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    • 专利摘要:
    flush syringe assembly, method of flushing a vascular access device and method of sterilizing a vascular access device. embodiments of the invention are directed to flush syringe assemblies (100) comprising an integrated contamination prevention device (170) integrated with the flush device connector positioned so that the practitioner cannot forget to apply the disinfectant. flush syringe assemblies comprise a tube (110) with an elongated plunger rod (120) disposed therein and a cap (130) comprising a passage (134). the piston rod (120) includes a stopper (150) of which at least a portion (155) may be incorporated into the cap passage (130) to form a plug (155) in the cap (130).
    公开号:BR112015012480B1
    申请号:R112015012480-1
    申请日:2013-11-26
    公开日:2021-08-10
    发明作者:Girum Yemane Tekeste
    申请人:Becton Dickinson And Company；
    IPC主号:
    专利说明:

    FIELD
    [0001] The embodiments of the invention generally relate to apparatus and methods for preventing blood reflux in vascular access devices (VAD). More specifically, embodiments of the invention are directed to technology to reduce the risk of bloodstream infections (CRBSI) and maintenance of intravenous (IV) line clearance including one or more IV connector cleaning, backflow prevention, capping technology connector, syringe sets, and particularly syringe sets for use in lavage procedures, to vascular access devices (VADs) such as peripheral catheters and central venous catheters. FUNDAMENTALS
    [0002] VADs are commonly used therapeutic devices still accounted for 18,000 bloodstream infections in American ICUs in 2009, according to the CDC, which also reports a 12-25% mortality rate. MMWR Morb. Deadly Wkly. Rep. 2011;60:243-248. In the same article, CDC attributes bloodstream infections and additional deaths to VAD use in regular hospital rooms and outpatient clinics.
    [0003] If not properly maintained, VADs, which include peripheral catheters and central venous catheters, can seal with blood clots or disseminated infection. To ensure that VADs are used properly and do not become sealed or infected, protocols have been developed. These protocols include sterilizing the VAD and flushing the catheter with a flushing solution. VAD protocols generally recommend that lavage procedures be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusions, and parenteral nutrition. The purpose of these lavage procedures is to confirm catheter clearance, avoid drug incompatibilities, ensure complete drug dose administration, prevent thrombus formation, and minimize the risk of bloodstream infections. Before each washing procedure is performed, the VAD must be sterilized. A recent study reported that 30% of the time, there is no effort to sterilize the VAD before washing and when an attempt is made to sterilize the VAD, aseptic practices are not fully adhered to.
    [0004] Catheters are flushed using syringe sets filled with various fluids. In some cases, different fluids are injected sequentially according to protocol. For example, a saline solution followed by an anticoagulant such as heparin. The size of the syringe used to flush the LV lines varies due to a number of factors, including the size and length of the catheter. Typically 1 ml, 3 ml, 5 ml and 10 ml volume syringes are used.
    [0005] It is important in the lavage procedure not to draw blood back into the catheter, where it can clot and seal the catheter, commonly referred to as "reflux". In order to prevent blood backflow into the catheter, the user is encouraged to maintain positive pressure in the line during the flushing procedure. This may involve tightening the IV line and removing the syringe and cannula from the LV port while still applying pressure to the syringe plunger rod during the flushing procedure. When using a syringe with an elastomeric stopper, the stopper is often compressed when it contacts the distal end of the syringe tube at the completion of the flushing procedure. When a user relieves pressure on the plunger after the flush procedure is completed, the stopper will expand back to its normal size, thereby removing the liquid from the catheter into the syringe tube. This is undesirable as it can cause blood to enter the catheter at the distal end of the catheter (reflow), where it will remain stationary until the next time the VAD is used.
    [0006] IV lines are now washed by a wide variety of healthcare professionals, not just those who in the past were dedicated to catheter maintenance. In the case of outpatient care, patients themselves can even wash their own catheters. These less experienced people may prematurely release the compressive force on the stopper or use excessive force that would deform the stopper, which can draw blood into the catheter and cause blood backflow. Consequently, there is a need for flush syringe assemblies that promote sterilization of the VAD and help reduce or eliminate blood backflow during the flushing procedure, even if flushing protocols are not accurately followed. ABSTRACT
    [0007] One or more embodiments of the invention are directed to flushing syringe assemblies comprising a tube, an elongated plunger rod, a cap, a gasket and a disinfection system. The tube includes a side wall having an inner surface that defines a chamber for retaining fluid, an outer surface, an open proximal end, a distal end that includes a distal wall having a passage through which there is fluid communication with the chamber. The elongated piston rod is disposed within the tube. The piston rod comprises a distal end that includes a stopper slidably positioned in fluid impermeable contact with the inner surface of the tube to drive fluid out of the chamber by movement of the stopper relative to the tube. The stopper comprises a stopper corpora and a detachable stopper tip. The cover comprises an outer wall around a Luer connection. The cap comprises a passage for fluid communication therethrough, wherein the passage is cut from below to receive and retain the tip of the stopper when the piston rod is fully recessed. The cap further comprises a distal end for releasably attaching the cap to a vascular access device (VAD) and a proximal end for releasably attaching the cap to the tube. The gasket is external to the tube and has a distal end and a proximal end, and an inner surface and an outer surface. The gasket slides from the distal to the proximal position with respect to the tube. The disinfection system comprises a disinfectant contained in a center, in which the disinfection system is released after proximal movement of the joint.
    [0008] In some embodiments, the cover is threaded to engage the complementary threads on the VAD. In one or more embodiments, the cap engages the VAD with a forced fit. In certain embodiments, the lid passage is coated with an antimicrobial agent.
    [0009] In some embodiments, the cut under the cap passage creates a tight fit tight enough to keep the stopper tip inside the cap after the plunger rod moves away from the cap after emptying the syringe fluid.
    [0010] In one or more embodiments, the tip of the stopper has threads that mate with complementary threads in the body of the stopper. In some embodiments, the end of the stopper is secured to the body of the stopper using a forced fit. In the detailed modalities, the stopper body is made of material selected from the list consisting of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials and combinations thereof. In certain embodiments, the stopper tip is made of material selected from the list consisting of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials and combinations thereof.
    [0011] In one or more embodiments, the outer surface of the tube further comprises two annular positioning edges, a distal annular positioning edge and a proximal annular positioning edge. In some embodiments, the inner surface of the gasket further comprises at least one annular positioning groove for controlling the position of the gasket relative to the tube, engaging with the annular positioning edges on the outer surface of the tube. In detailed embodiments, the outer surface of the tube comprises one or more edges that extend along a length of the tube and mate with the corresponding groove in the inner surface of the joint.
    [0012] In some embodiments, the plunger is of sufficient length relative to the gasket and tube such that when the plunger is completely lowered after all the wash solution has been expelled from the syringe, the gasket retracts to expose the cap.
    [0013] In some embodiments, the gasket further comprises one or more cutouts to provide visibility of the tube contents. In one or more embodiments, the distal end of the gasket is threaded to engage the complementary threads in the disinfectant system. In specific embodiments, the distal end of the gasket is secured to the disinfectant system using a forced fit.
    [0014] In some embodiments, the disinfection system further comprises a removable cover to protect the disinfectant system prior to use and a means of transporting the disinfectant. In one or more modalities, the disinfectant is made from material selected from the list consisting of alcohol, antiseptic gel and combinations thereof.
    [0015] Additional embodiments of the invention are directed to methods of washing a VAD. A flush syringe set is provided as described in this document. The protective cover is removed using one hand from the distal end of the flush syringe assembly, thereby exposing a disinfectant contained in the distal end of the syringe assembly. Disinfectant is applied to the VAD connector using one hand. The same hand ejects the disinfectant system. The flush syringe assembly is attached to the VAD. Using one hand, the flush syringe assembly is held and the plunger is lowered to flush the VAD with flushing solution that is contained in the chamber. Use the same hand to continue lowering the plunger after the tube is empty to incorporate the end of the stopper into the VAD and retract the gasket to expose the cap. The cap, including the tip of the built-in stopper, is separate from the flush syringe assembly.
    [0016] In some embodiments, the method further comprises removing the cap including the tip of the built-in stopper and repeating the steps by separating the cap, including the tip of the stopper from the flush syringe assembly.
    [0017] Other embodiments of the invention are directed to flushing syringe assemblies comprising a tube, a cap, a removable disinfection system, an elongated plunger rod, a gasket and an amount of flushing solution. The tube includes a side wall having an inner surface that defines a chamber for retaining fluid, an outer surface, an open proximal end, a distal end that includes a distal wall with a tip extending distally therefrom having a passage through. from which there is fluid communication with the camera. The tube further comprises an outer surface containing one or more annular positioning discontinuities. The cap comprises an end and a proximal end defining a length, an irregularly shaped outer wall, a shaped central passageway providing fluid communication from the chamber to a patient vascular access device (VAD). The cap further comprises an annular distal end channel which releasably secures the cap to the VAD, and an annular proximal end channel which releasably secures the cap to the tube. The removable disinfection system comprises a disinfectant. The elongated plunger rod is disposed within the tube and comprises a distal portion and a proximal portion. The plunger rod further comprises a distal end which includes a stopper slidably positioned in fluid impermeable contact with the interior surface of the tube to expel fluid from the chamber by movement of the stopper relative to the tube. The stopper has a distal face and a proximal end. The distal face of the stopper further comprises a shaped stopper tip which is detachable from the stopper and insertable into the cap when the piston rod is fully recessed. The gasket is external to the tube and has an inner surface and an outer surface, an open proximal end containing at least one flange, and an open distal end defining a recess with an irregular inner surface to contain and prevent rotation of the cap relative to the Joins. The distal end is further connected to the removable disinfection system. The gasket further comprises one or more annular positioning discontinuities complementary to one or more annular discontinuities in the tube, which together control the distal movement of the tube relative to the gasket. The amount of wash solution is in the chamber between the stopper and the distal wall of the tube.
    [0018] In some embodiments, the annular channel of the distal end of the cap further comprises a straight inner wall and outer wall that are threaded to complement the VAD, and the annular channel of the distal annular end extends less than the length of the cap.
    [0019] In one or more embodiments, the annular channel of the proximal end of the cap further comprises a straight outer wall and inner wall that are releasably secured to the tube, and the proximal end channel extends less than the length of the cap. . In detailed embodiments, the annular channel of the proximal end of the cap is secured to the tube by one or more of a forced fit and threaded connector.
    [0020] In some embodiments, the profiled central passageway of the cap extends the entire length of the cap to establish a fluid connection between the tube and the VAD, and the profile of the central passageway is cut from below near the proximal end to complement the profile of the outer surface of the stopper tip. In detailed embodiments, the shaped central passageway of the lid is coated with an antimicrobial agent.
    [0021] In one or more modalities, the stopper or any part of the stopper is detachable from the stopper and capable of being incorporated into the VAD. In some embodiments, the stopper has a cavity to hold the end of the stopper through one or more of a threaded connection and a forced fit. In detailed embodiments, the profile of the distal end of the stopper tip is configured to complement the profile of the central passageway of the cap and create a tight fit between them sufficient to retain the stopper tip within the VAD after the flush syringe assembly is removed. . In specific modalities, the stopper tip is threadedly attached to the stopper using threads on the stopper tip that complement those on the VAD, allowing both to be removed in one movement by the professional.
    [0022] In some embodiments, the annular positioning discontinuities in the tube comprise two annular positioning edges, a distal annular positioning edge and a proximal annular positioning edge, and the discontinuity in the gasket comprises a groove configured to interact with the positioning edges ring on the tube.
    [0023] In one or more embodiments, the outer surface of the tube further comprises one or more linear discontinuities spaced around the tube that run along a length of the tube and mate with a corresponding discontinuity in the inner surface of the joint.
    [0024] Additional embodiments of the invention are directed to methods of sterilizing a VAD connector prior to washing. The protective cover is removed from the distal end of the syringe assembly, as described in this document, to expose a disinfectant contained in the distal end of the syringe assembly. Disinfectant is applied to the VAD connector and the gasket is recessed to eject the disinfectant or disinfectant transport medium and disinfectant reservoir.
    [0025] Other embodiments of the invention are directed to methods of preventing contamination of a VAD connector while being used by a patient. The method comprising leaving a Luer cap containing an incorporated plunger tip connected to the VAD connector to protect the VAD connector from contact with bacteria or other contaminants. BRIEF DESCRIPTION OF THE FIGURES
    [0026] In order that the way in which the characteristics of the invention reported above are obtained and can be understood in detail, a more specific description of the invention, briefly summarized above, can be taken by reference to the modalities thereof, which are illustrated in the figures attached. It should be noted, however, that the attached figures illustrate only typical embodiments of this invention and, therefore, should not be considered limiting of its scope, for the invention to be able to admit other embodiments equally effective.
    [0027] FIG. 1 shows a perspective view of a flush syringe assembly in accordance with one or more embodiments of the invention;
    [0028] FIG. 2 shows a perspective view of a syringe tube, in accordance with one or more embodiments of the invention;
    [0029] FIG. 3 shows a cross-sectional side view of a syringe tube in accordance with one or more embodiments of the invention;
    [0030] FIG. 4A shows a distal perspective view of a cap in accordance with one or more embodiments of the invention;
    [0031] FIG. 4B shows a proximal perspective view of a cap in accordance with one or more embodiments of the invention;
    [0032JA FIG. 5 shows a cross-sectional view of a cap, according to one or more embodiments of the invention;
    [0033] FIG. 6 shows a perspective view of a gasket, according to one or more embodiments of the invention;
    [0034] FIG. 7 shows a cross-sectional view of a joint, according to one or more embodiments of the invention;
    [0035] FIG. 8 shows a distal perspective view of a stopper in accordance with one or more embodiments of the invention;
    [0036] FIG. 9 shows a cross-sectional view of a stopper, according to one or more embodiments of the invention;
    [0037] FIG. 10 shows a distal perspective view of a detachable stopper tip in accordance with one or more embodiments of the invention;
    [0038] FIG. 11 shows a cross-sectional view of a detachable stopper tip, in accordance with one or more embodiments of the invention;
    [0039] FIG. 12 shows a perspective view of a flush syringe assembly, in accordance with one or more embodiments of the invention;
    [0040] FIG. 13 shows a cross-sectional view of a flush syringe assembly, in accordance with one or more embodiments of the invention;
    [0041] FIG. 14 shows a perspective view of a flush syringe assembly and a VAD prior to cleaning the VAD, in accordance with one or more embodiments of the invention;
    [0042] FIG. 15 shows an expanded cross-sectional view of a flush syringe assembly and a VAD prior to cleaning the VAD, in accordance with one or more embodiments of the invention;
    [0043] FIG. 16 shows a cross-sectional view of a flush syringe assembly cleaning a VAD, in accordance with one or more embodiments of the invention;
    [0044] FIG. 17 shows an expanded cross-sectional view of the flush syringe assembly cleaning a VAD, in accordance with one or more embodiments of the invention;
    [0045] FIG. 18 shows a cross-sectional view of a flush syringe assembly after retracting the gasket to disengage the disinfectant system, in accordance with one or more embodiments of the invention;
    [0046] FIG. 19 shows an expanded cross-sectional view of the flush syringe assembly and disinfectant system after disengaging, in accordance with one or more embodiments of the invention;
    [0047] FIG. 20 shows an expanded cross-sectional view of a stopper and the detachable stopper tip, in accordance with one or more embodiments of the invention;
    [0048] FIG. 21 shows a cross-sectional view of a VAD being connected to the flush syringe assembly, in accordance with one or more embodiments of the invention;
    [0049] FIG. 22 shows an expanded cross-sectional view of the VAD connected to the flush syringe assembly, in accordance with one or more embodiments of the invention;
    [0050] FIG. 23 shows a cross-sectional view of the flush syringe assembly connected to the VAD in the home position, in accordance with one or more embodiments of the invention;
    [0051] FIG. 24 shows a cross-sectional view of the flush syringe assembly connected to the VAD during flushing, in accordance with one or more embodiments of the invention;
    [0052] FIG. 25 shows a cross-sectional view of the flush syringe assembly connected to the VAD after flushing, in accordance with one or more embodiments of the invention;
    [0053] FIG. 26 shows an expanded cross-sectional view of the flush syringe assembly connected to the VAD after flushing with the stopper tip engaged with the cap, in accordance with one or more embodiments of the invention;
    [0054] FIG. 27 shows a cross-sectional view of the flush syringe assembly connected to the VAD after flushing during the initial withdrawal stage with the cap exposed, in accordance with one or more embodiments of the invention;
    [0055] FIG. 28 shows an expanded cross-sectional view of the flush syringe assembly connected to the VAD after flushing with the cap exposed under the gasket, in accordance with one or more embodiments of the invention;
    [0056] FIG. 29 shows an expanded cross-sectional view of the piston rod, gasket and tube during removal, in accordance with one or more embodiments of the invention;
    [0057] FIG. 30 shows a perspective view of the flush syringe assembly with the retracted gasket being removed from the VAD, leaving the cap and stopper tip in the VAD, in accordance with one or more embodiments of the invention;
    [0058] FIG. 31 shows a cross-sectional view of the flush syringe assembly and the VAD after disconnection, in accordance with one or more embodiments of the invention; and
    [0059] FIG. 32 shows an expanded cross-sectional view of the VAD with the cap and the tip of the stopper incorporated into the cap, in accordance with one or more embodiments of the invention. DETAILED DESCRIPTION
    [0060] Before describing the various exemplary embodiments of the invention, it should be understood that the invention is not limited to the construction details or process steps set out in the following description. The invention is capable of other modalities and of being practiced or being carried out in various ways.
    [0061] The modalities of the invention are directed to sets of syringes with valves and plugs that allow one or more of the prevention of blood backflow, the elimination of the need for positive catheter displacement connectors and the protection of the IV connector by capping the IR connector.
    [0062] The devices can prevent the backflow of blood into the IV catheter lumens after the catheter flushing procedure, eliminate the need for positive displacement IV catheter connectors or valves and/or protect the IV connector from contamination by the capping of the IR connector. These systems have the potential to extend catheter residence times, reduce the use of Cathflo® (t-PA, Alteplase) and cap IV connectors to reduce the risk of bacterial colonization at the connector inlet port. One or more modalities are directed at connector disinfection/cleaning systems, washing IV lines, preventing backflow, capping/sealing connector entry port surfaces (eg, to prevent microorganisms from entering IV lines or popularizing the connector input port surfaces).
    [0063] The figures show modalities of a syringe set comprising an integrated contamination prevention device integrated into the VAD connector wash positioned so that the professional cannot forget to apply the disinfectant. Those skilled in the art will understand that the syringe assembly shown is merely one embodiment, and that the syringe assembly may have different structures and components. In that regard, one or more embodiments of the invention are directed to flush syringe assemblies 100 including a tubing 110, an elongated plunger rod 120, a cap 130 and a valve 140.
    [0064] Referring to FIGS. 2 and 3, tube 110 has a side wall 111 with an inner surface 112 defining a chamber 114 for retaining a fluid, an outer surface 113, an open proximal end 115 and a distal end 116. The distal end 116 includes a distal wall 117 with a passage 118 therethrough in fluid communication with chamber 114 allowing a fluid within chamber 114 to exit the chamber through passage 118. In some embodiments, tube 110 does not include a flange to provide force opposite to the direction of movement of the piston rod.
    [0065] The outer surface 113 of tube 110 may be smooth or textured, depending on the desired frictional quality of the resulting syringe assembly 100. For example, a textured outer surface 113 may offer the user a more secure and stable grip than a smooth surface. Additionally, the roughness or frictional feel of the outer surface 113 can be modified by the chemical composition of the material used in the syringe tube 110.
    [0066] The tube 110 may also include features to control the linear movement of the tube with respect to a joint and to restrict its relative rotational movement. To control linear movement of tube 110 relative to the joint, the tube may include at least one annular positioning edge 167, 168 on the outer surface. In the embodiment shown in FIG. 1, the tube includes a proximal annular positioning edge 168 and a distal annular positioning edge 167. To control linear movement, some annular edges of embodiments 167, 168 may mate with corresponding features on the inner surface of the gasket. In some embodiments, distal annular positioning edge 167 positions gasket 160 during transport of the flush syringe assembly. In one or more embodiments, the proximal annular positioning edge 168 stops movement of the gasket 160 relative to the tube 110 after the disinfectant means is ejected.
    [0067] To control the pivotal movement of the gasket 160 relative to the tube 110, the tube may contain an edge 167 which may extend, for example, substantially from the proximal end 115 of the tube 110 towards the distal end 116. The edge 167 can extend along any portion of the length of tube 110. Edges 138 can start and stop at any point along the length of tube 110. Edges 138 (or edge) can be sized to fit with a corresponding groove 177 on the inner surface 163 of a gasket 160 to facilitate alignment of tube 110 with gasket 160 while the plunger is lowered.
    [0068] Although the modalities have been described and shown as having an edge that extends from the tube to interact with a groove in the joint, it will be understood by those skilled in the art that these features can be reversed. For example, there may be at least one annular locating groove in the tube that interacts with at least one annular locating edge on the inner surface of the joint. In some embodiments, there is at least one annular positioning discontinuity in the tube and at least one complementary annular positioning discontinuity in the inner surface of the gasket. Similarly, the tube may contain a linear discontinuity that extends along a length of the tube that interacts with a complementary discontinuity on the inner surface of the joint.
    [0069] Tube 110 may also include a tip 119 that extends distally from tube 110. Tip 119 may have an outer diameter that is different from or equal to the outer diameter of the rest of tube 110. For example, as shown in In the Figures, the outer diameter of the tip 119 has an outer diameter smaller than the portion of the tube that is proximate to the tip 119. The tip 119 of the tube 110 may include a luer slip fitting (not shown) or a luer locking ring. around the tip 119 concentrically or inside the tip. Tip 119 shown in the Figures is a luer lock connector 127 inside the tip.
    [0070] An elongated piston rod 120 is disposed within the tube 110, as shown in FIGS. 1 and 8-9. Plunger rod 120 includes an elongated body portion 121 with a proximal end 122 and a distal end 123.
    [0071] The elongated body portion 121 of the plunger rod 120 has an axial length extending from the proximal end 122 to the distal end 123. The body portion 121 may include a single beam or features, which may have cylindrical or other shapes. formats. As shown in the Figures, the body part 121 is formed by two perpendicularly intersecting joists 124, 125. The joists may have a "plus" or cruciform cross-section. In the embodiment shown, the two crisscrossing beams 124, 125 intersect to form an outer surface, outlining four quadrants that face the inner surface 112 of tube 110 and extend along the axial length of the proximal end 122 to the end. distal 123 of the piston rod 120. Although the figures show embodiments of the piston rod having a cruciform cross section, it will be understood by those skilled in the art that the shape and/or cross section of the piston rod can be any suitable shape or cross section and that the embodiments of the invention are not limited to the shapes shown in the figures.
    The plunger rod 120 may also include a thumb pad 126 at the proximal end 122 of the elongated body portion 121. The shape of the thumb pad 126 may vary depending on the desired use of the flush syringe assembly 100. The pad of thumb 126 shown in the figures is round, but it will be understood by those skilled in the art that this is merely representative of one possible shape. Other shapes include, but are not limited to, square, rectangular, triangular, oval, pentagonal, hexagonal, and cruciform. The shape of the thumb pad 126, in some embodiments, substantially matches the shape of the elongated body portion 121 of the plunger rod 120, the tube 110, or other components.
    [0073] In some embodiments, the thumb rest has a plurality of edges 127 in it. Edges 127 can enhance the user's ability to press plunger rod 120 distally to tube 110, providing a surface with a higher coefficient of friction. The shape of edges 127 or the edge pattern can be changed depending on the desired use of the plunger rod 120. For example, edges 127 can be a series of parallel lines, or curves in a design. In one or more embodiments, edges 127 are shaped to form a logo. The ridges 127 can be integrally formed with the piston rod 120 or can be separate pieces that are secured to the piston rod. The surface of the edges 127 may be textured differently from the piston rod or they may be the same. Edges 127 with a textured surface can provide a greater increase in the coefficient of friction compared to smooth edges.
    [0074] A stopper 150 can be connected to the distal end 123 of the plunger rod 120. The shape and size of the stopper 150 can be any suitable shape or size, depending, for example, on the shape and size of the tube 110 or the Plunger rod 120. Plunger rod 120 is slidably positioned on tube 110 so that stopper 150 is in fluid tight contact with inner surface 112 of tube 110 and for distal movement of piston rod 120 with respect to tube 110 causes stopper 150 to push fluid out of tube 110. In some embodiments, stopper 150 is slidably positioned in fluid impermeable contact with inner surface 112 of tube 110 to convey fluid to out of chamber 114 by movement of stopper 150 relative to tube 110.
    [0075] The piston rod 120 shown in FIG. 1 includes a connector 128 on the distal end 123 of the plunger rod 120. The connector 128 shown includes screw threads 129 to which the stopper 150, or other component, can be secured by cooperative interaction with the screw threads on the stopper 150. It is understood by those skilled in the art that there are other types of connector 128 in addition to screw threads 129. For example, the connector may include one or more axially spaced rings on the outer surface of connector 128. The spaced rings may cooperatively interact with one or more grooves in the stopper 150 to secure the stopper 150 to the distal end 123 of the plunger rod 120.
    [0076] The stopper 150 may be connected to the distal end 123 of the elongated plunger rod 120 by any suitable means. In some embodiments, stopper 150 is connected by a mechanical connection, such as the interaction of complementary screw threads, as shown in FIG. 9 and press fit connections. Stopper 150 can be a single piece or multiple pieces. In some embodiments, stopper 150 is a multi-piece, having a stopper body 151 and a detachable stopper tip 155, as shown in FIGS. 1, 10, and 11. In one or more embodiments, stopper 150 includes a conical-shaped distal surface 152 and a tube 110 includes a conical-shaped inner surface on distal wall 117. Those skilled in the art will understand that conical shape may also include frustoconical shapes. In some embodiments, stopper 150 includes a shape that is complementary to the shape of the distal end of tube 110 so that latch 150 is effective to expel the contents of chamber 114 through distal end 116 of tube 110. Stopper 150 can be positioned slidingly a fluid impermeable fitting with the inner surface 112 of the tube 110 to draw fluid into and drive the fluid out of the chamber 114. If the syringe assembly is pre-filled by the manufacturer, the stopper 150 need not be used or capable of drawing fluid into tube 110.
    [0077] The stopper 150 may be made of any material suitable to provide a seal with the inner surface 112 of the tube 110. For example, the stopper 150 may be made of thermoplastic elastomers, natural rubber, synthetic rubber or thermoplastic materials, or combinations of the same. The stopper 150 can be integrally formed or composed of separate components of the same material or of different materials together. Plunger rod 120 can be made of a material that is more rigid than stopper 150, such as polypropylene, polyethylene, and the like. Materials must be chosen to be compatible with the procedure being used.
    [0078] As shown in FIGS. 8 and 9, the stopper may include a cavity 153 at the distal end to allow a detachable stopper tip 155 to be connected thereto. The tip of the detachable stopper 155 may be connected to the stopper 150 by any suitable connection including, but not limited to, screw threads or a forced fit. The stopper 150 shown in FIGS. 8 and 9 includes screw threads 154 in cavity 153 that can cooperatively interact with the tip of the peelable stopper 155.
    [0079] As shown in FIGS. 10 and 11, the tip of the detachable stopper 155 includes a body 156 with a proximal end 157 and a distal end 158. The proximal end 157 of the tip 155 shown in the Figures includes screw threads 159 that may interact with complementary threads on the stopper 150 It will be understood by those skilled in the art that the cooperative nature of screw threads secures the tip of the detachable stopper 155 to the stopper 150 during normal use and can be overcome to release the tip of the detachable stopper 155 from the stopper 150 when necessary, as further described. below.
    [0080] The distal end 158 of the detachable stopper tip 155 may be of any suitable shape. For example, as shown in FIG. 11, the distal end 158 of tip 155 may be shaped like a tow rope with a region of smaller diameter to form a secure connection with a mating surface. As described below, in use, the larger diameter end of tip 155 passes through the VAD, or other connection and is held in place by the smaller diameter part so that, after retraction of the stopper, the screw threads of the tip are overcome , releasing the end of the stopper and leaving the end stuck in the VAD.
    [0081] In some embodiments, the distal end 158 of the tip of the detachable stopper 155 comprises a shaped tip. The profiled tip can be sized and molded to be placed inside the VAD when the piston rod is fully recessed. For example, the tip of the detachable stopper can be placed in a correspondingly molded undercut region 192 in the cap 130 which can then be left at the end of the vascular access device, thereby sealing the VAD with the combined cap 130 and with the detachable stopper tip 155. The detachable stopper tip 155 with the profiled distal end 158 is configured to complement the center passage profile 134 of the cap 130 to create a forced fit therein sufficient to retain the detachable stopper tip within of the VAD after the wash syringe assembly 100 has been removed. For example, center passage 134 may include undercut region 192 described with reference to FIG. 5.
    [0082] In one or more embodiments, the stopper 150 or a portion of the stopper (for example, the tip of the detachable stopper 155) may be detached from the stopper 150 or the piston rod 120 and may be incorporated into the VAD, or in a region suitable undercut 192 on the cap 130.
    The cap 130 of various embodiments includes a body 131 with a proximal end 132, a distal end 133, and a tip 136 that extends distally from the distal end 133. The distal end 133 and the proximal end 132 define the length of cap 130. FIGS. 4A, 4B and 5 show a distal view, a proximal view, and a cross-sectional view, respectively, of a cap 130 in accordance with one or more embodiments of the invention. After assembly is assembled, the proximal end 132 of the cap 130 is adjacent the distal end 116 of the tube 110. The cap 130 comprises a passage 134 that extends through the tip 136 and body 131 of the cap 130. The passage 134 allows for a fluid communication between the chamber 114 of the tube 110 and the device attached to the distal end 133 of the cap 130. Thus allowing a fluid within the chamber 114 to be expelled through the distal end of the tube 110 and through the cap 130 of the distal end 133 to the proximal end 132.
    [0084] The transverse shape of the cap 130 may be of any suitable shape including, but not limited to, triangular, square, pentagonal, hexagonal, heptagonal, octagonal, polygonal, symmetrical or asymmetrical. The shape of the cap 130 can provide a comfortable feel to the user and an improved grip capability to allow the user to easily attach or detach the cap from the tube 110. In some embodiments, the cap 130 is irregularly molded. As used in this specification and the appended claims, the term "irregularly shaped" means that the cross-sectional shape provides a surface or edge that is detrimental to free rotation about the cross-section. For example, a hexagon or oval shape would be considered "irregular".
    [0085] As shown in FIG. 5, the distal end of passageway 134 can be shaped to cooperatively interact with a detachable stopper tip to form a seal. This profiled area may be referred to as an undercut region 192, but it will be understood by those skilled in the art that the profile is not limited to undercut profiles. In some embodiments, the shaped central passageway of the cap 130 extends the entire length of the cap 130 to establish fluid connection between the tube 110 and the VAD, and the profile of the central passageway is undercut near the proximal end to complement the profile of the cap. an outer surface of the stopper tip or the detachable stopper tip.
    [0086] The cap 130 includes a Luer connector 135 at the distal end 133, as shown in FIGS. 4A and 5. The Luer connector 135 allows the cap 130, and any connected tube 110, to be releasably connectable to a vascular access device (VAD) or other suitable device with the Luer-style coupler connection. The Luer 135 connector shown is a Luer Lok type connector comprising screw threads. However, the Luer connector can also be a Luer-slip connector without screw threads. In some embodiments, the distal end 133 of the cap 130 includes an annular channel that releasably attaches to the VAD, and the proximal end 132 has an annular channel that releasably attaches the cap 130 to the tube 110. Either of the annular channels may includes at least one screw thread to allow the cap to be screwed onto one or more of the 110 and VAD tube. In some embodiments, the cover can fit complementary threads on the VAD or fit the VAD with a forced fit.
    [0087] Additionally, the proximal end 132 of the cap 130, as shown in FIGS. 4B and 5, is removably attached to tube 110 through a suitable connector 137. Suitable connectors 137 include, but are not limited to, Luer slip connectors and Luer Lok connectors. FIG. 4B shows the proximal end 132 of a cap 130 in some embodiments. The Luer connector 137 shown in FIG. 4B is a Luer Lok type connector that includes screw threads.
    [0088] Passage 134 can be smooth, rough, coated or uncoated. In some embodiments, the inner surface of passageway 134 is coated with an antimicrobial agent.
    [0089] In some embodiments, the cap 130 includes an annular distal end channel 231 comprising an inner wall 232 and a straight outer wall 233 that are threaded to complement the threads on the VAD or form a forced fit. The distal end annular channel 231 may extend less than the length of the cap 130. For example, the distal end annular channel 231 may extend less than about 90% of the length of the cap 130, or less than about 80% of the length of the cap 130, or less than about 70% of the length of the cap 130, or less than about 60% of the length of the cap 130, or less than about 50% of the length of the cap 130.
    [0090] In some embodiments, the cap 130 includes an annular proximal end channel 235 comprising an outer wall 236 and a straight inner wall 237 that are releasably secured to the tube 110. The proximal end annular channel 235 is extendable less than the length of the cap 130. For example, the proximal end annular channel 235 may extend less than about 90% of the length of the cap 130, or less than about 80% of the length of the cap 130, or less than about 70% of the length of the cap 130, or less than about 60% of the length of the cap 130, or less than about 50% of the length of the cap 130. The proximal end annular channel 235 may be connected to the tube by one or more of the threaded connections or a forced fit.
    In some embodiments, the flush syringe 100 includes a gasket 160 and a disinfectant system 170. As shown in FIGS. 1 and 6 to 7, gasket 160 is coaxial and external to tube 110 and has a proximal end 161, a distal end 162, an inner surface 163, and an outer surface 164. The gasket 160 is slidable from a distal position to a proximal position. , with respect to tube 110. The joint in some arrangements covers cap 130 prior to use of flush syringe assembly 100. As shown in FIG. 7, gasket 160 can include a cavity 166 in distal end 162 that is sized to enclose cap 130. Flush syringe assembly 100 can be packaged with gasket 160 already in place or as a separate component. The gasket can be used to disengage the disinfectant carrier 175, described below, and/or cover the cap 130 until flushing of the vascular access device connection is complete.
    [0092]The shape of gasket 160 may vary depending on device usage. For example, as shown in the figures, gasket 160 is round, like tube 110, and sized to fit around tube 110. Gasket 160 has one or more cutouts 165 that allow visibility of tube 110 and the contents therein. The joint can have any number of snips 165, including, but not limited to, one, two, three, and four snips. For example, the joint 160 shown in the Figures has two cutouts 165 on opposite sides of the joint 160. Without being bound by any specific theory of operation, the cutouts are believed to provide greater visibility of pipe contents and/or increase the flexibility of the pipe. joint to allow the joint to conform more easily to the outer surface of the pipe and/or facilitate movement of the pipe relative to the joint.
    [0093] The distal end 162 of the gasket 160, in some embodiments, has a threaded portion 169 that can be used to secure the disinfection system 170. Although the threaded portion 169 is shown, it will be appreciated by those skilled in the art that other mechanisms of Fixtures can be used, including but not limited to forced adjustments.
    [0094] In some embodiments, the inner surface 163 of the gasket 160 comprises one or more grooves 171 that mate with the corresponding edge (or edges) 138 on the outer surface of the tube 110 to facilitate tube and gasket alignment, while the plunger is lowered. In one or more embodiments, the plunger is of sufficient length in relation to the joint and tube so that when the plunger is fully lowered, after the wash solution has been pushed through the VAD, the joint will retract, thereby exposing the cover.
    [0095] In some embodiments, the gasket is external to tube 110 and has an open proximal end 161 that contains at least one flange and an open distal end that defines a recess 166 with an inner surface for containing the cap. In detailed embodiments, recess 166 is irregularly shaped to prevent rotation of the cap relative to the gasket. For example, recess 166 may have a hexagonal shape, matching the hexagonal molded cap.
    [0096] In one or more embodiments, the gasket 160 comprises two linear grooves 177 positioned on opposite sides (spaced about 180°) running substantially from the proximal end of the gasket towards the distal end of the gasket. Linear grooves 177 can be configured to interact with edges 138 on the outer face of tube 110.
    [0097] Referring to FIG. 1, the disinfection system 170 comprises a disinfectant in a disinfectant carrier 175 contained in a center 180. The center 180 has a proximal face 181 and a distal face 182 and is sized to fit within the cover 185. The center 180 may be made of any suitable material, including, for example, a thermoplastic material. Distal face 182 from center 180 may be substantially flat or have a countersunk section.
    The disinfectant carrier 175 may be any suitable material capable of transporting and providing a means of disinfecting the vascular access device. Disinfectant carrier 175 may be adhered to distal face 182 of center 180 by any suitable means, including, but not limited to, medical grade adhesive or tape. In one or more embodiments, the disinfectant carrier 175 is sized to fit into a recess in the distal face 182 of the center 180 and can be secured there by either an adhesive or a forced fit.
    [0099] The disinfectant can be any suitable composition capable of cleaning the connection with the vascular access device. In one or more embodiments, disinfectant carrier 175 is saturated, or moistened, with a solution comprising the disinfectant. In some embodiments, the disinfectant comprises one or more disinfectant materials, such as alcohol or antiseptic gels. Disinfectant carrier 175 of some embodiments includes sufficient disinfectant to disinfect the VAD port of entry.
    [0100] In some embodiments, the disinfection system 170 further comprises a removable cover 185. The removable cover 185 is capable of protecting the disinfectant system before use, including the disinfectant carrier 175. The removable cover 185 can be connected to the center 180 with gasket 160 by one or more of a forced fit or by mating complementary threads.
    [0101] The disinfection system 170 can be mounted to the distal end of the flush syringe assembly 100 in a number of configurations. In one or more embodiments, the disinfection system 170 is arranged such that the disinfectant carrier 175 is fitted into a recess in the distal face 182 of the center 180. The proximal face 181 of the center 180 is positioned adjacent the distal end 133 of the cap 130 and is held in place by engagement with the inner surface of the distal end 162 of gasket 160 by complementary screw threads or by a forced fit. Cover 185 is positioned over disinfectant carrier 175 and center 180 and is secured to distal end 162 of gasket 160 by one or more of the screw threads or complementary threads or forced fit. In one or more embodiments, the disinfection system 170 is secured to the distal end 162 of the gasket 160 through a forced fit (or a forced fit). In some embodiments, the disinfectant system 170 is secured to the distal end 162 of the glove 160 by engaging the complementary threads.
    [0102] In one or more embodiments, the outer surface 113 of tube 110 includes at least one annular edge 167, as shown in FIGS. 1 and 2. The annular edge 167 is sized to provide an obstacle to the spontaneous movement of the joint 160 relative to the tube 110. The sentence may be provided, for example, by a forced fit or cooperative interaction between a complementary feature on the inner surface 163 of gasket 160. In some embodiments, outer surface 113 of tube 110 includes at least two annular edges 167, 168, as shown in Figures 1 through 8. Referring to FIG. 1, the annular positioning edges comprise a distal annular positioning edge 167 and a proximal annular positioning edge 168. Also shown in FIG. 1, the gasket 160 includes at least one annular positioning groove 171. The at least one annular positioning groove 171 is sized and positioned to help control the position of the gasket 160 with respect to the tube 110, engaging it with at least one annular positioning edge 167, 168 on the outer surface 113 of tube 110.
    [0103] In some embodiments, gasket 160 further comprises at least one wing 173 adjacent to the proximal end 161 of gasket 160. At least one wing 173 provides a user-adherable region to aid movement of gasket 160 relative to the tube 110.
    [0104] In some embodiments, the flush syringe assembly 100 further comprises a gasket 190. The gasket 190 can be sized to fit around the distal portion, including the tip 119 of the tube 110, between the cap 130 and the distal wall 117 of tube 110. Gasket 190 can be made of any suitable material, including, but not limited to, resilient rubber or plastic. Gasket 190 helps form a seal between tube 110 and gasket 160, and may have an outer diameter substantially equal to the outer diameter of tube 110 at the annular positioning edges 167, 168. In some embodiments, there is a forced fit between the tube 110 and gasket 160 without the need for a gasket 190.
    [0105] The operation of a syringe assembly, in accordance with one or more embodiments of the invention, is now described in relation to FIGS. 12 to 32. FIGS. 12 to 13 show an embodiment of the flush syringe assembly 100 in an initial state. Plunger rod 120 is positioned such that stopper 150 is adjacent to proximal end 115 of tube 110. In this position, chamber 114 has a maximum effective volume and can be filled with a drug or empty. It will be apparent to those skilled in the art that the flush syringe assembly 100 can be operated in an opposite manner whereby, in the initial state, the plunger rod 120 is positioned in the most distal position so that cavity volume is minimized. Additionally, the plunger rod 120 can be initially positioned at any point between the most proximal position and the most distal position, allowing for various uses and volumes of pre-filled medications.
    [0106] In the initial state, the disinfectant system 170 is connected to the distal end 162 of the joint 160 so that the center 180 is connected to the joint with the disinfectant carrier 175 and is positioned distally from the center 180, and so that the cover 185 cover both the center 180 and the disinfectant carrier 175. Although other types of connections may be used, the modality shown in the figures has the disinfection system 170 connected to the joint 160 by the cooperative interaction of screw threads on the outside of the joint 160 and on the center inner surface 180.
    [0107] As shown in FIGS. 14 and 15, removal of cover 185 exposes disinfectant carrier 175 for use. The center 180 and the distal face 182 of the center 180 can be seen as projecting slightly from the distal end 162 of the gasket 160. With the disinfectant carrier 175 exposed, as shown in FIGS. 16 and 17, the user can clean the connection with the vascular access device 199 by contacting the disinfectant carrier 175 with the VAD 199.
    [0108] Referring to FIGS. 18 and 19, after cleaning the vascular access device 199, the user applies proximally directed force on the joint 160 relative to the tube 110. The proximally directed force can be applied to the joint 160 with the help of the wing 173 over the joint 160 This proximally directed force causes the gasket 160 to slide proximally to the tube 110 so that the gasket slides from the distal position where the distal positioning edge 167 is located to a proximal position where the proximal positioning edge 168 is located. The proximal movement of the gasket 160 relative to the tube 110 is equivalent to the distal movement of the tube 110 relative to the gasket 160. The distal movement of the tube 110 relative to the gasket causes the tip 136 of the cap 130 to be pressed against the proximal face. 181 of center 180, forcing center 180 to become disengaged from distal end 162 of gasket 160. In the embodiment shown, center 180 is connected to distal end 162 of gasket 160, a forced fit so that pressure is directed distally over the center. 180 can cause the center 180 to be pushed out of the joint 160 without requiring a twisting motion. FIG. 19 shows a flush syringe assembly 100 after cleaning the vascular access device 199, and disengaging from the center 180. The distal end of the cap 130 can be seen extending from the distal end 162 of the gasket 160. FIG. . 20 shows the proximal end of the tube and the gasket with gasket 160 in the proximal position against latches 188 on the outer surface of the tube. Latches 188 provide additional interference to prevent the joint from moving too far along the length of the tube, thereby becoming disengaged from the tube.
    [0109] After the disinfection system 170 has been removed from the distal end of the syringe assembly, the vascular access device 199, which is now clean, can be attached to the distal end 133 of the cap 130. FIGS. 21-23 show the flush syringe assembly after removing the disinfection system 170 and attaching the VAD 199 to the cap 130. In FIG. 24, stopper 150 and plunger rod 120 are shown at an intermediate point along tube 110. This is representative of the flush syringe assembly in which part of the drug or solution within chamber 114 has been expelled through cap 130 into of the vascular access device 199.
    [0110] FIGS. 25 and 26 show plunger rod 120 and stopper 150 in the most distal position. Here, the distal end of the tip of the peelable stopper 155 has been forced into the undercut region 192 of the cap 130. FIGS. 27 and 28 show gasket 160 after proximal movement to expose the distal end cap of the gasket. FIG. 29 shows the proximal end of gasket 160, tube 110 and plunger rod 120 after proximal movement to expose cap 130.
    [0111] After the flush syringe is used, and the tip of the detachable stopper 155 has been forced into the undercut region 192 of the cap 130, 130 and the stopper tip 155 can be detached from the distal end of the tube 110 and left attached to vascular access device 199 as shown in FIGS. 30 to 32. This is effective for capping vascular access device 199 to prevent contamination and minimize the need for future cleaning. Capping the VAD 199 also helps prevent blood backflow through the VAD 199.
    [0112] Additional embodiments of the invention are directed to methods of washing a VAD. A flush syringe assembly as described in this document is provided along with instructions regarding proper operation of the flush syringe assembly. The flush syringe set is then used in accordance with the instructions provided.
    [0113] Other embodiments of the invention are directed to methods of washing a VAD comprising providing or receiving the washing syringe assembly described in this document. A hand is used to remove the protective cover 185 from the distal end of the flush syringe assembly, thereby exposing a disinfectant carrier 175 that carries a disinfectant. One hand is used to apply disinfectant to the VAD connector. The same hand is used to eject the disinfection system 170 from the distal end of the syringe assembly. The flush syringe assembly is attached to the VAD. One hand is used to hold the flush syringe assembly and lower the plunger to flush the VAD with a flushing solution that is contained within the syringe tube (both pre-filled and unfilled pre-filled). Using the same hand, the piston rod continues to be lowered after the tube is emptied to incorporate the stopper tip into the VAD and retract the gasket to expose the cap 130. The cap, including the tip of the built-in stopper, is separated from the assembly of washing syringe. In some embodiments, the cap with the built-in stopper tip can be removed from the VAD and the process repeated with another flush syringe assembly.
    权利要求:
    Claims (21)
    [0001]
    1. A flush syringe assembly comprising: a tube (110) including a sidewall (111) having an inner surface defining a chamber (114) for retaining fluid, an outer surface, an open proximal end (115), a distal end (116) including a distal wall (117) having a passage (118) through which there is fluid communication with the chamber (114); an elongated plunger rod (120) disposed within the tube (110), the rod of the plunger (120) comprising a distal end (123) that includes a stopper (150) slidably positioned in fluid impermeable contact with the inner surface of the tube (110) to drive fluid out of the chamber (114) by movement. of the stopper (150) with respect to the tube (110), wherein the stopper (150) comprises a stopper body (151) and a detachable stopper tip (155); a cap (130) having an outer wall around a a Luer connection (135), wherein the cap (130) comprises a passage (134) for communication fluid therethrough, wherein the passage (134) is cut from below to receive and retain the tip of the stopper (155) when the plunger rod (120) is fully recessed, the cap (130) further comprises a distal end for securing releasably the cap to a vascular access device (VAD) and a proximal end for releasably attaching the cap to the tube; characterized in that the flush syringe assembly further comprises a gasket (160) external to the tube (110 ) having a distal end (162) and a proximal end (161), and an inner surface (163) and an outer surface (164), wherein the gasket (160) slides from the distal to the proximal position with respect to the tube ( 110); and a disinfection system (170) comprising a disinfectant contained in a center (180), wherein the disinfection system (170) is released upon proximal movement of the gasket (160).
    [0002]
    2. Washing syringe assembly according to claim 1, characterized in that the cap (130) is threaded to fit the complementary threads on the VAD.
    [0003]
    3. Washing syringe assembly according to claim 1, characterized in that the cap (130) fits the VAD with a forced fit.
    [0004]
    4. Washing syringe assembly according to claim 1, characterized in that the undercut of the passage (134) of the cap (130) creates a tight enough tight fit to retain the tip of the stopper (155) within the cap (130) after moving the plunger rod (120) away from the cap (130) after emptying the fluid from the syringe.
    [0005]
    5. Washing syringe assembly according to claim 1, characterized in that the stopper tip (155) has threads that fit with the complementary threads on the stopper body (151).
    [0006]
    6. Washing syringe assembly according to claim 1, characterized in that the stopper tip (155) is secured to the stopper body (151) using a forced fit.
    [0007]
    7. Washing syringe assembly according to claim 1, characterized in that the stopper body (151) is made of material selected from the list consisting of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials and combinations of same.
    [0008]
    8. Washing syringe set according to claim 1, characterized in that the stopper tip is made of material selected from the list consisting of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials and combinations thereof.
    [0009]
    9. Flushing syringe assembly according to claim 1, characterized in that the gasket (160) additionally comprises one or more cutouts (165) to provide visibility of the contents of the tube (110).
    [0010]
    10. Wash syringe assembly according to claim 1, characterized in that the outer surface of the tube (110) further comprises two annular positioning edges (167, 168), a distal annular positioning edge (167) and a proximal annular positioning edge (168).
    [0011]
    11. Wash syringe assembly according to claim 10, characterized in that the inner surface (163) of the gasket (160) further comprises at least one annular positioning groove (171, 172) for controlling the position of the gasket (160) with respect to the tube (110), engaging with the annular positioning edges (167, 168) on the outer surface of the tube (110).
    [0012]
    12. Wash syringe assembly according to claim 11, characterized in that the outer surface of the tube (110) comprises one or more edges (138) that extend along a length of the tube (110) and fit with a mating groove (177) on the inner surface (163) of the gasket (160).
    [0013]
    13. Washing syringe assembly according to claim 1, characterized in that the plunger (120) has sufficient length in relation to the joint (160) and the tube (110) which, when the plunger (120) is completely recessed after all the wash solution has been expelled from the syringe, the gasket (160) retracts to expose the cap (130).
    [0014]
    14. Washing syringe assembly according to claim 1, characterized in that the distal end (162) of the gasket (160) is threaded to engage the complementary threads in the disinfection system (170).
    [0015]
    15. Flushing syringe assembly according to claim 1, characterized in that the distal end (162) of the gasket (160) is fixed to the disinfection system (170) using a forced fit.
    [0016]
    16. Wash syringe assembly according to claim 1, characterized in that the disinfection system (170) additionally comprises a removable cover (185) to protect the disinfection system (170) before use and a means of disinfectant transport.
    [0017]
    17. Washing syringe set according to claim 16, characterized in that the disinfectant is made of material selected from the list consisting of alcohol, antiseptic gel and combinations thereof.
    [0018]
    18. Washing syringe assembly according to claim 1, characterized in that the passage (134) of the cap (130) is coated with an antimicrobial agent.
    [0019]
    19. A method of washing a VAD characterized in that it comprises the steps of: (a) providing a washing syringe assembly as defined in claim 1; (b) using one hand to remove the protective cover (185) from the distal end of the flush syringe assembly, thereby exposing a disinfectant contained in the distal end of the syringe assembly; (c) use of one hand to apply the disinfectant to the VAD connector; (d) use of the same hand to eject the disinfection system; (e) coupling the flush syringe assembly to the VAD; (f) use one hand to hold the flush syringe assembly and lower the plunger (120) to flush the VAD with a flushing solution which is contained in the chamber (114); (g) using the same hand to continue lowering the plunger (120) after the tube (110) is deflated to incorporate the end of the stopper (155) into the VAD and retract the gasket (160) to expose the cap (130); and (h) separating the cap (130) including the tip of the stopper (155) incorporated from the flush syringe assembly.
    [0020]
    20. Method according to claim 19, characterized in that it further comprises: (i) removing the cap (130) including the tip of the stopper (155) incorporated; and (j) repeating steps (a) to (h).
    [0021]
    21. Method of sterilizing a vascular access device (VAD) connector prior to lavage, characterized in that it comprises the steps of: a) removing a protective cover from the distal end of the lavage syringe assembly as defined in any one of claims 1 to 18 to expose a disinfectant contained in the distal end of the syringe assembly; b) applying the disinfectant to the VAD connector; and c) lowering the gasket (160) to eject the disinfectant or disinfectant transport medium and disinfectant reservoir.
    类似技术:
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    同族专利:
    公开号 | 公开日
    SG11201503916YA|2015-06-29|
    CA2892853C|2020-09-22|
    US9233208B2|2016-01-12|
    ES2634865T3|2017-09-29|
    MX2015006768A|2015-08-06|
    AU2013352394B2|2016-07-14|
    US9943676B2|2018-04-17|
    BR112015012480A2|2017-08-22|
    US20140148781A1|2014-05-29|
    EP3210639A1|2017-08-30|
    JP2015536211A|2015-12-21|
    JP6231577B2|2017-11-15|
    WO2014085396A1|2014-06-05|
    US10850085B2|2020-12-01|
    ES2806643T3|2021-02-18|
    EP2925392B1|2017-04-26|
    JP2018008143A|2018-01-18|
    MX357902B|2018-07-30|
    AU2016225827B2|2017-12-14|
    US20160101277A1|2016-04-14|
    US20210031019A1|2021-02-04|
    EP3210639B1|2020-04-29|
    CN205108595U|2016-03-30|
    AU2016225827A1|2016-09-22|
    US20160101276A1|2016-04-14|
    EP2925392A1|2015-10-07|
    JP6685266B2|2020-04-22|
    CA2892853A1|2014-06-05|
    AU2013352394A1|2015-06-04|
    US10022530B2|2018-07-17|
    US20180304064A1|2018-10-25|
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    法律状态:
    2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-07-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-08-10| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 26/11/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/689,095|US9233208B2|2012-11-29|2012-11-29|Methods and apparatus for disinfecting and reflux prevention flush syringe assembly|
    US13/689,095|2012-11-29|
    PCT/US2013/071892|WO2014085396A1|2012-11-29|2013-11-26|Methods and apparatus for disinfecting and reflux prevention flush syringe assembly|
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