System and method for safety syringe

Abstract

To provide a system for mixing and injecting drug products.SOLUTION: A system is provided, including: a syringe body 34; proximal and distal stopper members 32, 36 disposed in the syringe body; a plunger member; and a needle hub assembly coupled to a distal needle interface of the syringe body. The proximal and distal stopper members form a proximal drug chamber 40 therebetween and form a distal drug chamber 42 between the distal stopper member and a distal end of the syringe body. The plunger member includes a needle retention feature, an energy-storage member, and an energy-storage member latching member, all disposed in a plunger interior. First and second sizes of the respective proximal and distal drug chambers can be modified by movement of the proximal and distal stopper members relative to the syringe body. The needle is at least partially retractable into the plunger interior upon manipulation of the plunger member relative to the syringe body.SELECTED DRAWING: Figure 6-1

Description

[Technical field]

[0001] The present invention relates generally to injection systems, devices, and processes that facilitate various levels of over-infusion control, and more particularly to systems and methods relating to multi-chambered safety syringes in healthcare environments. [Background technology]

[0002] Millions of syringes, such as that shown in FIG. 1A (2), are consumed daily in medical settings. A typical syringe (2) includes a cylindrical body (4), a plunger (6), and an injection needle (8). As shown in FIG. 1B, such syringes (2) can be utilized to inject fluids into a patient as well as to withdraw or expel fluids from or into a container, such as a vial, bag, or other drug containment system (10). Indeed, due to regulatory constraints and concerns over maintaining sterility in some countries, such as the United States, the use of vials (10) with syringes (2) in certain patient settings, as shown, requires that such vials must be used with a single patient and then disposed of, resulting in significant medical waste from the bottles to dispose of remaining medications, and further contributing to periodic shortages of certain critical medications. Referring to FIG. 2A, three luer-type syringes (12) are depicted. Each has a distally disposed luer fitting geometry (14) that can be coupled with other devices having similar mating geometry, such as the luer manifold assembly (16) shown in FIG. 2B. The luer manifold assembly of FIG. 2B can be used for intravenous administration of medicinal fluids to a patient with or without an intravenous infusion bag. The luer fitting (14) of the syringe in FIG. 2A is referred to as a "male" luer fitting, and that of FIG. 2B (18) is referred to as a "female" luer fitting. One of the luer interfaces is threaded such that the two sides are joined by relative rotation (in which case this configuration can be referred to as a "luer lock" configuration), which can be combined with a compressive load. In other words, in one embodiment of a luer lock, rotation, possibly together with compression, can be utilized to engage threads in the male fitting (14) that are configured to engage a flange of the female fitting (18) to fluid-tightly couple the devices together. In another embodiment, a tapered interface shape can be utilized to engage the luer using compression without threads or rotation (such a configuration is referred to as a "slip-on" or "conical" luer configuration).Although such luer couplings are considered relatively safe for the operator, there is a risk of spillage / leakage of medication and damage to parts during assembly of the luer coupling. On the other hand, the use of needle injection structures carries the risk of a sharp needle contacting or piercing unwanted persons or structures. For this reason, 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 against the syringe body (4) to cover the needle (8) when released from the locked position. Another embodiment of a safety syringe (24) is shown in FIGS. 4A and 4B. In such a configuration, the retractable needle (26) is configured to retract (28, 26) to a safe position within the tubular body (4) as shown in FIG. 4B after full insertion of the plunger (6) into the syringe body (4). Such a configuration configured to collapse on itself may lead to issues with blood splashing / aerosolization, safe storage of preloaded energy that may cause malfunction and premature activation, loss of accuracy in injecting the full dose due to dead space remaining in the spring compression volume, and / or loss of retraction speed control associated with pain and patient anxiety.

[0004] Further complicating the syringe market is the growing demand for prefilled syringe assemblies, as shown in Figures 5A and 5B, which typically include a syringe body, or "drug containment delivery system" (34), a plunger tip, a plug or stopper (36), and a distal seal or cap (35) that can fit over a Luer-type interface. (Figure 5A shows the cap 35 in place; Figure 5B shows the cap removed to reveal the Luer interface 14.) The liquid drug resides within the volume, or drug reservoir, between the distal seal and the distal end (37) of the plunger tip (36). The plunger tip (36) is made of a standard butyl rubber material and is coated with a biocompatible lubricous coating, such as polytetrafluoroethylene ("PTFE"), to facilitate favorable sealing and relative motion characteristics for the associated syringe body structure and material. The proximal end of the syringe body (34) of FIG. 5B includes a conventional integral syringe flange (38) that is integrally formed with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and can be configured to be around the entire or partial circumference of the syringe body (34). Partial flanges are referred to as "clip flanges" and others as "full flanges." The flanges are used to provide support for gripping the syringe with the fingers and depressing the plunger to inject. The syringe body (34) preferably includes a translucent material such as glass or a polymer. A plunger tip (36) can be positioned within the syringe body (34) to form a containment volume within the medication chamber or reservoir (40) and aid in the expulsion of associated fluid through the needle. Syringe body (34) may define a substantially cylindrical shape (i.e., a plunger tip 36 having a circular cross-sectional shape can establish a seal with syringe body (34)) or may be configured to have other cross-sectional shapes, such as elliptical.

[0005] Such assemblies are desirable because they can afford to meet all of the ever-changing global regulations for filling, packaging, and drug / drug interface material selection and component use, and can be standardized and mass-accurately manufactured by a small number of manufacturers worldwide. However, such simple configurations generally would not meet new global standards for single-use, safety, auto-disable, and needlestick protection. Therefore, certain suppliers are moving to more "vertical" solutions, such as those shown in FIG. 5C, which are an attempt to meet all, or at least some, of the criteria in one solution. As a result of attempting to meet these criteria for many different scenarios, such products have significant limitations (including some of those discussed above with reference to FIGS. 3-4B) and relatively high inventory and utilization costs.

[0006] Additionally, there is the additional requirement that many injectable liquids (e.g., medicines) must combine two or more components to create an injectable combination or solution immediately prior to delivery to the patient. Although multiple components can be mixed in separate open containers prior to drawing the injectable combination into a syringe, mixing in an open container and drawing into a syringe is imprecise and leads to loss of components or injectable combinations. Additionally, drawing the injectable combination into a syringe unnecessarily exposes the user to an uncapped needle.

[0007] Moreover, many injectable liquids (eg, medications) have the added requirement of minimizing the time the injectable liquid is exposed to metal (eg, the stainless steel of a needle).

[0008] There is a need for an injection system that addresses the shortcomings of currently available configurations, and in particular, a need exists for a multi-chamber safety injection system that can take advantage of 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

[0009] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments are described that relate to injection systems, and in particular to a multi-chamber safety injection system that moves the needle into a protective structure to minimize accidental user injury and contamination from used needles.

[0010] In one embodiment, a system for mixing and injecting a pharmaceutical agent includes a syringe body defining a proximal opening and a distal needle interface at a distal end thereof. The system also includes proximal and distal stop members disposed within the syringe body forming a proximal drug chamber between the proximal and distal stop members and a distal drug chamber between the distal stop member and the distal end of the syringe body. The system further includes a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stop member into the syringe body. The plunger member includes a needle retention mechanism disposed within the plunger, an energy storage member disposed within the plunger, and an energy storage member latch member disposed within the plunger. The system further includes a needle hub assembly coupled to the distal needle interface of the syringe body. The needle hub assembly includes a needle having a needle proximal end mechanism, a hub, and a needle latch member configured to couple the needle to the hub. The first and second sizes of the proximal and distal drug chambers, respectively, can be modified by movement of the proximal and distal stop members relative to the syringe body. Manipulation of the plunger member relative to the syringe body allows the needle to be at least partially retracted within the plunger to change the energy storage member latch member from a latched state to an unlatched state.

[0011] In another embodiment, a system for mixing and injecting a pharmaceutical agent includes a cartridge body defining a proximal opening and a distal needle interface at a distal end thereof. The system also includes proximal and distal stop members disposed within the cartridge body forming a proximal drug chamber between the proximal and distal stop members and a distal drug chamber between the distal stop member and the distal end of the cartridge body. The system further includes a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stop member relative to the cartridge body. The plunger member includes a needle retention mechanism disposed within the plunger interior, an energy storage member disposed within the plunger interior, and an energy storage member latch member disposed within the plunger interior. The system further includes a needle hub assembly coupled to the distal needle interface of the cartridge body. The needle hub assembly includes a needle having a needle proximal end mechanism, a hub, and a needle latch member configured to couple the needle to the hub. The first and second sizes of the proximal and distal drug chambers, respectively, can be modified by movement of the proximal and distal stop members relative to the cartridge body. The needle is at least partially retractable within the plunger upon manipulation of the plunger member relative to the cartridge body to change the energy storage member latch member from a latched state to an unlatched state.

[0012] In one or more embodiments, the needle is configured to be retracted completely through at least the distal stop member and into the plunger. An energy storage member latch member can be interconnected between an inner surface of the plunger member and the needle retention mechanism. The proximal and distal medicament chambers can contain first and second components of a medicament, respectively, that are to be mixed together prior to injection into a patient.

[0013] In one or more embodiments, the system includes a transport configuration in which the proximal end feature of the needle is disposed within the distal drug chamber, a transfer configuration in which the proximal end feature of the needle at least partially passes through a distal stop member and is disposed at least partially within the proximal drug chamber, and a mixing configuration in which the proximal and distal stop members contact one another, thereby transferring a first drug component from the proximal drug chamber to the distal drug chamber and mixing the first drug component with a second drug component in the distal drug chamber. The needle includes a distal end opening, an intermediate opening that is disposed within the distal drug chamber when the system is in the transport, transfer, and mixing configurations, and a proximal opening that is disposed within the proximal drug chamber when the system is in the transport and transfer configurations.

[0014] In one or more embodiments, the needle comprises a plurality of proximal openings, the proximal opening being one of the plurality of proximal openings. At least some of the proximal openings are disposed within the proximal drug chamber when the system is in the transport and transfer configurations, and at least some of the proximal openings are blocked by a proximal stopper member when the system is in the mixing configuration. The proximal stopper member comprises a plug configured to block at least some of the proximal openings when the system is in the mixing configuration. The length of the plug is greater than the distance between a most proximal of the plurality of proximal openings and a most distal of the plurality of proximal openings.

[0015] In one or more embodiments, the syringe or cartridge body includes a position indicator configured to abut a distal end of the distal stopper when the system is in the mixing configuration. The plunger member may include a retaining clip configured to selectively couple to the syringe or cartridge body when the system is in the mixing configuration to prevent proximal movement of the plunger member relative to the syringe or cartridge body. The retaining clip may be configured to generate an audible signal when the retaining clip is selectively coupled to the syringe or cartridge body.

[0016] In one or more embodiments, the proximal and distal stoppers include first and second polymer coatings, respectively, on their distal and proximal surfaces, and the proximal drug chamber is defined by the syringe or cartridge body and the first and second polymer coatings. The distal stopper may have a proximally tapered funnel and a space disposed at the tapered proximal end of the funnel.

[0017] In one or more embodiments, the hub comprises a collet and a sleeve. The collet can be configured to removably couple the needle hub assembly to the distal needle interface of the cartridge body when the sleeve is disposed about the collet. The hub can include a sealing member configured to surround an outer surface of the needle and form a fluid-tight seal thereabout.

[0018] In one or more embodiments, the system further includes a transfer pipe disposed within the distal drug chamber. When the needle hub assembly is removably coupled to the distal needle interface of the cartridge body, the needle and the transfer pipe are removably coupled. The transfer pipe has a reduced diameter portion at its distal end and can be configured to secure the needle thereto.

[0019] In yet another embodiment, a system for injection includes a syringe body defining a proximal opening and a distal needle interface at a distal end thereof. The system also includes proximal and distal stop members disposed within the syringe body forming a medicament chamber therebetween. The system further includes a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stop member relative to the syringe body. The plunger member includes a needle retention mechanism disposed within the plunger, an energy storage member disposed within the plunger, and an energy storage member latch member disposed within the plunger. The system further includes a needle hub assembly coupled to the distal needle interface of the syringe body. The needle hub assembly includes a needle having a needle proximal end mechanism, a hub, and a needle latch member configured to couple the needle to the hub. The needle proximal end mechanism is configured to cause the distal stop member to penetrate into the medicament chamber when the system is in the injection configuration. Upon manipulation of the plunger member relative to the syringe body, the needle can be at least partially retracted within the plunger, causing the energy storage member latch member to change from a latched state to an unlatched state.

[0020] In one or more embodiments, the drug chamber contains a drug that is sensitive to degradation during storage due to contact with the metallic material of the needle. The proximal and distal stoppers include first and second polymer coatings on their respective distal and proximal surfaces, and the drug chamber is defined by the syringe body and the first and second polymer coatings.

[0021] In one or more embodiments, the system includes a delivery configuration in which the needle proximal feature is not disposed inside the drug chamber, and the needle proximal feature may extend through the distal stopper and is disposed within the drug chamber, thereby providing a drug exit pathway for injecting a drug into a patient when the system is in the injection configuration.

[0022] In one or more embodiments, the needle includes a distal opening, an intermediate opening that is disposed within the drug chamber when the system is in the delivery and injection configuration, and a proximal opening that is disposed within the drug chamber when the system is in the injection configuration.

[0023] In yet another embodiment, a method of mixing and injecting medicaments into a patient includes providing a system including a syringe body defining a proximal opening and a distal needle interface at a distal end thereof. The system also includes proximal and distal stop members disposed on the syringe body forming a proximal medicament chamber between the proximal and distal stop members and a distal medicament chamber between the distal stop member and the distal end of the syringe body. The system further includes a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stop member relative to the syringe body. The system further includes a needle member including a distal needle tip, a medicament passageway, a plurality of transfer openings, and a proximal end. The method also includes the step of advancing the plunger member to insert the proximal end of the needle member into the distal stopper to drive the first drug component from the proximal drug chamber through the drug passage and into the distal drug chamber, and mixing the first drug component and the second drug component in the distal drug chamber to form a mixed drug.

[0024] In another embodiment, a method of mixing and injecting medicaments into a patient includes providing a system including a cartridge body defining a proximal opening and a distal needle interface at a distal end thereof. The system also includes proximal and distal stop members disposed within the cartridge body forming a proximal medicament chamber between the proximal and distal stop members and a distal medicament chamber between the distal stop member and the distal end of the cartridge body. The system further includes a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stop member relative to the cartridge body. The system further includes a needle member having a distal needle tip, a medicament passageway, a plurality of transfer openings, and a proximal end. The method also includes advancing the plunger member to pierce the proximal end of the needle member into the distal stopper to pass a first medicament component from the proximal medicament chamber through the medicament passageway and mix the first medicament component and a second medicament component in the distal medicament chamber to form a mixed medicament.

[0025] In one or more embodiments, the method further includes advancing the plunger member to inject the mixed medicament into the patient. The method may include automatically retracting the distal needle tip into the syringe body once the mixed medicament has been injected into the patient.

[0026] In yet another embodiment, a method of injecting a medication into a patient includes providing a system including a syringe body defining a proximal opening and a distal needle interface at a distal end thereof. The system also includes proximal and distal stop members disposed within the syringe body, forming a medication chamber between the proximal stop member and the distal stop member, and forming a distal medication chamber between the distal stop member and the distal end of the syringe body. The system further includes a plunger member defining a plunger interior and adapted to be manually manipulated to insert the proximal stop member relative to the syringe body. The system further includes a needle member having a distal needle tip, a medication passageway, a plurality of transfer openings, and a proximal end. The method also includes advancing the plunger member to pierce the proximal end of the needle member into the distal stopper to pass medication from the proximal medication chamber through the medication passageway and into the distal medication chamber.

[0027] In one or more embodiments, the method also includes advancing the plunger member to inject the medication into the patient. The method further includes automatically retracting the distal needle tip into the syringe body once the mixed medication has been injected into the patient.

[0028] In yet another embodiment, a system for mixing and injecting a pharmaceutical agent includes a syringe body defining a proximal opening and a distal needle interface at a distal end thereof. The system also includes proximal and distal stop members disposed within the syringe body forming a proximal drug chamber between the proximal and distal stop members, the distal stop member and the distal end of the syringe body. The system further includes a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stop member relative to the syringe body. The plunger member includes a needle retention mechanism disposed within the plunger, an energy storage member disposed within the plunger, and an energy storage member latch member disposed within the plunger. The system further includes a needle hub assembly coupled to the distal needle interface of the syringe body. The needle assembly includes a needle having a needle proximal end mechanism, a hub, and a needle latch member configured to couple the needle to the hub. The first and second sizes of the proximal and distal drug chambers, respectively, are modifiable by movement of the proximal and distal stop members relative to the syringe body. Manipulation of the plunger member relative to the syringe body allows the needle to be at least partially retracted within the plunger, changing the energy storage member latch member from a latched state to an unlatched state. The distal drug chamber comprises a partial vacuum.

[0029] In one or more embodiments, the distal stop member comprises a proximal gate having a closed configuration in which the needle proximal end mechanism cannot pass through the proximal gate and an open configuration in which the needle proximal end mechanism can pass through the proximal gate. The proximal gate comprises a pair of movable arms operably connected to a pair of spring elements that bias the proximal gate in the closed configuration. The needle proximal end mechanism may comprise a proximal shoulder that cannot pass through the proximal gate in the closed configuration but can pass through the proximal gate in the open configuration. The needle comprises a distal shoulder that cannot pass through the proximal gate in the closed configuration but can pass through the proximal gate in the open configuration, the distal shoulder being distal to the proximal shoulder. The proximal gate may comprise a pair of movable arms operably connected to a pair of self-biasing hinges.

[0030] In another embodiment, a method of mixing and injecting a medication into a patient includes providing a system including a syringe body defining a proximal opening and a distal needle interface at a distal end thereof. The system also includes proximal and distal stop members disposed on the syringe body forming a proximal medication chamber between the proximal and distal stop members and a distal medication chamber between the distal stop member and the distal end of the syringe body. The system further includes a plunger member defining a plunger interior and configured for manual manipulation to insert the proximal stop member relative to the syringe body. The system further includes a needle member having a distal needle tip, a medication passageway, a plurality of transfer openings, and a proximal end. The distal medication chamber contains a partial vacuum. The method also includes advancing the plunger member through the distal stop member and proximally penetrating the needle member such that a partial vacuum in the distal drug chamber draws a first drug component from the proximal drug chamber through the drug passageway and into the distal drug chamber to mix the first drug component and the second drug component in the distal drug chamber to form a mixed drug.

[0031] In one or more embodiments, the method also includes moving the distal stop member distally to collapse space in the distal medicament chamber and allow the system to perform an injection without purging the system. The method may also include advancing the plunger member to inject the medicament into the patient. The method may further include automatically retracting the distal needle tip into the syringe body once the medicament has been injected into the patient.

[0032] The above and other embodiments of the invention are described in the detailed description that follows. [Brief description of the drawings]

[0033] The above and other aspects of the embodiments will now be described in more detail with reference to the accompanying drawings, in which like elements are designated with common reference numerals and in which: [Figure 1] 1A and 1B show an embodiment of a conventional syringe configuration. [Diagram 2] 2A and 2B show an embodiment of a conventional syringe configuration. [Diagram 3] FIG. 3 shows an embodiment of a conventional syringe configuration. [Figure 4] 4A and 4B show an embodiment of a conventional syringe configuration. [Diagram 5] Figure 5A shows an embodiment of a conventional syringe configuration, Figure 5B shows an embodiment of a conventional syringe configuration, and Figure 5C shows an embodiment of a conventional syringe configuration. [Figure 6]FIG. 6A illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6B illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6C illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6D illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6E illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6F illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6G illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6H illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6I illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6J illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6K illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6L illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 6M illustrates an embodiment of a syringe-based dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use, according to various embodiments.FIG 6N shows an embodiment of a syringe-based dual chamber safety injection system in which the distal needle end / tip can be retracted to a protective configuration after use, according to various embodiments. FIG 6O shows an embodiment of a syringe-based dual chamber safety injection system in which the distal needle end / tip can be retracted to a protective configuration after use, according to various embodiments. FIG 6P shows an embodiment of a syringe-based dual chamber safety injection system in which the distal needle end / tip can be retracted to a protective configuration after use, according to various embodiments. [Figure 7]FIG. 7A illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7B illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7C illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7D illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7E illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7F illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7G illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7H illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7I illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7J illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7K illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7L illustrates an embodiment of a syringe-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted to a protective configuration after use, according to various embodiments. FIG. 7M illustrates an embodiment of a syringe-based dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use, according to various embodiments.FIGURE 7N shows an embodiment of a syringe-based dual-chamber safety injection system in which the distal needle end / tip can be retracted to a protective configuration after use, according to various embodiments. FIGURE 7O shows an embodiment of a syringe-based dual-chamber safety injection system in which the distal needle end / tip can be retracted to a protective configuration after use, according to various embodiments. FIGURE 7P shows an embodiment of a syringe-based dual-chamber safety injection system in which the distal needle end / tip can be retracted to a protective configuration after use, according to various embodiments. [Figure 8] Figure 8A shows two embodiments of a harpoon connection interface that can be used with a dual chamber safety injection system according to various embodiments. Figure 8B shows two embodiments of a harpoon connection interface that can be used with a dual chamber safety injection system according to various embodiments. [Figure 9] 9A and 9B show various aspects of a mixed configuration latch according to one embodiment that can be used with a dual chamber safety injection system according to various embodiments. [Figure 10] 10A and 10B show various aspects of a mixed configuration indicator according to one embodiment that can be used with a dual chamber safety injection system according to various embodiments. [Figure 11]FIG. 11A shows in detail various aspects of the dual-chamber safety injection system shown in FIG. 6A-10B to demonstrate various aspects of the system. FIG. 11B shows in detail various aspects of the dual-chamber safety injection system shown in FIG. 6A-10B to demonstrate various aspects of the system. FIG. 11C shows in detail various aspects of the dual-chamber safety injection system shown in FIG. 6A-10B to demonstrate various aspects of the system. FIG. 11D shows in detail various aspects of the dual-chamber safety injection system shown in FIG. 6A-10B to demonstrate various aspects of the system. FIG. 11E shows in detail various aspects of the dual-chamber safety injection system shown in FIG. 6A-10B to demonstrate various aspects of the system. [Figure 12] FIG. 12A shows various aspects of a distal stop bushing according to an embodiment that can be used with a dual-chamber safety injection system according to various embodiments. FIG. 12B shows various aspects of a distal stop bushing according to an embodiment that can be used with a dual-chamber safety injection system according to various embodiments. FIG. 12C shows various aspects of a distal stop bushing according to an embodiment that can be used with a dual-chamber safety injection system according to various embodiments. FIG. 12D shows various aspects of a distal stop bushing according to an embodiment that can be used with a dual-chamber safety injection system according to various embodiments. FIG. 12E shows various aspects of a guide disk according to an embodiment that can be used with a dual-chamber safety injection system according to various embodiments. FIG. 12F shows various aspects of a guide disk according to an embodiment that can be used with a dual-chamber safety injection system according to various embodiments. [Figure 13] 13A, 13B, and 13C show various aspects of a proximal stopper screw according to one embodiment that can be used with a dual chamber safety injection system according to various embodiments. [Figure 14]FIG. 14A illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 14B illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 14C illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 14D illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 14E illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 15A illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 15B illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 15C illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 15D illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 15E illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 15F illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. [Figure 16]FIG. 16A illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 16B illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 16C illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 16D illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 16E illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. FIG. 16F illustrates various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use, according to various embodiments. 16G and 16H show various aspects of a cartridge-based dual-chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use, according to various embodiments. [Figure 17]FIG. 17A illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 17B illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 17C illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 17D illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 17E illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 17F illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 17G illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 17H illustrates various aspects of a dual-chamber safety injection system configured with a user-attachable needle utilizing a Luer coupling, according to various embodiments. FIG. 17I illustrates various aspects of a dual-chamber safety injection system configured with a user-attachable needle utilizing a Luer coupling, according to various embodiments. FIG. 17J illustrates various aspects of a dual-chamber safety injection system configured with a user-attachable needle utilizing a Luer coupling, according to various embodiments. FIG. 17K illustrates various aspects of a dual-chamber safety injection system configured with a user-attachable needle utilizing a Luer coupling, according to various embodiments. [Figure 18]FIG. 18A illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 18B illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 18C illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 18D illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 18E illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 18F illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. FIG. 18G illustrates various aspects of a dual-chamber safety injection system configured to have a user-attachable needle using a Luer-style coupling, according to various embodiments. [Figure 19] FIG. 19A illustrates a dual chamber drug mixing and delivery system that delivers drugs to a patient via an IV port or other delivery method that does not involve injection into the patient. FIG. 19B illustrates a dual chamber drug mixing and delivery system that delivers drugs to a patient via an IV port or other delivery method that does not involve injection into the patient. FIG. 19C illustrates a dual chamber drug mixing and delivery system that delivers drugs to a patient via an IV port or other delivery method that does not involve injection into the patient. FIG. 19D illustrates a dual chamber drug mixing and delivery system that delivers drugs to a patient via an IV port or other delivery method that does not involve injection into the patient. [Figure 20]FIG 20A illustrates a safety injection system for storing and delivering medications that are sensitive to contact with stainless steel, according to one embodiment; FIG 20B illustrates a safety injection system for storing and delivering medications that are sensitive to contact with stainless steel, according to one embodiment; FIG 20C illustrates a safety injection system for storing and delivering medications that are sensitive to contact with stainless steel, according to one embodiment; FIG 20D illustrates a safety injection system for storing and delivering medications that are sensitive to contact with stainless steel, according to one embodiment. [Figure 21] Figure 21A shows a needle latch mechanism with adjustable force to disengage the needle. Figure 21B shows a needle latch mechanism with adjustable force to disengage the needle. Figure 21C shows a needle latch mechanism with adjustable force to disengage the needle. Figure 21D shows a needle latch mechanism with adjustable force to disengage the needle. [Figure 22] FIG. 22A shows one embodiment of the internal mechanism of a safety injection system for storing and delivering medications that are sensitive to contact with stainless steel. FIG. 22B shows one embodiment of the internal mechanism of a safety injection system for storing and delivering medications that are sensitive to contact with stainless steel. FIG. 22C shows one embodiment of the internal mechanism of a safety injection system for storing and delivering medications that are sensitive to contact with stainless steel. FIG. 22D shows one embodiment of the internal mechanism of a safety injection system for storing and delivering medications that are sensitive to contact with stainless steel. [Figure 23] FIG. 23 illustrates aspects of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Figure 24] FIG. 24 illustrates aspects of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Diagram 25] 25 illustrates aspects of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use according to various embodiments, the system including an exemplary distal stop bushing. [Figure 26] 26 illustrates aspects of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use according to various embodiments, the system including an exemplary distal stop bushing. [Figure 27] FIG. 27 illustrates an embodiment of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Figure 28] FIG. 28 illustrates an embodiment of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Figure 29] FIG. 29 illustrates an embodiment of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Diagram 30] FIG. 30 illustrates aspects of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Diagram 31] FIG. 31 illustrates an embodiment of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Diagram 32] FIG. 32 illustrates an embodiment of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Diagram 33] FIG. 33 illustrates an embodiment of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be retracted into a protective configuration after use according to various embodiments. [Diagram 34] 34 illustrates aspects of a vacuum assisted dual chamber safety injection system that allows the distal needle end / tip to be withdrawn into a protective configuration after use according to various embodiments. The system includes an exemplary distal stop bushing.

[0034] In order to better understand how the above and other advantages and objects of the various embodiments are achieved, the embodiments will be described in more detail with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements of similar structure or function are represented by the same reference numerals throughout. It is understood that these drawings are only intended to illustrate certain exemplary embodiments, and should not be considered as limiting the scope of the embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] Exemplary Dual Chamber Safety Syringe System 6A and 6B, there are shown perspective and longitudinal cross-sectional views of a dual chamber safety injection system comprising a conventional commercially available pre-filled syringe body (34) with conventional proximal and distal stoppers (32, 36) therein. The proximal and distal stopper members (32, 36) together with the syringe body (34) define proximal and distal drug chambers (40, 42). The proximal and distal stopper members (36, 37) occlude the proximal and distal ends of the proximal drug chamber (40). The distal stopper member (36) occludes the proximal end of the distal drug chamber (42). A needle coupling assembly (606) is disposed at the distal end of the distal drug chamber (42) with a needle cover member (63) installed for storage. The dual chamber safety injection system controls the transfer of a first drug component from a proximal drug chamber (40) to a distal drug chamber (42) and the expulsion of a mixed / combined drug from the distal drug chamber (42) upon sequential insertion of the plunger assembly into the syringe body (34) by a user to various degrees. The plunger assembly includes a proximal stopper member (32), a plunger housing member (69), and a plunger operation interface (128). The first drug component disposed 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 that mixes with the second drug component in the distal drug chamber (42). The second drug component in the distal drug chamber (42) may be a dry form of drug, such as a powder, microspheres, emulsion, lyophilized drug or freeze-dried drug, or a caked drug, such as a solid drug. The second drug component in the distal drug chamber (42) may be a liquid that mixes with the first drug component from the proximal drug chamber (40).

[0036] The dual chamber safety injection system has a staked needle configuration and when presented to a user, the needle assembly, including the needle coupling assembly (606), the needle distal / tip portion (48), the needle coupling member (83, see e.g., FIG. 6E), and the needle proximal end (50), is seated in a position ready for injection after removal of the needle cover member (63). The cover member includes an elastomeric sealing material on its inner surface and interfaces with the needle distal end (48) or the distal housing portion (610) during storage. Alternatively, the needle cover member (63) may include a vent (not shown) to allow pressure resulting from the movement and mixing of the drug components to escape from the inside of the syringe body (34) while preventing contamination from entering the syringe body (34). Although the staked needle is depicted as being fixed in place, the staked needle may be removably coupled to the syringe body (34) using a luer interface, with the proximal end (50) of the needle member extending through the luer interface into the distal drug chamber (42). In the embodiment shown in Figures 6A-22D, the majority of the safety needle retraction hardware is within the plunger housing.

[0037] 6C and 6D, upon initial assembly (i.e., in a factory or processing facility - not on-site as in the "staked needle" configuration), the proximal housing assembly (608) is configured to snap-fit ​​(i.e., using a snap ring element 604 that includes or is coupled to the proximal housing assembly) onto a slightly recessed radial portion (602) of the syringe body that is formed within the syringe body during manufacture of the syringe body.

[0038] 6E and 6F, the needle spine assembly (76) comprises an injection member having a distal needle end (48) and a needle proximal end (50) coupled to a needle connecting member (83). The needle coupling member (83) is configured to have a narrowed or radially reduced portion (111) configured to interface with the latch member (612) and the movable block member (614) such that during injection, the needle distal end (48), the needle coupling member (83), and the needle proximal end (50) remain fixed in position relative to the syringe body (34), but after full insertion of the plunger assembly against the small diameter flange (80) (33—see, e.g., FIG. 7N) (i.e., before or after complete expulsion of the medicament contained within the distal medicament chamber 42 of the syringe body 34), the movable block member (614) advances relative to the distal housing portion (610) such that a number of cantilevered latch members (616) (two are shown) are pressed out of the way by the movable housing. In particular, the needle spine assembly (76) is forced distally by the full advancement of the plunger assembly, which advances the movable block member (614) and moves the cantilevered latch member (616). Movement of the cantilevered latch member (616) allows the needle distal end (48), connecting member (83), and proximal end (50) to be retracted through their connections, thereby safely positioning the needle distal end (48) within the plunger housing member (69). Alternatively, the needle distal end (48) can be retracted to a position below the exterior surface of the distal housing portion (610) to safely protect the sharp tip from the user. In other words, the cantilevered latch member (616) maintains the position of the needle / syringe assembly and the needle distal end (48) during the injection until it is pushed out of the way by the movable block member (614) upon full plunger insertion. After the plunger is fully inserted, the needle is freed for automatic withdrawal when triggered by further distal movement of the needle spine assembly (76), as described in U.S. Patent Application Nos. 09 / 099,952, 14 / 696,342 and 62 / 416,102.These US patent applications are incorporated herein by reference.

[0039] In one embodiment, the plunger assembly includes a coupling member that forms a gap in the plunger assembly, allowing the plunger operating interface to continue to move distally after the distal stop member reaches the distal end of the syringe body and expels substantially all of the mixed medicament from the syringe body. In this embodiment, the plunger operating interface is pushed distally a small distance after full injection to collapse the coupling member and the gap, release the cantilevered latch member, couple the needle spine assembly to the energy storage member, and release the energy storage member to retract the coupled needle spine assembly at least into the syringe body. This embodiment is described in further detail in U.S. Patent Application Serial No. 62 / 416,102, which is incorporated herein by reference.

[0040] FIG 6E shows an embodiment of a needle spine assembly (76) that includes the elements of the needle assembly without the needle coupling assembly (606). The distal portion (48) of the needle spine assembly (76) includes a sharpened hypodermic needle tip formed on the injection member (78). As shown in FIGS. 6G and 6H, the proximal end (50) of the needle also includes a sharpened tip (86) formed on the coupling member that forms the distal portion. A generally hollow coupling member (83) couples the coupling member to the tubular injection member (78). The injection member (78), the sharpened tip (86) on the proximal end (50) of the needle, and the hollow coupling member (83) are held together by an interference fit, welding, and / or adhesive. The proximal-most end (84) of the needle proximal end (50) in the illustrated embodiment includes a "harpoon" geometry that is configured to be pierced and held by a mating dependent member to retract the needle spine assembly (76) into the plunger housing member (69), as described in more detail below. The needle proximal end (50) may be fabricated from a sheet metal component using, for example, laser cutting, etching, stamping, and / or machining techniques. Other aspects of the needle spine assembly (76), such as the flow paths and flow occlusions therethrough, are shown at least in Figures 6M-6O and described below.

[0041] Figure 6P is a detailed cross-sectional view of needle coupling assembly (606) snapped onto syringe body (34). Figures 6I-6L are partial perspective wireframe views providing a more direct visualization of latch member (612) and cantilever latch member (616) relative to needle portions (48, 83, 50, 111). The function of latch member (612) and cantilever latch member (616) in the needle retracted state is described in U.S. patent application Ser. Nos. 14 / 696,342 and 62 / 416,102, which are incorporated herein by reference.

[0042] FIG. 6P illustrates a distal seal (620) configured to seal between a distal drug chamber (42) in a drug container (e.g., syringe body (34)) and an exterior surface of a needle spine assembly (76). Preferably, the distal seal (620) is configured to seal around the outside of the needle coupling member (83). The seal is further configured to seal between the distal drug chamber (42) and an interior surface of the needle coupling assembly (606). FIG. 6P also illustrates a snap fit (630) between the distal end of the drug chamber (e.g., syringe body (34)) and the proximal end of the needle coupling assembly (606).

[0043] Returning to Figures 6A and 6B, for example, the dual chamber safety injection system includes a conventional syringe body (34) fitted with proximal and distal plunger tips (32, 36) configured for piercing with a proximal needle end (50) at the appropriate time to aid in the transfer of medication and needle retraction. The proximal plunger tip (32) is coupled to a plunger operating interface (128) by a plunger housing member (69) that defines an interior volume occupied by various other portions of the assembly, as described below, which are configured to retract the needle at the appropriate time in the use sequence. The needle coupling assembly (606) described above is included in the illustrated embodiment, although other embodiments may include a luer type needle assembly coupled to the syringe body (34). The illustrated version of the syringe body (34) includes a reduced diameter flange (33) coupled to a conventional integral syringe flange (38) having a geometry that allows it to be manipulated or engaged between an operator's index and middle fingers, for example, while the operator's thumb engages the plunger manipulation interface (128). Figures 6A and 6B show the assembly prior to use with the needle cover (63) in place to mechanically isolate the distal needle end (48). The needle cover (63) is removed and the assembly is ready for injection into a patient.

[0044] As shown in Figure 6M, the proximal and distal stopper members (32, 36) together with the syringe body (34) define a proximal drug chamber (40) with the dual chamber safety injection system in a delivery configuration. In particular, the distal end of the proximal stopper member (32) and the proximal end of the distal stopper member (36) are each coated with a lubricious polymer coating (e.g., PTFE), such that the first and second polymer coatings of the proximal and distal stopper members (32, 36) together with the syringe body (34) define the proximal drug chamber (40). The lubricious polymer coating also acts to insulate the rubber of the proximal and distal stopper members (32, 36) from the drug and drug components. The proximal and distal stopper members (32, 36) may be oriented as shown in Figure 6M, or the distal stopper may be inverted so that the lubricious coating faces the distal drug chamber (42) and the second drug component in the distal drug chamber (42) contacts the lubricious coating for storage. When the stopper is inverted, the needle guide assembly may be held in place by a centering guide disk, shown in Figure 12F and described below. In an alternative embodiment, the proximal and distal stopper members (32, 36) are rubber without a lubricious polymer coating.

[0045] Because the proximal stop member (32) is coupled to the plunger housing member (69) and the plunger actuation interface (128), a distal force applied to the plunger actuation interface (128) will move the proximal stop member (32) distally relative to the syringe body (34). Because the proximal drug chamber (40) is pre-filled with a substantially incompressible liquid and there is no path for the incompressible liquid to escape from the proximal drug chamber (40) in the transport configuration shown in FIG. 6M, distal movement of the proximal stop member (32) results in distal movement of the distal stop member (36).

[0046] As shown in FIG. 6N, after the distal stopper member (36) is moved distally relative to the syringe body (34) to place the dual chamber safety injection system in the transfer configuration, the needle proximal end (50) pierces the distal stopper member (36) and partially enters the proximal drug chamber (40). In fact, in the transfer configuration shown in FIG. 6N, the transfer pipe (46) portion of the proximal end (50) of the needle forms a fluid path between the proximal and distal drug chambers (40, 42). The transfer pipe (46) comprises a plurality of proximal openings (270) and a middle opening (266). The transfer pipe (46) is hollow and forms a flow path between the proximal-most opening (270) located in the proximal drug chamber (40) and the middle opening (266) located in the distal drug chamber (42). 6M-6O includes four proximal and intermediate openings (270) and (266), other embodiments may include more or fewer proximal and intermediate openings. Increasing the number of proximal and intermediate openings allows for greater positioning tolerance of the transfer pipe (46) / needle proximal end (50) relative to the distal stop member (42) while still maintaining an open flow path between the proximal and distal drug chambers (40, 42).

[0047] After the dual chamber safety injection system is in the transfer configuration as shown in FIG. 6N, more force is applied to the plunger operating interface (128) so that the proximal stopper member (32) can move proximally relative to the distal stopper member (36) because the liquid in the proximal drug chamber (40) can move to the distal drug chamber (42) via the transfer pipe (46). When the liquid is transferred to the distal drug chamber (42), it mixes with the contents of the distal drug chamber (42). In the embodiment shown in FIGS. 6A and 6B, the liquid in the proximal drug chamber (40) in the transfer configuration (FIGS. 6A, 6B, and 6M) is initially the first liquid component of the drug. The contents of the distal drug chamber (42) are the second component of the drug. The transfer of liquid from the proximal drug chamber (40) to the distal drug chamber (42) mixes the first and second components to produce the drug for injection.

[0048] As shown in FIG. 6O, continued force applied to the plunger operating interface (128) from the transfer configuration completes the transfer of liquid from the proximal drug chamber (40) to the distal drug chamber (42), placing the dual chamber safety injection system in the mixing configuration. In the mixing configuration, the first and second components are mixed and the drug is ready to be injected into the patient. The mixed drug is disposed in the distal drug chamber (42). Distal movement of the proximal stopper member (32) relative to the distal stopper member (36) brings the proximal and distal stopper members (32, 36) into contact and reduces the volume of the proximal drug chamber (40) to substantially zero. Thus, continued force applied to the plunger operating interface (128) moves the proximal and distal stopper members (32, 36) together, expelling the mixed drug through the distal opening / outlet port at the distal end of the transfer pipe (46), out of the distal drug chamber (42) through the needle, and into the patient. The transfer pipe 46 also includes a lumen plug 268 disposed between the proximal and distal ends of the lumen which prevents the mixed drug from being forced retrogradely through the flow channel during injection of the mixed drug into the patient.

[0049] 7A-7L, various embodiments of configurations designed to facilitate injection of a multi-dose drug and retraction of the needle into the syringe body are shown, where two or more drug components are combined to form an injectable or solution prior to delivery to the patient. In one variation, a liquid first pharmaceutical component / diluent (252) can be combined with a substantially non-liquid second pharmaceutical component (254), such as a drug in powder form, such as a lyophilized or freeze-dried drug, immediately prior to injection. The configurations described herein with reference to FIGS. 7A-7L are dual-chambered, utilizing two or more chambers within the same syringe body (34) to carry, mix, and inject the injectable solutions.

[0050] 7A and 7B, the proximal and distal medicament 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 medicament chamber (42) containing an air or gas gap as well as a non-liquid medicament (254). The proximal medicament chamber (40), opposite the distal stopper member (36), contains a liquid diluent (252) that is proximally contained by the proximal stopper member (32). The liquid diluent (252) is a first component of the medicament and the non-liquid medicament (254) is a second component of the medicament.

[0051] Referring to FIG. 7C and the associated cross-sectional view of FIG. 7D, various components of the needle coupling assembly are shown (here, a so-called "stake-type" needle coupling assembly (606) is shown, although other needle assembly luers described below may be used, including those with a luer-type coupling as well as a steak-type configuration). The lug feature (258) is configured to aid in coupling of the needle coupling assembly (606) to the needle cover member (63), as shown, for example, in FIG. 7A. A small O-ring may be utilized as a seal member (260) around the needle shaft, and a larger O-ring may be utilized as a seal member (262) at the syringe body (34) / needle coupling assembly (606) interface. Alternatively, the small O-ring (260) and the large O-ring (262) may be combined into a single seal that performs both O-ring seal functions. The small O-ring (260) may also be used to seal both around the needle shaft and to the syringe body (34).

[0052] The needle includes a plurality (e.g., four) proximal openings / ports (270) configured to receive and release a liquid diluent from a more distally located central opening / aperture (266); a lumen plug (268) occludes the needle lumen to provide a flow path from the proximal openings (270) to the central opening (266) under conditions as described above with reference to Figures 6N and 7H. The needle also includes a distal opening (264) on the opposite side of the lumen plug (268) from the central opening (266). The distal opening (264) is fluidly connected through the needle to the needle distal end (48) for injecting a liquid into a patient.

[0053] Referring to Figure 7E, the proximal harpoon interface (84) is configured to sequentially pierce the proximal and distal stop members (32, 36) and couple a coupling mechanism (such as the needle retaining mechanism, element 712, described in Figures 7N and 7P) within the plunger rod. Figure 7F shows a spike-style harpoon coupling interface (85) configured to sequentially pierce both the proximal and distal stop members (32, 36) and couple with a coupling mechanism within the plunger rod to retract the needle member at least partially into the plunger rod after an injection has been administered to the patient.

[0054] Figures 7A, 7B, and 7G-7P show the sequence of actions for an injection procedure using the dual chamber safety injection system as described above. With reference to Figures 7A and 7B, the injection assembly is in a stable configuration and can be shipped or brought to a patient treatment scenario for injection. A first drug component / liquid diluent (252) is isolated from a second non-liquid drug component (254), both within the syringe body on either side of the distal stopper member (36).

[0055] 7G and 7H show the initial insertion movement of the plunger assembly (44) which advances the distal stopper member (36) and the proximal stopper member (32) together relative to the syringe body (34). Referring to FIG. 7H, the distal stopper member (36) is advanced sufficiently across to pierce the proximal end (50) of the needle assembly, forming a fluid pathway between the two pre-isolated chambers (40, 42) of the syringe body (34). As a result, the liquid first drug component (252) in the proximal drug chamber (40) flows through the transfer pipe (46) into at least one of the proximal openings (270) and out the more distal intermediate opening (266) to reach the non-liquid second drug component (254) in the distal drug chamber (42).

[0056] Figures 7I and 7J show that the stopper members (36, 32) are further inserted until they are directly adjacent to one another, causing 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 non-liquid second drug component (254) mix to form a mixed dosing solution (272).

[0057] In some embodiments, especially with a lyophilized non-liquid second drug component, the mixed dosing solution (272) can be formed with minimal or no agitation or over time. In other embodiments, especially with drugs held in suspension or emulsified drugs, vigorous shaking may be required to facilitate mixing. When vigorous shaking is required, it is convenient for the user to be able to remove their thumb from the plunger operating interface (128). During the transfer of the liquid first drug component (252) from the proximal drug chamber (40, 42) to the distal drug chamber (40, 42), pressure may build up in the distal drug chamber (42). This pressure acts on the proximal and distal stopper members (32, 36) to resist stopper movement. The increased pressure also moves the stopper members (32, 36) and, if the user is not holding the plunger assembly (44) with their thumb, the plunger operating interface (128) proximally. A mixing configuration latch or "mixing click" (shown in FIGS. 9A and 9B and described below) on the plunger assembly (44) is utilized to provide resistance to movement of the plunger operating interface (128) due to pressure buildup, allowing the user to release their thumb from the plunger operating interface (128) for shaking or mixing the medication. The mixing click may also provide an audible and / or tactile indication that transfer of the liquid first pharmaceutical component (252) is complete. The distal medication chamber (42) may include an agitator to assist in mixing the medication components.

[0058] With the assembly ready to inject the mixed solution (272), the needle cover member (63) may be removed and the plunger assembly (44) and associated stopper members (36, 32) pushed / inserted to expose the needle distal end (48) for injection into the patient, as shown in Figures 7M and 7N. Referring to Figures 7O and 7P, when the plunger assembly (44) and associated stopper members (32, 36) are fully pushed / inserted, the sharpened needle distal / point (48) automatically retracts at least partially through the distal and proximal ends into the syringe body (34), into the needle coupling assembly (606), or at least partially into a safe position within the plunger assembly (44). Automatic retraction of the needle at least partially within the plunger is described in U.S. Patent Application Serial Nos. 14 / 696,342 and 62 / 416,102.

[0059] Existing lyophilization manufacturing processes lyophilize (freeze-dry) a solution (e.g., liquid drug) inside a syringe chamber that is sealed near the drug with a stopper. The distal tip of the syringe remains open during lyophilization, and the drug is placed into the lyophilization process through the inner diameter ("ID") of the syringe tip. This existing method requires that the needle be placed in place prior to lyophilization due to the adhesive curing process, which typically does not allow the use of traditional glued staked needles. Traditional 25 gauge to 34 gauge staked needles have an ID of approximately 0.010 inches to 0.003 inches. IDs in this range are typically too small to lyophilize the drug in a reasonable amount of time. The staked needle assembly shown in Figures 6A-7P uses a Luer taper tip syringe with a tip ID of approximately 0.040 inches that is lyophilizable. The staked needle of Figures 6A-7P attaches to the syringe with a snap fit after lyophilization has occurred, sealing the drug container and allowing the use of existing lyophilization processes.

[0060] While the embodiment shown in Figures 6A-7P transfers liquid through a transfer pipe (46), in other dual chamber embodiments, liquid can be transferred through a bypass channel / passageway formed in the syringe body. The bypass channel can be formed in or near the wall of the glass syringe using a mandrel during syringe formation. The bypass channel has an opening into the syringe body that can be selectively blocked by proximal and distal stop members to control liquid transfer. Such embodiments are described in further detail in U.S. patent application Ser. No. 14 / 696,342.

[0061] A. Exemplary Harpoon Binding Interface Figures 8A and 8B show two embodiments of a dual chamber safety syringe system having different and various harpoon coupling interfaces (87, 88). The embodiment shown in Figure 8A has an articulating needle coupling interface (87). The embodiment shown in Figure 8B has a tree-like harpoon coupling interface (88). For clarity, the spring has been omitted from Figure 8B. These coupling interfaces (87, 88), their corresponding needle retention mechanisms (712), and their use to selectively retract the needle are described in U.S. Patent Application Serial No. 62 / 416,102, previously described herein. These various harpoon coupling interfaces (87, 88) can be used with those shown in Figures 6A-7P.

[0062] B. Mixed Configuration Latches 9A and 9B show a mixing configuration latch (300) on the plunger assembly (44) that can be used with the embodiment shown in FIGS. 6A-8B. The mixing configuration latch (300) is distally tapered and biased (e.g., by a spring) to extend radially from the plunger assembly (44). The mixing configuration latch (300) is configured such that when the dual chamber safety syringe system is in the mixing configuration (i.e., when the proximal and distal stop members are in contact with each other), the mixing configuration latch (300) moves distally past a detent (302) on the small diameter flange (33) coupled to the syringe body (34), as shown in FIG. 9B. At that point, the mixing configuration latch (300) extends radially from the plunger assembly (44) and prevents proximal movement of the plunger assembly (44) relative to the syringe body (34).

[0063] By preventing proximal movement of the plunger assembly (44), the user can release pressure on the plunger operating interface (128) without the pressure built up in the distal drug chamber driving the plunger assembly (44) proximally as the first liquid drug component is forced from the proximal drug chamber (40) into the distal drug chamber (42).

[0064] The radial expansion of the mixing configuration latch (300) after radial compression by the tapered portion past the detent (302) generates an audible or tactile signal (i.e., a click). This audible or tactile signal indicates to the user that the dual chamber safety syringe system is in the mixing configuration and that the user may release pressure on the plunger operated interface (128). The user may also agitate and / or invert the dual chamber safety syringe system to mix the drug components (252, 254) after hearing or feeling the audible or tactile signal.

[0065] C. Mixed Composition Indicator Figures 10A and 10B show a portion of the dual chamber safety injection system shown in Figures 6A-9B, including the proximal and distal stop members (32, 36) with the system in a transport configuration (Figure 10A) and a mixing configuration (Figure 10B). Comparing Figures 10A and 10B, it can be seen that the proximal drug chamber (40) in the system in the transport configuration collapses when the system is in the mixing configuration. As described above, the liquid first drug component (252) in the proximal drug chamber (40) in the system in the delivery configuration is transported through at least one of the proximal openings (270), the distal drug chamber (42), the delivery pipe (46) and the central opening (266).

[0066] For optimal performance, the pressure applied by the user to the plunger operating interface (128) to move the proximal stop member (32) distally relative to the distal stop member (36) should not exceed the pressure required to transfer liquid at a maximum velocity ("maximum transfer pressure") through the transfer pipe (46). The maximum transfer pressure is determined by various system parameters, including but not limited to the cross-sectional area, length and liquid viscosity of the transfer pipe. When the applied pressure exceeds the maximum transfer pressure, the incompressible liquid remaining in the proximal drug chamber (40) transfers the applied pressure to the distal stop member (36), causing the distal stop member (36) and its associated needle spine assembly (76) to move distally relative to the syringe body.

[0067] By moving the distal stopper member (36) relative to the needle spine assembly (76) prior to reaching the mixed configuration, the transfer of liquid can be stopped early by moving the distal opening member (36) past the central opening (266) before all of the drug in the proximal drug chamber (40) has been transferred to the distal drug chamber (42). The lumen plug (268) prevents the transfer of liquid from the proximal and central openings (270, 266) to the distal opening (264), causing the distal stopper member (36) to close the intermediate opening (266), substantially stopping the transfer of liquid prematurely. If more pressure is applied, the distal stopper member (36) can move further distally to position the intermediate opening (266) in the proximal drug chamber (40) prior to the completion of the liquid transfer, again stopping the transfer of liquid prematurely. Thus, application of greater than the maximum transfer pressure may result in incomplete liquid transfer, which may affect dissolution of the substantially non-liquid second drug component (254) and / or the concentration of the mixed drug solution (272).

[0068] To address the issue of the user applying more than the maximum delivery pressure, the embodiment shown in Figures 10A and 10B includes a mixed configuration indicator (304), which is a visual indicator located on the syringe body (34). The mixed configuration indicator (304) in Figures 10A and 10B is a ring (e.g., painted, etched, etc.) located on the syringe body (34) that indicates the approximate optimal position of the distal edge of the distal stopper member (36) when the system is in the mixed configuration. This visual indication / cue allows the user to visually detect when the distal stopper member (36) has moved too far distally relative to the syringe body (34) before the system reaches its mixed configuration. When the user detects such movement, the user reduces pressure on the plunger operating interface (128) to stop / slow the distal movement of the distal stopper member (36). In some embodiments, an audible or tactile signal from the mixed configuration latch (300) indicates to the user when the system has reached the mixed configuration and that it is safe to push the distal stop member (36) distally past the mixed configuration indicator (304).

[0069] The dual chamber safety injection system with mixing configuration indicator (304) may include instructions instructing the user to "do not pass the front / distal stopper through the mixing line until a click is heard." The mixing configuration indicator (304) allows the user to vary the applied pressure, allowing the system to transfer liquid with minimal movement of the distal stopper member (36). The mixing configuration indicator (304) can eliminate the need for various friction increasing mechanisms previously used to control the movement of the stopper during the liquid transfer stage of the mixing process.

[0070] D. Distal stop bushing and proximal stop screw Figures 11A-11E show in more detail the dual chamber safety injection system shown in Figures 6A-10B to demonstrate various features of the system. As best seen in Figure 11E, the proximal and distal stopper members (32, 36) start out as off-the-shelf stoppers for a conventional injection system, but each of the proximal and distal stopper members (32, 36) are modified with additional components to optimize the performance of the dual chamber safety injection system.

[0071] FIG. 11E shows that the distal stopper member (36) is disposed within the syringe body (34) in the opposite orientation to the typical orientation of the stopper, with the lubricious coating (308) on the distal stopper member (36) facing the proximal drug chamber (40) and the female threads on the inner surface of the distal stopper member (36) facing the distal drug chamber (42). Meanwhile, the proximal stopper member (32) is disposed within the syringe body (34) in the typical orientation, with its lubricious coating (306) facing the proximal drug chamber (40) and its female threads facing the plunger assembly (44). The female threads of the proximal and distal stopper members (32, 36) are configured for attachment. Typically, the female threads are used for attachment of the plunger assembly. However, the dual chamber safety ejection system described herein takes advantage of the female threads to attach additional components to optimize performance. The lubricious coating (306, 308) may be PTFE, which acts as a fluid barrier to protect the proximal and distal stopper members (32, 36) (e.g., made of butyl rubber) from the first drug component (40) in the proximal drug chamber, and vice versa.

[0072] The distal stop bushing (310) is secured to the distal stop member (36) by utilizing an interaction between external threads (312) on the distal stop bushing (310) and distally facing internal threads on the distal stop member (36). The distal stop bushing (310) is shown in isolation in FIGS. 12A-12D. As shown in FIGS. 11E and 12D, the distal stop bushing (310) defines a distally facing alignment funnel (314) when the distal stop bushing (310) is attached to a distal stop member (36) that is attached to the dual chamber safety injection system. The distally facing alignment funnel (314) is configured to guide the proximal end (50) of the needle into position when the dual chamber safety injection system is assembled. 11E and 12D, the distal stop bushing (310) also defines a receiving space (316) configured to receive the proximal end of the needle (50) when the dual-chamber safety injection system is assembled into a shipping configuration. The receiving space (316) is located adjacent to a "penetrating" portion of the rubber distal stop bushing (310) that is configured to be penetrated by the proximal end of the needle (50), exposing at least one proximal opening (270) into the proximal medication chamber (40) for fluid transfer. During assembly, a distally facing alignment funnel (314) guides the proximal end of the needle (50) into the receiving space (316), which secures the proximal end of the needle (50) during shipping and storage of the dual-chamber safety injection system. The alignment funnel (314) also guides the proximal end of the needle (50) during fluid transfer and / or needle retraction to ensure that the proximal end of the needle (50) enters the plunger rod funnel for needle retraction (U.S. Patent Application Serial No. 62 / 416,102, incorporated herein by reference). The distal stopper bushing (310) also defines a bushing flange (318) that seals against the distally facing surface of the distal stopper member (36) to limit contact between the second drug component in the distal drug chamber (42) and the distal stopper member (36) during transport and storage of the dual chamber safety injection system.The bushing flange (318) also prevents leakage of liquid between the distal stop bushing (310) and the distal stop member (36) under pressure. In an alternative embodiment, the distal stop bushing (310) and the distal stop member (36) are integrated into a solid rubber stopper member with a molded "through" section and funnel shape. A lubricous coating may be applied to the proximal and / or circumferential sides of the distal end, distal stop member (36) and / or alignment funnel (314).

[0073] 12E and 12F show another embodiment of a guide disk (320) having similar features as the distal stop bushing (310) described above. The guide disk (320) also defines an alignment funnel (314') that tapers proximally toward the receiving space (316'). The guide disk (320) defines radial spring arms (321) that interface with the inner surface of the syringe body (34) to center the guide disk (320) and unlatch and / or retract the needle while guiding the proximal end (50) of the needle through the distal stop member (36) and into the plunger rod assembly (44) (as described in U.S. Patent Application Serial No. 62 / 416,102, incorporated herein by reference). As shown in FIG. 12E, the guide disc (320) may be used with a distal stop member (36') positioned in a conventional manner (ie, facing distally).

[0074] The proximal stop screw (322) is secured to the proximal stop member (32) by interaction between male threads (324) on the proximal stop screw (322) and proximally facing female threads on the proximal stop member (32). The proximal stop screw (322) is shown alone in Figures 13A-13C. As shown in Figures 11E and 13C, the proximal stop screw (322) defines an alignment funnel (326) and a seal space (328). The seal space (328) has a length greater than or equal to the distance between the proximal-most opening (270) and the middle opening (266) (see Figures 6N and 6O).

[0075] The alignment funnel (326) is configured to guide the needle proximal end (50) into the sealed space (328) after the needle proximal end (50) penetrates both the distal and proximal stop members (36, 32). During the early injection phase, the intermediate opening (266) remains within the distal drug chamber (42) and provides a fluid path through the transfer pipe (46) to the plunger assembly (44). The sealed space (328) of the proximal stop screw (322) is configured to prevent liquid (e.g., mixed drug solution (272)) from passing back through the transfer pipe (46) in the intermediate opening (266) and out of the proximal opening (270). The proximal stop screw (322) includes a proximal bulkhead (330) that maintains a seal, preventing the movement of liquid back through the intermediate opening (266) until the intermediate opening (266) is positioned within and sealed by the proximal stop screw (322). The proximal stopper screw (322) may be made of a hard plastic portion (with external threads (324)) and a rubber or elastomer portion that defines an alignment funnel (326) and a sealed space (328), and includes a proximal septum (330).

[0076] Exemplary Dual Chamber Safety Cartridge System 14A and 14B show a cartridge (134) and a syringe body (34), respectively, that are similarly sized. Both the cartridge (134) and the syringe body (34) may be made of glass. The syringe body (34) is configured for use in an injection system, whereas the cartridge (134) is configured to store a substance (e.g., a medicament). This results in some differences between the cartridge (134) and the syringe body (34). For example, the proximal end of the syringe body (34) includes a conventional integral syringe flange (38), whereas the proximal end of the cartridge (134) does not include an integral flange. Additionally, the distal end of the syringe body (34) includes a luer-type taper configured to allow snap engagement of the needle coupling assembly (606), whereas the distal end of the cartridge (134) includes a flange (102) configured to secure a conventional cartridge seal (not shown). A conventional cartridge seal comprises a resiliently compressible seal member at least partially surrounded by a resiliently deformable closure (e.g., an aluminum ring). As shown in Figures 14A and 14B, the distal opening of the cartridge (134) is significantly larger than the corresponding distal opening of the syringe body (34). This provides more airflow for lyophilization, as discussed above.

[0077] 14C and 14D show a dual chamber safety injection system built around a cartridge (134) instead of a syringe body (34). The use of a cartridge (134) instead of a syringe body (34) results in two changes to the dual chamber safety injection system. First, the small diameter flange (33) is glued or press fit into the cartridge (134) instead of being coupled to the syringe flange.

[0078] A second difference in the dual chamber safety injection system built around the cartridge (134) involves the connection of the needle coupling assembly (606) to the distal end of the cartridge (134), as shown in FIGS. 14C-16H. As shown in FIG. 14E, the needle coupling assembly (606) is coupled to the distal end of the cartridge (134) using a collet (104) and a sleeve (106). The collet (104) can be welded onto the base plate of the needle coupling assembly (606). FIGS. 15A and 15B show the system assembly process with the needle distal portion (50) of the needle coupling assembly (606) inserted into the distal drug chamber (42). As shown in FIGS. 15B and 15D, the collet (104) can be extended to pass partially proximally over the flange (102) at the distal end of the cartridge (134). As shown in Figures 15D and 15E, after the proximal end (108) of the collet (104) passes proximally over the flange (102), the sleeve (106) can be slid proximally over the collet (104) to prevent the collet (104) from opening and disengaging from the flange (102). Securing the sleeve (106) over the collet (104) on the flange (102) secures the needle coupling assembly (606) to the distal end of the cartridge (134).

[0079] Figures 16A-16C also show the attachment of the coupling assembly (606) to the distal end of the cartridge (134). Figures 16A and 16B also show the needle proximal end (50) and the alignment funnel (314) on the distal stopper bushing (310) that guides the needle proximal end (50) into the receiving space (316) during assembly of the dual-chamber safety injection system. Figure 16D shows the attachment of the small diameter flange (33) to the proximal end of the cartridge (134), the insertion of the plunger assembly (44), and the fixing of the proximal stopper member (32) to the cartridge (134). The dual-chamber safety injection system with the cartridge (134) shown in Figure 16D is ready for shipping, storage, preservation, and use (i.e., mixing, injection, and automatic ejection). The following steps are exactly the same as those shown for the dual-chamber safety injection system with a syringe in Figures 7A-7P.

[0080] Figures 16G and 16H detail the interface between the collet (104) and the flange (102) without (Figure 16G) and with (Figure 16H) the sleeve (106G). Figures 16G and 16H show a needle seal (110) disposed within the needle coupling assembly (606) and configured to fluidly seal the annular space between the inner diameter of the opening at the distal end of the cartridge (134) and the outer diameter of the needle spine assembly (76). The needle seal (110) can be made from an elastically deformable material such as rubber. The needle seal (110) also includes a pair of glands (112) that extend within the inner diameter of the needle seal (110). The glands (112) function like two O-rings to seal the needle spine assembly (76).

[0081] The various features of the dual chamber safety injection system built around the cartridge (134) may also be used with auto-injectors or pen-type injectors. The cartridges for these systems may incorporate integral glass or plastic finger flanges similar to those employed in syringe-based systems.

[0082] Exemplary dual chamber safety injection system with luer connector Figures 17A-19D show various dual chamber safety injection systems having a luer connector 114 at the distal end. As shown in Figures 17A-17H, the internally threaded female luer lock connector 114 is attached to a collet 104 and sleeve 106 as shown in Figure 14A and described above to form a needle hub 116 for use with a cartridge 134. The collet 104 and sleeve 106 can be used to attach the needle hub 116 to the distal end of the cartridge 134 shown in Figures 14A-16H as described above for attaching the needle coupling assembly 606 to the cartridge 134. The distal end of the female luer lock connector 114 is temporarily sealed with a removable luer cap 118. Once the needle hub (116) is attached to the cartridge (134), the luer cap (118) can be removed and a luer needle (120) can be attached to the needle hub (116) and the female luer lock connector (114) as shown in FIG. 17E, to the dual chamber safety injection system.

[0083] After the luer needle (120) is attached to the needle hub (116) and the dual chamber safety injection system, the system is ready for shipping, storage, and use (i.e., mixing, injection, and automatic retraction) by performing the exact same steps as shown for the dual chamber safety injection system with a syringe in Figures 7A-7P. Similar mixing, injection, and retraction steps as shown in Figures 7A-7P are shown for the dual chamber safety injection system with a female luer lock connector (114) in Figures 17A-17H.

[0084] The use of a female luer lock connector (114) and an interchangeable luer needle (120) creates an additional problem. The proximal end (122) of the luer needle (120) is connected to the transfer pipe (46), and the luer needle (120) must be connected to the female luer lock connector on the needle hub (116). During installation of the luer needle (120), the needle cover member (63) guides the luer needle (120) into the needle hub (116) so that the proximal end (122) of the luer needle (120) is aligned with the transfer pipe (46) and improves the connection between the luer needle (120) and the transfer pipe (46). Needle cover member guidance is described in U.S. patent application Ser. No. 14 / 696,342, which is incorporated herein by reference. Figures 17J and 17K, and Figures 18C-18F show the connection between the Luer needle (120) and the transfer pipe (46). As can be seen in these figures, the externally threaded male Luer lock connector (124) on the Luer needle (120) guides the proximal end (122) of the Luer needle (120) into the transfer pipe (46) to secure the connection therebetween. The threads of the Luer lock connectors (114, 124) press the proximal end (122) of the Luer needle (120) into the transfer pipe (46) for an airtight press-fit or snap-fit. The distal end of the transfer pipe (46) also includes a latch groove (111) configured to interact with one or more cantilevered latch members (616) to prevent the transfer pipe (46) from being pushed proximally into the cartridge (134) during installation.

[0085] 19A-19D show an embodiment in which a dual-chamber safety injection system with a female luer lock connector (114) at the distal end is used for mixing (with or without a luer cap (118)) and injection without a luer needle. The connector (114) can be a luer taper, or a luer slip, or other fluid connector. As shown in FIG. 19D, the dual-chamber safety injection system can be connected to any luer lock access port (130), such as those connected to IV tubing and IV bags. In such an embodiment, the dual-chamber safety injection system does not retract, since there is no sharp needle and therefore no retraction mechanism is necessary. In this case, the transfer pipe (46) allows the transfer of liquid from the proximal drug chamber (40) to the distal drug chamber (42), and then the mixed drug (272) can be injected into the IV tubing or other injection system.

[0086] Although the dual chamber safety injection system with the luer connector shown in Figures 17A-19D includes a cartridge, the luer connector can also be used with syringes and other dual chamber safety injection systems.

[0087] Exemplary Safe Injection System for Metal-Sensitive Medications Many injectables (e.g., pharmaceuticals) are sensitive to degradation during storage due to contact with metals such as those found in needles. FIGS. 20A-20D illustrate the use of a pre-filled dual-chamber safety injection system that minimizes exposure of such sensitive pharmaceuticals to metals during storage. For example, as shown in FIG. 20A, which illustrates a transport configuration for a dual-chamber safety injection system, a sensitive drug (132) can be pre-filled into the system and stored in the proximal drug chamber (40). Thus, the sensitive drug (132) is only exposed to the glass of the syringe body (34) and the hydrophilic or lubricious coating (e.g., PTFE) on the proximal and distal stopper members (32, 36) during transport and storage. The distal drug chamber (42) only comprises the needle proximal end (50) and does not contain an injectable drug. In fact, the distal stopper member (36) separates the sensitive drug (132) from the proximal end (50) of the sensitive metal needle.

[0088] Just prior to injection, the user applies pressure to the plunger operating interface (128), thereby pushing the proximal and distal stop members (32, 36) and the sensitive medication (132) contained therebetween distally. The needle proximal end (50) is configured to have a single opening located just proximal to the distal stop member (36), as shown in FIG. 20B, when the distal stop member (36) is located at the distal end of the syringe body (34). Thus, the dual chamber safety injection system is ready to inject, as shown in FIG. 20B. From the configuration shown in FIG. 20B, further pressure from the user on the plunger operating interface (128) injects the sensitive medication (132) through the distal end of the needle (48) and collapses the proximal medication chamber (42), as shown in FIG. 20C. 20C-20D, the needle spine assembly (76) is retracted into the syringe body (34) and at least partially into the plunger assembly (44), as described in U.S. Patent Application Nos. 14 / 696,342 and 62 / 416,102, which are incorporated herein by reference. Thus, the time that the sensitive drug (132) is exposed to the metal of the needle spine assembly (76) is minimized in the time it takes to complete the injection.

[0089] Although the dual chamber safety injection system shown in Figures 20A-20D is configured for use with a syringe, similar systems can be configured for use with cartridges containing sensitive drugs. While the dual chamber safety injection system shown in Figures 20A-20D includes direct injection from the proximal drug chamber (40), other systems include transfer of the sensitive drug from the proximal drug chamber (40) to the distal drug chamber (42) prior to injection, as shown in Figures 22A-22D.

[0090] Needle latch member 21A-21D show the interaction between the latch groove (111) on the distal end of the transfer pipe (46) and the needle latch member (612) which prevents proximal movement of the needle spine assembly (76) (including the transfer pipe (46)) before the injection is completed.

[0091] FIG. 21A illustrates a transfer pipe (46) having a latch groove (111) formed thereon and into which the proximal end of the distal needle end (48) is inserted. In one embodiment, the proximal end of the distal needle end (48) may be the proximal end of a Luer needle, as described above. The transfer pipe (46) has a necked-down or radially reduced latch groove (111) configured to interact with the latch member (612) and the moveable block member (614) such that during assembly and use of the system (e.g., mixing and injection), the needle spine assembly (76) including the transfer pipe (46) remains fixed in place relative to the syringe body (34) but is displaced after the plunger assembly is fully inserted against the smaller diameter flange (33—see, e.g., FIG. 7N) (i.e., within the distal drug chamber 42 of the syringe body 34). When the needle spine assembly (76) is forced distally by the advancement of the plunger (approximately or thereafter) to advance the movable block member (614) relative to the distal housing portion (610) and cause the multiple (two shown) cantilevered latch members (616) of the latch member (612) to be pushed out of the way by the movable block member (614) to retract the needle spine assembly (76) (i.e., the distal end (48), transfer pipe (46), and proximal end (50) of the needle) thereby safely positioning the distal end (48) of the needle within the plunger assembly (44). Alternatively, the distal end (48) of the needle may be retracted to a position below the exterior surface of the distal housing portion (610) to safely protect the sharp tip from the user. In other words, the cantilevered latch member (616) retains the position of the needle distal ends (48) during injection and needle / syringe assembly until they are pushed out of the way by the movable blocking member (614) when the plunger is fully inserted (see FIG. 21D). The needles are then free to be withdrawn as described in U.S. patent application Ser. Nos. 14 / 696,342 and 62 / 416,102, which are incorporated herein by reference.

[0092] The movable block member (614) has a smaller distal portion (617) and a larger proximal portion (618) to increase the force required to unlatch the needle spine assembly (76). The larger proximal portion (618) is configured to create a block outer diameter (622) dimension that interferes with the inner diameter (624) of the latch (612), increasing the force required to slide the movable block and thus remove the needle.

[0093] It reduces the torque applied to the cantilevered latch member (616), thereby increasing the force required to unlatch.

[0094] Vacuum assisted dual chamber safe injection system Figures 23-34 show various embodiments of a vacuum-assisted dual chamber safety injection system similar to that shown in Figures 6A-10B. The dual chamber safety injection system has a conventional off-the-shelf pre-filled syringe body (34) having proximal and distal stopper members (32, 36) disposed therein. The proximal and distal stopper members (32, 36) together with the syringe body (34) define proximal and distal drug chambers (40, 42). The proximal and distal stopper members (32, 36) occlude the proximal and distal ends of the proximal drug chamber (40). The distal stopper member (36) occludes the proximal end of the distal drug chamber (42). The dual chamber safety injection system provides for varying degrees of user control over the transfer of a first drug component from a proximal drug chamber (40) to a distal drug chamber (42) and the expulsion of the mixed / combined drug from the distal drug chamber (42) which is successively inserted distally of the plunger assembly relative to the syringe body (34). The plunger assembly includes a proximal stopper member (32), a plunger housing member (69), and a plunger operating interface (128). The first drug component disposed in the proximal drug chamber (40) is a liquid, such as an aqueous or oil-based drug solution, a gel, or a diluent that mixes with the second drug component in the distal drug chamber (42). The second drug component in the distal drug chamber (42) is a dry form of drug, such as a powder, microspheres, emulsion, lyophilized or freeze-dried, or the like, or a cake, such as a solid drug. The second drug component in the distal drug chamber (42) may also be a liquid that mixes with the first drug component from the proximal drug chamber (40).

[0095] As mentioned above, the proximal and distal stop members (32, 36) of the dual chamber safety injection system are configured to be pierced by the proximal needle end (50) at the appropriate time to aid in the transfer of medication. FIG. 23 shows the assembly prior to use with the needle cover (63) in place to mechanically isolate the distal needle end (48). The needle cover (63) is removed to allow the assembly to be injected into a patient. In some embodiments (not shown), the needle cover member (63) includes a vent (not shown) to allow pressure resulting from the transfer and mixing of medication components to escape from the interior of the syringe body (34) while preventing contaminants from entering the syringe body (34). However, such a venting needle cover member is not always desirable.

[0096] When the first drug component moves under pressure from the proximal drug chamber (40) to the distal drug chamber (42) without venting, pressure is created in the distal drug chamber (42) that expels liquid (e.g., mixed drug) from the distal drug chamber (42) prior to injection (e.g., through the distal end (48) of the needle).

[0097] Thus, the vacuum assisted dual chamber safety injection system shown in FIG. 23 creates a partial vacuum (e.g., 0.1 ATM or 90% vacuum) in the distal medicine chamber (42) before transferring liquid from the proximal medicine chamber (40). The partial vacuum assists in the movement of liquid from the proximal medicine chamber (40). For example, after a portion of the transfer pipe (46) is forced through the proximal stopper member (32) to position the proximal opening (270, see FIG. 29) in the proximal medicine chamber (40), the partial vacuum in the distal medicine chamber (42) draws liquid from the proximal medicine chamber (40) into the distal medicine chamber (42). The partial vacuum reduces the amount of distal force that must be applied via the plunger assembly to the proximal stopper member (32) to transfer liquid from the proximal medicine chamber (40) to the distal medicine chamber (42). The transfer of liquid also at least partially relieves the vacuum in the distal medicine chamber (42).

[0098] As shown in FIG. 24, the partial vacuum in the distal drug chamber (42) creates a force ("Fv") on the distal stopper member (36) that must be temporarily resisted to maintain the dual chamber safety injection system in a transport-storage-premix state. The distal force (Fv) on the distal stopper member (36) is approximately the difference between the pressure in the proximal drug chamber (40) and the pressure in the distal drug chamber (42) multiplied by the area of ​​the distal stopper member (36). In one embodiment, Pressure in the proximal drug chamber (40) = 1 ATM = 14.7 psi Pressure in the distal drug chamber (42) = 0.1 atm = 0.15 psi Standard 3cc stopper tip area = 0.09in 2 Force on distal stop member (36) (Fv) = 0.09 (14.7 - 0.15) = 1. 31 lbs The resistance of the distal stop member (36) to puncture by the harpoon coupling interface (not shown) is sufficient to overcome a force (Fv) of 1.31 lbs. However, with a sharper harpoon coupling interface or a distal stop member (36) with less puncture resistance, a partial vacuum in the distal medicament chamber (42) may result in premature puncture of the distal stop member (36) by the harpoon coupling interface and premature transfer of liquid from the proximal medicament chamber (40) to the distal medicament chamber (42).

[0099] 25 and 26 show a distal stop bushing (310) with a proximal gate (332). The distal stop bushing (310) is configured to thread onto the distal end of the distal stop member (36). The proximal gate (332) includes a pair of movable arms (334) that are biased toward one another by respective spring elements (336). As such, the proximal gate (332) has two configurations: a closed configuration in which the harpoon coupling interface cannot pass through the proximal gate (332); and an open configuration in which the harpoon coupling interface can pass through the proximal gate (332). In the open configuration, the movable arms (334) are forced away from one another (e.g., relative movement between the harpoon coupling interface and the distal stop member (36) opens the gate, as shown below).

[0100] When the dual chamber injection system is in the transport / storage / premix state (see Figures 23, 24, 27, and 28), the gate (332) is in a closed state. As shown in Figures 27 and 28, the closure member (322) prevents the harpoon coupling interface from contacting the distal stopper member (36), so that the closure gate transmits the force (Fv) generated by the partial vacuum in the distal medication chamber (42) to the harpoon coupling interface and needle spine assembly (76) without penetrating the distal stopper member (36). The harpoon coupling interface (89, see Figure 28) includes a proximal shoulder (90) that interferes with the closure gate (322) and prevents the harpoon coupling interface (89) from passing through the gate. The harpoon coupling interface (89) has a hollow 3D arrowhead shape as described in U.S. patent application "System and Method for a Safe Syringe," filed November 1, 2017, Attorney Docket No. CM20015, which is incorporated herein by reference.

[0101] After sufficient distal force is applied to the plunger assembly, the distal force applied to the plunger, together with the force (Fv) on the distal stopper member (36) from the partial vacuum in the distal medicament chamber (42), overcomes the biasing force of the spring element (336) in the arm (334) of the gate (332) to move the gate (332) from the closed configuration to the open configuration. The harpoon coupling interface (89) then partially penetrates the distal stopper member (36) and subsequently the transfer pipe (46), as shown in FIG. 29. Because the outer diameter of the transfer pipe (46) is smaller than the distal end of the harpoon coupling interface (89), the gate (332) closes after the proximal end of the harpoon coupling interface (89) has passed.

[0102] Movement of the needle spine assembly (76) through the distal stop member (36) is then momentarily halted by a distal shoulder (92) formed in the needle interface member (83) of the needle spine assembly (76) that has a larger outer diameter than the transfer pipe (46). The distal shoulder (92) does not pass through the closed gate (322), thereby holding the needle spine assembly (76) and the distal stop member (36) in the position shown in FIG. 29. In this position, the transfer pipe (46) straddles the distal stop member (36) allowing fluid to transfer therethrough. The partial vacuum in the distal medicament chamber (42) and a distal force are applied to the plunger assembly, pulling and pushing fluid from the proximal medicament chamber (40) into the distal medicament chamber (42). The mechanical interference between the distal shoulder (92) and the closed gate (322) minimizes movement of the distal stop member (36) during fluid transfer.

[0103] Figure 30 shows the configuration of the dual chamber safety injection system after liquid transfer from the proximal drug chamber (40) to the distal drug chamber (42) is substantially complete. The proximal stopper member (32) seals the harpoon coupling interface (89, see Figure 29) and the opening of the transfer pipe (46, see Figure 29), stopping the liquid transfer. The partial vacuum in the distal drug chamber (42) provides space in the distal drug chamber (42) after liquid transfer to allow the user to mix the first and second drug components by stirring these components.

[0104] Figure 31 shows the configuration of the dual chamber safety injection system after a distal force sufficient to overcome the mechanical interference between the distal shoulder (92, see Figure 29) and the closure gate (322, see Figure 322) is applied to the plunger assembly (i.e., by opening the gate (322)). The partial vacuum collapses this space by moving the distal and proximal stop members (36, 32) after they are no longer prevented from moving distally by the distal shoulder (92, see Figure 29) and the closure gate (322, see Figure 29). The distal force applied to the plunger assembly also helps collapse the space in the distal medication chamber (42) (compare Figures 30 and 31).

[0105] After the partial vacuum collapses the space in the distal medication chamber (42), the distal medication chamber contains small air bubbles that do not need to be purged prior to injection. Thus, the vacuum assisted dual chamber safety injection system functions without purging, unlike other injection systems. Thus, the vacuum assisted dual chamber safety injection system described herein can be used with auto-injectors, pens, and other "reusable" or "disposable" housing interfaces without purging.

[0106] Figure 32 shows the configuration of the dual chamber safety injection system after the needle latch member (612) has been disengaged from the needle spine assembly (76) and the harpoon coupling interface (89) has been secured to the needle holding mechanism as described above. For clarity, the energy storage member has been omitted from Figure 32.

[0107] Figure 33 shows the configuration of the dual chamber safety injection system after the retraction mechanism has been triggered to retract the needle spine assembly (76) proximally relative to the syringe body (34) until the needle distal sharp end (34) is in a safe position within the needle hub, as described above. For clarity, the energy storage member has been omitted from Figure 33.

[0108] FIG. 34 illustrates a distal stop bushing (310) with a proximal gate (332) according to another embodiment. The difference between the distal stop bushing (310) of FIG. 34 and the distal stop bushing (310) of FIGS. 25-28 is the design of the proximal gate (332). In the proximal gate (332) shown in FIG. 34, when the distal shoulder (92) pushes the movable arms (334) in a proximal direction, the pair of movable arms (334) rotate about their respective self-actuating hinges (338). The force of the distal shoulder (92) against the movable arms (334) brings the arms closer together, thereby securing the transfer pipe (46) to the movable arms (334). This secures the transfer pipe (46) in an optimal position for liquid transfer. The position of the transfer pipe (46) in the fixed position can vary the axial length of the self-actuating hinge (338) to adjust the force exerted by the movable arm (334) on the transfer pipe (46). After fluid transfer is completed, the increased distal force on the plunger assembly overcomes the mechanical interference between the distal shoulder (92) and the closure gate (322) to allow injection.

[0109] The vacuum assisted dual chamber safety injection system shown in Figures 23-33 and described herein facilitates the transfer of liquid from the proximal medication chamber (40) to the distal medication chamber (42) by drawing liquid into the distal medication chamber (42) and minimizing the pressure rise in the distal medication chamber (42) due to the liquid transfer. The vacuum assisted dual chamber safety injection system also includes a distal stop bushing (310) having a proximal gate (332) to prevent premature movement of the distal stop member (36) caused by a partial vacuum in the distal medication chamber (42).

[0110] Various exemplary embodiments of the present invention are described herein. These examples are referred to in a non-limiting sense. These examples are provided to illustrate the 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 acts or steps to the objective, spirit or scope of the present invention. Moreover, it will be apparent to those skilled in the art that each of the variations described and illustrated herein has individual components and features that can be readily separated or combined with the features of some other embodiments without departing from the spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims associated with this disclosure.

[0111] Any of the devices described for performing a diagnostic or interventional procedure on a subject can be provided in a packaged combination for use in performing such an intervention. These supply "kits" can further comprise instructions for use and can be packaged in a sterile tray or container, such as those commonly used for such purposes.

[0112] The present invention includes methods that can be carried out using the apparatus of the present invention. The methods include the act of providing such suitable apparatus. Such providing is performed by an end user. In other words, the act of "providing" merely requires the end user to obtain, access, access, locate, configure, activate, power on or otherwise act to provide the necessary apparatus in the method. The methods recited herein may be carried out in any order of the recited events that is logically possible, as well as the order of the recited events.

[0113] Exemplary embodiments of the present invention are described above with details regarding material selection and manufacture. Other details of the present invention can be found in the above-referenced patents and publications, as well as in relation to matters generally known or recognized by those skilled in the art. For example, it is obvious to those skilled in the art that one or more lubricious coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, PTFE, hydrophilic gels or silicones) can be used on various parts of the device, such as relatively large interface surfaces of movable joint parts, as necessary, to facilitate low-friction manipulation and advancement of such subject instruments against other parts or nearby tissue structures. The same is true for method-based embodiments of the present invention in the sense of additional actions as generally or logically used.

[0114] Moreover, while the present invention has been described with reference to several embodiments optionally incorporating various features, the present invention is not limited to each and every variation of the present invention as contemplated and described or shown. Various modifications can be made to the invention as described above, and equivalents (whether recited herein or not) 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 the upper and lower limits of that range and any intervening values ​​within the stated range, or between any intervening values ​​within that range, are encompassed by the invention.

[0115] Also, any feature of the described inventive variation is intended to 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 that there are multiple of the same items. More specifically, as used in this specification and the claims related thereto, the singular forms "a," "an," "the," and "the" include plural referents unless otherwise indicated. In other words, the use of the article may be "at least one" of the subject item in the above description as well as in the claims related to this disclosure. It is further noted that such claims may be drafted to exclude optional elements. It is intended that this statement may be used as a predicate to the use of exclusive language such as "solely," "only," and the like in connection with the recitation of claim elements or the use of "negative" limitations.

[0116] Without using such exclusive terminology, the term "comprising" in the claims relating to this disclosure means that the inclusion of any additional elements is permitted, regardless of whether a given number of elements are recited in such claim or whether the addition of features can be considered to transform the nature of the elements recited in such claim. Unless specifically defined herein, all technical and scientific terms used herein are to be given the broadest possible commonly understood meaning while maintaining the validity of the claims.

[0117] The scope of the present invention should not be limited to the examples provided and / or the present specification, but rather should be limited only by the scope of the language of the claims associated with this disclosure.

Claims

1. In a system for mixing and injecting medicines: a syringe body defining a proximal opening and a distal needle interface at a distal end thereof; proximal and distal stop members disposed on the syringe body forming a proximal medicament chamber therebetween and a distal medicament chamber between the distal stop member and a distal end of the syringe body; a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member into the syringe body, a needle retention mechanism disposed within the plunger; an energy storage member disposed within the plunger; an energy storage member latch member disposed within the plunger; a plunger member comprising: a needle hub assembly coupled to the distal needle interface of the syringe body, a needle having a needle proximal end structure; Hub and; a needle latch member configured to connect the needle to the hub; a needle hub assembly comprising: comprising; the first and second sizes of the proximal and distal medicament chambers, respectively, are alterable by movement of the proximal and distal stop members relative to the syringe body; Upon actuation of the plunger member relative to the syringe body, the needle can be at least partially retracted within the plunger member to change the energy storage member latch member from a latched state to an unlatched state; A system for mixing and injecting medicines, comprising:

2. The system of claim 1 , wherein the needle is configured to be retracted at least completely through the distal stop member and into the plunger.

3. 2. The system of claim 1, wherein the energy storage member latch member is interconnected between an inner surface of the plunger member and the needle retention mechanism.

4. 2. The system of claim 1, wherein the proximal and distal drug chambers contain first and second components, respectively, of a drug that are mixed together prior to injection into a patient.

5. The system further comprises: a delivery arrangement, the needle proximal end structure being disposed within the distal medication chamber; a delivery arrangement, the needle proximal end structure extending at least partially through the distal stopper member and disposed at least partially within the proximal medication chamber; a mixing arrangement where the proximal and distal stop members contact one another, thereby transferring the first drug component from the proximal drug chamber to the distal drug chamber and mixing the first drug component with a second drug component in the distal drug chamber; The system of claim 1 comprising:

6. The needle comprises: a distal end opening; a central opening disposed in the distal medication chamber when the system is in a transport, transfer, and mixing configuration; a proximal opening disposed in the proximal medication chamber when the system is in a transport and delivery configuration; The system of claim 5 comprising:

7. 7. The system of claim 6, wherein the needle further comprises a plurality of proximal openings, and the proximal opening is one of the plurality of proximal openings: at least some of the proximal openings are disposed in proximal medication chambers when the system is in a transport and transfer configuration; at least some of the proximal openings are blocked by the proximal stopper member when the system is in a mixing configuration; 7. The system according to claim 6.

8. 8. The system of claim 7, wherein the proximal stop member comprises a plug configured to block at least some of the proximal openings when the system is in a mixing configuration.

9. 9. The system of claim 8, wherein the length of the plug is greater than the distance between a proximal-most opening of the plurality of proximal openings and a distal-most opening of the plurality of proximal openings.

10. 6. The system of claim 5, wherein the syringe body includes a position indicator configured to be adjacent a distal end of the distal stopper when the system is in a mixing configuration.

11. 6. The system of claim 5, wherein the plunger member includes a retaining clip configured to be selectively coupled to the syringe body when the system is in a mixing configuration to prevent proximal movement of the plunger member relative to the syringe body.

12. 12. The system of claim 11, wherein the retaining clip is configured to generate an audible signal when selectively coupled to the syringe body.

13. 2. The system of claim 1, wherein the proximal and distal stoppers include first and second polymer coatings on their respective distal and proximal surfaces, and the proximal drug chamber is defined by the syringe body and the first and second polymer coatings.

14. The distal stopper comprises: a proximally tapered funnel; a space disposed at the tapered proximal end of the funnel; The system of claim 1 comprising:

15. In a drug mixing and injection system: a cartridge body defining a proximal opening and a distal needle interface at a distal end of the opening; proximal and distal stopper members disposed within the cartridge body forming a proximal medicament chamber between the proximal and distal stopper members and a distal medicament chamber between the distal stopper member and a distal end of the cartridge body; a plunger member defining a plunger interior and configured to be manually manipulated to insert a proximal stopper member relative to the cartridge body, a needle retention mechanism disposed within the plunger; an energy storage member disposed within the plunger; an energy storage member latch member disposed within the plunger; a plunger member comprising: a needle hub assembly removably coupled to a distal needle interface of the cartridge body, a needle having a needle proximal end structure; Hub and a needle latch member configured to connect the needle to the hub; a needle hub assembly comprising: Equipped with the first and second sizes of the proximal and distal medicament chambers, respectively, are alterable by movement of proximal and distal stop members relative to the syringe body; Upon actuation of the plunger member relative to the syringe body, the needle can be at least partially retracted within the plunger member to change the energy storage member latch member from a latched state to an unlatched state; A system for mixing and injecting medicines, comprising:

16. 16. The system of claim 15, wherein the energy storage member latch member is interconnected between an inner surface of the plunger member and the needle retention mechanism.

17. 16. The system of claim 15, wherein the proximal and distal drug chambers contain first and second components, respectively, of a drug that are mixed together prior to injection into a patient.

18. The system further comprises: a delivery arrangement, the needle proximal end structure being disposed within the distal medication chamber; a delivery arrangement, the needle proximal end structure extending at least partially through the distal stopper member and disposed at least partially within the proximal medication chamber; a mixing arrangement where the proximal and distal stop members contact one another, thereby transferring the first drug component from the proximal drug chamber to the distal drug chamber and mixing the first drug component with a second drug component in the distal drug chamber; 16. The system of claim 15, comprising:

19. 16. The system of claim 15, wherein the hub comprises a collet and a sleeve, the collet configured to removably couple the needle hub assembly to a distal needle interface of the cartridge body when the sleeve is disposed about the collet.

20. 16. The system of claim 15, wherein the hub includes a seal member configured to surround an exterior surface of the needle and form a fluid-tight seal.

21. 16. The system of claim 15, further comprising a transfer pipe disposed within the distal drug chamber, wherein the needle and the transfer pipe are removably connected when the needle hub assembly is removably connected to the distal needle interface of the cartridge body.

22. 22. The system of claim 21, wherein the transfer pipe comprises at a distal end a reduced diameter portion adapted to secure the needle.

23. In the injectable system: a syringe body defining a proximal opening and a distal needle interface at a distal end of the syringe body; proximal and distal stop members disposed within the syringe body, the stop members forming a medicament chamber therebetween; a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member relative to the syringe body, a needle retention mechanism disposed within the plunger; an energy storage member disposed within the plunger; an energy storage member latch member disposed within the plunger; a plunger member comprising: a needle hub assembly coupled to a distal needle interface of the syringe body, a needle having a needle proximal end structure and disposed distally of the distal stopper when the system is in a shipping configuration; Hub and a needle latch member configured to connect the needle to the hub; a needle hub assembly comprising: Equipped with configured to penetrate the distal stopper member into the medicament chamber when the system is in an injection configuration; Upon actuation of the plunger member relative to the syringe body, the needle can be at least partially retracted within the plunger member to change the energy storage member latch member from a latched state to an unlatched state; A system for mixing and injecting medicines, comprising:

24. 24. The system of claim 23, wherein the energy storage member latch member is interconnected between an inner surface of the plunger member and the needle retention mechanism.

25. 24. The system of claim 23, wherein the drug chamber contains a drug that is sensitive to degradation during storage due to contact with metallic materials of the needle.

26. the system comprising a delivery configuration in which the needle proximal end structure is not disposed inside the medicament chamber; 24. The system of claim 23, wherein the needle proximal end structure is disposed through the distal stopper and into the drug chamber, thereby providing a drug exit path for injecting a drug into a patient when the system is in an injection configuration.

27. The needle comprises: a distal end opening; a central opening disposed in the medicament chamber when the system is in a delivery and injection configuration; a proximal end opening disposed in the medicament chamber when the system is in an injection configuration; 27. The system of claim 26, comprising:

28. 27. The system of claim 26, wherein the syringe body includes a position indicator configured to be adjacent a distal end of the distal stopper when the system is in an injection configuration.

29. 27. The system of claim 26, wherein the plunger member includes a retaining clip configured to be selectively coupled to the syringe body when the system is in a mixing configuration to prevent proximal movement of the plunger member relative to the syringe body.

30. 30. The system of claim 29, wherein the retaining clip is configured to generate an audible signal when selectively coupled to the syringe body.

31. 24. The system of claim 23, wherein the proximal and distal stoppers include first and second polymer coatings on their respective distal and proximal surfaces, and the proximal drug chamber is defined by the syringe body and the first and second polymer coatings.

32. The distal stopper comprises: a proximally tapered funnel; a space disposed at the tapered proximal end of the funnel; 24. The system of claim 23, comprising:

33. 1. A method of mixing and injecting drugs into a patient, comprising: a syringe body defining a proximal opening and a distal needle interface at a distal end of the syringe body; proximal and distal stop members disposed on the syringe body forming a proximal medicament chamber between the proximal and distal stop members and a distal medicament chamber between the distal stop member and a distal end of the syringe body; a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member into the syringe body; a needle member having a distal needle tip, a drug pathway, a plurality of transfer openings, and a proximal end; providing a system comprising: advancing the plunger member to pierce the proximal end of the needle member through the distal stopper to pass the first drug component from the proximal drug chamber, through the drug passageway, and into the distal drug chamber to mix the first drug component with the second drug component in the distal drug chamber to create a mixed drug; A method comprising:

34. 34. The method of claim 33, further comprising the step of advancing the plunger member to inject the mixed medicament into a patient.

35. 35. The method of claim 34, further comprising automatically retracting the distal needle tip into the syringe body when the mixed medicament is injected into the patient.

36. 1. A method of mixing and injecting medications into a patient, comprising: a cartridge body defining a proximal opening and a distal needle interface at a distal end thereof; proximal and distal stopper members disposed within the cartridge body defining a proximal medicament chamber therebetween and a distal medicament chamber between the distal stopper member and a distal end of the cartridge body; a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member relative to the cartridge body; a needle member having a distal needle tip, a drug passageway, a plurality of transfer openings, and a proximal end; providing a system comprising: advancing the plunger member to pierce the proximal end of the needle member through the distal stopper to pass the first drug component from the proximal drug chamber, through the drug passageway, and into the distal drug chamber to mix the first drug component with the second drug component in the distal drug chamber to create a mixed drug; A method comprising:

37. 37. The method of claim 36, further comprising the step of advancing the plunger member to inject the mixed medicament into a patient.

38. 38. The method of claim 37, further comprising automatically retracting the distal needle tip into the cartridge body when the mixed medicament is injected into the patient.

39. 1. A method of injecting a medicament into a patient, comprising: a syringe body defining a proximal opening and a distal needle interface at a distal end thereof; proximal and distal stop members disposed within the syringe body, the stop members defining 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 a distal end of the syringe body; a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member relative to the syringe body; a needle member having a distal needle tip, a drug passageway, a plurality of transfer openings, and a proximal end; providing a system comprising: advancing the plunger member to pierce the proximal end of the needle member through the distal stopper to pass the first drug component from the proximal drug chamber, through the drug passageway, and into the distal drug chamber; The method comprising:

40. 40. The method of claim 39, further comprising the step of advancing the plunger member to inject the medication into a patient.

41. 41. The method of claim 40, further comprising automatically retracting the distal needle tip into the syringe body when the medication is injected into the patient.

42. In a drug mixing and injection system: a syringe body defining a proximal opening and a distal needle interface at a distal end thereof; proximal and distal stop members disposed within the syringe body, the stop members defining 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 a distal end of the syringe body; a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member relative to the syringe body; a needle retaining structure disposed within the plunger; an energy storage member disposed within the plunger; an energy storage member latch member disposed within the plunger; a plunger member comprising: a needle hub assembly coupled to a distal needle interface of the syringe body, a needle having a needle proximal end structure; Hub and a needle latch member configured to connect the needle to the hub; a needle hub assembly comprising: Equipped with the first and second sizes of the proximal and distal medicament chambers, respectively, being alterable by movement of the proximal and distal stop members relative to the syringe body; manipulating the plunger member relative to the syringe body causes the needle to at least partially retract within the plunger to change the energy storage member latch member from a latched state to an unlatched state; the distal medication chamber comprises a partial vacuum; A system characterized by:

43. 43. The system of claim 42, wherein the distal stop member comprises a proximal gate having a closed configuration that prevents the needle proximal end structure from passing through the proximal gate and an open configuration that allows the needle proximal end structure to pass through the proximal gate.

44. 44. The system of claim 43, wherein the proximal gate comprises a pair of movable arms operably connected to a pair of spring elements.

45. 45. The system of claim 44, wherein the pair of spring elements bias the proximal gate in the closed configuration.

46. 44. The system of claim 43, wherein the needle proximal end structure comprises a proximal shoulder that cannot pass through the proximal gate in a closed configuration but can pass through the proximal gate in an open configuration.

47. 47. The system of claim 46, wherein the needle comprises a distal shoulder that cannot pass through the proximal gate in a closed configuration but can pass through the proximal gate in an open configuration, the distal shoulder being distal to the proximal shoulder.

48. 44. The system of claim 43, wherein the proximal gate comprises a pair of movable arms operatively connected to a pair of self-energizing hinges.

49. 1. A method of mixing and injecting drugs into a patient, comprising: a syringe body defining a proximal opening and a distal needle interface at a distal end thereof; proximal and distal stopper members disposed within the syringe body defining a proximal drug chamber therebetween and a distal drug chamber between the distal stopper member and a distal end of the cartridge body; a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member relative to the syringe body; a needle member having a distal needle tip, a drug passageway, a plurality of transfer openings, and a proximal end; Equipped with the distal medication chamber contains a partial vacuum; Providing a system; advancing the plunger member to pierce the proximal end of the needle member into the distal stopper such that a partial vacuum in the distal drug chamber passes a first drug component from the proximal drug chamber, through the drug passageway, and into the distal drug chamber to mix the first drug component with a second drug component in the distal drug chamber to create a mixed drug; A method comprising:

50. 50. The method of claim 49, further comprising the step of moving the distal stop member distally to collapse space in the distal medication chamber to allow an injection to be performed without purging the system.

51. 50. The method of claim 49, further comprising the step of advancing the plunger member to inject the medication into a patient.

52. 52. The method of claim 51, further comprising automatically retracting the distal needle tip into the syringe body when the medication is injected into the patient.

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