System for a safety syringe

Abstract

The present invention relates to a system for sequential injection of liquids, comprising a syringe body defining a proximal opening of the syringe and a distal needle interface, a proximal stop member and a distal stop member forming a proximal chamber and a distal chamber. The system further comprises a first liquid in the distal chamber and a second liquid in the proximal chamber, and a plunger configured to be manually manipulated to insert the proximal stop member distally. Furthermore, the system comprises a needle hub assembly coupled to the syringe body, the needle assembly comprising a needle. The needle defines a needle interior and a distal opening, an intermediate opening and a proximal opening. The distal opening, the intermediate opening and the proximal opening are fluidly couplable through the needle interior. Manipulation of the plunger member to insert the proximal stop member first expels the first liquid from the distal chamber and then sequentially expels the second liquid from the proximal chamber.

Description

Technical Field

[0001] This invention generally relates to injection systems, injection devices, and injection processes for facilitating control of various levels of fluid infusion, and particularly to systems and methods related to sequential injection in medical settings. Background Technology

[0002] Millions of syringes are consumed daily in the healthcare environment, such as Figure 1A (2) As described. A typical syringe (2) includes a tubular body (4), a plunger (6), and an injection needle (8). Figure 1B As shown, this syringe (2) can be used not only to inject fluids into a patient, but also to draw or discharge fluids from containers such as vials, bottles, bags, or other drug-containing systems (10). In practice, due to regulatory restrictions in some countries such as the United States and considerations for aseptic maintenance, when using vials (10) with syringes (2) in a patient-specific setting, such vials can only be used for a single patient and must then be disposed of—leading to significant medical waste in the disposal of vials and leftover medications, and even periodic shortages of certain critical medications.

[0003] refer to Figure 2A The illustration depicts three Luer-type syringes (12), each having a Luer connector geometry (14) disposed on its distal side so that it can be coupled to other devices having similar matching geometries, such as... Figure 2B The Luer manifold assembly (16) is depicted in the image. With or without the use of an intravenous infusion bag, Figure 2B The Luer manifold assembly can be used to administer intravenous liquid medications to patients. Figure 2A The Luer connector (14) of the syringe can be called a "male" Luer connector, while Figure 2B (18) can be referred to as a “female” Luer connector; one of the Luer interfaces can be threaded (in this case, the configuration can be referred to as a “Luer lock” configuration), allowing the two sides to be engaged by relative rotation, which can be combined with compressive loads. In other words, in a Luer lock embodiment, rotation (possibly accompanied by compression) can be used to engage the threads within the male connector (14), which are configured to engage the flange on the female connector (18), bringing the device together into a fluid-tight connection. In another embodiment, a tapered interface geometry can be used to provide Luer engagement by compression without threads or rotation (this configuration can be referred to as a “slip-on” or “conical” Luer configuration). While such Luer connections are considered relatively safe for the operator, there is a risk of drug spillage / leakage and component breakage during the assembly of the Luer connection.

[0004] On the other hand, using a needle-injection configuration carries the risk of sharp needles coming into contact with or puncturing unwanted people or structures. Therefore, so-called "safety syringes" have been developed. Figure 3 An embodiment of a safety syringe (20) is shown, wherein when released from a locked position relative to the syringe body (4), a tubular protective member (22) is spring-biased to cover the needle (8). Figures 4A-4B Another embodiment of the safety syringe (24) is shown. With this configuration, after the plunger (6) is fully inserted relative to the syringe body (4), the retractable needle (26) is configured to retract (28, 26) into a safe position within the tubular body (4), such as... Figure 4B As shown. This self-collapsed structure may be associated with blood splashing / nebulization issues, safe storage of preloaded energy (which may fail and activate before it is expected), loss of accuracy in administering the full dose due to residual dead space within the spring compression volume, and / or loss of retraction speed control that may be related to pain and patient anxiety.

[0005] Complicating the syringe market further is the increasing demand for pre-filled syringe components, such as... Figure 5A and 5B The described features typically include a syringe body or "closed-container delivery system" (34), a plunger head, a plunger or stop (36), and a distal seal or cap (35) that can be mounted on a Luer-type interface. Figure 5A The hood (35) is shown in the proper position; Figure 5B The cap has been removed to reveal the Luer interface (14). Liquid medication may be present in a volume or medication reservoir (40) between the distal seal and the distal end (37) of the plunger head (36). The plunger head (36) may comprise a standard butyl rubber material and may be coated, for example, with a biocompatible smooth coating (e.g., polytetrafluoroethylene (“PTFE”)) to facilitate preferred sealing and relative motion characteristics with respect to the associated syringe body structure and materials. Figure 5BThe proximal end of the syringe body (34) includes a conventional one-piece syringe flange (38), which is integrally formed with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and may be configured to surround a full circumference or a partial circumference of the syringe body (34). The partial flange is referred to as the "clamping flange," while the other portion is referred to as the "full flange." The flange is used to grip the syringe with a finger to provide support for pushing the plunger to inject. The syringe body (34) preferably comprises a translucent material, such as glass or polymer. To form a closed volume within the chamber or reservoir (40) and to facilitate the expulsion of the associated fluid through the needle, a plunger head (36) may be disposed within the syringe body (34). The syringe body (34) may define a substantially cylindrical shape (i.e., such that the plunger head (36) having a circular cross-sectional shape can establish a seal against the syringe body (34)) or be configured to have other cross-sectional shapes, such as elliptical.

[0006] Such components are ideal because they can be standardized and precisely mass-produced by a select few manufacturers worldwide, capable of meeting all the ever-changing regulations globally regarding the selection of filling, packaging, and drug / pharmaceutical interface materials and component usage. However, this simple construction often fails to meet the emerging global standards for single-use, safety, automatic failure, and needle-puncture resistance. Therefore, some suppliers have shifted to more "vertical" solutions, such as... Figure 5C In (41), the solution attempts to satisfy all or at least some of the standards with a single solution; because these products attempt to satisfy these standards in many different situations, they may have significant limitations (including those mentioned above). Figure 3-4B (as described in some of the descriptions) as well as relatively high inventory and usage costs.

[0007] Furthermore, an increasing number of injectable liquids (e.g., pharmaceuticals) have the additional requirement that two or more components be injected sequentially (e.g., into a patient) within a short time interval (e.g., seconds) between each other. Multiple components can be injected sequentially using separate injection devices (e.g., pre-loaded syringes), or multiple components can be drawn from separate open containers and injected sequentially using the same injection device. However, such sequential injection or sequential drawing and injection of multiple components using separate injection devices inevitably results in multiple needle insertions into the patient and may be inaccurate, leading to component loss. Furthermore, sequential injection or sequential drawing of multiple components into a syringe using separate injection devices results in unnecessary exposure of the user to one or more uncapped needles. Additionally, sequential injection or sequential drawing and injection of multiple components using separate injection devices leads to unacceptable lag between the injections of multiple components.

[0008] In some cases, chemical reactions may occur between the components of a multi-component injection. Using conventional two-lumen syringes, where the components are mixed together inside the syringe, these components may be incompatible with the reactive ones, making the mixture unsuitable for injection. Some illustrative examples of this phenomenon include an increase in the viscosity of the combined drug when the components are mixed, making it difficult to inject through the needle. Similarly, other reactions such as exothermic or endothermic reactions may also occur. This can hinder the use of conventional two-lumen injection systems.

[0009] Existing dual-chamber injection systems (e.g., see U.S. Patent No. 4,874,381) utilize an external bypass channel formed in the outer wall of the syringe body. The external bypass channel is positioned such that as the plunger moves distally, a distal stop moves distally, exposing the external bypass channel to both the proximal and distal chambers. This allows fluid to flow from the proximal chamber around the distal stop into the distal chamber, where it mixes with the drug component in the distal chamber. If the needle or syringe is capped for drug storage, these external bypass dual-chamber injection systems experience an increase in pressure in the distal chamber during transfer and mixing. This pressure increase results in delivery resistance and makes it difficult to deliver all the fluid from the proximal chamber to the distal chamber. Furthermore, the increased pressure increases the force that must be maintained on the plunger rod during mixing. To minimize the effects of this pressure increase, external bypass dual-chamber injection systems require either removing the needle cap before fluid transfer and mixing, or opening the syringe and attaching the needle after mixing has occurred, to allow the pressure in the distal chamber to dissipate during transfer and mixing. These requirements increase the risk of needlestick injuries and / or require additional steps from the user. It is advantageous to incorporate a pre-attached needle with integrated needle retraction and protection and ventilation into a dual-chamber injection system. The needle protection and ventilation invention disclosed herein is applicable to externally bypassed dual-chamber injection systems. Furthermore, integrating a plunger position control method to maintain precise control over the distal stop position during transfer and mixing would be beneficial.

[0010] In addition, an increasing number of injectable fluids (such as medications) have another requirement: minimizing the time that injectable fluids are exposed to metal (such as stainless steel needles). Another requirement is the need for systems suitable for patient self-injection.

[0011] Needle-prick protection technology also needs to be integrated into the injection system. The ability to retract the needle tip at least partially into the syringe protects the person administering the injection and the patient from accidental needle pricks.

[0012] There is a need for an injection system that addresses the shortcomings of currently available constructions. Specifically, there is a need for a multi-chamber safe injection solution that can leverage the existing and relatively well-controlled supply chain of pre-filled syringe assemblies for conventional delivery, such as those described above. Figure 5A and Figure 5B Those mentioned above.

[0013] The retractable needle assembly can move the sharp distal end of the needle within the needle hub or within the injection system body / syringe body to prevent accidental needlesticking.

[0014] Some existing injection and / or needle retraction systems include needle assemblies with openings that can become blocked when other parts of the needle assembly are compressed during assembly and / or use. Some existing injection and / or needle retraction systems include needle assemblies that may structurally fail during assembly and / or use. Some existing injection and / or needle retraction systems include needle assemblies that allow injectables and / or components of injectables to be accidentally ejected / expelled from the interior of the injection system body to the exterior through a distal opening in the injection system body.

[0015] A needle retraction system and its components are needed to overcome the shortcomings of currently available structures. Specifically, a needle assembly with an opening is needed to prevent clogging when other parts are compressed during assembly and / or use. A needle assembly resistant to structural failure during assembly and / or use is also needed. Furthermore, a needle assembly is needed to prevent accidental leakage / ejection of the injected material through a distal opening in the injection system body. Overcoming these and other limitations of needle retraction systems allows for the cost-effective and easy manufacture of injection and / or needle retraction systems. Summary of the Invention

[0016] Some embodiments relate to injection systems. Specifically, these embodiments relate to multi-chamber sequential injection systems and multi-chamber safety injection systems that move the needle into a protected configuration to minimize accidental injury to the user and contamination of used needles.

[0017] In one embodiment, a system for sequentially injecting liquids includes a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop and a distal stop disposed within the syringe body, forming a proximal chamber between the proximal and distal stop members and a distal chamber between the distal stop member and the distal end of the syringe body. The system also includes a first liquid in the distal chamber and a second liquid in the proximal chamber. Furthermore, the system includes a plunger configured for manual actuation to distally insert the proximal stop relative to the syringe body. Additionally, the system includes a needle seat assembly coupled to the distal needle interface of the syringe body, the needle (seat) assembly including a needle. The needle defines a needle interior, a distal opening, an intermediate opening, and a proximal opening. The distal opening, intermediate opening, and proximal opening are fluidly connected through the needle interior. Actuating the plunger assembly to distally insert the proximal stop relative to the syringe body first expels the first liquid from the distal chamber through the needle, and then sequentially expels the second liquid from the proximal chamber through the needle.

[0018] In one or more embodiments, the needle includes a tubular member and a solid proximal feature structure coupled thereto. An interior, distal opening, intermediate opening, and proximal opening may be formed within the tubular member. The solid proximal feature structure may be coupled to the tubular member via a weld. This weld may be a fillet weld configured to reduce the cutting of the proximal stop member when the needle penetrates it, compared to a needle without a fillet weld. The weld may taper proximally. The proximal opening may be adjacent to the weld. The solid proximal feature structure may be cold-formed. The distal end of the solid proximal feature structure may be located in the proximal end of the tubular member. The distal end of the solid proximal feature structure and the proximal end of the tubular member may define an annular lumen that fluidly connects the proximal opening to the interior, intermediate opening, and distal opening of the needle.

[0019] In one or more embodiments, the proximal opening has a rounded / arched / arc-shaped edge, which, compared to a needle without a rounded edge, is configured to reduce cutting of the proximal stop member when the needle penetrates it. The proximal opening can be an elongated / long slot. The length of the long slot can provide tolerances / tolerances / boundaries for variations associated with the proximal and / or distal stop members. Variations associated with the proximal and / or distal stop members can be selected from the group consisting of: deformation of the proximal surface of the distal stop member, the position of the proximal stop member relative to the long slot, and the position of the distal stop member relative to the long slot. The length of the long slot can be between approximately 1 / 32 inch and approximately 1 / 16 inch. The distance between the long slot and the solid proximal end minimizes backflow of the first and second fluids into the plunger. The long slot can be formed using a grinding wheel. The first and second dimensions of the distal and proximal chambers can be changed by the movement of the proximal and distal stop members relative to the syringe body.

[0020] In one or more embodiments, the plunger assembly includes a needle-holding feature disposed within the plunger, an energy storage member disposed within the plunger, and an energy storage member locking member disposed within the plunger. The needle hub assembly may include a needle hub and a needle-retaining member configured to engage a needle to the needle hub. When the plunger assembly is manipulated relative to the syringe body to transition the energy storage member locking member from a locked state to an unlocked state, the needle may at least partially retract into the plunger. The needle may be configured to completely penetrate at least the distal stop member to at least partially retract into the plunger. The energy storage member locking member may be configured to transition from a locked state to an unlocked state after a second fluid has been expelled from the proximal chamber through the needle, at least partially retracting the needle into the plunger. The needle-holding feature may be configured to actuate the energy storage member locking member from a locked state to an unlocked state when the plunger assembly is manipulated to insert the proximal stop member into the distal end of the syringe body.

[0021] In one or more embodiments, the distance between the proximal opening and the distal end of the syringe body is substantially equal to the length of the distal stop member, such that when the distal stop member is inserted into the distal end of the syringe body, the proximal stop member is inserted distally relative to the needle to position the proximal opening in the proximal chamber. The proximal stop member, the distal stop member, and the syringe body may be configured such that a distally directed force applied to the proximal stop member is transmitted through a second fluid to the distal stop member until the proximal stop member is inserted distally relative to the needle to position the proximal opening in the proximal chamber.

[0022] In one or more embodiments, the system has a first injection configuration and a second injection configuration. In the first injection configuration, a proximal opening is disposed in a distal chamber or a distal stop member. In the second injection configuration, the proximal opening is disposed in a proximal chamber, thereby allowing a second fluid to be delivered from the proximal chamber through the proximal opening and the interior of the needle, and to flow out of the distal opening. The proximal and distal stop members may include respective first and second polymer coatings on their respective distal and proximal surfaces, such that the proximal chamber is defined by the syringe body and the first and second polymer coatings. The distal stop member may have a funnel-shaped portion that tapers proximally, and a space disposed at the tapered proximal end of the funnel-shaped portion. The intermediate opening may be adjacent to the distal end of the syringe body.

[0023] In another embodiment, a method for sequentially injecting a first fluid and a second fluid into a patient includes providing a system comprising a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop member and a distal stop member disposed within the syringe body, forming a proximal chamber between the proximal and distal stop members and a distal chamber between the distal stop member and the distal end of the syringe body. The system further includes a first fluid in the distal chamber and a second fluid in the proximal chamber. Additionally, the system includes a plunger configured for manual actuation to distally insert the proximal stop member relative to the syringe body. Furthermore, the system includes a needle having a needle interior, a distal opening, an intermediate opening, and a proximal opening, wherein the distal opening, intermediate opening, and proximal opening are fluidly connected through the needle interior. The method further includes advancing the plunger member to expel a first portion of the first fluid from the distal chamber through the needle interior and the distal opening. The method further includes advancing the plunger assembly to expel a second fluid from the proximal chamber through a proximal opening, the needle interior, and a distal opening. Additionally, the method includes further advancing the plunger assembly to expel a second portion of the first fluid from the proximal chamber through the needle interior and the distal opening.

[0024] In one or more embodiments, the method further includes automatically retracting the distal needle tip into the needle hub or syringe body as a second portion of the first fluid is discharged through the distal opening. The method may also include completely penetrating at least the distal stop member with the needle and retracting the needle at least partially into the plunger. The method may further include inserting the distal end of the needle into the patient before advancing the plunger member to discharge a first portion of the first fluid from the distal chamber, thereby positioning the distal opening of the needle within the patient before the first portion of the first fluid is discharged. The method may further include removing air from the distal chamber before inserting the distal end of the needle into the patient. Removing air from the distal chamber may include holding the syringe body in a substantially vertical position and manipulating the plunger member to distally insert the proximal stop member relative to the syringe body. Advancing the plunger member may distally insert the proximal stop member relative to the syringe body, thereby applying a distally directed force with the second fluid to distally insert the distal stop member relative to the syringe body, thereby discharging a first portion of the first fluid from the distal chamber through the needle interior and the distal opening.

[0025] In one or more embodiments, the system has a first injection configuration, a second injection configuration, and a third injection configuration. In the first injection configuration, a proximal opening is disposed in a distal chamber or a distal stop member. In the second injection configuration, a proximal opening is disposed in a proximal chamber, allowing a second fluid to transfer from the proximal chamber through the proximal opening and the needle interior, and to flow out through the distal opening. In the third injection configuration, the proximal and distal stop members are in contact with each other, and the proximal opening is blocked by the proximal and / or distal stop members. The system can be in the first injection configuration when the plunger member is advanced to expel a first portion of the first fluid from the distal chamber through the needle interior and the distal opening. The system can be in the second injection configuration when the plunger member is further advanced to expel the second fluid from the proximal chamber through the proximal opening, the needle interior, and the distal opening. The system can be in the third injection configuration when the plunger member is advanced to expel a second portion of the first fluid from the distal chamber through the needle interior and the distal opening.

[0026] In one or more embodiments, the needle includes a tubular member and a solid proximal feature structure coupled thereto, wherein an interior, a distal opening, a central opening, and a proximal opening are formed within the tubular member. The solid proximal feature structure can be coupled to the tubular member via a weld. The weld can be a fillet weld configured to reduce the cutting of the proximal stop member when the needle penetrates it, compared to a needle without a fillet weld. The distal end of the solid proximal feature structure can be disposed within the proximal end of the tubular member. The distal end of the solid proximal feature structure and the proximal end of the tubular member can define an annular lumen that fluidly connects the proximal opening to the interior, central opening, and distal opening of the needle.

[0027] In one or more embodiments, the proximal opening has a rounded edge configured to reduce the amount of cutting into the proximal stop member when the needle penetrates it, compared to a needle without a rounded edge. The proximal opening may be an elongated groove. The length of the elongated groove can provide tolerance for variations associated with the proximal and / or distal stop members. Variations associated with the proximal and / or distal stop members can be selected from the group consisting of: deformation of the proximal surface of the distal stop member, the position of the proximal stop member relative to the elongated groove, and the position of the distal stop member relative to the elongated groove. The length of the elongated groove can be between approximately 1 / 32 inch and approximately 1 / 16 inch. The length of the elongated groove can minimize backflow of the first and second fluids into the plunger.

[0028] In one or more embodiments, the distal stop member has a funnel-shaped section that tapers proximally, and a space disposed at the tapered proximal end of the funnel-shaped section. The method may further include the funnel-shaped section guiding a needle into the space at the tapered proximal end of the funnel-shaped section, thereby aligning a proximal feature of the needle with a needle-holding feature structure within the plunger. The intermediate opening may be adjacent to the distal end of the syringe body.

[0029] In another embodiment, a system for sequentially injecting liquids includes a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop, an intermediate stop, and a distal stop disposed within the syringe body, forming a proximal chamber between the proximal and intermediate stop members, an intermediate chamber between the intermediate and distal stop members, and a distal chamber between the distal stop member and the distal end of the syringe body. The system also includes a first liquid in the distal chamber, a second liquid in the intermediate chamber, and a third liquid in the proximal chamber. Furthermore, the system includes a plunger configured for manual actuation to distally insert the proximal stop relative to the syringe body. Additionally, the system includes a needle hub assembly coupled to the distal needle interface of the syringe body, the needle assembly including a needle. The needle may define a needle interior, a distal opening, an intermediate opening, and a proximal opening. The distal opening, intermediate opening, and proximal opening are fluidly connected through the needle interior. Manipulating the plunger assembly to insert the proximal stop assembly distally relative to the syringe body allows the first, second, and third fluids to be expelled sequentially through the needle.

[0030] In one or more embodiments, the plunger member is manipulated to insert the proximal stop member distally relative to the syringe body, thereby sequentially discharging a first fluid, a second fluid, and a third fluid through the needle in the following order: a first portion of the first fluid is discharged from the distal chamber, a second fluid is discharged from the intermediate chamber, a second portion of the first fluid is discharged from the distal chamber, and a third fluid is discharged from the proximal chamber.

[0031] In one or more embodiments, a plunger member is manipulated to distally insert a proximal stop member relative to the syringe body, thereby sequentially expelling a first fluid, a second fluid, and a third fluid through the needle in the following order: expelling the first fluid from the distal chamber, expelling the second fluid from the intermediate chamber, and expelling the third fluid from the proximal chamber. The needle may include a tubular member and a solid proximal feature structure coupled thereto, wherein the needle interior, distal opening, intermediate opening, and proximal opening may be formed in the tubular member. The solid proximal feature structure may be coupled to the tubular member by a weld. The weld may be a fillet weld configured to reduce the cutting of the proximal and intermediate stop members when the needle penetrates them, compared to a needle without a fillet weld. The weld may taper proximally. The solid proximal feature structure may be cold-formed. The distal end of the solid proximal feature structure may be disposed in the proximal end of the tubular member. The distal end of the solid proximal feature structure and the proximal end of the tubular member can define an annular lumen that fluidly connects the proximal opening to the needle interior, the intermediate opening, and the distal opening.

[0032] In one or more embodiments, the proximal opening has a rounded edge configured to reduce the amount of cutting into the proximal and intermediate stop members when the needle penetrates them, compared to a needle without a rounded edge. The proximal opening may be an elongated groove. The length of the elongated groove can provide tolerance for variations associated with the proximal, intermediate, and / or distal stop members. Variations associated with the proximal and / or distal stop members can be selected from the group consisting of: deformation of the proximal surface of the distal stop member, deformation of the proximal surface of the intermediate stop member, the position of the proximal stop member relative to the elongated groove, the position of the intermediate stop member relative to the elongated groove, and the position of the distal stop member relative to the elongated groove. The length of the elongated groove can be between approximately 1 / 16 inch and approximately 1 / 8 inch. The distance between the elongated groove and the solid proximal end minimizes backflow of the first, second, and third fluids into the plunger. The elongated groove can be formed using a grinding wheel.

[0033] In one or more embodiments, the first, second, and third dimensions of the distal, intermediate, and proximal chambers can be modified by the movement of the proximal, intermediate, and distal stop members relative to the syringe body. The plunger assembly may include a needle-holding feature disposed within the plunger, an energy storage member disposed within the plunger, and an energy storage member locking member disposed within the plunger. The needle hub assembly may include a needle hub and a needle-retaining member configured to engage a needle to the needle hub. When the plunger assembly is manipulated relative to the syringe body to transition the energy storage member locking member from a locked to an unlocked state, the needle may at least partially retract into the plunger. The needle may be configured to completely pierce at least the distal and intermediate stop members to at least partially retract into the plunger. The energy storage member locking member may be configured to transition from a locked to an unlocked state after a third fluid has been expelled from the proximal chamber through the needle, at least partially retracting the needle into the plunger. The needle-holding feature structure can be configured such that when the plunger member is manipulated to insert the proximal stop member into the distal end of the syringe body, the actuation energy storage member locking member changes from a locked state to an unlocked state.

[0034] In one or more embodiments, the proximal stop, intermediate stop, and distal stop, and the syringe body, can be configured such that a distally directed force applied to the proximal stop is transmitted via a third fluid to the intermediate stop and via a second fluid to the distal stop until the proximal stop is inserted distally relative to the needle to position the proximal opening in the intermediate chamber. The system can have a first injection configuration, a second injection configuration, and a third injection configuration. In the first injection configuration, the proximal opening is located in the distal chamber or the distal stop; in the second injection configuration, the proximal opening is located in the intermediate chamber, allowing the second fluid to transfer from the intermediate chamber through the proximal opening and the interior of the needle and out of the distal opening; in the third injection configuration, the proximal opening is located in the proximal chamber, allowing the third fluid to transfer from the proximal chamber through the proximal opening and the interior of the needle and out of the distal opening. The proximal stop and intermediate stop may include respective first and second polymer coatings on their respective distal and proximal surfaces, such that the proximal chamber is defined by the syringe body and the first and second polymer coatings. The distal stop may have a funnel-shaped section that tapers proximally, and a space disposed at the proximal conical end of the funnel-shaped section. The intermediate opening may be adjacent to the distal end of the syringe body.

[0035] In another embodiment, a method for sequentially injecting a first liquid and a second liquid into a patient includes providing a system comprising a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop member, an intermediate stop member, and a distal stop member disposed within the syringe body, forming a proximal chamber between the proximal and intermediate stop members, an intermediate chamber between the intermediate and distal stop members, and a distal chamber between the distal stop member and a distal end of the syringe body. The system further includes a first liquid in the distal chamber, a second liquid in the intermediate chamber, and a third liquid in the proximal chamber. Additionally, the system includes a plunger configured for manual actuation to distally insert the proximal stop member relative to the syringe body. Furthermore, the system includes a needle having a needle interior, a distal opening, an intermediate opening, and a proximal opening, wherein the distal opening, intermediate opening, and proximal opening are fluidly connected through the needle interior. The method also includes advancing the plunger member to expel a first portion of the first liquid from the distal chamber through the needle interior and the distal opening. The method further includes advancing the plunger assembly to expel a second fluid from the intermediate chamber through a proximal opening, the needle interior, and a distal opening. Additionally, the method includes further advancing the plunger assembly to expel a second portion of the first fluid from the proximal chamber through the needle interior and the distal opening. Furthermore, the method includes further advancing the plunger assembly to expel a third fluid from the proximal chamber through the proximal opening, the needle interior, and the distal opening.

[0036] In one or more embodiments, the method further includes automatically retracting the distal needle tip back into the needle hub or syringe body when a second portion of the first liquid is discharged through the distal opening.

[0037] In another embodiment, a method for sequentially injecting a first liquid and a second liquid into a patient includes providing a system comprising a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop member, an intermediate stop member, and a distal stop member disposed within the syringe body, forming a proximal chamber between the proximal and intermediate stop members, an intermediate chamber between the intermediate and distal stop members, and a distal chamber between the distal stop member and the distal end of the syringe body. The system also includes a first liquid in the distal chamber and a second liquid in the intermediate chamber. Furthermore, the system includes a third liquid in the proximal chamber. Additionally, the system includes a plunger configured for manual actuation to distally insert the proximal stop member relative to the syringe body, and a needle having a needle interior, a distal opening, an intermediate opening, and a proximal opening, wherein the distal opening, intermediate opening, and proximal opening are fluidly connected through the needle interior. The method further includes advancing the plunger member to expel the first liquid from the distal chamber through the needle interior and the distal opening. The method further includes advancing the plunger assembly to expel a second fluid from the intermediate chamber through a proximal opening, the needle interior, and a distal opening. Additionally, the system includes further advancing the plunger assembly to expel a third fluid from the proximal chamber through a proximal opening, the needle interior, and a distal opening.

[0038] In one or more embodiments, the method further includes automatically retracting the distal needle tip back into the needle hub or syringe body when a third liquid is discharged through the distal opening.

[0039] Some embodiments relate to injection systems. Specifically, some embodiments relate to a safety injection system with a needle assembly having channels that resist compression and structural failure. Other embodiments relate to a safety injection system with a needle assembly having a distal valve to prevent accidental ejection of the injectable through a distal opening in the body of the injection system.

[0040] In one embodiment, the syringe assembly includes a syringe body having a syringe interior, a proximal end, and a distal end, and a needle attachment interface disposed at its distal end. The assembly also includes a needle assembly having a proximal portion, an intermediate connector, and a distal portion. The assembly further includes a needle locking assembly configured to prevent proximal movement of the needle assembly in a closed state and to release the needle assembly in an open state to allow proximal movement. The proximal portion has a crescent-shaped or dumbbell-shaped cross-section. The needle assembly is configured to retract into the syringe body after injection using the syringe assembly.

[0041] In one or more embodiments, the proximal portion includes a plurality of blades, two of which form an angle of approximately 90°. The proximal portion may include a segment having a taper of approximately 12° to 15°. The proximal portion may include a reduced-diameter segment and a proximal tip having a distally extending portion of approximately 0.0075 inches relative to the reduced-diameter segment. The distal portion may include a sharp distal end.

[0042] In one or more embodiments, the assembly includes a proximal stop member and a distal stop member. The proximal and distal stop members, along with the syringe body, define a proximal chamber, and the distal stop member and the syringe body define a distal chamber. The needle assembly may include a radially extending annular flange adjacent to the proximal end of an intermediate connector. The distal portion may include a radially enlarged portion defining a longitudinal tube having a square / rounded square cross-sectional shape. The distal portion may include a radially smaller portion having a rounded triangular cross-sectional shape.

[0043] In one or more embodiments, the distal stop member includes a stop insert comprising a pair of tabs. The syringe assembly may be configured to transfer fluid from the proximal chamber to the distal chamber to mix with components in the distal chamber before ejecting a mixture of fluid and components from the distal chamber. The syringe assembly may be configured to eject fluid from the distal chamber before ejecting fluid from the proximal chamber. The proximal portion may have two separated segments, each segment having a crescent-shaped or dumbbell-shaped cross-section.

[0044] In another embodiment, the syringe assembly includes a syringe body having a syringe interior, a proximal end, and a distal end, and a needle assembly including a flow regulator disposed adjacent to the distal end of the syringe body.

[0045] In one or more embodiments, the flow regulator includes a housing defining a liquid port and a compliant pin. The flow regulator may include a resilient seal configured to form a fluid-tight seal between the housing and a distal end of the syringe body. The resilient seal may be configured to close the liquid port in the presence of low pressure within the internal chamber of the syringe body. The resilient seal may also be configured to open the liquid port in the presence of high pressure within the internal chamber of the syringe body. The assembly may include a stop member with a stop insert. The internal shape of the stop insert may be complementary to the external shape of the flow regulator.

[0046] Some embodiments relate to injection systems. Specifically, some embodiments relate to safety injection systems with needle assemblies having channels that resist compression and structural failure. Some embodiments relate to multi-chamber sequential injection systems and multi-chamber safety injection systems that move the needle into a protected structure to minimize accidental injury and contamination to the user from used needles.

[0047] In one embodiment, a system for sequentially injecting liquids includes a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop and a distal stop disposed within the syringe body, forming a proximal chamber between the proximal and distal stop members and a distal chamber between the distal stop member and the distal end of the syringe body. The system also includes a first liquid in the distal chamber and a second liquid in the proximal chamber. Furthermore, the system includes a plunger configured for manual actuation to distally insert the proximal stop relative to the syringe body. Additionally, the system includes a needle assembly having a proximal portion, an intermediate connector, and a distal portion. The proximal portion has a crescent-shaped or dumbbell-shaped cross-section. Actuating the plunger assembly to distally insert the proximal stop relative to the syringe body first expels the first liquid from the distal chamber through the needle, and then sequentially expels the second liquid from the proximal chamber through the needle.

[0048] In one or more embodiments, the distal portion includes a sharp distal end. The proximal portion and the intermediate connector may have corresponding diameters that are substantially equal to each other. The proximal portion may include a solid proximal feature structure, and the intermediate connector may include a tubular member. The solid proximal feature structure may be cold-formed. The distal end of the solid proximal feature structure may be disposed in the proximal end of the tubular member.

[0049] In one or more embodiments, the proximal portion forms a longitudinal channel on its surface. The length of the longitudinal channel may be substantially equal to the length of the distal stop member, such that when the distal stop member is inserted into the distal end of the syringe body, the proximal stop member is inserted distally relative to the needle to position the proximal end of the longitudinal channel in the proximal chamber. The proximal and distal stop members, as well as the syringe body, may be configured such that a distally directed force applied to the proximal stop member is transmitted through a second fluid to the distal stop member until the proximal stop member is inserted distally relative to the needle to position the proximal opening in the proximal chamber. The length of the longitudinal channel may provide tolerance for variations associated with the proximal and / or distal stop members. Variations associated with the proximal and / or distal stop members may be selected from the group consisting of: deformation of the proximal surface of the distal stop member, the position of the proximal stop member relative to the longitudinal channel, and the position of the distal stop member relative to the longitudinal channel.

[0050] In one or more embodiments, the distance between the longitudinal channel and the solid proximal end minimizes reverse leakage of the first and second fluids into the plunger. The longitudinal channel can be formed by stamping or injection molding.

[0051] In one or more embodiments, the system has a first injection configuration and a second injection configuration. In the first injection configuration, the proximal end of the longitudinal channel is disposed in the distal chamber or the distal stop member. In the second injection configuration, the proximal end of the longitudinal channel is disposed in the proximal chamber, thereby allowing a second fluid to transfer from the proximal chamber through the longitudinal channel and flow out from the distal opening of the distal portion of the needle assembly. The first and second dimensions of the distal and proximal chambers can be changed by movement of the proximal and distal stop members relative to the syringe body.

[0052] In one or more embodiments, the system further includes a needle hub assembly having a needle seat and a needle retaining member configured to removably engage a needle to the needle seat. The plunger assembly may include a needle-holding feature structure disposed within the plunger, an energy storage member disposed within the plunger, and an energy storage member locking member disposed within the plunger. When the plunger assembly is manipulated relative to the syringe body to transition the energy storage member locking member from a locked state to an unlocked state, the needle may at least partially retract into the plunger. The needle may be configured to completely pierce at least the distal stop member to at least partially retract into the plunger. The energy storage member locking member may be configured to transition from a locked state to an unlocked state after a second fluid has been expelled from the proximal chamber through the needle, at least partially retracting the needle into the plunger. The needle-holding feature structure may be configured to actuate the energy storage member locking member from a locked state to an unlocked state when the plunger assembly is manipulated to insert the proximal stop member into the distal end of the syringe body. The proximal stop member and the distal stop member may include a corresponding first polymer coating and a second polymer coating on their respective distal and proximal surfaces, such that the proximal chamber is defined by the syringe body and the first and second polymer coatings.

[0053] In another embodiment, the system for sequentially injecting liquids includes a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop and a distal stop disposed within the syringe body, forming a proximal chamber between the proximal and distal stop members and a distal chamber between the distal stop member and the distal end of the syringe body. The system also includes a first liquid in the distal chamber and a second liquid in the proximal chamber. Furthermore, the system includes a plunger configured for manual actuation to distally insert the proximal stop member relative to the syringe body. Additionally, the system includes a fluid transfer assembly having a proximal portion and an intermediate connector. The proximal portion has a longitudinal channel formed on its surface. The intermediate connector has a distal anchoring member. Actuating the plunger assembly to distally insert the proximal stop member relative to the syringe body first expels the first liquid from the distal chamber via a needle, and then sequentially expels the second liquid from the proximal chamber via a needle.

[0054] In one or more embodiments, the proximal portion is a solid metal elongated body, and the intermediate connector is a polymer body with a recess configured to receive the distal end of the proximal portion. The fluid transfer assembly can be molded from a polymer into a single piece. The fluid transfer assembly can also be formed from metal into a single piece.

[0055] In one or more embodiments, the distal anchoring member has a rectangular cross-sectional shape. The distal anchoring member may include a slot having a biasing member disposed therein, the biasing member configured to apply a radially outward force against the inner wall of the distal pin interface. The distal anchoring member may include a corrugated member configured to apply a radially outward force against the inner wall of the distal pin interface. The distal anchoring member may include a pair of flexible arms configured to apply a radially outward force against the inner wall of the distal pin interface. The distal anchoring member may include a rubber sleeve configured to increase friction between the distal anchoring member and the inner wall of the distal pin interface. The distal anchoring member may also include a proximal opening and a distal opening configured to pass beside the rubber sleeve.

[0056] In another embodiment, a system for sequentially injecting liquids includes a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop and a distal stop disposed within the syringe body, forming a proximal chamber between the proximal and distal stop members and a distal chamber between the distal stop member and the distal end of the syringe body. The system also includes a first liquid in the distal chamber and a second liquid in the proximal chamber. Furthermore, the system includes a plunger configured for manual actuation to distally insert the proximal stop member relative to the syringe body. Additionally, the system includes a fluid transfer assembly having a proximal portion and an intermediate connector. The intermediate connector has a distal anchoring member. Actuating the plunger assembly to distally insert the proximal stop member relative to the syringe body first expels the first liquid from the distal chamber via a needle, and then sequentially expels the second liquid from the proximal chamber via a needle.

[0057] In one or more embodiments, the proximal portion defines a plurality of arms at its distal end, and the intermediate connector is a polymer body with an opening configured to receive the arms of the proximal portion. The plurality of arms may taper radially outward to engage the proximal portion to the intermediate connector. The plurality of arms may taper radially outward to apply a radially outward force to the inner wall of the distal needle interface.

[0058] In one or more embodiments, the distal anchoring member includes a slot having a biasing member disposed therein. The distal anchoring member may define a pair of bumps in the slot. The biasing member may define a pair of slots configured to receive the pair of bumps. The biasing member may be configured to apply a radially outward force against the inner wall of the distal pin interface, the proximal portion of which may have a longitudinal channel formed on its surface.

[0059] In another embodiment, the system for sequentially injecting liquid includes a syringe body defining a proximal syringe opening and a distal needle interface thereat. The system also includes a proximal stop and a distal stop disposed within the syringe body, forming a proximal chamber between the proximal and distal stop members and a distal chamber between the distal stop member and the distal end of the syringe body. The system also includes a powdered drug component in the distal chamber and a liquid drug component in the proximal chamber. Furthermore, the system includes a plunger configured for manual actuation to distally insert the proximal stop member relative to the syringe body. Additionally, the system includes a needle assembly having a proximal portion, an intermediate connector, and a distal portion. The system also includes a one-way valve partially disposed in the distal needle interface and configured to minimize migration of the powdered drug component from the distal chamber to the needle assembly.

[0060] In one or more embodiments, manipulating the plunger assembly to insert the proximal stop member distally relative to the syringe body a first distance transfers a liquid drug component from the proximal chamber to the distal chamber to form a mixture of liquid and powdered drug components. Manipulating the plunger assembly to insert the proximal stop member distally relative to the syringe body a second distance allows the mixed liquid drug to be discharged through a one-way valve and needle assembly from the distal chamber.

[0061] In one or more embodiments, the distal portion includes a sharp distal end. The system may also include a needle retraction system disposed in the plunger member, the needle retraction system being configured to retract the needle assembly at least partially into the plunger member after injection. The one-way valve may include a proximal valve portion and a distal valve portion, and the proximal valve portion may include a sleeve extending distally from its center.

[0062] In one or more embodiments, the sleeve is configured to have a tightness tolerance with the distal valve portion of the needle assembly passing through it, such that powdered drug components cannot pass between the distal valve portion of the needle assembly and the sleeve. The tightness tolerance allows liquid drug to pass under pressure between the distal valve portion of the needle assembly and the sleeve. The sleeve may define multiple longitudinal channels on its surface.

[0063] In one or more embodiments, the proximal valve portion of the one-way valve defines an opening therethrough, and when the liquid drug is pressurized in the distal chamber, a liquid flow path is formed between the proximal and distal valve portions of the one-way valve, extending from the distal chamber through the opening, along a longitudinal channel through the needle assembly, and to the outside of the system. The proximal and distal valve portions of the one-way valve may be configured to have a tightness tolerance, preventing powdered drug components from passing between the proximal and distal valve portions. The tightness tolerance allows the liquid drug to pass between the proximal and distal valve portions of the one-way valve under pressure. The proximal valve portion may be rigid, and the distal valve portion may be flexible. When the liquid drug is pressurized in the distal chamber, at least a portion of the distal valve portion may bend away from the proximal valve portion.

[0064] The above and other embodiments of the present invention are described in the following detailed description. Attached Figure Description

[0065] The foregoing and other aspects of the embodiments are described in further detail with reference to the accompanying drawings, wherein the same elements in the different drawings are indicated by common reference numerals, wherein:

[0066] Figures 1A to 5C Several aspects of a conventional syringe configuration are shown.

[0067] Figure 6A-18A safe sequential injection method using a pre-filled dual-chamber sequential safety injection system is shown according to some embodiments.

[0068] Figure 19A-22 A safe sequential injection method using a pre-filled dual-chamber sequential safety injection system is shown according to some embodiments.

[0069] Figure 23A-24 A safe sequential injection method using a pre-filled dual-chamber sequential safety injection system is shown according to some embodiments.

[0070] Figure 25A-36 A sequential injection method using a pre-filled three-chamber sequential injection system is shown according to some embodiments.

[0071] Figures 37 to 42 A multi-chamber injection system according to some embodiments is shown, the system including a distal tubular member coupled to the distal end of the syringe body via a connector / retainer.

[0072] Figure 43A and Figure 43B Perspective and side views of a safety injection system according to some embodiments.

[0073] Figure 44A This is a perspective view of a pin header assembly according to some embodiments.

[0074] Figure 44B , Figure 45A , Figure 45B and Figure 46 Perspective views, exploded views, detailed longitudinal sectional views, and detailed perspective views of a needle assembly according to some embodiments.

[0075] Figure 47A and Figure 47B These are perspective and side views of the proximal portion of a needle assembly according to some embodiments.

[0076] Figures 48A-48B , Figures 49A-49B and Figures 50A-50B Perspective view, detailed perspective view, and axial / lateral sectional view of the proximal portion of the needle assembly according to two embodiments.

[0077] Figure 51 A theoretical pipeline according to some embodiments is schematically depicted.

[0078] Figure 52A and Figure 52B A detailed perspective view of the proximal portion and intermediate connector of the needle assembly according to two embodiments.

[0079] Figure 53 , Figures 54A-54B , Figure 55 , Figure 56 and Figure 57 The proximal tip of the needle assembly is shown in a side view, detailed perspective view (front and rear view), perspective view, axonometric view and perspective view of the proximal portion according to some embodiments.

[0080] Figures 58 to 61 A longitudinal sectional view of the multiple steps of injection and needle capture using a safety injection system according to some embodiments.

[0081] Figures 62 to 66 A longitudinal sectional view of the multiple steps of injection and needle capture using a safety injection system according to other embodiments.

[0082] Figure 67A and Figure 67B Perspective and side views of a dual-chamber safety injection system according to some embodiments.

[0083] Figure 68A and Figure 68B Perspective and exploded views of a fluid transfer assembly according to some embodiments.

[0084] Figure 69A , Figure 69B and Figure 70 Perspective and side views of the proximal portion of a fluid transfer assembly according to some embodiments.

[0085] Figure 71A , Figure 71C and Figure 71D This is a detailed perspective view of the proximal portion of a fluid transfer assembly according to some embodiments.

[0086] Figure 71B This is an axial view of the proximal portion of a fluid transfer assembly according to some embodiments.

[0087] Figure 72A , Figure 72B , Figure 73A , Figure 73B and Figure 73C Perspective view, side view and axial cross-sectional view of the distal connector of a fluid transfer assembly according to some embodiments.

[0088] Figure 74A and Figure 74B Detailed longitudinal and axial cross-sectional views of the distal connector of a fluid transfer assembly inserted into the distal end of the syringe body according to some embodiments.

[0089] Figure 75A and Figure 75B The following is a longitudinal sectional view and an exploded view of the distal connector of a stop member with a stop insert according to some embodiments.

[0090] Figure 76A , Figure 76B and Figure 76C This is a detailed perspective view of a stop member with a stop insert according to some embodiments.

[0091] Figure 77 Several steps of fluid transfer and injection using a dual-chamber injection system according to some embodiments are schematically depicted.

[0092] Figure 78A and Figure 78B Perspective and side views of a dual-chamber safe sequential injection system according to some embodiments.

[0093] Figure 79 A detailed longitudinal sectional view of a dual-chamber safe sequential injection system according to some embodiments.

[0094] Figure 80 Several steps of sequential injection using a dual-chamber injection system according to some embodiments are schematically depicted.

[0095] Figure 81 A detailed longitudinal sectional view of a dual-chamber safe sequential injection system according to some embodiments.

[0096] Figure 82 Several steps of injection using a dual-chamber injection system according to some embodiments are schematically depicted.

[0097] Figure 83A A detailed perspective view of a fluid transfer assembly according to some embodiments.

[0098] Figure 83B and Figure 84 This is a detailed perspective view of the proximal portion of a fluid transfer assembly according to some embodiments.

[0099] Figure 85 Several steps of sequential injection using a dual-chamber injection system according to some embodiments are schematically depicted.

[0100] Figure 86 A perspective view of a dual-chamber injection system with a flow regulator according to some embodiments.

[0101] Figures 87 to 91 A detailed perspective view of a dual-chamber injection system with a flow regulator according to some embodiments.

[0102] Figures 92 to 97 The longitudinal sectional views at varying levels of detail illustrate a safe sequential injection method using a pre-filled dual-chamber sequential safety injection system according to some embodiments.

[0103] Figure 98 This is a perspective view of a pin header assembly according to some embodiments.

[0104] Figure 99 This is a perspective view of a needle assembly according to some embodiments.

[0105] Figure 100 This is a detailed perspective view of the proximal component of a needle assembly according to some embodiments.

[0106] Figure 101 and Figure 102 These are perspective and longitudinal sectional views of the proximal component of the needle according to some embodiments.

[0107] Figure 103A and Figure 103B This is an axial cross-sectional view of the distal ends of the two proximal needle members according to some embodiments.

[0108] Figures 104 to 109 The longitudinal sectional views at varying levels of detail illustrate sequential injection methods using a pre-filled needleless dual-chamber sequential injection system according to some embodiments.

[0109] Figure 110 and Figure 111 Perspective views and exploded perspective views of a fluid transfer assembly according to some embodiments.

[0110] Figures 112A to 112C Perspective, longitudinal, and axial cross-sectional views of the fluid transfer proximal component according to some embodiments.

[0111] Figures 113 to 118 The longitudinal sectional views at varying levels of detail illustrate sequential injection methods using a pre-filled needleless dual-chamber sequential injection system according to some embodiments.

[0112] Figure 119 and Figure 120 This is a perspective view of a fluid transfer assembly according to some embodiments.

[0113] Figures 121A to 121C The images show longitudinal and axial cross-sectional views of the proximal side of fluid transfer according to some embodiments.

[0114] Figure 122 and Figure 123 This is a perspective view of a fluid transfer assembly according to some embodiments.

[0115] Figure 124 A detailed longitudinal sectional view of an injection system including fluid transfer connecting / joining components / parts according to some embodiments.

[0116] Figure 125A and Figure 125B Perspective views and exploded perspective views of fluid transfer connection components / parts according to some embodiments.

[0117] Figure 126A and Figure 126B Perspective and top views of the fluid transfer distal anchor of a fluid transfer connection member / part according to some embodiments.

[0118] Figure 127A and Figure 127B Perspective and side views of biasing members of fluid transfer connection members / parts according to some embodiments.

[0119] Figure 128 A detailed longitudinal sectional view of an injection system including fluid transfer connection components / parts according to some embodiments.

[0120] Figure 129A , Figure 129B and Figure 130 Perspective views, exploded perspective views, and exploded side views of fluid transfer connection components / parts according to some embodiments.

[0121] Figure 131 A detailed longitudinal sectional view of an injection system including fluid transfer connection components / parts according to some embodiments.

[0122] Figure 132A and Figure 132B Perspective and side views of fluid transfer connection components / parts according to some embodiments.

[0123] Figure 133 A detailed longitudinal sectional view of an injection system including fluid transfer connection components / parts according to some embodiments.

[0124] Figure 134A , Figure 134B and Figure 135 Perspective views, exploded perspective views, and longitudinal sectional views of fluid transfer connection components / parts according to some embodiments.

[0125] Figure 136 This is a longitudinal sectional view of a fluid transfer assembly installed within the syringe body according to some embodiments.

[0126] Figure 137 and Figure 138 These are perspective and longitudinal sectional views of a fluid transfer assembly according to some embodiments.

[0127] Figures 139A to 139C Perspective views, axial cross-sectional views, and longitudinal sectional views of the fluid transfer proximal component according to some embodiments.

[0128] Figure 140 A series of side views depict the assembly steps of a fluid transfer assembly according to some embodiments.

[0129] Figure 141 This is a longitudinal sectional view of a fluid transfer assembly installed within the syringe body according to some embodiments.

[0130] Figure 142 This is a perspective view depicting the assembly steps of a fluid transfer assembly according to some embodiments.

[0131] Figure 143 This is a longitudinal sectional view of a fluid transfer connection member / part installed within the syringe body according to some embodiments.

[0132] Figures 144A to 145C A series of perspective and longitudinal sectional views depict the assembly steps of fluid transfer connection components / parts according to some embodiments.

[0133] Figure 146 and Figure 147 The images show longitudinal sectional views and detailed longitudinal sectional views of a dual-chamber safety injection system including a check valve, according to some embodiments.

[0134] Figures 148A to 148C Perspective view, side view, and exploded view of the use of a one-way valve in a dual-chamber safety injection system according to some embodiments.

[0135] To better understand how the above and other advantages and objectives of the various embodiments are obtained, a more detailed description of the embodiments is provided with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements with similar structures or functions are indicated throughout by similar reference numerals. It should be understood that these drawings depict only certain illustrated embodiments and should not be considered as limiting the scope of the embodiments. Detailed Implementation

[0136] Exemplary pre-filled multi-chamber sequential injection system and method

[0137] I. Dual-chamber safe injection system and method

[0138] Figure 6A , Figure 6B and Figure 7The following are longitudinal side views, longitudinal sectional views, and detailed longitudinal sectional views of a pre-filled dual-chamber sequential safety injection system (100) according to some embodiments. The pre-filled dual-chamber sequential safety injection system (100) includes a conventionally available pre-filled syringe body (34) in which conventional, readily available proximal and distal stop members (32, 36) are provided. The proximal and distal stop members (32, 36), together with the syringe body (34), define a proximal chamber and a distal chamber (40, 42). A first liquid and a second liquid (252, 254) are contained in the distal and proximal chambers (42, 40), respectively. The proximal and distal stop members (32, 36) block the proximal and distal ends of the proximal chamber (40). The distal stop member (36) blocks the proximal end of the distal chamber (42). In some embodiments, the distal surface of the proximal stop member (32) and the proximal surface of the distal stop member (36) are both coated with a smooth polymer coating (e.g., PTFE or ETFE). The first and second polymer coatings of the proximal and distal stop members (32, 36) together define a proximal chamber (40) with the syringe body (34). The smooth polymer coating also serves to isolate the rubber of the proximal and distal stop members (32, 36) from the second liquid (254). The proximal and distal stop members (32, 36) can be as follows: Figure 6A and Figure 6B The orientation is shown, or the distal stop member (36) can be flipped so that the lubricating coating faces the distal chamber (42) so that the first liquid (252) in the distal chamber (42) contacts the lubricating coating for storage.

[0139] A needle hub assembly (606) is located at the distal end of the distal chamber (42). The needle hub assembly (606) includes a needle hub (608) and a needle assembly (“needle”) (76) removably connected thereto. In some embodiments, a needle cap member (not shown) may be mounted on the needle hub assembly (606) for storage. The dual-chamber sequential safety injection system (100) facilitates the sequential injection of a first liquid (252) from the distal chamber (42) followed by the injection of a second liquid (254) from the proximal chamber (40), depending on the extent to which the user sequentially inserts the plunger assembly (44) relative to the syringe body (34). The plunger assembly (44) includes a plunger housing member (69) coupled to the proximal stop member (32) and a plunger actuation interface (128). The first and second liquids (252, 254) located in the distal and proximal chambers (42, 40), respectively, can be any liquid or gel, such as a water-based or oil-based drug solution.

[0140] The dual-chamber sequential safety injection system (100) features a stoked needle configuration in which, when presented to the user, the needle hub assembly (606') is positioned to prepare for injection after removal of the needle cap assembly (not shown), which may contain a resilient sealing material on its inner surface to engage with the distal end of the needle (78) and / or the distal needle hub (608) during storage. Although the stoked needle is depicted in its mounted position, it can be removably coupled to the syringe body (34) using a Luer slide or Luer lock interface (not shown), the proximal end (50) of the needle (76); see Figure 7 The needle extends through the Luer interface and into the distal chamber (42). Alternatively, the needle may be fixedly or removably mounted on the sleeve body rather than on the flange of the syringe.

[0141] The needle (76) includes the proximal end of the needle (50; see also) Figure 7 ) and distal end of the needle (78; see Figure 6A and Figure 6B ), which is connected to the pin connecting member (83; see Figure 7 The needle connector (83) is a tubular member that connects to the pointed distal end (78) of the needle and also defines a distal opening (81). The needle connector (83) also defines a proximal opening and an intermediate opening (85, 80). The intermediate opening (80) is located adjacent to the distal end of the syringe body (34). The proximal opening (85) is located adjacent to the proximal end of the needle connector (83). The proximal end (50) of the needle is a solid proximal feature structure.

[0142] like Figure 12 As shown, the distal end (87) of the proximal end (50) of the solid needle is disposed inside the tubular needle connector (83). The proximal end (89) of the tubular needle connector (83) is welded to the proximal end (50) of the solid needle by fillet weld. The proximal end (89) of the tubular needle connector (83) tapers proximally to facilitate the needle (76) piercing a rubber stop, such as the distal stop (36), while reducing or avoiding cutting / shredding of the rubber stop (as described herein). Otherwise, cutting / shredding of the rubber stop would produce unwanted rubber particles that could interfere with the injection system and / or be injected into the patient. The proximal and distal edges (91) of the proximal opening (85) may also be rounded / rounded (e.g., by tumbling or grinding) to reduce or avoid cutting / shredding of the rubber stop during its penetration.

[0143] For example Figure 12As shown, the distal end (87) of the proximal end (50) of the solid needle and the tubular needle connecting member (83) define an annular cavity (93). The annular cavity (93) fluidly connects the proximal opening (85) to the interior of the needle (76) and the intermediate opening (80); see also Figure 7 The proximal opening (85) and distal opening (81) are fluidly connected to the interior of the needle via an annular lumen (93). This allows the proximal opening (85) to be located near the proximal end (89) of the tubular needle connector (83), thus allowing for a more compact system design. The fluid connection of the proximal opening (85) to the interior of the needle via an annular lumen (93) also allows for a greater portion of the distal end (87) of the proximal end (50) of the solid needle to be located within the tubular needle connector (83), thereby facilitating the manufacture of the pre-filled dual-chamber sequential safety injection system (100).

[0144] For example Figure 12 As shown, the proximal opening (85) is an elongated groove that can be formed in the tubular needle connector (83) using a grinding wheel. Using a grinding wheel facilitates mass production of the tubular needle connector (83). The length of the proximal opening (85) provides tolerance for variations associated with the proximal stop and / or the distal stop (32, 36). Variations associated with the proximal stop and / or the distal stop (32, 36) can be deformation of the proximal surface of the distal stop, the position of the proximal stop relative to the elongated groove, and / or the position of the distal stop relative to the elongated groove (as described herein). The length of the proximal opening (85) also minimizes or prevents backflow of the first and second fluids (252, 254) into the plunger. In some embodiments, the length of the proximal opening (85) is between approximately 1 / 32 inch and approximately 1 / 16 inch. The proximal and distal edges (91) of the proximal opening (85) may also be rounded (e.g., by tumbling or grinding) to reduce or avoid cutting / shredding of the rubber stop during its penetration, as described herein.

[0145] In short, the additional components of the dual-chamber sequential safety injection system (100) include a retraction system within the plunger member (44): a needle-holding feature structure; an energy storage member (e.g., a spring); and an energy storage member lock. Figures 6A to 24 In the illustrated embodiment, the main portion of the safety needle retraction hardware is located within the plunger housing (69). Additional components also include needle retaining members (e.g., O-rings, needle locks, and / or detents) within the needle holder (608). Additional components also include a funnel-shaped element in the distal stop member (36) to guide the proximal end of the needle (50) to the center of the distal stop member (36).

[0146] Figure 6A-18A safe sequential injection method using the pre-filled dual-chamber sequential safety injection system (100) described herein is illustrated according to some embodiments. Figure 6A , Figure 6B and Figure 7 A pre-filled dual-chamber sequential safety injection system (100) in a first-ready / ready-to-use configuration is depicted. The only difference between the first-ready configuration and the transport configuration (not shown) is that the needle cap member (not shown) present in the transport configuration has been removed in the first-ready configuration. In the first / ready configuration, the proximal opening (85) is disposed together with the intermediate opening (80) in the distal chamber (42). Thus, there is no flow path between the proximal chamber (40) and the distal opening (81). Therefore, any distally directed force applied to the plunger actuation interface (128) is transmitted through the plunger member (44), the proximal stop member (32), and the incompressible second fluid (254) in the proximal chamber (40) to move the distal stop member (36) distally relative to the syringe body (34). Moving the distal stop member (36) distally relative to the syringe body (34) increases the pressure in the distal chamber (42), which drives the first liquid (252) from the distal chamber (42) through the intermediate opening and the proximal opening (80, 85) and out of the distal opening (81).

[0147] Figure 8A , Figure 8B and Figure 9 A pre-filled dual-chamber sequential safety injection system (100) is depicted after the distal stop member (36) has been moved distally a first distance relative to the syringe body (34). The distal chamber (42) has partially contracted / reduced in size, and some of the first fluid (252) has been ejected from the pre-filled dual-chamber sequential safety injection system (100) through the distal opening (81). The distal movement of the distal stop member (36) relative to the syringe body (34) also causes the proximal end (50) of the needle (76) to penetrate the distal stop member (36). Figure 9 As shown, when the proximal end (50) of the needle (76) penetrates the distal stop member (36) in a proximal direction, the rubber material of the distal stop member (36) is deformed / tents in a proximal direction due to friction between the distal stop member (36) and the proximal end (50). This friction can be reduced by applying lubricant to multiple components of the pre-filled dual-chamber sequential safety injection system (100). The proximal opening (85) remains in the distal chamber (42) or is blocked by the distal stop member (36). Therefore, there is no flow path between the proximal chamber (40) and the distal opening (81), and as described above, the distal force applied to the plunger actuation interface (128) is still transmitted to the distal stop member (36).

[0148] Figure 10A, Figure 10B , Figure 11 and Figure 12 A pre-filled dual-chamber sequential safety injection system (100) is depicted after the distal stop member (36) has been moved distally (a distance greater than the first distance) relative to the syringe body (34) by a second distance. The distal chamber (42) has almost completely contracted / almost entirely disappeared, and most of the first fluid (252) has been ejected from the pre-filled dual-chamber sequential safety injection system (100) through the distal opening (81). Further distal movement of the distal stop member (36) relative to the syringe body (34) also causes the proximal end (50) of the needle (76) to penetrate the distal stop member (36) further. Figure 11 and Figure 12 As shown, when the proximal end (50) of the needle (76) penetrates the distal stop member (36) in a proximal direction, the rubber material of the distal stop member (36) deforms / stretches in a proximal direction due to friction between the distal stop member (36) and the proximal end (50). Also as... Figure 11 and Figure 12 As shown, with further penetration of the proximal end (50) of the needle (76), a proximal opening (85) is now positioned in the proximal chamber (40). Therefore, a flow path now exists between the proximal chamber (40) and the distal opening (81), and the distally directed force applied to the plunger actuation interface (128) now moves the proximal stop member (32) distally relative to the syringe body (34) to eject the second fluid (254) from the proximal chamber (40). The opening of the flow path between the proximal chamber (40) and the distal opening (81) places the pre-filled dual-chamber sequential safety injection system (100) in a second configuration in which the second fluid (254) can be ejected from the proximal chamber (40).

[0149] like Figure 12 As shown, when the proximal end (50) of the needle (76) penetrates the distal stop member (36) in the proximal direction, the length of the proximal opening (85) provides tolerance for the degree of deformation / stretching of the distal stop member (36). Specifically, even if the deformation / stretching of the distal stop member (36) exceeds expectations, the proximal opening (85) will still fluidly approach the side chamber (40) at the distal opening (81). Figure 12It is also shown that the proximal end (89) of the tubular needle connecting member (83) is welded to the proximal end (50) of the solid needle via a fillet weld that tapers proximally to facilitate the needle (76)'s penetration of the distal stop member (36) while minimizing or avoiding cutting / shredding of the distal stop member (36). Otherwise, cutting / shredding of the rubber stop member would produce unwanted rubber particles that could interfere with the injection system and / or be injected into the patient. The proximal and distal edges (91) of the proximal opening (85) are also rounded (e.g., by tumbling or grinding) to minimize or avoid cutting / shredding of the distal stop member (36) during its penetration.

[0150] Figure 13A , Figure 13B and Figure 14 A pre-filled dual-chamber sequential safety injection system (100) is depicted after the proximal stop member (32) has moved a first distance distally relative to the syringe body (34). The proximal chamber (40) has partially contracted / reduced in size, and some second fluid (254) has been ejected from the pre-filled dual-chamber sequential safety injection system (100) through the distal opening (81). Figure 14 As shown, because the proximal opening (85) is in the proximal chamber (40), there is now a flow path between the proximal chamber (40) and the distal opening (81). The flow path between the proximal chamber (40) and the distal opening (81) allows the proximal stop member (32) to move distally toward the distal stop member (36) by injecting some second fluid (254) through the proximal opening (85). Because the distal force applied to the plunger actuation interface (128) is transmitted to move the proximal stop member (32), the distal stop member (36) has essentially stopped moving at this point.

[0151] Figure 15A , Figure 15B and Figure 16 A pre-filled dual-chamber sequential safety injection system (100) is depicted after the proximal stop member (32) has been moved distally a second distance (further than the first distance) relative to the syringe body (34). The proximal chamber (40) has completely contracted / disappeared, and substantially all of the second fluid (254) has been ejected from the pre-filled dual-chamber sequential safety injection system (100) through the distal opening (81). Further distal movement of the proximal stop member (32) relative to the syringe body (34) also causes the proximal end (50) of the needle (76) to penetrate the proximal stop member (32) and enter the plunger assembly (44). With the penetration of the proximal stop member (32), the proximal end (50) of the needle (76) is captured by the needle-holding feature structure.

[0152] like Figure 16As shown, when the proximal chamber (40) contracts, the length of the proximal opening (85) provides tolerance for positional variations of the proximal and distal stop members (32, 36). Specifically, even if the proximal and distal stop members (32, 36) are positioned slightly differently when the proximal chamber (40) contracts, the proximal opening (85) will still fluidly approach the proximal chamber (40) at the distal opening (81). The length of the proximal opening (85) is also configured to prevent reverse leakage of the first and second fluids (252, 254) into the plunger assembly (44) by limiting the distance between the proximal opening (85) and the proximal end (50) of the solid needle, ensuring that the proximal opening (85) never enters the plunger assembly (44).

[0153] Figure 17A , Figure 17B and Figure 18 A pre-filled dual-chamber sequential safety injection system (100) is depicted after the proximal stop member (32) has moved a third distance (farther than the first and second distances) distally relative to the syringe body (34). As the proximal end (50) of the needle (76) moves further proximally into the plunger assembly (44), a storage member lock is actuated to release a storage member (spring) that at least partially pulls / retracts the needle (76) into / from the plunger assembly (44) to position the sharp distal end (78) of the needle (76) within the syringe body (34). The retraction of the needle (76) places the pre-filled dual-chamber sequential safety injection system (100) into a safe configuration for post-injection disposal.

[0154] Figure 19A-22 The latter part of a safe sequential injection method using the pre-filled dual-chamber sequential safety injection system (100') described herein, according to some embodiments, is depicted. Figure 19A , Figure 19B and Figure 20 A pre-filled dual-chamber sequential safety injection system (100') is depicted in the middle of a safe sequential injection method, in a position similar to... Figure 15A , 15B The method steps for using system (100) are described in 16. One difference between the pre-filled dual-chamber sequential safety injection systems (100, 100') is that the proximal end (50') and needle (76') of system (100') are longer than the corresponding proximal ends (50) and needles (76) of system (100). In this way, the proximal opening (85) of system (100') enters the proximal chamber (not shown, but see [reference]) before the distal chamber (42) substantially contracts. Figure 7 (40)). Therefore, in the corresponding Figure 6A-14 During the steps, only a first portion of the first liquid (252) is ejected from the distal chamber (42). Figure 20As shown, when the proximal chamber (40) has completely contracted / disappeared and substantially all of the second fluid (254) has been ejected from the pre-filled dual-chamber sequential safety injection system (100) through the distal opening (81), a second portion of the first fluid (252) remains in the distal chamber (42).

[0155] Figure 21A , Figure 21B and Figure 22 A pre-filled dual-chamber sequential safety injection system (100') is depicted after the proximal and distal stop members (32, 36) are moved distally relative to the syringe body (34) by a certain distance. The distal movement of the proximal and distal stop members (32, 36) relative to the syringe body (34) causes a second portion of the first liquid (252) to be ejected from the distal chamber (42) through the central opening (80). Figure 19A-22 The spray / injection pattern of the depicted embodiment is a first portion of the first liquid (252) in the distal chamber (42), followed by substantially all of the second liquid (254) in the proximal chamber (40), and finally a second portion of the first liquid (252) in the distal chamber (42). Figure 17A , Figure 17B and Figure 18 As shown and as described above, after the second portion of the first liquid (252) has been sprayed, the needle (76') retracts at least partially into the plunger assembly (44). Although in Figure 19A-22 The image depicts a specific portion of the first liquid (252), but the dimensions of multiple portions of the needle (76') can be modified to adjust the various portions of the first liquid (252).

[0156] Figure 23A , Figure 23B and Figure 24 A pre-filled dual-chamber sequential safety injection system (100”) in a first-ready configuration according to some embodiments is depicted. Multiple components of the pre-filled dual-chamber sequential safety injection system (100”) can be coupled with… Figure 6A-18 The corresponding components of the depicted pre-filled dual-chamber sequential safety injection system (100) are identical. One difference between the pre-filled dual-chamber sequential safety injection systems (100, 100”) is that, compared with... Figure 6A-18 Compared to the distal chamber (42) of the system (100) depicted, Figure 23A , Figure 23B and Figure 24The depicted system (100) has a larger distal chamber (42). Thus, the system (100″) is configured to inject more of the first fluid (252) from the larger distal chamber (42″). In fact, the distal chamber (42″) is larger because more of the first fluid (252) is added during the manufacturing process of the system (100″). The system (100″) can be used to inject more of the first fluid (252) in a manner similar to... Figure 6A-18 The method described herein involves sequentially injecting the first and second liquids (252, 254).

[0157] As shown in the pre-filled dual-chamber sequential safety injection system (100, 100', 100"), multiple components of the system (100, 100', 100") and their positions can be modified to tailor the amount of the first and second liquids (252, 254) to be injected, including portions of the first liquid (252) that can be injected before and after the second liquid (254).

[0158] II. Three-chamber injection system and method

[0159] Figure 25A , Figure 25B and Figure 26A pre-filled three-chamber sequential injection system (200) according to some embodiments is depicted in longitudinal side view, longitudinal sectional view, and detailed longitudinal sectional view. The pre-filled three-chamber sequential injection system (200) includes a conventional, off-the-shelf pre-filled syringe body (34) in which conventional, off-the-shelf proximal stop, intermediate stop, and distal stop (32, 33, 36) are provided. The proximal, intermediate, and distal stop (32, 33, 36) together with the syringe body (34) define a proximal chamber, an intermediate chamber, and a distal chamber (40, 41, 42). A first fluid, a second fluid, and a third fluid (252, 253, 254) are contained in the distal chamber, the intermediate chamber, and the proximal chamber (42, 41, 40), respectively. The proximal and intermediate stop (32, 33) block the proximal and distal ends of the proximal chamber (40). The intermediate stop and the distal stop (33, 36) block the proximal and distal ends of the intermediate chamber (41). The distal stop (36) blocks the proximal end of the distal chamber (42). In some embodiments, multiple surfaces of the proximal stop, intermediate stop, and distal stop (32, 33, 36) are coated with a smooth polymer coating (e.g., PTFE or ETFE) such that the coating, together with the syringe body (34), defines the distal chamber, intermediate chamber, and proximal chamber (42, 41, 40). The smooth polymer coating also serves to isolate the rubber of the proximal stop, intermediate stop, and distal stop (32, 33, 36) from the first liquid, the second liquid, and the third liquid (252, 253, 254), respectively. The proximal stop, intermediate stop, and distal stop (32, 33, 36) can be as follows: Figure 6A and Figure 6B The orientation shown, or the distal stop member (36) can be flipped.

[0160] The needle hub assembly (606) is located at the distal end of the distal chamber (42). The needle hub assembly (606) includes a needle hub (608) and a needle assembly (“needle”) (76) coupled thereto. In some embodiments, a needle cap member (not shown) may be mounted on the needle hub assembly (606) for storage. The pre-filled three-chamber sequential injection system (200) facilitates the sequential injection of a first portion of a first liquid (252) from the distal chamber (42), followed by the injection of a second liquid (253) from the intermediate chamber (41), followed by the injection of the remaining portion of the first liquid (252) from the distal chamber (42), and then the injection of a third liquid (254) from the proximal chamber (40), depending on the extent to which the user sequentially inserts the plunger assembly (44) relative to the syringe body (34). The plunger assembly (44) is coupled to the proximal stop member (32) and includes a connection to a plunger actuation interface (128). The first, second, and third liquids (252, 253, and 254) located in the distal, intermediate, and proximal chambers (42, 41, and 40), respectively, can be any liquid or gel, such as an aqueous or oil-based drug solution.

[0161] The pre-filled three-chamber sequential injection system (200) has a peg-supported needle configuration, wherein, when presented to the user, the needle hub assembly (606) is positioned in the ready-to-injection position, and after removal of the needle cap assembly (not shown), the needle cap assembly (not shown) may contain a resilient sealing material on its inner surface to engage with the distal end of the needle (78) and / or the distal needle hub (608) during storage. Although the peg-supported needle is illustrated in place, it can be removably coupled to the syringe body (34) using a Luer slider or Luer lock interface (not shown), the proximal end (50) of the needle (76); see Figure 26 The needle extends through the Luer interface and into the distal chamber (42). Alternatively, the needle may be fixedly or removably mounted on the sleeve body rather than on the flange of the syringe.

[0162] The needle (76) includes the proximal end of the needle (50; see also) Figure 26 ) and distal end of the needle (78; see Figure 6A and Figure 6B ), which is connected to the pin connecting member (83; see Figure 7 The needle connector (83) is a tubular member that connects to the pointed distal end (78) of the needle and defines a distal opening (81). The needle connector (83) also defines a proximal opening and a central opening (85, 80). The central opening (80) is located adjacent to the distal end of the syringe body (34). The proximal opening (85) is located adjacent to the proximal end of the needle connector (83). The proximal end (50) of the needle is a solid proximal feature structure.

[0163] The pre-filled three-chamber sequential injection system (200) comprises many identical components and is similar in design to... Figure 6A-18 The pre-filled dual-chamber sequential safety injection system (100) is assembled in the manner described. For example, a tubular needle connecting member (83) is welded to the proximal end (50) of a solid needle with a fillet weld configured to facilitate the needle (76) penetration of a rubber stop, such as the distal stop member (36), while reducing or avoiding cutting / shredding of the rubber stop (as described herein). The proximal and distal edges of the proximal opening (85) may also be rounded (e.g., by tumbling or grinding) to reduce or avoid cutting / shredding of the rubber stop during its penetration.

[0164] An elongated groove can be formed in the tubular needle connector (83) using a grinding wheel. Using a grinding wheel facilitates mass production of the tubular needle connector (83). The length configuration of the proximal opening (85) provides tolerance for variations associated with the proximal stop, intermediate stop, and / or distal stop (32, 33, 36). Variations associated with the proximal stop, intermediate stop, and / or distal stop (32, 33, 36) can be deformation of the proximal surface of the distal stop, deformation of the proximal surface of the intermediate stop, the position of the proximal stop relative to the elongated groove, the position of the intermediate stop relative to the elongated groove, and / or the position of the distal stop relative to the elongated groove (as described herein). In some embodiments, the length of the proximal opening (85) is between approximately 1 / 16 inch and approximately 1 / 8 inch. The proximal and distal edges of the proximal opening (85) may also be rounded (e.g., by tumbling or grinding) to reduce or avoid cutting / shredding of the rubber stop during its penetration, as described herein.

[0165] The additional components also include a funnel in the distal stop member (36) for guiding the proximal end (50) of the needle to the center of the distal stop member (36).

[0166] Figure 25A-36 A sequential injection method using the pre-filled three-chamber sequential injection system (200) described herein is illustrated according to some embodiments. Figure 25A , Figure 25B and Figure 26A pre-filled three-chamber sequential injection system (200) in a first / ready configuration is depicted. The only difference between the first / ready configuration and the transport configuration (not shown) is that the needle cap member (not shown) present in the transport configuration has been removed in the first / ready configuration. In the first / ready configuration, the proximal opening (85) is disposed together with the intermediate opening (80) in the distal chamber (42). Thus, there is no flow path between the intermediate chamber and the proximal chambers (41, 40) and the distal opening (81). Therefore, any distally directed force applied to the plunger actuation interface (128) is transmitted through the plunger member (44), the proximal stop member (32), the incompressible third fluid (254) in the proximal chamber (40), the intermediate stop member (33), and the incompressible second fluid (253) in the intermediate chamber (41) to move the distal stop member (36) distally relative to the syringe body (34). The distal stop member (36) moves distally relative to the syringe body (34), increasing the pressure in the distal chamber (42), which drives the first liquid (252) from the distal chamber (42) through the intermediate opening and the proximal opening (80, 85) and out of the distal opening (81).

[0167] Figure 27A , Figure 27B and Figure 28 A pre-filled three-chamber sequential injection system (200) is depicted after the distal stop member (36) has been moved distally a first distance relative to the syringe body (34). The distal chamber (42) has partially contracted / reduced in size, and some of the first fluid (252) has been ejected from the pre-filled three-chamber sequential injection system (200) through the distal opening (81). The distal movement of the distal stop member (36) relative to the syringe body (34) also causes the proximal end (50) of the needle (76) to penetrate the distal stop member (36). Figure 28 As shown, when the proximal end (50) of the needle (76) penetrates the distal stop member (36) in a proximal direction, the rubber material of the distal stop member (36) deforms / stretches in a proximal direction due to friction between the distal stop member (36) and the proximal end (50). This friction can be reduced by applying lubricant to multiple components of the pre-filled three-chamber sequential injection system (200). The proximal opening (85) remains in the distal chamber (42) or is blocked by the distal stop member (36). Therefore, there is no flow path between the intermediate chamber (41) and the distal opening (81), and as described above, the distal force applied to the plunger actuation interface (128) is still transmitted to the distal stop member (36).

[0168] Figure 29A , Figure 29B and Figure 30A pre-filled three-chamber sequential injection system (200) is depicted after the distal stop member (36) has been moved a second distance (further than the first distance) distally relative to the syringe body (34). The distal chamber (42) has further contracted, and a first portion of the first fluid (252) has been ejected from the pre-filled three-chamber sequential injection system (200) through the distal opening (81). Further distal movement of the distal stop member (36) relative to the syringe body (34) also results in further penetration of the proximal end (50) of the needle (76) through the distal stop member (36). Figure 30 As shown, when the proximal end (50) of the needle (76) penetrates the intermediate stop member (33) in a proximal direction, the rubber material that forms the distal stop member (36) deforms / stretches in a proximal direction due to friction between the distal stop member (36) and the proximal end (50). Also as... Figure 30 As shown, as the proximal end (50) of the needle (76) passes through the distal stop member (36), the proximal opening (85) is now positioned in the intermediate chamber (41). Therefore, a flow path now exists between the intermediate chamber (41) and the distal opening (81), and the distally directed force applied to the plunger actuation interface (128) now moves the intermediate stop member (33) distally relative to the syringe body (34) to eject the second liquid (253) from the intermediate chamber (41). The opening of the flow path between the intermediate chamber (41) and the distal opening (81) places the pre-filled three-chamber sequential injection system (200) in a second configuration in which the second liquid (253) can be ejected from the intermediate chamber (41).

[0169] Figure 31A , Figure 31B and Figure 32 A pre-filled three-chamber sequential injection system (200) is depicted after the intermediate stop member (33) moves distally relative to the syringe body (34) until it contacts the distal stop member (36). Intermediate chamber (41; see...) Figure 26 The syringe has contracted, and essentially all of the second fluid (253) has been ejected from the pre-filled three-chamber sequential injection system (200) through the distal opening (81). Further distal movement of the intermediate stop member (33) relative to the syringe body (34) also causes the proximal end (50) of the needle (76) to penetrate the intermediate stop member (33). Figure 32 As shown, when the proximal end (50) of the needle (76) penetrates the distal stop member (36) in a proximal direction, the rubber material of the intermediate stop member (33) deforms / stretches in a proximal direction due to friction between the intermediate stop member (33) and the proximal end (50). Also as... Figure 32As shown, as the proximal end (50) of the needle (76) passes through the intermediate stop member (33), the proximal opening (85) is now blocked by the intermediate stop member and the distal stop members (33, 36). Therefore, the only open flow path in the system (200) is from the distal chamber (42) through the distal opening (81) / intermediate opening (80) to the distal opening, and the distally directed force applied to the plunger actuation interface (128) now moves the intermediate stop member and the distal stop member (33, 36) distally relative to the syringe body (34) to eject a second portion of the first liquid (252) from the distal chamber (42). The reopening of the flow path between the distal chamber (42) and the distal opening (81) places the pre-filled dual-chamber sequential safety injection system (100) in a third configuration, in which a second portion of the first liquid (252) can be ejected from the distal chamber (42).

[0170] Figure 33A , Figure 33B and Figure 34 A pre-filled three-chamber sequential injection system (200) is depicted after the intermediate stop member and the distal stop member (33, 36) move distally relative to the syringe body (34) until the distal stop member (36) contacts the distal end of the syringe body (34). Distal chamber (42; see...) Figure 26 The syringe has contracted, and essentially all of the first fluid (252) has been ejected from the pre-filled three-chamber sequential injection system (200) through the distal opening (81). Further distal movement of the intermediate stop member (33) relative to the syringe body (34) also causes the proximal end (50) of the needle (76) to penetrate the intermediate stop member (33). Furthermore... Figure 34 As shown, as the proximal end (50) of the needle (76) passes through the intermediate stop member (33), the proximal opening (85) is now positioned in the proximal chamber (40). Therefore, a flow path now exists between the proximal chamber (40) and the distal opening (81), and the distally directed force applied to the plunger actuation interface (128) now moves the proximal stop member (32) distally relative to the syringe body (34) to eject a third fluid (254) from the proximal chamber (40). The opening of the flow path between the proximal chamber (40) and the distal opening (81) places the pre-filled dual-chamber sequential safety injection system (100) in a fourth configuration in which the third fluid (254) can be ejected from the proximal chamber (40).

[0171] Figure 35A , Figure 35B and Figure 36 A pre-filled three-chamber sequential injection system (200) is depicted after the proximal stop member (32) moves distally relative to the syringe body (34) until it contacts the intermediate stop member (33). Proximal chamber (40; see...) Figure 26 The system has contracted, and virtually all of the third fluid (254) has been ejected from the pre-filled three-chamber sequential injection system (200) through the distal opening (81). Figure 35A , Figure 35B and Figure 36 The completed state of the sequential injection method using a pre-filled three-chamber sequential injection system (200) is depicted.

[0172] Figure 25A-36 The spray / injection pattern of the depicted embodiment is as follows: a first portion of a first liquid (252) in the distal chamber (42), followed by substantially all of a second liquid (253) in the intermediate chamber (41), followed by a second portion of the first liquid (252) in the distal chamber (42), and finally substantially all of a third liquid (254) in the proximal chamber (40). Although in Figure 25A-36 The diagram depicts a specific portion of the first liquid (252), but the dimensions of multiple portions of the needle (76) can be modified to adjust the individual portions of the first liquid (252). Multiple components of the system (200) and their positions can be modified to tailor the amounts of the first, second, and third liquids (252, 253, 254) to be injected, including the portion of the first liquid (252) that can be injected. Although Figure 25A-36 The system (200) described herein does not include a safety needle retraction system, but the three-chamber sequential injection system can be modified to include a safety needle retraction system. Although Figure 25A-36 The depicted system (200) includes three chambers, but the injection system according to some embodiments may include more than three chambers.

[0173] Exemplary distal tube connector / retainer

[0174] Figures 37 to 42 A multi-chamber injection system (3700) is depicted, comprising a distal tubular member (3783) connected to the distal end (3782) of a syringe body (3734) via a connector / retainer (3784). The distal end (3782) of the syringe body (3734) may be a Luer lock connector for connection to a needle (not shown). Figure 37 The distal end (3782) of the syringe body (3734) with a cap (3786) attached thereto is shown. Figure 38 The distal end (3782) of the syringe body (3734) without the cap (3786) is shown.

[0175] Figure 39The connector / retainer (3784) is shown in more detail. The connector / retainer (3784) includes a rhomboid portion (3788) and a flat portion (3790). The rhomboid portion (3788) is elastically compressible to fit into the interior of the distal end (3782) of the syringe body (3734) from the proximal direction. Figure 41 and Figure 42 The diagram illustrates the insertion of a connector / retainer (3784) with a distal tubular member (3783) into the distal end (3782) of the syringe body (3734) during assembly. Once installed within the distal end (3782) of the syringe body (3734), the rhomboid portion (3788) is biased to expand, thereby increasing friction between the inner surface of the distal end (3782) of the syringe body (3734) and the rhomboid portion (3788) to resist longitudinal (e.g., proximal) movement of the connector / retainer (3784) and the distal tubular member (3783) connected thereto relative to the syringe body (3734).

[0176] The flat portion (3790) of the connector / retainer (3784) is larger in at least one dimension than the opening at the distal end (3782) of the syringe body (3734). Thus, the flat portion (3790) of the connector / retainer (3784) interferes with the distal end (3782) of the syringe body (3734) to limit the distal movement of the connector / retainer (3784) and the distal tubular member (3783) attached thereto relative to the syringe body (3734).

[0177] like Figure 40 As shown, after assembly, the flow path (3792) between the inside and outside of the syringe body (3734) is opened by the connector / retainer (3784).

[0178] The connector / retainer (3784) may be cut or stamped from a sheet metal (such as stainless steel) into a single piece, with the distal end of the rhomboid portion (3788) located in the middle of the cut / stamped part. The cut / stamped part may then be bent to form the rhomboid portion (3788). The material cut / stamped by the cut / stamped part makes the rhomboid portion (3788) elastic. The two parts forming the flat portion (3790) may be stacked on top of each other. The free end of the flat portion (3790) may include one or more tangs configured to fit into a distal opening at the distal end of the distal tubular member (3783) to facilitate the attachment of the connector / retainer (3784) to the distal tubular member (3783) (e.g., by welding).

[0179] III. Exemplary safe injection system

[0180] Figure 43Aand Figure 43B A single-chamber, peg-supported needle safety injection system (600) according to some embodiments is depicted. The safety injection system (600) includes a needle hub assembly (610) coupled to a syringe body (620), and a plunger member (630) coupled to a stop member (640) disposed inside the syringe body (620). The needle hub assembly (610) includes a needle assembly (650), such as those described below. The safety injection system (600) includes a needle retraction system. The needle retraction system is primarily disposed inside the plunger member (630). After injection, the needle retraction system applies a proximal force to the needle assembly (650) to at least partially pull the needle assembly (650) into the needle hub assembly (610) and / or the syringe body (620), such that the sharp distal tip (652) of the needle assembly (650) is disposed within the needle hub assembly (610) and / or the syringe body (620) to prevent accidental needle prick. In some embodiments, the force directed towards the proximal side is approximately 2 to approximately 3 pounds.

[0181] Exemplary pin component

[0182] Figures 44A to 58 Several needle components and their features according to various embodiments are described.

[0183] Figure 44A A needle hub assembly (610) with a rigid needle cover (612) is depicted according to some embodiments. Figure 44A The proximal end of the needle assembly (650) is also shown. Figure 44B A needle assembly (650) according to some embodiments is depicted.

[0184] Figure 45A for Figure 44B An exploded view of the depicted needle assembly (650). The needle assembly (650) includes a proximal portion (660) and a distal portion (654), each configured to be partially disposed in its respective proximal and distal ends of an intermediate connector (670). The distal end of the distal portion (654) includes a sharp distal tip (652) configured to pierce the target tissue for injection. The intermediate connector (670) includes an annular recess (672) configured to interfere with a needle lock to prevent the needle assembly (650) from retracting proximally before the injection is completed.

[0185] The proximal portion (660) includes a proximal tip (680) located at its proximal end and one or more longitudinal channels (662) extending from its distal end. Figure 45B It is a longitudinal sectional view of an intermediate connector (670) according to some embodiments, wherein the proximal and distal portions (660, 654) are partially disposed therein. Figure 45BThe proximal portion (660) is shown to include two longitudinal channels (662) formed on generally opposing surfaces of the proximal portion (660). The longitudinal channels (662) form two flow paths that enter the intermediate connector (670) from the outside of the needle assembly (650), then enter the distal portion (654) through a proximal opening (656) in the distal portion (654), and exit at the sharp distal tip (652) of the distal portion (654).

[0186] Figure 46 The proximal end of the intermediate connector (670) is depicted, into which the distal end of the proximal portion (660) is inserted until only the proximal end of the longitudinal channel (662) remains outside the intermediate connector (670). The proximal end of the longitudinal channel (662) forms an opening (664) that fluidly connects the interior and exterior of the needle assembly (650).

[0187] Figure 47A and Figure 47B The images show perspective and side views of the proximal portion (660) of a needle assembly (650) according to some embodiments. The proximal portion (660) can be formed by stamping a flat sheet of metal or a metal wire to form the various features of the proximal portion (660) described herein. The proximal portion (660) formed by stamping reduces manufacturing complexity and cost.

[0188] Figure 48A and Figure 48B This is a perspective view of two proximal portions (660A, 660B) according to two embodiments. Figure 49A and Figure 49B This is a detailed perspective view of the distal ends of the proximal portions (660A, 660B). Figure 50A and Figure 50B It is an axial cross-sectional view of the distal ends of the proximal portions (660A, 660B).

[0189] like Figure 50A and Figure 50B As shown in the optimal configuration, the axial cross-sections at the distal ends of the proximal portions (660A, 660B) form crescent and dumbbell shapes, respectively. The crescent and dumbbell shapes define one and two longitudinal channels (662A, 662B), respectively. The longitudinal channels (662A, 662B) have elliptical / circular cross-sections, which minimizes the restrictions on fluid flow through the longitudinal channels (662A, 662B). Circular cross-sections are efficient for fluid flow because they minimize the interaction between the fluid and the channel walls, which would otherwise impose zero-velocity boundary conditions on the flowing fluid. Minimizing wall exposure minimizes the amount of shear resistance experienced by the fluid during flow. This is because, according to the Hagen-Poiseuille formula:

[0190]

[0191] Theoretical pipeline 1400 (see) Figure 51 The resistance and r 4 Inversely proportional, so even if the cross-sectional area remains constant, it is inversely proportional to the dual-channel (662B) (see...). Figure 50B Compared to a single circular channel (662A) (see...) Figure 50A It may also have lower fluid flow resistance.

[0192] Even with longitudinal channels (662A, 662B) formed therein, the proximal portions (660A, 660B) possess sufficient bending moments of inertia to enhance rigidity and resistance to bending. In fact, the proximal portions (660A, 660B) resemble I-beams and exhibit similar rigidity characteristics. Resistance to bending is particularly important when the proximal portions (660A, 660B) pierce the stop member (640). Minimizing the bending of the proximal portions (660A, 660B) when they pierce the stop member (640) increases the likelihood of capturing the proximal tip (680) of the proximal portion (664), thereby enabling the retraction of the needle assembly (650) (see...). Figures 58 to 62 as well as Figures 63 to 66 ).

[0193] The diameters of the proximal portions (660A) and (660B) are also relatively large (e.g., about 0.026 inches, compared to a cold-formed proximal portion with a diameter of about 0.020 inches). The larger diameter of the proximal portion (660) results in a higher total bending moment of inertia and greater bending resistance, which also increases the likelihood of capture. The diameters of the proximal portions (660A) and (660B) are also very close to those of the intermediate portion (670), which can have a diameter of about 0.036 inches. The similarity in diameter makes the needle assembly (650) easier to retract through the stop member during retraction compared to the needle assembly made from the cold-formed proximal portion, because the proximal opening of the intermediate portion (670) is less likely to hook / obstruct the stop member during retraction due to the relatively small diameter difference between the intermediate portion (670) and the proximal portion (660).

[0194] Figure 52A and Figure 52B Detailed perspective views of the distal ends of the proximal portions (660A, 660B) show the cut-out sections of the intermediate connectors (670), in which the distal ends are partially disposed. For example... Figure 52A and Figure 52BAs shown, the crescent-shaped and dumbbell-shaped cross-sectional shapes of the proximal portions (660A, 660B) provide ample contact between the outer diameter of the proximal portions (660A, 660B) and the inner diameter of the tubular intermediate connector (670). This ample contact reduces the welding power required to connect the proximal portions (660A, 660B) and the tubular intermediate connector (670). This reduction in required welding power further minimizes the possibility of blockage of the channels (662A, 662B) caused by the shrinkage of the weld metal between the proximal portions (660A, 660B) and the tubular intermediate connector (670).

[0195] Figures 53 to 57 The proximal tip (680) of the proximal portion (664) is described in more detail. The proximal tip (680) includes a pyramidal proximal puncture tip (682), a moderately tapered middle portion (684), and a toroid-shaped distal flange (686). (See image.) Figure 56 As shown, the pyramid-shaped proximal puncture tip (682) comprises four faces / blades (683). As... Figure 53 As shown, when viewed from the side, the edge of the blade (683) defining the pyramidal proximal puncture tip (682) forms a tip of approximately 90°. Compared to the blunter 90° tip, the middle portion (684) has a sharper taper of approximately 12° to 15°. The sharper taper of the middle portion (684) reduces the force required to pierce the stop member.

[0196] A pyramidal proximal puncture tip (682) and a moderately tapered intermediate portion (684) form the composite tip shape of the proximal tip (680). The 90° pyramidal proximal puncture tip (682) is configured to hook / grip the distal surface of a stop member (640), which may be convex in shape and, in some embodiments, may be coated with a smooth, hard coating that does not slip off the distal surface of the stop member (640). The 12° to 15° intermediate portion (684) is configured to require a lower puncture force when the proximal tip (680) penetrates the stop member (640). The transition between the pyramidal proximal puncture tip (682) and the intermediate portion (684) is smooth and is therefore configured to minimize the funnel component from being hooked or jammed during the retraction of the needle assembly (650) by the proximal tip (680) capturing the proximal portion (664) of the proximal tip (680). Figures 58 to 62 as well as Figures 63 to 66 ).

[0197] The proximal portion (660) of the needle assembly (650) also includes a reduced diameter portion (664) immediately adjacent to the distal side tip (680). In embodiments where the proximal portion (660) of the needle assembly (650) is formed by stamping, the radial extension between the outer diameter of the annular distal flange (686) and the reduced diameter portion (664) can reach approximately 0.0075 inches. This relatively large extension (e.g., compared to a cold-formed proximal tip) increases the likelihood and safety of capturing the proximal tip (680) of the proximal portion (664), thereby enabling the retraction of the needle assembly (650) (see...). Figures 58 to 62 as well as Figures 63 to 66 ).

[0198] IV. Exemplary safe injection system

[0199] Figures 58 to 62 Injection and needle capture using a safety injection system (2100) according to some embodiments are depicted. Figure 58 A safe injection system (2100) is described, which includes having similar features Figures 53 to 57 The needle assembly (650) is depicted in the proximal portion (660) of an embodiment in a pre-injection configuration. The safety injection system (2100) includes a needle retraction system.

[0200] exist Figure 59 In the middle, the proximal tip (680) of the proximal portion (660) is about to pierce the stop member (640), which is shown as having a convex distal surface. The 90° pyramidal proximal piercing tip (682) of the proximal tip (680) is configured to hook / grab the distal surface (642) of the stop member (640) without slipping off. As mentioned above, the distal surface (642) of the stop member (640) may also be coated with a smooth, hard coating.

[0201] Figure 60 The continuous distal movement of the stop member (640) relative to the needle assembly (650) is depicted. The needle retraction system according to some embodiments includes a funnel member (632) configured to guide the proximal tip (680) into a needle-catching cup (634). A smooth transition between the pyramidal proximal puncture tip (682) and the intermediate portion (684) is configured to minimize the funnel member (632) from being hooked or jammed during the capture of the proximal tip (680) of the proximal portion (664) by the needle-catching cup (634).

[0202] Figure 61 and Figure 62The diagram illustrates the continuous distal movement of the stop member (640) relative to the needle assembly (650). The interaction between the proximal tip (680) and the funnel member (632) guides the proximal tip (680) into the needle-catching cup (634). The relatively large radial extension (approximately 0.0075 inches) between the outer diameter of the annular distal flange (686) of the proximal tip (680) and the tapered diameter portion (664) increases the likelihood and security of the proximal tip (680) being caught by the needle-catching cup (634). The relatively large radial extension also allows for a wider opening in the needle-catching cup (634) without affecting the retention of the proximal tip (680) after capture. The wider opening and the moderately tapered middle portion (684) allow the proximal tip (680) to insert into the needle-catching cup (634) without triggering a needle retraction mechanism (e.g., a spring-release lock).

[0203] Figures 63 to 66 Injection and needle capture using a safe injection system (2600) according to some embodiments are depicted. Figure 63 A safe injection system (2600) is described, which includes having similar features to... Figures 53 to 57 The needle assembly (650) of the proximal portion (660) of the depicted embodiment. The safe injection system (2600) includes a needle retraction system. Figures 58 to 62 The described safety injection system (2100) and Figures 63 to 66 The difference between the depicted safety injection systems (2600) is that, instead of a needle-catching cup (634) shown in the safety injection system (2100), the safety injection system (2600) includes a pair of self-tightening / self-excited tongues (634') forming a funnel-shaped element (632'). Furthermore, this pair of self-tightening tongues (634') is molded into the trigger component to reduce the number of components (e.g., for assembly).

[0204] Figure 63 A safe injection system (2600) is described, which includes having similar features to... Figures 53 to 57 The needle assembly (650) is depicted in the proximal portion (660) of an embodiment in a pre-injection configuration. The safety injection system (2600) includes a needle retraction system.

[0205] Figures 64 to 66Injection and needle capture are depicted as the stop member (640) moves distally relative to the needle assembly (650). The interaction between the proximal tip (680) and the funnel member (632') guides the proximal tip (680) proximal to the pair of self-tightening tongues (634'). The relatively large radial extension (approximately 0.0075 inches) between the outer diameter of the annular distal flange (686) of the proximal tip (680) and the reduced diameter portion (664) increases the likelihood and safety of the proximal tip (680) being captured by the self-tightening tongues (634'). The self-tightening tongues (634') are separated by two slots (636) (see...). Figure 65 The two slots (636) are parallel to the sidewalls and longitudinal axis of the needle-catching member. Due to the parallel construction of the slots (636) relative to the sidewalls of the needle-catching member, the tongue (634') tightens around the reduced diameter portion (664) of the needle assembly (650) when the proximal tip (680) is pulled distally relative to the tongue (634'), thus the tongue (634') is self-energized. The rotation of the tongue (634') and the portion of the funnel (632') away from the slots (636) contribute to this self-energizing feature. The needle-catching member also includes a pair of windows (638) that facilitate the rotation of the tongue (634').

[0206] The relatively large radial extension also allows for a wider opening between the self-tightening tongues (634') without affecting the retention of the proximal tip (680) after capture. In embodiments with a relatively large radial extension (e.g., 0.0075 inches), the self-tightening tongues (634') are configured to capture the proximal tip (680) with a pull force of up to 12 pounds. The wider opening and the moderately tapered middle portion (684) allow the proximal tip (680) to insert between the self-tightening tongues (634') without triggering a needle retraction mechanism (e.g., a spring-release lock).

[0207] V. Exemplary dual-chamber injection system

[0208] Figures 67A to 77A dual-chamber injection system (3600) with a fluid transfer assembly (3650) according to some embodiments is depicted. The fluid transfer assembly (3650) is similar to the needle assembly (650) described herein because it has one or more channels (3662) and a proximal tip (3680), similar to the corresponding channels (662) and proximal tip (680) in the needle assembly (650) described herein. The dual-chamber injection system (3600) includes a needle connector (3610) formed at the distal end of a syringe body (3620) and a plunger member (3630) coupled to a proximal stop member (3640) disposed inside the syringe body (3620). A distal stop member (3690) is also disposed inside the syringe body (3620). Although not shown here, the dual-chamber injection system (3600) may include a needle retraction system. The needle retraction system is disposed primarily inside the plunger member (3630).

[0209] Figure 68A and Figure 68B A fluid transfer assembly (3650) according to some embodiments is depicted. Figure 68B yes Figure 68A An exploded view of the depicted fluid transfer assembly (3650). The fluid transfer assembly (3650) includes a proximal portion (3660) configured to be partially disposed in the proximal end of an intermediate connector (3670). The fluid transfer assembly (3650) also includes a distal connector (3700) configured to receive the distal end of the intermediate connector, which in turn is configured to be partially disposed in the proximal end of the distal connector (3700). The intermediate connector (3670) includes a radially extending annular flange (3674) configured to interfere with a distal stop member (3690).

[0210] Figures 69A to 71D A proximal portion (3660) and several components thereof of a fluid transfer assembly (3650) according to some embodiments are depicted. The proximal portion (3660) of the fluid transfer assembly (3650) includes a proximal tip (3680), a longitudinal channel (3662), and a radially extending annular flange (3674). The proximal tip (3680) in the fluid transfer assembly (3650) is similar to the proximal tip (680) in the needle assembly (650) described herein. Specifically, the proximal tip (3680) includes a pyramidal proximal puncture tip (3682), a moderately tapered middle portion (3684), and an annular distal flange (3686) (see...). Figure 71AThese are structurally and functionally similar to the corresponding pyramidal proximal puncture tip (682), moderately tapered middle portion (684), and annular distal flange (686) of the proximal tip (680). Similar to the proximal tip (680), the transition between the pyramidal proximal puncture tip (3682) and the middle portion (3684) in the proximal tip (3680) is smooth. Therefore, the proximal tip (3680) is configured to prevent the funnel element (3696) from being hooked or jammed as much as possible during the passage of the proximal tip (3680) through the distal stop member (3690) (see See Figures 75A to 77 ).

[0211] like Figure 71B As shown, the longitudinal channel (3662) in the proximal portion (3660) of the fluid transfer assembly (3650) has an arcuate / circular cross-section, which minimizes the restriction on fluid flow through the longitudinal channel (3662).

[0212] like Figure 71C and Figure 71D As shown, the radially extending annular flange (3674) is configured to temporarily interfere with a pair of tongues (3698) in the stop insert (3694) to hold the distal stop member (3690) and the fluid transfer assembly (3650) in a transfer configuration relative to each other when a sufficiently large force is applied to the plunger member (3630) to transfer fluid through the longitudinal channel (3662) (see [reference]). Figures 75A to 77 The tongues (3698) are also configured to allow a radially extending annular flange (3674) to pass through them when additional force is applied to the plunger member (3630) after the transfer of fluid through the longitudinal channel (3662) is complete. The longitudinal channel (3662) is configured such that fluid flow stops after the annular flange (3674) has moved to the proximal side of the tongues (3698).

[0213] Figures 72A to 74B A distal connector (3700) according to various embodiments is depicted. The distal connector (3700) includes a radially enlarged proximal portion (3710) and a distal portion (3720). The radially enlarged proximal portion (3710) is configured to receive the distal end of an intermediate connector (3670) of a fluid transfer assembly (3650). Figure 73C As shown, the opening (3712) in the proximal portion (3710) has a square-round cross-sectional shape. Therefore, when the tubular intermediate connector (3670) with a circular cross-sectional shape is inserted into the opening (3712) of the proximal portion (3710) (see... Figure 74A A mechanical fit is formed between the distal end of the intermediate connector (3670) and the proximal portion (3710) of the distal connector (3700).

[0214] like Figure 73B and Figure 74B As shown, the distal portion (3720) is configured to fit into the distal opening of the syringe body (3620) to which the fluid transfer assembly (3650) is attached. The outer side of the distal portion (3720) has a rounded triangular cross-section. Therefore, when the distal connector (3700) is inserted into the opening (3622) at the distal end of the syringe body (3620) (see...) Figure 74A A mechanical fit is formed between the distal portion (3720) of the distal connector (3700) and the distal end of the syringe body (3620). Figure 74B Three channels (3730) formed between the exterior of the distal portion (3720) of the distal connector (3700) and the distal end of the syringe body (3620). These channels (3730) allow fluid to drain from the interior of the syringe body (3620) to the exterior of the syringe body (3620).

[0215] Figures 75A to 76C A distal stop member (3690) for use with a dual-chamber injection system according to some embodiments is depicted. The distal stop member (3690) includes an off-the-shelf rubber stop (3692) and a stop insert (3694) disposed therein. The stop insert (3694) includes a pair of elastically deformable tongues (3698) (see...). Figures 76A to 76B This forms part of the distally facing funnel member (3696). As described herein, when a sufficient amount of force is applied to the plunger member (3630) to transfer fluid through the longitudinal channel (3662) in the fluid transfer assembly (3650), the tongue (3698) is configured to temporarily interfere with the radially extending annular flange (3674) of the fluid transfer assembly (3650) to hold the distal stop member (3690) and the fluid transfer assembly (3650) in a transfer configuration relative to each other (see See...). Figure 77 The tongue (3698) is also configured to allow a radially extending annular flange (3674) to pass through it when additional force is applied to the plunger member (3630) after the transfer of fluid through the longitudinal channel (3662) is completed.

[0216] Figure 77 Several steps of fluid transfer and injection (4000) using a dual-chamber injection system such as the system (3600) described herein are illustrated. In step (4010), the system is in a delivery configuration in which the proximal tip (3680) is positioned against the distal surface of a rubber stop (3692).

[0217] In step (4020), sufficient force has been applied to the plunger assembly (3630) to drive the distal stop member (3690) distally against the proximal tip (3680), thereby piercing the rubber stop member (3692). When the delivery tube assembly (3650) and the distal stop member (3690) are in the positions depicted in step (4020), the system is in a fluid delivery configuration in which the proximal and distal chambers are fluidly connected via a longitudinal channel (3662) in the needle assembly (3650). As described herein, interference between the tongue (3698) of the stop insert (3694) and the radially extending annular flange (3674) of the needle assembly (3650) will be maintained in the fluid delivery configuration while force continues to be applied to the plunger assembly (3630) to deliver fluid from the proximal chamber to the distal chamber.

[0218] In step (4030), the proximal stop member (3640) has moved distally until it contacts the distal stop member (3690), thereby completing the fluid transfer. At this point, since the fluid transfer has stopped, an additional force can be applied to the distal stop member (3690).

[0219] In step (4040), the increased force applied to the distal stop member (3690) overcomes the interference between the tongue (3698) of the stop insert (3694) and the radially extending annular flange (3674) of the needle assembly (3650) to move the distal stop member (3690) distally relative to the fluid transfer member (3650), thereby ejecting fluid from the distal chamber to the outside of the syringe body (3620).

[0220] In step (4050), the ejection of fluid from the distal chamber to the outside of the syringe body (3620) is completed. The distal stop member (3690) has moved to the distal end of the syringe body (4020).

[0221] VI. Exemplary sequential safety injection system

[0222] Figures 78A to 85Sequential safety injection systems (4200, 4400) with needle assemblies (4650, 4750) according to some embodiments are depicted. The needle assemblies (4650, 4750) are similar to the needle assembly (650) described herein, having one or more channels (4662) and a proximal tip (4680), similar to the corresponding channels (662) and proximal tips (680) in the needle assembly (650) described herein. The sequential safety injection systems (4200, 4400) include a needle hub assembly (4610) coupled to a syringe body (4620), and a plunger member (4630) coupled to a proximal stop member (4640) disposed within the syringe body (4620). A distal stop member (4690) is also disposed within the syringe body (4620). The sequential safety injection system (4600) also includes a needle retraction system. The needle retraction system is primarily disposed within the plunger member (4630).

[0223] Figure 79 A sequential safety injection system (4200) according to some embodiments is depicted. The sequential safety injection system (4200) includes a needle assembly (4650) having a proximal portion (4660) and a distal portion (4654), each portion configured to be partially disposed in a corresponding proximal and distal end of an intermediate connector (4670). The needle assembly (4650) is similar to the needle assembly (650) described herein, having one or more channels and a proximal tip, similar to the corresponding channel (662) and proximal tip (680) in the needle assembly (650) described herein. The intermediate connector (4670) includes an annular recess (4672) configured to interfere with a needle lock to prevent the needle assembly (4650) from retracting proximally before the injection is completed. The intermediate connector (4670) also includes a vent opening (4676) for releasing pressure accumulated during injection.

[0224] Figure 80 Several steps of sequential injection (4300) using a dual-chamber injection system (such as the system (4200) described herein) are described. At step (4310), the system is in a delivery configuration in which the proximal tip of the needle assembly is positioned against the distal surface of the rubber stop of the distal stop member (4290).

[0225] In step (4320), sufficient force has been applied to the plunger assembly to drive the distal stop member (4290) distally against the proximal tip, thereby piercing the rubber stop. The distal movement of the distal stop member (4290) ejects fluid from the distal chamber through the longitudinal channel in the needle assembly (4650).

[0226] In step (4030), the distal stop member (4290) has moved distally until it is located at the distal end of the syringe body (4620), thereby completing the fluid transfer from the distal chamber. Because the longitudinal channel is no longer fluidly connected to the distal chamber, the fluid transfer from the distal chamber also ceases. Conversely, the movement of the distal stop member (4290) brings the longitudinal channel into fluid communication with the proximal chamber.

[0227] In step (4040), the proximal stop member (4240) has moved distally until it contacts the distal stop member (4290), thereby completing the fluid transfer from the proximal chamber. Thus, the system (4200) has been used to sequentially inject fluid first from the distal chamber and then from the proximal chamber. After fluid injection from both the distal and proximal chambers, the needle retraction system can apply a proximal force to the needle assembly (4650) to at least partially pull the needle assembly (4650) into the interior of the needle hub assembly (4610) and / or the syringe body (4620), such that the sharp distal tip of the needle assembly (4650) is positioned within the needle hub assembly (4610) and / or the syringe body (4620) to prevent accidental needle puncture.

[0228] Figure 81 and Figure 82 A dual-chamber safety injection system (4400) according to some embodiments is described. Figure 81 and Figure 82 The described safety injection system (4400) and Figure 79 and Figure 80 The difference between the described sequential safety injection systems (4200) is that the safety injection system (4200) includes a distal slot (4676) in the intermediate connector (4670), while the safety injection system (4400) does not include a distal slot in the intermediate connector (4670). The distal chamber of the dual-chamber safety injection system (4400) does not store fluid drug / injection agent. Figure 82 The sequence of steps (4510) to (4540) (4500) depicted is designed to minimize the interaction between the stainless steel components of the needle assembly (4650) and the drug stored in the proximal chamber of the dual-chamber safety injection system (4400) during long-term storage of the pre-filled dual-chamber safety injection system (4400). The drug and the stainless steel components only come into brief contact during injection. The dual-chamber safety injection system (4400) may include only a polymer locking mechanism to further minimize the interaction between the injectable and the metal. Figure 82 The steps (4510) to (4540) described in the text are almost identical to Figure 80Steps (4310) to (4340) described herein are identical, except that no fluid drug / injection is stored in the distal chamber of the dual-chamber safety injection system (4400). Therefore, steps (4520) and (4530) only introduce the needle assembly (4650) into the proximal chamber for injecting fluid therein (immediately after the introduction of the needle assembly (4650)).

[0229] Figures 83A to 85 Multiple components of a needle assembly (4550) for use with a sequential safety injection system (e.g., the system (4200, 4400) described herein) according to some embodiments are depicted. Figures 83A to 85 The depicted needle assembly (4550) and Figures 78A to 82 The difference between the depicted needle assemblies (4650) is that the needle assembly (4550) includes two longitudinally separated longitudinal channels (4562A, 4562B) (see...). Figure 83B and Figure 84 (instead of a single vertical channel),

[0230] Figure 83A A needle assembly (4550) for use with a safe sequential injection system according to some embodiments is depicted. The needle assembly (4550) has a proximal portion (4560) and a distal portion (4554), each configured to be partially disposed in the respective proximal and distal ends of an intermediate connector (4570). The needle assembly (4550) is similar to the needle assembly (650) described herein, having one or more channels and a proximal tip, similar to the corresponding channel (662) and proximal tip (680) in the needle assembly (650) described herein. The intermediate connector (4570) includes an annular recess (4572) configured to interfere with a needle lock to prevent the needle assembly (4550) from retracting proximally before the injection is completed.

[0231] Figure 83B A proximal portion (4560) of a needle assembly (4550) according to some embodiments is depicted. The proximal portion (4560) has a distal longitudinal channel (4562A) and a proximal longitudinal channel (4562B). The proximal portion (4560) also has a proximal tip (4580) similar to the proximal tip (680) described herein. Figure 84 The proximal portion (4560) is depicted in more detail, showing the proximal longitudinal channel (4562B). The distal longitudinal channel (4562A) is configured to provide an outlet from the distal chamber to the outside of the syringe body (4520). The proximal longitudinal channel (4562B) is configured to provide an outlet from the proximal chamber to the outside of the syringe body (4520).

[0232] Figure 85Several steps of sequential injection (4800) using a dual-chamber injection system having the needle assembly (4550) described herein are described. In step (4810), the system is in a delivery configuration in which the proximal tip (4580) of the needle assembly (4550) is disposed against the distal surface of the rubber stop of the distal stop member (4690).

[0233] In step (4820), sufficient force has been applied to the plunger assembly (4630) to drive the distal stop member (4690) distally against the proximal tip (4580), thereby piercing the rubber stop. The distal movement of the distal stop member (4690) ejects fluid from the distal chamber through the distal longitudinal channel (4562A) in the needle assembly (4550).

[0234] In step (4830), the distal stop member (4690) has moved distally until it is located at the distal end of the syringe body (4620), thus completing the fluid transfer from the distal chamber. Because the proximal longitudinal channel (4562B) is fluidly connected to the proximal chamber, the fluid transfer from the distal chamber also stops. At this point, fluid transfer from the proximal chamber can begin through the proximal longitudinal channel (4562B).

[0235] In step (4040), the proximal stop member (4840) has moved distally until it contacts the distal stop member (4690), thereby completing the fluid transfer from the proximal chamber through the proximal longitudinal channel (4562B). Thus, the system has been used to sequentially inject fluid first from the distal chamber and then from the proximal chamber. After fluid injection from both the distal and proximal chambers, the needle retraction system can apply a proximal force to the needle assembly (4550) to at least partially pull the needle assembly (4550) into the interior of the needle hub assembly (4610) and / or the syringe body (4620), such that the sharp distal tip of the needle assembly (4550) is positioned within the needle hub assembly (4610) and / or the syringe body (4620) to prevent accidental needle prick.

[0236] VII. Exemplary injection system with valve

[0237] Figures 86 to 91 An injection system (4900) with a flow regulator (4950) is depicted according to some embodiments. Figure 86An injection system (4900) is described, which is a dual-chamber injection system with a flow regulator (4950). The injection system (4900) includes a conduit (4910) coupled to a syringe body (4920) and a plunger member (4930) coupled to a proximal stop member (4940) disposed within the syringe body (4920). The needle hub assembly (4910) also includes a distal stop member (4990) disposed within the syringe body (4920). The proximal and distal stop members (4940, 4990) define a proximal chamber (4942). The distal stop member (4990) and the distal end of the syringe body (4920) define a distal chamber (4992). The proximal and distal chambers (4942, 4992) can contain liquids and / or lyophilized powders configured to be mixed prior to injection.

[0238] During the mixing of drug components using a dual-chamber injection system, pressure can build up in the distal chamber, which may unintentionally / prematurely eject some drug components from the distal chamber of existing systems. The flow regulator (4950) in the injection system (4900) described herein minimizes and / or prevents unintentional / premature injection of drug components from the distal chamber (4992) during mixing and unintentional migration of drug components from the distal chamber through the distal opening during transport.

[0239] Figure 88 A flow regulator (4950) installed in an injection system (4900) according to some embodiments is described in more detail. The flow regulator (4950) includes a housing (4952) defining a harpoon mount (4954) configured to engage (e.g., by mechanical engagement) with the distal end of a transfer conduit (4910). The housing (4952) also defines a liquid port (4956) configured to provide an outlet from a distal chamber (4992) to the outside of the syringe body (4920). The flow regulator (4950) also includes a resilient seal (4958). The housing (4952) further defines a compliant pin (4960) configured to wed into the inner diameter of a distal opening (4922) of the syringe body (4920). The compliant pin (4960) is hollow to provide a selectively open flow path between the liquid ports (4956) through the compliant pin (4960) and out of the distal opening (4920).

[0240] Figure 88 and Figure 89 A detailed longitudinal sectional view of the flow regulator (4950) installed in the injection system (4900), showing the flow regulator (4950) in the off position. Figure 88 Construct and open ( Figure 89The resilient seal (4958) in the flow regulator (4950) is configured and / or biased to remain closed when the pressure in the distal chamber (4992) is below a predetermined pressure (e.g., 5 psi). Pressure in the distal chamber (4992) above the predetermined pressure will push the resilient seal (4958) open.

[0241] Figure 88 A flow regulator (4950) in a closed configuration is shown. With low pressure in the distal chamber (4992), a resilient seal (4958) is biased to close the liquid port (4956) defined by the housing (4952) (see paths A and B). Furthermore, the resilient seal (4958) provides a fluid tight seal between the housing (4952) and the distal end of the syringe body (4920) (see path C). Thus, with the flow regulator (4950) in place and low pressure in the distal chamber (4992), all potential flow paths (A, B, and C) are closed to prevent unintentional / premature ejection of drug components from the distal chamber (4992).

[0242] Figure 89 A flow regulator (4950) in an open configuration is shown. With high pressure in the distal chamber (4992) (e.g., during injection), a resilient seal (4958) is pushed away from the liquid port (4956) defined by the housing (4952) to open paths A and B. However, the resilient seal (4958) continues to provide a fluid tight seal between the housing (4952) and the distal end of the syringe body (4920) (see path C). Thus, with the flow regulator (4950) in place and high pressure in the distal chamber (4992), two of the three flow paths (A and B) are open to allow the mixed drug to be ejected from the distal chamber (4992).

[0243] Figure 90 and Figure 91 The end of injection using the dual-chamber injection system (4900) described herein is depicted. At the end of injection of the mixed drug from the distal chamber (4992), the distal stop member (4990) is located at the distal end of the syringe body (4920). When a flow regulator (4950) is added to the system (4900), the complementary conical shapes of the guide (4994) in the distal stop member (4990) and the flow regulator (4950) minimize space loss. The flow regulator (4950) described herein minimizes and / or prevents unintentional / premature injection of drug components from the distal chamber (4992).

[0244] VIII. Exemplary pre-filled dual-chamber sequential safety injection system and method

[0245] Figures 92 to 94A longitudinal sectional view and two increasingly detailed longitudinal sectional views are depicted for a pre-filled dual-chamber sequential safety injection system (100”') according to some embodiments. The pre-filled dual-chamber sequential safety injection system (100”') includes a conventional, off-the-shelf pre-filled syringe body (34) in which conventional, off-the-shelf proximal and distal stop members (32, 36) are provided. The proximal and distal stop members (32, 36), together with the syringe body (34), define a proximal chamber and a distal chamber (40, 42). A first fluid and a second fluid (252, 254) are contained in the distal and proximal chambers (42, 40), respectively. The proximal and distal stop members (32, 36) block the proximal and distal ends of the proximal chamber (40). The distal stop member (36) blocks the proximal end of the distal chamber (42). In some embodiments, the distal surface of the proximal stop member (32) and the proximal surface of the distal stop member (36) are both coated with a smooth polymer coating (e.g., PTFE or ETFE). The first and second polymer coatings of the proximal and distal stop members (32, 36) together define a proximal chamber (40) with the syringe body (34). The smooth polymer coating also serves to isolate the rubber of the proximal and distal stop members (32, 36) from the second liquid (254). The proximal and distal stop members (32, 36) can be as follows: Figures 92 to 94 The orientation is shown, or the distal stop member (36) can be flipped so that the lubricating coating faces the distal chamber (42) so that the first liquid (252) in the distal chamber (42) contacts the lubricating coating for storage.

[0246] The needle hub assembly (606') is located at the distal end of the distal chamber (42). The needle hub assembly (606') includes a needle hub (608) and a needle assembly (“needle”) (76”) removably coupled thereto. In some embodiments, a needle cap member (not shown) may be mounted on the needle hub assembly (606') for storage. The pre-filled dual-chamber sequential safety injection system (100”') facilitates the sequential injection of a first fluid (252) from the distal chamber (42) followed by the injection of a second fluid (254) from the proximal chamber (40), depending on the user's sequential insertion of the plunger assembly (44) relative to the syringe body (34) to varying degrees. The plunger assembly (44) includes a plunger housing member (69) coupled to the proximal stop member (32) and the plunger actuation interface (128). The first and second liquids (252, 254) located in the distal and proximal chambers (42, 40), respectively, can be any liquid or gel, such as water-based or oil-based drug solutions.

[0247] The pre-filled dual-chamber sequential safety injection system (100”') features a peg-supported needle configuration in which, when presented to the user, the needle hub assembly (606”') is positioned to prepare for injection after removal of the needle cap assembly (not shown), which may contain a resilient sealing material on its inner surface to engage with the distal needle member (78) and / or the distal needle hub (608) during storage. Although the peg-supported needle is depicted in its installed position, it may be removably coupled to the syringe body (34) (e.g., using a Luer slider or Luer lock interface (not shown)), where the proximal member (50; see Figure 93 and Figure 94 The needle extends through the Luer interface and into the distal chamber (42). Alternatively, the needle may be fixedly or removably mounted on the sleeve body rather than on the flange of the syringe.

[0248] The needle assembly (76”) includes a proximal needle member (50; see also) Figure 93 and Figure 94 ) and distal component of the needle (78; in Figure 93 and Figure 94 (Omitted in Chinese; see also) Figure 92 ) Connected to the pin connecting member (83; see Figure 93 and Figure 94 The needle assembly (76”) consists of the opposite (i.e., their respective proximal and distal) ends. The needle connecting member (83') is a tubular member connected to the distal needle member (78), which also defines a pointed distal end (81) having a distal opening (82). The needle assembly (76”) defines a proximal longitudinal channel (85’) and an intermediate opening (80’). The intermediate opening (80’) is disposed adjacent to the distal end of the syringe body (34). The proximal longitudinal channel (85’) is defined by the proximal needle member (50”). In some embodiments, the proximal needle member (50”) is a solid proximal feature structure.

[0249] like Figure 94As shown, the distal anchor (87) of the proximal member of the needle proximal member (50”) is disposed inside the proximal end (89) of the tubular needle connecting member (83’). In some embodiments, the needle proximal member (50”) is coupled to the proximal end (89) of the tubular needle connecting member (83’) via an interference fit between the distal anchor (87) and the proximal end (89) of the tubular needle connecting member (83’). In other embodiments, the proximal end (89) of the tubular needle connecting member (83’) is welded to the needle proximal member (50”). In some embodiments, the weld is a “lap joint” weld, passing through the needle connecting member (83’) and into the needle proximal member (50”). The cross-section of the needle proximal member (50”) at the weld can be rectangular, crescent-shaped, or dumbbell-shaped, such that the components are fastened together, but allowing liquid to flow through the interior of the needle connecting member (83’) through the joint.

[0250] In some embodiments, the needle proximal component (50”) is formed by stamping a sheet of metal or metal wire to form multiple features of the needle proximal component (50”). Forming the needle proximal component (50”) by stamping reduces manufacturing complexity and cost. The outer diameters of the needle proximal component (50”) and the needle connecting component (83”) are substantially similar, which facilitates the retraction of the needle assembly (76”) while minimizing obstruction / hooking of the proximal and distal stop components (32, 36).

[0251] In short, the additional components of the pre-filled dual-chamber sequential safety injection system (100”') include a retraction system within the plunger member (44): a needle-holding feature structure; an energy storage member (e.g., a spring); and an energy storage member lock. Figures 92 to 97 In the depicted embodiment, a significant portion of the safety pin retraction hardware is located within the plunger housing (69). Additional components also include pin retaining members (e.g., O-rings, pin locks, and / or pawls) within the pin holder (608). Additional components also include a funnel-shaped element in the distal stop member (36) to guide the proximal pin member (50”) to the center of the distal stop member (36).

[0252] Figures 92 to 97 A safe sequential injection method is shown using the pre-filled dual-chamber sequential safety injection system (100”') described herein, according to some embodiments.

[0253] Figures 92 to 94A pre-filled dual-chamber sequential safety injection system (100”') in a first (initial) / ready configuration is depicted. The only difference between the first / ready configuration and the transport configuration (not shown) is that the needle cap member (not shown) present in the transport configuration has been removed in the first / ready configuration. In the first / ready configuration, the proximal longitudinal channel (85’) is arranged together with the intermediate opening (80’) in the distal chamber (42). Thus, there is no flow path between the proximal chamber (40) and the distal opening (82). Therefore, any flow applied to the plunger actuation interface (128) pointing distally is not possible. Force is transmitted through the plunger member (44), the proximal stop member (32), and the incompressible second fluid (254) in the proximal chamber (40) to move the distal stop member (36) distally relative to the syringe body (34). This distal movement of the distal stop member (36) relative to the syringe body (34) increases the pressure in the distal chamber (42), which drives the first fluid (252) from the distal chamber (42) through the intermediate opening (80'), the tubular needle connecting member (83'), and the distal needle member (78), and out of the distal opening (82) of the distal needle member (78).

[0254] Figure 95 A pre-filled dual-chamber sequential safety injection system (100”') is depicted after the distal stop member (36) has been moved distally a first distance relative to the syringe body (34). The distal chamber (42) has partially contracted / reduced in size, and some of the first fluid (252) has been ejected from the pre-filled dual-chamber sequential safety injection system (100”') through the distal opening (82). The distal movement of the distal stop member (36) relative to the syringe body (34) also causes the proximal needle member (50”) of the needle assembly (76”) to penetrate the distal stop member (36). The proximal longitudinal channel (85’) remains in the distal chamber (42) or is blocked by the distal stop member (36). Therefore, there is no flow path between the proximal chamber (40) and the distal opening (82), and as described above, the distally directed force applied to the plunger actuation interface (128) is still transmitted to the distal stop member (36).

[0255] Figure 96 The distal stop member (36) is depicted moving distally a second distance (ratio) relative to the syringe body (34). Figure 95 The first, more distant section is described in the pre-filled dual-chamber sequential safety injection system (100”'). The distal chamber (42, see...) Figure 95 The first liquid (252, see below) has almost completely shrunk / almost completely disappeared, and most of the first liquid (252, see below) has also disappeared. Figure 95The syringe has been ejected from the pre-filled dual-chamber sequential safety injection system (100”') through the distal opening (82). Further distal movement of the distal stop member (36) relative to the syringe body (34) also causes the proximal needle member (50”) of the needle assembly (76”) to penetrate further into the distal stop member (36). With the further penetration of the proximal needle member (50”) of the needle assembly (76”), a proximal longitudinal channel (85”) is now formed in the proximal chamber (40). Therefore, a flow path now exists between the proximal chamber (40) and the distal opening (82), and is applied to… The distal force of the plunger actuation interface (128) now moves the proximal stop member (32) distally relative to the syringe body (34) and the distal stop member (36) to eject the second liquid (254) from the proximal chamber (40). The opening of the flow path between the proximal chamber (40) and the distal opening (82) places the pre-filled dual-chamber sequential safety injection system (100”') in a second configuration in which the second liquid (254) can be sequentially ejected from the proximal chamber (40) after most of the first liquid (252) has been ejected from the distal chamber (42).

[0256] Figure 96 A pre-filled dual-chamber sequential safety injection system (100”') is also depicted after the proximal stop member (32) has moved a first distance distally relative to the syringe body (34), wherein the pre-filled dual-chamber sequential safety injection system (100”') is in a second configuration. The proximal chamber (40) has partially contracted / reduced in size, and some second fluid (254) has been ejected from the pre-filled dual-chamber sequential safety injection system (100) through the distal opening (82). Figure 100 As shown, because the proximal longitudinal channel (85') is in the proximal chamber (40), there is a flow path between the proximal chamber (40) and the distal opening (82). The flow path between the proximal chamber (40) and the distal opening (82) allows the proximal stop member (32) to move distally toward the distal stop member (36) by injecting some second fluid (254) via the proximal longitudinal channel (85'). Because the distal force applied to the plunger actuation interface (128) is transmitted to move the proximal stop member (32), the distal stop member (36) has essentially stopped moving at this point.

[0257] Figure 97 The second liquid (254, see description) is depicted. Figure 96 ) has been from the proximal chamber (40, see Figure 96After the needle is substantially emptied from the syringe, the proximal stop member (32) continues to move distally into the pre-filled dual-chamber sequential safety injection system (100”'), which is in a second configuration. As the proximal needle member (50”) of the needle assembly (76”) moves further proximally into the plunger assembly (44), the energy storage member lock is actuated to release the energy storage member (spring), which at least partially pulls / retracts the needle assembly (76”) into / retracts into the plunger assembly (44) to position the sharp distal end (81) of the distal needle member (78) of the needle assembly (76”) within the syringe body (34). The retraction of the needle assembly (76″) places the pre-filled dual-chamber sequential safety injection system (100”') in a safe configuration for disposal after injection.

[0258] Exemplary pin component

[0259] Figures 98 to 103B A needle assembly (76”) for use with a prefilled dual-chamber sequential safety injection system (100”') according to some embodiments is depicted.

[0260] Figure 98 A needle hub assembly (606') according to some embodiments is depicted, to which a rigid needle guard (612) is attached. Figure 98 The needle proximal member (50”) and the needle connecting member (83”) of the needle assembly (76”) are also shown.

[0261] Figure 99 A needle assembly (76”) according to some embodiments is depicted. The needle assembly (76”) includes a proximal needle member (50”) and a distal needle member (78”), each member being configured to be partially disposed in a respective proximal and distal end of a needle connecting member (83”). The proximal needle member (50”) includes a proximal tip (84) located at its proximal end, the proximal tip (84) being configured to be captured after injection for retraction of the needle assembly (76”). The distal end of the distal needle member (78) includes a sharp distal end (81) configured to pierce the target tissue for injection. The sharp distal end (81) defines a distal opening (82) for injection. The needle connecting member (83”) includes an annular recess (72) configured to interfere with a needle lock to prevent the needle assembly (76”) from retracting proximally before the injection is completed.

[0262] Figure 100The proximal tip (84) of the proximal member (50”) of the needle is described in more detail. The proximal tip (84) includes a multifaceted proximal puncture tip (86). The multifaceted proximal puncture tip (86) facilitates penetration of the proximal stop and the distal stop (32, 36). The proximal member (50”) of the needle assembly (76”) also includes a reduced diameter portion (88) immediately adjacent to the distal side tip (84). The reduced diameter portion (88) increases the likelihood and safety of capturing the proximal tip (84) of the proximal member (50”) of the needle so that the needle assembly (76”) can be retracted.

[0263] Figure 101 A proximal member (50”) of a needle according to some embodiments is depicted. The proximal member (50”) includes a proximal tip (84) at its proximal end, a proximal longitudinal channel (85’) between its proximal and distal ends, and two distal longitudinal channels (90) extending from its distal end.

[0264] Figure 102 This is a longitudinal sectional view of the proximal member (50”) of the needle. The proximal member (50”) includes two distal longitudinal channels (90) formed in generally opposing surfaces of the proximal member (50”). Figure 99 As shown, when the proximal needle member (50”) is partially disposed in the needle connecting member (83’), the distal longitudinal channel (90) forms two flow paths from the outside of the needle assembly (76”) into the needle connecting member (83’), then into the distal needle member (78), and out from the sharp distal end (81) of the distal needle member (78).

[0265] Figure 99 The needle assembly (76”) is depicted fully assembled, with the distal end of the proximal needle member (50”) inserted into the needle connecting member (83’) until only the proximal end of the distal longitudinal channel (90) remains outside the needle connecting member (83’). The proximal end of the distal longitudinal channel (90) forms a central opening (80’) in the needle assembly (76”), which fluidly connects the interior and exterior of the needle assembly (76”).

[0266] Figure 103A and Figure 103B A cross-sectional view of the respective distal end of the needle proximal member (50″, 50B) according to some embodiments. Figure 103A The distal end of the depicted needle proximal member (50”) has a dumbbell-shaped cross-section, similar to Figure 101 and Figure 16 The depicted needle proximal component (50”). Figure 103BThe distal end of the depicted needle proximal member (50B) has a crescent-shaped cross-section. The dumbbell shape and the crescent shape define two and one distal longitudinal channels (90, 90B), respectively. The distal longitudinal channels (90, 90B) have rounded cross-sections, which minimizes the restrictions on fluid flow through them. Circular cross-sections are efficient for fluid flow because they minimize the interaction between the fluid and the channel walls, which would otherwise impose zero-velocity boundary conditions on the flowing fluid. Minimizing wall exposure minimizes the amount of shear resistance experienced by the fluid during flow. This is because, according to the Hagen-Poiseuille formula:

[0267]

[0268] Theoretical pipe resistance and R 4 (The radius of the cross-sectional area) is inversely proportional, so even if the cross-sectional area remains constant, it is inversely proportional to the radius of the dual-channel (90) (see...). Figure 103A Compared to a single circular channel (90B) (see...) Figure 103B It may have lower fluid flow resistance.

[0269] Even with the distal longitudinal channels (90, 90B) formed therein, the proximal needle members (50", 50B) possess sufficient bending moment of inertia to enhance rigidity and bending resistance. In fact, the proximal needle members (50", 50B) are similar to I-beams and have similar rigidity characteristics. Bending resistance is particularly important when the proximal needle members (50", 50B) pierce the stop member (640). Minimizing the bending of the proximal needle members (50", 50B) when they pierce the stop member (640) increases the likelihood of capturing the proximal tip (84) of the proximal needle member (50") so that the needle assembly (76") can retract.

[0270] The diameter of the needle proximal member (50″, 50B) is also relatively large (e.g., approximately 0.026 inches, compared to approximately 0.020 inches for a cold-formed proximal member). This larger diameter results in a higher total bending moment of inertia and greater resistance to bending, which also increases the likelihood of catching. The diameter of the needle proximal member (50″, 50B) is also very close to that of the needle connecting member (83′), which has a diameter of approximately 0.036 inches. This similarity in diameter makes it easier for the needle assembly (76″) to retract through the stop member during retraction, as the diameter difference between the needle connecting member (83′) and the needle proximal member (50″) is relatively small, making it less likely for the needle connecting member (83′) to hook onto the stop member during retraction.

[0271] IX. Exemplary pre-filled needle-free dual-chamber sequential injection system and method

[0272] Figures 104 to 106 A longitudinal sectional view and two increasingly detailed longitudinal sectional views are depicted of a prefilled needle-free dual-chamber sequential injection system (1800) according to some embodiments. The prefilled needle-free dual-chamber sequential safety injection system (1800) is similar to Figures 92 to 94 The pre-filled dual-chamber sequential injection system (100) is depicted. There are two main differences between the systems (1800, 100). First, Figures 104 to 106 The depicted dual-chamber sequential injection system (1800) does not include a "needle" extending outside the syringe body (1834), similar to Figures 92 to 94 The distal needle component (78) in the depicted dual-chamber sequential injection system (100). Second, Figures 104 to 106 The described dual-chamber sequential injection system (1800) does not include anything similar to Figures 92 to 94 The needle retraction system in the depicted dual-chamber sequential injection system (100). Therefore, the dual-chamber sequential injection system (1800) is not a "safe" injection system.

[0273] The pre-filled needleless dual-chamber sequential injection system (1800) includes a conventional, off-the-shelf pre-filled syringe body (1834) with conventional, off-the-shelf proximal and distal stop members (1832, 1836). The proximal and distal stop members (1832, 1836), together with the syringe body (1834), define a proximal lumen and a distal chamber (1840, 1842). A first fluid and a second fluid (1852, 1854) are contained in the distal lumen and the proximal chamber (1842, 1840), respectively. The proximal and distal stop members (1832, 1836) block the proximal and distal ends of the proximal chamber (1840). The distal stop member (1836) blocks the proximal end of the distal chamber (1842). In some embodiments, the distal surfaces of the proximal stop member (1832) and the proximal surfaces of the distal stop member (1836) are coated with a smooth polymer coating (e.g., PTFE or ETFE). The first and second polymer coatings of the proximal and distal stop members (1832, 1836) together define a proximal chamber (1840) with the syringe body (1834). The smooth polymer coating also serves to isolate the rubber of the proximal and distal stop members (1832, 1836) from the second liquid (1854). The proximal and distal stop members (1832, 1836) can be as follows: Figures 104 to 106 The orientation is shown, or the distal stop member (1836) can be flipped so that the lubricating coating faces the distal chamber (1842), so that the first liquid (1852) in the distal chamber (1842) comes into contact with the lubricating coating for storage.

[0274] Figures 104 to 106 The depicted dual-chamber sequential injection system (1800) does not include a “needle” extending to the exterior of the syringe body (1834). Instead, the dual-chamber sequential injection system (1800) includes a fluid transfer assembly (1876). The fluid transfer assembly (1876) of the pre-filled needleless dual-chamber sequential injection system (1800) facilitates the sequential injection of a first fluid (1852) from the distal chamber (1842) followed by the injection of a second fluid (1854) from the proximal chamber (1840), depending on the user's insertion of the plunger assembly (1844) to varying degrees relative to the syringe body (1834). The plunger assembly (1844) includes a plunger housing member (1869) coupled to the proximal stop member (1832) and a plunger operating interface (1828). The first liquid (1852) and the second liquid (1854), located in the distal chamber (1842) and the proximal chamber (1840) respectively, can be any liquid or gel, such as an aqueous or oil-based drug solution.

[0275] The fluid transfer assembly (1876) of the prefilled needleless dual-chamber sequential injection system (1800) is configured for use with a connector (e.g., a Luer lock or Luer slide interface coupled to a needle with a tip or a fluid transfer tube (not shown).

[0276] The fluid transfer assembly (1876) includes a fluid transfer proximal member (1850; see also) Figure 105 and Figure 106 ) Connected to the fluid transfer connection component (1883; see also) Figure 105 and Figure 106The fluid transfer proximal member (1850) is a metal pin in which a proximal channel (1885) is formed. The fluid transfer connecting member (1883) is configured to engage with the distal end of the fluid transfer proximal member (1850) and secure the fluid transfer assembly (1876) in a distal opening of the syringe body (1834). The fluid transfer connecting member (1883) includes a fluid transfer distal anchor (1891) comprising an open core (1892) to provide compliance with the fluid transfer distal anchor (1891). The fluid transfer connecting member (1883) can be mechanically engaged with the fluid transfer proximal member (1850). The fluid transfer connecting member (1883) can secure the fluid transfer assembly (1876) to the syringe body (1834) via a mechanical engagement between the fluid transfer distal anchor (1891) and the distal end of the syringe body (1834). A fluid transfer connection member (1883) may define one or more channels therein to provide an intermediate opening (1880) between the interior and exterior of the syringe body (1834) / distal chamber (42). The intermediate opening (1880) is disposed adjacent to the distal end of the syringe body (1834). A proximal longitudinal channel (1885) is defined by a proximal fluid transfer member (1850). In some embodiments, the proximal fluid transfer member (1850) is a solid proximal feature structure.

[0277] In some embodiments, the fluid transfer proximal member (1850) is formed by stamping a sheet of metal or metal wire to form multiple features of the fluid transfer proximal member (1850). Forming the fluid transfer proximal member (1850) by stamping reduces manufacturing complexity and cost.

[0278] Figures 104 to 109 A safe sequential injection method is shown using the pre-filled needleless dual-chamber sequential injection system (1800) described herein, according to some embodiments.

[0279] Figures 104 to 106 A pre-filled needleless dual-chamber sequential injection system (1800) in a first / ready configuration is depicted. The only difference between the first / ready configuration and the transport configuration (not shown) is that the syringe body cap (not shown) in the transport configuration has been removed in the first / ready configuration.

[0280] In the first / ready configuration, the proximal longitudinal channel (1885) is disposed together with the intermediate opening (1880) in the distal chamber (1842). Thus, there is no flow path between the proximal chamber (1840) and the distal opening (1882). Therefore, any distally directed force applied to the plunger actuation interface (1828) is transmitted through the plunger member (1844), the proximal stop member (1832), and the incompressible second fluid (1854) in the proximal chamber (1840) to move the distal stop member (1836) distally relative to the syringe body (1834). The distal stop member (1836) moves distally relative to the syringe body (1834), increasing the pressure in the distal chamber (1842). This drives the first fluid (1852) from the distal chamber (1842) through the intermediate opening (1880) formed between the fluid transfer connecting member (1883) and the distal end of the syringe body (1834), and out of the distal end of the syringe body (1834) (e.g., into the Luer connector).

[0281] Figure 107 and Figure 108 Depicts a pre-filled needleless double-chamber sequential injection system (1800) after the distal stop member (1836) moves distally relative to the syringe body (1834) until the distal stop member (1836) is almost in contact with the distal end of the syringe body (1836). Distal chamber (1842, see...) Figure 105 It has almost completely shrunk / almost completely disappeared, and most of the first liquid (1852, see 1852) has been lost. Figure 105The solution has been ejected from the pre-filled needleless dual-chamber sequential injection system (1800) through the distal end of the syringe body (1836). The distal movement of the distal stop member (1836) relative to the syringe body (1834) also causes the proximal fluid transfer member (1850) of the fluid transfer assembly (1876) to penetrate the distal stop member (1836). With the penetration of the proximal fluid transfer member (1850) of the fluid transfer assembly (1876), a proximal longitudinal channel (1885) is now positioned in the proximal chamber (1840). Therefore, a flow path now exists between the proximal chamber (1840) and the intermediate opening (1880), and the distal force applied to the plunger actuation interface (1828) now moves the proximal stop member (1832) distally relative to the syringe body (1834) and the distal stop member (1836) to eject the second liquid (1854) from the proximal chamber (1840). The opening of the flow path between the proximal chamber (1840) and the distal opening (1882) places the pre-filled needleless dual-chamber sequential injection system (1800) in a second configuration in which the second liquid (1854) can be sequentially ejected from the proximal chamber (1840) after most of the first liquid (1852) has been ejected from the distal chamber (1842).

[0282] Figure 109 The second liquid was described (1854, see...) Figure 107 It has been largely removed from the proximal chamber (1840, see...) Figure 96 The pre-filled needleless dual-chamber sequential injection system (1800) after ejection, wherein the proximal stop member (1832) moves distally, and the pre-filled needleless dual-chamber sequential injection system (1800) is in the second configuration.

[0283] Exemplary fluid transfer component

[0284] Figures 110 to 112C A fluid transfer assembly (1876) for use with a prefilled needleless dual-chamber sequential injection system (1800) according to some embodiments is depicted.

[0285] Figure 110 and Figure 111The following is a perspective view and exploded view of a fluid transfer assembly (1876) according to some embodiments. The fluid transfer assembly (1876) includes a proximal fluid transfer member (1850) configured to be partially disposed in and connected to a fluid transfer connecting member (1883) at its proximal end. The proximal fluid transfer member (1850) includes a proximal puncture tip (1884) at its proximal end, configured to puncture a distal stop member (1836). The fluid transfer connecting member (1883) includes a distal fluid transfer anchor (1891) configured to secure the fluid transfer assembly (1876) to a distal opening in a syringe body (1834) with an interference fit.

[0286] Figures 112A to 112C Perspective, longitudinal, and axial cross-sectional views of a fluid transfer proximal member (1850) according to some embodiments. The fluid transfer proximal member (1850) includes a proximal puncture tip (1884) at its proximal end and a proximal longitudinal channel (1885) between its proximal and distal ends.

[0287] The diameter of the fluid transfer proximal member (1850) is also relatively large (e.g., approximately 0.026 inches to approximately 0.040 inches, compared to approximately 0.020 inches for a cold-formed proximal member). This larger diameter results in a higher total bending moment of inertia and greater resistance to bending, which also increases the likelihood of capture. Due to its relatively large diameter and solid construction, the fluid transfer proximal member (1850) possesses sufficient bending moment of inertia to enhance rigidity and drag. Resistance to bending is particularly important when the fluid transfer proximal member (1850) pierces the distal stop member (1836). Minimizing bending when the fluid transfer proximal member (1850) pierces the distal stop member (1836) contributes to the proper functioning of the pre-filled needleless dual-chamber sequential injection system (1800) during sequential injection.

[0288] Figures 113 to 121C A pre-filled needle-free dual-chamber sequential injection system (2700) and a fluid transfer assembly (2776) used therewith are described according to some embodiments. The pre-filled needle-free dual-chamber sequential injection system (2700) and the fluid transfer assembly (2776) are similar to Figures 104 to 112C The pre-filled needle-free dual-chamber sequential injection system (1800) and fluid transfer assembly (1876) are depicted. The difference between these two systems (2700, 1800) and assemblies (2776, 1876) lies in... Figures 113 to 121CThe fluid transfer assembly (2776) depicted is molded or formed as a single piece (e.g., made of polymer or metal sheet or wire). The fluid transfer assembly (2776) still includes a fluid transfer proximal portion (2750) and a fluid transfer connecting portion (2783). Molding or forming the fluid transfer assembly (2776) as a single piece simplifies system manufacturing and assembly. The fluid transfer assembly (2776) formed of metal, including the fluid transfer connecting portion (2783), minimizes system failures caused by stress-induced fractures of the fluid transfer distal anchoring portion (2791) of the fluid transfer connecting portion (2783), which could occur in structures formed of polymers.

[0289] Figures 113 to 115 A longitudinal sectional view and two increasingly detailed longitudinal sectional views are depicted of a pre-filled needle-free dual-chamber sequential injection system (2700) according to some embodiments. The pre-filled needle-free dual-chamber sequential safety injection system (2700) is similar to... Figures 92 to 94 The depicted pre-filled dual-chamber sequential injection system (100) includes a conventional, off-the-shelf pre-filled syringe body (2734) with conventional, off-the-shelf proximal and distal stop members (2732, 1836). The proximal and distal stop members (2732, 1836), together with the syringe body (2734), define a proximal chamber and a distal chamber (2740, 1842). A first liquid and a second liquid (2752, 1854) are contained in the distal and proximal chambers (2742, 1840), respectively. The proximal and distal stop members (2732, 1836) block the proximal and distal ends of the proximal chamber (2740). The distal stop member (2736) blocks the proximal end of the distal chamber (2742). In some embodiments, the distal surfaces of the proximal stop member (2732) and the proximal surfaces of the distal stop member (2736) are coated with a smooth polymer coating (e.g., PTFE or ETFE). The first and second polymer coatings of the proximal and distal stop members (2732, 1836) together define a proximal chamber (2740) with the syringe body (2734). The smooth polymer coating also serves to isolate the rubber of the proximal and distal stop members (2732, 1836) from the second liquid (2754). The proximal and distal stop members (2732, 1836) can be as follows: Figures 104 to 106 The orientation is shown, or the distal stop member (2736) can be flipped so that the lubricating coating faces the distal chamber (2742), so that the first liquid (2752) in the distal chamber (2742) contacts the lubricating coating for storage.

[0290] Figures 113 to 115The depicted dual-chamber sequential injection system (2700) does not include a “needle” extending to the exterior of the syringe body (2734). Instead, the dual-chamber sequential injection system (2700) includes a fluid transfer assembly (2776), which, as described above, is molded or formed as a single piece. The fluid transfer assembly (2776) of the pre-filled needleless dual-chamber sequential injection system (2700) facilitates the sequential injection of a first liquid (2752) from the distal chamber (2742) followed by the injection of a second liquid (2754) from the proximal chamber (2740), depending on the user's insertion of the plunger assembly (2744) to varying degrees relative to the syringe body (2734). The plunger assembly (2744) includes a plunger housing member (2769) coupled to the proximal stop member (2732) and a plunger actuation interface (2728). The first and second liquids (2752, 1854), located in the distal and proximal chambers (2742, 1840) respectively, can be any liquid or gel, such as an aqueous or oil-based drug solution.

[0291] The fluid transfer assembly (2776) of the prefilled needleless dual-chamber sequential injection system (2700) is configured for use with a connector (e.g., a Luer lock or Luer slide interface coupled to a needle with a tip or a fluid transfer tube (not shown).

[0292] The fluid transfer assembly (2776) includes a fluid transfer proximal portion (2750; see also) Figure 114 and Figure 115 ) and fluid transfer connection components (2783; see Figure 114 and Figure 115 The fluid transfer proximal portion (2750) has a proximal channel (2785) molded or formed therein. The fluid transfer connection portion (2783) is configured to secure the fluid transfer assembly (2776) in a distal opening of the syringe body (2734). The fluid transfer connection portion (2783) includes a fluid transfer distal anchor (2791) comprising a cylindrical opening core (2792) to provide compliance with the fluid transfer distal anchor (2791). The fluid transfer connection portion (2783) can secure the fluid transfer assembly (2776) to the syringe body (2734) via an interference fit between the fluid transfer distal anchor (2791) and the distal end of the syringe body (2734). The fluid transfer connection portion (2783) may define one or more channels therein to provide an intermediate opening (2780) between the interior and exterior of the syringe body (2734) / distal chamber (2742). The central opening (2780) is located adjacent to the distal end of the syringe body (2734). The proximal longitudinal channel (2785) is defined by the proximal fluid transfer section (2750).

[0293] Figures 113 to 118 A safe sequential injection method is shown using the pre-filled needleless dual-chamber sequential injection system (2700) described herein, according to some embodiments.

[0294] Figures 113 to 115 A pre-filled needleless dual-chamber sequential injection system (2700) in a first / ready configuration is depicted. The only difference between the first / ready configuration and the transport configuration (not shown) is that the syringe body cap (not shown) in the transport configuration has been removed in the first / ready configuration.

[0295] In the first / ready configuration, the proximal longitudinal channel (2785) is disposed together with the intermediate opening (2780) in the distal chamber (2742). Thus, there is no flow path between the proximal chamber (2740) and the distal opening (2782). Therefore, any distally directed force applied to the plunger actuation interface (2728) is transmitted through the plunger member (2744), the proximal stop member (2732), and the incompressible second fluid (2754) in the proximal chamber (2740) to move the distal stop member (2736) distally relative to the syringe body (2734). The distal stop member (2736) is moved distally relative to the syringe body (2734), increasing the pressure in the distal chamber (2742). This drives the first fluid (2752) to flow from the distal chamber (2742) through an intermediate opening (2780) at the distal end of the syringe body (2734) (e.g., into a Luer connector), which is formed between the tubular fluid transfer connection (2783) and the distal end of the syringe body (2734).

[0296] Figure 116 and Figure 117 A pre-filled needleless dual-chamber sequential injection system (2700) is depicted after the distal stop member (2736) has moved distally relative to the syringe body (2734) until the distal stop member (2736) is almost in contact with the distal end of the syringe body (2734). The distal chamber (2742, see...) Figure 114 The first liquid (2752, see...) has almost completely shrunk / almost completely disappeared, and most of the first liquid (2752, see...) has... Figure 114The fluid has been ejected from the pre-filled needleless dual-chamber sequential injection system (2700) through the distal end of the syringe body (2734). The distal movement of the distal stop member (2736) relative to the syringe body (2734) also causes the proximal fluid transfer portion (2750) of the fluid transfer assembly (2776) to penetrate the distal stop member (2736). With the penetration of the proximal fluid transfer portion (2750) of the fluid transfer assembly (2776), a proximal longitudinal channel (2785) is now positioned in the proximal chamber (2740). Therefore, a flow path now exists between the proximal chamber (2740) and the intermediate opening (2780), and the distal force applied to the plunger actuation interface (2728) now causes the proximal stop member (2732) to move distally relative to the syringe body (2734) and the distal stop member (2736) to eject the second liquid (2754) from the proximal chamber (2740). The opening of the flow path between the proximal chamber (2740) and the distal opening (2782) places the pre-filled needleless dual-chamber sequential injection system (2700) in a second configuration in which the second liquid (2754) can be sequentially ejected from the proximal chamber (2740) after the first liquid (2752) has been mostly ejected from the distal chamber (2742).

[0297] Figure 118 The second liquid (2754, see also) is described Figure 107 It has been extracted from the proximal chamber (2740, see...) Figure 96 The pre-filled needleless dual-chamber sequential injection system (2700) after basic ejection, wherein the proximal stop member (2732) moves distally, and the pre-filled needleless dual-chamber sequential injection system (2700) is in the second configuration.

[0298] Figures 119 to 121C A fluid transfer assembly (2776) for use with a prefilled needleless dual-chamber sequential injection system (2700) according to some embodiments is depicted.

[0299] Figure 119 and Figure 120 This is a perspective view of a fluid transfer assembly (2776) according to some embodiments. The fluid transfer assembly (2776) includes a proximal fluid transfer portion (2750) and a fluid transfer connection portion (2783). The proximal fluid transfer portion (2750) includes a proximal puncture tip (2784) at its proximal end, configured to puncture a distal stop member (2736). The fluid transfer connection portion (2783) includes a distal fluid transfer anchor (2791) configured to secure the fluid transfer assembly (2776) to a distal opening in a syringe body (2734) via an interference fit.

[0300] Figures 121A to 121CThe figures show perspective and axial cross-sectional views of a fluid transfer assembly (2776) according to some embodiments. The proximal fluid transfer portion (2750) includes a proximal puncture tip (2784) at its proximal end and a proximal longitudinal channel (2785) between its proximal and distal ends. The distal fluid transfer anchor (2791) has a triangular cross-sectional shape to provide a flow channel from the central opening (2780) to the exterior of the syringe body (2734). The distal fluid transfer anchor (2791) also defines a cylindrical opening core (2792) to provide compliance to the distal fluid transfer anchor (2791), which allows the distal fluid transfer anchor (2791) to deform slightly to create an interference fit with the distal opening of the syringe body (2734).

[0301] The diameter of the fluid transfer proximal portion (2750) is also relatively large (e.g., approximately 0.026 inches to approximately 0.040 inches, compared to approximately 0.020 inches for the cold-formed proximal portion). This larger diameter results in a higher total bending moment of inertia and greater resistance to bending, which also increases the likelihood of capture. Due to its relatively large diameter and solid structure, the fluid transfer proximal portion (2750) possesses sufficient bending moment of inertia to enhance rigidity and drag. Resistance to bending is particularly important when the fluid transfer proximal portion (2750) pierces the distal stop member (2736). Minimizing bending when the fluid transfer proximal portion (2750) pierces the distal stop member (2736) contributes to the proper functioning of the pre-filled needleless dual-chamber sequential injection system (2700) during sequential injection.

[0302] Figure 122 and Figure 123 This is a perspective view of a fluid transfer assembly (2776') used with a pre-filled needle-free dual-chamber sequential injection system (2700) according to some embodiments. The fluid transfer assembly (2776') is similar to... Figures 119 to 121C The fluid transfer assembly (2776) is depicted. The difference between the two fluid transfer assemblies (2776', 2776) is the addition of a rib and a draft (2792') at the distal end of the proximal fluid transfer portion (2750'), which facilitates penetration of the distal stop member (2736). Another difference is that the proximal puncture tip (2784') has multiple facets / is polyhedral in shape to facilitate penetration of the distal stop member (2736).

[0303] Exemplary fluid transfer distal anchor

[0304] Although the fluid transfer assemblies (1876, 2776, 2776') are described herein as fluid transfer distal anchors (1891, 2791, 2791') having a simple triangular cross-section, according to some embodiments, the fluid transfer assemblies can be used with other fluid transfer distal anchors configured to secure the fluid transfer assembly to a distal opening of the syringe body. The fluid transfer distal anchors described herein can be used with any fluid transfer assembly, including the fluid transfer assemblies (1876, 2776, 2776') described herein.

[0305] Figures 124 to 127B An injection system (3900) including a fluid transfer connection member / part (3983) according to some embodiments is depicted. For clarity, the remaining parts of the fluid transfer assembly are omitted. The fluid transfer connection member / part (3983) includes a fluid transfer distal anchor (3991) at its distal end.

[0306] The fluid transfer distal anchor (3991) defines a slot (3993) and includes a biasing member (3994) disposed within the slot (3993). The fluid transfer distal anchor (3991) also defines two pegs (3995) (see...). Figure 124 , Figure 126A and Figure 126B These two bolts are configured to hold the biasing member (3994) within the slot (3993). Biasing member (3994) (see...) Figure 127A and Figure 127B ) is a spring-shaped metal ring configured to interfere with the inner diameter of the distal end (3995) of the syringe body (3934) (see... Figure 124 This creates an interference fit, thereby holding the fluid delivery distal anchor (3991) in the distal end (3995) of the syringe body (3934) while minimizing stress on the remaining portion of the fluid delivery distal anchor (3991).

[0307] Figures 128 to 130 An injection system (4100) including a fluid transfer connection member / part (4183) according to some embodiments is depicted. For clarity, the remaining parts of the fluid transfer assembly are omitted. The fluid transfer connection member / part (4183) includes a fluid transfer distal anchor (4191) at its distal end.

[0308] The distal fluid transfer anchor (4191) is in the form of a corrugated metal wire segment, configured to interfere with the inner diameter of the distal end (4195) of the syringe body (4134) (see...). Figure 128This creates an interference fit, thereby retaining the distal fluid transfer anchor (4191) in the distal end (4195) of the syringe body (4134). The corrugated wire distal fluid transfer anchor (4191) can be press-fitted into the remainder of the fluid transfer connection member / part (4183).

[0309] Figures 131 to 132B An injection system (4600) including a fluid transfer connection member / part (4683) according to some embodiments is depicted. For clarity, the remaining parts of the fluid transfer assembly are omitted. The fluid transfer connection member / part (4683) includes a fluid transfer distal anchor (4691) at its distal end.

[0310] The fluid transfer distal anchor (4691) takes the form of a pair of long, flexible plastic arms configured to interfere with the inner diameter of the distal end (4695) of the syringe body (4634) (see [link]). Figure 131 This creates an interference fit, thereby holding the fluid transfer distal anchor (4691) in the distal end (4695) of the syringe body (4634) with very low static stress. The length of the flexible plastic arm (4691) and the relatively small interference with the inner diameter of the distal end (4695) of the syringe body (4634) allow the flexible plastic arm (4691) to operate in an elastic region, which ensures the applied radial spring force while minimizing static stress and the risk of stress fracture in the glass distal end (4695) of the syringe body (4634) and the body of the fluid transfer distal anchor (4691).

[0311] Figures 133 to 135 An injection system (4700) including a fluid transfer connection member / part (4783) according to some embodiments is depicted. For clarity, the remaining parts of the fluid transfer assembly are omitted. The fluid transfer connection member / part (4783) includes a fluid transfer distal anchor (4791) at its distal end.

[0312] The distal anchor (4791) for fluid transfer includes a recessed portion (4793) and a rubber sleeve (4794), the rubber sleeve (4794) being disposed within the recessed portion (4793) and configured to interfere with the inner diameter of the distal end (4795) of the syringe body (4734) (see [link to product details]). Figure 133 This creates an interference fit, holding the fluid transfer distal anchor (4791) in the distal end (4795) of the syringe body (4734). The fluid transfer distal anchor (4791) also includes proximal and distal openings (4796, 4797) to bypass the seal created by the rubber sleeve (4794) and the distal end (4795) of the syringe body (4734) (see...). Figure 135 ).

[0313] Exemplary fluid transfer component

[0314] Figures 136 to 140 A fluid transfer assembly 5076 according to some embodiments is described. Figure 136 The image depicts a longitudinal sectional view of a fluid transfer assembly 5076 mounted in a syringe body 5034 according to some embodiments. The fluid transfer assembly 5076 can be used in a pre-filled needle-free dual-chamber sequential injection system according to some embodiments, for example, in... Figures 104 to 109 and Figures 113 to 118 The pre-filled needle-free dual-chamber sequential injection systems 1800 and 2700 are depicted. Similar to fluid transfer assemblies 1876 and 2776, fluid transfer assembly 5076 is configured for use with a dual-chamber sequential injection system that does not include a "needle" extending outside the syringe body 5034. Furthermore, fluid transfer assembly 5076 is not configured to work with systems similar to... Figures 92 to 94 It is used in conjunction with the needle retraction system in the depicted dual-chamber sequential injection system 100.

[0315] The fluid transfer assembly 5076 is configured for use with a conventional, off-the-shelf prefilled syringe body 5034 and conventional, off-the-shelf proximal and distal stop members (not shown) disposed therein.

[0316] The fluid transfer assembly 5076 facilitates the sequential injection of a first fluid from the distal chamber followed by a second fluid from the proximal chamber in a pre-filled needle-free dual-chamber sequential injection system, depending on the user's degree of insertion of the plunger assembly relative to the syringe body 5034. The sequential injection system and several system components are respectively similar to... Figures 104 to 109 as well as Figures 113 to 118 The pre-filled needleless dual-chamber sequential injection systems 1800 and 2700 are described.

[0317] The fluid transfer assembly 5076 is configured for use with a connector (e.g., a Luer lock or Luer slide interface coupled to a needle with a tip or a fluid transfer tube (not shown)). The fluid transfer assembly 5076 includes a fluid transfer proximal member 5050 coupled to the proximal end of the fluid transfer distal anchor 5091.

[0318] Figure 137 and Figure 138A fluid transfer assembly 5076 according to some embodiments is depicted. The fluid transfer assembly 5076 includes a proximal fluid transfer member 5050 partially disposed in the proximal end of a fluid transfer connecting member 5083, which in turn is partially disposed in the proximal end of a distal fluid transfer anchor 5091. The proximal fluid transfer member 5050 includes a proximal tip 5084 at its proximal end, the proximal tip 5084 being configured to penetrate a distal stop member during sequential injection. The proximal fluid transfer member 5050 may be a solid metal body, and the fluid transfer connecting member 5083 may be a metal tube. The proximal fluid transfer member 5050 may be welded to the fluid transfer connecting member 5083.

[0319] The proximal end of the fluid transfer connection member 5083 is a split tube that defines two arms 5082, which connect the fluid transfer connection member 5083 to the distal fluid transfer anchor 5091 and the fluid transfer assembly 5076 to the syringe body 5034.

[0320] like Figures 139A to 139C As shown, the fluid transfer proximal member 5050 includes a longitudinal opening 5052 and a crossbeam 5054 partially defined therein. Figure 140 As shown, the longitudinal opening 5052 is configured to receive two arms 5082 on either side of the crossbeam 5054 during assembly. After the arms 5082 are inserted past the crossbeam 5054, the arms 5082 plastically deform outward to connect the fluid transfer connection member 5083 to the fluid transfer distal anchor 5091 and prevent the two components from separating without introducing static stress into the fluid transfer distal anchor 5091. The outward plastic deformation of the two arms 5082 mechanically prevents the disassembly of the fluid transfer connection member 5083 and the fluid transfer distal anchor 5091 without introducing static stress into the fluid transfer distal anchor 5091. The outwardly deformed arms 5082 interfere with the inner diameter of the distal end 5096 of the syringe body 5034 (see [reference]). Figure 136 This creates an interference fit that connects the fluid transfer assembly 5076 to the distal end 5096 of the syringe body 5034, while minimizing stress on the remainder of the fluid transfer distal anchor 5091, which may be formed of a polymer.

[0321] Figure 141 and Figure 142 A fluid transfer assembly 5176 according to some embodiments is described. Figure 141 This is a longitudinal sectional view depicting a fluid transfer assembly 5176 mounted in a syringe body 5134 according to some embodiments. The fluid transfer assembly 5176 is similar to... Figures 136 to 140The fluid transfer assembly 5076 depicted is configured for use with a dual-chamber sequential injection system that does not include a "needle" extending outside the syringe body 5134, and is configured for use with a non-retractable system. The fluid transfer assembly 5176 also includes a proximal fluid transfer member 5150 coupled to the proximal end of the distal fluid transfer anchor 5191. Figure 136 and Figure 141 The difference between the fluid transfer assemblies 5076 and 5176 depicted is that the fluid transfer proximal member 5150 extends distally to define a pair of arms 5182, rather than being connected to a tubular member that separates distally.

[0322] Figure 141 The fluid transfer distal anchor 5191 depicted Figure 136 The depicted fluid transfer distal anchor 5091 is identical. During assembly, arm 5182 is inserted across beam 5154, and arm 5182 plastically deforms outward to connect fluid transfer proximal member 5150 to fluid transfer distal anchor 5191 and prevent disassembly of the two components without introducing static stress into fluid transfer distal anchor 5191. The outwardly deformed arm 5182 also connects to syringe body 5134 (see...) Figure 141 The inner diameter of the distal end 5196 of the syringe body 5134 is interfered with to produce an interference fit that connects the fluid transfer assembly 5176 to the distal end 5196 of the syringe body 5134, while minimizing stress on the rest of the fluid transfer distal anchor 5191, which may be formed of plastic and polymer.

[0323] Exemplary fluid transfer distal anchor

[0324] Figures 143 to 145C An injection system 5200, including a fluid transfer connection member / part 5283, is depicted according to some embodiments. For clarity, the remaining parts of the fluid transfer assembly are omitted. Figure 143 and Figure 144A As shown, the fluid transfer connection member / part 5283 includes a fluid transfer distal anchor 5291 at its distal end.

[0325] The fluid transfer distal anchor 5291 defines a slot 5293, and the fluid transfer connection member / part 5283 includes a diamond-shaped biasing member 5294 disposed in the slot 5293. The fluid transfer distal anchor 5291 also defines two protrusions 5295 (see...). Figure 143 and Figures 145A to 145C Furthermore, the biasing member 5294 defines two slots 5297 configured to receive two protrusions 5295 to retain the biasing member 5294 within the slot 5293 (see [link]). Figure 143 and Figures 145B to 145C ). 5294 (see ) ... ) ) ) ) ) ) """ ) "" ) 5225"" """""""""""""""""""""""""""""""""""""" Figure 144B and Figure 145A It is a rhomboid metal ring, similar to a spring, constructed to fit into the syringe body 5234 (see...). Figure 143 The inner diameter of the distal end 5296 of the syringe body 5234 is interfered with to create an interference fit that holds the fluid transfer distal anchor 5291 in the distal end 5296 of the syringe body 5234, while minimizing stress on the rest of the fluid transfer distal anchor 5291.

[0326] Figure 144B and Figure 145A A diamond-shaped biasing member 5294 is depicted before being installed in a slot 5293 defined by a fluid transfer distal anchor 5291. Figure 145B The diagram shows a diamond-shaped biasing member 5294 inserted into a slot 5293 defined by a fluid transfer distal anchor 5291. Figure 145B In the middle, the diamond-shaped bias member 5294 is in a "free" state, in which it can pass between the two protrusions 5295 defined by the fluid transfer of the distal anchor 5291.

[0327] exist Figure 145C In this process, after the diamond-shaped biasing member 5294 is inserted into the slot 5293 defined by the fluid transfer distal anchor 5291, the diamond-shaped biasing member 5294 is compressed / curled to plastically deform the diamond-shaped biasing member 5294, such that a pair of slots 5297 engage a pair of protrusions 5295. The engagement of the slots 5297 with the pair of protrusions 5295 mechanically connects the diamond-shaped biasing member 5294 to the fluid transfer distal anchor 5291 without introducing any static stress into the fluid transfer distal anchor 5291. Figure 145C As shown Figure 144A The fully assembled fluid transfer connection component / part 5283 is shown.

[0328] When the fluid transfer connection member / part 5283 is inserted into the syringe body 5234 (see...) Figure 143 When the distal end 5296 of the syringe body 5234 is in contact with the inner diameter of the distal end 5296 of the syringe body 5234, the diamond bias member 5294 interferes with the inner diameter of the distal end 5296 of the syringe body 5234 to produce an interference fit that holds the distal anchor 5291 in the distal end 5296 of the syringe body 5234 for fluid transfer.

[0329] X. Exemplary dual-chamber injection system

[0330] Figures 146 to 148CA dual-chamber safety injection system 5300 according to some embodiments is depicted, having a syringe body 5320 with a one-way valve 5400 disposed at its distal end. The dual-chamber safety injection system 5300 also includes a needle assembly 5350 extending through the one-way valve 5400, and proximal and distal stop members 5340 and 5390 disposed within the syringe body 5320. The proximal and distal stop members 5340 and 5390 define proximal and distal chambers 5360 and 5370 within the syringe body 5320. The dual-chamber safety injection system 5300 also includes a plunger member 5330, which includes a needle retraction system. The needle retraction system is primarily disposed within the plunger member 5330.

[0331] In some embodiments, a liquid drug component is disposed in a proximal chamber 5360, and a powdered (e.g., lyophilized powder) drug component is disposed in a distal chamber 5370. The dual-chamber safety injection system 5300 is configured such that applying a distally directed force to the plunger member 5330 moves the proximal stop member 5340 distally, thereby transferring the liquid drug component from the proximal chamber 5360 to the distal chamber 5370. The dual-chamber safety injection system 5300 can then be agitated (e.g., inverted) to mix the liquid and powdered drug components, thereby forming a mixed liquid drug. A distally directed force is then continued to be applied to the plunger member 5330 to move the proximal and distal stop members 5340, 5390 distally to inject the mixed liquid drug from the distal chamber 5370 through the needle assembly 5350. After the mixed liquid medication is ejected from the distal chamber 5370, the needle retraction system in the plunger member 5330 retracts the needle assembly 5350 at least partially into the plunger member 5330 to position the sharp distal end of the needle assembly 5350 inside the syringe body 5320.

[0332] Figures 148A to 148C The 5400 check valve is described in detail. For example... Figure 148C As shown, the one-way valve 5400 includes a rigid (e.g., plastic) proximal portion 5410 with a circular base 5412 defining a pair of side openings 5414, and a sleeve 5416 extending distally from its center. The sleeve 5416 includes a plurality of longitudinal channels 5418 defined on its outer surface.

[0333] The one-way valve 5400 also includes a compliant / flexible (e.g., rubber) distal portion 5420 with a central opening 5422 configured to receive a sleeve 5416. Figure 147As shown, the inner diameter of the sleeve 5416 is only slightly larger than the outer diameter of the portion of the needle assembly 5350 that passes through it. This tight tolerance prevents powdered drug components from unintentionally passing through the one-way valve 5400 and entering and clogging the needle assembly 5350. The tolerance between the side openings 5414 and the proximal and distal portions 5410, 5420 of the one-way valve 5400 is also tight enough to prevent powdered drug components from passing through. The compliant distal portion 5420 stretches around the circular base 5412 of the rigid proximal portion 5410, fitting tightly and blocking both side openings 5414, preventing any powdered drug components from passing through. On the other hand, the one-way valve 5400 allows mixed liquid drugs to pass under pressure (as described below) through the side opening 5414 between the proximal and distal portions 5410, 5420 of the one-way valve 5400, along multiple longitudinal channels 5418 on the sleeve 5416, through the central opening 5352 (see...). Figure 147 The powdered drug component enters the needle assembly 5350 and flows out of the dual-chamber safety injection system 5300. Therefore, the one-way valve 5400 prevents the powdered drug component from passing through and entering and clogging the needle assembly 5350, while allowing liquid (e.g., a mixed liquid drug) to pass through the needle assembly 5350 (e.g., under pressure applied by the plunger member) and exit the dual-chamber safety injection system 5300.

[0334] In their default assembled state, the proximal and distal portions 5410 and 5420 of the one-way valve 5400 contact each other at the distal side of the circular base 5412, closing the two side openings 5414 to prevent the powdered drug components from flowing out of the distal chamber 5370. However, after the liquid drug is mixed and ready for injection, the distally directed force applied to the plunger member 5330 generates pressure in the distal chamber 5370, thereby injecting the mixed liquid drug under pressure. The pressure in the distal chamber causes the compliant distal portion 5420 of the one-way valve 5400 to separate from the rigid proximal portion 5410 of the one-way valve 5400, thereby releasing the blockage of the two side openings 5414 and allowing the mixed liquid drug to pass under pressure through the one-way valve 5400, along the multiple longitudinal channels 5418 on the sleeve 5416, through the intermediate opening 5352 (see...). Figure 147 It enters the needle assembly 5350 and flows out from the dual-chamber safety injection system 5300.

[0335] While the prefilled dual-chamber safety injection systems described and depicted herein include syringes with peg-supported needles, several configurations / implementations described herein (e.g., sequential injection, pawl dual-chamber, threaded plunger assembly, needle cap with protection and ventilation) can be used for cartridges of autoinjectors, as well as injection systems with Luer connectors, transfer tubes, and needleless designs.

[0336] This document describes several exemplary embodiments of the invention. Reference is made to these examples in a non-limiting sense. They are provided to illustrate broader aspects of the invention's applicability. Various changes can be made to the described invention, and equivalents can be substituted, without departing from the true spirit and scope of the invention. Furthermore, many modifications can be made to adapt particular circumstances, materials, composition of substances, processes, process actions, or steps to the purpose, gist, or scope of the invention. Further, those skilled in the art will understand that each individual variation described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any other several embodiments without departing from the scope or spirit of the invention. All such modifications are within the scope of the claims relating to this disclosure.

[0337] Any device used to perform thematic diagnostic or interventional procedures may be provided in a package for performing such interventions. These supply “kits” may also include instructions for use and be packaged in a sterile tray or container typically used for this purpose.

[0338] This invention includes a method that can be implemented using the subject matter apparatus. The method may include the action of providing such a suitable apparatus. This provision can be performed by an end user. In other words, the "providing" action merely requires the end user to obtain, access, approach, locate, set, activate, power on, or otherwise provide the necessary apparatus in the subject matter method. The methods described herein can be performed in any logically possible order of events and in the sequence of events.

[0339] Exemplary aspects of the invention, as well as details regarding material selection and manufacture, have been set forth above. Further details of the invention will be understood in conjunction with the patents and publications cited above, and are generally known or understood by those skilled in the art. For example, those skilled in the art will understand that one or more smooth coatings (e.g., hydrophilic polymers, such as polyvinylpyrrolidone-based compositions, fluoropolymers, such as tetrafluoroethylene, PTFE, ETFE, hydrophilic gels, or silicone resins) can be used in conjunction with multiple parts of the device, such as relatively large interface surfaces of movable coupling portions, for example, to facilitate low-friction manipulation or propulsion of these objects relative to other parts of the device or nearby tissue structures, if desired. The same applies to the method-based aspects of the invention in terms of additional actions typically or logically employed.

[0340] Furthermore, although the invention has been described with reference to several examples that optionally incorporate multiple features, the invention is not limited to what is described or indicated for each variation of the invention. Many changes may be made to the described invention without departing from the true spirit and scope of the invention, and equivalents (whether recorded herein or not included for brevity) may be substituted. Moreover, where numerical ranges are provided, it should be understood that every intermediate value between the upper and lower limits of the range, as well as any other stated or intermediate values ​​within the range, is included within the scope of the invention.

[0341] Furthermore, any optional features of the variations of the invention contemplated herein may be stated and claimed independently, or in combination with any one or more features described herein. References to singular items include the possibility that multiple identical items exist. More specifically, as used herein and in the related claims, the singular forms “a,” “an,” “the,” and “the” include plural objects unless otherwise specifically stated. In other words, the use of articles refers to “at least one” of the subject matter in the foregoing description and the claims relating to this disclosure. It should also be noted that such claims may be drafted to exclude any optional elements. Therefore, this statement is intended to serve as a premise for the use of exclusive terms such as “solely” and “only” in relation to the recitation or “negative” definition of claim elements.

[0342] Without using such exclusive terms, the term "comprising" in claims relating to this disclosure shall allow the inclusion of any additional elements regardless of whether a given number of elements are listed in such claims, or the added features may be regarded as transforming the nature of the elements set forth in such claims. Except as specifically defined herein, all technical and scientific terms used herein are given the broadest possible meaning in their common understanding while preserving the validity of the claims.

[0343] The scope of this invention is not limited to the examples and / or subject matter descriptions provided, but is limited only by the scope of the claims relating to this disclosure.

Claims

1. A system for sequentially injecting liquid, comprising: A syringe body defining a proximal opening of the syringe and a distal needle interface thereat; A proximal stop member and a distal stop member are disposed in the syringe body, forming a proximal chamber between the proximal stop member and the distal stop member, and forming a distal chamber between the distal stop member and the distal end of the syringe body; The first fluid in the distal chamber; The second fluid in the proximal chamber; A plunger configured for manual actuation to insert a proximal stop member distally relative to the syringe body; and A needle hub assembly connected to the distal needle interface of the syringe body, the needle hub assembly including a needle, in, The needle defines the needle interior, distal opening, intermediate opening, and proximal channel. The distal opening and the intermediate opening are connected by fluid flow through the inside of the needle, and The plunger assembly is manipulated to insert the proximal stop assembly distally relative to the syringe body. Initially, a first fluid is expelled from the distal chamber via the needle, and then a second fluid is sequentially expelled from the proximal chamber via the needle. Needles include: The distal portion has a sharp distal tip that defines the distal opening. A tubular intermediate connector having a proximal end and a distal end, and defining a portion of the interior of the needle. A solid, one-piece proximal feature structure having a distal end that connects to the proximal end of an intermediate connector, and defining the intermediate opening with the distal end of the proximal feature structure. Among them, the distal end of the solid, single-piece proximal feature structure has a crescent-shaped or dumbbell-shaped cross-section. The tubular intermediate connector has a continuous outer surface without side openings along its entire length. The distal end of the solid, single-piece proximal feature structure is located in the open proximal end of the tubular intermediate connector.

2. The system according to claim 1, wherein, The solid, single-piece proximal feature structure is connected to the tubular component via a weld.

3. The system according to claim 2, wherein, The weld is a fillet weld, which is configured such that when the needle penetrates the proximal stop member, it reduces the cutting of the proximal stop member compared to a needle without a fillet weld.

4. The system according to claim 2, wherein, The welded section gradually tapers towards the near side.

5. The system according to claim 2, wherein, The opening in the middle is adjacent to the welded part.

6. The system according to claim 1, wherein, The solid, one-piece proximal feature structure is cold-formed.

7. The system according to claim 1, wherein, The distal end of the solid, single-piece proximal feature structure is located at the proximal end of the tubular member.

8. The system according to claim 1, wherein, The central opening has a rounded edge, which is configured to reduce the cutting of the proximal stop member when the needle penetrates it, compared to a needle without a rounded edge.

9. The system according to claim 1, wherein, The opening in the middle is a long groove.

10. The system according to claim 9, wherein, The length of the elongated groove provides tolerance to accommodate variations associated with the proximal and distal stop members.

11. The system according to claim 10, wherein, The changes associated with the proximal stop member and / or the distal stop member are selected from the group consisting of: deformation of the proximal surface of the distal stop member, the position of the proximal stop member relative to the elongated groove, and the position of the distal stop member relative to the elongated groove.

12. The system according to claim 10, wherein, The length of the elongated slot is between 1 / 32 inch and 1 / 16 inch.

13. The system according to claim 9, wherein, The distance between the elongated groove and the solid, one-piece proximal feature structure minimizes reverse leakage of the first and second fluids into the plunger.

14. The system according to claim 9, wherein, The elongated groove is formed using a grinding wheel.

15. The system according to claim 1, wherein, The corresponding first and second dimensions of the distal and proximal chambers can be changed by the movement of the proximal and distal stop members relative to the syringe body.

16. The system according to claim 1, wherein, The plunger assembly includes: A needle-holding feature structure located inside the plunger; Energy storage components located inside the plunger; and The energy storage component locking component is located inside the plunger. The pin header assembly includes: Needle hub; and A needle retaining member configured to connect the needle to the needle holder. Specifically, when the plunger component is manipulated relative to the syringe body to switch the energy storage component locking component from a locked state to an unlocked state, the needle can retract at least partially into the plunger.

17. The system according to claim 16, wherein, The needle is configured to completely pierce at least the distal stop member so as to retract at least partially into the plunger.

18. The system according to claim 16, wherein, The energy storage component locking component is configured to switch from a locked state to an unlocked state after the second liquid has been discharged from the proximal chamber through the needle, at least partially retracting the needle into the plunger.

19. The system according to claim 16, wherein, The needle-holding feature structure is configured such that when the plunger member is manipulated to insert the proximal stop member into the distal end of the syringe body, the actuation energy storage member locking member changes from a locked state to an unlocked state.

20. The system according to claim 1, wherein, The proximal stop member and the distal stop member include respective first polymer coatings and second polymer coatings on their respective distal and proximal surfaces, such that the proximal chamber is defined by the syringe body and the first and second polymer coatings.

21. The system according to claim 1, wherein, The distal stop member has: The funnel-shaped part gradually tapers towards the proximal side, and The space located at the near end of the cone-shaped part of the funnel.

22. The system according to claim 1, wherein, The central opening is located near the distal end of the syringe body.

Images