum (1032) is in a closed configuration. The inner member (1050) defines a proximal opening (1054) that is closed / blocked by the distal septum (1032) when the distal septum (1032) is in a closed configuration. The inner member (1050) further defines an annular groove (1056) configured to interfere with a radially inward annular member (1048) of the outer member (1030) to secure the inner member (1050) within the outer member (1030).

[0085] like Fig.18 As shown, when the distal diaphragm (1032) is in a closed configuration against the inner member (1050), the distal diaphragm (1032) closes the proximal opening (1054), thereby blocking fluid flow therethrough. In addition, when the distal diaphragm (1032) is in a closed configuration, the distally extending member (1052) closes the distal opening (1034) in the distal diaphragm (1032), thereby blocking fluid flow therethrough.

[0086] Fig.19 The injection system (1000) and valve (1020) are shown in an open configuration, wherein flow between the distal drug chamber (42) and the distal needle hub (1010) is enabled. In the open configuration, the distal septum (1032) deforms / deflects distally away from the inner member (1050), thereby opening the proximal opening (1054) in the inner member (1050) and the distal opening (1034) in the distal septum (1032). When the pressure in the distal drug chamber (42) increases, the distal septum (1032) is opened from the distal septum (1032). Fig.18 The closed configuration shown converts to Fig.19 In some embodiments, the distal diaphragm (1032) is configured to transition from a closed configuration to an open configuration when the pressure in the distal medication chamber (42) is equal to or greater than about 10 psi. The distal diaphragm (1032) is configured such that when the distal diaphragm (1032) is in the open configuration, the distal diaphragm (1032) exerts minimal resistance to the flow of fluid from the distal medication chamber (42) through the proximal opening and the distal opening (1054, 1034).

[0087] The inner member (1050) defines a proximally extending outer cylindrical member (1058) and the outer member (1030) defines a proximally extending inner cylindrical member (1046). The proximally extending inner cylindrical member (1046) is coaxially disposed around a portion of the elongated fluid delivery member / needle member (50). The proximally extending outer cylindrical member (1058) is coaxially disposed around a portion of the proximally extending inner cylindrical member (1046).

[0088] Fig. 20 and Fig.21 A dual chamber injection system (1100) is shown with a valve (1120) disposed therein, according to some embodiments. FIG. 6A to FIG. 7P The dual chamber injection system shown, the dual chamber injection system (1100) includes an injection system body (34), proximal and distal stop members (32, 36), a plunger member (44), and an elongated fluid delivery member (50'). The proximal and distal stop members (32, 36) together with the injection system body (34) form a proximal drug chamber and a distal drug chamber (40, 42) as described herein. The proximal and distal drug chambers (40, 42) are pre-filled with a liquid first drug component and a non-liquid second drug component (not shown for clarity; see Fig. 6A and Figure 6B 252, 254 and Fig.21 254 in). The elongated fluid delivery member (50') defines a central opening (52) that is fluidly coupled to an open distal end of the elongated fluid delivery member (50') via a fluid delivery inner fluid, thereby forming a flow path through the elongated fluid delivery member (50').

[0089] The injection system body (34) includes a distal needle hub (1110) at its distal end. In some embodiments, the distal needle hub (1110) may be a Luer connector. The distal needle hub (1110) may have many small spaces formed therein. If the non-liquid second drug component moves into some of the small spaces in the distal needle hub (1110), the non-liquid second drug component may clog these small spaces and prevent any liquid from leaving the injection system body (34). The non-liquid second drug component in these small spaces may not dissolve, thereby changing the final concentration of the drug in the mixed drug. Fig. 20 and Fig.21 Dual chamber injection system (1100) is shown in a storage / transport configuration with distal needle hub (1110) sealed with cap (620).

[0090] The valve (1120) may perform one, two, three, or all of the following four functions. First, during assembly and storage of the injection system (1100), the valve (1120) may minimize and / or eliminate movement of the non-liquid second drug component into the distal needle hub (1110). Second, the valve (1120) may center and stabilize the elongated fluid delivery member (50'), thereby facilitating the elongated fluid delivery member (50') to pierce the distal stop member (36). Third, the valve (1120) may minimize and / or eliminate drug loss from a vented injection during the shaking mixing process (see Fig.26 Fourth, in the vented injection system (1100), wherein the distal needle hub (1110) is open to the atmosphere to allow air to escape during the process of transferring the liquid from the proximal chamber (40) to the distal chamber (42), the valve (1120) can prevent the mixed drug from being lost from the opening of the distal needle hub (1110) during the process of shaking and mixing the drug components (see Fig.25 and Fig.26 ). The fourth function is to prevent drug loss and protect the environment from toxic drugs. These valve functions, especially the third and fourth functions, help to fully mix the drug components in the proximal chamber and the distal chamber (40, 42) before the mixed drug is ejected distally out of the injection system body (34) through the distal needle interface (1110) (for example, into a drug bag or needle).

[0091] Fig. 22 The injection system (1100) and valve (1120) in a closed configuration are depicted in more detail, wherein flow between the distal drug chamber (42) and the intermediate opening (52) of the elongated fluid delivery member (50') is blocked. The valve (1120) can be formed of an elastic material. The valve (1120) includes an outer member (1130) and an inner member (1150). The outer member (1130) can be formed of an elastic material, and the inner member (1150) can be formed of a rigid material. The elastic material forming the outer member (1130) can be one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic plastic, polytetrafluoroethylene (PTFE), thermosetting plastic. The outer member (1130) can be coated with a lubricating polymer, such as PTFE, silicone oil and / or other lubricating coatings. The rigid material forming the inner member (1150) can be one or more of the following materials: polymer, metal, glass, ceramic, hard rubber, stainless steel, titanium, glass-coated polymer, ceramic-coated polymer, cyclic olefin copolymer (COC), cyclic olefin polymer (COP). The inner member (1150) can be coated with a lubricating polymer, such as PTFE, silicone oil and / or other lubricating coatings.

[0092] The outer member (1130) includes a distal septum (1132) defining a distal opening (1134). Fig. 22 In the illustrated embodiment, the distal opening (1134) is located approximately in the center of the distal diaphragm (1132). The outer member (1130) also includes a seal (1122) surrounding the diaphragm opening (1134) and configured to seal when the elastic diaphragm (1132) is in the Fig. 22 The closed configuration shown prevents fluid from flowing from the distal drug chamber (42) through the middle opening (52) of the elongated fluid delivery member (50'). The outer member (1130) also includes an outward annular member (1136) that is configured to form a fluid tight seal between the valve (1120) and the inner surface of the injection system body (34). In addition, the outer member (1130) includes a support member (1160) extending distally to position the elastic diaphragm (1132) proximally away from the proximal surface of the inner member (1150), thereby providing a space (1140) into which the elastic diaphragm (1132) can deflect. The outer member (1130) also defines an annular groove (1142) that is configured to secure the internal member (1150) in the outer member (1130). In Fig. 22 In the closed configuration shown, the elastic diaphragm (1132) is disposed proximal to the intermediate opening (52) in the elongated fluid delivery member (50'), thereby providing a fluid tight seal separating the intermediate opening (52) from the distal drug chamber (42). When no external force acts on the elastic diaphragm (1132), the elastic diaphragm (1132) is configured / biased to Fig. 22 Closed configuration shown.

[0093] The inner member (1150) includes a distally extending member (1158) configured to form a friction fit in the distal needle hub (1110). The friction fit between the distally extending member (1158) and the inner surface of the distal needle hub (1110) couples the inner member (1150) and the valve (1120) to the injection system body (34).

[0094] Fig.23The injection system (1100) and valve (1120) are shown in an open configuration, wherein flow between the distal drug chamber (42) and the intermediate opening (52) of the elongated fluid delivery member (50') is enabled. In the open configuration, the distally extending support member (1160') of the outer member (1130) bends / collapses / contracts to allow the elastic diaphragm (1132) to deform / deflect distally above the intermediate opening (52), thereby opening a flow path between the distal drug chamber (42) and the intermediate opening (52) of the elongated fluid delivery member (50'). When the pressure in the distal drug chamber (42) increases, the elastic diaphragm (1132) is displaced from the distal drug chamber (42) to allow the elastic diaphragm (1132) to deform / deflect distally above the intermediate opening (52). Fig. 22 The closed configuration shown converts to Fig.23 In some embodiments, the elastomeric diaphragm (1132) is configured to transition from the closed configuration to the open configuration when the pressure in the distal drug chamber (42) is equal to or greater than about 10 psi. The elastomeric diaphragm (1132) is configured such that when the elastomeric diaphragm (1132) is in the open configuration, the elastomeric diaphragm (1132) exerts minimal resistance to the flow of fluid from the distal drug chamber (42) through the intermediate opening (1152). The cap (680) has also been removed from the distal needle hub (1110) to complete the flow path between the distal drug chamber (42) and the exterior of the injection system (1100).

[0095] In some embodiments, the injection system (1100) and valve (1120) are in Fig.23 The open configuration shown is to vent air / pressure accumulated in the distal drug chamber (42) when fluid is transferred from the proximal drug chamber (40) to the distal drug chamber (42) (see Fig.25 In some embodiments, the injection system (1100) and valve (1120) are in Fig.23 The open configuration shown allows the mixed drug / medicine to be ejected from the distal drug chamber (42) (see Fig. 27 ).

[0096] Fig.24 In more detail, the Fig. 22 A similar injection system (1100) and valve (1120) in a closed configuration. Fig. 22 and Fig.24 The difference between the illustrated injection systems (1100) is that the cap (680) has been replaced by a needle coupling assembly (606) which couples to the distal needle hub (1110) to complete the flow path between the distal drug chamber (42) and the exterior of the injection system (1100).

[0097] Figure 25 to Figure 27 According to some embodiments, the use of Figure 20 to Figure 24The multiple steps of the injection method of the injection system (1100) are shown. Fig.25 In the embodiment of the present invention, the proximal stop member (36) has moved distally until the proximal drug chamber (40, see Fig. 20 ) is completely collapsed, and the liquid first drug component (252) therein has been transferred to the distal drug chamber (42). During the process of fluid transfer from the proximal drug chamber (40) to the distal drug chamber (42), the increased pressure in the distal drug chamber (42) causes the distally extending support member (1160') of the outer member (1130) to shorten / contract, such as Fig.23 This allows the air / pressure in the distal drug chamber (42) to be vented to the exterior of the injection system (1100) through the elongated fluid delivery member (50').

[0098] exist Fig.26 In the process, the fluid transfer from the proximal drug chamber (40) to the distal drug chamber (42) is complete and the pressure in the distal drug chamber (42) returns to normal (i.e., atmospheric / external pressure). This allows Fig.23 The distally extending support member (1160') of the outer member (1130) is shown to rebound / extend to Fig. 22 and Fig.24 The distally extending support member (1160) is shown, thereby closing the valve (1120). This closed configuration allows the liquid first drug component (252) and the non-liquid second drug component (not shown) in the distal drug chamber (42) to mix while minimizing the accidental discharge of the components from the distal drug chamber (42).

[0099] exist Fig. 27 , the needle coupling assembly (606) has been coupled to the distal needle hub (1110), and excess air has been exhausted from the distal drug chamber (42). Fig.23 As shown, the increased pressure in the distal drug chamber (42) causes the distally extending support member (1160') of the outer member (1130) to contract. This allows the air / pressure in the distal drug chamber (42) to be discharged to the exterior of the injection system (1100) through the elongated fluid delivery member (50') and allows the mixed drug to be ejected from the distal drug chamber (42).

[0100] Figure 28 to Figure 32An injection system (1200) according to some embodiments is shown, which has a valve (1220) disposed therein. The injection system (1200) includes an injection system body (34), a stop member (32), a plunger member (44), and a needle assembly, which includes a needle proximal end (53) and a needle engaging member (54). The stop member (32) forms a chamber (42) with the injection system body (34). The chamber (42) can be pre-filled with an injectable fluid (252). The needle proximal end (53) and the needle engaging member (54) define an intermediate opening (52), which is coupled to the open distal end of the needle assembly through the internal fluid of the needle engaging member (54), thereby forming a flow path through the needle assembly.

[0101] like Fig.29 and Fig.30 As shown, the valve (1220) includes an outer member (1230) and an inner member (1232). The inner member (1232) is an elastic diaphragm having a circumferential inner surface (1234). The inner member and / or the outer member (1232, 1234) can be made of an elastic material, which can be one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic plastic, polytetrafluoroethylene (PTFE), thermosetting plastic. The inner member and / or the outer member (1232, 1234) can be coated with a lubricating polymer, such as PTFE, silicone oil and / or other lubricating coatings.

[0102] When the injectable fluid (252) in the chamber (42) is at a relatively low pressure (e.g., less than about 25 psi), the valve (1220) / internal member / elastic diaphragm (1232) is in a closed configuration, such as Fig.29 and Fig.30 In the closed configuration, the inner member / elastic membrane (1232) is substantially flat and is configured to form a fluid tight seal against the circumferential outer surface of the needle proximal end (53). The fluid tight seal prevents the injectable fluid (252) from flowing from the chamber (42) to the intermediate opening (52) in the needle assembly (e.g., during transportation and storage of the injection system (1200)).

[0103] like Fig.31 and Fig.32 As shown, when the injectable fluid (252) in the chamber (42) is pressurized (e.g., greater than or equal to about 25 psi) by applying a distal force to the plunger member (44) and the stop member (32) attached thereto, the valve (1220) / internal member / elastic diaphragm (1232) is moved from Fig.29 and Fig.30 The closed configuration shown moves to Fig.31 and Fig.32The valve (1220) is in the open configuration. In the open configuration, the pressure in the chamber (42) elastically deforms the internal member / elastic membrane (1232) distally relative to the needle assembly, thereby eliminating the seal between the chamber (42) and the intermediate opening (52) in the needle assembly (e.g., during injection). When the internal member / elastic membrane (1232) elastically deforms distally relative to the needle assembly, the circumferential inner surface (1234) moves away from the proximal end (53) of the needle, thereby opening a flow path (1242) between the internal member / elastic membrane (1232) and the proximal end (53) of the needle. When the valve (1220) is in the open configuration, the injectable fluid (252) can flow from the chamber (42) through the flow path (1242) to the intermediate opening (52) in the needle assembly for injection.

[0104] Figure 28 to Figure 32 The valve (1220) shown only adds one additional component (e.g., valve (1220)) to form a sealed syringe / injection system (1200). The valve (1220) can produce a sealed version of a dual chamber injection system and a single chamber injection system. In addition, because the valve (1220) does not need to be aligned with any opening on the needle assembly, the valve (1220) can be used with greater tolerances in the components of the injection system (1200) and in the assembly of the system (1200).

[0105] Figure 33 to Figure 35 An injection system (1300) according to some embodiments is shown, which has a valve (1320) disposed therein. The injection system (1300) includes an injection system body (34), a stop member, a plunger member, and a needle (51). The stop member (32) forms a chamber (42) with the injection system body (34). The chamber (42) can be pre-filled with an injectable fluid (252). The needle (51) has an open proximal end and a distal end.

[0106] like Fig.33 and Fig.34 As shown, the valve (1320) includes a resilient diaphragm (1330) having a circumferential inner surface (1334) defining a central diaphragm opening (1342). The valve (1320) also includes a plug member (1332) configured to close when the valve is in a position such as Fig.33 and Fig.34 When the injectable fluid (252) in the chamber (42) is at a relatively low pressure (e.g., less than about 30 psi), the valve (1320) / elastic diaphragm (1330) is in the closed configuration shown, as described below. Fig.33 and Fig.34The closed configuration shown. In the closed configuration, the internal elastic diaphragm (1330) is substantially flat and is configured to form a fluid-tight seal against the circumferential outer surface of the plug member (1332). The fluid-tight seal prevents the injectable fluid (252) from flowing from the chamber (42) to the proximal opening of the needle (51) (e.g., during transportation and storage of the injection system (1300)). The elastic diaphragm (1330) can be made of one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic plastic, polytetrafluoroethylene (PTFE), thermosetting plastic. The elastic diaphragm (1330) can be coated with a lubricating polymer, such as PTFE, silicone oil and / or other lubricating coatings. The rigid material forming the plug member (1332) can be one or more of the following materials: polymer, metal, glass, ceramic, hard rubber, stainless steel, titanium, glass-coated polymer, ceramic-coated polymer, cyclic olefin copolymer (COC), cyclic olefin polymer (COP). The internal member can be coated with a lubricating polymer, such as a PTFE film, silicone oil, and / or other lubricating coating.

[0107] like Fig.35 As shown, when the injectable fluid (252) in the chamber (42) is pressurized (e.g., greater than or equal to about 30 psi) by applying a distal force to the plunger member (44) and the stop member (32) attached thereto, the elastic diaphragm (1330) is displaced from the piston member (44) to the piston member (44). Fig.33 and Fig.34 The closed configuration shown moves to Fig.35 1. The valve (1320) is in the open configuration shown. In the open configuration, the pressure in the chamber (42) causes the elastic diaphragm (1330) to elastically deform away from the stop member, thereby eliminating the seal between the chamber (42) and the proximal opening of the needle (51) (e.g., during injection). When the elastic diaphragm (1330) is elastically deformed distally away from the stop member, the circumferential inner surface (1334) moves away from the plug member (1332), thereby releasing the plug member (1332) from the diaphragm opening (1342) and opening the diaphragm opening (1342). When the valve (1320) is in the open configuration, the injectable fluid (252) can flow from the chamber (42) through the diaphragm opening (1342) to the proximal opening of the needle (51) for injection.

[0108] In some embodiments, the plug member (1332) includes a smaller radius portion disposed longitudinally between proximal and distal larger radius portions. In an alternative embodiment, the plug member (1332) can be a ball bearing sized and shaped to close the diaphragm opening (1342) when the valve (1320) is in a closed configuration and to move away from the diaphragm opening (1342) when the valve (1320) is in an open configuration. In some embodiments, the plug member (1332) has a diameter of approximately 0.050 inches and a cross-sectional area in the proximal direction of approximately 0.002 square inches. In such an embodiment, a pressure of approximately 30 psi applied to the valve (1320) causes the diaphragm (1330) to deflect, such as Fig.35 The deflection of the diaphragm (1330) allows the pressurized film of the injectable fluid (252) to flow between the diaphragm (1330) and the plug member (1332), which reduces the friction between the two parts to near zero and allows the shear force of the injectable fluid (252) flowing through the plug member (1332) to move the plug member (1332) away from the diaphragm opening (1342), as shown. Fig.35 shown.

[0109] In another embodiment, plug member (1332) may have proximal and / or distal engagement ribs extending from the outer diameter to increase mechanical interference with resilient diaphragm (1330), thereby increasing the pressure required to remove plug member (1332). Although valve (1320) is shown in a single chamber injection system (1330), valve (1320) may be used to create a seal pattern for dual chamber and single chamber injection systems.

[0110] Figure 33 to Figure 35 The valve (1320) shown mitigates the increase in required operating pressure as the injection system ages, where a valve including an elastomeric polymer / hard polymer interface may become oversized over time. The valve (1320) includes an elastomeric polymer diaphragm (1330) and a metal plug member (1334), and the interaction between these components minimizes the increase in operating pressure as the injection system (1300) ages.

[0111] The predetermined amount of force to convert the valve / diaphragm from the closed configuration to the open configuration can be adjusted to suit a combination of system functional requirements and aesthetic impression on the user. If the activation force is too low, it may work, but it will be too difficult for the user to apply a light enough force, and the user may overshoot. If the force is too large, the user may find it "too hard" to activate the system. Fortunately, the predetermined amount of force can be "tuned" over a range by changing various component characteristics.

[0112] In some embodiments, various aspects of the valves (820, 920, 1020, 1120, 1220, 1320) disclosed herein can be modified to adjust the amount of force / pressure required to open the valve (820, 920, 1020, 1120, 1220, 1320). These aspects include, but are not limited to: (1) the outer diameter of the diaphragm (832, 932, 1032, 1132, 1232, 1330); (2) the thickness of the diaphragm (832, 932, 1032, 1132, 1232, 1330); (3) the amount of interference between the plug member (1332) and the elastic diaphragm (1330). The amount of interference between the plug member (1332) and the resilient diaphragm (1330) may be altered by adding protrusions / ridges to the circumferential inner surface (1334) defining the central diaphragm opening (1342) to increase the amount of interference, thereby increasing the amount of force / pressure required to remove / release the plug member (1332) to open the valve (1320).

[0113] Although the above embodiment includes a dual-chamber safety injection system, the scope of the claims also includes other multi-chamber safety injection systems. For a multi-chamber safety injection system with more than two chambers, more than two stopper members are inserted into the injection system body (e.g., syringe body, cartridge body, etc.) to define a corresponding number of chambers.

[0114] Although the prefilled dual chamber safety injection system shown and described herein includes a syringe with a staked needle, the various configurations / embodiments described herein (e.g., continuous injection, ratcheting dual chamber, threaded plunger member, shield, and vented needle cover) can be used for cartridges of automatic injectors, as well as injection systems with Luer connections, transfer tubes, and needle-free.

[0115] Various exemplary embodiments of the present invention are described herein. Reference is made to these examples in a non-restrictive sense. They are provided to illustrate the more widely applicable aspects of the present invention. Various changes may be made to the described invention, and equivalents may be substituted without departing from the true spirit and scope of the present invention. In addition, many modifications may be made to adapt specific circumstances, materials, compositions of matter, processes, process actions or steps to the purpose, spirit or scope of the present invention. In addition, it will be appreciated by those skilled in the art that each individual variation described and illustrated herein has discrete components and features, which may be easily separated or combined from the features of any other several embodiments, without departing from the scope or spirit of the present invention. All of these modifications are within the scope of the claims associated with the present disclosure.

[0116] Any device described for carrying out the diagnostic or interventional (therapeutic) procedure in question may be provided in packaged combination for use in carrying out such intervention. These supply "kits" may further include instructions for use and be packaged in sterile trays or containers commonly used for this purpose.

[0117] The present invention includes methods that can be implemented using the devices discussed. The methods can include the act of providing such suitable devices. Such provision can be performed by the end user. In other words, the "providing" action simply requires the end user to obtain, access, approach, locate, set up, activate, power on or otherwise provide the necessary devices in the method discussed. The methods described herein can be performed in any order of the events described that is logically possible and in the order of the events described.

[0118] Exemplary aspects of the invention and details about material selection and manufacturing have been set forth above. As for other details of the invention, these can be understood in conjunction with the patents and publications cited above and what is generally known or understood by those skilled in the art. For example, it will be understood by those skilled in the art that one or more lubricious coatings (e.g., hydrophilic polymers, such as polyvinylpyrrolidone-based compositions, fluoropolymers, such as tetrafluoroethylene, PTFE (polytetrafluoroethylene), ETFE (ethylene-tetrafluoroethylene copolymers), hydrophilic gels or silicones) can be used in conjunction with various parts of the device (e.g., relatively large interfaces / interface surfaces of removable coupling portions), for example, so as to manipulate or propel these objects with low friction relative to other parts of the device or nearby tissue structures if necessary. This is also true for the method-based aspects of the invention in terms of additional actions that are typically or logically employed.

[0119] In addition, although the present invention has been described with reference to several examples, which optionally incorporate various features, the present invention is not limited to the contents described or indicated for the various variations of the present invention. Various changes may be made to the described invention, and equivalents (whether cited herein or not included for the sake of brevity) may be substituted without departing from the true spirit and scope of the present invention. In addition, where a numerical range is provided, it is understood that each intermediate value between the upper and lower limits of the range and any other stated or intermediate value within the stated range are included in the present invention.

[0120] In addition, it is contemplated that any optional features of the invention changes may be independently elaborated and claimed, or combined with any one or more features described herein. References to singular items include the possibility of multiple identical items. More specifically, as used herein and in the related claims, the singular forms "one", "an", "said" and "the" include plural objects unless otherwise specifically stated. In other words, the use of articles allows the items discussed in "at least one" specification and in the claims associated with the present disclosure. It should also be noted that such claims can be written to exclude any optional elements. Therefore, this statement is intended to be used as a premise basis for the use of exclusive terms (such as "only", "only", etc.) related to the recorded claim elements or the use of "negative" limitations.

[0121] In the absence of such exclusive terms, the term "comprising" in the claims related to the present disclosure shall allow for the inclusion of any additional elements, whether or not a given number of elements are recited in such claims, or the added features may be considered to transform the nature of the elements recited in such claims. Unless specifically defined otherwise, all technical and scientific terms used herein are given the broadest commonly understood meaning possible while maintaining claim validity.

[0122] The scope of the present invention is not limited to the examples provided and / or subject specification, but is only limited by the scope of the claims associated with this disclosure.

Claims

1. An injection system comprising: an injection system body defining a proximal opening at a proximal end thereof and a distal needle hub at a distal end thereof; A proximal stop member and a distal stop member disposed in the injection system body, a proximal drug chamber being formed between the proximal stop member and the distal stop member, and a distal drug chamber being formed between the distal stop member and a distal end of the injection system body; a plunger member configured to cause a proximal stop member to be inserted therein relative to the injection system body; and A valve forming an openable barrier between the distal needle hub and the distal drug chamber, the valve comprising: an outer member including a distal septum defining a distal opening therein, and an inner member including a distally extending member configured to fit within and block the distal opening of the distal septum when the distally extending member is disposed within the distal opening of the distal septum, Therein, the distal septum is configured to elastically deform distally away from the inner member upon an increase in pressure in the distal drug chamber to allow flow from the distal drug chamber to the distal needle hub.

2. The system according to claim 1, wherein: The distal diaphragm is biased in a closed configuration in which the distal diaphragm is positioned against the inner member such that a distal opening in the distal diaphragm is positioned about a distally extending member of the inner member unless the distal diaphragm is deformed in an open configuration in which the distal diaphragm is positioned away from the inner member.

3. The system according to claim 2, wherein: The distal septum is configured to transition from a closed configuration to an open configuration when a pressure in the distal drug chamber is equal to or greater than about 10 psi.

4. The system according to claim 2, wherein: When the distal septum is in the open configuration, the distal septum presents minimal resistance to fluid flow from the distal drug chamber through the distal opening in the distal septum to the distal needle hub.

5. The system according to claim 2, wherein: The outer member also includes a plurality of radially outward annular members configured to form a fluid tight seal between the outer member and an inner surface of the injection system body.

6. The system according to claim 5, wherein: At least one pair of longitudinally adjacent radially outer annular members of the plurality of radially outer annular members defines a space between the longitudinally adjacent radially outer annular members.

7. The system according to claim 2, wherein: The outer member also includes a distally extending ring configured to provide space for the distal septum to deform distally to transition from a closed configuration to an open configuration.

8. The system according to claim 2, wherein: The outer member defines an annular groove configured to secure the inner member in the outer member.

9. The system according to claim 2, wherein: The inner member defines an annular groove, and The outer member also includes a radially inward annular member configured to interfere with the annular groove in the inner member to secure the inner member in the outer member.

10. The system according to claim 2, wherein: The inner member defines a proximal opening, and Therein, when the distal septum is in the closed configuration, the distal septum blocks fluid flow through the proximal opening.

11. The system according to claim 2, wherein: The outer member is formed of a deformable material, and Wherein, the internal component is formed of a rigid material.

12. The system according to claim 2, wherein: The system further includes a needle member removably coupled to the distal needle hub, wherein the inner member defines an outer cylindrical member extending proximally, wherein the outer member defines a proximally extending inner cylindrical member coaxially disposed about a portion of the needle and at least partially coaxially located within the proximally extending outer cylindrical member.

13. The system according to claim 12, wherein: The outer member also includes a distally facing funnel-shaped portion disposed adjacent the distal opening in the distal septum.

14. An injection system comprising: an injection system body defining a proximal opening at a proximal end thereof and a distal needle hub at a distal end thereof; A proximal stop member and a distal stop member disposed in the injection system body, a proximal drug chamber being formed between the proximal stop member and the distal stop member, and a distal drug chamber being formed between the distal stop member and a distal end of the injection system body; a plunger member configured to cause a proximal stop member to be inserted therein relative to the injection system body; a fluid delivery member removably coupled to the distal needle hub and having a central opening disposed adjacent the distal end of the syringe body; and A valve forming an openable barrier between the intermediate opening and the distal drug chamber, the valve comprising: an elastic diaphragm defining a diaphragm opening therein and disposed about the fluid transport member and adjacent the intermediate opening therein, and a seal surrounding the septum opening configured to prevent fluid flow from the distal drug chamber through the intermediate opening of the fluid delivery member when the resilient septum is in the closed configuration, Therein, the elastic diaphragm is configured to elastically deform to an open configuration when pressure in the distal drug chamber increases to move the seal distally relative to the fluid delivery member, thereby allowing fluid to flow from the distal drug chamber through the central opening of the fluid delivery member.

15. The system of claim 14, wherein: The resilient diaphragm is biased in a closed configuration in which the seal is disposed proximally of the intermediate opening about the fluid delivery member unless the resilient diaphragm is deformed to an open configuration in which the resilient diaphragm is at least partially disposed distally of the intermediate opening.

16. The system of claim 14, wherein: The resilient diaphragm is configured to transition from a closed configuration to an open configuration when a pressure in the distal drug chamber is equal to or greater than about 10 psi.

17. The system of claim 14, wherein: When the elastomeric septum is in the open configuration, the elastomeric septum presents minimal resistance to fluid flow from the distal drug chamber through the distal opening in the elastomeric septum to the distal needle hub.

18. The system of claim 14, wherein: The valve also includes a plurality of radially outward annular members configured to form a fluid tight seal between the valve and an inner surface of the injection system body.

19. The system of claim 18, wherein: At least one pair of longitudinally adjacent radially outer annular members of the plurality of radially outer annular members defines a space between the longitudinally adjacent radially outer annular members.

20. The system of claim 14, wherein: The valve also includes a distally extending ring configured to provide space for the elastic diaphragm to deform distally to transition from a closed configuration to an open configuration.

21. The system of claim 14, wherein: The valve also includes a distally facing funnel-shaped portion disposed adjacent the diaphragm opening.

22. The system of claim 14, wherein: The valve is formed from a deformable material.

23. The system of claim 14, wherein: The valve also includes a distally extending support member disposed adjacent the diaphragm opening.

24. The system of claim 23, wherein: The distally extending support member is configured to elastically deform from a normal configuration to a contracted configuration when pressure in the distal drug chamber increases to allow the diaphragm to deform to an open configuration, thereby causing the seal to move distally relative to the fluid delivery member to allow fluid to flow from the distal drug chamber through the intermediate opening of the fluid delivery member.

25. The system of claim 24, wherein: The distally extending support member is configured to return from the collapsed configuration to the normal configuration in the presence of normal pressure in the distal drug chamber.

26. An injection system comprising: an injection system body defining a proximal opening at a proximal end thereof and a distal needle hub at a distal end thereof; a stop member disposed in the injection system body, forming a drug chamber between the stop member and a distal end of the injection system body; a plunger member configured to cause a proximal stop member to be inserted therein relative to the injection system body; A needle hub assembly coupled to the distal needle hub, the needle hub assembly comprising: a needle hub coupled to the distal needle hub, and a needle member removably coupled to the needle hub and having a central opening disposed adjacent a distal end of the injection system body; and a valve forming an openable barrier between the intermediate opening and the drug chamber, the valve comprising an elastic diaphragm having a circumferential inner surface defining a diaphragm opening in the elastic diaphragm, and the elastic diaphragm being disposed around the needle member proximal to the intermediate opening in the needle member, wherein the circumferential inner surface is configured to form a seal around the needle member to prevent fluid from flowing from the drug chamber to the central opening of the needle member when the resilient septum is in the closed configuration, and The elastic diaphragm is configured to elastically deform into an open configuration when the pressure in the drug chamber increases, so that the elastic diaphragm deforms distally relative to the needle member, thereby moving the circumferential inner surface away from the needle member to allow fluid to flow from the drug chamber to the middle opening of the needle member.

27. The system of claim 26, wherein: The needle member is made of metal.

28. An injection system comprising: an injection system body defining a proximal opening at a proximal end thereof and a distal needle hub at a distal end thereof; a stop member disposed in the injection system body, forming a drug chamber between the stop member and a distal end of the injection system body; a plunger member configured to insert the stopper member therein relative to the injection system body; and A valve for forming an openable barrier between a distal needle hub and a drug chamber, the valve comprising: an outer member including a diaphragm defining a diaphragm opening therein, and an internal member configured to fit within the diaphragm opening, wherein the internal component is configured to block the septum opening when the septum is in the closed configuration, and the internal component is arranged in the septum to form the openable barrier between the distal needle hub and the drug chamber, and The septum is configured to elastically deform to an open configuration when pressure in the drug chamber increases, so that the elastic septum deforms distally away from the stop member, thereby allowing the internal member to separate from the septum to allow fluid to flow from the drug chamber to the distal needle hub.

29. The system of claim 28, wherein: The internal components are made of metal.

30. The system of claim 28, wherein: The inner member includes a smaller radius portion longitudinally disposed between the proximal larger radius portion and the distal larger radius portion.

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