Polymeric injection system

Abstract

To provide an injection system including a molded polymeric injection system body, and a device, and to provide manufacturing and assembly methods thereof.SOLUTION: An injection system includes a molded body member having a body connection member at a distal end thereof. The system also includes a needle hub assembly 800 coupled to the distal end of the injection system body. The needle hub assembly includes a needle hub 812 coupled to the body connection member, a needle 810 coupled to the needle hub, and a barbed band disposed around a proximal end of the needle hub and having a barb. The barbed band allows rotation of the needle hub assembly relative to the body connection member in a first direction, while preventing rotation of the needle hub assembly relative to the body connection member in a second direction.SELECTED DRAWING: Figure 12

Description

[Technical field]

[0001] The present invention relates generally to infusion systems and devices, and more particularly to infusion systems and devices associated with infusion in healthcare environments. More specifically, the present invention relates to infusion systems and devices that include molded polymeric infusion system bodies, and methods of manufacture and assembly thereof. [Background technology]

[0002] Millions of syringes (2), such as those shown in FIG. 1A, are consumed daily in medical settings. A typical syringe (2) includes a tubular body (4), a plunger (6), and a needle (8). As shown in FIG. 1B, such syringes (2) can be utilized not only to inject fluids into a patient, but also to withdraw fluids from or expel fluids into a container, such as a vial, bag, or other drug containment system (10). In fact, in some countries, such as the United States, concerns regarding maintaining sterility and regulatory constraints dictate that if a syringe (2) is used with a vial (10), as shown in a particular patient environment, such vial must only be used with a single patient and then disposed of, resulting in a lot of medical waste from the vial and remaining drug waste, and also contributing to periodic shortages of certain important drugs.

[0003] Referring to FIG. 2A, three luer type syringes (12) are shown, each having a distally disposed luer fitting configuration (14) for mating with other devices having a similar fitting configuration, such as the luer manifold assembly (16) shown in FIG. 2B. The luer manifold assembly of FIG. 2B can be used to administer liquid medications intravenously to a patient with or without the use of an intravenous infusion bag. The luer fitting (14) of the syringe in FIG. 2A is sometimes referred to as a "male" luer fitting, and the luer fitting (18) of FIG. 2B is sometimes referred to as a "female" luer fitting, with one of the luer interfaces being threaded (in which case the configuration may be referred to as a "luer lock" configuration) to couple the two through 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 utilized to engage threads on the male fitting (14), which are configured to engage a flange on the female fitting (18) to bring the device into a fluid-tight coupling. In another embodiment, a tapered interface shape may be utilized to provide the luer engagement using compression without threads or rotation (such an arrangement may be referred to as a "slip-on" or "conical" luer arrangement). While such luer connections are perceived to be relatively safe for the operator, there is a risk of spillage / leakage of the drug or damage to parts during loading to provide the luer connection.

[0004] On the other hand, the use of needle injection configurations poses the risk of the sharp needle contacting or piercing a person or an unwanted structure. For this reason, so-called "safety syringes" have been developed. One embodiment of a safety syringe (20) is shown in FIG. 3, in which a tubular shield member (22) is spring-biased to cover the needle (8) when released from a locked position relative to the syringe body (4). Another embodiment of a safety syringe (24) is shown in FIGS. 4A and 4B. In this configuration, after the plunger (6) is fully inserted relative to the syringe body (4), a retractable needle (26) is configured to retract (28, 26) into a safe position within the tubular body (4), as shown in FIG. 4B. Such a configuration configured to retract into itself may be associated with issues of blood splatter / aerosolization, safe storage of pre-loaded energy that may malfunction and actuate too early, loss of precision in delivering a full dose injection due to residual dead space within the spring compression volume, and / or loss of retraction speed control that may be associated with pain and patient anxiety.

[0005] The syringe market has become more complex due to the increasing demand for pre-filled syringe assemblies such as those shown in Figures 5A and 5B, which generally comprise a syringe body or "drug containment and delivery system" (34), a plunger tip, plug or stopper (36), and a distal seal or cap (35) that is attached to a luer interface (Figure 5A shows the cap 35 in place, while Figure 5B has the cap removed to illustrate the luer interface (14)). The liquid drug resides in a volume or drug reservoir (40) between the distal seal (35) and the distal end (37) of the plunger tip (36). The plunger tip (36) may comprise a standard butyl rubber material, coated with a biocompatible lubricious coating (e.g., polytetrafluoroethylene ("PTFE") or the like to facilitate favorable sealing and relative motion characteristics relative to the associated syringe body (34) structure and material. The proximal end of the syringe body (34) in FIG. 5B comprises a conventional one-piece syringe flange (38) that is integrally formed with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and is configured to be fully or partially circumferential around the syringe body (34). A partial flange is known as a "clipped flange" and may be formed by forming a groove in the syringe body (34) that is formed with the material of the syringe body (34). , the other flange is known as the "full flange." The flange is used to grip the syringe with the fingers and provides support for depressing the plunger to perform the injection. The syringe body (34) preferably comprises a translucent material such as glass or a polymer. A plunger tip (36) may be disposed within the syringe body (34) to form a contained volume within a medication chamber or reservoir (40) and aid in the evacuation of associated fluids through the needle. The syringe body may define a generally cylindrical shape (i.e., such that a plunger tip 36 having a circular cross-sectional shape establishes a seal with the syringe body) or may be configured to have other cross-sectional shapes, such as an elliptical shape.

[0006] Such assemblies are desirable because they can be standardized and precisely mass-produced by the few manufacturers in the world who can afford to meet all of the world's ever-changing regulations regarding filling, packaging, and drug / drug interfacing material selection and component use. However, such simple configurations generally cannot meet new global standards for single-use, safety, auto-disable, and needlestick protection. For this reason, certain suppliers have been moving to more "vertical" solutions, such as systems (41) as shown in FIG. 5C, which attempt to meet all or at least some of the standards in one solution by including most or all of the parts (body, stopper, needle, plunger, etc.) necessary to perform an injection. As a result of attempting to meet those standards in many different scenarios, such products have significant limitations (including some of the limitations discussed above with reference to FIGS. 3-4B) and can have relatively high inventory and usage costs.

[0007] Some injection system bodies are formed by molding polymers such as cyclic olefin copolymers ("COC") or cyclic olefin polymers ("COP") or other polymers suitable for injection molding, blow molding or other manufacturing processes. Molding of injection system bodies is a cost-effective, high-throughput method of manufacturing injection system components with acceptable error rates. For example, FIG. 6 shows a molded polymeric syringe body 600 including an integral luer connector 610 and internal threads 612 to facilitate coupling of a needle hub assembly (not shown; see, e.g., FIG. 8) to the molded polymeric syringe body 600. The luer connector 610, internal threads 612, and the distal end of the syringe body 600 with the internal threads 612 together form a needle coupling assembly / luer nut 614. The integrated needle coupling assembly / luer nut 614 eliminates the step of attaching a luer nut to the distal end of the syringe body.

[0008] In other embodiments, the injection system body (e.g., syringe or cartridge body) is constructed from a polymer and an inert coating is disposed on a surface, preferably an inner surface, of the injection system body. The inert coating is configured to separate the liquid drug from the polymer of the injection system body. Examples of inert coating materials include, but are not limited to, silica-based coatings (e.g., silicon dioxide, glass, borosilicate glass, hydrophobic organosiloxanes) and other polymeric materials configured to be non-reactive with the drug in the injection system body. The inert coating can be disposed on the inner surface of the injection system body using a process such as plasma deposition, chemical adhesives, and / or other adhesive or mechanical methods. The inert coating material is also configured to reduce the permeability of gases (e.g., oxygen, nitrogen, or other gases) through the injection system body during storage of the injection system pre-filled with the drug. The inert coating can also provide a lubricious surface to reduce static and / or dynamic friction as the stopper slides through the injection system body. The lubricious surface can be configured to reduce or eliminate the need to apply silicone oil to the inner surface of the injection system body. The inert coating can also reduce the amount of leachable or extractable chemicals that migrate from the polymeric infusion system body to a drug contained within the drug chamber of the polymeric infusion system body during storage. The inert coating can also reduce changes in pH of a drug contained within the drug chamber of the infusion system body during storage.

[0009] FIG. 7 illustrates in greater detail the distal end of the molded polymeric syringe body 600 shown in FIG. 6. FIG. 7 illustrates two challenges with currently available molded polymeric syringe bodies. First, the internal threads 612 of the molded polymeric syringe body 600 are smooth to facilitate loosening and removing a mold core (not shown) from the molded syringe body 600. The smoothness of the internal threads 612 reduces the amount of interference available for coupling a needle hub assembly (not shown) onto the molded polymeric syringe body 600. In effect, if the internal threads 612 are smooth enough to allow for inadvertent unscrewing / removal of the mold core (not shown) after molding, the internal threads 612 also allow for inadvertent removal of the needle hub assembly and other connectors coupled to the molded polymeric syringe body 600. Such inadvertent unscrewing / removal may occur during shipping, use, etc.

[0010] FIG. 7 shows that the opening 616 at the distal end of the luer connector 612 has a limited minimum size due to the mold forming process. The opening 616 of the molded polymeric syringe body 600 of FIG. 7 has a minimum diameter of about 2 mm (0.079 inches), which is more than twice the diameter of the needle / tube (not shown; see, e.g., FIG. 8) which is about 1 mm (0.036 inches). As a result, the needle is not well centered in the luer connector 610 or molded polymeric syringe body 600. Significant misalignment from the center position can prevent the needle / tube from interacting with other injection system components. Although FIGS. 6 and 7 show a molded polymeric syringe body 600, the mechanism for preventing removal of the needle hub assembly from the molded body member can also be used in molded polymeric cartridges according to various embodiments. Additionally, mechanisms for preventing removal of the needle hub from the injection system body may also be employed in injection systems that include an injection molded threaded Luer interface / needle coupling assembly secured to the distal end of a glass injection system body (e.g., a syringe).

[0011] There is a need for an infusion system component for use with a molded polymeric infusion system body that overcomes the shortcomings of currently available configurations. In particular, there is a need for a needle hub assembly having an anti-detachment / retention mechanism configured to more securely couple the needle hub assembly to the molded polymeric infusion system body. Additionally, there is a need for an infusion system component that centers the needle / tube in the molded polymeric infusion system body and its distal connector to minimize the possibility of system errors due to misalignment. By addressing these and other limitations of molded polymeric infusion system bodies, a cost-effective and easy to manufacture system body can be incorporated into more infusion systems. Summary of the Invention

[0012] Embodiments are directed to infusion systems, and in particular, to infusion system components for use with a molded polymeric infusion system body.

[0013] In one embodiment, an injection system includes a molded body member having a body connecting member at a distal end. The system also includes a needle hub assembly coupled to the distal end of the injection system body. The needle hub assembly includes a needle hub coupled to the body connecting member, a needle coupled to the needle hub, and a barbed band having barbs disposed about a proximal end of the needle hub. The barbed band allows rotation of the needle hub assembly relative to the body connecting member in a first direction while preventing rotation of the needle hub assembly relative to the body connecting member in a second direction.

[0014] In one or more embodiments, the system further includes a stopper member disposed within the molded body member and a plunger member coupled thereto, and the needle may be configured to be at least partially retracted within the molded body member upon manipulation of the plunger member to position the stopper member at a distal end of the molded body member.

[0015] In one or more embodiments, the needle hub includes a plurality of recesses configured to facilitate rotation of the needle hub assembly relative to the body connecting member. The body connecting member can include a space having an inwardly threaded portion. The body connecting member can include an integrated needle coupling assembly / luer nut.

[0016] In one or more embodiments, the system also includes a seal member disposed between the distal end of the body member and an inner surface of the needle hub. The seal member can include an inward extension configured to center the needle at the distal end of the body member. The barbed band can include spikes extending in a second direction and biased to protrude radially outward. The body member can be molded from a cyclic olefin copolymer or cyclic olefin polymer. The body member can have an inert coating on an inner surface of the medicament chamber of the body member.

[0017] In another embodiment, an injection system includes a molded body member including a body connecting member at a distal end thereof and a notch disposed on a distally facing surface thereof. The system also includes a needle hub assembly coupled to the distal end of the injection system body. The needle hub assembly includes a needle hub coupled to the body connecting member, a needle coupled to the needle hub, and a detent disposed on a proximally facing surface of the needle hub. The detent is configured to fit into the notch when the needle hub assembly is coupled to the body member to prevent rotation of the needle hub assembly relative to the body connecting member.

[0018] In one or more embodiments, the system further includes a stopper member disposed within the molded body member and a plunger member coupled thereto, and the needle may be configured to be at least partially retracted within the molded body member upon manipulation of the plunger member to position the stopper member at a distal end of the molded body member.

[0019] In one or more embodiments, the needle hub includes a plurality of recesses configured to facilitate rotation of the needle hub assembly relative to the body connecting member. The body connecting member can include a space having an inwardly threaded portion. The body connecting member can include an integrated needle coupling assembly / luer nut.

[0020] In one or more embodiments, the system also includes a seal member disposed between the distal end of the body member and an inner surface of the needle hub. The seal member can include an inward extension configured to center the needle at the distal end of the body member. The body member can be molded from a cyclic olefin copolymer or a cyclic olefin polymer. The body member can have an inert coating on an inner surface of the drug chamber of the body member.

[0021] In yet another embodiment, an injection system includes a molded body member having a body connecting member at a distal end. The system also includes a needle hub assembly coupled to the distal end of the injection system body. The needle hub assembly includes a needle hub coupled to the body connecting member, a needle coupled to the needle hub, and a retaining ring disposed about a proximal end of the needle hub and having a plurality of teeth. The retaining ring allows proximal movement of the needle hub assembly relative to the body connecting member while preventing distal movement of the needle hub assembly relative to the body connecting member.

[0022] In one or more embodiments, the system further includes a stopper member disposed within the molded body member and a plunger member coupled thereto, and the needle may be configured to be at least partially retracted within the molded body member upon manipulation of the plunger member to position the stopper member at a distal end of the molded body member.

[0023] In yet another embodiment, an injection system includes a molded body member having a body connecting member at a distal end. The system also includes a needle hub assembly coupled to the distal end of the injection system body. The needle hub assembly includes a needle hub coupled to the body connecting member, a needle coupled to the needle hub, and a brake tab disposed on an outer surface of the needle hub assembly and in contact with an inner surface of the body connecting member. The brake tab allows rotation of the needle hub assembly relative to the body connecting member in a first direction while preventing rotation of the needle hub assembly relative to the body connecting member in a second direction.

[0024] In one or more embodiments, the system further includes a stopper member disposed within the molded body member and a plunger member coupled thereto, and the needle may be configured to be at least partially retracted within the molded body member upon manipulation of the plunger member to position the stopper member at a distal end of the molded body member.

[0025] The above and other embodiments of the present invention are described in the following detailed description. [Brief description of the drawings]

[0026] The drawings described below are for illustration purposes only. The drawings are not intended to limit the scope of the present disclosure. The patent or application file contains at least one drawing of color. Copies of this patent or patent application publication with color drawing(s) will be provided by the U.S. Patent and Trademark Office upon request and payment of the necessary fee.

[0027] These and other aspects of the embodiments will now be described in further detail with reference to the accompanying drawings, in which like elements in the various drawings are designated with common reference numerals.

[0028] [Figure 1] 1A and 1B show various aspects of a conventional injection syringe configuration. [Diagram 2] 2A and 2B show various aspects of a conventional injection syringe configuration. [Diagram 3] FIG. 3 illustrates various aspects of a conventional injection syringe configuration. [Figure 4] 4A and 4B show various aspects of a conventional injection syringe configuration. [Diagram 5] 5A-5C show various aspects of conventional injection syringe configurations. [Figure 6] FIG. 6 illustrates a molded polymeric infusion system body according to some embodiments. [Figure 7] FIG. 7 illustrates a molded polymeric infusion system body according to some embodiments. [Figure 8] FIG. 8 illustrates a needle hub assembly for use with a molded polymeric injection system according to some embodiments. [Figure 9] FIG. 9 illustrates a needle hub assembly for use with a molded polymeric injection system according to some embodiments. [Figure 10] FIG. 10 illustrates a needle hub assembly and anti-detachment band for use in a molded polymeric injection system according to some embodiments. [Figure 11] FIG. 11 illustrates the mating of the needle hub assembly shown in FIGS. 8 and 9 with the molded polymeric injection system body shown in FIGS. 6 and 7, according to some embodiments. [Figure 12] FIG. 12 illustrates the needle hub assembly shown in FIGS. 8 and 9 coupled with the molded polymeric injection system body shown in FIGS. 6 and 7 according to some embodiments. [Figure 13] Figure 13 illustrates the needle hub assembly shown in Figures 8 and 9 coupled with the molded polymeric injection system body shown in Figures 6 and 7 according to some embodiments. Figures 13A and 13B illustrate a safety injection system with anti-detachment barbed band according to some embodiments. [Figure 14] FIG. 14 illustrates a needle hub assembly for use with a molded polymeric injection system according to some embodiments. [Figure 15] FIG. 15 illustrates a needle hub assembly for use with a molded polymeric injection system according to some embodiments. [Figure 16] 16A and 16B show a needle hub assembly for use with a molded polymeric injection system according to some embodiments. [Figure 17] 17A and 17B show a needle hub assembly and a retaining ring for use with a molded polymeric injection system according to some embodiments. [Figure 18] FIG. 18 illustrates a needle hub assembly according to some embodiments and a needle hub for use with a retaining ring in a molded polymeric injection system. [Figure 19] Figures 19A and 19B show a needle hub assembly and a needle hub for use with a retaining ring in a molded polymeric injection system according to some embodiments, and Figures 19C-19E show a safety injection system with a retaining ring according to some embodiments. [Figure 20] FIG. 20 illustrates the mating of a needle hub assembly having a locking detent according to some embodiments with a molded polymeric injection system body having a corresponding notch. [Figure 21] FIG. 21 illustrates the mating of a needle hub assembly having a locking detent according to some embodiments with a molded polymeric injection system body having a corresponding notch. [Figure 22] FIG. 22 illustrates the mating of a needle hub assembly having a locking detent according to some embodiments with a molded polymeric injection system body having a corresponding notch. [Figure 23] FIG. 23 illustrates the mating of a needle hub assembly having a dampening tab to a molded polymeric injection system body according to some embodiments. [Figure 24] 24A and 24B show a needle hub assembly having a braking tab in two positions according to some embodiments. [Diagram 25] FIG. 25 illustrates a needle hub assembly having a braking tab according to some embodiments. [Figure 26] FIG. 26 illustrates a needle hub assembly having a braking tab according to some embodiments. [Figure 27] FIG. 27 illustrates the mating of a needle hub assembly having a dampening tab to a molded polymeric injection system body according to some embodiments. [Figure 28] 28A and 28B show the mating of a needle hub assembly having a dampening tab to a molded polymeric injection system body according to some embodiments. [Figure 29] 29A and 29B show a safety injection system with braking tabs (or locking detents) according to some embodiments.

[0029] In order to better understand how the above and other advantages and objects of the various embodiments can be obtained, a more detailed description of the embodiments is provided with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale and that elements of similar structure or function are designated with similar reference numerals throughout. It should be understood that the drawings depict only certain exemplary embodiments and therefore should not be considered as limiting the scope of the embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] Anti-removal band with hook 8 and 9 show a needle hub assembly 800 for use with a molded polymeric infusion system body according to some embodiments. The needle hub assembly 800 includes a needle 810, a threaded needle hub 812, an anti-detachment band 814, a seal / guide 816, a needle latch 818, a needle latch actuator 820, and a rigid needle shield 822. The needle latch 818 and the needle latch actuator 820 are part of a needle retraction system as described herein.

[0031] The anti-detachment band 814 is shown in detail in FIG. 10. In some embodiments, the anti-detachment band 814 is made of metal to provide greater resilience and hardness to hold the needle hub assembly 800 on the molded polymeric infusion system body. The hardness of the metal forming the anti-detachment band 814 allows its anti-detachment barbs 826 to bite into the softer polymer making up the infusion system body 600 and prevent rotation of the needle hub assembly 800 relative to the infusion system body 600 in the removal direction described herein. The anti-detachment band 814 is approximately 75% of a fully circular band. An opening 822 in the anti-detachment band 814 allows the anti-detachment band 814 to snap onto the needle hub 812. The anti-detachment band 814 also includes a longitudinal extension 824 configured to be received in an opening in the needle hub 812 to prevent relative rotation of the anti-detachment band 814 and the needle hub 812.

[0032] As further shown in FIG. 10, the anti-detachment band 814 also includes a plurality (e.g., two) of anti-detachment barbs 826. The anti-detachment barbs 826 are oriented in a counterclockwise direction opposite to the clockwise direction of the inward threads of the molded polymeric injection system body. Additionally, the distal ends of the anti-detachment barbs 826 are biased to extend radially outward. As such, when the needle hub assembly 800 is threaded clockwise into the molded polymeric syringe body 600 shown in FIG. 11, the anti-detachment barbs 826 do not engage the smooth wall of the molded polymeric syringe body 600 adjacent the inward threads 612. However, when the needle hub assembly 800 is rotated in the counterclockwise direction y, the anti-detachment barbs 826 bite into the smooth wall of the molded polymeric syringe body 600. This interference prevents counterclockwise rotation of the needle hub assembly 800 relative to the molded polymeric syringe body 600 and removal of the needle hub assembly 800 from the molded polymeric syringe body 600. The anti-removal band 814 and its anti-removal hook 826 function as a one-way clutch that only allows clockwise rotation of the needle hub assembly 800 relative to the molded polymeric syringe body 600. While in this embodiment clockwise rotation is permitted and counterclockwise rotation is prevented, in other embodiments, the orientation of the anti-removal hook 826 and the internal threads of the molded polymeric injection system body can be changed to allow counterclockwise rotation and prevent clockwise rotation.

[0033] 11, the needle hub 812 also includes a number of recesses 828 having flat surfaces. The recesses 828 on the needle hub 812 allow a wrench or socket-like device (not shown) to rotate the needle hub assembly 800 relative to the molded polymeric syringe body 600. The wrench or socket-like device can be operated by a user or by a robot, facilitating both manual and automated assembly.

[0034] 12 shows the needle hub assembly 800 fully threaded into the molded polymeric syringe body 600. Anti-detachment hook 826 prevents the needle hub assembly 800 and the molded polymeric syringe body 600 from being manually separated from each other once they are assembled.

[0035] 13 shows a cross-sectional view of the needle hub assembly 800 fully threaded into the molded polymeric syringe body 600 to illustrate the function of the seal / guide 816. The needle / tube 810 passes through the seal / guide 616 and into the molded polymeric syringe body 600. The seal / guide 816 is pressed by the needle hub 812 against the distal end of the luer connector 810, thereby sealing the distal end of the molded polymeric syringe body 600 and preventing fluid from exiting the distal end of the molded polymeric syringe body 600 unless the fluid passes through the needle / tube 810.

[0036] Additionally, the seal / guide 816 includes an inward extension 830 that centers the needle / tube 810 in the opening 616 at the distal end of the luer connector 612, thereby stabilizing the needle / tube 810 within the opening 616 despite the differences in diameter of the needle / tube 810 and opening 616 discussed above. Centering and stabilizing the needle / tube 810 within the molded polymeric syringe body 600 facilitates precise interaction between the proximal end of the needle / tube 810 and various injection system components located at the distal end of the molded polymeric syringe body 600, as discussed above.

[0037] Exemplary Safety Syringe System (with Anti-Removal Hook Band) 13A and 13B are side views of a safe injection system 1300 having an anti-detachment barbed band 814 according to some embodiments. The safe injection system 1300 facilitates injection of a medication via a needle 810 and facilitates retraction of the needle 810 into the safe injection system 1300 such that the sharp distal end of the needle is contained therein to prevent accidental needle sticks.

[0038] The safe injection system 1300 includes a molded polymeric syringe body 600 defining a drug chamber 618, a stopper member 620 blocking a proximal end of the drug chamber 618, and a needle coupling assembly 614 formed at a distal end of the molded polymeric syringe body 600. The drug chamber 618 can have an inert coating on its inner surface. The safe injection system 1300 also includes a plunger assembly 700. The plunger assembly 700 is coupled to the stopper member 620 and includes a plunger housing member 710 and a plunger operating interface 730.

[0039] The safe injection system 1300 further includes a needle hub assembly 800 having a needle 810 releasably coupled to a threaded needle hub 812 by a needle latch 818, as shown in Figures 8 and 9 and described above. The threaded needle hub 812 can be coupled to the needle coupling assembly 614 via the inward threads 612 of the needle coupling assembly 614. As shown in Figures 11 and 12 and as described above, the barbed band 814 allows the needle hub assembly 800 to be threaded onto the needle coupling assembly 614 but prevents the needle hub assembly 800 from being removed therefrom. The needle latch 818 prevents proximal movement of the needle 810 relative to the threaded needle hub 812 until distal movement of the needle 810 opens / releases the needle latch 818. Distal movement of the needle 810 causes distal movement of the needle latch actuator 820 (from forces applied via the stopper member 620, the plunger housing member 710 and the plunger operating interface 730), thereby opening / releasing the needle latch 818.

[0040] The safe injection system 1300 responds to insertion of the plunger assembly 700 into the syringe body 600 by a user to control the distal exit of the medicament from the chamber 618. Figure 13A shows the safe injection system 1300 in a pre-injection configuration. Application of a distal force to the plunger actuation interface 730 causes the plunger member 700 to move distally relative to the molded polymeric syringe body 600, thereby expelling the medicament from the chamber 618 through the needle 810 to effect an injection.

[0041] 13B shows the safe injection system 1300 in a safe configuration after injection. When the plunger member 700 is manipulated distally such that the stopper member 620 is located near the distal end of the molded polymeric syringe body 600, the proximal end 622 of the needle 810 passes completely through the stopper member 620 and into the plunger interior 712 defined by the plunger housing member 710. After entering the plunger interior 712, the proximal end 622 of the needle 810 is coupled / captured by the needle retracting member 720 of the plunger assembly 700. The needle retracting member 720 is initially in a distal position (not shown) within the plunger interior 712. The needle retracting member 720 is coupled to a needle retracting spring 732. The needle retracting spring 732 is held in a compressed state by a spring latch 734 when the needle retracting member 720 is in the distal position. The needle retraction member 720 , the needle retraction spring 732 and the spring latch 734 reside in the plunger interior 712 .

[0042] When the stopper member 620 is positioned near the distal end of the molded polymeric syringe body 600, the needle pushes the needle latch actuator 820 distally to open / release the needle latch 818, thereby allowing proximal movement of the needle 810 relative to the needle hub assembly 800. When the stopper member 620 reaches the distal end of the molded polymeric syringe body 600, the needle retracting member 720 actuates the spring latch 734, releasing the needle retracting spring 732. Because the needle latch actuator 820 has already opened / released the needle latch 818, when the needle retracting member 720 actuates the spring latch 734, the needle retracting spring expands, moving the needle retracting member 720 and the associated needle 810 into the plunger interior 712, as shown in FIG. The sharpened distal tip of the needle 810 is retracted into the plunger interior 712 and the stopper member 620, thereby preventing an accidental needle stick after an injection is completed. In other embodiments, the sharpened tip of the needle 810 is retracted to a position proximal to the distal end of the threaded needle hub 812 to prevent an inadvertent needle stick.

[0043] Retaining ring 14-16B show a needle hub assembly 1400 for use with a molded polymeric infusion system body according to some embodiments. The needle hub assembly 1400 includes a needle 1410, a needle hub 1412, a retaining ring 1414, a seal / guide 1416, a needle latch 1418, a needle latch actuator 1420, and a rigid needle shield 1422.

[0044] 16A and 16B show that the needle hub 1412 defines a space 1424 sized and shaped to receive the retaining ring 1414 to prevent relative longitudinal movement between the retaining ring 1414 and the needle hub 1412. FIG. 16B shows that a seal / guide 1416 is mounted at the interior distal end of the needle hub 1412. The needle / tube 1610 passes through the seal / guide 1616 into the molded polymeric injection system body (e.g., the molded polymeric syringe body 600). The seal / guide 1416 can be pressed by the needle hub 1412 against the distal end of the luer connector 610, thereby sealing the distal end of the molded polymeric syringe body 600 and preventing fluid from exiting the distal end of the molded polymeric syringe body 600 other than through the needle / tube 1610.

[0045] The seal / guide also centers the needle / tube 1610 in the opening 616 at the distal end of the luer connector 612, thereby stabilizing the needle / tube 1610 at the opening 616 despite differences in diameter of the needle / tube 1610 and the opening 616, as described above. Centering and stabilizing the needle / tube 1610 within the molded polymeric syringe body 600 facilitates precise interaction between the proximal end of the needle / tube 1610 and various injection system components located at the distal end of the molded polymeric syringe body 600, as described above.

[0046] 17A and 17B show a metallic retaining ring 1414 for use with a needle hub 1412 of a needle hub assembly 1400 according to some embodiments. The metallic retaining ring 1414 includes teeth 1426 that are biased to bend more easily in one direction than in the opposite direction, allowing the retaining ring 1414 to slide more easily proximally over the luer connector 610 (see FIGS. 6 and 7 ) at the distal end of the molded polymeric syringe body 600, while providing relatively more resistance to removing the retaining ring 1414 distally over the luer connector 610. In effect, the teeth 1426 of the retaining ring 1414 can bite into the luer connector 610 as the needle hub assembly 1400 is pulled away from the molded polymeric syringe body 600.

[0047] There is a self-locking action that occurs between the teeth 1426 and the molded polymeric syringe body 600, which helps resist removal of the retaining ring 1414 on the luer connector 610. The teeth 1426 tend to bind more strongly to the luer connector 610 as more removal force is applied. This is due to the non-shallow angle that is formed between the teeth 1426 and the luer connector 610 after assembly, which increases the friction between the teeth 1426 and the luer connector 610 as the removal force increases, thereby preventing the teeth 1426 from releasing the luer connector 610. The dome-like curvature of the teeth 1426 and the surrounding metal of the retaining ring 1414 provide structural strength to the teeth 1426, which presses against the luer connector 610 with a substantial radial force, enhancing the self-locking action and helping the teeth 1426 resist releasing the luer connector 610. The needle hub 1412 defines a space 1424 in which the retaining ring 1414 is disposed, and the molded polymeric syringe body 600 includes a luer connector 610 configured to interact with the retaining ring 1414 such that interference between the luer connector 610 and the retaining ring 1414 allows attachment of the needle hub 1412 proximally to the molded polymeric syringe body 600 while preventing removal of the needle hub 1412 distally from the molded polymeric syringe body 600. The metallic retaining ring 1414 has greater hardness and resilience as compared to the molded polymeric syringe body 600 due to its metallic composition.

[0048] 18-19B show the needle hub 1412 with other components omitted for clarity. As shown in FIG. 19B, the needle hub 1412 defines a space 1424 sized and shaped to receive the retaining ring 1414 to prevent relative longitudinal movement between the retaining ring 1414 and the needle hub 1412. Thus, when the retaining ring 1414 is coupled to the molded polymeric syringe body 600, the needle hub 1412 and needle hub assembly 1400 are also coupled to the molded polymeric syringe body 600.

[0049] Exemplary Safety Syringe System (with Retaining Ring) 19C-19E show perspective and side views of a safe injection system 1900 having a retaining ring 1414 according to some embodiments. The safe injection system 1900 facilitates injection of a medication via a needle 1410 and facilitates retraction of the needle 1410 into the safe injection system 1900 such that the sharp distal end of the needle 1410 is contained therein to prevent accidental needle sticks.

[0050] The safe injection system 1900 includes a molded polymeric syringe body 600' defining a drug chamber 618, a stopper member 620 blocking a proximal end of the drug chamber 618, and a needle coupling member 614' formed at a distal end of the molded polymeric syringe body 600'. The drug chamber 618 can have an inert coating on its inner surface. The safe injection system 1900 also includes a plunger assembly 700. The plunger assembly 700 is coupled to the stopper member 620 and includes a plunger housing member 710 and a plunger operating interface 730.

[0051] The safe injection system 1900 further includes a needle hub assembly 1400 having a needle 1410 releasably coupled to a needle hub 1412 by a needle latch 818, as shown in Figures 15 and 16B and described above. As shown in Figures 15 and 16B and described above, a retaining ring 1414 allows the needle hub assembly 1400 to be inserted onto the needle coupling member 614' but prevents removal of the needle hub assembly 1400 therefrom. The needle latch 818 prevents proximal movement of the needle 1410 relative to the needle hub 1412 until distal movement of the needle 1410 opens / releases the needle latch 818. Distal movement of the needle 1410 causes distal movement of the needle latch actuator 820 (from forces applied via the stopper member 620, the plunger housing member 710 and the plunger operation interface 730) to open / release the needle latch 818.

[0052] The safety injection system 1900 responds to insertion of the plunger assembly 700 into the syringe body 600' by a user to control the distal exit of the medicament from the chamber 618. Figure 19B shows the safety injection system 1900 in a pre-injection configuration. Application of a distal force to the plunger actuation interface 730 causes the plunger member 700 to move distally relative to the molded polymeric syringe body 600', thereby expelling the medicament from the chamber 618 through the needle 1410 to effect an injection.

[0053] 19C shows the safe injection system 1900 in a safe configuration after injection. When the plunger member 700 is manipulated distally to position the stopper member 620 near the distal end of the molded polymeric syringe body 600′, the proximal end 622 of the needle 1410 passes completely through the stopper member 620 and into the plunger interior 712 defined by the plunger housing member 710. After entering the plunger interior 712, the proximal end 622 of the needle 1410 is coupled / captured to the needle retracting member 720 within the plunger assembly 700. The needle retracting member 720 is initially in a distal position (not shown) of the plunger interior 712. The needle retracting member 720 is coupled to a needle retracting spring 732. The needle retracting spring 732 is held in a compressed state by a spring latch 734 when the needle retracting member 720 is in the distal position. The needle retraction member 720 , the needle retraction spring 732 and the spring latch 734 reside in the plunger interior 712 .

[0054] When the stopper member 620 is positioned near the distal end of the molded polymeric syringe body 600', the needle pushes the needle latch actuator 820 distally to open / release the needle latch 818, thereby allowing proximal movement of the needle 810 relative to the needle hub assembly 800. When the stopper member 620 reaches the distal end of the molded polymeric syringe body 600', the needle retracting member 720 actuates the spring latch 734, releasing the needle retracting spring 732. Because the needle latch actuator 820 has already opened / released the needle latch 818, when the needle retracting member 720 actuates the spring latch 734, the needle retracting spring expands, moving the needle retracting member 720 and the associated needle 810 into the plunger interior 712, as shown in FIG. The sharpened distal tip of the needle 810 is retracted into the plunger interior 712 and the stopper member 620 to prevent an accidental needle stick after an injection is completed. In other embodiments, the sharpened tip of the needle 1410 is retracted to a position proximal to the distal end of the needle hub 1412 to prevent an inadvertent needle stick.

[0055] Locking detents and braking tabs 20-22 show a needle hub assembly 2000 for use with a molded polymeric infusion system body according to some embodiments. The needle hub assembly 2000 includes a needle 2010, a needle hub 2012 having a locking detent 2014, and a rigid needle shield 2022.

[0056] A detent 2014 extends from the proximally facing surface of the needle hub 2012. When the needle hub assembly 2000 is rotated clockwise on the molded polymeric syringe body 600, the detent 2014 slides into a notch 620 formed in the molded polymeric syringe body 600. The inclination of the detent 2014 allows the detent 2014 to slide into the notch 620 with clockwise rotation but prevents counterclockwise rotation. While clockwise rotation is permitted and counterclockwise rotation is prevented in this embodiment, the direction of the detent 2014 and the internal threads of the molded polymeric syringe body can be changed to permit counterclockwise rotation and prevent clockwise rotation in other embodiments. Although a single detent 2014 and notch 620 are shown in the drawings, the system can include multiple detents and notches, respectively. Although the notch is shown on the distal surface of the integrally molded syringe body 600, the notch may be formed in the distal surface of a molded polymeric Luer interface 614 that is attached to the distal end of the glass syringe.

[0057] The needle hub 2012 also includes a number of recesses 2028 having flat surfaces. The recesses 2028 on the needle hub 2012 allow a device such as a wrench or socket (not shown) to rotate the needle hub assembly 2000 relative to the molded polymeric syringe body 600. The device such as a wrench or socket can be operated by a user or by a robot, thereby facilitating both manual and automated assembly.

[0058] 23-28B show a needle hub assembly 2300 for use with an injection system body according to some embodiments. The needle hub assembly 2300 includes a needle 2310, a needle hub 2312 having a brake tab 2314, a needle latch 2318 (see FIG. 28A), and a needle latch actuator 2320 (see FIG. 28A).

[0059] The injection system body 600 shown here is a glass syringe body 600 with an internally threaded needle coupling assembly / luer nut 614 attached to its distal end. The brake tab can also be used with a fully integrated polymeric injection system body with an integrated needle coupling assembly / luer nut as shown in FIG. 7 above. The brake tab 2314 is shown in detail in FIGS. 24A, 24B, 25, 26, and 28B. As shown in FIGS. 24A and 24B, the brake tab 2314 has two positions. FIG. 24A shows the brake tab 2314 in an unlocked position, in which the needle hub 2312 can be coupled to the injection system body 600 by rotating the needle hub 2312 clockwise relative to the injection system body 600. 24B shows the brake tab 2314 in a locked position, which prevents the needle hub 2312 from being removed from the infusion system body 600 by rotating the needle hub 2312 counterclockwise relative to the infusion system body 600. Upon coupling the needle hub 2312 to the infusion system body 600 by clockwise rotation, the brake tab 2314 can be converted from the unlocked position to the locked position. Thus, the brake tab 2314 allows the needle hub assembly 2300 to be rotated clockwise on the infusion system body 600, but prevents the needle hub assembly 2300 from being rotated counterclockwise to be removed from the infusion system body 600. Although multiple brake tabs 2314 are shown in FIG. 23, the infusion system may be configured to use a single brake tab.

[0060] 28A and 28B show that when the needle hub assembly 2300 is rotated clockwise on the infusion system body 600, the tab 2314 can expand with pressure from the infusion system body 600 and grip the inward threads on the infusion system body 600. This further prevents counterclockwise rotation to remove the needle hub assembly 2300 from the infusion system body 600. While in this embodiment clockwise rotation is permitted and counterclockwise rotation is prevented, in other embodiments, counterclockwise rotation can be permitted and clockwise rotation prevented by changing the orientation of the brake tab 2314 and the inward threads of the infusion system body.

[0061] The needle hub assembly 2000, 2300 is shown without a seal / guide, however, in other embodiments, a seal / guide similar to that of the needle hub assembly 800, 1400 is present in the needle hub assembly 2000, 2300. Such a seal / guide would seal the interior of the molded polymeric injection system body 600 and center the needle / tube 2010 in the molded polymeric injection system body 600. The injection system body may be a syringe body or a cartridge body. The injection system body 600 may have an inert coating on its inner surface.

[0062] Exemplary Safety Syringe System (with Locking Detents or Braking Tabs) 29A and 29B show side views of a safe injection system 2900 having a braking tab 2314 according to some embodiments. The safe injection system 2900 facilitates injection of a medication via a needle 810 and facilitates retraction of the needle 810 into the safe injection system 2900 such that the sharp distal end of the needle is contained therein to prevent accidental needle sticks.

[0063] The safe injection system 2900 includes an injection system body 600″ defining a drug chamber 618, a stopper member 620 blocking a proximal end of the drug chamber 618, and a needle coupling assembly 614 formed at a distal end of the injection system body 600″. The safe injection system 2900 also includes a plunger assembly 700. The plunger assembly 700 is coupled to the stopper member 620 and includes a plunger housing member 710 and a plunger operating interface 730.

[0064] The safety injection system 2900 further includes a needle hub assembly 2300 having a needle 2310 releasably coupled to a threaded needle hub 2312 by a needle latch 818, as described below. The threaded needle hub 2312 may be coupled to the needle coupling assembly 614 via the inward threads 612″ of the needle coupling assembly 614. As shown in FIGS. 27-28B and as described above, the brake tab 2314 allows the needle hub assembly 2300 to be threaded onto the needle coupling assembly 614, but prevents the needle hub assembly 2300 from being removed therefrom. The needle latch 818 prevents proximal movement of the needle 2310 relative to the threaded needle hub 2312 until distal movement of the needle 2310 opens / releases the needle latch 818. Distal movement of the needle 2310 causes distal movement of the needle latch actuator 820 (from forces applied via the stopper member 620, the plunger housing member 710 and the plunger operating interface 730) to open / release the needle latch 818.

[0065] The safety injection system 2900 controls the distal exit of medicament from the chamber 618 upon insertion of the plunger assembly 700 into the injection system body 600" by a user. FIG. 29A shows the safety injection system 2900 in a pre-injection configuration. Application of a distal force to the plunger operating interface 730 moves the plunger member 700 distally relative to the molded polymeric injection system body 600", thereby expelling the medicament from the chamber 618 via the needle 2310 to perform the injection.

[0066] FIG. 29B shows the safety injection system 2900 in the safe configuration after injection. When the plunger member 700 is manipulated distally such that the stopper member 620 is disposed near the distal end of the molded polymeric injection system body 600", the proximal end 622 of the needle 2310 passes completely through the stopper member 620 and into the plunger interior 712 defined by the plunger housing member 710. After entering the plunger interior 712, the proximal end 622 of the needle 2310 is coupled / captured by a needle retracting member 720 within the plunger assembly 700. The needle retracting member 720 is initially in a distal position (not shown) of the plunger interior 712. The needle retracting member 720 is coupled to a needle retracting spring 732. The needle retracting spring 732 is held in a compressed state by a spring latch 734 when the needle retracting member 720 is in the distal position. The needle retracting member 720, the needle retracting spring 732 and the spring latch 734 reside in the plunger interior 712.

[0067] When the stopper member 620 is positioned near the distal end of the injection system body 600", the needle pushes the needle latch actuator 820 distally to open / release the needle latch 818, thereby allowing proximal movement of the needle 2310 relative to the needle hub assembly 2300. When the stopper member 620 reaches the distal end of the molded polymeric injection system body 600", the needle retracting member 720 actuates the spring latch 734, releasing the needle retracting spring 732. Because the needle latch actuator 820 has already opened / released the needle latch 818, when the needle retracting member 720 actuates the spring latch 734, the needle retracting spring expands, moving the needle retracting member 720 and the associated needle 2310 into the plunger interior 712, as shown in FIG. 29B. The sharp distal tip of the needle 2310 is retracted to a position proximal to the distal end of the threaded needle hub 2312 to prevent an accidental needle stick after an injection is completed. At least a portion of the needle 2310 is retracted at least partially through the stopper member 620. In other embodiments, the sharp distal tip of the needle 2312 is retracted through the stopper member 620 into the plunger interior 712 to prevent an accidental needle stick.

[0068] Although Figures 29A and 29B show a safety injection system 2900 with a braking tab 2314 according to some embodiments, a safety injection system with a locking detent 2014 will function similarly to the safety injection system 2900 shown in Figures 29A and 29B.

[0069] Additional Aspects In addition to the claimed invention, further embodiments or aspects of the invention are described herein, by way of non-limiting examples.

[0070] [Aspect 1] In the injection system, A molded body member comprising: a body connecting member at a distal end thereof; a molded body member including a notch disposed on a distally facing surface thereof; a needle hub assembly coupled to a distal end of the injection system body, a needle hub coupled to the body connecting member; a needle coupled to a needle hub; a detent disposed on a proximally facing surface of the needle hub; The detent is configured to fit into the notch when the needle hub assembly is coupled to the body member to prevent rotation of the needle hub assembly relative to the body connecting member.

[0071] [Aspect 2] In the system according to aspect 1, 11. The system further comprising a stopper member disposed within the molded body member and a plunger member coupled thereto, wherein the needle is configured to be at least partially retracted into the molded body member upon manipulation of the plunger member to position the stopper member at a distal end of the molded body member.

[0072] [Aspect 3] In the system according to aspect 1, The system, wherein the needle hub includes a plurality of recesses configured to facilitate rotation of the needle hub assembly relative to the body connecting member.

[0073] [Aspect 4] In the system according to aspect 1, The system, wherein the body connecting member includes a space having an inwardly facing thread.

[0074] [Aspect 5] In the system according to aspect 1, The system, wherein the body connecting member includes an integrated luer nut.

[0075] [Aspect 6] In the system according to aspect 1, The system further comprising a seal member disposed between the distal end of the body member and an inner surface of the needle hub.

[0076] [Aspect 7] In the system according to aspect 6, The system, wherein the seal member comprises an inward extension configured to center the needle at a distal end of the body member.

[0077] [Aspect 8] In the system according to aspect 1, The system, wherein the body member is molded from a cyclic olefin copolymer or a cyclic olefin polymer.

[0078] The anti-detachment mechanism disclosed herein prevents both manual removal of the needle hub assembly from the injection system body by a user and removal of the needle hub assembly from the injection system body due to pressure build-up within the injection system body during injection of a medicament through the needle. In particular, the anti-detachment mechanism disclosed herein prevents the needle hub assembly from becoming detached from the injection system body due to pressure built up within the injection system body during injection.

[0079] Although the embodiments herein show a molded polymeric syringe body, the removal prevention mechanism for the needle hub assembly from the molded body member may also be used with molded polymeric cartridges according to various embodiments.

[0080] Various exemplary embodiments of the present invention are described herein. These examples are referred to in a non-limiting sense. They are provided to illustrate the broader applicable aspects of the present invention. Various modifications can be made to the described invention and equivalents can be substituted without departing from the true spirit and scope of the invention. In addition, many modifications can be made to adapt a particular situation, material, composition of matter, process, process acts or steps to the objective, spirit or scope of the present invention. Moreover, 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 easily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. All such modifications are intended to be within the scope of the claims associated with this disclosure.

[0081] Any of the devices described for performing a subject infusion information gathering procedure may be provided in a packaged combination for use in performing such an intervention, and these supply "kits" may further include instructions for use and / or be packaged in a sterile tray or container as commonly employed for such purposes.

[0082] The present invention includes methods that may be performed with a subject device. The methods may include the act of providing such a suitable device. Such providing may be performed by an end user. That is, the act of "providing" merely requires the end user to obtain, access, approach, place, set up, activate, power on or take other actions to provide the required device in the subject method. Methods described herein may carry out the recited events in any order that is logically possible or in the sequence of events recited.

[0083] Exemplary embodiments of the present invention, together with details regarding material selection and manufacture, have been described above. As for other details of the present invention, they may be understood in conjunction with the patents and publications cited above, as well as generally known or understood by those skilled in the art. For example, those skilled in the art will understand that one or more lubricious coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, hydrophilic gels or silicones) may be used in conjunction with various parts of the device, such as relatively large interfaces of movably connected parts, as needed, to facilitate, for example, low-friction manipulation or advancement of such objects relative to other parts of the instrument or nearby tissue structures. The same will be true for method-based embodiments of the present invention with respect to additional actions commonly or logically taken.

[0084] Furthermore, while the present invention has been described with reference to several examples optionally incorporating various features, it is not intended to be limited to those described or disclosed as contemplated for each variation of the present invention. Various modifications can be made to the described invention, and equivalents (whether described herein or not included for brevity) can be substituted without departing from the true spirit and scope of the invention. Furthermore, when a range of values ​​is provided, it is to be understood that all intervening values ​​between the upper and lower limits of the range, as well as other stated or intervening values ​​within the stated range, are encompassed within the scope of the invention.

[0085] It is also contemplated that any feature of the described inventive variation may be described and claimed independently or in combination with any one or more of the features described herein. Reference to a singular item includes the possibility of a plurality of the same items. More specifically, as used in this specification and the claims related thereto, the singular forms "a," "an," "said," and "the" include plural referents unless otherwise indicated. In other words, the use of articles allows for "at least one" of the subject items in the above description, as well as the claims related to this disclosure. It is noted that such claims may be drafted to exclude any element. Thus, this statement is intended to function as a prior statement using exclusive terms such as "solely," "only," and the like in connection with the recitation of claim elements, or a prior statement to use a "negative" limitation.

[0086] Without using such exclusive terms, the term "comprising" in any claim relating to this disclosure shall be construed as allowing for the inclusion of any additional elements, regardless of whether a given number of elements are recited in such claim or whether the addition of features would be considered to change the nature of the elements recited in such claim. Except as specifically defined herein, all technical and scientific terms used herein shall be given the broadest possible and commonly understood meaning while maintaining the validity of the claims.

[0087] The breadth of the present invention is not intended to be limited by the examples and / or subject specification provided, but rather should be limited only by the scope of the language of the claims associated with this disclosure.

Claims

1. 1. An injection system comprising: a molded body member having a body connecting member at a distal end; a needle hub assembly coupled to a distal end of the injection system body; The needle hub assembly comprises: a needle hub coupled to the body connecting member; a needle coupled to the needle hub; a barbed band disposed about a proximal end of the needle hub and having a barb; an injection system, characterized in that the hooked band permits rotation of the needle hub assembly relative to the body connecting member in a first direction while preventing rotation of the needle hub assembly relative to the body connecting member in a second direction.

2. 2. The system of claim 1, 13. The system of claim 12, further comprising a stopper member disposed within the molded body member and a plunger member coupled thereto, wherein the needle is configured to be at least partially retracted into the molded body member upon manipulation of the plunger member to position the stopper member at a distal end of the molded body member.

3. 2. The system of claim 1, The system, wherein the needle hub includes a plurality of recesses configured to facilitate rotation of the needle hub assembly relative to the body connecting member.

4. 2. The system of claim 1, The system, wherein the body connecting member includes a space having an inwardly facing thread.

5. 2. The system of claim 1, The system according to claim 1, wherein the body connection member includes an integrated luer nut.

6. 2. The system of claim 1, The system further comprising a seal member disposed between the distal end of the body member and an inner surface of the needle hub.

7. 7. The system of claim 6, The system, wherein the seal member comprises an inward extension configured to center the needle at a distal end of the body member.

8. 2. The system of claim 1, the barbed band including a spike extending in the second direction and biased to protrude radially outward.

9. 2. The system of claim 1, The system, wherein the body member is molded from a cyclic olefin copolymer or a cyclic olefin polymer.

10. 1. An injection system comprising: a molded body member having a body connecting member at a distal end; a needle hub assembly coupled to a distal end of the injection system body; The needle hub assembly comprises: a needle hub coupled to the body connecting member; a needle coupled to the needle hub; a retaining ring disposed about a proximal end of the needle hub and having a plurality of teeth; 11. An injection system, comprising: a retaining ring that permits proximal movement of the needle hub assembly relative to the body connecting member while preventing distal movement of the needle hub assembly relative to the body connecting member.

11. 11. The system of claim 10, 13. The system of claim 12, further comprising a stopper member disposed within the molded body member and a plunger member coupled thereto, wherein the needle is configured to be at least partially retracted into the molded body member upon manipulation of the plunger member to position the stopper member at a distal end of the molded body member.

12. 1. An injection system comprising: a molded body member having a body connecting member at a distal end; a needle hub assembly coupled to a distal end of the injection system body; The needle hub assembly comprises: a needle hub coupled to the body connecting member; a needle coupled to the needle hub; a brake tab disposed on an outer surface of the needle hub assembly and contacting an inner surface of the body connecting member; 11. An injection system, comprising: a first connecting member for connecting a needle hub assembly to a first end of the first shaft; a second connecting member for connecting a needle hub assembly to a first end of the first shaft;

13. 13. The system of claim 12, 13. The system of claim 12, further comprising a stopper member disposed within the molded body member and a plunger member coupled thereto, wherein the needle is configured to be at least partially retracted into the molded body member upon manipulation of the plunger member to position the stopper member at a distal end of the molded body member.

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