Single hand removable tip cap for pre-filled syringe

Abstract

A syringe includes a barrel having a proximal end, a distal end, and a sidewall extending between the proximal end and the distal end, the distal end having a distal tip defining a channel. The syringe also includes a tip cap removably connected to the barrel distal tip restricting fluid flow from the channel. The tip cap includes a connector configured to receive the distal tip of the cartridge in frictional engagement with the distal tip; a cap shield connected to the connector and extending around the connector; and a release tab extending proximally from the cap shield, securing the tip cap to the cartridge. Also disclosed herein is a pre-filled rinse syringe comprising a predetermined volume of fluid disposed within a barrel of the syringe, and methods for evacuating fluid from the syringe and assembling the syringe and tip cap.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Utility Application No. 17 / 979,182, filed on November 2, 2022, entitled "Single - Hand Removable Tip Cap for Prefilled Syringe", the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure generally relates to tip caps for syringes such as prefilled syringes, and particularly to a tip cap that can be easily removed from the distal tip of a syringe by a physician, preferably using one hand. Background Art

[0004] Conventional syringes include a barrel having an open proximal end and an opposite distal end. The distal tip, sometimes referred to as a Luer or Luer tip, projects from the distal end of the syringe barrel and includes a narrow passageway or channel that is in fluid communication with the interior of the syringe barrel. Conventional syringes are typically pre - filled with a medical fluid such as a flush solution or a therapeutic agent during manufacture. When pre - filling the medical fluid, the syringe barrel can be sealed to prevent contamination of the medical fluid or loss of the medical fluid prior to use. The seal also prevents the physician from being unnecessarily exposed to the medical fluid contained in the syringe barrel, which is particularly important for toxic or otherwise harmful agents.

[0005] Some prefilled syringes have a stopper or closure, commonly referred to as a tip cap, mounted on the distal tip of the syringe barrel to seal the syringe barrel to prevent leakage and to avoid contamination of the medical fluid contained in the syringe barrel. Shortly before using the syringe, the physician removes the conventional tip cap from the distal tip of the syringe barrel by grasping the syringe barrel and pulling the tip cap axially away from the syringe barrel. Other tip caps are attached to the syringe barrel by a threaded collar. In this case, the tip cap can be removed from the syringe barrel by holding the syringe barrel with one hand while twisting the tip cap with the other hand to unscrew the tip cap. Maintaining a good seal is particularly important when the prefilled syringe is capped. This is generally achieved by attaching the tip cap tightly to the distal tip of the syringe barrel. However, when over - tightened, the tip cap may be difficult to remove or may be damaged. In addition, prefilled syringes can be autoclaved after filling and capping, such that the prefilled syringes are contained within a sterile package. The autoclaving procedure can cause an interaction between the tip cap and the syringe barrel, which further increases the difficulty of removing the tip cap from the distal tip of the syringe barrel.

[0006] Due to the tight connection between the tip cap and the distal tip of the syringe barrel, a physician may need to apply a relatively large grasping force to remove the tip cap from the distal end of the syringe barrel. For some physicians who lack the physical strength and dexterity required to properly grasp the tip cap, it may be difficult to tightly grasp the tip cap, especially considering the small size of a typical tip cap. Additionally, when tightly grasping the tip cap, the physician's fingers are very close to the distal tip of the syringe barrel. Thus, there is a risk that when removing the tip cap, the physician will contact the distal tip of the barrel, which may contaminate the distal tip of the syringe barrel.

[0007] Prefilled syringes are typically connected to a patient via a vascular access device (VAD), such as an intravenous (IV) catheter (e.g., a peripheral catheter or a central venous catheter), and are used to deliver fluid to the patient. If not properly maintained or if exposed to a non-sterile environment, such as when a non-sterile environment occurs when a physician manipulates or removes the tip cap from the syringe barrel, as previously described, the VAD may become contaminated, sealed with blood clots, and / or transmit infection. Many healthcare facilities implement sterile practices and procedures to avoid contamination and ensure proper use of the VAD and that it does not become sealed or infected. These procedures typically include sterilizing medical devices, including the VAD, and flushing the catheter with a flushing solution. Specifically, VAD practice standards generally recommend flushing procedures after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, blood transfusion, and / or administration of parenteral nutrition. These flushing procedures are designed to confirm catheter patency, avoid drug incompatibilities, ensure delivery of a full drug dose to the patient, prevent thrombus formation, and minimize the risk of bloodstream infection caused by VAD contamination.

[0008] Although the sterilization procedures implemented by healthcare facilities do address some contamination risks, there is still a need for improved designs of medical devices and tools that reduce the opportunity for contamination and simplify device use. In particular, a syringe design that ensures the distal tip of the syringe barrel remains sterile and uncontaminated throughout the fluid delivery procedure when using a VAD will address many of the current contamination problems that occur during the infusion procedure. Additionally, syringe and tip cap designs that are easy to open or remove and can be manipulated without touching the distal tip of the syringe will reduce the common contamination risks of conventional prefilled syringes. The syringe and tip cap designs of the present disclosure address these problems. SUMMARY OF THE INVENTION

[0009] According to one aspect of the present disclosure, a syringe includes: a barrel having a proximal end, a distal end, and a sidewall extending between the proximal end and the distal end, the distal end including a distal tip that defines a passageway. The syringe further includes a tip cap removably attached to the distal tip of the barrel to restrict fluid flow from the passageway. The tip cap includes: a connector configured to receive the distal tip of the barrel and form a friction engagement with the distal tip; a cap shield attached to the connector and extending around the connector; and a release tab extending proximally from the cap shield to secure the tip cap to the barrel.

[0010] According to another aspect of the present disclosure, a prefilled flush syringe includes the previously described syringe and a predetermined volume of fluid disposed within the barrel of the prefilled syringe. The prefilled syringe is configured such that the distal tip of the barrel is received within the connector of the tip cap, thereby preventing the fluid within the barrel from reaching the distal opening of the barrel through the passageway. Additionally, the release tab of the tip cap engages a portion of the barrel to secure the tip cap to the barrel.

[0011] According to another aspect of the present disclosure, as previously described, a method of expelling fluid from a syringe includes: removing a tip cap from the distal tip of a syringe barrel; attaching the distal tip of the syringe barrel to a vascular access device; and moving a plunger inserted within the syringe barrel through the barrel to expel the fluid from the barrel and through the passageway of the distal tip of the barrel to the vascular access device.

[0012] According to another aspect of the present disclosure, a method of assembling a previously described syringe includes: attaching a collar to the distal shield of the syringe barrel; attaching the distal loop of a tether to the tip cap; and moving the connector of the tip cap onto the distal tip of the barrel to form an assembled syringe.

[0013] According to one embodiment of the present invention, a syringe includes: a barrel and a tip cap, the barrel having a proximal end, a distal end, and a sidewall extending between the proximal end and the distal end, the distal end including a distal tip that defines a passageway, the tip cap removably attached to the distal tip of the barrel to restrict fluid flow from the passageway. The tip cap includes: a connector configured to receive the distal tip of the barrel and form a friction engagement with the distal tip; a cap shield attached to the connector and extending around the connector; and a release tab extending proximally from the cap shield to secure the tip cap to the barrel.

[0014] According to one embodiment of the present invention, the barrel includes at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0015] According to one embodiment of the present invention, the barrel further includes an annular flange and a plunger that moves through the barrel, the annular flange being around the proximal end of the barrel for gripping the barrel.

[0016] According to one embodiment of the present invention, the side wall of the barrel includes a tapered portion between the distal end of the barrel and the other parts of the barrel for guiding the fluid inside the barrel towards the channel at the distal tip.

[0017] According to one embodiment of the present invention, the distal tip includes a frustoconical tip that forms a sliding engagement with the inner surface of the tip cap connector.

[0018] According to one embodiment of the present invention, the distal tip includes a male Luer connector.

[0019] According to one embodiment of the present invention, the channel extends from the interior of the barrel to the distal opening of the distal tip.

[0020] According to one embodiment of the present invention, a tether connects the barrel to the tip cap such that when the connector of the tip cap is removed from the distal tip of the barrel, the tip cap hangs from the barrel.

[0021] According to one embodiment of the present invention, the distal end of the barrel further includes a distal shield that at least partially encloses the distal tip of the barrel.

[0022] According to one embodiment of the present invention, the distal shield of the barrel includes a proximal end connected to the syringe barrel, an open distal end, and a side wall extending between the proximal end and the distal end of the distal shield.

[0023] According to one embodiment of the present invention, the distal shield of the barrel includes an inner surface that includes threads for connecting the barrel to a female Luer connector.

[0024] According to one embodiment of the present invention, a collar is disposed around the distal shield of the barrel, and wherein the release tab includes a latch that removably engages the collar.

[0025] According to one embodiment of the present invention, the collar engages around the outer surface of the distal shield of the barrel.

[0026] According to one embodiment of the present invention, the collar includes a plastic ring.

[0027] According to one embodiment of the present invention, a tether connects the barrel to the tip cap such that when the connector of the tip cap is removed from the distal tip of the barrel, the tip cap can hang from the barrel, and wherein the tether includes a proximal loop, a distal loop, and a connecting member extending between the proximal loop and the distal loop, the proximal loop being positioned around the distal shield of the barrel, and the distal loop being connected around the cap shield of the tip cap.

[0028] According to one embodiment of the present invention, the connecting member is flexible.

[0029] According to one embodiment of the present invention, the proximal ring, the distal ring, and the connecting member comprise a flexible elastomeric material.

[0030] According to one embodiment of the present invention, a plunger is positioned within a barrel for expelling fluid from the barrel through a passage at a distal tip.

[0031] According to one embodiment of the present invention, the syringe is operable with one hand to both remove a tip cap from a distal opening of the barrel and expel fluid from the barrel through the passage of the barrel by moving the plunger through the barrel.

[0032] According to one embodiment of the present invention, the plunger comprises a stopper positioned within the barrel and a plunger rod extending proximally from the stopper through a proximal end portion of the barrel.

[0033] According to one embodiment of the present invention, the stopper comprises a thermoplastic elastomer such as isoprene.

[0034] According to one embodiment of the present invention, the stopper comprises a proximal end, a distal end, and an outer surface extending between the proximal end and the distal end, the outer surface sealing against an inner surface of the barrel.

[0035] According to one embodiment of the present invention, the plunger rod comprises a connector portion that is inserted into and engages a cavity of the stopper for securing the stopper to the plunger rod.

[0036] According to one embodiment of the present invention, a connector of the tip cap defines a frustoconical cavity sized to receive a distal tip of the barrel.

[0037] According to one embodiment of the present invention, the connector of the tip cap comprises a female Luer connector sized to receive a distal tip of the barrel.

[0038] According to one embodiment of the present invention, the connector of the tip cap tapers such that an inner diameter of a proximal end of the connector is greater than an inner diameter of a distal tip of the connector.

[0039] According to one embodiment of the present invention, an outer surface of the connector of the tip cap does not comprise threads.

[0040] According to one embodiment of the present invention, a cap shield of the tip cap comprises a proximal end, an open distal end, and a sidewall extending between the proximal end and the distal end, the proximal end comprising a flange that is connected to and extends radially from the connector of the tip cap.

[0041] According to one embodiment of the present invention, the sidewall of the cap shield comprises a plurality of protrusions extending outwardly from an outer surface of the cap shield, such as ribs, ridges, or stops.

[0042] According to one embodiment of the present invention, a rod extends distally from a distal end of a connector and is enclosed by a cap shield of a tip cap.

[0043] According to one embodiment of the present invention, a release tab includes a proximal end, a distal end, and a beam extending between the proximal end and the distal end. The proximal end has a latch for engaging a barrel, and the distal end is pivotally connected to the cap shield of the tip cap.

[0044] According to one embodiment of the present invention, the proximal end of the release tab further includes a push surface that is transverse or substantially transverse to the longitudinal axis of the connector of the tip cap and the longitudinal axis of the cap shield of the tip cap.

[0045] According to one embodiment of the present invention, pressing on the push surface causes the beam to pivot about the distal end of the release tab, which releases the latch from the barrel. And continuing to press against the push surface overcomes the frictional engagement between the connector of the tip cap and the distal tip of the barrel, which disconnects the tip cap from the distal tip of the barrel.

[0046] According to one embodiment of the present invention, a prefilled flush syringe has a predetermined volume of fluid disposed within a barrel of the prefilled syringe. The distal tip of the barrel is received within a connector of a tip cap, thereby preventing the fluid within the barrel from passing through a channel to a distal opening of the barrel. And the release tab of the tip cap is engaged to a portion of the barrel, thereby securing the tip cap to the barrel.

[0047] According to one embodiment of the present invention, the fluid includes a saline flush solution.

[0048] According to one embodiment of the present invention, the fluid includes a therapeutic agent.

[0049] According to one embodiment of the present invention, the barrel contains from about 1 mL to about 50 mL of fluid.

[0050] According to one embodiment of the present invention, the syringe further includes a collar connected around a distal shield of the syringe, and the release tab includes a latch that engages the collar.

[0051] According to one embodiment of the present invention, a method of discharging fluid from a syringe includes: removing a tip cap from a distal tip of a syringe barrel, attaching the distal tip of the syringe barrel to a vascular access device, and moving a plunger inserted into the barrel through the barrel to discharge the fluid from the barrel and through a channel in the distal tip of the barrel to the vascular access device.

[0052] According to one embodiment of the present invention, the fluid contained within the barrel of the syringe includes a saline flush solution.

[0053] According to one embodiment of the present invention, the fluid contained within the barrel of the syringe includes a therapeutic agent.

[0054] According to one embodiment of the present invention, the cartridge contains from about 1 mL to about 50 mL of fluid.

[0055] According to one embodiment of the present invention, removing the tip cap from the distal tip of the cartridge includes pressing the release tab to disengage the release tab from the cartridge, and once the release tab is disengaged, continuing to apply an axial force to the release tab to overcome the frictional engagement between the connector of the tip cap and the distal tip of the cartridge.

[0056] According to one embodiment of the present invention, the tip cap is manually removed from the cartridge with one hand.

[0057] According to one embodiment of the present invention, before attaching the syringe to the VAD, the plunger is advanced slightly through the cartridge to remove air from the interior of the cartridge.

[0058] According to one embodiment of the present invention, attaching the syringe cartridge to the VAD includes inserting the distal tip of the syringe cartridge through the septum of the fluid port of the VAD and twisting the syringe such that the threads of the syringe engage the corresponding threads of the female connector of the VAD.

[0059] According to one embodiment of the present invention, the distal tip of the cartridge includes a male Luer connector, and the male Luer connector is attached to the female Luer connector of the VAD by inserting the male Luer connector into the female Luer connector.

[0060] According to one embodiment of the present invention, it includes: attaching a collar to the distal shield of the syringe cartridge; attaching the distal loop of a tether to the tip cap; and moving the connector of the tip cap onto the distal tip of the cartridge, thereby forming an assembled syringe.

[0061] According to one embodiment of the present invention, attaching the collar to the distal shield includes sliding the collar onto the distal shield such that the collar is held on the distal shield by frictional engagement.

[0062] According to one embodiment of the present invention, the tether includes a proximal loop, a distal loop, and a flexible connector extending between the proximal loop and the distal loop.

[0063] According to one embodiment of the present invention, it includes sliding the proximal loop of the tether onto the distal shield of the syringe cartridge.

[0064] According to one embodiment of the present invention, moving the connector of the tip cap onto the distal tip of the syringe barrel causes the release tab to form an interference engagement with the collar. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1A A front view of a tip cap mounted to a syringe, according to one aspect of the present disclosure.

[0066] Figure 1B The Figure 1A exploded view of the tip cap and syringe.

[0067] Figure 2A The Figure 1A cross-sectional view of the tip cap for a syringe to be installed onto

[0068] Figure 2B According to one aspect of the present disclosure, a cross-sectional view showing the tip cap partially removed from Figure 1A a syringe.

[0069] Figure 2C According to one aspect of the present disclosure, a cross-sectional view of the tip cap removed from Figure 1A a syringe.

[0070] Figures 3A to 3C The Figure 1A cross-sectional view of the tip cap and syringe, showing the steps of assembling a syringe according to aspects of the present disclosure.

[0071] Figure 4A According to one aspect of the present disclosure, a Figure 1A front view of the tip cap.

[0072] Figure 4B According to one aspect of the present disclosure, a Figure 1A perspective view of the tip cap.

[0073] Figure 5 A flowchart showing the steps of flushing or fluid delivery using a prefilled syringe and tip cap according to one aspect of the present disclosure.

[0074] Figure 6 A flowchart showing the steps for assembling a syringe and tip cap according to one aspect of the present disclosure. Detailed Description

[0075] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for implementing the invention. However, various modifications, equivalents, variations, and alternatives will be apparent to a person skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the invention.

[0076] For the purposes of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and derivatives thereof shall relate to the orientation of the present invention in the drawings. As used herein, the term "proximal" refers to the part or end of a device, such as a syringe or catheter, that is grasped, manipulated or used by a physician or another user. The term "distal" refers to the end or part of the device that is furthest from the part of the device that is grasped, manipulated or used by the physician. For example, the "proximal end" of a catheter or IV line refers to the end that includes the fluid port that is connected to a fluid container, such as an IV bag or syringe. The "distal end" of a catheter or IV line refers to the end that is connected to the patient. However, it should be understood that the present invention may take alternative variations and step sequences, unless the contrary is expressly stated. It should also be understood that the specific devices and processes illustrated in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0077] Referring to the accompanying drawings, the present disclosure relates to a syringe 10, such as a prefilled syringe, having a distal tip that is covered by a tip cap 24 and is configured to be used by a physician to deliver a medical fluid to a patient, such as through a vascular access device (VAD). The physician may be, for example, a healthcare technician, a nurse, a physician assistant, a doctor, or other trained or untrained clinician or healthcare provider. The medical fluid may be a flush solution, such as saline and / or heparin lock flush solution. An example of a saline flush solution is 0.9% sodium chloride USP for injection. An example of a heparin lock flush solution is heparin sodium at 100 USP units per milliliter or heparin sodium at 10 USP units per milliliter in 0.9% sodium chloride. Other flush solutions known in the art may also be used with the syringe 10 of the present disclosure. The medical fluid may also be a medicament, total parenteral nutrition (TPN), or another therapeutic agent for treating chronic or acute diseases. Exemplary therapeutic agents may include, for example, drugs, chemicals, biological or biochemical substances that, when delivered to a patient in a therapeutically effective amount, may achieve a desired therapeutic effect.

[0078] The syringe 10 and tip cap 24 of the present disclosure are designed to reduce the risk of contamination and ensure that the distal tip of the syringe remains sterile and uncontaminated both before and during its connection to a VAD. Additionally, the syringe 10 of the present disclosure is designed to be easy to operate and, in particular, avoids the difficulties of removing the tip cap and cap of a conventional prefilled syringe. In some particularly advantageous examples, the syringe 10 and tip cap 24 of the present disclosure can be operated by a physician with one hand. Further, the syringe 10 and tip cap 24 can be configured such that the physician only touches the proximal portion of the tip cap 24, such that the physician is less likely to touch or contaminate the distal portion of the syringe 10 when removing the tip cap 24. Specifically, ideally, the physician should be able to remove the tip cap 24 from the syringe 10 by releasing the tip cap 24 from the syringe 10 by manipulating a tab of the tip cap 24 with one hand. In contrast, for a conventional prefilled syringe, the physician may need to grasp the syringe barrel of the syringe 10 with one hand and the tip cap 24 with the other hand in order to pull the tightly fitting tip cap 24 away from the distal tip of the syringe barrel. Once the tip cap 24 is disconnected or removed, the physician can expel the medical fluid from the syringe barrel of the syringe 10 with one hand, for example, by pushing a plunger or stopper through the syringe barrel.

[0079] In some examples, the syringe 10 disclosed herein includes a tether or other flexible holder for maintaining the tip cap 24 proximate to the distal end or the syringe 10, even after the tip cap 24 is otherwise disconnected from the distal tip of the syringe 10. In particular, the tether or another flexible connector can be configured such that when the tip cap 24 is removed from the syringe 10, the tip cap 24 hangs proximate to the distal end of the syringe 10 from the tether or another connector. Securing the tip cap 24 to the syringe 10 by a tether ensures that the tip cap 24 does not become a hazard or an impediment to the physician using the syringe 10 in the intended manner. For example, because the tip cap 24 is connected to the syringe barrel by a tether, the tip cap 24 does not pose a choking hazard like other small, single-use, or disposable molded parts. Additionally, the tether prevents the tip cap 24 from falling off the syringe 10 and landing in an inconvenient location, such as in a healthcare facility or on a surgical site, which could occur in the absence of other caps, clips, or syringe accessories that are connected to the syringe barrel by a tether or connector.

[0080] In some examples, the top cap 24 of the present disclosure can be configured to connect to a conventional prefilled syringe, such as a prefilled syringe that includes a male needleless connector or a male luer connector at its distal end. For example, as described in further detail herein, a collar or another anchoring device can be attached to the distal end of a conventional prefilled syringe. The top cap 24 can be engaged to the distal end of the syringe via the collar or anchoring device, which secures the top cap 24 to the syringe 10. In other examples, the syringe 10 can be specifically designed, molded, or configured to be used with the top cap 24 disclosed herein. For example, the syringe can include an integrally molded collar or anchor that engages the top cap 24 for securing the top cap 24 to the syringe 10.

[0081] In some examples, the syringe 10 of the present disclosure can be provided as a prefilled syringe, covered by the top cap 24, and containing a flush solution or other medical fluid. The prefilled syringe 10 can also include a clip, a holder, and / or other packaging to hold the plunger rod in place and ensure that the flush solution or another medical fluid does not leak from the prefilled syringe 10 at an unexpected time, such as during transportation.

[0082] Prefilled Syringe and Top Cap

[0083] Reference Figures 1A to 3C , in some examples, the syringe 10 of the present disclosure includes a barrel 12, the barrel 12 can include a proximal end 14, a distal end 16, and a side wall 20 extending between the proximal end 14 and the distal end 16, the distal end 16 includes a distal tip 18, the distal tip 18 defines a passage 28 for discharging a fluid such as a medical fluid F (shown in Figures 2A to 2C ) from inside the barrel 12. For example, the passage 28 can extend from the inside of the barrel 12 through the distal tip 18 to a distal opening 30. The syringe 10 can also include a plunger 22 positioned within the barrel 12 (shown in Figure 1A and Figure 1B ) for discharging the medical fluid F (shown in Figures 2A to 2C ) from the barrel 12 through the passage 28 of the distal tip 18.

[0084] The syringe 10 further includes a top cap 24, the top cap 24 is removably connected to the distal end 16 of the barrel 12 for sealing the medical fluid F within the barrel 12 and / or for restricting the flow of fluid from the passage 28 of the barrel 12. The top cap 24 can include: a connector 26 configured to receive the distal tip 18 of the barrel 12 and form a friction engagement with the distal tip 18; a cap shield 32 connected to the connector 26 and extending around the connector 26; and a release tab 54 extending proximally from the cap shield 32, the release tab 54 securing the top cap 24 to the barrel 12.

[0085] As used herein, "frictional engagement" can refer to a connection between a first portion of a surface, such as an inner surface of a connector 26 like tip cap 24, and a second portion of a surface, such as an outer surface of a distal tip 18. To form a frictional engagement, these surfaces are in face-to-face contact such that friction prevents or restricts these surfaces from sliding away from each other. Thus, these surfaces can be without protrusions, grooves, ridges, ribs, stops, or other locking structures necessary to form other types of engagement between the first and second portions. Additionally, mechanical fasteners or adhesives may not be required to secure the first portion to the second portion. Instead, the friction between the surfaces is sufficient to restrict movement of the first portion relative to the second portion. The frictional engagement can be overcome by applying sufficient force to the first and / or second portions such that the surfaces slide away from each other against the frictional force between the two surfaces.

[0086] In some examples, the tip cap 24 is configured to be manually removable, meaning that a physician can grasp a portion of the tip cap 24 and manipulate the portion of the tip cap 24 to manually remove the tip cap 24 from the barrel 12. Additionally, the tip cap 24 can be configured for single-handed operation. In particular, a physician desirably can remove the tip cap 24 from the barrel 12 with one hand and move the plunger 22 through the barrel to expel a medical fluid F from the barrel 12 through a passage 28 of the distal tip 18. The tip cap 24 also includes a cap shield 32 that extends around the connector 26. The cap shield 32 can be an annular or tubular structure having a proximal end 60 connected to the proximal end of the connector 26 and a distal end 62 that closes or encloses the open distal end of the connector 26.

[0087] Continuing to refer to Figures 1A to 3C , in some examples, the distal tip 18 of the barrel 12 can be an elongate and / or tubular member that defines a passage 28 and extends from a tapered portion 34 of the barrel 12 to a distal opening 30 of the distal tip 18. In some examples, the distal tip 18 can be a frustoconical member or structure sized to be adapted to form a frictional or sliding-type engagement with an inner surface 56 of the connector 26 of the tip cap 24. In some examples, the distal tip 18 can be a male needleless connector or a male Luer connector configured to be inserted into the connector 26 and also inserted into a female needleless connector of a fluid port or opening, such as a VAD.

[0088] As used herein, a "Luer connector" refers to a connector including a tapered portion (i.e., a Luer taper) for forming a friction fit between a distal tip 18 and a tapered cavity such as that of a female Luer connector, the tapered cavity being configured to receive and engage the distal tip 18. Thus, the distal tip 18 of the present disclosure may be a tapered elongate structure where the outer diameter of the proximal end of the distal tip 18 is wider than the outer diameter of the distal end of the distal tip 18. Similarly, the inner diameter of the proximal end of the connector 26 may be wider than the inner diameter of the distal end of the connector 26 such that the tapered distal tip 18 may be received within the connector 26.

[0089] As previously described, the distal tip 18 of the barrel 12 may be configured to be directly or indirectly connected to a female connector that forms a fluid port, valve, or another terminal passage portion of the VAD. In particular, a common type of fluid port of the VAD is a pierceable diaphragm or a pre-slit diaphragm made of rubber or another elastomeric material. The diaphragm may be pierced or opened by a blunt elongate member or a frusto-conical tip such as the distal tip 18 of the barrel 12 to provide fluid communication between the interior of the barrel 12 and the VAD for infusing fluid into or withdrawing fluid from a catheter of the VAD. More specifically, in some examples, the distal tip 18 may be configured to be used with a female needleless connector, specifically, with a female Luer connector within the size range permitted by various design protocols such as ISO 80369-7:2016 or ISO 80369-7:2021 (female Luer lock connector dimensions).

[0090] In some examples, the barrel 12 of the syringe 10 may be a conventional fluid delivery syringe barrel for medical procedures, such as made by an injection molding process. For example, as is known in the art, the barrel 12 may be substantially similar or identical in shape, size, and construction to the barrel of a syringe for administering a flush solution to a VAD. In some examples, as is known in the art, the barrel 12 may be a cylindrical or oval prism structure formed from a rigid thermoplastic material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, acrylonitrile butadiene styrene, or other injectable or formable resin materials. An exemplary barrel 12 for a flush syringe is described, for example, in U.S. Patent Application No. 2020 / 0061297, titled "Flush Syringe Assembly with Controlled Pulsatile Flushing", the entire content of which is incorporated herein by reference in its entirety. The size of the syringe barrel 12 may be determined based on the type of fluid injection being performed. For example, the barrel 12 may define an interior containing from about 1 mL to about 50 mL of medical fluid F or preferably from about 5 mL to 20 mL of medical fluid F.

[0091] In some examples, the sidewall 20 of the barrel 12 includes a tapered portion 34 near the distal end 16 of the barrel 12 (shown in Figures 2A to 2C . The tapered portion 34 may be located between the distal tip 18 of the barrel 12 and other portions of the sidewall 20 of the barrel 12. The tapered portion 34 may be configured to direct fluid in the barrel 12 toward the passage 28 of the distal tip 18 for discharging the medical fluid F in the barrel 12 through the distal opening 30 of the distal tip 18. In some examples, the tapered portion 34 may be shaped to reduce dead space having an inclined or angled surface corresponding to the distal surface of the stopper or plunger 22 that moves through the interior of the barrel 12 to ensure fluid movement through the barrel 12 to the passage 28. Reducing or eliminating the dead space between the stopper or plunger 22 and the distal end 16 of the barrel 12 helps ensure that an appropriate or desired amount of fluid is discharged from the barrel 12. In some examples, the barrel 12 also includes a finger flange 36 or a gripper. The finger flange 36 may extend around the proximal end 14 of the barrel 12 for gripping the barrel 12 and the plunger 22 to move the plunger 22 through the barrel 12.

[0092] The barrel 12 may also include a distal shield 74 on the distal end 16 of the barrel 12. The distal shield 74 may be a tubular structure that at least partially encloses the distal tip 18 of the barrel 12. The distal shield 74 of the barrel 12 may include a proximal end 76 connected to the syringe barrel 12, an open distal end 78, and a sidewall 80 extending between the proximal end 76 and the distal end 78 of the distal shield 74. Additionally, the distal shield 74 of the barrel 12 may include an inner surface 84 that includes threads 86 for connecting the barrel 12 to a female luer connector. In some examples, the threads 86 of the distal shield 74 may be configured to mate with the threads of the female connector, with a width at the crest of each thread of about 0.3 mm to about 1.0 mm and a width at the root of the threads of about 0.5 mm to about 1.2 mm. The distal tip 18 or end of the syringe barrel 12 may extend distally beyond the open distal end 78 of the distal shield 74 such that the distal tip 18 may be inserted through an opening in the female connector or a cover or diaphragm over a fluid port.

[0093] In some examples, syringe 10 further includes a collar 64 that surrounds the distal shield 74 of barrel 12. For example, collar 64 can be engaged by frictionally engaging the outer surface of the distal shield 74 of barrel 12. As described in further detail herein, the release tab 54 of tip cap 24 can include a latch 112 that removably engages collar 64 for securing tip cap 24 to barrel 12. In some examples, collar 64 can be a ring formed of a rigid plastic or a flexible elastomeric material that slides over the distal shield 74 of barrel 12. As previously described, collar 64 can be configured to be used with a conventional prefilled syringe having a conventional distal tip 18 and distal shield 74. In such a case, collar 64 can be a plastic or elastomeric ring that slides onto the distal shield 74 during the assembly of syringe 10 such that tip cap 24 can be engaged to syringe barrel 12. In other examples, barrel 12 can be specifically molded to be used with tip cap 24 of the present disclosure. For example, collar 64 or the ring can be a protrusion, such as a ridge or rib, that is integrally formed with and extends radially outward from other portions of the distal shield 74. In such a case, tip cap 24 can be engaged to the integral collar 64 or ring for securing tip cap 24 to barrel 12.

[0094] In some examples, syringe 10 further includes a tether 68 that connects barrel 12 to tip cap 24. Tether 68 can be configured to allow tip cap 24 to hang from barrel 12 when the connector 26 of tip cap 24 is not connected to the distal tip 18 of barrel 12. Instead, tip cap 24 can freely hang from barrel 12 at a short distance from distal tip 18. Desirably, portions of tether 68 are flexible, stretchable, and / or bendable such that tip cap 24 can be easily moved away from distal tip 18 and not become an obstacle during the use of syringe 10. In particular, when attempting to insert the distal tip 18 of syringe 10 into a fluid port or female connector of a VAD to perform a medical procedure, a physician should be able to move tether 68 and tip cap 54 away from the distal tip 18 of syringe 10.

[0095] In some examples, the tether 68 includes a proximal loop 70 connected around the distal shield 74 of the barrel 12, a distal loop 72 connected around the cap shield 32 of the tip cap 24, and a connecting member 88 extending between the proximal loop 70 and the distal loop 72. The connecting member 88 can be a flexible, bendable, and / or stretchable member such that when the syringe 10 is in use, the tip cap 24 can be moved out of the way. In some examples, the proximal loop 70, the distal loop 72, and the connecting member 88 can be integrally formed as a single molded component. For example, the proximal loop 70, the distal loop 72, and the connecting member 88 of the tether 68 can be molded together from an elastomeric material such as isoprene or silicone. In other examples, the connecting member 88 can be a separate component, such as an elastomeric section, wire, or cord, connected to the proximal loop 70 and the distal loop 72 by fasteners, connectors, or adhesives.

[0096] Referring again to Figure 1A and Figure 1B , the syringe 10 also includes a plunger 22 configured to move through the interior of the syringe barrel 12 for drawing a medical fluid F into the interior of the syringe barrel 12 (if the syringe 10 is not a pre-filled syringe 10) and / or for expelling the medical fluid F from the barrel 12 through the passage 28. In particular, the syringe 10 is desirably capable of being operated with one hand, both for removing the tip cap 24 from the distal tip 18 of the barrel 12 and for expelling the medical fluid F from the barrel 12 through the passage 28 of the barrel 12 by moving the plunger 22 through the barrel 12.

[0097] In some examples, the plunger 22 includes a stopper 38 and a plunger rod 40. The plunger rod 40 is connected to the stopper 38, extends from the stopper 38, and passes through the proximal end 14 of the barrel 12. The stopper 38 can have many of the characteristics of a conventional syringe stopper or plunger known in the art. For example, the stopper 38 can include a thermoplastic elastomeric material such as polypropylene or polyethylene and a synthetic or natural rubber (e.g., isoprene). Additionally, the stopper 38 can include a proximal surface 42 or end, a distal surface 44 or end, and an outer peripheral surface 46 extending between the proximal surface 42 and the distal surface 44. The outer peripheral surface 46 can be configured to seal against the inner surface of the sidewall 20 of the barrel 12 for moving the medical fluid F through the barrel 12. In some examples, the distal end or surface 44 of the stopper 38 can be tapered, having a slope or angle that matches the tapered portion 34 of the sidewall 20 of the barrel 12, as previously described.

[0098] The plunger 22 further includes a plunger rod 40 connected to the stopper 38. The plunger rod 40 can be, for example, an injection molded part formed of a rigid thermoplastic material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or another thermoplastic material. The plunger rod 40 can include a distal end 48 joined to the stopper 38. For example, the distal end 48 of the plunger rod 40 can include a connector that is inserted into a corresponding cavity or groove on the proximal surface 42 of the stopper 38. The plunger rod 40 can also include a proximal end 50 that projects proximally through the proximal end 14 of the barrel 12 and a body that extends between the proximal end 50 and the distal end 48 of the plunger rod 40. The proximal end 50 of the plunger rod 40 can include a thumb press plate 52 for manipulating the plunger rod 40 to move the plunger rod 40 and the stopper 38 through the syringe barrel 12. Within the scope of the present disclosure, the body of the plunger rod 40 can have a variety of cross-sectional shapes and configurations. For example, the body can have a generally cross-shaped cross-section. In other examples, the cross-section of the plunger rod 40 can be an I-beam shape, a hollow circle, a hollow square, a hollow rectangle, or an L-shape.

[0099] Reference Figures 2A to 2C and Figure 4A and Figure 4B , the syringe 10 further includes a tip cap 24 connected to the distal end 16 of the barrel 12. The tip cap 24 can be a single molded part, such as a part formed by injection molding. In other examples, the tip cap 24 can be formed of multiple parts joined together by conventional assembly techniques, such as by ultrasonic welding. The tip cap 24 can be made of a thermoplastic material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, acrylonitrile butadiene styrene, or other injectable or formable resin materials known in the art.

[0100] As previously described, the tip cap 24 includes: a connector 26 configured to receive the distal tip 18 of the barrel 12 and form a friction engagement with the distal tip 18; a cap shield 32 connected to the connector 26 and extending around the connector 26; and a release tab 54 extending proximally from the cap shield 32 to secure the tip cap 24 to the barrel 12.

[0101] As previously described, the connector 26 is sized to receive the distal tip 18 of the syringe barrel 12. For example, the connector 26 can define a frustoconical cavity sized to receive the distal tip 18 of the barrel 12. More specifically, in some examples, the connector 26 of the tip cap 24 can be formed as a female non-needle connector or a female Luer connector sized to receive the distal tip 18 of the barrel 12. Additionally, as previously described, the connector 26 can be tapered such that the inner diameter of the proximal portion of the connector 26 is wider than the inner diameter of the distal portion of the connector 26.

[0102] Unlike some conventional syringe caps, the tip cap 24 of the present disclosure does not engage the threads 86 on the inner surface 84 of the distal shield 74 of the barrel 12. Instead, the tip cap 24 is connected to the distal end 16 of the barrel 12 by a combination of frictional engagement between the distal tip 18 of the barrel 12 and the connector 26 of the tip cap 24 and interference engagement between the latch 112 of the release tab 54 and the collar 64 of the barrel 12. Thus, unlike other cap examples, the outer surface of the connector 26 of the tip cap 24 may not include threads.

[0103] In some examples, the cap shield 32 of the tip cap 24 includes a proximal end 60, an open distal end 62, and a sidewall 66 extending between the proximal end 60 and the distal end 62, the proximal end 60 including a flange that is connected to and extends radially from the connector 26 of the tip cap 24. The sidewall 66 of the cap shield 32 may also include a plurality of axial protrusions 96 extending outwardly from the outer surface of the cap shield 32, such as ribs, ridges, or stops. Protrusions 96, such as axial ridges, may increase the rigidity of the cap shield 32, ensuring that the cap shield 32 does not bend or deform during use. The tip cap 24 may also include a rod 98 extending distally from the distal end of the connector 26, and the rod 98 is at least partially enclosed by the cap shield 32 of the tip cap 24.

[0104] Reference Figures 2A to 2C 、 Figure 4A and Figure 4B As previously described, the release tab 54 of the tip cap 24 is configured to provide another attachment point between the tip cap 24 and the barrel 12 to enhance or secure the frictional engagement between the connector 26 of the tip cap 24 and the distal tip 18 of the barrel 12. As previously described, the release tab 54 is configured for single-handed release, meaning that the physician does not need to hold the syringe 10 with one hand and pull the tip cap 24 off the syringe 10 with the other hand. Additionally, the release tab 54 is positioned proximal to other portions of the tip cap 24 and / or proximal to the distal opening 30 of the syringe barrel 12, meaning that when the release tab 54 is used to remove the tip cap 24, it is unlikely that the physician will touch and contaminate the distal opening 30 and / or distal tip 18 of the syringe barrel 12, which can occur in the case of conventional syringes and caps.

[0105] In some examples, the release tab 54 includes a proximal end 110 that includes a latch 112 for engaging with a collar 64 by interference or snap-fit engagement. As used herein, the latch 112 can refer to a locking structure such as a hook, groove, curved surface, opening, snap-fit connector, or similar structure or portion for engaging a distal tip 18 and / or a portion of the barrel 12. In particular, the latch 112 can be configured to grip and / or press against the collar 64 to prevent or limit axial movement of the tip cap 24 relative to the barrel 12 until the latch 112 disengages from the collar 64. The release tab 54 also includes a distal end 114 and a beam 116 extending between the proximal end 110 and the distal end 114, and the distal end 114 is pivotally connected to a cap shield 32 of the tip cap 24 at a pivot point. The beam 116 is configured to move about the pivot point, as shown by the arrow A1 in Figure 2A from an engaged position (such as shown in Figure 2A ) to a disengaged position, which releases the latch 112 from the collar 64. In some examples, the beam 116 can include a movable hinge or biasing member biased to the engaged position. In such examples, the beam 116 snaps the latch 112 toward the collar 64 to secure the tip cap 24 to the barrel 12. To release the release tab 54 from the barrel 12, the physician applies sufficient force to the beam 116 to overcome the biasing force of the beam 116 or the hinge, which causes the beam 116 to pivot about the pivot point, thereby moving the latch 112 away from the collar 64.

[0106] In some examples, the proximal end 110 of the release tab 54 includes a push surface 118 or a push plate that is positioned transverse or substantially transverse to the longitudinal axis X1 of the connector 26 (shown in Figures 2A to 2C ) and the longitudinal axis X1 of the cap shield 32 of the tip cap 24. As used herein, a surface is transverse or orthogonal to an axis when a line passing through the surface is at a 90-degree angle to the axis. A surface is "substantially transverse" to an axis when it is within 10% of being transverse (e.g., at an angle of about 81 degrees to about 99 degrees relative to the axis X1).

[0107] The push surface 118 or the push plate can be a flat member sized to be suitable for a physician to press against, for example, with one finger, one thumb, or two fingers. In some examples, as shown in Figure 4B , the push surface 118 can include a protrusion 120 protruding on the push surface 118 to make the push surface 118 easier to press against and / or prevent the physician's finger(s) or thumb from slipping off the push surface 118 when attempting to release the release tab 54 from the barrel 12. The push surface 118 can be configured such that pressing on the push surface (in Figure 2AIn the direction of arrow F1) causes the beam 116 to pivot about the distal end 114 of the release tab 54, which disengages the latch 112 from the barrel 12. Once the release tab 54 is released, continue to apply an axial force to the tip cap 24 by pressing against the push surface 118. When the applied axial force overcomes the frictional engagement between the connector 26 of the tip cap 24 and the distal tip 18 of the barrel 12, the tip cap 24 slides off the distal tip 18 of the barrel 12 in the direction of arrow A2 (in Figure 2B ), which releases the tip cap 24 from the barrel 12. Once the physician stops applying force to the push surface 118, the release tab 54 moves back to the biased position, as shown by arrow A3 (in Figure 2B ).

[0108] Method for discharging fluid from a syringe with a tip cap

[0109] In Figure 5 shows a flow chart that illustrates the steps of discharging fluid to a VAD using the syringe 10. As Figure 5 shown, at step 210, the physician first obtains a prefilled syringe 10, where the interior of the syringe barrel 12 is filled with a predetermined volume of medical fluid F. For example, the prefilled syringe 10 may contain from about 1 mL to about 50 mL, or, preferably, from about 5 mL to about 20 mL of medical fluid F. The tip cap 24 of the prefilled syringe 10 is initially attached to the distal tip 18 of the barrel 12 to ensure that the medical fluid F remains inside the barrel 12, preventing contamination and / or leakage of the fluid. In this initial or prefilled position, the stopper 38 is positioned near the proximal end 14 of the barrel 12, and the plunger rod 40 extends proximally from the stopper 38 and through the proximal end 14 of the barrel 12.

[0110] At step 212, the physician prepares the syringe 10 for use by, for example, removing any packaging from the syringe 10 and removing the plunger cap (if present) that holds the plunger rod 40 in place.

[0111] At step 214, when ready to perform a flushing or injection procedure, the physician removes the tip cap 24 from the distal tip 18 of the barrel 12. To remove the tip cap 24, the physician presses on the push surface 118 at the proximal end 110 of the release tab 54, applying a force F1 (shown in Figure 2A ). The applied force F1 causes the beam 116 to pivot about the distal end 114 of the release tab 54, causing the latch 112 to disengage from the collar 64. Once the latch 112 disengages from the collar 64, the physician continues to apply pressure to the push surface 118 (as shown by arrow F2 in Figure 2B ). The force F2 overcomes the frictional engagement between the distal tip 18 of the barrel 12 and the inner surface 56 of the connector 26, causing the tip cap 24 to slide off the distal tip 18, as shown by Figure 2Bas shown by arrow A2 in. Once the tip cap 24 is removed from the distal tip 18, it can hang near the distal end 16 of the barrel 12 supported by the tether 68. For example, once the tip cap 24 is removed from the distal tip 18, it can swing in a downward direction (as shown by arrow A4 in Figure 2C ), remaining near the distal end 16 of the barrel 12.

[0112] In step 216, the physician then advances the stopper 38 slightly through the barrel 12 to remove air from inside the syringe barrel 12, for example, by pressing on the thumb plate 52 of the plunger rod 40 while grasping the finger flange 36 of the barrel 12, for example, between the ring finger and the index finger. In step 218, once all the air has been removed from the inside of the syringe barrel 12, the physician next attaches the distal tip 18 of the barrel 12 to the VAD. For example, the physician can insert the distal tip 18 of the barrel 12 into the corresponding port or valve of the VAD, particularly into the port or valve of a female needleless connector or a female Luer connector.

[0113] In step 220, once the distal tip 18 is attached to the VAD, the physician can use the plunger rod 40 to move the stopper 38 in the distal direction (as shown by arrow D in Figure 1A ), through the inside of the syringe barrel 12, to discharge the medical fluid F from the syringe barrel 12 and through the passage 28 of the distal tip 18. For example, as previously described, the physician can press on the thumb press plate 52 of the plunger rod 40 with the thumb while grasping the finger flange 36 of the syringe barrel 12 to move the plunger rod 40 in the distal direction (as shown by arrow D in Figure 1A ), which causes the stopper 38 to move distally through the syringe barrel 12 to force the medical fluid F to flow out of the syringe barrel 12. The physician continues to move the stopper 38 distally through the barrel 12 until all or substantially all of the medical fluid F has been discharged from the barrel 12 through the passage 28 of the distal tip 18 into the VAD.

[0114] In step 222, after discharging the medical fluid F from the syringe barrel 12, the syringe 10 can be disconnected from the VAD, for example, by rotating the syringe 10 to release the threads 86 of the distal shield 74 from the corresponding threads of the female connector, and / or by pulling the syringe 10 away from the female connector of the VAD.

[0115] As previously described, the prefilled syringe 10 of the present disclosure can be filled with a flushing solution and used to perform an initial or pre-flush of a patient line of a VAD. In this case, after the flushing solution is discharged from the syringe 10, the syringe 10 can be disconnected from the female connector, and another syringe containing another medical fluid such as a therapeutic agent can be connected to the female connector for delivering the therapeutic agent to the patient. In other examples, the prefilled syringe 10 of the present disclosure can contain a dose of a therapeutic agent to be delivered to the patient via the VAD. In this case, the syringe 10 can be attached to the female connector after flushing to deliver the therapeutic agent to the patient. In other examples, the prefilled syringe 10 of the present disclosure can contain a flushing solution and can be used for a post-flush operation. For example, after the therapeutic agent is delivered to the patient via the VAD, the prefilled syringe 10 can be connected to the VAD. The flushing solution can be discharged from the prefilled syringe 10 through the VAD to flush any remaining therapeutic agent in the VAD to the patient, thereby ensuring that the patient receives the full dose of the therapeutic agent. The post-flush procedure can also ensure that the patient line is clean by removing any debris or other contaminants from the patient line.

[0116] Method for assembling a syringe and a tip cap

[0117] Figure 6 is a flow chart showing a method for assembling the syringe 10 and for attaching the tip cap 24 to the syringe 10. Figures 3A to 3C The syringe 10 is shown in different stages of assembly. Specifically, Figure 3A parts of the syringe 10 and the tip cap 24 before assembly are shown. Figure 3B A partially assembled syringe 10 is shown. Figure 3C A fully assembled syringe 10 is shown, with the tip cap 24 attached to the syringe 10. As previously described, the tip cap 24 can be attached to a conventional prefilled syringe including a male Luer tip or connector. In other examples, the tip cap 24 can be attached to a specially molded or manufactured syringe that includes an integral element (e.g., a protrusion, a ring, a collar, or an anchor) on the distal tip 18 of the barrel 12 for mounting the tip cap 24 to the barrel 12.

[0118] In step 310, the assembly method includes moving the collar 64 in the direction of arrow A5 (shown in Figure 3A ), so that the collar 64 slides onto the distal shield 74 of the barrel 12. As previously described, the collar 64 can be a rigid plastic ring that slides onto the distal shield 74. Due to the frictional engagement between the inner surface of the collar 64 and the outer surface of the shield 74, the collar 64 can remain in place on the shield 74.

[0119] In step 312, the method further includes moving in the direction of arrow A6 (inFigure 3A The distal loop 72 of the mobile tether 68 (shown in

[0120] In step 314, after the collar 64 and the distal loop 72 are in place, the tip cap 24 is moved toward the distal tip 18 of the barrel 12 (as shown by Figure 3B arrow A7 in Figure 3C ), causing the connector 26 of the tip cap 24 to slide into the distal shield 74 and onto the distal tip 18 of the barrel 12. As previously described, the connector 26 forms a friction engagement with the distal tip 18 for holding the tip cap 24 on the distal tip 18. Additionally, moving the tip cap 24 toward the distal tip 18 causes the release tab 54 to move toward the collar 64. Specifically, the latch 112 of the release tab 54 contacts or latches against the proximal side of the collar 64 (as shown in Figure 3B ), creating an interference engagement between the collar 64 and the latch 112, which enhances the attachment between the tip cap 24 and the barrel 12. Moving the tip cap 24 toward the barrel 12 also causes the proximal loop 70 of the tether 68 to move proximally past the collar 64 (as shown by

[0121] In Figure 3C ), the syringe 10 and the tip cap 24 are shown in an assembled configuration. As shown in Figure 3C , both the proximal loop 70 of the tether 68 and the collar 64 are positioned on the distal shield 74 of the barrel 12. Additionally, the latch 112 contacts the proximal side of the collar 64, creating an interference engagement between the release tab 54 and the collar 64. Additionally, the connector 26 of the tip cap 24 engages (i.e., by friction engagement) and is positioned on the distal tip 18 of the barrel 12, preventing contamination of the distal tip 18 and also preventing fluid contained in the barrel 12 from leaking through the distal opening 30 of the distal tip 18. Additionally, the distal loop 72 of the tether 68 is attached to the cap shield 32 at a position distal to the flange on the proximal end 60 of the cap shield 32. Once the syringe 10 is in the assembled position (as shown in Figure 3C ), it can be used as previously described and as shown in the flowchart of Figure 5 .

[0122] Although examples of the syringe 10 and method including the tip cap 24 of the present disclosure are shown in the drawings and described in detail above, other examples will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative and not restrictive. The invention described above is defined by the appended claims, and all changes that fall within the meaning and scope of the claims will be embraced within the scope of the invention.

Claims

1. A syringe, comprising: a barrel including a proximal end, a distal end, and a sidewall extending between the proximal end and the distal end, the distal end including a distal tip that defines a passageway; and a tip cap removably connected to the distal tip of the barrel to restrict fluid flow from the passageway, the tip cap including: a connector configured to receive the distal tip of the barrel and form a friction engagement with the distal tip; a cap shield connected to the connector and extending around the connector; and a release tab extending proximally from the cap shield, the release tab securing the tip cap to the barrel.

2. The syringe according to claim 1, further comprising a tether connecting the barrel to the tip cap such that when the connector of the tip cap is removed from the distal tip of the barrel, the tip cap hangs from the barrel.

3. The syringe according to claim 1, wherein The distal end of the barrel further includes a distal shield that at least partially encloses the distal tip of the barrel.

4. The syringe according to claim 3, further comprising a collar around the distal shield of the barrel, and wherein the release tab includes a latch removably engageable with the collar.

5. The syringe according to claim 4, wherein the collar engages around an outer surface of the distal shield of the barrel.

6. The syringe according to claim 3, further comprising a tether connecting the barrel to the tip cap such that when the connector of the tip cap is removed from the distal tip of the barrel, the tip cap hangs from the barrel, and wherein the tether includes a proximal loop, a distal loop, and a connecting member extending between the proximal loop and the distal loop, the proximal loop positioned around the distal shield of the barrel and the distal loop connected around the cap shield of the tip cap.

7. The syringe according to claim 6, wherein, The proximal loop, the distal loop, and the connecting member of the tether comprise a flexible elastomeric material.

8. The syringe according to claim 1, wherein, The connector of the tip cap defines a frustoconical cavity sized to receive the distal tip of the barrel.

9. The syringe according to claim 1, wherein, The connector of the tip cap includes a female Luer connector sized to receive the distal tip of the barrel.

10. The syringe according to claim 1, wherein, The outer surface of the connector of the tip cap does not include threads.

11. The system according to claim 1, wherein, The cap shield of the tip cap includes a proximal end, an open distal end, and a sidewall extending between the proximal end and the distal end, the proximal end including a flange connected to the connector of the tip cap and extending radially therefrom.

12. The syringe according to claim 11, wherein, The sidewall of the cap shield includes a plurality of axial ridges extending outwardly from an outer surface of the cap shield.

13. The syringe according to claim 1, wherein, The tip cap further includes a rod extending distally from a distal end of the connector and enclosed by the cap shield of the tip cap.

14. The syringe according to claim 1, wherein, The release tab includes a proximal end, a distal end, and a beam extending between the proximal end and the distal end. The proximal end includes a latch for engaging the barrel, and the distal end is pivotally connected to the cap shield of the tip cap.

15. The syringe according to claim 14, wherein, The proximal end of the release tab further includes a push surface that is transverse or substantially transverse to the longitudinal axis of the connector of the tip cap and the longitudinal axis of the cap shield of the tip cap.

16. The syringe according to claim 15, wherein, Pressing on the push surface causes the beam to pivot about the distal end of the release tab, which releases the latch from the barrel. Continuing to press against the push surface overcomes the frictional engagement between the connector of the tip cap and the distal tip of the barrel, which disconnects the tip cap from the distal tip of the barrel.

17. The syringe according to claim 1, wherein, The tip cap is a one-piece molded component and includes at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

18. A prefilled flush syringe, comprising: The syringe according to claim 1; And A predetermined volume of fluid disposed within the barrel of the prefilled syringe, Wherein the distal tip of the barrel is received within the connector of the tip cap, thereby preventing the fluid within the barrel from reaching the distal opening of the barrel through the channel, and Wherein the release tab of the tip cap engages a portion of the barrel, thereby securing the tip cap to the barrel.

19. A method for discharging fluid from the syringe according to claim 1, the method comprising: Removing the tip cap from the distal tip of the syringe barrel; Attaching the distal tip of the syringe barrel to a vascular access device; And Moving a plunger inserted into the barrel through the barrel to discharge the fluid from the barrel and through the channel of the distal tip of the barrel to the vascular access device.

20. A method for assembling the syringe according to claim 1, the method comprising: Attaching a collar to the distal shield of the syringe barrel; Attaching the distal loop of the tether to the tip cap; And Moving the connector of the tip cap onto the distal tip of the barrel, thereby forming an assembled syringe.

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