A syringe integrated with a cap that can be easily opened

Abstract

The syringe includes a barrel having a proximal end, a distal end including a distal opening, and a sidewall extending between the proximal end and the distal end. The syringe further includes a plunger disposed within the barrel for discharging fluid from the barrel through the distal opening, and a cap connected to the distal end of the barrel including a connector that defines a flow path through the cap. The cap is movable relative to the barrel between a first position that prevents fluid flow to the flow path of the connector through the distal opening of the barrel and a second position that allows fluid flow to the flow path of the connector through the distal opening of the barrel.

Description

Technical Field

[0001] The present disclosure generally relates to syringes, such as medicament-filled syringes, and more particularly to syringes having an integrated cap that can be easily opened by a user, preferably using one hand.

Background Art

[0002] This application claims priority to Indian Patent Application No. 202211035495, filed on June 21, 2022, entitled "Syringe with an Integrated Cap that can be Easily Opened", the entire disclosure of which is hereby incorporated by reference in its entirety.

[0003] Conventional syringes include a barrel having a proximal end opposite the open distal end. The distal end, sometimes referred to as a luer, projects from the distal end of the syringe barrel and includes a narrow passage or channel that is in fluid communication with the interior of the syringe barrel. These conventional syringes are often pre-filled with a medical fluid, such as a flush solution or a therapeutic agent, during manufacture. When pre-filled with a medical fluid, the syringe barrel can be sealed to prevent contamination of the medical fluid and loss of the medical fluid prior to use. Sealing also prevents healthcare workers from being unnecessarily exposed to the medical fluid within the syringe barrel, which can be particularly important in the case of toxic or other harmful agents.

[0004] Some medicated syringes are fitted at the distal end of the syringe barrel with a stopper or closure, often referred to as a tip cap, to seal the syringe barrel and prevent leakage and contamination of the medical fluid contained therein. Prior art tip caps are removed from the distal end of the syringe barrel by a healthcare worker grasping the tip cap and pulling axially away from the syringe immediately prior to use of the syringe. When covering a medicated syringe with a tip cap, it is particularly important to maintain a good seal. This is usually achieved by firmly securing the tip cap to the distal end of the syringe barrel. However, if tightened too much, the tip cap can be difficult to remove and can be damaged. Further, medicated syringes can be autoclaved after filling and capping and can be contained within a sterile package. Autoclaving can cause an interaction between the tip cap and the syringe barrel, further increasing the difficulty of removing the tip cap from the distal end of the syringe barrel.

[0005] Due to the tight connection between the tip cap and the distal end of the syringe barrel, a healthcare worker may need to apply a significant amount of gripping force to remove the tip cap from the distal end of the syringe barrel. Grasping the tip cap firmly can be difficult for healthcare workers lacking the physical strength and dexterity required to correctly grasp the tip cap, especially considering the small size of a typical tip cap. Further, when firmly gripping the tip cap, the healthcare worker's finger is in close proximity to the distal end of the syringe barrel. Thus, there is a risk of contact with the distal end of the barrel when the healthcare worker removes the tip cap, which can contaminate the distal end of the syringe barrel.

[0006] When the tip cap is removed, which is done immediately before the procedure is carried out, the luer tip at one end of the syringe barrel is exposed to a non-sterile environment, creating an additional opportunity for unwanted contamination. Further, in some cases, a healthcare provider may remove the tip cap to perform preparatory work (such as flushing air from the syringe barrel), and then reattach the same tip cap to the distal end of the syringe before performing the fluid delivery procedure. The reattachment of the tip cap presents another opportunity for the distal end of the syringe barrel to become contaminated.

[0007] Medication-filled syringes are often connected to a vascular access device (VAD), such as an intravenous (IV) catheter (e.g., a peripheral catheter or a central venous catheter), and used to deliver fluid to a patient. If not properly maintained, or if exposed to a non-sterile environment that can occur when a healthcare provider manipulates or removes the tip cap from the syringe barrel as described above, the VAD can become contaminated, occluded with a thrombus, and / or an infection can spread. In many healthcare facilities, sterilization procedures and protocols are implemented to avoid contamination and ensure that the VAD is properly used, sealed, or not infected. These protocols often include sterilizing medical devices that include the VAD and flushing the catheter with a flush solution. Specifically, the implementation criteria for VADs typically recommend performing a flush procedure before and after catheter placement, before infusion, before medication administration, before blood sampling, before blood transfusion, and / or before parenteral nutrition administration. These flush procedures are aimed at verifying the patency of the catheter, avoiding drug incompatibilities, delivering the full dose of medication to the patient, preventing thrombus formation, and minimizing the risk of bloodstream infection due to VAD contamination.

[0008] Sterilization procedures carried out in healthcare facilities do address a certain level of contamination risk, but there is a need for improved designs of medical devices and tools that reduce the opportunity for contamination and simplify the use of the devices. In particular, a syringe design that ensures that the distal end of the syringe barrel remains sterile and uncontaminated throughout the fluid delivery procedure using a VAD addresses many of the current contamination problems that occur during the injection procedure. Furthermore, syringe and cap designs that are easy to open and remove and can be operated without touching the distal end of the syringe reduce the contamination risks common to conventional pre-filled syringes. The syringe and integrated cap designs of the present disclosure address these problems.

Prior Art Documents

Patent Documents

[0009]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0010] According to one aspect of the present disclosure, a syringe includes a barrel having a proximal end, a distal end including a distal opening, and a sidewall extending between the proximal end and the distal end. The syringe further includes a plunger disposed in the barrel for discharging fluid from the barrel through the distal opening, and a cap connected to the distal end of the barrel including a connector defining a flow path through the cap. The cap is movable relative to the barrel between a first position in which fluid flow through the flow path of the connector through the distal opening of the barrel is blocked and a second position in which fluid flow through the flow path of the connector through the distal opening of the barrel occurs.

[0011] According to another aspect of the present disclosure, a medicament-filled flushing syringe includes the aforementioned syringe and a predetermined amount of fluid disposed within the barrel of the medicament-filled syringe. The cap of the aforementioned syringe is initially in a first position, thereby preventing the fluid within the barrel from passing from the open distal end of the barrel into the flow path of the connector.

[0012] According to another aspect of the present disclosure, a method of discharging fluid from the aforementioned syringe includes moving the cap of the aforementioned syringe from a first position to a second position such that fluid flow from the barrel into the flow path of the connector is enabled, attaching the connector of the cap to a vascular access device, and moving the plunger through the barrel to discharge the fluid from the barrel through the flow path of the connector to the vascular access device.

[0013] Here, non-limiting exemplary embodiments of the embodiments of the present disclosure will be described in the following numbered paragraphs.

[0014] Paragraph 1: A syringe comprising a barrel including a proximal end, a distal end including a distal opening, and a sidewall extending between the proximal end and the distal end, a plunger disposed in the barrel for discharging fluid from the barrel through the distal opening, and a cap connected to the distal end of the barrel including a connector defining a flow path through the cap, wherein the cap is movable relative to the barrel between a first position that prevents fluid flow from the distal opening of the barrel into the flow path of the connector and a second position that allows fluid flow from the distal opening of the barrel into the flow path of the connector. Syringe.

[0015] Paragraph 2: The syringe according to Paragraph 1, wherein the cap rotates relative to the barrel to move from the first position to the second position.

[0016] Item 3: The syringe according to item 1 or 2, wherein the cap rotates about the longitudinal axis of the barrel and moves from the first position to the second position.

[0017] Item 4: The syringe according to any one of items 1 to 3, wherein the cap is configured to be manually moved from the first position to the second position.

[0018] Item 5: The syringe according to item 4, wherein the syringe can perform both operations of discharging fluid from the barrel through the flow path of the connector by moving the cap from the first position to the second position and moving the plunger through the barrel with one hand.

[0019] Item 6: The syringe according to any one of items 1 to 5, wherein the barrel contains at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0020] Item 7: The syringe according to any one of items 1 to 6, wherein the barrel includes an annular flange around the proximal end of the barrel for gripping the barrel and the plunger and moving the plunger through the barrel.

[0021] Item 8: The syringe according to any one of items 1 to 7, wherein the plunger includes a stopper disposed in the barrel and a plunger rod extending proximally from the stopper through the proximal end of the barrel.

[0022] Item 9: The syringe according to item 8, wherein the stopper contains a thermoplastic elastomer such as isoprene.

[0023] Item 10: The syringe according to item 8 or 9, wherein the stopper includes a proximal end, a distal end, and an outer surface extending between the proximal end and the distal end that seals the inner surface of the barrel.

[0024] Item 11: The syringe according to any one of Items 8 to 10, wherein the plunger rod includes a connector portion that is inserted into and engaged with a cavity of the stopper for fixing the stopper to the plunger rod.

[0025] Item 12: The syringe according to any one of Items 1 to 11, wherein the connector of the cap includes at least one of a luer connector, a screw connector, or a snap connector.

[0026] Item 13: The syringe according to any one of Items 1 to 12, wherein the connector is tapered such that an outer diameter of a proximal end of the connector is wider than an outer diameter of a distal end of the connector.

[0027] Item 14: The syringe according to any one of Items 1 to 13, further including at least one seal between the distal opening of the barrel and the cap, and the at least one seal includes at least one hole for fluid flow from the barrel to a flow path of the connector.

[0028] Item 15: The syringe according to Item 14, wherein the at least one hole of the at least one seal is offset from a longitudinal axis of the syringe and is not in line with the distal opening of the barrel.

[0029] Item 16: The syringe according to Item 14 or 15, wherein the at least one hole of the at least one seal is smaller than the distal opening of the barrel.

[0030] Item 17: The syringe according to any one of Items 14 to 16, wherein the at least one seal includes at least two holes each offset from a longitudinal axis of the syringe.

[0031] Item 18: The syringe according to any one of Items 14 to 17, wherein the at least one seal includes a disk formed of a thermoplastic elastomer including the at least two holes that is spaced from a longitudinal axis of the barrel and is not in line with the distal opening of the barrel.

[0032] Item 19: The syringe according to item 18, wherein the disk includes a proximal ridge extending from a proximal surface of the disk disposed in a corresponding groove at the distal end of the barrel, and a distal ridge extending from a distal end of the disk disposed in a corresponding groove at the proximal end of the cap.

[0033] Item 20: The syringe according to any one of items 1 to 19, wherein the at least one seal includes a proximal fixed seal disposed between the distal end of the barrel and the proximal end of the cap, and a distal rotatable seal disposed within a proximal opening of the cap.

[0034] Item 21: The syringe according to item 20, wherein the distal seal rotates with the cap, and the proximal seal remains fixed even when the cap moves between the first position and the second position.

[0035] Item 22: Each of the proximal seal and the distal seal includes at least one hole offset from a longitudinal axis of the syringe and not in line with the distal opening of the barrel, and when the cap is in the second position, the at least one hole of the distal seal is in line with the at least one hole of the proximal seal, and fluid from the barrel passes through the holes of the proximal seal and the distal seal and flows into the flow path of the connector. The syringe according to item 20 or 21.

[0036] Item 23: The syringe according to any one of items 1 to 22, wherein the cap further includes a shield extending around the connector, and the shield includes an inner surface having threads configured to engage threads of a female connector to fix the syringe and the cap to the female connector.

[0037] Item 24: The syringe according to item 23, wherein a distal end of the connector projects beyond the shield.

[0038] Item 25: The barrel further includes an extension portion extending distally from the distal end of the barrel, and the cap is connected to the extension portion and at least partially surrounded by the extension portion, the syringe according to item 23 or 24.

[0039] Item 26: The extension portion includes a proximal end extending from the distal end of the barrel, an open distal end, and an annular side wall extending between the proximal end and the distal end, the syringe according to item 25.

[0040] Item 27: The cap includes a locking ring configured to engage with the cap to keep the cap fitted to the proximal end of the extension portion, the syringe according to item 26.

[0041] Item 28: The side wall of the barrel includes a tapered portion between the distal end of the barrel and the other portion of the barrel to guide the fluid in the barrel toward the distal opening of the barrel, the syringe according to any one of items 25 to 27.

[0042] Item 29: The cap includes at least one tab extending radially outward from the shield to rotate the cap relative to the barrel, the syringe according to any one of items 25 to 28.

[0043] Item 30: The extension portion includes at least one slot, and the at least one tab of the cap extends through the slot, and the at least one tab can be gripped by a user to rotate the cap relative to the barrel, the syringe according to item 29.

[0044] Item 31: The at least one slot extending from the distal end of the extension portion includes an axial portion for inserting the cap into the extension portion and a circumferential portion for rotating the cap relative to the barrel between the first position and the second position, the syringe according to item 30.

[0045] Item 32: The syringe according to any one of items 25 to 31, wherein the extension further includes a protrusion on an inner surface thereof to limit rotation of a seal disposed over the distal opening of the barrel.

[0046] Item 33: The syringe according to item 32, wherein the protrusion includes an axially extending ridge, rib, or pillar on the inner surface of the extension.

[0047] Item 34: The syringe according to any one of items 1 to 33, wherein a direction of rotation for connecting the syringe to a female connector is opposite to a direction of rotation for moving the cap from the first position to the second position.

[0048] Item 35: A pre-filled flushing syringe comprising the syringe according to any one of claims 1 to 34 and a predetermined amount of fluid disposed within a barrel of a pre-filled syringe, wherein the cap is initially in a first position, thereby preventing the fluid within the barrel from passing from the open distal end of the barrel into the flow path of the connector.

[0049] Item 36: The pre-filled syringe according to item 35, wherein the fluid includes a saline flush solution.

[0050] Item 37: The pre-filled syringe according to item 35 or 36, wherein the fluid includes a therapeutic agent.

[0051] Item 38: The pre-filled syringe according to any one of items 35 to 37, wherein the barrel contains from about 1 mL to about 50 mL of fluid.

[0052] Item 39: A method of discharging fluid from a syringe according to any one of claims 1 to 34, the method comprising moving the cap from a first position to a second position so that fluid can flow from the barrel into the flow path of the connector, attaching the connector of the cap to a vascular access device, and moving the plunger through the barrel to discharge the fluid from the barrel through the flow path of the connector to the vascular access device.

[0053] Item 40: The method according to item 39, wherein the fluid contained in the barrel of the syringe comprises a physiological saline flush solution.

[0054] Item 41: The method according to item 39 or 40, wherein the fluid contained in the barrel of the syringe comprises a therapeutic agent.

[0055] Item 42: The method according to item 40 or 41, wherein the barrel contains from about 1 mL to about 50 mL of fluid.

[0056] Item 43: The method according to any one of items 39 to 42, wherein the cap is manually moved from the first position to the second position by gripping a part of the cap and rotating the cap with respect to the longitudinal axis of the syringe.

[0057] Item 44: The method according to item 43, wherein the cap is manually moved from the first position to the second position by gripping a part of the cap with one hand.

[0058] Item 45: The method according to any one of items 39 to 44, further comprising advancing the plunger slightly through the barrel before attaching the syringe to the VAD to remove air from the interior of the barrel.

[0059] Item 46: Attaching the cap to the VAD includes inserting the distal end of the connector through a septum of the flow path of the VAD and screwing the syringe such that the threads of the syringe engage corresponding threads of a female connector of the VAD, the method according to any one of items 39 to 45.

[0060] Item 47: The cap is moved from the first position to the second position by rotating the cap relative to the barrel in a first direction, and the cap is attached to the VAD by rotating the syringe in a second direction opposite to the first direction, the method according to item 46.

[0061] Item 48: The connector includes a male Luer connector, and the cap is attached to the female Luer connector of the VAD by inserting the male Luer connector into a female Luer connector, the method according to any one of items 39 to 47.

Brief Description of the Drawings

[0062]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 4C

Figure 5A

Figure 5B

Figure 5C

Figure 5D

Figure 6

DETAILED DESCRIPTION OF THE INVENTION

[0063] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of the invention.

[0064] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the drawings. As used herein, the term "proximal" refers to a part or end of a device, such as a syringe or catheter, that is grasped, manipulated, or used by a medical practitioner or other user. The term "distal" refers to the end or part of a device that is furthest from the part or end of the device that is grasped, manipulated, or used by a medical practitioner. For example, the "proximal end" of a catheter or IV line refers to the end that includes a fluid port 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 a patient. However, it should be understood that the present invention may contemplate alternative variations and step sequences unless explicitly specified to the contrary. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0065] Referring to the figures, the present disclosure is directed to a syringe 10, such as a medicament-filled syringe, configured to be used by a healthcare provider to deliver a medical fluid to a patient, for example, through a vascular access device (VAD). The healthcare provider can be, for example, a medical technician, a nurse, a physician's assistant, a physician, or other trained or untrained clinician, caregiver. The medical fluid can be a flush solution such as saline and / or a 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 0.9% sodium chloride containing 100 USP units of heparin sodium per mL, or 10 USP units of heparin sodium per mL. Other flush solutions known in the art can be used with the syringe 10 of the present disclosure. The medical liquid can also be a medicament used in the treatment of chronic or acute diseases, a total parenteral nutrition (TPN) solution, or another therapeutic agent, as is known in the art. Exemplary therapeutic agents can include, for example, agents, chemicals, biological substances, or biochemical substances that, when delivered to a patient in a therapeutically effective amount, result in a desired therapeutic effect.

[0066] As described above, the syringe 10 of the present disclosure is intended to reduce risks and ensure that the distal end of the syringe barrel is sterilized and free of contamination before and during connection to a VAD. Further, the syringe 10 of the present disclosure is designed to be easy to operate, and in particular, is designed to avoid the difficulty of removing the tip cap of a conventional pre-filled syringe. In some particularly advantageous examples, the syringe 10 of the present disclosure can be operated by a healthcare provider with one hand. Specifically, as will be described in more detail herein, a healthcare provider can open and close the syringe cap with one hand, for example, by pressing, sliding, pulling, or otherwise manipulating the tab of the syringe cap. In contrast, as described above, in the case of a conventional pre-filled syringe, a healthcare provider has to hold the syringe barrel with one hand and grasp the tip cap with the other hand to pull the tightly-fitting tip cap away from the distal end of the syringe barrel. When the syringe cap is opened, a healthcare provider can discharge the medical fluid from the syringe barrel of the syringe 10 with one hand, for example, by pushing the plunger or stopper into the syringe barrel.

[0067] In some examples, the syringe 10 of the present disclosure can be provided as a pre-filled syringe containing a flush solution or other medical fluid. The pre-filled syringe 10 can also include a cap, clip, retainer, and / or other packaging for holding the plunger rod in place and preventing the flush solution or other medical fluid from leaking out of the pre-filled syringe 10 during unexpected times such as during transportation.

[0068] Syringe with integrated cap Referring to FIGS. 1A and 1B, in some examples, the syringe 10 of the present disclosure includes a barrel 12 including a proximal end 14, a distal end 16 including a distal opening 18 (most clearly shown in FIG. 2C), and a side wall 20 extending between the proximal end 14 and the distal end 16. The syringe 10 further includes a plunger 22 disposed in the barrel 12 for discharging a medical fluid F (shown in FIGS. 5B and 5D) from the barrel 12 through the distal opening 18. The syringe 10 further includes a cap 24, valve, cover, sealing device or similar structure connected to the distal end 16 of the barrel 12 to seal the medical fluid F within the barrel 12 and direct the flow of fluid from the interior of the barrel 12 to discharge the medical fluid F from the barrel 12. In some examples, the cap 24 includes a connector 26 or stem extending distally from the distal end of the barrel 12. The connector 26 can be an elongate and / or tubular member defining a flow passage or channel 28 extending from the proximal end 30 of the cap 24 to the distal end 32 of the connector 26. As will be described in more detail herein, the connector 26 can be a male non-needle connector configured to be inserted into a female non-needle connector such as a fluid port or an opening of a VAD. For example, the cap 24 can be configured to be used with a female non-needle connector such as a female luer connector within a range of dimensions permitted by various design protocols such as ISO80369-7:2016 or ISO80369-7:2021 (female luer lock connector dimensions). In some specific examples, the cap 24 can be sized to engage a female non-needle connector having a width at the peak of each thread of about 0.3 mm to about 1.0 mm and a width at the root of the thread of about 0.5 mm to about 1.2 mm.

[0069] Connector 26 is inserted into the female connector, and fluid communication is established between the VAD and the interior of barrel 12 through cap 24. Further, cap 24 is movable relative to barrel 12 between a closed, i.e., a first position (shown in FIGS. 5A and 5B), where fluid flow through the flow path of connector 26 through distal opening 18 of barrel 12 is prevented, and an open, i.e., a second position (shown in FIGS. 5C and 5D), where fluid flow to the VAD through distal opening 18 of barrel 12 and the flow path 28 of connector 26 occurs. For example, cap 24 can be configured to twist or rotate, such as rotate about the longitudinal axis L1 of barrel 12 and syringe 10 (shown in FIGS. 1A and 5A - 5D), whereby cap 24 is moved from the closed position (shown in FIGS. 5A and 5B) to the open position (shown in FIGS. 5C and 5D).

[0070] In some examples, cap 24 is configured to be manually movable, which means that a healthcare provider can grasp a portion of cap 24 and rotate, twist, slide, or otherwise move cap 24 from the closed position to the open position. Further, as described above, cap 24 can be configured to be operable with one hand. In particular, it is desirable that a healthcare provider can move cap 24 from the closed position to the open position using one hand and simultaneously discharge medical fluid F from barrel 12 through the flow path of connector 26 by moving plunger 22 through barrel 12.

[0071] Continuing to refer to FIGS. 1A and 1B, as well as FIGS. 2A-2C, barrel 12 can be a conventional fluid delivery syringe barrel used in medical procedures, for example, manufactured by an injection molding process. For example, barrel 12 can have a shape, size, and configuration substantially similar to that of a syringe barrel used to administer a flush solution to a VAD, as is known in the art. In some examples, barrel 12 can be a cylindrical or oval columnar structure formed from a rigid thermoplastic material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, acrylonitrile butadiene styrene, or other injection molding or moldable resin materials known in the art. An exemplary barrel 12 of a flush syringe is described, for example, in Patent Document 1 titled "Flush Syringe Assembly with Controlled Pulsatile Flushing," the entire disclosure of which is incorporated herein by reference. The dimensions of syringe barrel 12 can be determined based on the type of fluid injection being performed. In particular, barrel 12 can be configured to contain various fluid volumes depending on the fluid delivery procedure being performed. For example, barrel 12 can define an interior that contains from about 1 mL to about 50 mL of medical fluid, or from about 5 mL to about 20 mL of medical fluid.

[0072] In some examples, the sidewall 20 of the barrel 12 includes a tapered portion 34 (shown in FIGS. 2B and 2C) near the distal end 16 of the barrel 12. For example, the tapered portion 34 can be disposed between the distal end 16 of the barrel 12 and other portions of the sidewall 20 of the barrel 12. The tapered portion 34 can be configured to direct fluid within the barrel 12 toward the distal opening 18 of the barrel 12 for discharging the medical fluid within the barrel 12 through the distal opening 18 toward the fluid passage or flow path 28 of the connector 26. The tapered portion 34 can be formed to reduce a dead space having an inclined or angled surface corresponding to the distal surface of the stopper or plunger, thereby ensuring that fluid moves through the interior of the barrel 12 and that fluid moves through the barrel 12 toward the distal opening 18. 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 further includes a finger flange 36 or grip. For example, as shown in FIGS. 1A and 1B, the finger flange 36 can 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.

[0073] Continuing to refer to FIGS. 1A and 1B, syringe 10 further includes a plunger 22 configured to move through the interior of syringe barrel 12 to aspirate a medical fluid into the interior of syringe barrel 12 (when syringe 10 is not a pre-filled syringe) and / or to discharge fluid F from barrel 12 through the fluid passage or flow path 28 of connector 26. Plunger 22 may include a stopper 38 and a plunger rod 40 connected to and extending from stopper 38 and passing through the proximal end 14 of barrel 12. Stopper 38 may have many of the features of conventional syringe stoppers or plungers known in the art. For example, stopper 38 may include a thermoplastic elastomeric material such as polypropylene or polyethylene, and synthetic or natural rubber (such as isoprene). Further, stopper 38 may include a proximal face 42 or proximal end, a distal face 44 or distal end, and an outer peripheral surface 46 extending between proximal face 42 and distal face 44. Outer peripheral surface 46 may be configured to seal against the inner surface of side wall 20 of barrel 12 to move medical fluid F through barrel 12. In some examples, the distal end or distal face 44 of stopper 38 may be tapered to have an inclination or angle that matches the tapered portion 34 of side wall 20 of barrel 12, as described above.

[0074] The plunger 22 also includes a plunger rod 40 connected to the stopper 38. The plunger rod 40 can be an injection molded part formed from a rigid thermoplastic such as, for example, polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or another thermoplastic known in the art. The plunger rod 40 includes a distal end 48 that engages the stopper 38. For example, the distal end 48 of the plunger rod 40 can include a connector (not shown) that is inserted into a corresponding cavity or slot on the proximal face 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 that operates the plunger rod 40 to move the plunger rod 40 and the stopper 38 through the syringe barrel 12. The body of the plunger rod 40 can have various cross-sectional shapes and structures within the scope of the present disclosure. 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.

[0075] In some examples, syringe 10 further includes a seal or seal (referred to herein as the first or proximal seal 54 and most clearly shown in FIG. 3A) to seal the distal opening 18 of barrel 12 and ensure that fluid passing through the distal opening 18 of barrel 12 passes securely through the flow passage or flow path 28 of connector 26. The proximal seal 54 can be disposed between the distal opening 18 of barrel 12 and cap 24. In some examples, the proximal seal 54 includes a substantially flat sheet or disk of a fluid-impermeable material such as silicone, rubber, isoprene, or similar flexible elastomer that seals the distal end 16 and distal opening 18 of barrel 12. The proximal seal 54 can include one or more through-holes 56, openings, or fluid ports for the flow of fluid from barrel 12 to flow path 28 of connector 26. For example, as shown in FIG. 3A, the proximal seal 54 includes two holes 56. The holes 56 of the proximal seal 54 can be offset from the longitudinal axis L1 of syringe 10 (shown in FIGS. 1A and 5A-5D) and may not be in line with the distal opening 18 of barrel 12, which means that the distal opening 18 of barrel 12 and the holes 56 of the proximal seal 54 are not coaxially centered. Further, for example, as shown in FIG. 3A, the holes 56 of the proximal seal 54 may be smaller than the distal opening 18 of barrel 12 (e.g., smaller in diameter and / or area). The arrangement of the distal opening 18 of barrel 12 and holes 56 causes the flow of fluid from barrel 12 through holes 56 to flow path 28 to follow a somewhat curved path, as indicated by arrow A2 in FIGS. 5C and 5D.

[0076] In some examples, the proximal seal 54 includes a structure for maintaining the position of the proximal seal 54 over the distal opening 18 of the barrel 12. For example, the proximal seal 54 can include a proximal ridge 58 or O-ring extending from a proximal face 60 of the proximal seal 54 disposed in a corresponding groove 62 at the distal end 16 of the barrel 12, and a distal ridge 64 extending from a distal face 66 of the proximal seal 54 disposed in a corresponding groove 68 at the proximal end 30 of the cap 24. The proximal ridge 58 or O-ring surrounds the distal opening 18 and forms a seal around the opening 18. The seal formed by the proximal ridge 58 or O-ring helps prevent fluid from pooling under the proximal seal 54 and ensures that fluid passing through the distal opening 18 moves into the flow path 28 of the connector 26.

[0077] Referring to FIGS. 1A and 1B, and FIGS. 4A and 4B, syringe 10 further includes a cap 24 connected to the distal end 16 of barrel 12. For example, as will be described in more detail herein, barrel 12 may include a locking structure such as a slot, groove, notch, protrusion, ridge, or similar structure to provide a mechanical engagement between cap 24 and barrel 12, thereby securing cap 24 to barrel 12 near the distal opening 18 of barrel 12. Cap 24 includes a stem or connector 26 that defines a fluid passageway or flow path 28, through which fluid can flow from barrel 12 through connector 26. As described above, in some examples, connector 26 of cap 24 includes a male Luer connector. In other examples, connector 26 can be a male threaded connector, snap connector, elongate tube, or similar connector as known in the art. As used herein, a "Luer connector" refers to a connector that includes a taper (i.e., a Luer taper) to create a frictional engagement between connector 26 and a tapered cavity such as the cavity of a female Luer connector configured to receive and engage male connector 26. Thus, connector 26 of the present disclosure can be a tapered elongate structure where the outer diameter of the proximal end of connector 26 is wider than the outer diameter of the distal end 32 of connector 26. Connector 26 can be directly or indirectly connected to a female connector that forms a fluid port, valve, or other terminal access portion of the VAD. In particular, a common type of fluid port of the VAD is a pierceable septum or pre-slit septum made of rubber or another elastomeric material. The septum can be pierced or opened by a blunt elongate member or a pyramidal tip such as the distal end 32 of connector 26 to provide fluid communication between the interior of barrel 12 and the VAD for injecting fluid into or withdrawing fluid from the VAD catheter.

[0078] In some examples, the cap 24 further includes a separate seal (referred to herein as the distal seal 70) inserted into the proximal end or proximal opening 30 of the cap 24. Similar to the proximal seal 54, the distal seal 70 includes a flat sheet or disk having a diameter that matches the inner diameter of the cap 24. The distal seal 70 includes an opening or through-hole 72 that may be similar in shape and position to the hole 56 of the proximal seal 54. As shown in FIGS. 5A - 5D, the distal seal 70 is disposed immediately distal to the proximal seal 54 and may in some cases be in face - to - face contact with the proximal seal 54. As described in more detail herein, the proximal seal 54 is generally a fixed seal 54 that does not move or rotate as the cap 24 moves from the closed position to the open position. In contrast, the distal seal 70 inserted into the proximal opening 30 of the cap 24 is configured to rotate with the cap 24 such that the distal seal 70 moves from the closed position to the open position.

[0079] Both the proximal seal 54 and the distal seal 70 include holes 56, 72 to allow fluid flow from the barrel 12 to the connector 26. For example, as shown in FIGS. 3A and 4C, the proximal seal 54 and the distal seal 70 may each include two similarly sized through - holes 56, 72. The through - holes 56, 72 are each offset from the longitudinal axis L1 of the syringe 10 and are not in line with the distal opening 18 of the barrel 12. Further, when the cap 24 is in the closed position, as shown in FIGS. 5A and 5B, the hole 56 of the proximal seal 54 is not in line with the hole 72 of the distal seal 70. When the cap 24 is in the open position (shown in FIGS. 5C and 5D), the hole 56 of the proximal seal 54 and the hole 72 of the distal seal 70 are axially aligned and fluid from the barrel 12 flows through the holes 56, 72 of the proximal seal 54 and the distal seal 70 and into the flow path 28 of the connector 26.

[0080] In some examples, the cap 24 further includes a shield 74 that extends around the connector 26. The shield 74 can be an annular or tubular structure having a proximal end connected to the proximal end of the connector 26 and an open distal end 76 that surrounds or encircles the connector 26. The shield 74 includes an inner surface that includes threads 78 configured to engage the threads of the female connector to secure the syringe 10 and the cap 24 to the female connector. For example, the female connector can be a female non-needle connector such as a female luer connector, a threaded connector, or a snap connector known in the art. As described above, the threads 78 of the shield 74 can be configured to mate with a female connector thread having a width at the top of each thread of from about 0.3 mm to about 1.0 mm and a width at the root of the thread of from about 0.5 mm to about 1.2 mm

[0081] The distal end 32 or end of the connector 26 can extend distally beyond the open distal end 76 of the shield 74 such that the distal end or tip 32 of the connector 26 can be inserted through a cover or septum over an opening or fluid port of the female connector. In some examples, the cap 24 can be configured to rotate in a first direction to move from a closed position to an open position. The threads 78 on the inner surface of the shield 74 can be arranged such that the cap 24 and the syringe 10 rotate in an opposite or second direction to secure the cap 24 and the syringe 10 to the female connector and to discharge fluid from the syringe 10 to the VAD.

[0082] Continuing to refer to FIGS. 1A and 1B, as well as FIGS. 2A-2C, barrel 12 further includes a structure for securing cap 24 over distal opening 18 of barrel 12, allowing fluid to flow through distal opening 18 into flow passage or channel 28 of connector 26. For example, barrel 12 may include an extension 80 that extends distally from distal end 16 of barrel 12. As shown in FIGS. 1A and 1B, cap 24 is connected to and at least partially surrounded by extension 80. Extension 80 may be an annular or tubular structure that includes a proximal end 82 extending from distal end 16 of barrel 12, an open distal end 84, and an annular sidewall 86 extending between proximal end 82 and distal end 84. In some examples, cap 24 may be inserted or press-fit into extension 80 through open distal end 84 of extension 80. Extension 80 may be integrally formed with other portions of barrel 12 or may be a separate component that is connected to other portions of barrel 12 by an adhesive, ultrasonic welding, or other suitable connection process, as known in the art.

[0083] In some examples, the extension 80 includes one or more slots 88 or openings that penetrate the sidewall 86 of the extension 80. The cap 24 can include one or more tabs 90 that radially extend outward from the shield 74 through the slots 88 of the extension 80, thereby allowing the cap 24 to be rotated relative to the barrel 12. For example, as shown in FIG. 4A, the cap 24 includes two tabs 90. Each tab 90 includes a beam portion 92 configured to penetrate one of the slots 88 of the extension 80 and a grip or handle 94 that can be manipulated by a healthcare provider to move the cap 24 from a closed position to an open position. In some examples, the handle 94 can include a surface that includes ridges, protrusions, and similar structures to make it easier to grasp and manipulate the tab 88. In particular, the tabs 90 can be configured such that a healthcare provider can grasp the tabs 90 with the thumb and index finger and rotate the cap 24 between a closed position and an open position. For example, when a healthcare provider grasps or presses on the tab 90 to slide the tab 90 into the slot 88, the cap 24 rotates from a closed position to an open position, and fluid can flow from the barrel 12 of the syringe 10 through the cap 24.

[0084] In some examples, the slot 88 can include an axial portion or segment that axially extends through the sidewall 86 from the distal end 84 of the extension 80. The axial portion or segment allows the tab 90 to be inserted into the extension 80 with the tab 90 protruding from the slot 88. The slot 88 can also include a circumferential portion or segment for rotating the cap 24 between a closed position and an open position relative to the barrel 12.

[0085] Referring specifically to FIG. 2C, the inner surface of the extension 80 may include a structure for fixing the proximal seal 54 fitted to the proximal end 82 of the extension 80 in a predetermined position. For example, as shown in FIG. 2C, the extension 80 may include protrusions such as axially extending ridges 96, ribs, pillars, or similar structures on the inner surface of the extension 80 to limit the rotation of the proximal seal 54 disposed on the distal opening 18 of the barrel 12. As shown in FIG. 3A, the proximal seal 54 may include notches 55, slots, or grooves arranged to receive the ridges 96 on the inner surface of the extension 80. By the engagement of the ridge 96 and the notch 55 of the proximal seal 54, the position of the proximal seal 54 is maintained, and in particular, the proximal seal 54 is prevented from rotating when the cap 24 rotates between the closed position and the open position.

[0086] As shown in FIG. 2C, the extension 80 may also include raised circumferential protrusions such as a protruding ridge or a locking ring 98. The locking ring 98 may be arranged to ensure that the cap 24 and the proximal seal 54 remain fitted to the distal end 16 of the barrel 12, and prevent the cap 24 and the proximal seal 54 from being lifted from the distal opening 18 of the barrel 12 when the cap 24 rotates between the closed position and the open position. For example, the cap 24 may include a proximal protrusion 75 that radially extends outward from the outer surface of the shield 74. When the cap 24 is inserted into the extension 80, the protrusion 75 deflects away from the locking ring 98, and the cap 24 can move through the extension 80. When the cap 24 is fully received in the extension 80, the protrusion 75 snaps into place and locks into engagement with the locking ring 98, fixing the cap 24 to the proximal end 82 of the extension 80.

[0087] As described above, the distal end 16 of the barrel 12 may also include an annular groove 62 (shown in FIG. 2C) that receives a ridge 58 or an O-ring extending from the proximal face 60 of the proximal seal 54, and this ridge 58 or O-ring also contributes to maintaining the position of the proximal seal 54 within the extension 80 of the barrel 12. As described above, the ridge 58 or O-ring also seals the distal opening 18 and prevents fluid from accumulating between the distal end 16 of the barrel 12 and the proximal seal 54.

[0088] Method for discharging fluid from a syringe with an integrated cap A flowchart showing the steps for discharging fluid into a VAD using the syringe 10 is shown in FIG. 6. As shown in FIG. 6, at step 110, the healthcare provider first obtains a drug-filled syringe 10 with a predetermined amount of medical fluid F filled inside the syringe barrel. For example, the drug-filled syringe 10 may contain from about 1 mL to about 50 mL, or from about 5 mL to 20 mL of medical fluid. The cap 24 of the drug-filled syringe 10 is initially in a first position, i.e., a closed position, where the medical fluid F remains inside the barrel 12 to prevent fluid contamination and / or fluid leakage. In this initial, i.e., filled position, the stopper 38 is disposed near the proximal end 14 of the barrel 12, and the plunger rod 40 extends proximally from the stopper 38 and passes through the proximal end 14 of the barrel 12.

[0089] At step 112, the healthcare provider prepares the syringe 10 for use, for example, by removing the packaging from the syringe 10 and removing the plunger cap (if present) that holds the plunger rod 40 in place. In the initial position, the cap 24 is in the closed position, i.e., fluid cannot pass through the connector 26. Instead, as indicated by the arrow A1 in FIGS. 5A and 5B, since the hole 72 of the distal seal 70 is not aligned with the hole 56 of the proximal seal 54, the distal seal 70 blocks fluid from passing through the flow path 28 of the connector 26.

[0090] In step 114, when ready to perform the flushing or injection procedure, the healthcare provider moves the cap 24 to the open position. For example, the healthcare provider grasps one or more of the tabs 90 of the cap 24 with the thumb and index finger, as shown in A3 (of FIG. 1A), and slides the tab 90 through the slot 88 of the extension 80, which rotates the cap 24 from the closed position to the open position. Moving the cap 24 to the open position establishes fluid communication between the interior of the syringe barrel 12 and the fluid passage or flow path 28 of the connector 26, whereby the medical fluid F can be discharged from the syringe 10.

[0091] In step 116, the healthcare provider then advances the stopper 38 slightly through the barrel 12, for example, by pressing the thumb plate 52 of the plunger rod 40 while pinching the finger flange 36 of the barrel 12 with the ring finger and index finger, to remove air from the interior of the syringe barrel 12. In step 118, when air has been removed from the interior of the syringe barrel 12, the healthcare provider then attaches the connector 26 of the cap 24 to the VAD. For example, the healthcare provider may insert the distal end or tip 32 of the connector 26 into the corresponding port or valve of the VAD, particularly the port or valve of a female needleless connector. As the syringe 10 is moved distally to press the connector 26 into the septum of the female connector, the healthcare provider may also rotate the syringe 10 and the integrated cap 24 in the direction A4 (shown in FIG. 1A) such that the threads 78 on the inner surface of the shield 74 engage the corresponding threads of the female connector to secure the syringe 10 and the integrated cap 24 to the female connector. As described above, the direction of rotation (indicated by arrow A4 in FIG. 1A) for securing the shield 74 of the cap 24 to the female connector may be opposite to the direction of rotation (indicated by arrow A3 in FIG. 1A) for moving the cap 24 from the closed position to the open position.

[0092] In step 120, with the cap 24 in the open position and attached to the VAD, a healthcare provider can use the plunger rod 40 to move the stopper 38 distally (as indicated by arrow D in FIG. 1A) through the interior of the syringe barrel 12 to discharge the medical fluid F from the syringe barrel 12 through the flow passage or channel 28 of the connector 26. For example, as described above, the healthcare provider grasps the finger flange 36 of the syringe barrel 12 and presses the thumb press plate 52 of the plunger rod 40 with the thumb to move the plunger rod 40 distally (as indicated by arrow D in FIG. 1A), whereby the stopper 38 moves distally through the syringe barrel 12 and, as indicated by arrow A2 (shown in FIGS. 5C and 5D), the medical fluid F can be pushed out of the syringe barrel 12. The healthcare provider 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 flow passage or channel 28 of the connector 26 to the VAD.

[0093] In step 122, after the fluid F has been discharged from the syringe barrel 12 through the connector 26, the syringe 10 can be removed from the VAD by rotating the syringe 10 in the A3 direction (shown in FIG. 1A) to disengage the threads 78 of the shield 74 from the corresponding threads of the female connector.

[0094] As described above, the medicament-filled syringe 10 of the present disclosure is filled with a flush solution and can be used to perform a primary flush or pre-flush of a patient line of a VAD. In this case, after the flush solution is discharged from the syringe 10, the syringe 10 can be removed from the female connector, and another syringe containing another medical fluid such as a therapeutic agent can be connected to the female connector to provide the therapeutic agent to the patient. In other examples, the medicament-filled syringe 10 of the present disclosure can contain a dosage of a therapeutic agent to be delivered to a patient through a VAD. In this case, it is possible to attach the syringe 10 to the female connector after flushing to provide the therapeutic agent to the patient. In other examples, the medicament-filled syringe 10 of the present disclosure contains a flush solution and can be used for a post-flush operation. For example, after a therapeutic agent has been delivered to a patient through a VAD, it is possible to connect the medicament-filled syringe 10 to the VAD. The flush solution can be discharged from the medicament-filled syringe 10 through the connector 26 and the VAD to flush the therapeutic agent remaining in the VAD to ensure that the entire dosage of the therapeutic agent is provided to the patient. The post-flush procedure can also ensure that the patient line is clean by removing debris or other contaminants from the patient line.

[0095] Examples of the syringe 10 with the integrated cap 24 and the method of the present disclosure are shown in the accompanying drawings and described in detail above, but other examples will be apparent to those skilled in the art and can be readily implemented without departing from the scope and spirit of the invention. Accordingly, the above description is intended to be illustrative rather than limiting. The invention described above is defined by the appended claims, and all changes to the invention within the meaning and equivalent scope of the claims are included within its scope.

Claims

1. A barrel including a proximal end, a distal end including a distal opening, and a side wall extending between the proximal end and the distal end; A plunger disposed in the barrel for discharging fluid from the barrel through the distal opening; A cap connected to the distal end of the barrel, the cap including a connector defining a flow path therethrough; A syringe comprising: The cap is movable relative to the barrel between a first position in which fluid flow through the flow path of the connector through the distal opening of the barrel is prevented and a second position in which fluid flow through the flow path of the connector through the distal opening of the barrel occurs. Syringe.

2. The cap rotates relative to the barrel about the longitudinal axis of the barrel to move from the first position to the second position. The syringe according to claim 1.

3. The cap is configured to be manually moved from the first position to the second position. The syringe according to claim 1.

4. The syringe can perform both operations of moving the cap from the first position to the second position and discharging fluid from the barrel through the flow path of the connector by moving the plunger through the barrel with one hand. The syringe according to claim 3.

5. The plunger includes a stopper disposed in the barrel and a plunger rod extending proximally from the stopper through the proximal end of the barrel. The syringe according to claim 1.

6. The connector of the cap includes at least one of a luer connector, a screw connector, or a snap connector. The syringe according to claim 1.

7. The syringe further includes at least one seal disposed between the distal opening of the barrel and the cap, the at least one seal including at least one hole for fluid flow from the barrel to the flow path of the connector. The syringe according to claim 1.

8. Each of the at least one seal includes at least two holes offset from the longitudinal axis of the syringe. The syringe according to claim 7.

9. The at least one seal includes a disk formed from a thermoplastic elastomer including at least two holes spaced from the longitudinal axis of the barrel and not in line with the distal opening of the barrel. The syringe according to claim 7.

10. The disk includes a proximal ridge extending from a proximal face of the disk disposed in a corresponding groove at the distal end of the barrel, and a distal ridge extending from a distal end of the disk disposed in a corresponding groove at the proximal end of the cap. The syringe according to claim 9.

11. The at least one seal includes a proximal fixed seal disposed between the distal end of the barrel and the proximal end of the cap, and a distal rotatable seal disposed within the proximal opening of the cap. The syringe according to claim 7.

12. Each of the proximal seal and the distal seal is offset from the longitudinal axis of the syringe and includes at least one hole not in line with the distal opening of the barrel. When the cap is in a second position, the at least one hole of the distal seal is in line with the at least one hole of the proximal seal, and fluid from the barrel flows through the holes of the proximal seal and the distal seal to the flow path of the connector. The syringe according to claim 11.

13. The cap further includes a shield extending around the connector, the shield including an inner surface including threads configured to engage threads of a female connector to secure the syringe and the cap to the female connector. The syringe according to claim 1.

14. The barrel further includes an extension extending distally from the distal end of the barrel, the cap being connected to and at least partially surrounded by the extension. The syringe according to claim 13.

15. The extension includes a proximal end extending from the distal end of the barrel, an open distal end, and an annular sidewall extending between the proximal end and the distal end. The cap includes a locking ring configured to engage the cap to keep the cap fitted to the proximal end of the extension. The syringe according to claim 14.

16. The cap includes at least one tab extending radially outward from the shield for rotating the cap relative to the barrel. The extension portion includes at least one slot, the at least one tab of the cap extends through the slot, and the at least one tab can be gripped by a user to rotate the cap relative to the barrel. The syringe according to claim 14.

17. The extension portion further includes a protrusion on an inner surface of the extension portion to limit rotation of a seal disposed over the distal opening of the barrel. The protrusion includes an axially extending ridge, rib, or pillar on the inner surface of the extension portion. The syringe according to claim 14.

18. The direction of rotation for connecting the syringe to the female connector is opposite to the direction of rotation for moving the cap from the first position to the second position. The syringe according to claim 1.

19. A medicament-filled flushing syringe, the syringe according to claim 1, a predetermined amount of fluid disposed within the barrel of the medicament-filled syringe, comprising wherein the cap is initially in a first position, thereby preventing fluid within the barrel from passing from the open distal end of the barrel into the flow path of the connector. A medicament-filled flushing syringe.

20. A method of discharging fluid from the syringe according to claim 1, the method comprising: moving the cap from a first position to a second position to enable flow of fluid from the barrel into the flow path of the connector; attaching the connector of the cap to a vascular access device; moving the plunger through the barrel to discharge the fluid from the barrel through the flow path of the connector into the vascular access device. A method comprising.

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