Shielded Tip Irrigation Syringe

Abstract

To provide a flush syringe providing a physical barrier around a syringe tip promoting aseptic practice by decreasing or removing "contact" contamination of the tip of the syringe.SOLUTION: A flush syringe assembly may include: a barrel (20) including a side wall (21), an open proximal end (23) and a distal end (24), a distal wall (25), and an elongate tip (26); a collar which is provided with a side wall (31), a plurality of grooves arranged in an inner surface of an open distal end (34) of the collar, an open distal end (34), and a proximal end (35), with an inner diameter and an outer diameter of the open distal end larger than an inner diameter and an outer diameter of the proximal end, respectively; and a plunger rod provided with a stopper.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present disclosure relates generally to syringe assemblies, and more particularly to syringe assemblies with a physical barrier that prevents contact of the syringe tip with the surrounding non-sterile environment. Embodiments of the present disclosure ensure aseptic technique for use in vascular access device (VAD) cleaning procedures. Embodiments of the present disclosure also relate to techniques for reducing the risk of bloodstream infections (CRBSIs) and maintaining intravenous (IV) tubing patency with capping techniques, particularly syringe assemblies used in cleaning procedures. [Background technology]

[0002] Vascular access devices (VADs) are commonly used for therapeutic devices, including peripheral and central venous catheters. If not properly maintained or exposed to a non-sterile environment, VADs can become contaminated, seal with blood clots, or spread infection. To ensure proper use and prevent VADs from becoming contaminated, sealed, or infected, protocols have been developed to ensure aseptic practices. These protocols include sterilizing the VAD and flushing the catheter with a flushing solution. Catheters are flushed using syringe assemblies filled with various fluids. In some cases, different fluids are injected sequentially according to the protocol. For example, saline is followed by an anticoagulant such as heparin. The size of the syringe used to flush intravenous (IV) tubing varies depending on various factors, including the size and length of the catheter. Syringes with 1 ml, 3 ml, 5 ml, and 10 ml capacities are typically used. VAD protocols often recommend flushing procedures after catheter placement, before fluid injection, and before and after medication administration, blood sampling, transfusions, and parenteral nutrition. The goals of these flushing procedures are to confirm catheter patency, avoid drug incompatibilities, ensure complete drug administration, prevent clot formation, and minimize the risk of bloodstream infection.

[0003] Conventional cleaning syringes have a barrel with a luer tip at one end that is exposed to a non-sterile environment when the syringe tip is removed from the packaging, thus providing an opportunity for undesirable contamination. As a result, a need exists for a cleaning syringe that provides a physical barrier around the syringe, and in particular the syringe tip, that promotes aseptic practice by reducing or eliminating "touch" contamination of the syringe tip with the surrounding non-sterile environment. Summary of the Invention

[0004] One embodiment of the present disclosure relates to an irrigation syringe assembly including a barrel having a sidewall with an inner surface defining a chamber for holding a fluid, an open proximal end, and a distal end having a distal wall with an elongated tip extending distally therefrom, the distal wall having a passageway therethrough in fluid communication with the chamber. The irrigation syringe assembly also includes a collar mounted on the distal wall of the barrel and surrounding the elongated tip. The collar can include at least one sidewall with an inner surface defining a compartment, an open distal end, and a proximal end adjacent the distal wall of the barrel. The irrigation syringe assembly can also include an elongated plunger rod disposed within the barrel (the plunger rod having a distal portion and a proximal portion). The plunger rod can also include a distal end with a stopper slidably disposed in fluid-tight engagement with the inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber upon movement of the stopper relative to the barrel. The elongated plunger rod can extend outward from the open proximal end of the barrel.

[0005] In one or more embodiments, the distal wall of the barrel includes a plurality of threads that connect the barrel to the collar. In some embodiments, the proximal end of the collar may be threaded onto the distal end of the barrel.

[0006] In one or more embodiments, a section of the collar surrounds the elongate tip. In one or more embodiments, the collar may be removable.

[0007] In one or more embodiments, the collar can have a convex inner surface or a concave inner surface.

[0008] In one or more embodiments, the collar has the shape of a trapezoidal prism.

[0009] In one or more embodiments, the fluid is a cleaning fluid.

[0010] One embodiment of the present disclosure relates to an irrigation syringe assembly including a barrel having a sidewall with an inner surface defining a chamber for holding a fluid, an open proximal end, and a distal end having a distal wall with an elongated tip extending distally therefrom, the distal wall having a passageway therethrough in fluid communication with the chamber. A collar can be attached to the distal wall of the barrel and surround the elongated tip. The collar can have at least one sidewall with an inner surface defining a compartment, an open distal end, and a proximal end adjacent the distal wall of the barrel. A removable cap having a body, a proximal end, and a closed distal end can be attached to the distal end of the collar. An elongated plunger rod (the plunger rod having a distal portion and a proximal portion) can be disposed within the barrel. A stopper can be slidably disposed on the distal end of the plunger rod and disposed in fluid-tight engagement with the inner surface of the barrel for drawing fluid into and expelling fluid from the chamber upon movement of the stopper relative to the barrel.

[0011] In one or more embodiments, the collar section surrounds the elongate tip.

[0012] In one or more embodiments, the distal wall of the barrel may include a plurality of threads for connecting the barrel to the collar, and in one or more embodiments, the distal end of the collar may include a plurality of threads for connecting the collar to the removable cap.

[0013] In one or more embodiments, the collar may be removable.

[0014] In one or more embodiments, the collar may have a convex or concave inner surface. In certain embodiments, the collar has the shape of a trapezoidal prism.

[0015] In one or more embodiments, the fluid is a cleaning fluid.

[0016] In one or more embodiments, the removable cap may include an outward flaring that extends from the body of the cap and corresponds with the opening at the distal end of the elongate tip.

[0017] In one or more embodiments, the removable cap has a cross-sectional shape that is triangular, square, pentagonal, hexagonal, heptagonal, octagonal, symmetrical, or asymmetrical polygonal. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 illustrates a partial perspective view of a cleaning syringe having a collar, according to one or more embodiments of the present disclosure. [Figure 2] FIG. 2 illustrates a top perspective view of a cleaning syringe with a collar, according to one or more embodiments of the present disclosure. [Figure 3] FIG. 3 illustrates a side view of a cleaning syringe with a collar and a cap, according to one or more embodiments of the present disclosure. [Figure 4] FIG. 4 illustrates a cross-sectional view of a cleaning syringe with a collar and a cap, in accordance with one or more embodiments of the present disclosure. [Figure 5] FIG. 5 illustrates a top perspective view of a cleaning syringe with a collar, according to one or more embodiments of the present disclosure. [Figure 6] FIG. 6 illustrates a side view of a cleaning syringe with a collar and a cap, according to one or more embodiments of the present disclosure. [Figure 7] FIG. 7 illustrates a cross-sectional view of a cleaning syringe with a collar and a cap, in accordance with one or more embodiments of the present disclosure. [Figure 8]FIG. 8 illustrates a perspective view of an assembled cleaning syringe with a collar and cap, according to one or more embodiments of the present disclosure. [Figure 9] FIG. 9 illustrates a perspective view of a cleaning syringe with a collar and the cap removed, in accordance with one or more embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] (Detailed Description of the Invention) Before describing several specific embodiments of the present disclosure, it is to be understood that the disclosure is not limited to the configurations or process steps set forth below. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0020] The following definitions are provided for terms used in this disclosure.

[0021] "Irrigation Syringe Assembly" includes the syringe shown for use in irrigating the VAD. Irrigation practices ensure and maintain catheter patency and help prevent mixing of incompatible medications.

[0022] "a", "an" and "the" include the singular and the plural.

[0023] "Catheter-related bloodstream infection" or "CRBSI" refers to an infection resulting from the presence of a catheter or IV line.

[0024] As used herein, the term "Luer connector" refers to a connecting collar, a standard method for interconnecting syringes, catheters, hub needles, IV tubing, and the like. Luer connectors consist of interlocking male and female tubing that are slightly tapered to hold together even with a pressure / twist fit alone. Luer connectors can optionally include an additional threaded outer rim for added safety. The male end of the Luer connector typically associates with an irrigation syringe and can mate with the female end located on the VAD. Luer connectors have a distal end, a proximal end, a monolithically shaped outer wall, and a defined central passageway that fluidly connects the chamber of the syringe barrel to the VAD hub. Luer connectors also have a distal channel that detachably attaches the Luer connector to the VAD hub and a proximal channel that detachably attaches the Luer connector to the syringe barrel.

[0025] Clinicians must juggle multiple tasks while flushing an intravenous (IV) catheter, requiring a level of dexterity to perform the procedure while preventing contact of the syringe tip with the surrounding environment. If the syringe tip comes into contact with a non-sterile surface, "touch" contamination can occur, resulting in microbial growth in the IV line, resulting in catheter-related bloodstream infections ("CRBSIs") and potentially fatal central line-associated bloodstream infections ("CLABSIs"). Embodiments of the present disclosure relate to flushing syringes having a collar that surrounds the elongated tip of the syringe. The collar provides a physical barrier around the syringe tip. Due to its shape, the collar of the present disclosure helps facilitate placement of the flushing syringe with the catheter hub and / or needleless connector, thereby reducing the chance of "touch" contamination.

[0026] A syringe assembly is provided that includes a plunger rod and a syringe barrel having an open proximal end and a distal tip, the distal syringe tip surrounded by a collar to prevent contact of the syringe tip with the surrounding non-sterile environment, thereby reducing contamination of the syringe, while facilitating alignment of the syringe with a catheter hub or needleless connector. Referring to FIGS. 1-7 , a syringe assembly 10 according to the present disclosure generally comprises a barrel 20 including a sidewall 21 having an inner surface defining a chamber 22 for holding a fluid. In one or more embodiments, the fluid is an irrigation fluid. The barrel 20 further comprises an open proximal end (not shown), a distal wall 25 (adapted for connection to a collar 30) having an elongated tip 26 extending distally therefrom, and a distal end 24 having a passageway 27 therethrough in fluid communication with the chamber. The open proximal end of the barrel is located at the end opposite the distal end 24. The distal wall 25 may include a plurality of threads 28 for attachment to the collar 30, however, the collar 30 may be engaged onto the distal wall through a variety of methods including press fitting, adhesion, retention, co-injection molding, etc.

[0027] As shown in FIG. 2, a collar 30 is attached to the distal end 24 of the barrel. The collar 30 includes at least one sidewall 31 having an inner surface 32 defining a compartment 33 surrounding the elongated tip 26, an open distal end 34, and a proximal end 35 adjacent the distal wall 25 of the barrel. The elongated tip 26 is adapted for connection to the hub of a vascular access device. The collar 30 may include a plurality of threads 36 on its inner surface for connection to the vascular access device. As shown in FIGS. 4, 5, and 7, the collar 30 may include an engagement portion 38 on the proximal end 35 for attachment to the distal wall 25 of the barrel. During manufacture, the irrigation syringe assembly 10 can be provided with the collar 30 connected at its proximal end 35 to the distal wall 25 of the barrel. Engagement may be via a variety of methods, including, but not limited to, press-fitting, adhesion, retention, or co-injection molding. The shape of the collar 30 may vary. Collar 30 may have a convex inner surface (e.g., paraboloid), a concave inner surface, a straight profile (e.g., semi-conical), or a trapezoidal prism shape. The length of this extension from the body of the syringe and the degree of openness / straightness of the profile (how wide the collar is at its farthest point from the syringe barrel) can vary.

[0028] In one or more embodiments, the collar 30 may be removable from the syringe assembly 10 .

[0029] In one embodiment, the collar 30 may include a plurality of threads 36 adapted for connection to the hub of a vascular access device. In one or more embodiments, the collar 30 surrounds an elongated tip adapted for connection to the hub of a vascular access device. In one or more embodiments, the elongated tip is a luer tip.

[0030] As shown in FIGS. 3, 4, and 6, the open distal end 34 of the collar 30 may include a removable cap 40. The removable cap 40 includes a body 41 having a proximal end 42 and a closed distal end 43. The distal end 43 and the proximal end 42 define a length of the cap 40. FIGS. 3, 4, 6, and 7 show side and cross-sectional views, respectively, of the cap 40, according to one or more embodiments of the present disclosure. The cap distal end 430 may be recessed within the distal end 43 such that a cap recess 431 is formed at the cap distal end 43. In assembly, the proximal end 42 of the cap 40 is adjacent the distal end 43 of the collar 30. As shown in FIGS. 4 and 7, the cap 40 may include an outwardly facing overhang 44 extending from the body of the cap 40 and corresponding to the opening at the distal end of the elongated tip 26. The proximal end 42 of the removable cap 40 may include a plurality of threads on its outer surface for mating with corresponding grooves located on the inner surface of the distal end of the collar 30. In one or more embodiments, at least one screw thread is provided to allow the cap to be screwed onto the collar 30.

[0031] The cross-sectional shape of the cap 40 may be any suitable shape, including, but not limited to, a triangle, a square, a pentagon, a hexagon, a heptagon, an octagon, or a symmetrical or asymmetrical polygon. The shape of the cap 40 may provide a comfortable feel to the user and enhance the gripping force, allowing the user to easily connect and disconnect the cap from the collar 30. In some embodiments, the cap 40 is irregularly shaped. As used herein and in the claims, the term "irregularly shaped" means that the cross-section presents surfaces or edges where free rotation about the cross-section is detrimental. For example, a hexagon or an oval shape would be considered "irregular."

[0032] The syringe assembly 10 may be filled with a flushing solution using known methods. Additionally, the syringe assembly 10 may be provided prefilled by the manufacturer or supplier. The flushing solution may be any solution intended for flushing or maintaining the performance of a VAD. Preferably, the flushing solution is selected from the group consisting of saline and heparin lock flushing solutions. These solutions are known in the art and readily available. Specific examples of saline flushing solutions include, but are not limited to, 0.9% sodium chloride for injection, USP. Specific examples of heparin lock flushing solutions include, but are not limited to, 0.9% sodium chloride with 100 USP units or 10 USP units of heparin chloride per mL.

[0033] Once the syringe assembly 10 is coupled to the VAD, fluid communication can occur from the syringe barrel 20 to the vascular access device. Fluid is drawn from the barrel 20 through the integral passageway 27 into the IV or catheter. Due to the presence of the collar 30, fluid communication into the patient through the vascular access device occurs under sterile conditions without additional swabbing steps and diligence by the clinician.

[0034] In one or more embodiments, a collar 30 may be integrally formed on the distal wall 25 of the syringe barrel 20 for fluid communication to a vascular access device.

[0035] The barrel may include a tip extending distally from the barrel. The tip can have an outer diameter that is different from or the same as the outer diameter of the remainder of the barrel. For example, as shown in the figures, the outer diameter of the tip has a smaller outer diameter than the barrel portion that is the proximal end of the tip. The tip of the barrel may include a luer slip coupling or a locking luer-type collar concentrically surrounding or within the tip.

[0036] 8 illustrates a perspective view of an assembled cleaning syringe with a collar and cap according to one or more embodiments of the present disclosure. FIG. 9 illustrates a perspective view of an assembled cleaning syringe with a collar and cap removed according to one or more embodiments of the present disclosure.

[0037] The elongated plunger rod 50 may have a distal portion and a proximal portion 52, with the distal end 51 having a stopper 54 slidably disposed in fluid-tight engagement with the inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber upon movement of the stopper relative to the barrel, the elongated plunger rod extending outwardly from the open proximal end 23 of the barrel, the stopper having a distal surface.

[0038] An elongated plunger rod may be disposed within barrel 20. The plunger rod comprises an elongated body portion having a proximal end and a distal end.

[0039] The elongated body portion of the plunger rod has an axial length extending from the proximal end to the distal end. The body portion may have a cylindrical or other shape, and may comprise a single beam or feature. The body portion may be formed by two perpendicularly intersecting beams.

[0040] The plunger rod 50 may also include a thumb press 55 at the proximal end 52 of the elongated body portion. The shape of the thumb press may vary depending on the desired use of the irrigation syringe assembly. The shape of the thumb press may be circular, rectangular, square, rectangular, triangular, oval, pentagonal, hexagonal, and cross-shaped.

[0041] A stopper 54 can be connected to the distal end of the plunger rod. The shape and size of the stopper can be any suitable shape or size, depending, for example, on the shape and size of the barrel and plunger rod. The plunger rod 50 is slidably disposed within the barrel 20, with the stopper in fluid-tight contact with the inner surface of the barrel, and distal movement of the plunger rod 50 relative to the barrel 20 causes the stopper 54 to expel fluid from the barrel. In some embodiments, the stopper is slidably disposed in fluid-tight contact with the inner surface of the barrel so that movement of the stopper relative to the barrel expels fluid from the chamber. The stopper can be connected to the distal end of the elongate plunger by any suitable means. In some embodiments, the connection is made by a mechanical connection, such as the interaction of complementary screw threads and a press-fit connection. The stopper can be slidably disposed in fluid-tight engagement with the inner surface of the barrel to draw fluid into and expel fluid from the chamber.

[0042] The stopper may be made of any material suitable for providing a seal with the inner surface of the barrel. For example, the stopper may be made of a thermoplastic elastomer, natural rubber, synthetic rubber, or thermoplastic material, and combinations thereof. The stopper may be integrally molded or constructed of separate materials, either the same or different materials joined together. The plunger rod may be made of a stronger material than the stopper, such as polypropylene, polyethylene, etc. Materials should be selected to be compatible with the device being used.

[0043] Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and that other arrangements can be devised without departing from the spirit of the disclosure and scope of the claims herein.

Claims

1. 1. A cleaning syringe assembly comprising: a barrel (20) comprising a sidewall (21) with an inner surface defining a chamber (22) for holding a fluid, open proximal and distal ends (23 and 24), and a distal wall (25) and an elongated tip (26) extending distally from the distal end (24), the elongated tip (26) having a passageway in fluid communication with the distal end and the chamber; a collar (30) mounted on and contacting the distal wall (25) of the barrel (20), extending axially from the barrel (20) farther than the elongated tip (26) of the barrel (20), and completely surrounding the elongated tip (26) and the distal wall (25), said collar (30) having a continuous sidewall (31) having an inner surface (32) defining at least one compartment (33); a plurality of grooves disposed on the inner surface of the open distal end (34) of the collar that correspond to the threads of a removable cap; a collar having an open distal end (34) that passes over and completely surrounds the distal end of the barrel (26), and a proximal end (35) that is adjacent the distal wall (25) of the barrel, the collar having a parabolic shape, the open distal end (34) having an inner diameter and an outer diameter, and the open proximal end (35) of the collar having an inner diameter and an outer diameter, the inner diameter and outer diameter of the open distal end (34) being larger than the inner diameter and outer diameter of the proximal end (35), respectively, the collar providing a physical barrier around the syringe tip; and an elongated plunger rod disposed within the barrel, the plunger rod having a distal end and a proximal end, the distal end having a stopper slidably disposed in fluid-tight engagement with an inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber upon movement of the stopper relative to the barrel, the elongated plunger rod extending outwardly from the open proximal end of the barrel, the stopper having a distal end surface; 1. A cleaning syringe assembly comprising:

2. 2. The washing syringe assembly of claim 1, wherein the distal wall (25) of the barrel comprises an engagement portion that connects the barrel (20) to the collar (30).

3. 10. The washing syringe assembly of claim 1, wherein the collar is removable.

4. 2. The washing syringe assembly of claim 1, wherein the distal end (34) of the collar has a convex inner surface.

5. 10. The washing syringe assembly of claim 1, wherein the collar has a concave inner surface.

6. 10. The washing syringe assembly of claim 1, wherein the collar has a trapezoidal prism shape.

7. 2. The washing syringe assembly of claim 1, wherein the fluid is a washing fluid.

8. 1. A cleaning syringe assembly comprising: a barrel (20) comprising a sidewall (21) with an inner surface defining a chamber (22) for holding a fluid, open proximal and distal ends (23 and 24), and a distal wall (25) and an elongated tip (26) extending distally from the distal end (24), the elongated tip (26) having a passageway in fluid communication with the distal end and the chamber; a collar (30) contiguously mounted on the distal wall (25) of the barrel (20) and completely surrounding the elongated tip (26) and the distal wall (25), said collar (30) comprising: a continuous sidewall (31) having an inner surface (32) defining at least one compartment (33); a plurality of grooves disposed on the inner surface of the open distal end (34) of the collar; an open distal end (34) having a parabolic shape and passing past and completely surrounding the distal end of the elongated tip (26); and a proximal end (35) adjacent the distal wall (25) of the barrel, wherein the open distal end (34) of the collar has inner and outer diameters, and the open proximal end (35) of the collar has inner and outer diameters, the inner and outer diameters of the open distal end (34) being larger, respectively, than the inner and outer diameters of the proximal end (35), providing a physical barrier around the syringe tip; and a removable cap mounted on the distal end of the collar, the removable cap having a body, a proximal end, and a closed distal end with a plurality of threads on an outer surface of the removable cap; an elongated plunger rod disposed within the barrel, the plunger rod having a distal end and a proximal end; and a stopper slidably disposed on the distal end of the plunger rod and disposed in fluid-tight engagement with an inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber upon movement of the stopper relative to the barrel; 1. A cleaning syringe assembly comprising:

9. 9. The washing syringe assembly of claim 8, wherein the collar section (33) surrounds the elongated tip (26) and the distal wall (25).

10. 9. The washing syringe assembly of claim 8, wherein a plurality of grooves disposed on an inner surface of the open distal end (34) of the collar connect to a plurality of threads on an outer surface of the removable cap.

11. The washing syringe assembly of claim 8 , wherein the collar is removable.

12. 9. The washing syringe assembly of claim 8, wherein the distal end (34) of the collar has a convex inner surface.

13. 9. The washing syringe assembly of claim 8, wherein the collar has a concave inner surface.

14. 9. The washing syringe assembly of claim 8, wherein the collar has a trapezoidal prism shape.

15. 9. The washing syringe assembly of claim 8, wherein the fluid is a washing fluid.

16. 9. The washing syringe assembly of claim 8, wherein the removable cap includes an outward projection that extends from the body of the removable cap and fits into a passage on the distal end of the elongate tip.

17. 10. The washing syringe assembly of claim 9, wherein the removable cap has a cross-sectional shape that is triangular, square, pentagonal, hexagonal, heptagonal, octagonal, symmetrical, or asymmetrical polygonal.

18. 1. A cleaning syringe assembly comprising: a barrel (20) comprising a sidewall (21) with an inner surface defining a chamber (22) for holding a fluid, open proximal and distal ends (23 and 24), and a distal wall (25) and an elongated tip (26) extending distally from the distal end (24), the elongated tip (26) having a passageway in fluid communication with the distal end and the chamber; a collar (30) contiguously mounted on the distal wall (25) of the barrel (20) and completely surrounding the elongated tip (26) and the distal wall (25), said collar (30) comprising: a continuous sidewall (31) having an inner surface (32) defining at least one compartment (33); a plurality of grooves disposed on the inner surface of the open distal end (34) of the collar; an open distal end (34) that passes over and completely surrounds the distal end of the elongated tip (26); and a proximal end (35) adjacent the distal wall (25) of the barrel, said collar having a parabolic shape, said open distal end (34) having inner and outer diameters, and said open proximal end (35) having inner and outer diameters, said inner and outer diameters of said open distal end (34) being larger, respectively, than said proximal end (35), providing a physical barrier around the syringe tip; and a removable cap mounted on the distal end of the collar, the removable cap having a body, a proximal end, and a closed distal end with a plurality of threads on an outer surface of the removable cap; an elongated plunger rod disposed within the barrel, the plunger rod having a distal end and a proximal end; and a stopper slidably disposed on the distal end of the plunger rod and disposed in fluid-tight engagement with an inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber upon movement of the stopper relative to the barrel; Equipped with A cleaning syringe assembly, wherein a plurality of grooves disposed on an inner surface of the open distal end (34) of the collar connect with a plurality of threads on an outer surface of the removable cap.

19. 20. The washing syringe assembly of claim 18, wherein the collar has a convex inner surface.

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