Safety syringe systems and methods

Abstract

To provide a method for preparing a pre-filled multi-chamber injection system.SOLUTION: A method includes a step for providing an injection system body, in which the injection system body defines an opened proximal end, an inner body, and an opened distal end. The method includes a step for introducing a first material into a distal end of the inner body. The method includes a step for arranging a distal stopper member in the inner body, in which the distal stopper member and the injection system body define a proximal chamber and a distal chamber in the inner body. The method includes a step for introducing a second material into the inner body. The method includes a step for arranging the proximal stopper member in the inner body. The method includes a step for at least partially inserting a longitudinal member into the inner body, in which the longitudinal member has a plurality of flow paths for fluidly connecting the proximal chamber and the distal chamber. The method includes a step for connecting a plunger member to the proximal stopper member.SELECTED DRAWING: Figure 13

Description

Technical Field

[0001] The present disclosure generally relates to infusion systems, devices, and processes for facilitating various levels of control over fluid infusion, and more particularly, to systems and methods related to multi-chamber safety syringes in a medical environment.

Background Art

[0002] Millions of syringes, as shown in Figure 1A(2), are consumed daily in the healthcare setting. A typical syringe (2) includes a tubular body (4), a plunger (6), and a needle (8). As shown in Figure 1B, such syringes (2) can be used not only to inject fluids into patients but also to draw fluids from or into containers such as vials, bags, or other drug encapsulation systems (10). In fact, in some countries, such as the United States, due to concerns about maintaining sterility and regulatory constraints, if a vial (10) is used with a syringe (2), as shown in certain patient settings, such a vial must be used for only one patient and then disposed of, resulting in a large amount of medical waste from the discarded vials and remaining medication, and also causing periodic shortages of certain essential medications. Referring to Figure 2A, three Luer syringes (12) are shown, each having a Luer connector shape (14) located distally, which are connected to other devices having similar connector shapes, such as the Luer manifold assembly (16) shown in Figure 2B. The Luer manifold assembly in Figure 2B can be used to intravenously administer liquid medication to a patient, with or without the use of an intravenous infusion bag. The Luer connector (14) of the syringe in Figure 2A is sometimes called a “male” Luer connector, and the Luer connector (18) in Figure 2B is sometimes called a “female” Luer connector. One end of the Luer interface is threaded (in this case, the configuration is sometimes called a “Luer lock” configuration), and the two are connected by relative rotation, which may also be combined with a compressive load. In other words, in one embodiment of a Luer lock, rotation, possibly along with compression, is used to engage the threads of the male fitting (14), which then engage with a flange on the female fitting (18) to bring the device into a fluid-sealed coupling state. In another embodiment, a tapered interface shape may be used to provide a Luer engagement using compression without the use of threads or rotation (such configurations may be referred to as “slip-on” or “conical” Luer configurations).While such Luer connectors are considered relatively safe for operators, there is a risk of drug spillage, leakage, or component damage during assembly. On the other hand, using needle injection configurations carries the risk of sharp needles coming into contact with or puncturing people or undesirable structures. For these reasons, so-called "safety syringes" have been developed.

[0003] One embodiment of the safety syringe (20) is shown in Figure 3, in which a tubular shielding member (22) is spring-biased to cover the needle (8) when released from the locked position relative to the syringe body (4). Another embodiment of the safety syringe (24) is shown in Figures 4A and 4B. In this configuration, after the plunger (6) is fully inserted into the syringe body (4), a retractable needle (26) is retracted (28, 26) into a safe position within the tubular body (4), as shown in Figure 4B. Such a self-contained configuration may be associated with issues of blood splatter / aerosolization, safe storage of pre-loaded energy that could malfunction and act too quickly, loss of precision when delivering a full dose due to residual dead space in the spring-compressed volume, and / or loss of retraction speed control which may be associated with pain or patient anxiety.

[0004] The increasing demand for pre-filled syringe assemblies, as shown in Figures 5A and 5B, is further complicating the syringe market, which generally comprises a syringe body or “drug containment delivery system” (34), a plunger tip, plug or stopper (36), and a distal seal or cap (35) attached to a Luer interface (Figure 5A shows the cap 35 in position, while Figure 5B shows the cap removed to illustrate the Luer interface 14). The liquid drug resides in the volume between the distal seal and the distal end (37) of the plunger tip (36) or in a drug reservoir (40). The plunger tip (36) may include standard butyl rubber material and may be coated with a biocompatible lubricating coating (e.g., polytetrafluoroethylene ("PTFE")) to facilitate favorable sealing and relative motion characteristics with respect to the associated syringe body structure and material. The proximal end of the syringe body (34) in Figure 5B includes a conventional integrated syringe flange (38) formed integrally with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and to be either the entire circumference or a portion of the circumference around the syringe body (34). A partial flange is known as a "clipped flange," and the other flange The lunge is known as a "full flange." The flange is used to grasp the syringe with the fingers and provides support for pushing the plunger to perform the injection. The syringe body (34) preferably comprises a translucent material such as glass or polymer. The plunger tip (36) may be positioned within the syringe body (34) to form a sealed volume within a chamber or reservoir (40) and to assist in the discharge of the associated fluid through the needle. The syringe body (34) may be defined as substantially cylindrical (i.e., so that the plunger tip 36 having a circular cross-sectional shape establishes a seal against the syringe body (34)) or may be configured to have other cross-sectional shapes such as elliptical.

[0005] Such assemblies are desirable because they can be standardized and precisely mass-produced by a few manufacturers in the world that can afford to meet all of the world's ever-changing regulations regarding filling, packaging, and the selection of pharmaceutical / medical interfacing materials and the use of components. However, such simple configurations generally cannot meet new global standards for single use, safety, auto-deactivation, and needle-stick prevention. For this reason, certain suppliers have moved towards more "vertical" solutions, such as those shown in Figure 5C (41), which attempt to meet all or at least some of the standards in a single solution, and as a result of trying to meet those standards in many different scenarios, such products have significant limitations (including the limitations mentioned above with reference to Figures 3-4B) and can be relatively high in inventory and usage costs.

[0006] In some cases, a multi-component injection system can mix the injectable components (e.g., liquids, solids, and / or powders) before injection.

[0007] Furthermore, as the amount of liquid to be injected (e.g., pharmaceuticals) increases, the additional requirement arises to inject two or more components consecutively (e.g., into the patient) preferably at short intervals from each other (e.g., within a few seconds). Multiple components can be injected consecutively using separate injection devices (e.g., pre-loaded syringes), or they can be injected consecutively by drawing them from separate open containers using the same injection device. However, consecutive injections using such separate injection devices, or by drawing and injecting multiple components consecutively, inevitably involve inserting multiple needles into the patient and can be inaccurate and lead to component loss. Furthermore, consecutive injections using separate injection devices, or by drawing and injecting multiple components consecutively into syringes, can unnecessarily expose the user to one or more uncapped needles. In addition, consecutive injections using separate injection devices, or by drawing and injecting multiple components consecutively, can result in unacceptable delays between the injections of multiple components.

[0008] Furthermore, the increasing variety of liquids that may be injected (e.g., pharmaceuticals) raises yet another requirement: minimizing the time that metals (e.g., stainless steel of the needle) are exposed to such liquids. Yet another requirement is the desirability of a system suitable for patient self-injection.

[0009] Furthermore, it is desirable to incorporate needle-stick prevention technology into the injection system. The ability to retract at least partially the sharp end of the needle into the syringe protects both the person administering the injection and the patient from accidental needle-stick injuries.

[0010] An injection system is needed to address the shortcomings of currently available configurations. In particular, there is a need for a multi-chamber safe injection solution that can utilize the existing, relatively well-controlled supply chain of conventionally available pre-filled syringe assemblies, as illustrated with reference to Figures 5A and 5B. [Overview of the project]

[0011] The embodiments relate to injection systems. In particular, the embodiments cover multi-chamber safe injection systems that move the needle into a protective configuration to minimize accidental user injury and contamination of spent needles.

[0012] In one embodiment, a method for preparing a pre-filled multi-chamber injection system includes the step of providing an injection system body, the injection system body defining an open proximal end, an interior of the body, and an open distal end. The method also includes the step of introducing a first substance into the distal end of the interior of the body. The method further includes the step of positioning a distal stopper member into the interior of the body via the open proximal end of the injection system body, the distal stopper member and the injection system body defining a proximal chamber and a distal chamber within the body, and the first substance being placed in the distal chamber. Furthermore, the method includes the step of introducing a second substance into the interior of the body. Furthermore, the method includes the step of positioning a proximal stopper member into the interior of the body via the open proximal end of the injection system body, the proximal stopper member defining the proximal end of the proximal chamber, and the second substance being placed in the proximal chamber. The method also includes the step of inserting an elongated member at least partially into the main body, the elongated member having a plurality of flow channels for fluidly connecting the proximal chamber and the distal chamber, and a proximal end configured to penetrate the distal stopper member. The method further includes the step of connecting a plunger member to the proximal stopper member.

[0013] In one or more embodiments, introducing a first substance into the distal end inside the body includes introducing a liquid into the distal end inside the body and freeze-drying the liquid. Introducing a first substance into the distal end inside the body may include introducing a powder or solid into the distal end inside the body. The method may further include the step of placing the injection system body in a rack in a first configuration before placing the distal stopper member inside the body, with the distal end of the injection system body facing downwards when the injection system body is in the first configuration. The method may also include the step of reorienting the injection system body in the rack to a second configuration before introducing the first substance into the distal chamber through the open distal end, with the proximal end of the injection system body facing downwards when the injection system body is in the first configuration. The method may include the step of returning the injection system body in the rack to the first configuration and placing the proximal stopper member inside the body before introducing the second substance into the body.

[0014] In one or more embodiments, the rack includes a feature for holding the injection method body in a first configuration and a second configuration within the rack. The distal stopper member may include a funnel therein, and the method further includes the step of guiding the proximal end of the needle to the center of the distal stopper member by the funnel. The funnel may include a U-shaped retaining member / detent. The proximal end of the needle may include a 3D arrowhead shape, and the method further includes the step of temporarily preventing distal movement of the distal stopper member by the 3D arrowhead interfering with the U-shaped retaining member / detent. The method may include the step of freeze-drying the first substance in the distal chamber before coupling the needle hub assembly to the distal end of the injection system body.

[0015] In one or more embodiments, the method includes the step of inserting a proximal stopper member into the body through the open proximal end of the injection system body by utilizing the pressure difference between the proximal and distal sides of the proximal stopper member. The method may include the step of maintaining a vacuum in the proximal chamber while inserting the proximal stopper member into the body through the open proximal end of the injection system body. The method may include the step of positioning the proximal stopper member above the open proximal end of the injection system body before inserting the proximal stopper member into the body. The method may include the step of positioning a tube adjacent to the proximal stopper member so that the proximal chamber is fluidly coupled to the ambient atmosphere while inserting the proximal stopper member into the body through the open proximal end of the injection system body. The method may include maintaining a vacuum in the distal chamber during the method. The method may include performing one or more steps of the method in a vacuum.

[0016] In one or more embodiments, the method includes the step of coupling a flange to the injection system body so as to prevent the flange from moving along the longitudinal axis and so as to allow the plunger to move relative to the flange along the longitudinal axis. The method may include the step of coupling a plunger to a proximal stopper member to facilitate the movement of the proximal stopper member along the longitudinal axis. The injection system body, needle hub assembly, proximal stopper member and distal stopper member may be pre-sterilized. The method may include the step of preparing a plurality of pre-filled multi-chamber injection systems. The method may include the steps of introducing a third substance into the body through an open proximal end and positioning a second proximal stopper member into the body through the open proximal end of the injection system body, wherein the second proximal stopper member may define the proximal end of a second proximal chamber and the third substance may be positioned in the second proximal chamber.

[0017] In one embodiment, a method for preparing a pre-filled multi-chamber infusion system includes the step of placing the infusion system body (syringe / cartridge) in a rack in a first configuration, wherein the infusion system body defines an open proximal end, an interior of the body, and an open distal end, and the distal end of the infusion system body is oriented downward when the infusion system body is in the first configuration. The method also includes the step of placing a distal stopper member into the interior of the body through the open proximal end of the infusion system body, wherein the distal stopper member and the infusion system body define a proximal chamber and a distal chamber within the body. The method further includes the step of reorienting the infusion system body in the rack to a second configuration in which the proximal end of the infusion system body is oriented downward. Furthermore, the method includes the step of introducing a first substance into the distal chamber through the open distal end. Furthermore, the method includes the step of connecting a needle hub assembly to the distal end of the infusion system body, the needle hub assembly including a needle having a needle proximal end, the needle proximal end of which interferes with a distal stopper member to temporarily prevent distal movement of the distal stopper member. The method also includes the step of returning the infusion system body in the rack to the first configuration. The method further includes the step of introducing a second substance into the body through an open proximal end. Furthermore, the method includes the step of positioning a proximal stopper member into the body through the open proximal end of the infusion system body such that the proximal stopper member defines the proximal end of the proximal chamber, and the second substance is placed in the proximal chamber.

[0018] In another embodiment, a method for preparing a pre-filled multi-chamber infusion system includes the step of coupling a needle hub assembly to an infusion system body (syringe / cartridge), wherein the needle hub assembly includes a needle having a proximal end, and the infusion system body defines an open proximal end, an interior of the body, and a distal end that is closed by the needle hub assembly. The method also includes the step of placing the infusion system body in a rack in a first configuration, with the distal end of the infusion system body facing downward when the infusion system body is in the first configuration. The method further includes the step of introducing a first substance into the interior of the body through the open proximal end. Furthermore, the method includes the step of positioning a distal stopper member into the interior of the body through the open proximal end of the infusion system body, wherein the distal stopper member and the infusion system body define a proximal chamber and a distal chamber within the body, with the proximal end of the needle interfering with the distal stopper member to temporarily prevent distal movement of the distal stopper member, and the first substance being placed in the distal chamber. Furthermore, the method includes the step of introducing a second substance into the syringe through an open proximal end. The method also includes the step of positioning a proximal stopper member inside the body through the open proximal end of the injection system body such that the proximal stopper member defines the proximal end of the proximal-distal chamber, and the second substance is placed in the proximal chamber.

[0019] In yet another embodiment, a method for preparing a pre-filled multi-chamber cartridge includes the step of placing the cartridge body in a rack in a first configuration, the cartridge body defining an open proximal end, an interior body, and an open distal end. When the cartridge body is in the first configuration, the distal end of the cartridge body is oriented downward. The method also includes the step of placing a distal stopper member into the interior body via the open proximal end of the cartridge body, the distal stopper member and the cartridge body defining a proximal chamber and a distal chamber within the interior body. The method further includes the step of reorienting the cartridge body in the rack to a second configuration in which the proximal end of the cartridge body is oriented downward. Furthermore, the method includes the step of introducing a first substance into the distal chamber via the open distal end. Furthermore, the method optionally includes the step of attaching a cartridge cap to the distal end of the cartridge body. The method also includes the step of coupling a needle hub assembly to the distal end of the cartridge body via a cartridge cap, wherein the needle hub assembly includes a needle having a needle proximal end, the needle proximal end of which interferes with a distal stopper member to temporarily prevent distal movement of the distal stopper member. The method further includes the step of returning the cartridge body in the rack to the first configuration. Furthermore, the method includes the step of introducing a second material into the body via an open proximal end. Furthermore, the method includes the step of positioning the proximal stopper member into the body via the open proximal end of the cartridge body such that the proximal stopper member defines the proximal end of the proximal chamber, and the second material is positioned in the proximal chamber.

[0020] In yet another embodiment, a method for preparing a prefilled multi-chamber cartridge optionally includes the step of coupling a cartridge cap to a cartridge body, the cartridge body defining an open proximal end, an interior of the body, and a distal end closed by the cartridge cap. The method also includes the step of coupling a needle hub assembly to the distal end of the cartridge body via the cartridge cap, the needle hub assembly including a needle having a needle proximal end. The method further includes the step of placing the cartridge body in a rack in a first configuration, with the distal end of the cartridge body facing downward when the cartridge body is in the first configuration. Furthermore, the method includes the step of introducing a first substance into the interior of the body via the open proximal end. Furthermore, the method includes the step of positioning a distal stopper member into the interior of the body via the open proximal end of the cartridge body, the distal stopper member and the cartridge body defining a proximal chamber and a distal chamber within the body, the needle proximal end interfering with the distal stopper member to temporarily prevent distal movement of the distal stopper member, and the first substance being positioned in the distal chamber. The method also includes the step of introducing a second substance into the syringe through an open proximal end. The method further includes the step of positioning a proximal stopper member inside the cartridge body through the open proximal end of the cartridge body such that the proximal stopper member defines the proximal end of the proximal chamber, and the second substance is placed in the proximal chamber.

[0021] In another embodiment, a method for preparing a prefilled multi-chamber cartridge optionally includes the step of coupling a cartridge cap to a cartridge body, the cartridge body defining an open proximal end, an interior of the body, and a distal end that is closed by the cartridge cap. The method includes the step of placing the cartridge body in a rack in a first configuration, with the distal end of the cartridge body facing downward when the cartridge body is in the first configuration. The method further includes the step of introducing a first substance into the interior of the body through the open proximal end. Furthermore, the method includes the step of positioning a distal stopper member into the interior of the body through the open proximal end of the cartridge body, the distal stopper member and the cartridge body defining a proximal chamber and a distal chamber within the body, the proximal end of the needle interfering with the distal stopper member to temporarily prevent distal movement of the distal stopper member, and the first substance being positioned in the distal chamber. Furthermore, the method includes the step of coupling a needle hub assembly to the distal end of the cartridge body from above the cartridge cap, the needle hub assembly including a needle having a proximal end that penetrates the cartridge cap. The method also includes the step of introducing a second substance into the syringe through an open proximal end. The method further includes the step of positioning a proximal stopper member inside the cartridge body through the open proximal end of the cartridge body such that the proximal stopper member defines the proximal end of the proximal chamber, and the second substance is placed in the proximal chamber.

[0022] In yet another embodiment, a method for preparing a pre-filled multi-chamber cartridge includes the step of placing the cartridge body in a rack in a first configuration, the cartridge body defining an open proximal end, a body interior, and an open distal end. When the cartridge body is in the first configuration, the distal end of the cartridge body is oriented downward. The method also includes the step of placing a distal stopper member into the body interior through the open proximal end of the cartridge body, the distal stopper member and the cartridge body defining a proximal chamber and a distal chamber within the body interior. The method further includes the step of reorienting the cartridge body in the rack to a second configuration in which the proximal end of the cartridge body is oriented downward. Furthermore, the method includes the step of introducing a first substance into the distal chamber through the open distal end. Furthermore, the method includes the step of coupling a cartridge cap to the distal end of the cartridge body, the cartridge cap including a transfer tube, the transfer tube interfering with the distal stopper member to temporarily prevent the distal movement of the distal stopper member. The method also includes the step of returning the cartridge body in the rack to the first configuration. The method further includes the step of introducing a second substance into the body through an open proximal end. Furthermore, the method includes the step of positioning a proximal stopper member into the body through the open proximal end of the cartridge body such that the proximal stopper member defines the proximal end of the proximal chamber, and the second substance is placed in the proximal chamber.

[0023] In yet another embodiment, a method for preparing a pre-filled multi-chamber cartridge optionally includes the step of coupling a cartridge cap to a cartridge body, the cartridge body defining an open proximal end, an interior of the body, and a distal end closed by the cartridge cap. The method also includes the step of passing the cartridge cap through a transfer tube. The method further includes the step of placing the cartridge body in a rack in a first configuration, with the distal end of the cartridge body facing downward when the cartridge body is in the first configuration. The method further includes the step of introducing a first substance into the interior of the body through the open proximal end. The method further includes the step of positioning a distal stopper member into the interior of the body through the open proximal end of the cartridge body, the distal stopper member and the cartridge body defining a proximal chamber and a distal chamber within the body, the transfer tube interfering with the distal stopper member to temporarily prevent distal movement of the distal stopper member, and the first substance being placed in the distal chamber. The method also includes the step of introducing a second substance into a syringe through the open proximal end. The method further includes the step of positioning a proximal stopper member inside the cartridge body through the open proximal end of the cartridge body such that the proximal stopper member defines the proximal end of the proximal chamber, and a second substance is placed inside the proximal chamber.

[0024] In one or more embodiments, the method includes the step of coupling a flange and a plunger member to the injection system body such that the flange is prevented from moving along the longitudinal axis and the plunger is able to move on the longitudinal axis.

[0025] In yet another embodiment, the automatic injector system includes a disposable injector system (syringe / cartridge) and a reusable drive system. The disposable injector system has an injector system body, which includes a proximal end, a distal end, and the interior of the injector system body between them. The disposable injector system also includes a stopper member located inside the injector system body. The disposable injector system further includes a plunger member coupled to the stopper member. Furthermore, the disposable injector system includes a finger flange coupled to the injector system body at its proximal end. Furthermore, the disposable injector system includes a needle hub assembly coupled to the injector system body at its distal end. The disposable injector system also includes a rigid needle shield coupled to the needle hub assembly. The reusable drive system includes a drive system body having an interior drive system body. The disposable injector system also includes a plunger actuator / pusher for moving the plunger member distally relative to the injector system body when the injector system is mounted on the drive system. The disposable injector system further includes a flange holder / carriage for moving the injector system distally and / or proximal relative to the drive system body when the injector system is mounted on the drive system.

[0026] In one or more embodiments, the drive system includes a first motor for moving a plunger actuator / pusher, a second motor for moving a flange holder / carriage, a controller operably coupled to the first and second motors, a display operably coupled to the controller, and a sensor operably coupled to the controller. The sensor can be selected from the group consisting of accelerometers, contact sensors, position sensors, gyroscopes, thermometers, and skin contact sensors. The drive system may include multiple sensors.

[0027] In yet another embodiment, the auto-injector system includes a disposable injection system (syringe / cartridge) and a reusable drive system. The disposable injection system has an injection system body that includes a proximal end, a distal end, and an interior of the injection system body therebetween. The disposable injection system also includes first and second stopper members disposed within the injection system body. The first stopper member and the injection system body define a first chamber, and the first and second stopper members and the injection system body define a second chamber. The disposable injection system further includes a plunger member coupled to the second stopper member. Additionally, the disposable injection system includes a finger flange coupled to the proximal end of the injection system body. Further, the disposable injection system includes a needle hub assembly coupled to the distal end of the injection system body. Also, the disposable injection system includes a rigid needle shield coupled to the needle hub assembly. The reusable drive system includes a drive system body having an interior of the drive system body. The reusable drive system also includes a plunger actuator / pusher that moves the plunger member distally with respect to the injection system body when the injection system is attached to the drive system. The reusable drive system further includes a flange holder / carriage for moving the injection system distally and / or proximally with respect to the drive system body when the injection system is attached to the drive system.

[0028] In one or more embodiments, the drive system includes a first motor that moves the plunger actuator / pusher, a second motor that moves the flange holder / carriage, a controller operably coupled to the first and second motors, a display operably coupled to the controller, and a sensor operably coupled to the controller. The sensor can be selected from the group consisting of an accelerometer, a contact sensor, a position sensor, a gyroscope, a thermometer, and a skin contact sensor. The drive system can include a plurality of sensors.

[0029] In another embodiment, a method of automatically mixing and injecting a substance includes providing the above-described automatic injector system, wherein the injection system is attached to a drive system and a plunger actuator / pusher and a flange holder / carriage are disposed in a proximal first position. The method includes the controller moving, by a first motor, a plunger actuator and a plunger member and a second stopper member operatively coupled thereto in a distal direction relative to the injection system body to transfer fluid from a second chamber to a first chamber to form an injectable medicament. The method further includes the controller moving, by the first motor, the plunger actuator and the plunger member and the second stopper member operatively coupled thereto in a further distal direction relative to the injection system body to inject the injectable medicament through a needle hub assembly.

[0030] In one or more embodiments, the method further includes the controller causing a message to be displayed on a display instructing the user to agitate a device to facilitate mixing of powder and fluid within the first chamber to form an injectable medicament. The method can further include the controller causing a message to be displayed on a display instructing the user to turn the automatic injector system upward and remove a rigid needle shield from the automatic injector system before the controller moves, by the first motor, the plunger actuator and the plunger member and the second stopper member operatively coupled thereto in a further distal direction relative to the injection system body. The method can further include a sensor detecting that the automatic injector system is in an upward orientation and, only when the sensor detects that the automatic injector system is in an upward orientation, the controller moving, by a second motor, a flange holder / carriage in a proximal direction relative to the drive system body to separate a rigid needle shield from a needle hub assembly.

[0031] In one or more embodiments, the method further includes the step of the controller displaying a message on a display instructing the user to position the automatic injector system in contact with the patient before the controller moves the plunger actuator, the plunger member and the second stopper member operably coupled thereto, further distally relative to the infusion system body using a first motor. The method may further include the step of a sensor detecting contact between the automatic injector system and the patient, and only if the sensor has detected contact between the automatic injector system and the patient, the controller moving the plunger actuator, the plunger member and the second stopper member operably coupled thereto, further distally relative to the infusion system body using the first motor. The method may further include the step of the controller displaying a message on a display indicating the end of the infusion and instructing the user to remove the infusion system after the controller has moved the plunger actuator, the plunger member and the second stopper member operably coupled thereto, further distally relative to the infusion system body using the first motor.

[0032] In yet another embodiment, the multi-chamber safety infusion system includes a syringe body defining the interior of the syringe body, and a distal coupling member at its distal end. The system includes a proximal stopper member and a distal stopper member located inside the syringe body, forming a proximal chamber between the proximal and distal stopper members, and a distal chamber between the distal stopper member and the distal end of the syringe body. The system also includes a plunger member configured to be manually operated for inserting the proximal stopper member into the syringe body. The system further includes a mixing tube located inside the syringe body. Furthermore, the system includes a vent plug located at least partially on the distal coupling member, defining a plurality of channels configured to allow gas to escape from inside the syringe body while forming a liquid-tight seal.

[0033] In yet another embodiment, the infusion system includes a syringe body having a proximal opening defined at its proximal end and a distal needle interface defined at its distal end. The system also includes a proximal stopper member and a distal stopper member disposed within the syringe body, forming a proximal drug chamber between the proximal and distal stopper members and a distal drug chamber between the distal stopper member and the distal end of the syringe body. The system further includes a plunger member configured to be manually operated to insert the proximal stopper member into the syringe body, the plunger member having a smooth outer surface. Furthermore, the system includes a fluid transfer assembly. Furthermore, the system comprises a finger flange including a retraction prevention mechanism. The retraction prevention mechanism includes a brake tab configured to apply a counterforce to the plunger member to prevent its proximal movement relative to the brake tab, and a retaining feature configured to maintain the retraction prevention mechanism in a recess of the finger flange.

[0034] In one or more embodiments, the finger flange also includes another recess configured for attaching the finger flange to the flange of the syringe body. The anti-retraction mechanism may also include a plurality of fit tabs configured to reduce the tolerance between the recess and the dimensions of the anti-retraction mechanism. The anti-retraction mechanism may be a metal clip.

[0035] In one or more embodiments, the brake tab is an elastic, self-acting claw. The brake tab can be positioned at an acute angle distal to the plane of the anti-retraction mechanism. The acute angle and elasticity of the brake tab can increase the frictional force against the plunger member when it retracts proximally. The acute angle of the brake tab also generates a reaction force parallel to the plunger member, applied by the sharp, curved edge of the brake tab that contacts the surface of the plunger member. This force prevents the plunger member from moving proximally. Furthermore, the acute angle and elasticity of the brake tab allow the brake tab to exert an outward force on the inner wall of the finger flange via the anti-retraction mechanism when the plunger member retracts proximally.

[0036] In one or more embodiments, the finger flange also includes an opening having an edge configured to interfere with the anti-retraction mechanism and hold the anti-retraction mechanism within the recess. The anti-retraction mechanism may have a "C" or "O" shape. The anti-retraction mechanism can prevent the plunger member from being removed from the syringe body after the plunger member has been inserted into the syringe body. The opposing forces may include frictional forces and reaction forces. The brake tab may be configured to engage with the smooth outer surface of the plunger member as the plunger member moves proximal to the anti-retraction mechanism.

[0037] The above-described embodiments and other embodiments of the present invention are described in the following detailed description. [Brief explanation of the drawing]

[0038] The embodiments described above and other embodiments of the embodiment are described in further detail with reference to the accompanying drawings, in which the same elements in various drawings are indicated by common reference numerals.

[0039] [Figure 1] Figures 1A and 1B show various configurations of conventional injection syringes. [Figure 2] Figures 2A and 2B show various configurations of conventional injection syringes. [Figure 3] Figure 3 shows various configurations of conventional injection syringes. [Figure 4] Figures 4A and 4B show various configurations of conventional injection syringes. [Figure 5] Figures 5A to 5C show various configurations of conventional injection syringes. [Figure 6] Figures 6A and 6B illustrate various embodiments of a syringe-based dual-chamber safety infusion system in which the distal end / tip of the needle is retracted into a protective configuration after use, according to several embodiments. [Figure 7]Figures 7A to 7P show various aspects of a syringe-based dual-chamber safety infusion system during steps of a method for mixing and injecting using the system according to several embodiments. [Figure 8] Figures 8A and 8B illustrate various aspects of a syringe-based dual-chamber safe infusion system according to several embodiments. [Figure 9] Figures 9A to 9C illustrate various embodiments of a distal stopper member having a stopper bushing with a detent for use with a syringe-based dual-chamber safety infusion system according to several embodiments. [Figure 10] Figures 10A to 10C show various embodiments of stopper member bushings with detents for use in syringe-based dual-chamber safety infusion systems according to several embodiments. [Figure 11] Figures 11A to 11C show various configurations of detents used with stopper member bushings in syringe-based dual-chamber safe infusion systems according to several embodiments. [Figure 12] Figures 12A to 12C show racks containing multiple injection systems / syringe bodies housed in a container, according to several embodiments. [Figure 13] Figure 13 is a flowchart showing a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 14] Figures 14A to 14J illustrate various steps in a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 15] Figures 15A to 15D show various forms of detents for use with stopper member bushings for use in multi-chamber safety injection systems according to several embodiments. [Figure 16] Figures 16 and 16A illustrate the interaction between the detent and the proximal end of the needle according to several embodiments. [Figure 17]Figure 17 shows a rack containing multiple injection systems / syringe bodies, housed in a container, according to several embodiments. [Figure 18] Figure 18 is a flowchart showing a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 19] Figures 19A to 19H illustrate various steps in a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 20] Figures 20A to 20D show racks containing multiple cartridge bodies housed in a container, according to several embodiments. [Figure 21] Figure 21 is a flowchart showing a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 22] Figures 22A to 22J illustrate various steps in a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 23] Figures 23A and 23B show various embodiments of cartridge caps for use with multi-chamber safety injection systems according to several embodiments. [Figure 24] Figures 24A and 24B show cartridge bodies for use with multi-chamber safety injection systems according to several embodiments. [Figure 25] Figure 25 shows a rack containing multiple cartridge bodies housed in a container, according to several embodiments. [Figure 26] Figure 26 is a flowchart showing a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 27] Figures 27A to 27G illustrate various steps in a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 28]Figure 28 is a flowchart showing a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 29] Figures 29A to 29H illustrate various steps in a method for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. [Figure 30] Figure 30 shows a cartridge stopper for use with a multi-chamber safety injection system according to several embodiments. [Figure 31] Figures 31A to 31H illustrate various steps of a method for injecting a drug using an automatic injector according to several embodiments. [Figure 32] Figures 32A to 32J illustrate various steps in a method for mixing drug components using an automatic injector according to several embodiments, and for injecting the mixed drug. [Figure 33] Figure 33 illustrates various steps in a method for mixing drug components and injecting the mixed drug using a syringe having a Luer connector according to several embodiments. [Figure 34] Figure 34 illustrates various steps in a method for mixing drug components and injecting the mixed drug using a syringe having a Luer connector according to several embodiments. [Figure 35] Figure 35 illustrates various steps in a method for mixing drug components and injecting the mixed drug using a syringe having a Luer connector according to several embodiments. [Figure 36] Figure 36 illustrates various steps in a method for mixing drug components and injecting the mixed drug using a syringe having a Luer connector according to several embodiments. [Figure 37] Figure 37 illustrates various steps in a method for mixing drug components and injecting the mixed drug using a syringe having a Luer connector according to several embodiments. [Figure 38]Figure 38 illustrates various steps in a method for mixing drug components and injecting the mixed drug using a syringe having a Luer connector according to several embodiments. [Figure 39] Figure 39 illustrates various steps in a method for mixing drug components and injecting the mixed drug using a syringe having a Luer connector according to several embodiments. [Figure 40] Figure 40 illustrates various steps in a method for mixing drug components and injecting the mixed drug using a syringe having a Luer connector according to several embodiments. [Figure 41] Figure 41 shows various embodiments of a multi-chamber safety injection system having a vent plug according to several embodiments. Figure 41A shows a retraction prevention mechanism according to several embodiments. [Figure 42] Figure 42 shows various embodiments of a multi-chamber safety injection system having a vent plug according to several embodiments. [Figure 43] Figures 43A to 43D show various embodiments of a multi-chamber safety injection system having a vent plug according to several embodiments. [Figure 44] Figure 44 shows various embodiments of a multi-chamber safety injection system having a vent plug according to several embodiments. [Figure 45] Figure 45 shows various embodiments of a multi-chamber safety injection system having a vent plug according to several embodiments. [Figure 46] Figure 46 shows various embodiments of a multi-chamber safety injection system having a vent plug according to several embodiments. [Figure 47] Figure 47 shows various embodiments of a multi-chamber safety injection system having a vent plug according to several embodiments. [Figure 48] Figure 48 shows vent plugs according to several embodiments. [Figure 49] Figure 49 shows a reversal prevention mechanism according to several embodiments. [Figure 50] Figure 50 shows a rollback prevention mechanism according to several embodiments. [Figure 51] Figure 51 shows a rollback prevention mechanism according to several embodiments. [Figure 52] Figure 52 shows a rollback prevention mechanism according to several embodiments. [Figure 53] Figure 53 shows a rollback prevention mechanism according to several embodiments. [Figure 54] Figure 54 shows a rollback prevention mechanism according to several embodiments. [Figure 55] Figure 55 shows a rollback prevention mechanism according to several embodiments. [Figure 56] Figure 56 shows a rollback prevention mechanism according to several embodiments.

[0040] To better understand how the above and other advantages and objectives of various embodiments are obtained, a more detailed description of the embodiments is provided with reference to the accompanying drawings. Note that the drawings are not drawn to a fixed scale, and elements of similar structure or function are indicated by the same reference numerals throughout. It should be understood that these drawings show only specific exemplary embodiments and should not be considered to limit the scope of the embodiments. [Modes for carrying out the invention]

[0041] Exemplary pre-filled dual-chamber safety injection system Referring to Figures 6A and 6B, perspective and longitudinal section views are shown of a pre-filled dual-chamber safety infusion system (100) having a conventional off-the-shelf pre-filled syringe body (34) with conventional proximal and distal stopper members (32, 36) positioned inside. The proximal and distal stopper members (32, 36), together with the syringe body (34), define the proximal and distal chambers (40, 42). The proximal and distal stopper members (36, 37) close the proximal and distal ends of the proximal chamber (40). The distal stopper member (36) closes the proximal end of the distal chamber (42). In some embodiments, the distal end of the proximal stopper member (32) and the proximal end of the distal stopper member (36) may be coated with a lubricating polymer coating (e.g., PTFE), and the first and second polymer coatings of the proximal and distal stopper members (32, 36), together with the syringe body (34), define the proximal chamber (40). The lubricating polymer coating serves to isolate the rubber of the proximal and distal stopper members (32, 36) from the second liquid (254). The proximal and distal stopper members (32, 36) may be oriented as shown in Figures 6A and 6B, or the distal stopper (36) may be inverted so that the lubricating coating faces the distal chamber (42) and the first liquid (252) in the distal chamber (42) comes into contact with the lubricating coating for storage.

[0042] The needle coupling assembly (606) is positioned at the distal end of the distal chamber (42) with the needle cover member (63) attached for storage. The dual-chamber safe infusion system facilitates the continuous infusion of a second liquid (254) from the proximal chamber following the infusion of a first liquid (252) from the distal chamber (42) by sequentially inserting the plunger assembly (44) into the syringe body (34) to varying degrees. The plunger assembly (44) includes a proximal stopper member (32), a plunger housing member (69), and a plunger operating interface (128). The first and second liquids, respectively, located in the distal and proximal chambers (42, 40) may be any liquid or gel, such as an aqueous or oily drug solution.

[0043] The dual-chamber safety infusion system (100) has a staked needle configuration in which, when provided to the user, the needle assembly, including the needle spine assembly ("needle") (76) and the needle coupling assembly (606), is installed in a fixed position ready for infusion after the needle cover member (63) has been removed, and the needle cover member may have an elastomer sealing material on its inner surface that contacts the distal end (78) and / or distal housing portion of the needle during storage. Alternatively, the needle cover member (63) may include a vent (not shown) that can release pressure resulting from the movement of liquid (252, 254) from inside the syringe body (34) while preventing contamination from entering the syringe body (34). Although the staked needle is depicted as fixed in place, it can be removably coupled to the syringe body (34) using a Luer slip or Luer lock interface (not shown), with the proximal end (50) of the needle member extending into the distal chamber (42) through the Luer interface. Alternatively, the needle may be fixedly or removably mounted to the flange of the cartridge body instead of the syringe. In the embodiments shown in Figures 6A and 6B, a substantial portion of the safe needle retraction member resides within the plunger housing.

[0044] Referring to Figures 7A to 7L, various embodiments of configurations designed to facilitate the injection of multipart drugs and the retraction of the needle into the syringe body are illustrated, where two or more drug components are combined immediately before delivery to the patient to form a combination or solution for injection. In one embodiment, a liquid first drug component / diluent (252) can be combined immediately before injection with a substantially non-liquid second drug component (254), such as a powder and / or solid (e.g., compressed powder) form of the drug, such as a lyophilized drug component. The second drug component (254) may consist of a powder drug generally formed into a solid form. The solid form can be created by compressing the powder and / or by using a binder material. This solid drug component can be configured in cylindrical, tubular, spherical, polygonal and / or toroidal shapes. The solid drug (254) can be placed in a distal drug chamber (42) during and / or instead of the lyophilization step. The second drug component (254) in solid form is configured to dissolve and / or disperse upon contact with a liquid. The configurations described herein with reference to Figures 7A–7L relate to a dual-chamber configuration in which two or more chambers within the same syringe body (34) are used for transferring, mixing, and injecting the injection solution.

[0045] Referring to Figures 7A and 7B, a distal stopper member (36) between two internal parts of the syringe body (34) forms proximal and distal drug chambers (40, 42). The distal drug chamber (42) contains an air or gas gap and a non-liquid drug (254), while the proximal drug chamber (40), located opposite the distal stopper member (36), contains a liquid diluent (252), which is confined to the proximal side by the proximal stopper member (32). The liquid diluent (252) is the first component of the drug, and the non-liquid drug (254) is the second component of the drug.

[0046] Referring to the corresponding cross-sectional views in Figures 7C and 7D, various components of the needle coupling assembly are shown (here, a so-called “staked” needle coupling assembly (606) is illustrated, but other needle assemblies, including not only staked configurations but also Luer coupling configurations, can be used as described later). The lug feature (258) is configured to assist in coupling the needle coupling assembly (606) to the needle cover member (63), as shown, for example, in Figure 7A. A small O-ring can be used as a sealing member (260) around the needle shaft, while a large O-ring can be used as a sealing member (262) at the syringe body (34) / needle coupling assembly (606) interface. Alternatively, a small O-ring (260) and a large O-ring (262) can be combined to create a single seal that performs both O-ring sealing functions. Alternatively, a small O-ring (260) can be used to seal both around the needle shaft and the syringe body (34).

[0047] The needle includes a plurality (e.g., four) of proximal openings / ports (270) configured to allow the inflow of a liquid diluent discharged from an intermediate opening / port (266) located further distally, and a lumen plug (268) occludes the needle lumen to form a flow path from the proximal opening (270) to the intermediate opening (266) under conditions as described herein with reference to Figure 7H. The needle also includes a distal opening (264) opposite the lumen plug (268) from the intermediate opening (266). The distal opening (264) is fluidically coupled to the distal end (48) of the needle via the needle for injecting the fluid into the patient.

[0048] Referring to Figure 7E, the proximal harpoon interface (84) is configured to continuously penetrate the proximal and distal stopper members (32, 36) and to couple with a coupling feature within the plunger rod (such as a needle-holding feature, element 712, as illustrated in Figures 7N and 7P). Figure 7F shows a spiked harpoon coupling interface (85) which continuously penetrates both the proximal and distal stopper members (32, 36) and is configured to couple with a coupling feature within the plunger rod to at least partially retract the needle member into the plunger rod after the injection has been administered to the patient.

[0049] Figures 7A, 7B, 7G-7P illustrate a series of operations in an infusion procedure utilizing the dual-chamber safe infusion system described above. Referring to Figures 7A and 7B, the infusion assembly is in a stable configuration that can be brought into a shipping or infusion patient care scenario, with the first drug component / liquid diluent (252) separated from the second non-liquid drug component (254), both located within the syringe body and on opposite sides of the distal stopper member (36).

[0050] Figures 7G and 7H show the initial insertion operation of the plunger assembly (44), which advances the distal (36) and proximal (32) stopper members together against the syringe body (34). Referring to Figure 7H, sufficient advancement by the proximal end (50) of the needle assembly pierces and crosses the distal stopper member (36) creates a fluid path between the two previously separated chambers (40, 42) of the syringe body (34), allowing the liquid first drug component (252) in the proximal drug chamber (40) to flow through the transfer tube (46) into at least one of the proximal openings (270) and exit through the more distal intermediate opening (266) to reach the non-liquid second drug component (254) in the distal drug chamber (42).

[0051] Figures 7I and 7J show that as the stopper members (36, 32) are further inserted until they are adjacent to each other, the liquid first drug component / diluent (252) moves into the distal drug chamber (42) and merges with the non-liquid second drug component (254). Figures 7K and 7L show that, over time and / or by manual stirring, the liquid first drug component / diluent (252) and the previously non-liquid second drug component (254) are mixed to form a mixed drug solution (272).

[0052] In some embodiments, particularly using a lyophilized non-liquid second pharmaceutical component, the mixed pharmaceutical solution (272) can be formed with minimal or no stirring or time. In other embodiments, particularly with pharmaceuticals held in suspension or emulsified pharmaceuticals, vigorous shaking may be required to facilitate mixing. When shaking vigorously, it is convenient for the user if they can release their thumb from the plunger operating interface (128). During the transfer of the liquid first pharmaceutical component (252) from the proximal pharmaceutical chamber to the distal pharmaceutical chamber (40, 42), pressure may build up in the distal pharmaceutical chamber (42). This pressure acts on the proximal and distal stopper members (32, 36) to resist the movement of the stoppers. Also, if the user is not restraining the plunger assembly (44) with their thumb, the pressure buildup may cause the stopper members (32, 36) and the plunger operating interface (128) to move proximal. A mixing configuration latch or "mixing click" (shown in Figures 9A and 9B, and described later) in the plunger assembly (44) can be used to resist the movement of the plunger operating interface (128) due to pressure buildup, allowing the user to remove their thumb from the plunger operating interface (128) for shaking or mixing of the drug. The mixing click may also provide an audible and / or tactile indication that the transfer of the liquid first drug component (252) is complete. The distal drug chamber (42) may also include a stirring device to assist in mixing the drug components.

[0053] In an assembly ready for injection of the mixed solution (272), the needle cover member (63) can be removed, as shown in Figures 7M and 7N, and the plunger assembly (44) and associated stopper members (36, 32) can be pushed down / inserted to allow injection into the patient with the exposed distal end of the needle (48). Referring to Figures 7O and 7P, full push-down / insertion of the plunger assembly (44) and associated stopper members (32, 36) allows the sharp distal end / tip (48) of the needle to automatically retract to a safe position within the syringe body (34), needle coupling assembly (606), or at least partially within the plunger assembly (44), at least partially through the distal and proximal stopper members (36, 32).

[0054] Exemplary distal bushing system with detent in dual-chamber safe injection Figures 8A and 8B show a pre-filled dual-chamber safety injection system (800) according to several embodiments. This system (800) includes a stopper bushing (810) in which a detent (812) is positioned (see Figure 8B). The detent (812) is configured to interact with the pointed proximal end (884) of the needle spine assembly (876) and the shoulder (816) at the joint between the needle proximal end (850) and the needle connector member (883) to provide resistance to the distal movement of the distal stopper member (836) relative to the needle spine assembly (876) (see Figure 8B).

[0055] The interaction between the detent (812) and the proximal end (884) maintains the distal stopper member (836) in a usable position during storage and transport, as in the configurations shown in Figures 8A and 8B. This interaction maintains the position of the distal stopper member (836) even in the presence of a vacuum or partial vacuum in the distal chamber (842) (e.g., for lyophilized components). If the detent (812) is absent and the distal chamber (842) is vacuumed, the distal stopper member (836) will eventually move distally relative to the needle spine assembly (876), thereby penetrating it. As a result, the system becomes unusable.

[0056] The interaction between the detent (812) and the shoulder (816) maintains the distal stopper member (836) in the transfer position during the transfer of liquid from the proximal chamber (840) to the distal chamber (842). This interaction allows the user to apply a wider range of force to the plunger member to transfer the liquid while minimizing the risk of premature movement of the distal stopper member (836).

[0057] Figures 9A and 9C illustrate the interaction between the detent (812) and the pointed proximal end (884) of the needle spine assembly (876) and the shoulder (816) of the needle spine assembly (876) in the pre-filled dual-chamber safety injection system (800) shown in Figures 8A and 8B. As shown in Figure 9A, the distal stopper member (836) has a detent (812) and includes a stopper bushing (810) that defines a positioning funnel (814). In Figure 9A, the positioning funnel (814) guides the proximal end (884) of the needle spine assembly (876) to be positioned adjacent to the detent (812).

[0058] Figure 9B shows the storage / transport configuration of the system (800). In this configuration, the pointed proximal end (884) of the needle spine assembly (876) is positioned adjacent to and partially within the detent (812). Various properties of the proximal end (884) and the detent (812) (e.g., geometric shape, material, etc.) can be modified to adjust the force required to push the proximal end (884) over the detent (812). These properties are described in detail below. In one embodiment, the force required to push the proximal end (884) over the detent (812) is approximately 2 pounds to approximately 5 pounds. As described above, even if a vacuum or partial vacuum in the distal chamber (842) propels the distal stopper member (836) distally, the interaction between the proximal end (884) and the detent (812) prevents premature movement of the distal stopper member (836) relative to the needle spine assembly (876). This allows the prefilled dual chamber system (800) to be stored while minimizing the risk of premature movement of the distal stopper member (836) that could render the system (800) unusable.

[0059] Figure 9C shows the transfer configuration of the system (800). In this configuration, the distal stopper member (836) is pushed distally beyond the pointed proximal end (884) of the needle spine assembly (876) by a force applied by the user to the plunger member. The proximal opening (885) is located within the proximal chamber (840), thereby enabling the transfer of liquid from the proximal chamber (840) to the distal chamber (842). The vacuum within the distal chamber (842) draws the liquid out of the proximal chamber (840), while a user-generated force applied to the proximal stopper member (832) via the plunger member assists the transfer of liquid. In this configuration, the shoulder (816) of the needle spine assembly (876) is located adjacent to the detent (812). Various properties of the shoulder (816) and detent (812) (e.g., geometric shape, material, etc.) can be modified to adjust the force required to push the shoulder (816) over the detent (812). These properties are described in detail below. In one embodiment, the force required to push the shoulder (816) over the detent (812) is approximately 2 to 5 pounds. The shoulder is formed at the joint between the needle proximal end (850) and the needle joint member (883). The interaction between the shoulder (816) and the detent (812) means that the pressure applied to the plunger member while the system (800) is held in the transfer configuration shown in Figure 9C assists in the transfer of liquid from the proximal chamber (840) to the distal chamber (842). The force required to overcome the interference between the shoulder (816) and the detent (812) provides the user more freedom to press the plunger member to assist in liquid transfer. This increases the likelihood of complete liquid transfer.

[0060] Figures 10A–10C show a stopper bushing (810) for use with the pre-filled dual-chamber safety injection system (800) shown in Figures 8A and 8B. The stopper bushing (810) has a detent (812) inserted into a slot in the bushing (810) along an axis perpendicular to the longitudinal axis of the needle spine assembly. As shown in Figure 10C, the detent can be made from a curved wire in the shape of a "U".

[0061] Figures 11A–11C show detents (1112, 1112') for use with stopper bushings in a prefilled dual-chamber safety injection system according to several embodiments. The detents (1112, 1112') are formed from a sheet of metallic material and therefore have a flattened cross-section. Both detents (1112, 1112') have a "U" shape and include a notch (1118) configured to receive rounded shapes such as the pointed proximal end and shoulder of a needle spine assembly. The detent (1112') shown in Figure 11B includes a chamfered / adjusted through-face (1120) around the outer circumference of the notch (1118) of the detent (1112') adjacent to the pointed proximal end of the needle spine assembly when in the storage / transport configuration described above. The chamfered through-face (1120) can be modified to adjust the amount of force required to pass through the detent (1112').

[0062] Figure 11C shows the pointed proximal end (1184) of the needle spine assembly (1176) positioned within the notch (1118) of the detent (1112) when in a storage / transport configuration, etc.

[0063] In one embodiment, the resistance force provided by the detent (1112) as it slides over the pointed proximal end (1184) of the needle spine assembly (1176) is moduloable. The detent (1112) resists passage by the proximal end (1184) during storage (e.g., several years). By applying a force of a preset magnitude, the proximal end (1184) slides through the detent (1112). Subsequently, the resistance force against the movement of the needle spine assembly (1176) through the detent (1112) is minimal until the detent (1112) reaches the shoulder (816, see Figure 9C). When the detent (1112) contacts the shoulder, the resistance force increases to ensure that the progression of the detent (1112) (and the distal stopper member) against the needle (1176) is stopped. After the liquid transfer described above, the user applies a pre-set force of a different magnitude to push the detent (1112) over the shoulder. Once the shoulder is cleared, the friction caused by the interaction between the detent (1112) and the needle (1176) is minimized, facilitating injection and needle retraction.

[0064] The pre-set force can be adjusted to accommodate a combination of the system's functional requirements and the user's aesthetic preferences. If the operating force is too small, even if the system functions, it may be difficult to apply sufficient force, potentially leading to user overexertion. Conversely, if the force is too large, the user may find the system "too difficult" to operate. Fortunately, the pre-set force can be "adjusted" within a certain range by changing the properties of various components.

[0065] The embodiments described above include a dual-chamber safe infusion system, but the claims also include other multi-chamber safe infusion systems. In a multi-chamber safe infusion system having two or more chambers, two or more stopper members are inserted into the infusion system body (e.g., syringe body, cartridge body, etc.) to define the corresponding number of chambers.

[0066] Exemplary Method for Manufacturing a Multi-Chamber Safety Injection System The injection system / syringe fills the distal chamber from the front. Figures 12A and 12B show a rack 1210 containing multiple infusion system / syringe bodies 1410 housed in a container 1212. The rack 1210 and container 1212 are made from sterilizable material. The container 1212 can be closed with a seal 1214 (Figure 12A) to maintain the sterility of the rack 1210 and the infusion system / syringe bodies 1410 contained within it.

[0067] Figure 12C shows the rack 1210 removed from the container 1212 and one infusion system / syringe body 1410 removed from the rack 1210. The rack 1210 has a plurality of feature parts (e.g., sleeves and / or flanges) 1216 for holding the infusion system / syringe body 1410 in a first configuration in which the distal end of the infusion system / syringe body 1410 is directed generally downward (see Figure 14A). In some embodiments, the feature parts 1216 are also configured to hold the infusion system / syringe body 1410 in a second configuration in which the proximal end of the infusion system / syringe body 1410 is directed generally downward (see Figure 14C).

[0068] Figure 13 shows a method 1300 for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. The corresponding partially assembled components are shown in Figures 14A to 14J.

[0069] In the 1310, the injection system / syringe body 1410 is arranged in the rack in a first (downward) configuration, as shown in Figure 14A. The injection system / syringe body 1410 can be placed in the rack by the user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0070] In 1312, as shown in Figure 14B, the distal stopper member 1414 is positioned inside 1412 of the infusion system / syringe body 1410. The distal stopper member 1414 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The distal stopper member 1414 and the infusion system / syringe body 1410 define proximal and distal chambers 1416, 1418 inside the body 1412. The distal stopper member 1414 can be positioned on the open proximal end of the infusion system / syringe body 1410, thereby allowing for easy insertion of the distal stopper member 1414 into the body 1412.

[0071] In 1314, the infusion system / syringe body 1410 is reoriented to a second (upward) configuration, as shown in Figure 14C. After reoriented to the second configuration, the infusion system / syringe body 1410 can be repositioned in the rack. The infusion system / syringe body 1410 can be reoriented and / or repositioned by the user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0072] In 1316, the first substance 1420 is introduced into the distal chamber 1418 through the open distal end of the injection system / syringe body 1410, as shown in Figure 14C. The first substance 1420 can be introduced directly through the opening at the distal end of the injection system / syringe body 1410. In some embodiments, a tube can be inserted through the opening at the distal end of the injection system / syringe body 1410, and the first substance 1420 can be introduced through that tube. The first substance 1420 may be a liquid, a solid (e.g., compressed powder), and / or a powder. In some embodiments where the first substance 1420 is a liquid, the first substance 1420 can be freeze-dried in any step to form a powder, as shown in Figure 14D.

[0073] In 1318, as shown in Figures 14E and 14F, a needle hub assembly 1422 is coupled to the distal end of the infusion system / syringe body 1410. The needle hub assembly 1422 includes a needle 1424 having a needle proximal end 1426. The needle proximal end 1426 interferes with a distal stopper member 1414 to temporarily prevent distal movement of the distal stopper member 1414 relative to the infusion system / syringe body 1410. The needle hub assembly 1422 can be coupled to the distal end of the infusion system / syringe body 1410 by a user (e.g., using a tool) or by a mechanical device (e.g., a robot). Alternatively, the infusion system / syringe body 1410 can be closed with a Luer cap, as disclosed in Figures 33 to 40 and described later. In this case, a dual-chamber system is provided without a pre-installed needle. The transfer tube component can be pre-inserted into the syringe body or attached when positioning the Luer cap. The user can attach the needle at the time of use using a Luer slip or Luer lock connection method.

[0074] In some alternative embodiments, the injection system / syringe body 1410 can be supplied together with the attached needle hub assembly 1422 or Luer cap. In some embodiments, the attached injection system / syringe body 1410, needle hub assembly 1422 and / or Luer cap can be pre-sterilized. In other embodiments, pre-sterilized components can be supplied and assembled at the time of filling.

[0075] The components of the distal stopper member 1414 that interfere with the proximal end of the needle 1426 are shown in Figures 15A–15D, 16, and 16A. Figure 15A shows the U-shaped retaining member / detent 1428 and the bushing / funnel 1430. After the U-shaped retaining member / detent 1428 is coupled to the bushing / funnel 1430, the bushing / funnel 1430 is screwed onto the stopper member 1414. Figures 16 and 16A show the stages of the manufacturing process, identified by 1318 and also shown in Figure 14F. As shown in Figure 16A, the proximal end of the needle 1426 has an enlarged portion that interferes with the U-shaped retaining member / detent 1428. This interference increases the amount of force required to move the proximal end of the needle 1426 beyond the distal stopper member 1414. The increased force allows for the presence of a vacuum within the distal chamber 1418 of the infusion system / syringe body 1410 without causing premature movement of the needle proximal end 1426 beyond the distal stopper member 1414 during storage of the multi-chamber safety infusion system. The bushing funnel 1430 guides the needle proximal end 1426 into the U-shaped retaining member / detent 1428 during assembly.

[0076] In 1320, as shown in Figure 14G, the infusion system / syringe body 1410 is returned to its original first (downward) configuration. After returning to its original first configuration, the infusion system / syringe body 1410 can be repositioned in the rack. The infusion system / syringe body 1410 can be reoriented and / or repositioned by the user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0077] In 1322, the second substance 1432 is introduced into the proximal chamber 1416 through the open proximal end of the injection system / syringe body 1410, as shown in Figure 14H. The second substance 1432 can also be introduced directly through the opening at the proximal end of the injection system / syringe body 1410. The second substance 1432 may be a liquid or another fluid.

[0078] In 1324, as shown in Figure 14I, the proximal stopper member 1434 is positioned inside 1412 of the injection system / syringe body 1410. The proximal stopper member 1434 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The proximal stopper member 1434 closes the proximal chamber 1416 defined by the injection system / syringe body 1410 and the distal stopper member 1414. The proximal stopper member 1434 is positioned above the open proximal end of the injection system / syringe body 1410, thereby allowing the proximal stopper member 1434 to be easily inserted into the body interior 1412.

[0079] To draw the proximal stopper member into the main body interior 1412, the pressure difference on both sides of the proximal stopper member 1434 can be utilized. For example, a vacuum can be formed on the distal side of the proximal stopper member 1434. In some embodiments, a small tube is placed adjacent to the proximal stopper member 1434 to release the pressure accumulated when the proximal stopper member 1434 is inserted into the main body interior 1412. The small tube is removed after assembly.

[0080] In any step shown in Figure 14J, the finger flange 1336 and plunger member 1438 are coupled to the injection system / syringe body 1410. The finger flange 1436 can be coupled to the injection system / syringe body 1410 in such a way that it is prevented from moving along the longitudinal axis of the body 1410 (for example, by snapping it onto a glass flange at the proximal end of the body 1410). The plunger member 1438 can be coupled to the injection system / syringe body 1410 in such a way that it can move along the longitudinal axis of the body 1410. The distal end of the plunger member 1438 is also coupled to a proximal stopper member 1434 (for example, using threads) so that the movement of the plunger member 1438 relative to the injection system / syringe body 1410 causes the proximal stopper member 1434 to move. The finger flange 1436 and plunger member 1438 can be coupled to the injection system / syringe body 1410 by the user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0081] The method 1300 for manufacturing / assembling the multi-chamber safety infusion system shown in Figure 13 may be carried out entirely or partially in a vacuum (e.g., a vacuum chamber or vacuum room). The infusion system / syringe body 1410, proximal and distal stopper members 1414, 1434, needle hub assembly 1422, finger flange 1436, and plunger member 1438 may be sterilized before assembly.

[0082] Method 1300, shown in Figures 13 and 14A-14J, is used to manufacture / assemble a single multi-chamber safety injection system, but the same method 1300 can also be used to manufacture / assemble multiple multi-chamber safety injection systems in parallel or in series. Method 1300, shown in Figures 13 and 14A-14J, includes a dual-chamber system having two stopper members 1414 and 1434, but in some embodiments, a third stopper member can be added to the multi-chamber safety injection system using steps similar to those described in steps 1322 and 1324 to define a third chamber. In some embodiments, four or more stopper members and chambers can be formed in the multi-chamber safety injection system.

[0083] The injection system / syringe fills the distal chamber from the rear. Figure 17 shows a rack 1210 housed in a container 1212, containing multiple infusion system / syringe bodies 1410 coupled to multiple needle hub assemblies 1422. The rack 1210 and container 1212 are made of sterilizable material. The container 1212 can be closed with a seal 1214 (see Figure 12B) to maintain the sterility of the rack 1210 and the infusion system / syringe bodies 1410 and needle hub assemblies 1422 housed within it. The rack 1210 is removed from the container 1212, and one infusion system / syringe body 1410 coupled to a needle hub assembly 1422 is removed from the rack 1210. The rack 1210 has several feature parts (e.g., sleeves and / or flanges) 1216 for holding the infusion system / syringe body 1410 and the needle hub assembly 1422 with the distal end of the infusion system / syringe body 1410 facing generally downward (see Figure 19A).

[0084] Figure 18 shows a method 1800 for manufacturing / assembling a multi-chamber safety infusion system according to several embodiments. Corresponding partially assembled components are shown in Figures 19A to 19H. The infusion system / syringe body 1410, proximal and distal stopper members 1414, 1434, needle hub assembly 1422, finger flange 1436, and plunger member 1438 are shown in Figures 14A to 16A and may be the same system components as described above.

[0085] In the 1810, as shown in Figure 19A, the needle hub assembly 1422 is coupled to the distal end of the infusion system / syringe body 1410. The needle hub assembly 1422 includes a needle 1424 having a needle proximal end 1426. The needle hub assembly 1422 is coupled to the distal end of the infusion system / syringe body 1410 by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). In some alternative embodiments, the infusion system / syringe body 1410 can be supplied together with the coupled needle hub assembly 1422. In some embodiments, the coupled infusion system / syringe body 1410 and needle hub assembly 1422 can be pre-sterilized. In other embodiments, pre-sterilized components can be supplied and assembled at the time of filling.

[0086] In 1812, the injection system / syringe body 1410, coupled to the needle hub assembly 1422, is placed in a rack with the injection system / syringe body 1410 facing downwards, as shown in Figures 17 and 19A. The injection system / syringe body 1410 can be placed in the rack by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). Alternatively, the injection system / syringe body 1410 can be closed with a Luer cap, as disclosed in Figures 33 to 40 and described later. In this case, a dual-chamber system is provided without a pre-installed needle. The transfer tube component can be pre-inserted into the syringe body or installed when the Luer cap is placed. The user can attach the needle at the time of use using a Luer slip or Luer lock connection method.

[0087] In 1814, as shown in Figure 19B, the first substance 1420 is introduced into the distal chamber 1418 through the open proximal end of the injection system / syringe body 1410. The first substance 1420 can also be introduced directly through the opening at the proximal end of the injection system / syringe body 1410. The first substance 1420 may be a liquid, a solid (e.g., compressed powder), and / or a powder. In some embodiments where the first substance 1420 is a liquid, the first substance 1420 can be freeze-dried in any step to form a powder, as shown in Figure 19C.

[0088] In 1816, as shown in Figures 19D and 19E, the distal stopper member 1414 is positioned inside 1412 of the infusion system / syringe body 1410. The distal stopper member 1414 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The distal stopper member 1414 and the infusion system / syringe body 1410 define proximal and distal chambers 1416, 1418 inside the body 1412. The distal stopper member 1414 is positioned above the open proximal end of the infusion system / syringe body 1410, as shown in Figure 19D, thereby allowing easy insertion of the distal stopper member 1414 into the body 1412.

[0089] The proximal end of the needle 1426 interferes with the distal stopper member 1414, temporarily preventing the distal movement of the distal stopper member 1414 relative to the injection system / syringe body 1410. The components of the distal stopper member 1414 that interfere with the proximal end of the needle 1426 are shown in Figures 15A to 15D, 16, and 16A, and are described above.

[0090] In 1818, the second substance 1432 is introduced into the proximal chamber 1416 through the open proximal end of the injection system / syringe body 1410, as shown in Figure 19F. The second substance 1432 can also be introduced directly through the opening at the proximal end of the injection system / syringe body 1410. The second substance 1432 may be a liquid or another fluid.

[0091] In the 1820, as shown in Figure 19G, the proximal stopper member 1434 is positioned inside 1412 of the injection system / syringe body 1410. The proximal stopper member 1434 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The proximal stopper member 1434 closes the proximal chamber 1416 defined by the injection system / syringe body 1410 and the distal stopper member 1414. The proximal stopper member 1434 is positioned above the open proximal end of the injection system / syringe body 1410, thereby allowing the proximal stopper member 1434 to be easily inserted into the body interior 1412. The proximal stopper member 1438 can be inserted using a pressure difference or a small tube, as described above.

[0092] In any step shown in Figure 19H, the finger flange 1436 and plunger member 1438 are coupled to the injection system / syringe body 1410. The finger flange 1436 can be coupled to the injection system / syringe body 1410 in such a way that it is prevented from moving along the longitudinal axis of the body 1410 (for example, by snapping it onto the glass flange at the proximal end of the body 1410). The plunger member 1438 can be coupled to the injection system / syringe body 1410 in such a way that it can move along the longitudinal axis of the body 1410. The distal end of the plunger member 1438 is also coupled to a proximal stopper member 1434 (for example, using threads) so that the movement of the plunger member 1438 relative to the injection system / syringe body 1410 causes the proximal stopper member 1434 to move. The finger flange 1436 and plunger member 1438 can be coupled to the injection system / syringe body 1410 by the user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0093] Method 1800, shown in Figures 18 and 19A-19H, is used to manufacture / assemble a single multi-chamber safety injection system, but the same method 1800 can also be used to manufacture / assemble multiple multi-chamber safety injection systems in parallel or in series. Method 1800, shown in Figures 18 and 19A-19H, includes a dual-chamber system having two stopper members 1414 and 1434, but in some embodiments, a third stopper member can be added to the multi-chamber safety injection system using steps similar to those of 1818 and 1820 described above, thereby defining a third chamber. In some embodiments, four or more stopper members and chambers can be formed in the multi-chamber safety injection system.

[0094] The cartridge fills the distal chamber from the front. Figures 20A and 20B show a rack 1210' containing multiple cartridges 1410' housed in a container 1212. The rack 1210' and container 1212 are made from sterilizable material. The container 1212 can be sealed with a seal 1214 (Figure 20A) to maintain the sterility of the rack 1210' and cartridges 1410' contained within it.

[0095] Figure 20C shows a rack 1210' removed from a container 1212 and a cartridge 1410' removed from the rack 1210'. The rack 1210' has a plurality of feature parts (e.g., sleeves and / or flanges) 1216' for holding the cartridge 1410' in a first configuration in which the distal end of the cartridge 1410' is directed generally downward (see Figure 22A). In some embodiments, the feature parts 1216' are also configured to hold the cartridge 1410' in a second configuration in which the proximal end of the cartridge 1410' is directed generally downward (see Figure 22C).

[0096] Figure 21 shows a method 2100 for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. The corresponding partially assembled components are shown in Figures 22A to 22J.

[0097] In the 2110, the cartridge 1410' is arranged in the rack in a first (downward) configuration, as shown in Figure 22A. The cartridge 1410' can be placed in the rack by a user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0098] In 2112, as shown in Figure 22B, the distal stopper member 1414 is positioned inside 1412 of the cartridge 1410'. The distal stopper member 1414 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The distal stopper member 1414 and the cartridge 1410' define proximal and distal chambers 1416, 1418 inside the main body 1412. The distal stopper member 1414 can be positioned on the open proximal end of the cartridge 1410', thereby allowing for easy insertion of the distal stopper member 1414 into the main body 1412.

[0099] In 2114, cartridge 1410' is reoriented to a second (upward) configuration, as shown in Figure 22C. After reoriented to the second configuration, cartridge 1410' can be repositioned in the rack. Cartridge 1410' can be reoriented and / or repositioned by a user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0100] In 2116, the first substance 1420 is introduced into the distal chamber 1418 through the open distal end of the cartridge 1410', as shown in Figure 22C. The first substance 1420 can be introduced directly through the opening at the distal end of the cartridge 1410'. In some embodiments, a tube can be inserted through the opening at the distal end of the cartridge 1410', and the first substance 1420 can be introduced through that tube. The first substance 1420 may be a liquid, a solid (e.g., compressed powder), and / or a powder. In some embodiments where the first substance 1420 is a liquid, the first substance 1420 can be freeze-dried in any step to form a powder, as shown in Figure 22D.

[0101] In the 2118, as shown in Figure 22E, the cartridge cap 1440 and needle hub assembly 1422' are coupled to the distal end of the cartridge 1410'. First, the cartridge cap 1440 can be coupled to the distal end of the cartridge 1410' by a user (e.g., using a tool) or by a mechanical device (e.g., a robot). An exemplary cartridge cap 1440 is shown in Figures 23A and 23B. The cartridge cap 1440 includes a crimp seal 1442 having an opening and a partition wall 1444. The crimp seal 1442 can be made from aluminum, and the partition wall 1444 can be made from rubber. The cartridge cap 1440 can be coupled to the distal end of the cartridge 1410' by crimping the crimp seal 1442 at its distal end to the periphery and enlarged portion of the cartridge 1410'.

[0102] Next, as shown in Figure 22G, the needle hub assembly 1422' is coupled to the distal end of the cartridge 1410' on the cartridge cap 1440. As shown in Figure 22F, the needle hub assembly 1422' includes a needle 1424 having a needle proximal end 1426. The needle proximal end 1426 interferes with the distal stopper member 1414 to temporarily prevent the distal movement of the distal stopper member 1414 relative to the cartridge 1410'. The needle hub assembly 1422' is coupled to the distal end of the cartridge 1410' by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The components of the distal stopper member 1414 that interfere with the needle proximal end 1426 are shown and described above in Figures 15A-15D, 16, and 16A.

[0103] In some alternative embodiments, the cartridge 1410' can be supplied together with the attached needle hub assembly 1422' or Luer cap. In some embodiments, the attached cartridge 1410', needle hub assembly 1422' and / or Luer cap can be pre-sterilized. In other embodiments, pre-sterilized components can be supplied and assembled at the time of filling.

[0104] The embodiment shown in Figure 22E includes a cartridge cap 1440, but this cartridge cap 1440 is optional, and in some embodiments, the needle hub assembly 1422' is directly coupled to the distal end of the cartridge 1410' (compare Figure 24A (without cap) and Figure 24B (with cap)).

[0105] In the 2120, as shown in Figure 22G, cartridge 1410' is returned to its original first (downward) configuration. After returning to its original first configuration, cartridge 1410' can be repositioned in the rack. Cartridge 1410' can be reoriented and / or repositioned by the user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0106] In 2122, as shown in Figure 22H, the second substance 1432 is introduced into the proximal chamber 1416 through the open proximal end of the cartridge 1410'. The second substance 1432 can also be introduced directly through the opening at the proximal end of the cartridge 1410'. The second substance 1432 may be a liquid or another fluid.

[0107] In the 2124, as shown in Figure 22I, the proximal stopper member 1434 is positioned inside 1412 of the cartridge 1410'. The proximal stopper member 1434 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The proximal stopper member 1434 closes the proximal chamber 1416 defined by the cartridge 1410' and the distal stopper member 1414. The proximal stopper member 1434 is positioned above the open proximal end of the cartridge 1410', thereby allowing the proximal stopper member 1434 to be easily inserted into the body interior 1412. The proximal stopper member 1438 can be inserted using a pressure difference or a small tube, as described above.

[0108] In any step shown in Figure 22J, the finger flange 1436 and plunger member 1438 are coupled to the cartridge 1410'. The finger flange 1436 can be coupled to the cartridge 1410' in such a way that it is prevented from moving along the longitudinal axis of the body 1410 (e.g., using adhesive). The plunger member 1438 can be coupled to the cartridge 1410' in such a way that it can move along the longitudinal axis of the body 1410. The distal end of the plunger member 1438 is also coupled to the proximal stopper member 1434 (e.g., using threads) so that the movement of the plunger member 1438 relative to the cartridge 1410' causes the proximal stopper member 1434 to move. The finger flange 1436 and plunger member 1438 can be coupled to the cartridge 1410' by the user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0109] The method 2100 for manufacturing / assembling the multi-chamber safety injection system shown in Figure 21 may be carried out entirely or partially in a vacuum (e.g., a vacuum chamber or vacuum room). The cartridge 1410', proximal and distal stopper members 1414, 1434, needle hub assembly 1422', finger flange 1436, and plunger member 1438 may be sterilized before assembly.

[0110] Method 2100, shown in Figures 21 and 22A-22J, is used to manufacture / assemble a single multi-chamber safety injection system, but the same method 2100 can also be used to manufacture / assemble multiple multi-chamber safety injection systems in parallel or in series. Method 2100, shown in Figures 21 and 22A-22J, includes a dual-chamber system having two stopper members 1414 and 1434, but in some embodiments, a third stopper member can be added to the multi-chamber safety injection system using steps similar to those described in steps 2122 and 2124 to define a third chamber. In some embodiments, four or more stopper members and chambers can be formed in the multi-chamber safety injection system.

[0111] The cartridge fills the distal chamber from the rear, and then fills after penetration. Figure 25 shows a rack 1210' housed in a container 1212, containing multiple cartridges 1410' coupled to multiple needle hub assemblies 1422'. The rack 1210' and container 1212 are made of sterilizable material. The container 1212 can be closed with a seal 1214 (see Figure 12B) to maintain the sterility of the rack 1210' and the cartridges 1410' and needle hub assemblies 1422' contained within it. The rack 1210' is removed from the container 1212, and one cartridge 1410' coupled to a needle hub assembly 1422' is removed from the rack 1210'. The rack 1210' has multiple features (e.g., sleeves and / or flanges) 1216' for holding the cartridges 1410' and needle hub assemblies 1422' with the distal ends of the cartridges 1410' facing generally downwards (see Figure 27A).

[0112] Figure 26 shows a method 2600 for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. Corresponding partially assembled components are shown in Figures 27A to 27G. The cartridge 1410', proximal and distal stopper members 1414, 1434, needle hub assembly 1422', cartridge cap 1440, finger flange 1436, and plunger member 1438 are shown in Figures 22A to 24B and may be the same system components as those described above.

[0113] In the 2610, as shown in Figure 27A, the cartridge cap 1440 and needle hub assembly 1422' are coupled to the distal end of the cartridge 1410'. First, the cartridge cap 1440 can be coupled to the distal end of the cartridge 1410' by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). An exemplary cartridge cap 1440 is shown in Figures 23A and 23B and described above. The cartridge cap 1440 can be coupled to the distal end of the cartridge 1410' by crimping a crimp seal 1442 at its distal end onto the periphery and enlarged portion of the cartridge 1410'. This step can be performed during filling or before filling, providing the cartridge to the filling machine in a pre-sterilized state.

[0114] Next, as shown in Figure 27A, the needle hub assembly 1422' is coupled to the distal end of the cartridge 1410' on the cartridge cap 1440. As shown in Figure 22F, the needle hub assembly 1422' includes a needle 1424 having a needle proximal end 1426. Although the embodiment shown in Figure 27A includes a cartridge cap 1440, this cartridge cap 1440 is optional, and in some embodiments, the needle hub assembly 1422' is coupled directly to the distal end of the cartridge 1410' (compare Figure 24A (without cap) and Figure 24B (with cap)). The coupling of the needle hub assembly 1422' to the cartridge 1410' can be performed at the time of filling, or it can be coupled before filling to provide a pre-sterilized coupled system to the filling machine.

[0115] In 2612, the cartridge 1410' coupled to the needle hub assembly 1422' is placed in the rack with the cartridge 1410' facing downwards, as shown in Figures 25 and 27A. The cartridge 1410' can be placed in the rack by a user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0116] In 2614, as shown in Figure 27B, the first substance 1420 is introduced into the distal chamber 1418 through the open proximal end of the cartridge 1410'. The first substance 1420 can also be introduced directly through the opening at the proximal end of the cartridge 1410'. The first substance 1420 may be a liquid, a solid (e.g., compressed powder), and / or a powder. In some embodiments where the first substance 1420 is a liquid, the first substance 1420 can be freeze-dried in any step to form a powder, as shown in Figure 27C.

[0117] In the 2616, as shown in Figures 27C and 27D, the distal stopper member 1414 is positioned inside 1412 of the cartridge 1410'. The distal stopper member 1414 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The distal stopper member 1414 and the cartridge 1410' define proximal and distal chambers 1416, 1418 inside the main body 1412. The distal stopper member 1414 is positioned on the open proximal end of the cartridge 1410', as shown in Figure 27C, thereby allowing the distal stopper member 1414 to be easily inserted into the main body 1412.

[0118] The proximal end 1426 of the needle interferes with the distal stopper member 1414, temporarily preventing the distal movement of the distal stopper member 1414 relative to the cartridge 1410'. The components of the distal stopper member 1414 that interfere with the proximal end 1426 of the needle are shown in Figures 15A to 15D, 16, and 16A, and are described above.

[0119] In 2618, the second substance 1432 is introduced into the proximal chamber 1416 through the open proximal end of cartridge 1410', as shown in Figure 27E. The second substance 1432 can also be introduced directly through the opening at the proximal end of cartridge 1410'. The second substance 1432 may be a liquid or another fluid.

[0120] In the 2620, as shown in Figure 27F, the proximal stopper member 1434 is positioned inside 1412 of the cartridge 1410'. The proximal stopper member 1434 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The proximal stopper member 1434 closes the proximal chamber 1416 defined by the cartridge 1410' and the distal stopper member 1414. The proximal stopper member 1434 is positioned above the open proximal end of the cartridge 1410', thereby allowing for easy insertion of the proximal stopper member 1434 into the body interior 1412. The proximal stopper member 1438 can be inserted using a pressure difference or a small tube, as described above.

[0121] In any step shown in Figure 27G, the finger flange 1436 and plunger member 1438 are coupled to the cartridge 1410'. The finger flange 1436 can be coupled to the cartridge 1410' in such a way that it is prevented from moving along the longitudinal axis of the body 1410 (for example, by snapping it onto a glass flange at the proximal end of the body 1410). The plunger member 1438 can be coupled to the cartridge 1410' in such a way that it can move along the longitudinal axis of the body 1410. The distal end of the plunger member 1438 is coupled to a proximal stopper member 1434 (for example, using threads) so that the movement of the plunger member 1438 relative to the cartridge 1410' causes the proximal stopper member 1434 to move. The finger flange 1436 and plunger member 1438 can be coupled to the cartridge 1410' by the user (for example, using a tool) or by a mechanical device (for example, a robot).

[0122] Method 2600, shown in Figures 26 and 27A-27G, is used to manufacture / assemble a single multi-chamber safety injection system, but the same method 2600 can also be used to manufacture / assemble multiple multi-chamber safety injection systems in parallel or in series. Method 2600, shown in Figures 26 and 27A-27G, includes a dual-chamber system having two stopper members 1414 and 1434, but in some embodiments, a third stopper member can be added to the multi-chamber safety injection system using steps similar to those described in steps 2618 and 2620 above, thereby defining a third chamber. In some embodiments, four or more stopper members and chambers can be formed in the multi-chamber safety injection system.

[0123] The cartridge fills the distal chamber from the rear, and then penetrates after filling. Figure 28 shows a method 2800 for manufacturing / assembling a multi-chamber safety injection system according to several embodiments. Corresponding partially assembled components are shown in Figures 29A to 29G. The cartridge 1410', proximal and distal stopper members 1414, 1434, needle hub assembly 1422', cartridge cap 1440, finger flange 1436, and plunger member 1438 are shown in Figures 22A to 24B and may be the same system components as those described above.

[0124] In the 2810, as shown in Figure 29A, the cartridge cap 1440 is coupled to the distal end of the cartridge 1410'. The cartridge cap 1440 can be coupled to the distal end of the cartridge 1410' by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). Exemplary cartridge caps 1440 are shown in Figures 23A and 23B and described above. The cartridge cap 1440 can be coupled to the distal end of the cartridge 1410' by crimping a crimp seal 1442 at its distal end onto the periphery and enlarged portion of the cartridge 1410'. In some alternative embodiments, the cartridge 1410' can be supplied with the cartridge cap 1440 coupled, and both components can be pre-sterilized.

[0125] In the 2812, the cartridge 1410' coupled to the cartridge cap 1440 is placed in the rack with the cartridge 1410' facing downwards, as shown in Figures 20C and 29A. The cartridge 1410' can be placed in the rack by a user (e.g., using a tool) or by a mechanical device (e.g., a robot).

[0126] In 2814, the first substance 1420 is introduced into the distal chamber 1418 through the open proximal end of cartridge 1410', as shown in Figure 29B. The first substance 1420 can also be introduced directly through the opening at the proximal end of cartridge 1410'. The first substance 1420 may be a liquid, a solid (e.g., compressed powder), and / or a powder. In some embodiments where the first substance 1420 is a liquid, the first substance 1420 can be freeze-dried in any step to form a powder, as shown in Figure 29C.

[0127] In the 2816, as shown in Figure 29E, the needle hub assembly 1422' is coupled to the distal end of the cartridge 1410' on the cartridge cap 1440. As shown in Figure 22F, the needle hub assembly 1422' includes a needle 1424 with a proximal end 1426. During insertion of the needle hub assembly 1422' into the cartridge interior 1412, the needle 1424 and the proximal end 1426 penetrate the cartridge cap 1440. The partition wall 1444 of the cartridge cap 1440, shown in Figures 23A and 23B, is configured to be penetrated by the proximal end 1426. In some alternative embodiments, the cartridge 1410' can be supplied with the needle hub assembly 1422' coupled, and both components can be pre-sterilized.

[0128] In the 2818, as shown in Figures 29E and 29F, the distal stopper member 1414 is positioned inside 1412 of the cartridge 1410'. The distal stopper member 1414 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The distal stopper member 1414 and the cartridge 1410' define proximal and distal chambers 1416, 1418 inside the main body 1412. The distal stopper member 1414 is positioned above the open proximal end of the cartridge 1410', thereby allowing for easy insertion of the distal stopper member 1414 into the main body 1412. The distal stopper member 1414 can be inserted using a pressure difference or a small tube, as described above.

[0129] The proximal end 1426 of the needle interferes with the distal stopper member 1414, temporarily preventing the distal movement of the distal stopper member 1414 relative to the cartridge 1410'. The components of the distal stopper member 1414 that interfere with the proximal end 1426 of the needle are shown in Figures 15A to 15D, 16, and 16A, and are described above.

[0130] In the 2820, the second substance 1432 is introduced into the proximal chamber 1416 through the open proximal end of the cartridge 1410', as shown in Figure 29G. The second substance 1432 can also be introduced directly through the opening at the proximal end of the cartridge 1410'. The second substance 1432 may be a liquid or other fluid.

[0131] In the 2822, as shown in Figure 29H, the proximal stopper member 1434 is positioned inside 1412 of the cartridge 1410'. The proximal stopper member 1434 can be inserted by the user (e.g., using a tool) or by a mechanical device (e.g., a robot). The proximal stopper member 1434 closes the proximal chamber 1416 defined by the cartridge 1410' and the distal stopper member 1414. The proximal stopper member 1434 is positioned above the open proximal end of the cartridge 1410', thereby allowing for easy insertion of the proximal stopper member 1434 into the body interior 1412. The proximal stopper member 1438 can be inserted using a pressure difference or a small tube, as described above.

[0132] In any step (not shown), the finger flange and plunger member are coupled to the cartridge 1410'. The finger flange can be coupled to the cartridge 1410' in such a way that it is prevented from moving along the longitudinal axis of the body 1410 (for example, by snapping it onto a glass flange at the proximal end of the body 1410). The plunger member can be coupled to the cartridge 1410' in such a way that it can move along the longitudinal axis of the body 1410. The distal end of the plunger member is also coupled to a proximal stopper member 1434 (for example, using threads) so that the movement of the plunger member relative to the cartridge 1410' causes the proximal stopper member 1434 to move. The finger flange and plunger member can be coupled to the cartridge 1410' by the user (for example, using a tool) or by a mechanical device (for example, a robot).

[0133] Method 2800, shown in Figures 28 and 29A-29G, is used to manufacture / assemble a single multi-chamber safety injection system, but the same method 2800 can also be used to manufacture / assemble multiple multi-chamber safety injection systems in parallel or in series. Method 2800, shown in Figures 28 and 29A-29G, includes a dual-chamber system having two stopper members 1414 and 1434, but in some embodiments, a third stopper member can be added to the multi-chamber safety injection system using steps similar to those of 2818 and 2820 described above, thereby defining a third chamber. In some embodiments, four or more stopper members and chambers can be formed in the multi-chamber safety injection system.

[0134] Figure 30 shows a cartridge stopper 1446 according to several embodiments. The cartridge stopper 1446 can be made from a flexible polymer so that it can be penetrated by the needle proximal end 1426. Furthermore, the cartridge stopper 1446 includes a vent 1448 for freeze-drying of the liquid inside the cartridge 1412.

[0135] Automatic injector system Single Chamber Figures 31A to 31H show an automated injector system 3100 including a disposable infusion system / syringe 3110 and a reusable drive system 3150 according to several embodiments. The automated injector system 3100 enables the use of readily available infusion systems / syringes 3110 in clinical settings without adding items to the supply chain. The automated injector system 3100 also features safety features that minimize the exposure of sharp needles, as will be discussed later. The advantages and other benefits of the automated injector system 3100 are described below.

[0136] As shown in Figure 31A, the disposable infusion system / syringe 3110 includes an infusion system / syringe body 3112, a stopper member 3114, a plunger member 3116, a finger flange 3118, a needle hub assembly 3120, a rigid needle shield 3122, and a pull ring 3124 for facilitating the removal of the rigid needle shield 3122 from the needle hub assembly 3120. The infusion system / syringe 3110 may also be a safety infusion system that retracts the sharp needle at least into the infusion system / syringe body 3112 to minimize the risk of needle stick injury. The reusable drive system 3150 includes a drive system body 3152, a plunger actuator / pusher 3154, a flange holder / carriage 3156, and a collar 3164.

[0137] As shown in Figure 31B, when the injection system / syringe 3110 is attached to the drive system 3150, the plunger actuator / pusher 3154 is configured to move the plunger member 3116 distally relative to the injection system / syringe body 3112. The flange holder / carriage 3156 is configured to move the injection system 3110 distally and / or proximal relative to the drive system body 3152. The plunger actuator / pusher 3154 and the flange holder / carriage 3156 are in their respective fully proximal positions in Figures 31A and 31B. In this position, the collar 3164 of the drive system 3150 prevents the sharp needle of the injection system / syringe 3110 from coming into contact with the user's skin. Furthermore, in Figure 31B, the rigid needle shield 3122 prevents the needle from coming into contact with the user's skin.

[0138] Figure 31C shows the automatic injector system 3100 in a closed configuration (as opposed to the open configurations in Figures 31A and 31B). In the closed configuration, various user interface components of the drive system 3150 are visible. The drive system 3150 includes a display 3158, a button 3160, and a light ring 3162 around the button 3160. In the system configuration shown in Figure 31C, the display 3158 provides an indication of the size of the injector system / syringe (e.g., 1.0 ml). The button 3160 allows the user to input into the automatic injector system 3100. The light ring 3162 can change color to indicate different steps in the injection process. As shown in Figure 31C, the pull ring 3124 extends distally beyond the color 3164, making it accessible at the distal end of the drive system 3150.

[0139] The upper half of the drive system 3150 is separated from Figures 31D to 31G to visualize the various components of the automatic injector system 3100 during injection in a closed configuration of the drive system 3150.

[0140] In Figure 31D, the rigid needle shield 3122 has been removed from the needle hub assembly 3120. In some embodiments, the automatic injector system 3100 instructs the user on the display 3158 to pull the pull ring 3124 to remove the rigid needle shield 3122 from the needle hub assembly 3120. In some embodiments, the automatic injector 3100 includes a component (e.g., one or more arms) that grips the rigid needle shield 3122 while the flange holder / carriage 3156 moves the injector system / syringe 3110 (e.g., from distal to proximal position) to separate the rigid needle shield 3122 from the needle hub assembly 3120. In such embodiments, the user only needs to remove the separated rigid needle shield 3122 from the automatic injector system 3100. The collar 3164 prevents the needle 3126 from being exposed to the user.

[0141] In Figure 31E, the flange holder / carriage 3156 moves the injection system / syringe 3110 distally. Simultaneously, the plunger actuator / pusher 3154 moves the same distance distally to maintain contact with the thumb pad at the proximal end of the plunger member 3116. By moving the injection system / syringe 3110 distally, the needle 3126 extends distally beyond the collar 3164, thereby exposing the needle 3126 for injection. Before the flange holder / carriage 3156 moves the injection system / syringe 3110 distally, the automatic injector system 3100 can instruct the user on the display 3158 to press the automatic injector against the injection site. In such embodiments, moving the injection system / syringe 3110 distally allows for puncture of the injection site.

[0142] In Figure 31F, the plunger actuator / pusher 3154 is moved to its fully distal position. This movement drives the plunger member 3116 and the stopper member 3114 attached to it distally, releasing the drug from the infusion system / syringe 3110 to the patient via the needle 3126.

[0143] In Figure 31G, the two movements of the plunger member 3116 and the stopper member 3114, as well as the injection end position, retract the needle 3126 into the injection system / syringe body 3112. The retraction of the needle 3126 makes it safe to remove the injection system / syringe 3110 from the drive system 3150, as shown in Figure 31H. After the used injection system / syringe 3110 is removed, a new injection system / syringe 3110 can be loaded into the drive system 3150 to prepare the automatic injector system 3100 for another injection.

[0144] The drive system 3150 includes a first motor for moving a plunger actuator / pusher 3154, a second motor for moving a flange holder / carriage 3156, a controller operably coupled to the first and second motors, and one or more sensors operably coupled to the controller. The sensors may include one or more of an accelerometer, a contact sensor, a position sensor, a gyroscope, a thermometer, and a skin contact sensor. In some embodiments, the sensor is a skin contact sensor, and the controller injects the drug only when the skin contact sensor has confirmed contact between the automatic injector system 3100 and the patient.

[0145] Dual Chamber Figures 32A to 32J show an automatic injector system 3200 configured for use with a multi-chamber injection system 3210. The drive system 3250 shown in Figures 32A to 32J is similar to the drive system 3150 shown in Figures 31A to 31H. In fact, drive systems 3150 and 3250 may be the same drive system with modified programming.

[0146] As shown in Figure 32A, the disposable infusion system / syringe 3210 includes an infusion system / syringe body 3212, first and second stopper members 3228, 3214, plunger member 3216, finger flange 3218, needle hub assembly 3220, and rigid needle shield 3222. The infusion system / syringe 3210 may also be a safety infusion system that retracts the sharp needle at least into the infusion system / syringe body 3212 to minimize the risk of needle stick injury. The reusable drive system 3250 includes a drive system body 3252, plunger actuator / pusher 3254, flange holder / carriage 3256, and collar 3264.

[0147] As shown in Figure 32B, when the injection system / syringe 3210 is attached to the drive system 3250, the plunger actuator / pusher 3254 is configured to move the plunger member 3216 distally relative to the injection system / syringe body 3212. The flange holder / carriage 3256 is configured to move the injection system 3210 distally and / or proximal relative to the drive system body 3252. The plunger actuator / pusher 3254 and the flange holder / carriage 3256 are in their respective fully proximal positions in Figures 32A and 32B. In this position, the collar 3264 of the drive system 3250 prevents the sharp needle of the injection system / syringe 3210 from coming into contact with the user's skin. Furthermore, in Figure 32B, the rigid needle shield 3222 prevents the needle from coming into contact with the user's skin.

[0148] Figure 32C shows the automatic injector system 3200 in a closed configuration (as opposed to the open configurations in Figures 32A and 32B). In the closed configuration, various user interface components of the drive system 3250 are visible. The drive system 3250 includes a display 3258, a button 3260, and a light ring 3262 around the button 3260. In the system configuration shown in Figure 32C, the display 3258 provides an indication of the size of the injector system / syringe (e.g., 1.0 ml). The button 3260 allows the user to input into the automatic injector system 3200. The light ring 3262 can change color to indicate the various steps of the injection process. As shown in Figure 32C, the rigid needle shield 3222 does not extend distally beyond the collar 3264, so the distal end of the drive system 3250 is not easily accessible.

[0149] Figures 32D to 32J illustrate various steps in a method of mixing and injecting a drug using an automated injector system 3200 according to several embodiments. In Figure 32D, display 3258 provides a message instructing the user to press button 3262 to mix the drug with the diluent. This message may be accompanied by a light ring 3262 turning green to indicate proceed. When the user presses button 3262, the plunger actuator / pusher 3254 moves distally, as shown in Figures 7G to 7J, to transfer the diluent from the proximal chamber to the distal chamber. In Figure 32E, display 3250 provides a message instructing the user to shake the automated injector system 3202 to mix the drug with the diluent.

[0150] In Figure 32F, the display 3250 provides a message instructing the user to orient the automatic injector system 3200 upward, which will move the rigid needle shield 3222. As shown in Figure 32G, when the position sensor of the automatic injector system 3200 detects that the system 3200 is orienting upward, the flange holder / carriage 3256 moves the injector system / syringe 3210 distally, extending the rigid needle shield 3222 for removal. By removing the rigid needle shield 3222 only when the system 3200 is orienting upward, accidental discharge of the drug due to pressure increases caused by fluid transfer and mixing can be prevented.

[0151] In some embodiments, the user is expected to pull the rigid needle shield 3222 away from the needle hub assembly 3220. In some embodiments, the automatic injector 3200 includes a component (e.g., one or more arms) that grips the rigid needle shield 3222 while the flange holder / carriage 3256 moves the injection system / syringe 3210 (e.g., from distal to proximal) to separate the rigid needle shield 3222 from the needle hub assembly 3220. In such embodiments, the user only needs to remove the separated rigid needle shield 3222 from the automatic injection system 3200. The collar 3264 prevents the needle 3226 from being exposed to the user, as shown in Figure 32H.

[0152] In Figure 32F, the display 3250 provides a message instructing the user to position the automatic injector system 3200 on the user's thigh and to press button 3260 to perform the injection. In some embodiments, a skin contact sensor prevents the injection until contact is detected between the automatic injector system 3200 and the user. Contact detection and preparation for injection can be indicated using a light ring 3262 (e.g., a green ring for proceeding). When the user presses button 3260 for injection, the flange holder / carriage 3256 moves the injection system / syringe 3210 distally to insert the needle into the patient, as shown in Figures 7K-7P, and the plunger actuator / pusher 3254 moves distally to complete the injection.

[0153] After the injection is complete, the display 3250 provides the user with a message instructing them to confirm the injection and remove and discard the used syringe. The automatic injector system 3200 can be prepared for another injection by loading a new injection system / syringe 3210 into the drive system 3252.

[0154] Multi-chamber safety injection system with Luer connector Figures 33–40 show a multi-chamber safety infusion system 3300 having a Luer connector 3310. As shown in Figures 33 and 34, the Luer connector 3310 is a standard connector that facilitates the use of the system 3300 with a wide variety of needles and tubes. The system 3300 includes a standard Luer cap 3312 for sealing the Luer connector 3310 during mixing of drug components prior to delivery / infusion.

[0155] In some embodiments, the pharmaceutical component comprises a pharmaceutical solvent 3314 in a proximal chamber and a pharmaceutical powder and / or solid (e.g., compressed powder) 3316 in a distal chamber. The pharmaceutical solvent 3314 can be transferred from the proximal chamber to the distal chamber via a transfer tube 3318 having various openings for mixing with the pharmaceutical powder and / or solid 3316. The distal end of the transfer tube 3318 can be coupled to a wide variety of needles and tubes via a Luer connector 3310. The finger flange and plunger member also include a ratchet / retraction prevention system 3320 for restricting the movement of the plunger member distally during mixing.

[0156] Figure 35 shows a transfer tube 3318 for use with a multi-chamber safety injection system 3300 according to several embodiments. The proximal end of the transfer tube 3318 includes a through-tip 3322 configured to penetrate a distal stopper member to allow the drug diluent 3314 to be transferred from the proximal chamber to the distal chamber and mixed with the drug powder and / or solid 3316. The next feature located distally along the transfer tube 3318 is a liquid inlet slot 3324 configured to allow the drug diluent 3314 to enter from the proximal chamber. The next feature is a liquid outlet opening 3326 configured to allow the drug diluent 3314 to exit into the distal chamber. The liquid inlet slot 3324 and the liquid outlet opening 3326 are configured to span the distal stopper member to maximize the movement of the liquid. The next feature is a blocking rod 3328 for preventing the drug diluent 3314 from exiting the distal end of the transfer tube 3318. The next feature is a washer 3330 configured to provide a reaction force to allow the through-tip 3322 to penetrate the distal stopper member. The next feature is an outlet slot 3332 configured to allow the mixed agent to enter the distal end of the transfer tube 3318. The most distal feature is an expanded end opening 3334 configured to mate with various needles and tubes via a Luer connector 3310. The expanded end opening provides friction with the Luer passage to hold the transfer tube 3318 in place during the filling of the system 3300.

[0157] Figure 36 shows the fluid path 3336 during the transfer of the drug diluent 3314 from the proximal chamber to the distal chamber. As described above, the fluid path 3336 passes through the liquid inlet slot 3324, moves along the proximal portion of the transfer tube 3318, and exits through the liquid outlet opening 3326. When the drug diluent 3314 is transferred from the proximal chamber to the distal chamber, the pressure in the distal chamber increases. The ratchet / anti-retraction system 3320 prevents undesirable proximal movement of the plunger member due to the accumulated pressure in the distal chamber. The teeth 3338 of the ratchet / anti-retraction system 3320 are present only on the distal portion of the plunger member and interact with the tabs 3340 of the finger flange during mixing. The ratchet / anti-retraction system 3320 holds the plunger member in place even if the user releases pressure on the plunger member during transfer. Alternative ratchet / anti-retraction systems are described below.

[0158] Figure 37 shows the fluid path 3336 at the end of the transfer of the drug diluent 3314 from the proximal chamber to the distal chamber. The liquid inlet slot 3324 allows the transfer of the drug diluent to continue even when the proximal and distal stoppers are close to each other.

[0159] Figure 38 shows the multi-chamber safety injection system 3300 after the transfer of the drug diluent 3314 is complete. The ratchet system 3320 prevents pressurized air in the distal chamber from pushing the plunger member proximal. The user can shake the system 3300 to mix the drug diluent 3314 with the drug powder and / or solid 3316 in the distal chamber.

[0160] Figure 39 shows the multi-chamber safety injection system 3300 after the Luer cap 3312 has been removed, with the system 3300 in an upward position to prevent any of the mixed agents from being released due to the pressure in the distal chamber. Instead, pressurized air is purged from the distal chamber. A needle 3342 with a corresponding Luer connector is coupled to the Luer connector 3310 of the system 3300, and the system 3300 is prepared for injection.

[0161] Figure 40 shows the multi-chamber safety injection system 3300 during injection. The fluid path 3344 during injection extends along the outside of the distal end of the transfer tube 3318 and passes through the needle 3342. During injection, a blocking rod 3328 prevents the mixed drug from moving backward into the plunger member. The plunger member also includes an elastomer seal to prevent backflow. The plunger member moves relative to the finger flange so that the ratchet teeth of this gauge are away from the tab, allowing the plunger member to move both distally and proximal during injection.

[0162] Vent plug Figures 41 to 47 show a multi-chamber infusion system 4100 having a vent plug 4154 according to several embodiments. The vent plug 4154 is configured (e.g., sized and shaped) to allow air to escape from the system 4100 while substantially retaining the liquid. As shown in Figure 41, the system 4100 includes a syringe body 4110 having a needle coupling member 4156 at its distal end. The needle coupling member 4156 may be a female Luer connector. The system 4100 also includes a finger flange 4136 coupled to the proximal end of the syringe body 4110 and a plunger member 4138 inserted into the syringe body 4110 via the finger flange 4136.

[0163] Furthermore, proximal and distal stopper members 4134 and 4114 are arranged inside the syringe body 4110. The proximal and distal stopper members 4134 and 4114 and the syringe body 4110 define the proximal chamber 4116. The distal stopper member 4114 and the syringe body 4110 define the distal chamber 4118. In the embodiment shown in Figure 41, the distal chamber 4118 contains a gas 4152 (e.g., air), and the proximal chamber 4116 contains a liquid 4132. The system 4100 also includes a mixing tube 4124 configured to pass through the distal stopper member 4114 to fluidly connect the proximal and distal chambers 4116 and 4118. Figure 41A shows a retraction prevention mechanism 3321 (described later) for use with the multi-chamber infusion system 4100 according to several embodiments.

[0164] System 4100 further includes a cap 4150 (e.g., a Luer cap) coupled to a needle coupling member 4156 for storing the components of System 4100 before use (e.g., injection). Furthermore, System 4100 includes a vent plug 4154, which is at least partially within the needle coupling member 4156 and positioned around the distal end of the mixing tube 4124. The vent plug 4154 is configured (e.g., sized and shaped) to allow air to escape from System 4100 while substantially retaining the liquid.

[0165] Figure 42 shows the system 4100 described in Figure 41 after the plunger member 4138 and the proximal stopper member 4134 coupled thereto have been inserted distally into the syringe body 4110 according to some embodiment. Before the proximal end of the mixing tube 4124 completely penetrates the distal stopper member 4114 (as shown in Figure 41), the incompressibility of the liquid 4132 in the proximal chamber 4116 transmits a distal force from the plunger member 4138 and the proximal stopper member 4134 to the distal stopper member 4114, causing the distal stopper member 4114 to move distally. The distal movement of the distal stopper member 4114 causes the proximal end of the mixing tube 4124 to completely penetrate the distal stopper member 4114, fluidly coupling the proximal and distal chambers 4116, 4118. By fluidically coupling the proximal and distal chambers 4116 and 4118, as shown in Figure 42, the liquid 4132 can be pushed from the proximal chamber 4116 to the distal chamber 4118 by a distal force from the plunger member 4138 and the proximal stopper member 4134.

[0166] Furthermore, as shown in Figure 42, the proximal chamber 4116 collapses almost completely, and almost all of the liquid 4132 is pushed from the proximal chamber 4116 into the distal chamber 4118. The liquid 4132 pushed into the distal chamber 4118 compresses the gas 4152 in the distal chamber 4118, increasing the pressure within the distal chamber 4118. If this increased pressure is not released from the distal chamber 4118, some of the liquid 4132 may be unintentionally discharged from the distal chamber 4118, wasting the liquid 4132 and reducing the precision and accuracy of the system 4100. Before the cap 4150 is removed from the system 4100, the increased pressure in the distal chamber 4118 may be pushed back through the mixing tube 4124, thereby causing some of the liquid 4132 to return to the proximal chamber 4116, potentially reducing the precision and accuracy of the system 4100. Furthermore, back pressure may also cause the proximal stopper member 4134 and plunger member 4138 to move proximal. Some multi-chamber injection systems include a latch on the plunger member to prevent proximal movement of the plunger member.

[0167] Figures 43A to 43D illustrate a method for mixing two parts of an injectable substance (e.g., a drug) for injection, according to several embodiments. The multi-chamber injection system 4100 shown in Figures 43A to 43D is similar to the multi-chamber injection system 4100 described above, shown in Figures 41 and 42. One difference is that the system 4100 shown in Figures 43A to 43D includes a dry component (e.g., lyophilized powder and / or solid, e.g., compressed powder) (not shown) (not shown) in the distal chamber 4118, which is solubilized by the liquid 4132 for the two parts of the injectable substance. In Figure 43A, the cap 4150 is removed from the needle coupling member 4156. In Figure 43B, distal forces from the plunger member 4138 and the proximal stopper member 4134 cause distal movement of the distal stopper member 4114, thereby allowing the proximal end of the mixing tube 4124 to completely penetrate the distal stopper member 4114 and displace the liquid 4132 from the proximal chamber 4116 into the distal chamber 4118. In Figure 43C, the system 4100 is shaken to mix the liquid 4132 in the distal chamber 4118 with its dry components (not shown). In Figure 43D, the needle 4166 is attached via the needle coupling member 4156 (e.g., a male Luer connector) to prepare the system 4100 for injection. Without the vent / liquid limiting component, during mixing in Figure 43C, the increased pressure in the distal chamber 4118 could dislodge some of the liquid 4132 (and solubilized dry components), reducing the precision and accuracy of the system 4100.

[0168] Figure 44 is a detail view of the distal end of a syringe body 4110 including a vent plug 4154 according to one embodiment, the vent plug being at least partially within the needle coupling member 4156 and around the distal end of the mixing tube 4124. Figure 45 is a further detail view of the distal end of the syringe body 4110 including a vent plug 4154 according to one embodiment. Figure 45 shows that the vent plug includes a plurality of channels 4158, which are configured (e.g., sized and shaped) to allow gas (e.g., air) to escape from the inside of the syringe body 4110 (e.g., distal chamber 4118 / see Figure 44) while preventing liquid from escaping from the inside of the syringe body 4110 (4160).

[0169] Figure 46 is a detail view of a vent plug 4154 for use in a multi-chamber infusion system 4100 according to several embodiments. For clarity, many components of the system 4100 are omitted. The vent plug 4154 is positioned around the mixing tube 4124 and includes multiple channels 4158. Figure 47 is a detail view of the vent plug 4154 for use in a multi-chamber infusion system 4100 according to several embodiments. Figure 47 shows the central opening 4162 of the vent plug 4154 into which the mixing tube 4124 is inserted. Figure 47 also shows the multiple channels 4158 molded into the inner surface of the vent plug 4154. The multiple channels 4158 are configured (e.g., sized and shaped) to allow gas to escape / vent from inside the syringe body 4110 while preventing liquid from escaping from inside the syringe body 4110. By releasing gas from inside the syringe body 4110 and releasing the pressure, unintended liquid discharge from inside the syringe body 4110 can be minimized, improving the precision and accuracy of the system 4100. Furthermore, by releasing gas from inside the syringe body 4110 and releasing the pressure, unintended proximal movement of the plunger member 4138 due to back pressure can be minimized, and as a result, it becomes unnecessary to provide a latch on the plunger member 4138 to prevent such proximal movement.

[0170] Figure 48 shows an alternative embodiment of the vent plug 4154 in which the vent channel 4158 is located on the outer surface of the vent plug 4154. The vent plug 4154 is configured to be attached to the distal needle interface 4156 (see Figure 45), and the vent channel 4158 contacts the inner surface of the distal needle interface 4156, maintaining the vent channel 4158 open to the outside of the syringe body 4110. The vent channel 4184 may be linear or nonlinear (as shown in Figure 48) having bends or curves along the longitudinal axis of the vent plug 4154. Figure 48 shows a nonlinear vent channel 4184, which creates a winding path for fluid flow along the longitudinal axis of the vent plug 4154. When fluid is pushed through the vent channel 4158, the bends or curves of the vent channel 4158 impede / resistance to the fluid flow. These vents are configured to utilize the fluid friction effect such that more viscous fluids (e.g., liquids) require higher pressure to flow through the vent channels 4158. For example, gases (e.g., air) flow through their vent channels 4158 at a preset pressure generated within the syringe body 4110. Liquids (e.g., water or liquid medication) require higher pressure to flow through the vent channels 4158. This pressure difference requirement for fluid flow provides a limit to prevent water or liquid medication from being unintentionally released from the end of the syringe body 4110 during mixing (see Figure 43C) when the syringe cap 4150 is removed. Pressure for fluid flow can also be generated by shaking the syringe during mixing, such as by gravitational acceleration due to the shaking applied to the surface of the liquid. The vent channels 4158 are configured so that the high gravitational acceleration resulting from shaking the syringe during mixing does not apply enough force to the liquid to release it during shaking. The vent channel 4158 can be configured to provide orifices, capillary channels, and / or high-fluid friction surfaces for fluid flow in order to adjust flow restrictions for various fluids.This embodiment also shows a central opening 4164 of a vent plug 4154 into which a mixing tube 4124 is inserted. The central opening 4164 can be positioned to completely penetrate the vent plug, or it can be a blind hole with a bottom for positioning the distal end of the mixing tube 4124.

[0171] Alternative ratchet / retraction prevention system Alternative embodiments of the ratchet / anti-retraction system are shown in Figures 41, 41A, 49–56. As shown in Figures 41 and 49, this ratchet / anti-retraction system is configured for use with plunger members 4138, 3516 having a smooth outer surface. The anti-retraction feature 3321, 4090 (see Figures 41A and 42) includes at least one brake tab 3321-1, 4092. The brake tab 3321-1, 4092 can be made of sheet metal or polymer material. The sheet metal brake tab 3321-1, 4092 has a sharp edge on the plunger member engagement surface 3329, thereby allowing the brake tab 3321-1, 4092 to deform the outer surface of the plunger members 4138, 3516. The anti-retraction features 3321, 4090 and the interconnected brake tabs 3321-1, 4092 can be configured to elastically deform when the plunger members 4138, 3516 are inserted via the anti-retraction features 3321, 4090, causing the brake tabs 3321-1, 4092 to flex. The elasticity of the brake tabs 3321-1, 4092 provides a biasing force that ensures contact between the plunger member engagement surface 3329 and the outside of the plunger members 4138, 3516.

[0172] The anti-retraction features 3321 and 4090 are inserted into the lateral slots 3323 and 3584 of the finger flanges 4136 and 3580 with the brake tabs 3321-1 and 4092 bent distally 3325. By pre-bending the brake tabs 3321-1 and 4092, when the plunger members 4138 and 3516 are inserted into the finger flanges 4136 and 3580, the brake tabs 3321-1 and 4092 can bend distally, while preventing the plunger members 4138 and 3516 from moving proximal. The amount of pre-bending is approximately 10 to 80 degrees, preferably 45 degrees, for each brake tab 3321-1 and 4092. Alternatively, the brake tabs 3321-1, 4092 may be flat when inserted into the lateral slots 3323, 3584, and may be bent when the plunger members 4138, 3516 are inserted into the finger flanges 4136, 3580. The bearing surfaces / fit tabs 3321-2, 3596, 4096 on the anti-retraction features 3321, 4090 are configured to engage with the inner surfaces of the finger flanges 4136, 3580 defining the lateral slots 3323, 3584 and to respond to the force applied to the brake tabs 3321-1, 4092 by the insertion of the plunger members 4138, 3516. The anti-retraction features 3321, 4090 may have retaining barbs / tabs 3327, 3594, 4094 for holding the anti-retraction features 3321, 4090 in lateral slots 3323, 3584 of the finger flanges 4136, 3580. Although the ratchet system described herein is intended for use with dual-chamber syringes, the ratchet system can be used in any syringe or cartridge injection system where it is desired to prevent proximal movement of the plunger member.

[0173] Figures 49–56 illustrate the addition of a unidirectional ratchet to the dual-chamber injection system described herein. The unidirectional ratchet allows the plunger member to move distally with minimal resistance, while preventing the plunger member from moving proximal by engaging the ratchet teeth with the outer surface of the plunger member. During the mixing stage of multi-component injection formulations, air pressure accumulates in the distal chamber as the liquid is transferred. This accumulated pressure generates a proximal reaction force on the thumb. Adding a toothless ratchet counteracts this reaction force, preventing the plunger member from moving proximal. With a toothless ratchet engaged, the user does not need to continuously apply a distal force to maintain the position of the plunger member. The ratchet may be toothless if the outer surface of the plunger member is smooth and the ratchet arm is configured to bite into the plunger member. In this case, the position of the plunger member is maintained in infinitesimally small increments. Alternatively, the ratchet can engage with an annular groove or thread on the outer surface of the plunger member to provide a gradually increasing stop. The annular groove can provide tactile and / or auditory click or feedback to indicate to the user that the ratchet is engaged.

[0174] Figure 49 shows a dual-chamber infusion system 3500 with a finger flange 3580 having a retraction prevention feature 3590 according to several embodiments. The retraction prevention feature 3590 prevents proximal movement of the plunger member 3516 relative to the syringe body 3510, while allowing distal movement. In addition to the syringe body 3510, plunger member 3516, finger flange 3580, and retraction prevention feature 3590, the dual-chamber infusion system 3500 also includes proximal and distal stopper members 3512, 3514 and a needle hub assembly 3570. The infusion system 3500 shown in Figure 49 may also include a needle assembly 3530 having a proximal end and a distal end. The proximal end is configured to have a fluid passage (not shown; see Figures 35(3324), 9C(885), and / or 7E(270)) for transferring fluid from the proximal chamber 3522 to the distal chamber 3524 when the plunger member 3516 is moved distally. The plunger member 3516 is inserted into the interior 3518 of the syringe body 3510 through the proximal opening of the syringe body. The proximal and distal stopper members 3512 and 3514, together with the syringe body 3510, define the proximal drug chamber 3522. The distal stopper member 3514 and the syringe body 3510 define the distal drug chamber 3524. The plunger member 3516 can be manually operated to insert the proximal stopper member 3512 into the syringe body 3510. When an incompressible fluid is placed in the proximal drug chamber 3522, inserting the proximal stopper member 3512 also inserts the distal stopper member 3514 into the syringe body 3510.

[0175] Figures 50 to 53 show the finger flange 3580, which is configured to be attached to a small flange 3511 formed at the proximal end of the syringe body 3510 (see Figure 53). As shown in Figure 50, the finger flange 3580 defines a first recess 3582 configured to receive the small flange 3511 for coupling the finger flange 3580 to the syringe body 3510. The finger flange 3580 also defines a second recess 3584 configured to receive the anti-retraction mechanism 3590. The anti-retraction mechanism 3590 includes a pair of brake tabs 3592 configured to provide a counteracting force against the proximal movement of the plunger member 3516 relative to the anti-retraction mechanism 3590, while allowing distal movement. The opposing forces may include the frictional force when the brake tab 3592 contacts the outer surface 3517 of the plunger member 3516 and the reaction force when the brake tab 3592 bites into the outer surface 3517 of the plunger member 3516. The acute angle of the brake tab 3592 generates a reaction force parallel to the plunger member 3516, applied by each of the sharp, curved edges of the brake tab 3592 that contact the surface 3517 of the plunger member 3516. This reaction force, along with the frictional force, prevents the plunger member 3516 from moving proximal. The finger flange 3580 further defines a "C"-shaped opening 3586 configured to receive the plunger member 3516 (see Figure 50). The "C"-shaped opening 3586 allows the finger flange 3580 to slide onto the small flange 3511 from the side after the plunger member 3516 has been inserted during assembly. Furthermore, the "C"-shaped finger flange 3580 and anti-retraction mechanism 3590 shown in Figures 49 to 53 can be slid / snap onto the small flange 3511 of the syringe body 3510 after the plunger member 3516 has been inserted. The syringe body 3510, with the plunger member 3516 screwed into the proximal stopper member 3514, can be packed more securely into the shipping tray for transport. The finger flange 3580 with the anti-retraction mechanism 3590 is snapped on after shipping, snapping around both the syringe body 3510 and the plunger member 3516.

[0176] As shown in Figure 51, the retraction prevention mechanism 3590 is a generally "C"-shaped clip. In some embodiments, the retraction prevention mechanism 3590 is cut or punched out from a metal sheet, and then a particular portion of it is bent into the final shape. The retraction prevention mechanism 3590 includes a pair of brake tabs 3592 configured to provide a frictional force to counteract the proximal movement of the plunger member 3516, as described above. The brake tabs 3592 are elastically deformable and self-actualizing. The brake tabs 3592 extend at an acute angle distal to the plane of the retraction prevention mechanism 3590 (i.e., the brake tabs 3592 are bent downward). The angle and elasticity of the brake tabs 3592 allow the plunger member 3516 to slide distally beyond the brake tabs 3592. When the plunger member 3516 is pulled proximal to the brake tab 3592, the brake tab 3592 contacts and bites into the outer surface 3517 of the plunger member 3516, preventing the proximal movement of the plunger member 3516 relative to the brake tab 3592. Since the brake tab 3592 is self-actuating, if an attempt is made to move it proximal to the plunger member 3592, the brake tab 3592 engages with the plunger member 3516 by increasing the frictional force applied to the plunger member 3516 and the amount of biting into the plunger member 3516, thereby preventing its proximal movement. In effect, the brake tab 3592 engages with the plunger member 3516 to form a pair of claws that prevent its proximal movement. In some embodiments, the plunger member (not shown) is provided with and / or has annular groove threads on it to enhance the ratchet effect of the brake tab 3592. The anti-reverse mechanism 3590 and brake tab 3592 prevent the plunger member 3516 from being removed from the dual-chamber injection system 3500 after use.

[0177] The anti-retraction mechanism 3590 also includes a pair of retaining tabs 3594 configured to hold the anti-retraction mechanism 3590 in a second recess 3584 of the finger flange 3580. The retaining tabs 3594 are bent inward and are configured to grip the inside of the second recess 3584 of the finger flange 3580 with frictional and reactive forces to prevent the anti-retraction mechanism 3590 from being removed from the second recess 3584. The retaining tabs 3594 are also self-actuating and provide increased frictional and reactive forces when the anti-retraction mechanism 3590 is pulled out of the second recess 3584. In the embodiment shown in Figure 52, the finger flange 3580 includes a pair of openings 3588 configured to receive the retaining tabs 3594 from the anti-retraction mechanism 3590, holding the anti-retraction mechanism 3590 in the second recess 3584 by interference instead of friction.

[0178] Furthermore, as shown in Figure 51, the retraction prevention mechanism 3590 includes four fit tabs 3596 configured to reduce the tolerance between the second recess 3584 and the retraction prevention mechanism 3590, thereby allowing the retraction prevention mechanism 3590 to fit more snugly into the second recess 3584. In some embodiments, the finger flange 3580 is molded from polymer, and therefore has a limit on the minimum size of the recess that can be accurately and precisely formed therein, resulting in a larger original tolerance. On the other hand, the retraction prevention mechanism 3590 is cut from a metal sheet and therefore has a profile thinner than the height of the second recess 3584. The fit tabs 3596 increase the thickness / height of the retraction prevention mechanism 3590, thereby giving it a tighter fit within the second recess 3584. The fit tabs 3596 also give the retraction prevention mechanism 3590 rigidity. Therefore, when the plunger member 3516 is pulled in the proximal direction, the brake tab 3592 exerts an outward force on the anti-retraction mechanism 3590 (due to its elasticity and angle). This outward force is transmitted through the anti-retraction mechanism 3590 and the fit tab 3596, and the rigidity of the anti-retraction mechanism 3590 pushes inward into the second recess 3584 of the finger flange 3500. This outward force is a reaction force to the frictional and reaction forces applied to the plunger member 3516, preventing its movement in the proximal direction.

[0179] Figures 54 to 56 show a dual-chamber injection system 4000 with a finger flange 4080 having a retraction prevention feature 4090 according to several embodiments. The dual-chamber injection system 4000 has many of the same components as the dual-chamber injection system 3500 described above, as shown in Figures 49 to 53. These components have the same reference numerals as the corresponding components of the dual-chamber injection system 3500. The difference between the dual-chamber injection systems 3500 and 4000 lies in the finger flanges 3590 and 4090. Unlike the finger flange 3590 shown in Figures 50 and 51, which has a "C"-shaped opening 3586 for receiving the plunger member 3516, the finger flange 4090 shown in Figures 55 and 56 has an "O"-shaped opening 4086 for receiving the plunger member 3516. The "O"-shaped opening 4086 provides an additional mechanism to prevent the plunger member 3516 from being removed from the dual-chamber injection system 4000 after use.

[0180] As shown in Figure 56, the anti-retraction mechanism 4090 within the finger flange 4080 has an "O" and / or rectangular shape. The anti-retraction mechanism 4090 can be cut from a metal sheet. Due to the "O" and / or rectangular shape of the finger flange 4080, the finger flange 4080 is snapped onto the small flange 3511 from the proximal direction during assembly. The plunger member 3516 is then inserted through the "O"-shaped opening 4086 of the finger flange 4080. The "O"-shaped opening 4086 of the finger flange 4080 also aligns the plunger member 3516 within the syringe body 3510.

[0181] The brake tab 4092 of the anti-reverse mechanism 4090 shown in Figure 56 is identical to the brake tab 3592 of the anti-reverse mechanism 3590 shown in Figure 51. The retaining tab 4094 in the anti-reverse mechanism 4090 shown in Figure 56 is the same as the retaining tab 3594 in the anti-reverse mechanism 3590 shown in Figure 51. The difference is that the anti-reverse mechanism 4090 has a single retaining tab 4094, while the anti-reverse mechanism 3590 has a pair of retaining tabs 3594. The fit tab 4096 of the anti-reverse mechanism 4090 shown in Figure 56 is the same as the fit tab 3596 of the anti-reverse mechanism 3590 shown in Figure 51. The difference is that the anti-reverse mechanism 4090 has three fit tabs 4096, while the anti-reverse mechanism 3590 has four fit tabs 3594.

[0182] The retraction prevention mechanism 4090 shown in Figures 54 to 56 is symmetrical and simplifies mass assembly, whether manual or automatic. In embodiments where the plunger member (not shown) has an annular groove and / or thread, the retraction prevention mechanism 4090 can prevent the plunger member 3516 from being removed from the dual-chamber injection system 4000. Furthermore, the pair of long beams of the "O"-shaped retraction prevention mechanism 4090 are deformable, allowing the retraction prevention mechanism 4092 to bend outward, thereby transmitting the outer reaction force to the inner wall of the second recess 4084 via the outer / long fit tab 4096.

[0183] The prefill dual-chamber safety infusion systems described herein include syringes with staked needles, but the infusion configurations and detent dual-chamber configurations described herein can be used with infusion systems that have cartridges and autoinjectors, and Luer connectors and transfer tubes, and do not have needles.

[0184] Various exemplary embodiments of the present invention are described herein. These examples are used in a non-limiting sense. They are provided to illustrate broader applicable aspects of the present invention. Various modifications can be made to the described inventions and substitutes can be made with equivalents without departing from the true spirit and scope of the invention. Furthermore, many modifications can be made to adapt specific situations, materials, composition of substances, processes, process actions or steps to the object, spirit or scope of the present invention. Moreover, as will be understood by those skilled in the art, each of the individual variations described and illustrated herein has individual components and features that can be readily separated from or combined with any of the features of several other embodiments without departing from the scope or spirit of the present invention. All such modifications are intended to fall within the scope of the claims relating to this disclosure.

[0185] Any of the devices described for performing the diagnostic or interventional procedure in question may be provided in a packaged combination for use when performing such intervention. These supply “kits” may further include instructions for use and may be packaged in sterile trays or containers as commonly employed for such purposes.

[0186] The present invention includes methods that can be performed using the device of interest. These methods may include the act of providing such a suitable device. Such provision may be performed by an end user. That is, the act of “providing” simply requires the end user to acquire, access, approach, position, set up, start up, power on, or perform other actions in order to provide the required device in the method of interest. The methods described herein may perform the described events in any logically possible order, or in the order of the described events.

[0187] Exemplary embodiments of the present invention, along with details relating to the selection and manufacture of materials, are described above. Further details of the present invention are generally known or understandable to those skilled in the art, as well as being understandable in connection with the previously cited patents and publications. For example, those skilled in the art will understand that one or more lubricating coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone compositions, fluoropolymers such as tetrafluoroethylene, PTFE, hydrophilic gels, or silicones) can be used in relation to various parts of a device, such as relatively large interfaces of movably bonded parts, thereby facilitating, for example, low-friction operation or advancement of such objects against other parts of the instrument or nearby tissue structures. The same would apply to embodiments based on the methods of the present invention with respect to additional actions that are generally or logically adopted.

[0188] Furthermore, while the present invention has been described with reference to several examples that optionally incorporate various features, it is not limited to those described or disclosed as intended with respect to each variation of the present invention. Various modifications can be made to the described invention without departing from the true spirit and scope of the invention, and equivalents can be substituted (whether described herein or not included for brevity). Furthermore, where a range of values ​​is provided, it should be understood that all intermediate values ​​between the upper and lower limits of that range, and other described or intermediate values ​​within the described range, are included within the scope of the present invention.

[0189] Furthermore, any feature of the variations of the present invention described herein is intended to be described and asserted independently or in combination with any one or more features of those described herein. References to singular items include the possibility of multiple instances of the same item. More specifically, as used herein and in the claims relating thereto, the singular forms “a,” “an,” “said,” and “the” include multiple referents unless otherwise specified. In other words, the use of articles allows for “at least one” of the subject items in the above description, as in the claims relating to this disclosure. It should be noted that such claims may be drafted to exclude any element. For this reason, this statement is intended to serve as a prior reference to use exclusive terms such as “single,” “only,” or “negative” limitations in relation to the enumeration of elements of a claim.

[0190] Without using such exclusive terminology, the term “including” in the claims relating to this disclosure shall enable the inclusion of any additional elements, regardless of whether a given number of elements are enumerated in such claims or whether the addition of features is deemed to alter the nature of the elements described in such claims. Unless otherwise specifically provided herein, all technical and scientific terms used herein shall be given meanings that are as broadly and generally understood as possible, while maintaining the validity of the claims.

[0191] The scope of the present invention is not limited to the provided examples and / or subject matter specification, but rather is limited only by the scope of the language of the claims relating to this disclosure.

Claims

1. In an automated injector system, A disposable infusion system, An injection system body having a proximal end, a distal end, and the internal part of the injection system body between them, Proximal stopper member and A plunger member coupled to the proximal stopper member, A finger flange coupled to the proximal end of the injection system body, A needle hub assembly including a needle having a sharp distal end, which is coupled to the distal end of the injection system body, A rigid needle shield coupled to the needle hub assembly, A retraction system is configured to retract the sharp distal end of the needle into the main body of the injection system after injection using the automatic injector system, A disposable infusion system equipped with, A reusable drive system, A drive system body having an internal drive system body, When the injection system is attached to the drive system, a plunger actuator / pusher moves the plunger member distally relative to the injection system body, A reusable drive system comprising a flange holder / carriage that moves the injection system distally or proximal to the drive system body when the injection system is attached to the drive system, A system characterized by including

2. In the system described in claim 1, The disposable injection system further includes a distal stopper member disposed inside the injection system body, wherein the distal stopper member and the injection system body define a distal chamber, and the proximal stopper member, the distal stopper member and the injection system body define a proximal chamber.

3. In the system described in claim 2, The aforementioned drive system further, A first motor for moving the plunger actuator / pusher, A second motor for moving the flange holder / carriage, A controller operably coupled to the first and second motors, A display operably coupled to the controller, A system characterized by comprising a sensor operably coupled to the controller.

4. In the system described in claim 3, The system is characterized in that the sensor is selected from the group consisting of an accelerometer, a contact sensor, a position sensor, a gyroscope, a thermometer, and a skin contact sensor.

5. In the system described in claim 3, The drive system is characterized by comprising a plurality of sensors.

6. In the system described in claim 1, The system is characterized in that the rigid needle shield includes a pull ring configured to facilitate the removal of the rigid needle shield from the needle hub assembly.

7. In the system according to claim 3, when the injection system is attached to the drive system and the plunger actuator / pusher and flange holder / carriage are positioned at the proximal first position, the controller The first motor moves the plunger actuator, the plunger member and the proximal stopper member operably coupled thereto distally relative to the injection system body, thereby transferring fluid from the proximal chamber to the distal chamber and performing a process to form an injectable drug. The system is characterized in that the controller is configured to use the first motor to move the plunger actuator, the plunger member and the proximal stopper member operably coupled thereto, further distal to the injection system body, thereby performing the process of injecting the injectable drug through the needle hub assembly.

8. In the system described in claim 7, The system is characterized in that the controller is configured to perform a process of displaying a message on the display instructing the user to agitate the device to promote mixing of the powder in the distal chamber and the fluid to form the injectable drug.

9. In the system described in claim 7, The system is characterized in that, before the controller moves the plunger actuator, the plunger member and the proximal stopper member operably coupled thereto, further distal to the injection system body by the first motor, the controller is configured to display a message on the display instructing the user to turn the automatic injector system upward and remove the rigid needle shield from the automatic injector system.

10. In the system described in claim 9, The sensor is configured to detect that the automatic injector system is in an upward position. The system is characterized in that, only when the sensor detects that the automatic injector system is in an upward position, the controller is configured to use the second motor to move the flange holder / carriage proximal to the drive system body, thereby separating the rigid needle shield from the needle hub assembly.

11. In the system described in claim 7, The system is characterized in that, before the controller moves the plunger actuator, the plunger member and the proximal stopper member operably coupled thereto, further distal to the injection system body by the first motor, the controller is configured to display a message on the display instructing the user to position the automatic injector system so that it is in contact with the patient.

12. In the system according to claim 11, The sensor is configured to detect contact between the automatic injector system and the patient. The system is characterized in that, only when the sensor detects contact between the automatic injector system and a patient, the controller is configured to use the first motor to move the plunger actuator, the plunger member and the proximal stopper member operably coupled thereto, further distal to the injector system body.

13. In the system described in claim 7, The system is characterized in that, after the controller moves the plunger actuator, the plunger member and the proximal stopper member operably coupled thereto, further distal to the injection system body using the first motor, the controller displays a message on the display indicating the end of injection and instructs the user to remove the injection system.

14. In the system according to claim 7, the rigid needle shield includes a pull ring, The system is characterized in that the controller is configured to use the second motor to move the flange holder / carriage in a proximal direction relative to the drive system body, thereby separating the rigid needle shield from the needle hub assembly.

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