Infusion systems and methods

Abstract

The 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 within the injection system body and defining a proximal drug chamber and a distal drug chamber. The system further includes a plunger member configured to insert the proximal stop member relative to the injection system body. The system further includes a valve forming an openable / closable 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 diaphragm is configured to elastically deform distally away from the inner member in response to an increase in pressure in the distal drug chamber to allow flow from the distal drug chamber to the distal needle interface.

Description

[Technical Field]

[0001] The present disclosure relates generally to infusion systems, devices and processes for facilitating various levels of control over fluid injection, and more particularly to systems and methods relating to multi-chamber infusion systems, with or without safety features, in a medical environment. [Background technology]

[0002] Millions of syringes, such as the one shown in FIG. 1A (2), are consumed daily in healthcare settings. A typical syringe (2) includes a tubular body (4), a plunger (6), and an injection needle (8). As shown in FIG. 1B, such syringes (2) can be utilized not only to inject fluids into patients, but also to withdraw or dispense fluids from or into containers such as vials, bags, or other drug containment systems (10). In fact, in some countries, such as the United States, due to concerns about maintaining sterility and regulatory constraints, if syringes (2) are used with vials (10) in certain patient settings, as shown, such vials must be used for only one patient and then disposed of, resulting in significant medical waste from the vials and remaining medication and contributing to periodic shortages of certain critical medications. Referring to FIG. 2A, three luer-type syringes (12) are shown, each having a distally disposed luer fitting configuration (14) for mating with other devices having a similar fitting configuration, such as the luer manifold assembly (16) shown in FIG. 2B. The luer manifold assembly of FIG. 2B can be used to administer liquid medications intravenously to a patient, with or without the use of an intravenous infusion bag. The luer fittings (14) of the syringes in FIG. 2A are sometimes referred to as "male" luer fittings, and the luer fittings (18) of FIG. 2B are sometimes referred to as "female" luer fittings, with one of the luer interfaces being threaded (in which case the configuration is sometimes referred to as a "luer lock" configuration) to couple the two through relative rotation, which may be combined with a compressive load. In other words, one embodiment of a luer lock utilizes rotation, possibly along with compression, to engage the threads of the male fitting (14), which are configured to engage a flange on the female fitting (18) to bring the device into a fluid-tight union. In another embodiment, a tapered interface shape may be utilized to provide the luer engagement using compression, without threads or rotation (such a configuration may be referred to as a "slip-on" or "conical" luer configuration).While such luer connections are perceived as relatively safe for the operator, there is a risk of spillage, leakage, or component damage during assembly of the luer connection. On the other hand, the use of needle injection configurations poses a risk of the sharp needle contacting or puncturing a person or unwanted structures. For these reasons, so-called "safety syringes" have been developed.

[0003] One embodiment of a safety syringe 20 is shown in FIG. 3, 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. Another embodiment of a safety syringe 24 is shown in FIGS. 4A and 4B. In this configuration, a retractable needle 26 is configured to retract (28, 26) into a safe position within the tubular body 4 after the plunger 6 is fully inserted into the syringe body 4, as shown in FIG. 4B. Such self-retracting configurations may be associated with issues such as blood splatter / aerosolization, safe storage of pre-loaded energy that could result in premature activation, loss of precision in delivering a full dose due to residual dead space within the spring compression volume, and / or loss of retraction speed control, which may be associated with pain or patient discomfort.

[0004] The syringe market has become more complex due to the increasing demand for pre-filled syringe assemblies such as those shown in Figures 5A and 5B, which generally comprise a syringe body or "drug containment and delivery system" (34), a plunger tip, plug or stopper (36), and a distal seal or cap (35) attached to a luer interface (Figure 5A shows the cap 35 in place, while Figure 5B has the cap removed to illustrate the luer interface 14). The liquid drug resides 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 is coated with a biocompatible lubricious coating (e.g., polytetrafluoroethylene ("PTFE") or the like) to facilitate favorable sealing and relative motion characteristics relative to the associated syringe body structure and material. The proximal end of the syringe body (34) in FIG. 5B comprises a conventional one-piece syringe flange (38) formed integrally with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and to circumferentially surround the syringe body (34) in its entirety or in part. The partial flange is known as a "clipped flange," while the other flange is known as a "full flange." The syringe body (34) preferably comprises a translucent material such as glass or a polymer and / or a combination thereof. A plunger tip (36) can be disposed within the syringe body (34) to form a contained volume within a chamber or reservoir (40) and aid in the evacuation of the associated fluid through the needle. The syringe body (34) can define a generally cylindrical shape (i.e., such that a plunger tip 36 having a circular cross-sectional shape establishes a seal with the syringe body (34)) or can be configured to have other cross-sectional shapes, such as an oval shape.

[0005] Such assemblies are desirable because they can be standardized and precisely mass-produced by the few manufacturers in the world who can afford to meet all of the world's ever-changing regulations regarding filling, packaging, and drug / drug interfacing material selection and component use. However, such simple configurations generally cannot meet new global standards for single-use, safety, self-disabling, and needlestick protection. For this reason, certain suppliers have shifted to more "vertical" solutions, such as those shown in Figure 5C, which attempt to meet all or at least some of the criteria in a single solution. However, as a result of attempting to meet those standards in many different scenarios, such products have significant limitations (including those discussed above with reference to Figures 3-4B) and can have relatively high inventory and usage costs.

[0006] In some cases, multi-component infusion systems may mix injectable components (e.g., liquids and / or powders) prior to injection. Some systems utilize a single injection device to aspirate liquid components from one container and inject them into another container, dissolving the dry components therein. The dissolved dry components are then drawn into the injection device for injection into the patient. Such systems require extensive handling of exposed needles, unnecessarily exposing the user to one or more uncapped needles. Furthermore, manually transferring liquid components from one container to another can result in incomplete transfer of the liquid components, affecting the ratio of components in the final mixed infusate. Furthermore, accessing and manipulating components from multiple containers complicates the injection process and increases the risk of user error. Therefore, a need exists for a multi-component infusion system that simplifies manual access and mixing of multiple components from multiple containers.

[0007] These limitations are addressed by multi-chamber injection systems configured to mix and inject multiple components. However, there remains a need for precise control of multi-chamber injection systems for accurate handling, mixing, and delivery of multi-component infusates.

[0008] Additionally, many infusion fluids (eg, pharmaceuticals) have the additional requirement of minimizing the time the infusion fluid is exposed to metal (eg, the stainless steel of a needle).

[0009] It is also desirable to incorporate needlestick protection technology into injection systems, where the ability to at least partially retract the sharp tip of the needle within the syringe protects the injector and the patient from inadvertent needlestick injuries.

[0010] There is a need for an injection system that addresses the shortcomings of currently available configurations. In particular, there is a need for a multi-chamber safety injection solution with precise control that can utilize the existing, relatively well-controlled supply chain of conventionally sourced pre-filled syringe assemblies, such as those described with reference to Figures 5A and 5B. Summary of the Invention

[0011] Embodiments are directed to infusion systems, and in particular to multi-chamber safety infusion systems that precisely control the handling, mixing, and delivery of multi-component infusates.

[0012] In one embodiment, an injection system includes an injection system body defining a proximal opening at its proximal end and a distal needle interface at its distal end. The system also includes a proximal stop member and a distal stop member disposed within the injection system body, forming a proximal drug chamber between the proximal stop member and the distal stop member and a distal drug chamber between the distal stop member and the distal end of the injection system body. The system further includes a plunger member configured to insert the proximal stop member relative to the injection system body. The system further includes a valve forming an openable and closable barrier between the distal needle interface and the distal drug chamber. The valve includes an outer member including a distal diaphragm defining a distal opening. The valve also includes an inner member including a distal extension member configured to fit within and block the distal opening of the distal diaphragm when disposed within the distal opening of the distal diaphragm. The distal diaphragm is configured to resiliently deform distally away from the inner member with increasing pressure in the distal medication chamber to allow flow from the distal medication chamber to the distal needle interface.

[0013] In one or more embodiments, the distal diaphragm is biased to a closed configuration in which the distal diaphragm is positioned against the inner member and the distal opening of the distal diaphragm is positioned around the distal extension of the inner member unless the distal diaphragm is deformed to an open configuration in which the distal diaphragm is positioned away from the inner member. The distal diaphragm can be configured to transform from the closed configuration to the open configuration when the pressure in the distal drug chamber is about 10 psi or greater. When the distal diaphragm is in the open configuration, the distal diaphragm offers minimal resistance to fluid flow from the distal drug chamber through the distal opening of the distal diaphragm to the distal needle interface.

[0014] In one or more embodiments, the outer member further includes a plurality of radially outwardly extending annular members configured to form a fluid-tight seal between the outer member and the inner surface of the infusion system body. At least one pair of longitudinally adjacent radially outwardly extending annular members of the plurality of radially outwardly extending annular members can define a space therebetween. The outer member can further include a distally extending ring configured to provide a space for distal deformation of the distal diaphragm to convert from the closed configuration to the open configuration.

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

[0016] In one or more embodiments, the system further includes a needle member removably coupled to the distal needle interface. The inner member can define an outer, proximally extending cylindrical member, and the outer member can define an inner, proximally extending cylindrical member coaxially disposed around a portion of the needle and at least partially coaxially disposed within the outer, proximally extending cylindrical member. The outer member can further include a distally facing funnel disposed adjacent the distal opening of the distal diaphragm.

[0017] In another embodiment, an injection system includes an injection system body defining a proximal opening at its proximal end and a distal needle interface at its distal end. The system also includes a proximal stop member and a distal stop member disposed within the injection system body, forming a proximal drug chamber between the proximal stop member and the distal stop member and a distal drug chamber between the distal stop member and the distal end of the injection system body. The system further includes a plunger member configured to insert the proximal stop member relative to the injection system body. The system further includes a needle member removably coupled to the distal needle interface and having an intermediate opening disposed adjacent the distal end of the syringe body. The system further includes a valve forming an openable / closable barrier between the intermediate opening and the distal drug chamber. The valve defines a diaphragm opening and includes an elastic diaphragm disposed around the needle member adjacent the intermediate opening. The valve also includes a seal around the diaphragm opening configured to prevent fluid flow from the distal drug chamber through the intermediate opening of the needle member when the elastic diaphragm is in a closed configuration. The elastic diaphragm is configured to elastically deform to an open state as pressure increases in the distal medication chamber, thereby displacing the seal distally relative to the needle member and permitting flow from the distal medication chamber through the intermediate opening in the needle member.

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

[0019] In one or more embodiments, the valve further includes a plurality of radially outwardly extending annular members configured to form a fluid-tight seal between the valve and the inner surface of the infusion system body. At least one pair of longitudinally adjacent radially outwardly extending annular members of the plurality of radially outwardly extending annular members can define a space therebetween. The valve can further include a distally extending ring configured to provide a space for the elastic diaphragm to deform distally to transform from a closed configuration to an open configuration. The valve can further include a distally facing funnel disposed adjacent the diaphragm opening. The valve can be formed from a deformable material.

[0020] In one or more embodiments, the valve further includes a distally extending support member disposed adjacent the diaphragm opening. The distally extending support member is configured to resiliently deform from a normal configuration to a contracted configuration upon increased pressure in the distal medication chamber, allowing the diaphragm to deform to an open configuration, thereby moving the seal distally relative to the fluid transfer member and permitting flow from the distal medication chamber through the intermediate opening in the fluid transfer member. The distally extending support member can be configured to return from the contracted configuration to the normal configuration when normal pressure is present in the distal medication chamber.

[0021] In yet another embodiment, 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 stopper member disposed within the injection system body, forming a medicament chamber between the stopper member and the distal end of the injection system body. The system further includes a plunger member configured to insert the stopper member relative to the injection system body. The system further 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 having an intermediate opening disposed adjacent the distal end of the injection system body. The system further includes a valve forming an openable barrier between the intermediate opening and the medicament chamber, the valve including a resilient diaphragm having a circumferentially inwardly facing surface defining a diaphragm opening and disposed around the needle member proximal to the intermediate opening. The circumferentially inwardly facing surface is configured to form a seal around the needle to prevent fluid flow from the medicament chamber to the intermediate opening of the needle when the resilient diaphragm is in a closed configuration, and the resilient diaphragm is configured to resiliently deform to an open configuration upon an increase in pressure in the medicament chamber, thereby deforming the resilient diaphragm distally relative to the needle and moving the circumferentially inwardly facing surface away from the needle, thereby allowing fluid flow from the medicament chamber to the intermediate opening of the needle.

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

[0023] In yet another embodiment, 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 stopper member disposed within the injection system body, forming a medicament chamber between the stopper member and the distal end of the injection system body. The system further includes a plunger member configured to insert the stopper member relative to the injection system body. The system further includes a valve forming an openable / closable barrier between the distal needle interface and the medicament chamber. The valve includes a diaphragm defining a diaphragm opening and a plug member configured to fit within the diaphragm opening. The plug member is configured to block the diaphragm opening when the diaphragm is in a closed configuration, the plug member disposed within the diaphragm to form an openable / closable barrier between the distal needle interface and the medicament chamber. The diaphragm is configured to resiliently deform to an open configuration upon an increase in pressure within the medication chamber, whereby the resilient diaphragm deforms distally away from the stopper member and moves the plug member away from the diaphragm, thereby permitting flow from the medication chamber to the distal needle interface.

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

[0025] These and other embodiments of the present invention are described in the detailed description that follows. [Brief explanation of the drawings]

[0026] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the U.S. Patent and Trademark Office upon request and payment of the necessary fee. [Figure 1] 1A and 1B show one embodiment of a conventional injection syringe configuration. [Figure 2] 2A and 2B show one embodiment of a conventional injection syringe configuration. [Figure 3] FIG. 3 shows one embodiment of a conventional injection syringe configuration. [Figure 4] 4A and 4B show one embodiment of a conventional injection syringe configuration. [Figure 5] 5A to 5C show one embodiment of a conventional injection syringe configuration. [Figure 6] 6A and 6B are perspective and longitudinal cross-sectional views illustrating various aspects of a syringe-based dual-chamber safety injection system, which, according to some embodiments, allows the distal needle end / tip to be retracted into a protective configuration after use. [Figure 7] 7A-7P are side and longitudinal cross-sectional views illustrating various aspects of a syringe-based dual-chamber injection system during steps of a mixing and injection method using the system, according to some embodiments. [Figure 8] FIG. 8 is a perspective view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments, with various components omitted for clarity. [Figure 9] FIG. 9 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments, with various components omitted for clarity. [Figure 10] FIG. 10 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments, with various components omitted for clarity. [Figure 11] FIG. 11 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments, with various components omitted for clarity. [Figure 12] FIG. 12 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments, with various components omitted for clarity. [Figure 13]FIG. 13 is a perspective view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 14] FIG. 14 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 15] FIG. 15 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 16] FIG. 16 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 17] FIG. 17 is a perspective view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 18] FIG. 18 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 19] FIG. 19 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 20] FIG. 20 is a perspective view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 21] FIG. 21 is a detailed perspective view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 22] FIG. 22 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 23] FIG. 23 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 24] FIG. 24 is a detailed longitudinal cross-sectional view illustrating various aspects of a syringe-based dual-chamber injection system according to some embodiments. [Figure 25]FIG. 25 is a detailed perspective view illustrating various steps in an injection method using a syringe-based dual-chamber injection system according to some embodiments. [Figure 26] FIG. 26 is a detailed perspective view illustrating various steps in an injection method using a syringe-based dual-chamber injection system according to some embodiments. [Figure 27] FIG. 27 is a detailed perspective view illustrating various steps in an injection method using a syringe-based dual-chamber injection system according to some embodiments. [Figure 28] FIG. 28 is a perspective view of a syringe-based injection system having a valve in a closed configuration according to some embodiments. [Figure 29] FIG. 29 is a detailed perspective view of a syringe-based injection system with a valve in a closed configuration according to some embodiments. [Figure 30] FIG. 30 is a detailed longitudinal cross-sectional view of a syringe-based injection system with a valve in a closed configuration according to some embodiments. [Figure 31] FIG. 31 is a detailed perspective view of a syringe-based injection system having a valve in an open configuration according to some embodiments. [Figure 32] FIG. 32 is a detailed longitudinal cross-sectional view of a syringe-based injection system having a valve in an open configuration according to some embodiments. [Figure 33] FIG. 33 is a perspective view of a syringe-based injection system having a valve in a closed configuration according to some embodiments. [Figure 34] FIG. 34 is a detailed perspective view of a syringe-based injection system with a valve in a closed configuration according to some embodiments. [Figure 35] FIG. 35 is a detailed perspective view of a syringe-based injection system having a valve in an open configuration according to some embodiments.

[0027] To better understand how the above and other advantages and objects of the various embodiments are obtained, a more detailed description of the embodiments will be provided 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 designated by similar reference numerals throughout. It should be understood that the drawings depict only certain exemplary embodiments, and therefore should not be considered to limit the scope of the embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0028] Exemplary Prefilled Dual Chamber Safety Infusion System Exemplary Dual Chamber Safety Syringe System 6A and 6B, perspective and longitudinal cross-sectional views of a dual-chamber safety injection system are shown, in which conventional proximal and distal stop members (32, 36) are disposed within a conventional, off-the-shelf, pre-filled syringe body (34). The proximal and distal stop members (32, 36), together with the syringe body (34), define proximal and distal medication chambers (40, 42). The proximal and distal stop members (36, 37) occlude the proximal and distal ends of the proximal medication chamber (40). The distal stop member (36) occludes the proximal end of the distal medication chamber (42). A needle coupling assembly (606) is disposed at the distal end of the distal medication chamber (42) and has a needle cover member (63) attached for storage. The dual-chamber safety injection system allows a user to control the transfer of a first drug component from a proximal drug chamber (40) to a distal drug chamber (42) and the distal expulsion of a mixed / combined drug from the distal drug chamber (42) by sequentially inserting a plunger member (44) into a syringe body (34) to varying degrees. The plunger member (44) includes a proximal stopper member (32), a plunger housing member (69), and a plunger operating interface (128). The first drug component (252) located in the proximal drug chamber (40) may be a liquid, such as an aqueous or oil-based drug solution, a gel, or the first drug component may be a diluent for mixing with the second drug component (254) in the distal drug chamber (42). The second drug component (254) in the distal drug chamber (42) may be a dry form of drug, such as a powder, microspheres, emulsion, lyophilized drug, or cake-like solid drug.

[0029] In some embodiments, the plunger member (44) can be configured to be manually manipulated to insert the proximal stopper member (44) into the syringe body (34). In some embodiments, the plunger member (44) can 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 inserted using a pen injection system.

[0030] The dual-chamber safety injection system has a staked needle configuration, and when provided to a user, the needle assembly, including the needle coupling assembly (606), needle distal / tip (48), needle coupling member, and needle proximal end (53), is installed in an injection-ready position after removal of the needle cover member (63), which includes an elastomeric sealing material on its inner surface for interacting with the needle distal end (48) or distal housing portion (610) during storage. Alternatively, the needle cover member (63) may include a vent (not shown) to allow pressure resulting from transfer and mixing of the drug components to escape from within the syringe body (34) while preventing the ingress of contaminants into the syringe body (34). While the staked needle is depicted as installed in a fixed position, the staked needle may also be removably coupled to the syringe body (34) using a luer interface (not shown), with the proximal needle end (53) of the needle member extending through the luer interface into the distal drug chamber (42). In the embodiment shown in Figures 6A-7P, the majority of the safety needle retraction hardware is located within the plunger housing (69).

[0031] The dual-chamber safety injection system (100) has a staked needle configuration, and when provided to a user, the needle assembly, including the needle spine assembly ("needle") (76) and needle coupling assembly (606), is installed in an injection-ready position after removal of the needle cover member (63), which includes an elastomeric sealing material on its interior surface for interacting with the needle distal end (78) and / or distal housing portion during storage. Alternatively, the needle cover member (63) may include a vent (not shown) that allows pressure resulting from transfer of the first drug component / diluent (252) to escape from the interior of the syringe body (34) while preventing the ingress of contamination into the syringe body (34). While the staked needle is depicted as installed in a fixed position, the staked needle may be removably coupled to the syringe body (34) using a luer slip or luer interface (not shown), with the needle proximal end (53) of the needle member extending through the luer interface into the distal chamber (42). Alternatively, the needle may be fixedly or removably attached to a flange on the cartridge body instead of the syringe. In the embodiment shown in Figures 6A and 6B, most of the safety needle retraction hardware is located within the plunger housing (69).

[0032] 7A-7P, various embodiments of configurations designed to facilitate multi-part drug injection and needle retraction into a syringe body are shown, in which two or more drug components are mixed to form an injection mixture or solution immediately prior to delivery to a patient. In one embodiment, a liquid first drug component / diluent (252) may be mixed with a substantially non-liquid second drug component (254), e.g., in powder form, of a drug such as a lyophilized drug component, immediately prior to injection. The configurations described herein with reference to FIGS. 7A-7P relate to dual-chamber configurations, in which two or more chambers within the same syringe body (34) are utilized to transport, mix, and inject the injection solution.

[0033] 7A and 7B, proximal and distal drug chambers (40, 42) are formed by a distal stopper member (36) between two portions of the interior of the syringe body (34), with the distal drug chamber (42) containing an air or gas gap as well as a non-liquid drug (254), and the proximal drug chamber (40), opposite the distal stopper member (36), containing a liquid diluent (252) proximally contained by the proximal stopper member (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. While the distal drug chamber (42) is described as containing a non-liquid drug (254) as a preferred embodiment, the distal drug chamber (42) can contain a liquid, solid, or gel-like drug intended to be mixed with the liquid diluent (252) in the proximal drug chamber (40).

[0034] Referring to FIG. 7C and the associated cross-sectional view of FIG. 7D, various components of a needle coupling assembly are shown (here, a so-called "staked" needle coupling assembly (606) is shown, although other needle assemblies, including luer coupling and staked configurations, as described below, can also be utilized). Lug feature (258) is configured to assist in coupling the needle coupling assembly (606) to the needle cover member (63), as shown, for example, in FIG. 7A. A small O-ring is utilized as a seal member (260) around the needle shaft, and a large O-ring is utilized as a seal member (262) at the syringe body (34) / needle coupling assembly (606) interface. Alternatively, the small O-ring (260) and large O-ring (262) can be combined into a single seal that performs both O-ring seal functions. The small O-ring (260) can also be used to seal both around the needle shaft and with the syringe body (34).

[0035] The needle includes multiple (e.g., four) proximal openings / ports (270) configured to allow the inflow of liquid diluent discharged from a more distally located intermediate opening / opening (266), and a lumen plug (268) occludes the needle lumen to form a flow path from the proximal opening (270) to the intermediate opening (266) under conditions such as those described above with reference to Figures 6N and 7H. The needle also includes a distal opening (264) opposite the lumen plug (268) from the intermediate opening (266). The distal opening (264) is fluidly connected through the needle to the needle distal end (48) for infusing liquid into a patient.

[0036] Referring to Figure 7E, proximal harpoon interface (84) is configured to pierce proximal and distal stop members (32, 36) sequentially and mate with a coupling feature on plunger member (44) (e.g., needle retaining feature, e.g., element (712) shown in Figures 7N and 7P). Figure 7F shows a spike-style harpoon coupling interface (85) configured to pierce both proximal and distal stop members (32, 36) sequentially and mate with a coupling feature on plunger member (44) to retract the needle member at least partially into plunger member (44) after an injection has been administered to the patient.

[0037] Figures 7A, 7B, and 7G-7P illustrate a sequence of actions for an injection procedure utilizing the dual-chamber safety injection system as described above. Referring to Figures 7A and 7B, the injection assembly is in a stable configuration ready for shipment or transport to an injection patient care scenario, with the first drug component / liquid diluent (252) separated from the second, non-liquid drug component (254), each within the syringe body on either side of the distal stopper member (36).

[0038] 7G and 7H illustrate the initial insertion of plunger member (44), advancing distal (36) and proximal (32) stopper members together relative to syringe body (34). Referring to FIG. 7H, advancement sufficient to pierce needle proximal end (53) of needle assembly across distal stopper member (36) creates a fluid pathway between the two previously separated chambers (40, 42) of syringe body (34), allowing liquid first drug component (252) in proximal drug chamber (40) to flow through transfer pipe (46), into at least one of proximal openings (270), and out the more distal intermediate opening (266) to reach non-liquid second drug component (254) in distal drug chamber (42).

[0039] Figures 7I and 7J show that further insertion of the stopper members (36, 32) until they are immediately adjacent one another has caused the liquid first drug component / diluent (252) to move into the distal drug chamber (42) and merge with the non-liquid second drug component (254). Figures 7K and 7L show that over time and / or manual agitation, the liquid first drug component / diluent (252) and the formerly non-liquid second drug component (254) mix to form a mixed drug solution (272).

[0040] In some embodiments, particularly for lyophilized, non-liquid second drug components, the mixed drug solution (272) can be formed with minimal or no agitation, or over time. In other embodiments, particularly for drugs held in suspension or emulsified drugs, vigorous shaking may be necessary to promote mixing. The user may find it convenient to remove their thumb from the plunger operating interface (128) during vigorous shaking. During transfer of the liquid first drug component (252) from the proximal drug chamber (40) to the distal drug chamber (42), pressure may build up within the distal drug chamber (42). This pressure acts on the proximal and distal stopper members (32, 36), preventing stopper movement. Additionally, if the user does not restrain the plunger member (44) with their thumb, the pressure buildup may cause the stopper members (32, 36) and plunger operating interface (128) to move proximally. A mixing configuration latch or "mixing click" on the plunger member (44) can be utilized to provide resistance to movement of the plunger operating interface (128) due to pressure buildup, allowing the user to remove their thumb from the plunger operating interface (128) for shaking or mixing the medication. The mixing click can also provide an audible and / or tactile indication that transfer of the liquid first medication component (252) is complete. The distal medication chamber (42) can also include an agitation device to assist in mixing the medication components.

[0041] When the assembly is ready to inject the mixed solution (272), the needle cover member (63) can be removed and the plunger member (44) and associated stopper members (36, 32) can be pushed / inserted to expose the needle distal tip (48) for injection into a patient, as shown in Figures 7M and 7N. As shown in Figures 7O and 7P, full pushing / insertion of the plunger member (44) and associated stopper members (32, 36) automatically retracts the sharp needle distal end / tip (48) at least partially through the distal and proximal stopper members (36, 32) to a safe position within either the syringe body (34), the needle coupling assembly (606), or at least partially within the plunger member (44). The needle is automatically retracted at least partially within the plunger.

[0042] Exemplary Dual Chamber Infusion System with Distal Valve FIG. 8 illustrates an infusion system (800) having a valve (820) disposed therein, according to some embodiments. While the infusion system (800) is shown without the dual-chamber component for clarity, the valve (820) is configured for use with either a single-chamber or dual-chamber infusion system, as described herein. In the case of a single-chamber infusion system, the medication is premixed and ready for injection. The illustrated infusion system (800) includes an infusion system body (34), a proximal stopper member (32), a plunger member (44), and an elongated fluid transfer member / needle member (50; see FIGS. 9 and 10). The elongated fluid transfer member / needle member (50) can be constructed of a metal, such as stainless steel. The proximal stopper member (32) forms a medication chamber (42) with the infusion system body (34). The infusion system body (34) includes a distal needle interface (810) at its distal end. In some embodiments, the distal needle interface (810) can include a pre-attached staked needle. In some embodiments, the distal needle interface (810) can be a luer connector.

[0043] Figure 9 shows the infusion system (800) and valve (820) in more detail in a closed configuration, preventing flow between the medication chamber (42) and the distal needle interface (810). The valve (820) includes an outer member (830) and an inner member (850). The outer member (830) can be formed from a resilient material, and the inner member (850) can be formed from a rigid material. The resilient material forming the outer member (830) can be one or more of rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastics, polytetrafluoroethylene (PTFE), and thermoset plastics. The outer member (830) can be coated with a lubricious polymer, such as PTFE, silicone oil, and / or other lubricious coatings. The rigid material forming the inner member (850) may be one or more of a polymer, metal, glass, ceramic, hard durometer rubber, stainless steel, titanium, glass-coated polymer, ceramic-coated polymer, cyclic olefin copolymer (COC), cyclic olefin polymer (COP). The inner member (850) may be coated with a lubricious polymer, such as a PTFE film, silicone oil, and / or other lubricious coating.

[0044] The outer member (830) includes a distal diaphragm (832) that defines a distal opening (834). In the embodiment shown in Figure 9, the distal opening (834) is approximately centered in the distal diaphragm (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 infusion system body (34). While a pair of outwardly facing annular members (836) is shown in Figure 9, there may be one, or more than two, annular members configured to form a fluid-tight seal between the outer member (830) and the inner surface of the infusion system body (34). Additionally, the outer member (830) includes a distally extending ring (838) for positioning the distal diaphragm (832) proximally away from the distal end of the infusion system body (34) and providing a space (840) within which the distal diaphragm (832) can flex. The outer member (830) also defines an annular groove (842) configured to secure the inner member (850) within the outer member (830). In the closed configuration shown in FIG. 9, the distal diaphragm (832) is positioned against the inner member (850). The distal diaphragm (832) is configured / biased to be in the closed configuration shown in FIG. 9 when no external force is acting on it.

[0045] The inner member (850) includes a distally extending member (852) configured to fit within and obstruct the distal openings (834) of the distal diaphragm (832) when the distal diaphragm (832) is in the closed configuration. In various embodiments, the distally extending member (852) can be made from a polymer, plastic, metal, glass, or other material. The inner member (850) defines a pair of proximal openings (854) that are closed / obstructed by the distal diaphragm (832) when the distal diaphragm (832) is in the closed configuration.

[0046] 9, when the distal diaphragm (832) is in a closed configuration abutting the inner member (850), the distal diaphragm (832) closes the proximal opening (854) to prevent flow therethrough. Additionally, when the distal diaphragm (832) is in the closed configuration, the distal extension member (852) closes the distal opening (834) of the distal diaphragm (832) to prevent flow therethrough.

[0047] Figure 10 shows the infusion system 800 and valve 820 in an open configuration, allowing flow between the medication chamber 42 and the distal needle interface 810. In the open configuration, the distal diaphragm 832 deforms / flexes distally away from the inner member 850, thereby unblocking the proximal opening 854 of the inner member 850 and the distal opening 834 of the distal diaphragm 832. The distal diaphragm 832 transforms from the closed configuration shown in Figure 9 to the open configuration shown in Figure 10 as pressure in the medication chamber 42 increases. In some embodiments, the distal diaphragm 832 is configured to transform from the closed configuration to the open configuration when the pressure in the medication chamber 42 is greater than or equal to about 10 psi. The distal diaphragm (832) is configured to provide minimal resistance to fluid flow from the medication chamber (42) through the proximal and distal openings (854, 834) when the distal diaphragm (832) is in the open configuration.

[0048] Figures 11 and 12 show an injection system (800') and a valve (820') according to some embodiments in closed and open configurations. The injection system (800') and the valve (820') shown in Figures 11 and 12 are similar to the injection system (800) and the valve (820) shown in Figures 9 and 10. The difference between the injection system (800, 800') and the valve (820, 820') is that the outer and inner members (830', 850') of the valve (820') are elongated to provide space between the radially outwardly extending annular members (836') of the outer member (830'). Spacing the radially outwardly extending annular members (836') facilitates vacuum-assisted assembly for moving the valve (820') axially along the injection system body (34) while maintaining stability that prevents the valve (820') from tilting. The valve (820) shown in Figures 9 and 10 is suitable for machine-assisted assembly (eg, with a vent tube) that minimizes tilt of the valve (820).

[0049] Another difference between valves 820, 820' is the locking mechanism between the outer and inner members 830', 850'. Inner member 850' defines an annular groove 856, and outer member 830' includes a radially inwardly extending annular member 844 configured to interfere with annular groove 856 to lock inner member 850' within outer member 830'.

[0050] In the closed configuration shown in FIG. 11 , the distal diaphragm (832) closes the proximal opening (854), preventing flow therethrough. Furthermore, when the distal diaphragm (832) is in the closed configuration, the distal extension member (852) closes the distal opening (834) of the distal diaphragm (832), preventing flow therethrough. Thus, flow from the medication chamber (42) through the valve (820′) to the needle interface member (810) is prevented when the distal diaphragm (832) is in the closed configuration shown in FIG. 11 .

[0051] As pressure in the medication chamber 42 increases (e.g., to 10 psi), the distal diaphragm 832 changes to the open configuration shown in FIG. 12 , which allows flow between the medication chamber 42 and the distal needle interface 810. In the open configuration, the distal diaphragm 832 deforms / flexes distally away from the inner member 850, thereby unblocking the proximal opening 854 of the inner member 850 and the distal opening 834 of the distal diaphragm 832. The distal diaphragm 832 is configured to provide minimal resistance to fluid flow from the medication chamber 42 through the proximal and distal openings 854, 834 when the distal diaphragm 832 is in the open configuration.

[0052] Valve (820) can be configured to perform one, two, three, or all four of the following functions. First, valve (820) can minimize and / or eliminate migration of non-liquid second drug components into distal needle interface (810) during assembly and storage of injection system (800). Second, valve (820) can prevent contact between stainless steel-sensitive drugs and elongated fluid transfer member / needle member (50), which may be constructed of stainless steel. Thus, valve (820) allows drugs that may corrode or deteriorate due to contact with stainless steel to be stored in the distal drug chamber. This is useful in dual-chamber and single-chamber configurations where drugs are premixed and preloaded into the drug chamber. Third, valve (820) can minimize and / or eliminate drug loss during shaking and mixing from vented injection system (800). Fourth, in a vented infusion system 800 in which the distal needle interface 810 is open to the atmosphere to allow air to escape during fluid transfer from the proximal chamber 40 to the distal chamber 42, the valve 820 can prevent loss of the mixed drug through the opening in the distal needle interface 810 during shaking and mixing of the drug components. This fourth function prevents drug loss and protects the environment from toxic drug. These valve functions, particularly the third and fourth functions, facilitate thorough mixing of the drug components in the proximal and distal chambers 40, 42 before the mixed drug is discharged distally from the infusion system body 34 through the distal needle interface 810 (e.g., into either a medicine bag or a needle).

[0053] Figure 13 illustrates a dual-chamber injection system (900) having a valve (920) disposed therein, according to some embodiments. Similar to the dual-chamber injection systems illustrated in Figures 6A-7P, 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 transfer member / needle member (50). As described herein, the proximal and distal stop members (32, 36) together with the injection system body (34) form proximal and distal medication chambers (40, 42). The proximal and distal medication chambers (40, 42) are pre-filled with a liquid first medication component and a non-liquid second medication component (not shown for clarity; see 252, 254 in Figures 6A and 6B). The elongated fluid transfer member / needle (50) defines an intermediate opening (52) that is fluidly coupled through the needle interior to the open distal end of the elongated fluid transfer member / needle (50), thereby forming a flow path through the elongated fluid transfer member / needle (50).

[0054] The injection system body (34) includes a distal needle interface (910) at its distal end. In some embodiments, the distal needle interface (910) may be a luer connector. The distal needle interface (910) may have numerous small spaces formed therein. If the non-liquid second drug component migrates into some of the small spaces of the distal needle interface (910), the non-liquid second drug component may block those small spaces and prevent the liquid from exiting the injection system body (34). The non-liquid second drug component in those small spaces may not dissolve, which may change the final concentration of the drug in the mixed drug.

[0055] Valve (920) can perform one, two, three, or all of the following four functions: First, valve (920) can minimize and / or eliminate migration of non-liquid second drug components into distal needle interface (910) during assembly and storage of injection system (900). Second, valve (920) can center and stabilize elongate fluid transfer member / needle member (50), thereby facilitating piercing of distal stopper member (36) by elongate fluid transfer member / needle member (50). Third, valve (920) can minimize and / or eliminate drug loss during shaking and mixing due to vent injection. Fourth, in a vented infusion system 900 in which the distal needle interface 910 is open to the atmosphere to allow air to escape during fluid transfer from the proximal chamber 40 to the distal chamber 42, the valve 920 can prevent loss of the mixed drug through the opening in the distal needle interface 910 during shaking and mixing of the drug components. This fourth function prevents drug loss and protects the environment from toxic drug. These valve functions, particularly the third and fourth functions, facilitate thorough mixing of the drug components in the proximal and distal chambers 40, 42 before the mixed drug is discharged distally from the infusion system body 34 through the distal needle interface 910 (e.g., into either a medicine bag or an infusion needle).

[0056] 14 shows the infusion system (900) and valve (920) in more detail in a closed configuration, preventing flow between the distal medication chamber (42) and the intermediate opening (52) of the elongate fluid transfer member / needle (50). The valve (920) can be formed from a resilient material, which may be one or more of rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastics, polytetrafluoroethylene (PTFE), and thermoset plastics. The valve (920) can be coated with a lubricious polymer, such as a PTFE film, silicone oil, and / or other lubricious coating.

[0057] The valve (920) includes a resilient diaphragm (932) defining a diaphragm opening (934) configured to receive at least a portion of the elongate fluid transfer member / needle (50) therein. In the embodiment shown in FIG. 14, the diaphragm opening (934) is approximately centrally located within the resilient diaphragm (932). The valve (920) also includes a seal (922) around the diaphragm opening (934) configured to prevent fluid flow from the distal medication chamber (42) through the intermediate opening (52) of the elongate fluid transfer member / needle (50) when the resilient diaphragm (932) is in the closed configuration shown in FIG. 14. The valve (920) further includes a pair of outwardly facing annular members (936) configured to form a fluid-tight seal between the valve (920) and the interior surface of the infusion system body (34). In some embodiments, there may be a single annular member, or there may be three or more annular members. Additionally, valve (920) includes a distally extending ring (938) that allows resilient diaphragm (932) to be positioned proximally away from the distal end of infusion system body (34) to provide space (940) through which resilient diaphragm (932) can flex. Additionally, valve (920) includes a distally facing funnel (944) that facilitates assembly and allows for central location of elongated fluid transfer member / needle member (50).

[0058] In the closed configuration shown in Figure 14, the resilient diaphragm (932) is positioned proximal to the intermediate opening (52) of the elongate fluid transfer member / needle member (50), thereby providing a fluid-tight seal separating the intermediate opening (52) from the distal medication chamber (42). The resilient diaphragm (932) is configured / biased to be in the closed configuration shown in Figure 14 in the absence of an external force.

[0059] Figure 15 shows the infusion system 900 and valve 920 in an open configuration allowing flow between the distal medication chamber 42 and the intermediate opening 52 of the elongate fluid transfer member / needle 50. In the open configuration, the elastic diaphragm 932 deforms / flexes distally past the intermediate opening 52, thereby opening a flow path between the distal medication chamber 42 and the intermediate opening 52 of the elongate fluid transfer member / needle 50. The elastic diaphragm 932 changes from the closed configuration shown in Figure 14 to the open configuration shown in Figure 15 when pressure in the distal medication chamber 42 increases. In some embodiments, the elastic diaphragm 932 is configured to convert from the closed configuration to the open configuration when pressure in the distal medication chamber 42 is equal to or greater than about 10 psi. When the resilient diaphragm (932) is in the open configuration, the resilient diaphragm (932) is configured to provide minimal resistance to fluid flow from the distal medication chamber (42) through the intermediate opening (952).

[0060] 16 shows the injection system 900 after the injection is complete and the elongate fluid transfer member / needle member 50 has been safely retracted into the injection system body 34. The needle can automatically retract at least partially into the plunger.

[0061] Figure 17 illustrates a dual-chamber injection system (1000) having a valve (1020) disposed therein, according to some embodiments. Similar to the dual-chamber injection systems illustrated in Figures 6A-7P and 13-16, 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 transfer member / needle member (50). The proximal and distal stop members (32, 36), together with the injection system body (34), form proximal and distal medication chambers (40, 42), as described herein. The proximal and distal medication chambers (40, 42) are pre-filled with a liquid first medication component and a non-liquid second medication component (not shown for clarity; see 252, 254 in Figures 6A and 6B). The elongated fluid transfer member / needle (50) defines an intermediate opening (52) that is fluidly coupled through the needle interior to the open distal end of the elongated fluid transfer member / needle (50), thereby forming a flow path through the elongated fluid transfer member / needle (50).

[0062] The injection system body (34) includes a distal needle interface (1010) at its distal end. In some embodiments, the distal needle interface (1010) may be a luer connector. The distal needle interface (1010) has multiple small spaces formed therein. The valve (1020) shown in FIG. 17 has the same function as the valve (920) shown in FIG. 13.

[0063] FIG. 18 shows the infusion system (1000) and valve (1020) in more detail in a closed configuration, preventing flow between the distal drug chamber (42) and the distal needle interface (1010). The valve (1020) includes an outer member (1030) and an inner member (1050). The outer member (1030) can be formed from a resilient material, and the inner member (1050) can be formed from a rigid material. The resilient material forming the outer member (1030) can be one or more of rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic plastic, polytetrafluoroethylene (PTFE), and thermoset plastic. The outer member (1030) can be coated with a lubricious polymer, such as a PTFE film, silicone oil, and / or other lubricious coating. The rigid material forming the inner member (1050) may be one or more of a polymer, metal, glass, ceramic, hard durometer rubber, stainless steel, titanium, glass-coated polymer, ceramic-coated polymer, cyclic olefin copolymer (COC), cyclic olefin polymer (COP). The inner member (1050) may be coated with a lubricious polymer, such as a PTFE film, silicone oil, and / or other lubricious coating.

[0064] The outer member (1030) includes a distal diaphragm (1032) defining a distal opening (1034). In the embodiment shown in FIG. 18, the distal opening (1034) is approximately centered in the distal diaphragm (1032). The outer member (1030) also includes a pair of outwardly extending annular members (1036) configured to form a fluid-tight seal between the outer member (1030) and the inner surface of the infusion system body (34). While two outwardly extending annular members (1036) are shown in FIG. 18, other embodiments may include a single annular member or three or more annular members. The outer member (1030) also includes a distally extending ring (1038) that can position the distal diaphragm (1032) proximally away from the distal end of the infusion system body (34) to provide a space (1040) through which the distal diaphragm (1032) can flex. The outer member 1030 also defines a radially inwardly extending annular member 1048 configured to secure the inner member 1050 within the outer member 1030. In the closed configuration shown in FIG. 18, the distal diaphragm 1032 is disposed against the inner member 1050. The distal diaphragm 1032 is configured / biased to be in the closed configuration shown in FIG. 18 in the absence of an external force. Additionally, the valve 1020 includes a distally facing funnel 1044 to facilitate assembly and to allow for central location of the elongated fluid transfer member / needle member 50.

[0065] The inner member (1050) includes a distally extending member (1052) configured to fit into and obstruct a distal opening (1034) of the distal diaphragm (1032) when the distal diaphragm (1032) is in the closed configuration. The inner member (1050) defines a proximal opening (1054) that is closed / obstructed by the distal diaphragm (1032) when the distal diaphragm (1032) is in the closed configuration. The inner member (1050) also defines an annular groove (1056) configured to interfere with the radially inwardly extending annular member (1048) of the outer member (1030) to secure the inner member (1050) within the outer member (1030).

[0066] 18, with the distal diaphragm (1032) abutting the inner member (1050) in the closed configuration, the distal diaphragm (1032) closes the proximal opening (1054) to prevent flow therethrough. Additionally, when the distal diaphragm (1032) is in the closed configuration, the distal extension member (1052) closes the distal opening (1034) of the distal diaphragm (1032) to prevent flow therethrough.

[0067] Figure 19 shows the infusion system 1000 and valve 1020 in an open configuration, allowing flow between the distal drug chamber 42 and the distal needle interface 1010. In the open configuration, the distal diaphragm 1032 deforms / flexes distally away from the inner member 1050, thereby unblocking the proximal opening 1054 of the inner member 1050 and the distal opening 1034 of the distal diaphragm 1032. The distal diaphragm 1032 transforms from the closed configuration shown in Figure 18 to the open configuration shown in Figure 19 as pressure increases in the distal drug chamber 42. In some embodiments, the distal diaphragm 1032 is configured to transform from the closed configuration to the open configuration when the pressure in the distal drug chamber 42 is about 10 psi or greater. When the distal diaphragm (1032) is in the open configuration, the distal diaphragm (1032) is configured to provide minimal resistance to fluid flow from the distal medication chamber (42) through the proximal and distal openings (1054, 1034).

[0068] Inner member (1050) defines an outer, proximally extending cylindrical member (1058), and outer member (1030) defines an inner, proximally extending cylindrical member (1046). Inner, proximally extending cylindrical member (1046) is coaxially disposed about a portion of elongate fluid transfer member / needle member (50). Outer, proximally extending cylindrical member (1058) is coaxially disposed about a portion of inner, proximally extending cylindrical member (1046).

[0069] Figures 20 and 21 illustrate a dual-chamber injection system (1100) having a valve (1120) disposed therein, according to some embodiments. Similar to the dual-chamber injection system shown in Figures 6A-7P, 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 transfer member (50'). The proximal and distal stop members (32, 36), together with the injection system body (34), form proximal and distal drug chambers (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 252, 254 in Figures 6A and 6B and 254 in Figure 21). The elongated fluid transfer member (50') defines an intermediate opening (52) that is fluidly coupled through the fluid transfer interior to the open distal end of the elongated fluid transfer member (50'), thereby forming a flow path through the elongated fluid transfer member (50').

[0070] The injection system body (34) includes a distal needle interface (1110) at its distal end. In some embodiments, the distal needle interface (1110) may be a luer connector. The distal needle interface (1110) has numerous small spaces formed therein. If the non-liquid second drug component migrates into some of the small spaces of the distal needle interface (1110), the non-liquid second drug component may block those small spaces and prevent liquid from exiting the injection system body (34). The non-liquid second drug component in those small spaces may not dissolve, which may change the final concentration of the drug in the mixed drug. The dual-chamber injection system (1100) shown in FIGS. 20 and 21 is in a storage / transport configuration with the distal needle interface (1110) sealed with the cap (620).

[0071] The valve 1120 can perform one, two, three, or all of the following four functions. First, the valve 1120 can minimize and / or eliminate migration of the non-liquid second drug component into the distal needle interface 1110 during assembly and storage of the injection system 1100. Second, the valve 1120 can center and stabilize the elongated fluid transfer member 50′, thereby facilitating piercing of the distal stopper member 36 by the elongated fluid transfer member 50′. Third, the valve 1120 can minimize and / or eliminate drug loss during shaking and mixing with vent injection (see FIG. 26). Fourth, in a vented infusion system 1100 in which the distal needle interface 1110 is open to the atmosphere to allow air to escape during fluid transfer from the proximal chamber 40 to the distal chamber 42, the valve 1120 can prevent loss of the mixed drug through the opening in the distal needle interface 1110 during shaking and mixing of the drug components (see FIGS. 25 and 26). This fourth function prevents drug loss and protects the environment from toxic drugs. These valve functions, particularly the third and fourth functions, facilitate thorough mixing of the drug components in the proximal and distal chambers 40, 42 before the mixed drug is discharged from the infusion system body 34 through the distal needle interface 1110 in the distal direction (e.g., into either a drug bag or the needle).

[0072] FIG. 22 shows the infusion system 1100 and valve 1120 in more detail in a closed configuration, preventing flow between the distal medication chamber 42 and the intermediate opening 52 of the elongate fluid transfer member 50'. The valve 1120 can be formed from a resilient material. The valve 1120 includes an outer member 1130 and an inner member 1150. The outer member 1130 can be formed from a resilient material, and the inner member 1150 can be formed from a rigid material. The resilient material forming the outer member 1130 can be one or more of rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastics, polytetrafluoroethylene (PTFE), and thermoset plastics. The outer member 1130 can be coated with a lubricious polymer, such as PTFE, silicone oil, and / or other lubricious coatings. The rigid material forming the inner member (1150) may be one or more of a polymer, metal, glass, ceramic, hard durometer rubber, stainless steel, titanium, glass-coated polymer, ceramic-coated polymer, cyclic olefin copolymer (COC), cyclic olefin polymer (COP). The inner member (1150) may be coated with a lubricious polymer such as PTFE, silicone oil, and / or other lubricious coatings.

[0073] The outer member 1130 includes a distal diaphragm 1132 defining a distal opening 1134. In the embodiment shown in FIG. 22, the distal opening 1134 is approximately central to the distal diaphragm 1132. The outer member 1130 also includes a seal 1122 around the diaphragm opening 1134 configured to prevent fluid flow from the distal medication chamber 42 through the intermediate opening 52 of the elongate fluid transfer member 50′ when the resilient diaphragm 1132 is in the closed configuration shown in FIG. 22. The outer member 1130 further includes an outwardly extending annular member 1136 configured to form a fluid-tight seal between the valve 1120 and the inner surface of the infusion system body 34. Additionally, the outer member 1130 includes a distally extending support member 1160 that can position the elastic diaphragm 1132 proximally away from the proximal face of the inner member 1150 to provide a space 1140 within which the elastic diaphragm 1132 can flex. The outer member 1130 also defines an annular groove 1142 configured to secure the inner member 1150 within the outer member 1130. In the closed configuration shown in FIG. 22 , the elastic diaphragm 1132 is positioned proximal to the intermediate opening 52 of the elongate fluid transfer member 50′, thereby providing a fluid-tight seal separating the intermediate opening 52 from the distal medication chamber 42. The elastic diaphragm 1132 is configured / biased to be in the closed configuration shown in FIG. 22 when no external force is acting on it.

[0074] The inner member (1150) includes a distally extending member (1158) configured to form a friction fit within the distal needle interface (1110). The friction fit between the distally extending member (1158) and the inner surface of the distal needle interface (1110) couples the inner member (1150) and the valve (1120) to the infusion system body (34).

[0075] Figure 23 shows the infusion system 1100 and valve 1120 in an open configuration, allowing flow between the distal medication chamber 42 and the intermediate opening 52 of the elongate fluid transfer member 50'. In the open configuration, the distally extending support member 1160' of the outer member 1130 buckles / collapses / shortens, thereby allowing the elastic diaphragm 1132 to deform / flex distally beyond the intermediate opening 52 and open a flow path between the distal medication chamber 42 and the intermediate opening 52 of the elongate fluid transfer member 50'. The elastic diaphragm 1132 transforms from the closed configuration shown in Figure 22 to the open configuration shown in Figure 23 when pressure in the distal medication chamber 42 increases. In some embodiments, the elastic diaphragm 1132 is configured to transform from the closed configuration to the open configuration when pressure in the distal medication chamber 42 is greater than or equal to about 10 psi. When the resilient diaphragm 1132 is in the open configuration, the resilient diaphragm 1132 is configured to provide minimal resistance to fluid flow from the distal medication chamber 42 through the intermediate opening 1152. The cap 680 is also removed from the distal needle interface 1110, completing the fluid path between the distal medication chamber 42 and the exterior of the infusion system 1100.

[0076] In some embodiments, the injection system (1100) and valve (1120) are in the open configuration shown in Figure 23 to vent any air / pressure that builds up in the distal drug chamber (42) as fluid is transferred from the proximal drug chamber (40) to the distal drug chamber (42) (see Figure 25). In some embodiments, the injection system (1100) and valve (1120) are in the open configuration shown in Figure 23 to allow the mixed drug / medicine to be vented from the distal drug chamber (42) (see Figure 27).

[0077] Figure 24 shows in more detail the infusion system 1100 and valve 1120 in a closed configuration similar to that of Figure 22. The difference between the infusion systems 1100 shown in Figures 22 and 24 is that the cap 680 has been replaced with a needle coupling assembly 606, which couples to a distal needle interface 1110 to complete the fluid path between the distal medication chamber 42 and the exterior of the infusion system 1100.

[0078] Figures 25-27 illustrate various steps in an injection method using the injection system 1100 shown in Figures 20-24, according to some embodiments. In Figure 25, the proximal stopper member 36 is moved distally until the proximal drug chamber 40 (see Figure 20) is fully collapsed, transferring the liquid first drug component 252 therein to the distal drug chamber 42. During fluid transfer from the proximal drug chamber 40 to the distal drug chamber 42, an increase in pressure within the distal drug chamber 42 causes the distally extending support member 1160' of the outer member 1130 to shorten, as shown in Figure 23. This allows air / pressure within the distal drug chamber 42 to be vented out of the injection system 1100 via the elongated fluid transfer member 50'.

[0079] In Figure 26, 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) has returned to normal (i.e., atmospheric / external pressure). This causes the distally extending support member (1160') of the outer member (1130) shown in Figure 23 to resiliently return / extend to the distally extending support member (1160) shown in Figures 22 and 24, 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 unintentional expulsion of the components of the distal drug chamber (42).

[0080] In Figure 27, the needle coupling assembly 606 is coupled to the distal needle interface 1110, allowing excess air to be vented from the distal medication chamber 42. As shown in Figure 23, as pressure increases in the distal medication chamber 42, the distally extending support member 1160' of the outer member 1130 shortens, allowing the air / pressure in the distal medication chamber 42 to be vented outside the infusion system 1100 via the elongated fluid transfer member 50', thereby allowing the mixed medication to be vented from the distal medication chamber 42.

[0081] 28-32 illustrate an injection system 1200 having a valve 1220 disposed therein, according to some embodiments. The injection system 1200 includes an injection system body 34, a stopper member 32, a plunger member 44, and a needle assembly including a needle proximal end 53 and a needle coupling member 54. The stopper member 32, together with the injection system body 34, forms a chamber 42. The chamber 42 may be pre-filled with an injectable fluid 252. The needle proximal end 53 and the needle coupling member 54 define an intermediate opening 52 that extends through the interior of the needle coupling member 54 and is fluidly coupled to the open distal end of the needle assembly, thereby forming a flow path through the needle assembly.

[0082] As shown in Figures 29 and 30, the valve (1220) includes an outer member (1230) and an inner member (1232). The inner member (1232) is a resilient diaphragm having a circumferentially inwardly facing surface (1234). The inner and / or outer members (1232, 1234) can be constructed from a resilient material, which can be one or more of rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic plastic, polytetrafluoroethylene (PTFE), and thermoset plastic. The inner and / or outer members (1232, 1234) can be coated with a lubricious polymer, such as PTFE, silicone oil, and / or other lubricious coating.

[0083] 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 / inner member / elastic diaphragm 1232 is in a closed configuration, as shown in Figures 29 and 30. In the closed configuration, the inner member / elastic diaphragm 1232 is essentially flat and configured to form a fluid-tight seal against the circumferential outward surface of the needle proximal end 53. This fluid-tight seal prevents the injectable fluid 252 from flowing from the chamber 42 to the intermediate opening 52 of the needle assembly (e.g., during transport and storage of the injection system 1200).

[0084] As shown in Figures 31 and 32, when the injectable fluid 252 within the chamber 42 is pressurized by applying a distally directed force (e.g., about 25 psi or greater) to the plunger member 44 and attached stopper member 32, the valve 1220 / inner member / elastic diaphragm 1232 transitions from the closed configuration shown in Figures 29 and 30 to the open configuration shown in Figures 31 and 32. In the open configuration, the pressure within the chamber 42 causes the inner member / elastic diaphragm 1232 to elastically deform distally relative to the needle assembly, thereby removing the seal between the chamber 42 and the intermediate opening 52 of the needle assembly (e.g., during injection). As the inner member / elastic diaphragm 1232 elastically deforms distally relative to the needle assembly, the circumferential inward surface 1234 moves away from the needle proximal end 53, thereby opening a flow path 1242 between the inner member / elastic diaphragm 1232 and the needle proximal end 53. With the valve 1220 in the open configuration, the injectable fluid 252 can flow from the chamber 42 through the flow path 1242 to the intermediate opening 52 of the injection needle assembly to effect an injection.

[0085] The valve 1220 shown in Figures 28-32 allows for the creation of a sealed syringe / injection system 1200 with the addition of only one extra component (e.g., valve 1220). Valve 1220 can create sealed versions of both dual-chamber and single-chamber injection systems. Furthermore, because valve 1220 does not need to align with any opening in the needle assembly, valve 1220 allows for greater tolerances in the components of injection system 1200 and in the assembly of system 1200.

[0086] 33-35 illustrate an injection system 1300 having a valve 1320 disposed therein, according to some embodiments. The injection system 1300 includes an injection system body 34, a stopper member, a plunger member, and a needle 51. The stopper member 32, together with the injection system body 34, forms a chamber 42. The chamber 42 is pre-filled with an injectable fluid 252. The needle 51 is open at its proximal and distal ends.

[0087] As shown in FIGS. 33 and 34 , the valve (1320) includes a resilient diaphragm (1330) having a circumferentially inwardly facing surface (1334) that defines a central diaphragm opening (1342). The valve (1320) also includes a plug member (1332) configured to be disposed within the central diaphragm opening (1342) when the valve is in a closed configuration, as shown in FIGS. 33 and 34 and described below. When the infusible fluid (252) in the chamber (42) is at a relatively low pressure (e.g., less than about 30 psi), the valve (1320) / resilient diaphragm (1330) is in the closed configuration, as shown in FIGS. 33 and 34 . In the closed configuration, the inner resilient diaphragm (1330) is essentially flat and configured to abut the circumferentially outwardly facing surface of the plug member (1332) to form a fluid-tight seal. The fluid-tight seal prevents injectable fluid 252 from flowing from chamber 42 into the proximal opening of needle 51 (e.g., during transport and storage of injection system 1300). Resilient diaphragm 1330 can be constructed from one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer, silicone rubber, thermoplastic, polytetrafluoroethylene (PTFE), and thermoset plastic. Resilient diaphragm 1330 can be coated with a lubricious polymer, such as PTFE, silicone oil, and / or other lubricious coatings. The rigid material forming plug member 1332 can be one or more of polymer, metal, glass, ceramic, hard durometer rubber, stainless steel, titanium, glass-coated polymer, ceramic-coated polymer, cyclic olefin copolymer (COC), and cyclic olefin polymer (COP). The inner member can be coated with a lubricious polymer, such as a PTFE film, silicone oil, and / or other lubricious coating.

[0088] As shown in Figure 35, when injectable fluid (252) within chamber (42) is pressurized by applying a distally directed force (e.g., about 30 psi or greater) to plunger member (44) and attached stopper member (32), resilient diaphragm (1330) transitions from the closed configuration shown in Figures 33 and 34 to the open configuration shown in Figure 35. In the open configuration, pressure within chamber (42) causes resilient diaphragm (1330) to resiliently deform distally away from the stopper member, thereby removing the seal between chamber (42) and the proximal opening of needle (51) (e.g., during injection). As resilient diaphragm 1330 elastically deforms distally away from stopper member, circumferential inward surface 1334 moves away from plug member 1332, thereby disengaging plug member 1332 from diaphragm opening 1342 and opening diaphragm opening 1342. With valve 1320 in the open configuration, injectable fluid 252 can flow from chamber 42 through diaphragm opening 1342 to the proximal opening of needle 51 for injection.

[0089] In some embodiments, the plug member (1332) includes a smaller radius portion longitudinally disposed between proximal and distal larger radius portions. In alternative embodiments, the plug member (1332) is a ball bearing and is sized and shaped to close the diaphragm opening (1342) when the valve (1320) is in a closed configuration and to disengage 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 surface area in the proximal direction of approximately 0.002 square inches. In such embodiments, a pressure of approximately 30 psi applied to the valve (1320) causes the diaphragm (1330) to deflect, as shown in FIG. 35. The deflection of the diaphragm (1330) causes a thin pressurized layer of injectable fluid (252) to flow between the diaphragm (1330) and the plug member (1332), thereby reducing friction between the two parts to nearly zero, and the shear force of the injectable fluid (252) flowing past the plug member (1332) causes the plug member (1332) to disengage from the diaphragm opening (1342), as shown in FIG. 35.

[0090] In another embodiment, plug member (1332) can have proximal and / or distal engagement ribs extending from its outer diameter, thereby increasing mechanical interference with elastic diaphragm (1330) and increasing the pressure required to dislodge plug member (1332). Although valve (1320) is shown in a single-chamber injection system (1330), valve (1320) can be used to create sealed versions of both dual-chamber and single-chamber injection systems.

[0091] The valve 1320 shown in Figures 33-35 mitigates the increase in required operating pressure as the injection system ages, which can be undesirably large in valves that include resilient polymer / hard polymer interfaces that adhere to each other over time. The valve 1320 includes a resilient polymer diaphragm 1330 and a metal plug member 1334, the interaction between which minimizes the increase in operating pressure as the injection system 1300 ages.

[0092] The magnitude of the preset force required to transform the valve / diaphragm from a closed to an open configuration can be adjusted to match a combination of the system's functional requirements and the aesthetic impact it has on the user. If the actuation force is too small, it may actuate but be too strong, making it difficult for the user to apply a light enough force. On the other hand, if the force is too large, the user may find the system "too difficult" to actuate. Fortunately, the preset force magnitude can be "tuned" within a range by modifying the properties of various components.

[0093] 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 valves (820, 920, 1020, 1120, 1220, 1320), including, but not limited to, (1) the outer diameter of the diaphragms (832, 932, 1032, 1132, 1232, 1330), (2) the thickness of the diaphragms (832, 932, 1032, 1132, 1232, 1330), and (3) the amount of interference between the plug member (1332) and the elastic diaphragm (1330). The amount of interference between plug member (1332) and elastic diaphragm (1330) can be varied by adding protrusions / bumps to the circumferentially inwardly facing surface (1334) that defines the central diaphragm opening (1342) to increase the amount of interference, thereby increasing the amount of force / pressure required to disengage / release plug member (1332) and open valve (1320).

[0094] While the above-described embodiments include dual-chamber safety injection systems, other multi-chamber safety injection systems are also encompassed within the scope of the claims. For multi-chamber safety injection systems having three or more chambers, three or more stopper members are inserted into the injection system body (e.g., syringe body, cartridge body, etc.) to define a corresponding number of chambers.

[0095] Although the prefilled dual chamber safety injection systems shown and disclosed herein include syringes with staked needles, the various configurations / embodiments described herein (e.g., continuous injection, dual chambers with detents, threaded plunger members, and shielded and vented needle covers) can also be used with cartridges, autoinjectors, and injection systems that have luer connectors, transfer piping, and no needles.

[0096] Various exemplary embodiments of the present invention have been described herein. These examples are referred to in a non-limiting sense. They are provided to illustrate broader applicable aspects of the present invention. Various modifications may be made to the described invention, and equivalents may be substituted, without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process operation, or step to the objective, spirit, or scope of the present invention. Moreover, as will be understood by those skilled in the art, each of the individual variations described and exemplified herein has individual components and features that can be readily separated from or combined with the features of any of the other embodiments without departing from the scope or spirit of the present invention. All such modifications are intended to be within the scope of the claims associated with this disclosure.

[0097] Any of the described devices for performing a subject diagnostic or interventional procedure may be provided in a packaged combination for use in performing such an intervention. These supply "kits" may further include instructions for use and may be packaged in a sterile tray or container as commonly employed for such purposes.

[0098] The present invention includes methods that may be performed using the subject devices. The methods may include the act of providing such a suitable device. Such providing may be performed by an end user. That is, the act of "providing" merely requires the end user to obtain, access, approach, place, set up, activate, power on, or take other action to provide the required device in the subject method. Methods described herein may carry out the recited events in any order that is logically possible or in the sequence of events recited.

[0099] Exemplary embodiments of the present invention, including details regarding material selection and manufacturing, have been described above. Other details of the present invention may be understood in connection with the above-cited patents and publications, as well as generally known or understood by those skilled in the art. For example, those skilled in the art will understand that one or more lubricious coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, PTFE, ETFE, hydrophilic gels, or silicones) may be used in connection with various portions of the device, such as relatively large interface surfaces of movably coupled portions, as needed, to facilitate, for example, low-friction manipulation or advancement of such objects relative to other portions of the instrument or nearby tissue structures. The same will be true for method-based embodiments of the present invention with respect to additional actions commonly or logically employed.

[0100] Furthermore, while the present invention has been described with reference to several examples optionally incorporating various features, the present invention is not limited to what has been described or disclosed as contemplated with respect to each variation of the invention. Various modifications can be made to the described invention, and equivalents (whether described herein or not included for brevity) can be substituted without departing from the true spirit and scope of the invention. Furthermore, when a range of values ​​is provided, it is understood that all intervening values ​​between the upper and lower limits of that range, as well as other stated or intervening values ​​within the stated range, are encompassed within the scope of the invention.

[0101] It is also contemplated that any feature of the described inventive variations may be described and claimed independently or in combination with any one or more of the features described herein. Reference to a singular item includes the possibility of a plurality of the same items. More specifically, as used in this specification and the appended claims, the singular forms "a," "an," "said," and "the" include plural referents unless otherwise indicated. In other words, the use of articles allows for "at least one" of the subject items in the above description, as well as the claims that accompany this disclosure. It should be noted that such claims may be drafted to exclude optional elements. Thus, this statement is intended to function as a precedent for using exclusive terms such as "solely," "only," etc., in connection with the recitation of claim elements, or for using a "negative" limitation.

[0102] Without using such exclusive language, the term "comprising" in any claim appended to this disclosure shall be construed as allowing for the inclusion of any additional elements, regardless of whether a given number of elements are recited in such claim or whether the addition of features would be considered to change the nature of the elements recited in such claim. Except as specifically defined herein, all technical and scientific terms used herein shall be given the broadest and most commonly understood meaning possible while maintaining the validity of the claims.

[0103] The breadth of the present invention is not limited to the examples and / or subject specification provided, but rather is limited only by the scope of the language of the claims appended to this disclosure.

Claims

1. In the injection system, an injection system body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof; proximal and distal stop members disposed within the injection system body, the proximal and distal stop members defining a proximal medication chamber therebetween and a distal medication chamber therebetween and a distal end of the injection system body; and a plunger member configured to insert the proximal stopper member relative to the injection system body; a valve forming an openable and closable barrier between the distal needle interface and the distal medication chamber, an outer member including a distal diaphragm defining a distal opening; a valve having an inner member including a distal extension member, the inner member configured to fit within and obstruct the distal opening of the distal diaphragm when the distal extension member is positioned in the distal opening of the distal diaphragm; an injection system, characterized in that the distal diaphragm is configured to elastically deform distally away from the inner member as pressure increases in the distal drug chamber to allow flow from the distal drug chamber to the distal needle interface.

2. 10. The system of claim 1, The system, wherein the distal diaphragm is biased to a closed configuration in which the distal diaphragm is positioned against the inner member and a distal opening of the distal diaphragm is positioned around a distal extension of the inner member unless the distal diaphragm is deformed to an open configuration in which the distal diaphragm is positioned away from the inner member.

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

4. 3. The system of claim 2, 10. The system of claim 9, wherein when the distal diaphragm is in an open configuration, the distal diaphragm provides minimal resistance to fluid flow from the distal drug chamber through a distal opening in the distal diaphragm to the distal needle interface.

5. 3. The system of claim 2, The system, wherein the outer member further comprises a plurality of radially outwardly extending annular members configured to form a fluid-tight seal between the outer member and an inner surface of the infusion system body.

6. 6. The system of claim 5, At least one pair of longitudinally adjacent radially outward annular members of the plurality of radially outward annular members defines a space therebetween.

7. 3. The system of claim 2, The system, wherein the outer member further includes a distally extending ring configured to provide a space for the distal diaphragm to deform distally and transform from a closed configuration to an open configuration.

8. 3. The system of claim 2, The system, wherein the outer member defines an annular groove configured to secure the inner member within the outer member.

9. 3. The system of claim 2, the inner member defines an annular groove; The system, wherein the outer member further includes a radially inwardly extending annular member configured to interfere with an annular groove in the inner member to secure the inner member to the outer member.

10. 3. The system of claim 2, the inner member defines a proximal opening; The system, wherein the distal diaphragm prevents fluid flow through the proximal opening when the distal diaphragm is in a closed configuration.

11. 3. The system of claim 2, the outer member is formed from a deformable material; The system wherein the inner member is formed from a rigid material.

12. 3. The system of claim 2, further comprising a needle member removably coupled to the distal needle interface; the inner member defines an outer, proximally extending cylindrical member; the outer member defining an inner, proximally extending cylindrical member coaxially disposed about a portion of the needle and at least partially coaxially disposed within the outer, proximally extending cylindrical member.

13. 13. The system of claim 12, The system, wherein the outer member further comprises a distally facing funnel disposed adjacent a distal opening of the distal diaphragm.

14. In the injection system, an injection system body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof; proximal and distal stop members disposed within the injection system body, the proximal and distal stop members defining a proximal medication chamber therebetween and a distal medication chamber therebetween and a distal end of the injection system body; and a plunger member configured to insert the proximal stopper member relative to the injection system body; a fluid transfer member removably coupled to the distal needle interface and having an intermediate opening disposed adjacent the distal end of the syringe body; a valve forming an openable / closable barrier between the intermediate opening and the distal medication chamber, a resilient diaphragm defining a diaphragm opening and positioned about the fluid transfer member adjacent the intermediate opening; a valve having a seal disposed around the diaphragm opening, the seal configured to prevent fluid flow from the distal medication chamber through the intermediate opening of the fluid transfer member when the resilient diaphragm is in a closed configuration; The injection system is characterized in that the elastic diaphragm is configured to elastically deform to an open state upon an increase in pressure in the distal drug chamber, thereby moving the seal distally relative to the fluid transfer member and allowing flow from the distal drug chamber through the intermediate opening of the fluid transfer member.

15. 15. The system of claim 14, The system, wherein the elastic diaphragm is biased to a closed configuration in which the seal is disposed around the fluid transfer member proximal to the intermediate opening unless the elastic diaphragm is deformed to an open configuration in which the seal is disposed at least partially distal to the intermediate opening.

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

17. 15. The system of claim 14, 10. The system of claim 9, wherein when the elastic diaphragm is in an open configuration, the elastic diaphragm provides minimal resistance to fluid flow from the distal drug chamber through a distal opening in the elastic diaphragm to the distal needle interface.

18. 15. The system of claim 14, The system, wherein the valve further comprises a plurality of radially outwardly extending annular members configured to form a fluid-tight seal between the valve and an inner surface of the infusion system body.

19. 20. The system of claim 18, At least one pair of longitudinally adjacent radially outward annular members of the plurality of radially outward annular members defines a space therebetween.

20. 15. The system of claim 14, The system, wherein the valve further includes a distally extending ring configured to provide a space for the distal diaphragm to deform distally to transform from a closed configuration to an open configuration.

21. 15. The system of claim 14, The system, wherein the valve further comprises a distally facing funnel disposed adjacent the diaphragm opening.

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

23. 15. The system of claim 14, The system, wherein the valve further includes a distally extending support member positioned adjacent the diaphragm opening.

24. 24. The system of claim 23, The system is characterized in that the distally extending support member is configured to elastically deform from a normal configuration to a contracted configuration in response to an increase in pressure in the distal medication chamber, allowing the diaphragm to deform to an open configuration, thereby moving the seal distally relative to the fluid transfer member and allowing flow from the distal medication chamber through an intermediate opening in the fluid transfer member.

25. 25. The system of claim 24, The system, wherein the distally extending support member is configured to return from a contracted configuration to a normal configuration when normal pressure is present in the distal medication chamber.

26. In the injection system, an injection system body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof; a stopper member disposed within the injection system body, the stopper member forming a medication chamber between the stopper member and the distal end of the injection system body; a plunger member configured to insert the stopper member into the injection system body; a needle hub assembly coupled to the distal needle interface, a needle hub coupled to the distal needle interface; a needle hub assembly including a needle member removably coupled to the needle hub and having an intermediate opening disposed adjacent a distal end of the injection system body; a valve forming an openable / closable barrier between the intermediate opening and the medicament chamber, the valve including a resilient diaphragm having a circumferentially inwardly facing surface defining a diaphragm opening, the resilient diaphragm being disposed about the needle member proximal to the intermediate opening; the circumferentially inwardly facing surface is configured to form a seal around the needle to prevent fluid flow from the medication chamber to the intermediate opening of the needle when the resilient diaphragm is in a closed configuration; the elastic diaphragm is configured to elastically deform to an open configuration as pressure increases in the medication chamber, thereby deforming the elastic diaphragm distally relative to the needle member, moving the circumferentially inwardly facing surface away from the needle member and permitting flow from the medication chamber to the intermediate opening of the needle member.

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

28. In the injection system, an injection system body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof; a stopper member disposed within the injection system body, the stopper member forming a medication chamber between the stopper member and the distal end of the injection system body; a plunger member configured to insert the stopper member into the injection system body; a valve forming an openable and closable barrier between the distal needle interface and the medication chamber, an outer member including a diaphragm defining a diaphragm opening; an inner member configured to fit within the diaphragm opening; the inner member is configured to obstruct the diaphragm opening when the diaphragm is in a closed configuration and the inner member is disposed within the diaphragm to form an openable barrier between the distal needle interface and the medication chamber; the diaphragm is configured to resiliently deform to an open configuration upon an increase in pressure within the medication chamber, whereby the resilient diaphragm deforms distally away from the stopper member and the inner member moves away from the diaphragm to allow flow from the medication chamber to the distal needle interface.

29. 29. The system of claim 28, The system wherein the inner member is made of metal.

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

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